HD Blog: Pharmaceutical Companies Archives

January 24, 2006

Amarin Insiders Hopeful

Some good news. The insiders and major investors in Amarin are putting more of their money into the company based on their expectations of Miraxion (LAX-101). It's not only looking promising as a helpful treatment for Huntington's Disease, it's also showing promising results as a treatment for Parkinson's Disease.

For those new to this...Miraxion is a purified form of EPA, a fish oil derivative. If you have Huntington's Disease, talk to your doctor about taking 1 gram's worth of EPA twice every day. That's roughly equivalent to the doses being used in Miraxion's Phase III trial.

Posted by Dave at 04:22 AM | Comments (0) | TrackBack

January 11, 2006

NeurotrophinCell Update

Living Cell Technologies has had their meeting with the FDA and they are indicating that it went well. They plan on initiating Phase I trials this year for NeurotrophinCell, now being referred to as NtCell, for the treatment of Huntington's Disease. See here for past postings on the promise of NtCell.

Posted by Dave at 07:00 AM | Comments (0) | TrackBack

September 28, 2005

ReNeuron Update

ReNeuron reports that it is still on track with its ReN001 stroke treatment program. They plan to apply for Phase I clinical trials next year.

ReN001 is a stem cell therapy designed to repair brains after strokes. ReN001 uses the same cells as their ReN005 treatment their developing for Huntington's Disease.

Successful trials of ReN001 would be very encouraging for those following the developments of the ReN005 Huntington's treatment.

More background in this post from last year.

Posted by Dave at 07:07 AM | Comments (0) | TrackBack

May 25, 2005

Miraxion Phase III Trial Update

Miraxion, Amarin's promising fish oil derived HD treatment, is coming...Phase III trial is set to go in the next few months. From the press release:

In addition, we have made significant progress in recent months on planning the upcoming Huntington's disease phase III trials with Miraxion and now have the requisite funding to commence them in mid 2005.

Amarin Announces Completion of $17.8 million Registered Direct Offering
LONDON, May 25 -- Amarin Corporation plc

(NASDAQSC: AMRN) today announced that it has completed its previously
announced registered direct offering with institutional and other accredited
investors, including certain directors and executive officers of Amarin, of
13.7 million American Depositary Shares for gross proceeds of $17.8 million.
The proceeds of the offering, after deducting the placement agent's fees and
estimated offering expenses, will be approximately $16.7 million. After
giving effect to Amarin's redemption of $2 million of loan notes in
connection with the purchase of shares by our chairman, Mr. Thomas Lynch, the
net proceeds will be approximately $14.7 million.
Directors and executive officers of Amarin have purchased an aggregate of
3.5 million shares in the offering, inclusive of the 1.5 million shares
issued on redemption of the loan notes, representing a total investment of
approximately $4.5 million.
Mr. Rick Stewart, Chief Executive Officer of Amarin commented, "we are
delighted to have successfully completed this $17.8 million registered direct
offering of Amarin shares. This offering, inclusive of the redemption of the
$2 million of loan notes, significantly strengthens Amarin's balance sheet.
We are now essentially debt-free. In addition, we have made significant
progress in recent months on planning the upcoming Huntington's disease phase
III trials with Miraxion and now have the requisite funding to commence them
in mid 2005."
Leerink Swann & Company served as placement agent for the transaction. A
copy of the prospectus supplement and accompanying prospectus related to the
offering may be obtained from Leerink Swann & Company at 590 Madison Avenue,
31st Floor, New York, NY 10022.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be the sale of the securities
in any state in which such offer, solicitation or sale would be unlawful
prior to registration or qualification under the securities laws of any such
state.
CORPORATE STRATEGY
Amarin's strategy is to directly commercialize its neurology pipeline in
the U.S. and to partner it for geographic markets outside the U.S. For
indications outside neurology, such as treatment unresponsive depression,
Amarin's strategy is to partner its pipeline globally. Amarin also intends to
acquire and in-license neurology products that Amarin can develop and market
directly in the U.S.
Amarin's goal is to capitalize on its strong reputation in neuroscience
and to become a leader in the development and commercialization of novel
drugs that address unmet medical needs.
About Amarin Corporation
Amarin Corporation plc is a neuroscience company focused on the
development and commercialization of novel drugs for the treatment of central
nervous system disorders. Miraxion, Amarin's lead development compound, is in
phase III development for Huntington's disease and in phase II development
for treatment unresponsive depression.
For press releases and other corporate information, visit our website at
http://www.amarincorp.com.
Statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties which may
cause the Company's actual results in future periods to be materially
different from any performance suggested herein. Such risks and uncertainties
include, without limitation, the inherent uncertainty of pharmaceutical
research, product development and commercialization, the impact of
competitive products and patents, as well as other risks and uncertainties
detailed from time to time in periodic reports. For more information, please
refer to Amarin Corporation's Annual Report for 2004 on Form 20-F and its
Form 6-Ks as filed with the U.S. Securities and Exchange Commission. The
Company assumes no obligation to update information on its expectations.

Posted by Dave at 09:53 AM | Comments (0) | TrackBack

January 12, 2005

Targeted Genetics

Now that you've read the latest great news from Sirna Therapeutics, here is some on their agreement with Targeting Genetics. Key item from Targeted Genetics press release:

The focus of the collaboration will be the development of a therapeutic short interfering RNA (siRNA) targeting the gene that encodes the Huntington’s Disease protein. The siRNA will be expressed from an AAV-vector. RNAi is a mechanism used by cells to regulate the expression of genes and replication of viruses. The RNA interference mechanism uses siRNA to induce the destruction of target RNA using naturally occurring cellular protein machinery. Sirna’s scientific advisor and collaborator, Dr. Beverly Davidson at the University of Iowa, has published data demonstrating that the delivery of siRNA using an AAV vector efficiently inhibited gene expression in an animal model of spinocerebellar ataxia 1 (SCA1), a member of a class of inherited human neurodegenerative diseases that includes Huntington's Disease (Nature Medicine 10:816-820 [2004]).
“There are no treatments for Huntington’s Disease, and we believe that vector expressed RNAi-based approaches may have significant potential in slowing or halting disease progression,” said Howard Robin, President and Chief Executive Officer at Sirna. “Dr. Davidson’s work using AAV vectors to deliver siRNA for the treatment of related neurodegenerative disorders is quite promising. Through the collaboration announced today we are gaining access to Targeted Genetics’ extensive capabilities in the development, clinical testing and manufacture of AAV-based products. We are excited to explore the potential of AAV-RNAi therapies for Huntington’s Disease, and are very pleased to be working with the leading AAV-based product development company.”

Targeted Genetics and Sirna Therapeutics Announce Huntington's Disease Collaboration

- Agreement Pairs Leaders in AAV-Based Gene Delivery and RNA Interference (RNAi) Technologies -

Date : Tuesday - January 11, 2005

SEATTLE, Jan. 11 /PRNewswire-FirstCall/ -- Targeted Genetics Corporation and Sirna Therapeutics, Inc. today announced that they have established a collaboration to develop novel therapies for the treatment of Huntington's Disease (HD), an incurable neurodegenerative disorder. The collaboration will combine Targeted Genetics' adeno-associated virus (AAV) delivery platform with Sirna's HD program and expertise in RNA silencing technologies.

"We are excited to continue expanding our AAV-based gene delivery platform into the area of RNA interference by working with Sirna, the leading company developing this innovative technology," said H. Stewart Parker, President and Chief Executive Officer of Targeted Genetics. "This collaboration is consistent with our strategy to leverage our gene delivery capabilities beyond gene replacement. Shutting down the production of disease-causing proteins by delivering expressed RNAi sequences complements the other applications of our technologies: providing a functional copy of the gene deficient in cystic fibrosis, delivering a gene encoding a therapeutic protein for rheumatoid arthritis and stimulating the immune system using a DNA-based vaccine against HIV."

The focus of the collaboration will be the development of a therapeutic short interfering RNA (siRNA) targeting the gene that encodes the Huntington's Disease protein. The siRNA will be expressed from an AAV-vector. RNAi is a mechanism used by cells to regulate the expression of genes and replication of viruses. The RNA interference mechanism uses siRNA to induce the destruction of target RNA using naturally occurring cellular protein machinery. Sirna's scientific advisor and collaborator, Dr. Beverly Davidson at the University of Iowa, has published data demonstrating that the delivery of siRNA using an AAV vector efficiently inhibited gene expression in an animal model of spinocerebellar ataxia 1 (SCA1), a member of a class of inherited human neurodegenerative diseases that includes Huntington's Disease (Nature Medicine 10:816-820 [2004]).

"There are no treatments for Huntington's Disease, and we believe that vector expressed RNAi-based approaches may have significant potential in slowing or halting disease progression," said Howard Robin, President and Chief Executive Officer at Sirna. "Dr. Davidson's work using AAV vectors to deliver siRNA for the treatment of related neurodegenerative disorders is quite promising. Through the collaboration announced today we are gaining access to Targeted Genetics' extensive capabilities in the development, clinical testing and manufacture of AAV-based products. We are excited to explore the potential of AAV-RNAi therapies for Huntington's Disease, and are very pleased to be working with the leading AAV-based product development company."

Under the terms of the agreement, development costs and revenue from partnering and sales of products developed under the collaboration will be shared between Sirna and Targeted Genetics.

About Huntington's Disease

Huntington's Disease (HD) is a devastating, degenerative brain disorder for which there is, at present, no effective treatment or cure. According to the National Institute of Neurological Disorders and Stroke, 30,000 people in the United States alone have HD, and at least another 150,000 are at risk for developing the disease. HD results from genetically programmed degeneration of neurons in certain areas of the brain. This degeneration causes uncontrolled movements, loss of intellectual faculties, and emotional disturbance.

HD typically begins in mid-life, between the ages of 30 and 45, though onset may occur as early as the age of 2. Children who develop the juvenile form of the disease rarely live to adulthood. Early symptoms of Huntington's Disease may affect cognitive ability or mobility and include depression, mood swings, forgetfulness, clumsiness, involuntary twitching and lack of co-ordination. As the disease progresses, concentration and short-term memory diminish and involuntary movements of the head, trunk and limbs increase. Walking, speaking and swallowing abilities deteriorate. Eventually the person is unable to care for him or herself. Death follows from complications such as choking, infection or heart failure.

About Targeted Genetics

Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and inflammatory arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer, and a broad platform of gene delivery technologies for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at http://www.targetedgenetics.com/.

About Sirna Therapeutics

Sirna Therapeutics is a clinical-stage biotechnology company developing RNAi-based therapies for serious diseases and conditions, including age-related macular degeneration (AMD), hepatitis, oncology, and diseases of the central nervous system. Sirna has initiated a Phase 1 clinical trial for its most advanced compound, Sirna-027, a chemically modified siRNA targeting the clinically validated vascular endothelial growth factor pathway to treat AMD. The Company has strategic partnerships with Eli Lilly and Archemix and a leading intellectual property portfolio in RNAi. More information on Sirna Therapeutics is available on the Company's web site at http://www.sirna.com/ .

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

Targeted Genetics Corporation and Sirna Therapeutics, Inc. have included in this press release certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 concerning their businesses, their collaboration, their development of an AAV-RNAi therapy for Huntington's Disease and their intellectual property, The words or phrases "can be," "expects," "may affect," "anticipates," "may depend," "believes," "estimates," "plans," "projects" and similar words and phrases are intended to identify such forward-looking statements. These forward-looking statements, involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Actual results could differ materially from expectations for a number of reasons, including failure of a partner to provide funding or other resources for the collaboration, failure to obtain positive results from preclinical programs and clinical trials, failure to obtain or maintain regulatory approvals, failure to obtain, maintain or protect our intellectual property and the other risks described in the section entitled "Factors Affecting Our Operating Results, Our Business and Our Stock Price" in Targeted Genetics' Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 and Sirna's Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change our expectations.

Targeted Genetics Corporation
CONTACT: Stephanie Seiler, Ph.D. of Targeted Genetics Corporation,
+1-206-713-0124

Web site: http://www.sirna.com/

Web site: http://www.targetedgenetics.com/

Posted by Dave at 06:26 AM | Comments (0) | TrackBack

SIRNA Takes A Big Step Forward For HD

Sirna Therapeutics has a potential treatment for Huntington's Disease that could end up being the effective treatment/cure we've been waiting for. They're doing everything we can hope for...

First they signed an agreement with the University of Iowa to collaborate with them on developing an HD RNAi treatment. As you might recall, they've had huge success on this.

Next they announce they are collaborating with HDSA and their "clinical investigators" (I assume they refer to the Centers of Excellence.)

Now Sirna has signed an agreement with Targeted Genetics Corporation to use their adeno-associated virus (AAV) delivery platform to deliver the RNAi treatment to the brain cells.

So in less than a year...Sirna has announced successes in RNAI, licenced the most promising treatment, made an agreement with the organization that has the resources to help do the clinical testing, is going to use the most promising delivery vehicle, and...they've already started human trials of an RNAi therapy for Macular Degeneration.

All indications are that Sirna is working aggressively to start human testing as soon as possible. Here's their press release on the latest agreement:

Sirna Therapeutics and Targeted Genetics Form Huntington's Disease Collaboration
- Agreement Pairs Leaders in RNA Interference (RNAi) and AAV-Based Delivery Technologies

BOULDER, Colo. and SEATTLE, Jan. 11 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (Nasdaq: RNAI) and Targeted Genetics Corporation (Nasdaq: TGEN) today announced that they have established a collaboration to develop a novel therapy for the treatment of Huntington's Disease (HD), an incurable neurodegenerative disorder. The collaboration significantly advances Sirna's HD program by using Targeted Genetics' adeno-associated virus (AAV) delivery platform to develop an HD product.

Under the terms of the agreement, development costs and revenue from partnering and sales of products developed under the collaboration will be shared between Sirna and Targeted Genetics.

About Huntington's Disease

About Sirna Therapeutics

Contact:
Martin E. Schmieg, Sr. Vice President & CFO of Sirna Therapeutics, Inc.,
+1.303.449.6500

About Targeted Genetics
Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and inflammatory arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer, and a broad platform of gene delivery technologies for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at www.targetedgenetics.com.

Contact:
Stephanie Seiler, Ph.D.
206-713-0124

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

Targeted Genetics Corporation and Sirna Therapeutics, Inc. have included in this press release certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 concerning their businesses, their collaboration, their development of an AAV-RNAi therapy for Huntington's Disease and their intellectual property. The words or phrases "can be," "expects," "may affect," "anticipates," "may depend," "believes," "estimates," "plans," "projects" and similar words and phrases are intended to identify such forward-looking statements. These forward-looking statements involve current expectations, forecasts of future events and other statements that are not historical facts. Inaccurate assumptions and known and unknown risks and uncertainties can affect the accuracy of forward-looking statements. Actual results could differ materially from expectations for a number of reasons, including failure of a partner to provide funding or other resources for the collaboration, failure to obtain positive results from preclinical programs and clinical trials, failure to obtain or maintain regulatory approvals, failure to obtain, maintain or protect our intellectual property and the other risks described in the section entitled "Factors Affecting Our Operating Results, Our Business and Our Stock Price" in Targeted Genetics' Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 and Sirna's Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. You should not rely unduly on these forward-looking statements, which apply only as of the date of this release. We undertake no duty to publicly announce or report revisions to these statements as new information becomes available that may change our expectations.

Posted by Dave at 05:57 AM | Comments (1) | TrackBack

January 07, 2005

SIRNA Branching Out

SIRNA is working one of the most promising treatments for Huntington's Disease utilizing RNAi.

The technology must be promising, they are branching out and are now working to apply RNAi to the treatment of Asthma. You can read the press release here.

Posted by Dave at 05:31 AM | Comments (0) | TrackBack

Stem Cell Therapeutics

Stem Cell Therapeutics Corp. just raised $8.5 million to help develop a product that assists the brain in generating its own stem cells.

I hope they succeed, but they are going to need a lot more funding - research is expensive. Their press release:

Stem Cell Therapeutics announces closing of initial public offering

/THIS RELEASE IS INTENDED FOR DISTRIBUTION IN CANADA ONLY AND IS NOT TO
BE DISTRIBUTED TO UNITED STATES NEWSWIRE SERVICES OR DISSEMINATED IN THE
UNITED STATES/

CALGARY, Jan. 6 /CNW/ - Stem Cell Therapeutics Corp. ("Stem Cell") is
pleased to announce that it has successfully completed its initial public
offering consisting of the maximum offering of 34,000,000 common shares at a
price of $0.25 per share, for gross proceeds of $8,500,000. Subsequent to the
closing, Stem Cell has 52,986,364 (63,711,364 on a diluted basis) common
shares outstanding. Dlouhy Merchant Group Inc. and First Associates
Investments Inc. co-led the financing.
Stem Cell received cash proceeds (net of agents' commissions and
expenses) of $7.64 million from the offering and intends to use these funds
for the research and development of new products, general and administrative
expenses including working capital, and possible acquisitions of additional
technology.

About Stem Cell Therapeutics Corp.: Calgary-based Stem Cell Therapeutics
Corp. is a biotechnology company focused on the development of our technology
platform and intellectual property to selectively induce a patient's own stem
cells to proliferate in the brain. Our core technology, which includes our
lead therapeutic product NTx(TM)-265, has been demonstrated to increase the
number of innate adult stem cells that grow in place when our therapeutic
approach is applied to test animals. This fundamental technology will be
further developed to create specific disease treatments for stroke,
Huntington's disease, Alzheimer's disease and other neurodegenerative
conditions.
Stem Cell's shares will be listed on the TSX Venture Exchange, under the
symbol "SSS".

The TSX Venture Exchange does not accept responsibility for the adequacy
or accuracy of this release.

These securities have not been registered under the United States
Securities Act of 1933, as amended, or the securities laws of any state, and
may not be offered or sold within the United States or to, or for the account
or benefit of U.S. persons unless an applicable exemption from U.S.
registration requirements is available.

Except for historical information, this press release may contain
forward-looking statements, which reflect the Company's current expectation
regarding future events. These forward-looking statements involve risk and
uncertainties, which may cause but are not limited to, changing market
conditions, the successful and timely completion of clinical studies, the
establishment of corporate alliances, the impact of competitive products and
pricing, new product development, uncertainties related to the regulatory
approval process and other risks detailed from time to time in the Company's
ongoing quarterly and annual reporting.

For further information: on Stem Cell Therapeutics Corp., visit
www.stemcellthera.com; or contact Dr. Joseph Tucker, Chief Executive Officer,
Stem Cell Therapeutics Corp., Phone : (403) 245-5495,
info@stemcellthera.com

Posted by Dave at 05:23 AM | Comments (0) | TrackBack

December 31, 2004

I Hate To Say This...

But if I was a financial counselor, I could not recommend investing in pharmaceutical companies this year.

Why? Well, they are now in the culteral cross-hairs with several groups targeting them. This will mean depressed stock prices, but more importantly - investors will gamble less of their money into pharmaceuticals. This means less research and more small drug companies unable to raise the money needed to stay alive.

So who is targeting the pharmaceutical industry?

Some on the FDA staff & anti-pharmaceutical groups - You may have seen the testimony last month, a FDA staffer appeared before a congressional committee arguing that several drugs should be pulled from the market due to side effects. What you may not have seen was others, testifying before the same committee, disagreeing strongly with that staffer. What's the big deal you say? After all, we all want safe drugs! The big deal is that they arguing for more long-term testing and slowing the rate that it takes (now 5-10 years) for a new drug to come to market. Ours is just one community that would see more deaths due to these delays.

Lawyers - Many prominent law firms are sharpening their knives at the prospect of suing pharmaceutical companies. Ultimately this will cost the industry billions. Some of the law firms are funding groups that are mentioned in the last paragraph. This generates positive articles in the press and more sympathetic juries.

Michael Moore - It seems each movie he releases is more popular than his previous one. He has a strong fan base. He is also a master at generating publicity and his latest target appears to be the pharmaceutical industry. There are reports that he is now doing his on-camera ambushes at various pharmaceutical companies.

I didn't see his last film, "Fahrenheit 9/11" though I know it has its fans & critics, but let me tell you about one that hit close to home - "Bowling for Columbine". I live near Columbine High School and I saw his distortions. I would even call them lies. Some examples that I can confirm from local coverage: The killers didn't go bowling, the Lockheed plant makes rockets for satellites not WMD's, he lied about the plaque & the plane, and many who appeared in the film state they were deceived by him.

Having seen his work first hand, my belief is his pharmaceutical movie will be filled in a similar, misleading way. That can't be good for the industry.

Am I overly concerned? Maybe, but I don't think so. Pharmaceutical stocks dropped 10% in 2004 while the S&P 500 rose 9%.

Posted by Dave at 05:39 AM | Comments (0) | TrackBack

November 19, 2004

The Pharmaceutical Industry

A regular reader here posted some excellent questions in response to the Tapestry article. One's that touch on a common question:

Will 'xyz' company go out of business before their Huntington's Disease treatment becomes available?

Answer: Maybe.

Here's what gets lost in the 'health care debate'...

Most pharmaceutical companies are not raking in the money. Sure, some of the biggest pharmaceutical companies make a pretty nice profit (for now) but there are a slew of young pharmaceutical companies with virtually no income and spending several million dollars a month.

These small companies start with 'seed capital' being put up by investors willing to gamble on a long shot. And it's little more than gambling at this point. The company then takes this seed capital and starts R&D on their chosen targets. From then on, and for the next several years, the young pharmaceutical company is working to show enough promise and results that more investors will provide them funding. If a key element of their research turns out to be a 'dud' then the company will not be able to raise new money and they go bankrupt. Anything of value will be liquidated to pay debtors.

So it's the norm and not the exception for companies like Tapestry & Amarin to have to constantly improvise in order to stay in business. And why would anyone want to invest in such a risky venture? Because of the lure of the big payoff. On average, pharmaceutical companies have to spend $800 million to get a drug successfully on the market.

And this is why the threat of price controls on drugs are so dangerous to our community. If there is no potential for a big payoff/large return then investors will deposit their money in safer places which offer same/better returns on their investment.

As for Tapestry, time will tell. They are now at a point where they have to focus on the research that is most likely to be successful and will generate positive cash flow the soonest. They're now focusing in on their cancer & Huntington's products. That's a good sign. If their research continues to be promising they WILL be able to raise additional funding when they need it.

As for timing, Tapestry's HD product hasn't made it to human testing yet. So, if the product 'works', it would still be 6-9 years before it became available.

Posted by Dave at 04:32 AM | Comments (0) | TrackBack

November 17, 2004

Tapestry Hits Hard Times

Pharmaceutical research is a high-risk business. The only thing that keeps the big money in it is the hope of a big financial payoff. Far too often pharmaceutical companies run out of money before they are able to bring a profitable treatment to market.

Tapestry Pharmaceuticals is the latest to hit hard times. It's winding down its research in gene editing techniques, Sickle Cell, & diagnostics to focus on their HD & cancer products.

Here's what to take away from this announcement...they are going to continue working on their Huntington's Disease treatment. Tapestry is betting the future of the company on their Huntinton's Disease treatment just as Amarin has with Miraxion.

Folks, treatments are (slowly) becoming a reality. Even cash-strapped pharmaceuticals agree!

Oh..their HD product greatly extended the life of cells in early testing.

Tapestry Pharmaceuticals Announces Plan to Discontinue Gene Editing Operations
Wednesday November 17, 12:00 pm ET
Company to Focus on Lead Oncology Compounds

BOULDER, Colo., Nov. 17 - Tapestry Pharmaceuticals, Inc. announced today that it will discontinue development of its gene editing technologies, including programs in Sickle Cell disease and diagnostics. Tapestry will continue development of its Huntington's disease program, but will wind down all other activities of its Genomics Division by January 31, 2005.
Tapestry has engaged Rodman & Renshaw as its financial advisor to assist in the sale or licensing of the assets of its Genomics Division.

"Although we believe our gene editing technology has considerable long- term value, this current restructuring now focuses the majority of our assets on the development of our nearer-term oncology clinical drug candidate portfolio," commented Leonard P. Shaykin, Chairman and CEO. "We anticipate filing Investigational New Drug applications for TPI 287, our third generation taxane, and TPI 273, our novel quassinoid, before the end of this year, and thereafter, we plan to enter into Phase I clinical trials for these compounds."

Tapestry expects annualized savings from this restructuring of about $4 million per year, including personnel, facility and other research and operating costs. As part of the restructuring, Tapestry will close its facility in Newark, Delaware and terminate the employment of about 20 people, or approximately 25% of the Company's current workforce. After the restructuring of the Genomics Division, operations other than the Huntington's program, will be accounted for as discontinued operations.

The assets related to the discontinued operations, available for sale, include contracts, patents and other intellectual property of the Genomics Division as well as research equipment and other physical assets. The assets related to the Huntington's disease program will be maintained, if any.

Neither the timing nor the terms of a sale of any of the assets of the Genomics Division are certain at this time, and the Company can give no assurance that any sale or other transaction will occur. Tapestry, therefore, does not intend to comment further on the status of the sales effort prior to signing and announcing any definitive sales or licensing agreement for any or all of these assets.

Tapestry Oncology Drug Development Programs

* TPI 287: Third generation taxane. TPI 287, a proprietary taxane, is
designed to overcome acquired resistance to taxane-based therapies by
circumventing MDR-1, a pathway associated with taxane-resistance.
Preclinical studies have demonstrated that this compound is
substantially more potent than paclitaxel in paclitaxel-resistant
tumors and is as potent, or more potent, than paclitaxel in
treatment-naive tumors.

* TPI 273: Proprietary quassinoid. TPI 273, a proprietary quassinoid,
is a semi-synthetic analog of a naturally occurring molecule that
induces cancer cell death in a variety of tumors including those that
have elevated myc protein.

About Tapestry Pharmaceuticals, Inc.

Tapestry Pharmaceuticals, Inc. is a company focused on the development of proprietary therapies for the treatment of cancer and Huntington's disease.

Forward Looking Statements

The statements in this press release that are not historical facts are forward-looking statements that represent management's assumptions and beliefs as of the date of this release, based on currently available information. Forward-looking statements can be identified by the use of words such as "believes," "intends," "estimates," "may," "will," "should," "anticipates," "expected" or comparable terminology or by discussions of strategy, and include statements as to the long-term value of the Company's gene editing technology, the prospects for sale of the assets of the genomics division, the filing of INDs on two of the Company's cancer compounds and their entry into clinical trials, the expected savings from the restructuring and the amount of restructuring charges and their breakdown. Such statements involves risks and uncertainties including whether others view our gene editing technology as having value given its early stage of development and other factors; that the assets of the genomics division have sufficient perceived worth to attract potential buyers; whether the results of pre-clinical research of the Company's cancer compounds demonstrate sufficient efficacy and do not demonstrate safety concerns; that the FDA does not require the submission of additional information before permitting Phase I clinical trials to commence; the incurrence of costs in addition to those projected for the termination of employees, exiting facilities and disposing of assets; that additional costs incurred after the restructuring result in less savings; as well as other factors identified under the captions "Risk Factors", "Special Note Regarding Forward-Looking Statements" or "Cautionary Note Regarding Forward-Looking Statements" in the Company's documents filed from time to time with the SEC, including the Company's Current Report on Form 8-K/A, dated February 11, 2004, Annual Report on Form 10-K/A for the year ended December 31, 2003 filed with the Securities and Exchange Commission on May 5, 2004, and Quarterly Report on Form 10-Q for the quarter ended September 29, 2004. Should one or more of these risks materialize (or the consequences of such a development worsen), or should the underlying assumptions prove incorrect, actual results could differ materially from those forecasted or expected. The Company disclaims any intention or obligation to update publicly or revise such statements whether as a result of new or additional information, future events or otherwise.

For further information, please contact L. Robert Cohen, Vice President, Investor Relations of Tapestry Pharmaceuticals, Inc. at 212 218 8715.

Posted by Dave at 11:19 PM | Comments (1) | TrackBack

November 02, 2004

Fast-Growing Market for RNAi

A press-release from a market research firm:

Fast-Growing Market for RNAi Products Shows No Signs of Slowing

ARLINGTON, Va., - The promise of RNA interference (RNAi) therapeutics to combat human illnesses such as Huntington's disease, Lou Gehrig's disease and hepatitis C has vastly increased scientific interest in the field. In fact, according to a recent survey, 65% of RNAi researchers only began using these techniques in the past 12 months. Increased activity by these current practitioners as well as an influx of new users will fuel rapid growth in the market for RNAi research products over the next year.

These findings were recently published by BioInformatics, LLC (http://www.gene2drug.com) in the report, "The Market for RNA Interference Products: Challenges and Opportunities," which is designed to help life science suppliers understand and respond to the needs of scientists using RNAi technology. Based on a 35-question survey of over 500 scientists who currently use small interfering RNA (siRNA), the report details RNAi experimental design with a special focus on customers' experiences with pre- designed, validated or library siRNA duplexes, chemically synthesized custom siRNAs and transfection reagents. Additionally, another 360 scientists who plan to use siRNA within the next year help shed light on the future direction of the market.

"By better understanding the preferences, needs and expectations of researchers, RNAi product suppliers can make refinements to existing tools as well as design new tools that support this technology," said Bill Kelly, President of BioInformatics, LLC.

This fast-growing market offers numerous opportunities for life science suppliers and has engendered interesting dynamics among competitors. According to the scientists surveyed, Ambion, Dharmacon (a subsidiary of Fisher Scientific International), Invitrogen (Nasdaq: IVGN) and Qiagen (Nasdaq: QGENF) dominate the market for RNAi products, however, their positions vary across market segments and geographic regions. For instance, while Ambion, Invitrogen and Qiagen are used equally in academia and industry, Dharmacon was cited as a supplier far more frequently by industrial researchers than by academic researchers. Results also indicate that Invitrogen has a consistent share of the market worldwide, while Ambion and Dharmacon are more frequently used in North America than other regions and Qiagen has a stronger market presence in Europe.

Market leaders also vary by specific product categories with some competitors specializing in one type of product, while others compete by offering a full line of RNAi products. For example, Dharmacon is the leading supplier of both pre-designed, validated or library siRNA duplexes as well as chemically synthesized custom siRNA duplexes, but the company has not established itself as a supplier of transfection reagents. On the other hand, Invitrogen is the top supplier of transfection reagents and has also become a major supplier of siRNA products following last year's acquisition of Sequitur and the Stealth(TM) RNAi technology.

To understand the factors that influence scientists to choose one supplier over another, the report analyzes the relationship between the importance, expectation and performance of various supplier attributes. Several attributes such as quality control and technical service/support for scientific questions were found to be important to scientists, however, suppliers aren't meeting their customers' expectations -- indicating key areas where suppliers need to focus. The report also evaluates the performance of leading suppliers with regards to less tangible, but critically important, elements of customer value such as customer loyalty and retention -- finding that some companies stand out above, and others below, the overall market average. "Our use of attitudinal and behavioral measurements in this survey provides management with a powerful tool to segment customers by their degree of loyalty, evaluate the effectiveness of initiatives to meet customer expectations and predict future corporate performance," said Kelly.

For a complimentary Executive Summary of this report, please visit: http://gene2drug.com/report/81/

ABOUT BIOINFORMATICS, LLC
BioInformatics, LLC is a market research firm located in Arlington, Virginia. BioInformatics supports marketing, sales and R&D executives in the life science, medical device and pharmaceutical industries through published research reports, custom research and consulting. BioInformatics sponsors the world's largest market research panel of scientific customers -- The Science Advisory Board (http://www.scienceboard.net) -- which consists of more than 22,000 scientists, physicians and other life science and medical professionals from 62 countries who participate in surveys that address emerging technologies, test customer reactions to new product concepts, measure brand awareness and assess advertising effectiveness.

For more information, please contact:

Alyssa Martin BioInformatics, LLC
2111 Wilson Blvd., Suite 250
Arlington, VA 22201
703.778.3080 x12 (phone) 703.778.3081 (fax)
a.martin@gene2drug.com

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October 21, 2004

Prestwick CEO Honored

As mentioned earlier this week, Dr. Christopher O'Brien has given the Guthrie Family Humanitarian Award by HDSA.

Here's the press release from Prestwick Pharmaceuticals:

Christopher O'Brien, MD, Honored with Guthrie Family Humanitarian Award
HDSA Gala Recognizes Leadership in Research and Community Service

WASHINGTON - Oct. 21, 2004 - Prestwick Pharmaceuticals, Inc., a CNS specialty pharmaceutical company, announced today that Christopher O'Brien, MD, the company's Chief Medical Officer, has been selected by the Huntington's Disease Society of America (HDSA) to receive the Guthrie Family Humanitarian Award for compassion and dedication to the care and support of people with Huntington's Disease (HD) and their families. Being held this evening at the Waldorf Astoria in New York City, the Annual Guthrie Awards Dinner pays tribute to the memories of legendary folk singer Woody Guthrie and his wife, Marjorie, principal founder of the national drive to cure HD.

A leader in neurological clinical research for the past 15 years, Dr. O'Brien joined Prestwick Pharmaceuticals in December 2003. He maintains his role as a neurologist in the HDSA Center of Excellence for Huntington's Disease clinic at the University of California San Diego where he is a member of the voluntary faculty.

"Dr. Chris O'Brien has played a pivotal role in the care and cure of Huntington's Disease. He was chosen to receive the Guthrie Family Humanitarian Award by both the Guthrie Family and HDSA because of his dedication and commitment to helping people with HD and their loved ones. He is an inspiration to all healthcare professionals and is deserving of this recognition," stated Barbara Boyle, HDSA National Executive Director/CEO.

"It's an honor to be selected for this prestigious award," said Christopher O'Brien, MD. "The HDSA has been leading the search for a cure for nearly four decades, and it is because of their work that HD has gone from being a virtually unknown disorder to one that is widely recognized as a priority for research and funding. I am proud to be part of their team."

Dr. O'Brien has served as investigator or director for more than 100 clinical trials and has authored more than 75 publications in the neuroscience literature. He is Fellow of the American Academy of Neurology and has served on the boards of various national foundations supporting Huntington's Disease, Parkinson's Disease, Dystonia and Tourette's Syndrome. Dr. O'Brien received his MD from the University of Minnesota, his neurology training at Minnesota and fellowship training in movement disorders and neuropharmacology at the University of Rochester.

HDSA

HDSA is a national, non-profit health organization dedicated to finding a cure for Huntington's Disease while providing support and services for those living with HD and their families. Founded in 1967 by Marjorie Guthrie, HDSA promotes and supports both basic and clinical HD research, aids families throughout the continuum of HD and educates families, the public and healthcare professionals about this devastating disease.

Huntington's Disease is an inherited, progressively degenerative brain disorder that results in a loss of both mental faculties and physical control. Symptoms usually appear in an individual between 30-50 years of age and progress over a 10-25 year period. HD affects the individual's ability to think, speak and walk. Presently, there is no effective treatment or cure. For more information about HD and HDSA please visit the national web site at www.hdsa.org or call (800) 345-HDSA.

Prestwick Pharmaceuticals

Prestwick recently announced positive Phase III results of the investigational drug tetrabenazine for chorea associated with Huntington's Disease. The company anticipates filing a New Drug Application (NDA) for tetrabenazine with the U.S. Food and Drug Administration (FDA) in the near future. Prestwick was granted fast track and orphan drug status by the FDA. Tetrabenazine is available in some European markets and Australia as XENAZINE(TM) and in Canada as NITOMAN(R) for the treatment of hyperkinetic movement disorders. For more information, visit http://www.prestwickpharma.com.

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October 20, 2004

Woo Hoo - HDSA & Sirna Pursue RNAi

Sirna Therapeutics has announced that it is going to start development of a RNAi treatment for Huntington's Disease. In a few months they'll select the compounds to use in preclinical trials.

They also announced that they are collaborating with HDSA and their 'network of clinical investigators'.

Though expected, this is great news. I'm very excited about the future of this treatment. It will take several years before it is fully developed and receives FDA approval, but I believe this one will become the effective treatment/'cure' that we've been waiting for.

(It's entirely foolish make statements like this about any treatment that isn't even in preclinical trials as normally only a tiny percentage of treatments will ultimately make it to FDA approval. Yet, I stand by my opinion on this one. The science is solid and impressive.)

Here's the press release:

Sirna Therapeutics Announces RNAi Therapeutic Development Program to Address Huntington's Disease
Sirna Partners With Huntington's Disease Society of America
Studies Ongoing With Collaborators at University of Iowa to Assess RNAi-Based Compounds for Neurodegeneration

BOULDER, Colo., Oct. 20 /PRNewswire-FirstCall/ -- Sirna Therapeutics, Inc. (Nasdaq: RNAI) today announced that the Company is moving forward with the development of an RNA interference (RNAI)-based treatment for Huntington's Disease. Huntington's Disease (HD) is a devastating, degenerative brain disorder for which there is, at present, no effective treatment or cure. HD affects more than 30,000 people in the United States, with another 200,000 at risk of inheriting the deadly gene. Early in 2005, Sirna expects to select investigational compounds for preclinical development based on the groundbreaking work of the Company's research collaborator, Dr. Beverly Davidson at the University of Iowa. Sirna also announced today its collaboration with the Huntington's Disease Society of America (HDSA) and is looking forward to working with the Society's network of clinical investigators.

Howard Robin, Sirna's President and Chief Executive Officer, commented, "We are extremely proud of our new relationship with the Huntington's Disease Society of America. The Society's efforts have been instrumentcl in bringing hope to patients and their families affected by this devastating disease. Sirna's researchers and scientists are dedicated to suppressing the expression of the gene that causes Huntington's Disease."

Dr. Roberto Guerciolini, Senior Vice President of Development and Chief Medical Officer at Sirna Therapeutics, commented, "For many neurodegenerative diseases, including Huntington's Disease, treatments are either non-existent or can do little to stop or reverse the progression of the disease. Together with our collaborator, Dr. Beverly Davidson, Sirna is leading the effort to develop an effective treatment for Huntington's Disease."

Sirna's collaborator, Dr. Beverly Davidson, recently demonstrated that a short interfering RNA (siRNA) efficiently inhibited gene expression in an animal model of a disease mimicking spinocerebellar ataxia 1 (SCA1), a member of a class of inherited human neurodegenerative diseases that includes Huntington's Disease. The study appeared in the August issue of Nature Medicine (Volume 10, pp 816, August 2004). The Company has exclusively licensed key patents from the University of Iowa Research Foundation for the use of RNAi technology in the field of neurological diseases, including those relating to SCA1, Huntington's, Parkinson's and Alzheimer's Diseases. These patents complement Sirna's intellectual property in Huntington's Disease and further strengthen the Company's broad intellectual property portfolio covering the seminal RNAi technology, chemical modifications, therapeutic targets, delivery and manufacturing of siRNAs.

About RNA Interference

Sirna Therapeutics is using its proprietary technology and expertise in nucleic acids to develop a new class of nucleic acid-based therapeutics involving RNA interference. RNAi is a mechanism used by cells to regulate the expression of genes and replication of viruses. The RNA interference mechanism uses short interfering RNA (siRNA) to induce the destruction of target RNA using naturally occurring cellular protein machinery. Harnessing the natural phenomenon of RNAi holds potential for the development of a new class of drugs with specificity towards a wide range of diseases that result from undesirable protein production or viral replication.

About the Huntington's Disease Society of America

The Huntington's Disease Society of America (HDSA) is a voluntary health agency with chapters, affiliates, support groups and Centers of Excellence throughout the United States. The Huntington's Disease Society of America (HDSA) funds and supports research to find a cure, helps people and families affected by the disease, and educates the public and healthcare professionals about this genetic disease.

The organization was founded by the late Marjorie Guthrie, widow of famous folk singer Woody Guthrie after he died of complications related to Huntington's Disease in 1967.

About Sirna Therapeutics

Sirna Therapeutics is a clinical-stage biotechnology company developing RNAi-based therapies for serious diseases and conditions, including age-related macular degeneration (AMD), hepatitis, oncology, and diseases of the central nervous system. Sirna has filed an IND for its most advanced compound, Sirna-027, a chemically modified siRNA targeting the clinically validated vascular endothelial growth factor pathway to treat AMD. The Company has strategic partnerships with Eli Lilly and Archemix and a leading intellectual property portfolio in RNAi. More information on Sirna Therapeutics is available on the Company's web site at http://www.sirna.com.

Statements in this press release which are not strictly historical are "forward-looking" statements which should be considered as subject to many risks and uncertainties. For example, Sirna's ability to select promising investigational compounds for preclinical development and its ability to achieve any progress in suppressing gene expression for Huntington's Disease, are subject to considerable scientific uncertainty. Other risks and uncertainties include Sirna's early stage of development and short operating history, whether Sirna can achieve and maintain profitability, whether Sirna can obtain and protect patents, the risk of third-party patent infringement claims, whether Sirna can engage collaborators and obtain regulatory approval for products, Sirna's concentration of stock ownership, and availability of materials for product manufacturing. These and additional risk factors are identified in Sirna's Securities and Exchange Commission filings, including the Forms 10-K and 10-Q and in other SEC filings. Sirna undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.

Sirna Contact: Martin E. Schmieg, Senior Vice President and Chief Financial Officer, Sirna Therapeutics, Inc., 303-449-6500

Media Contact: Justin Jackson, jjackson@burnsmc.com; Investor Contact: Aline Schimmel, aschimmel@burnsmc.com, Burns McClellan, Inc., 212-213-0006

HDSA contact: Deb Lovecky, 212-242-1968 extension 28, Dlovecky@hdsa.org.

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October 07, 2004

Amarin Loads Up

Now it's becoming clear why the Miraxion/LAX-101 trial isn't starting until 2005...Amarin needed the time to arrange the finances to fund the trial. Now they're ready.

Today Amarin announced that they've raised another $12.75 million while enabling the company to remain as a traded stock on NASDAQ. It's important to note that Amarin's management is buying stock. That's an important vote of confidence in the future of Amarin.

Amarin is banking heavily on the success of a Miraxion Phase III trial. They've got good reason to expect success. It appears that Miraxion is very effective in treating/slowing the Huntington's Disease in patients with CAG counts under 46. (It may also help those with higher counts, but to a lesser degree.)

Here's the press release from Amarin:

$3 Million of Existing Debt Converted Into Ordinary Shares

LONDON, October 7 - Amarin Corporation plc (NASDAQSC: AMRN) today announced that it has completed a private placement of 13,448,546 ordinary shares to a group of new and existing accredited investors and management, raising gross proceeds to the Company of $12.75 million.

The purchase price of $0.947 per share was based on the average closing price of Amarin's American Depositary Shares on Nasdaq for the ten trading days ended October 6, 2004. Amarin intends to file a registration statement with the U.S. Securities and Exchange Commission within 60 days covering the ordinary shares sold to investors.

As previously announced, following Mr. Thomas Lynch's purchase of Elan Corporation plc's (Elan) entire debt and equity interest in Amarin, $3 million of the outstanding $5 million Loan Notes acquired were converted into ordinary shares immediately following the closing of this private placement. The debt was converted at a price of $1.104, a 16.6% premium to the private placement price. Amarin's management investing in the private placement also bought shares at this higher price to comply with Nasdaq rules. The remaining $2 million of Loan Notes can be converted into ordinary shares at the option of the holder at the offer price of any subsequent equity financing.

Rick Stewart, chief executive officer of Amarin, commented, "This successful financing allows Amarin to drive forward with its plans for the phase III clinical trials with MiraxionTM, our lead compound for Huntington's disease. Additionally, it will facilitate in-licensing discussions for new late-stage compounds and out-licensing discussions with prospective partners for indications outside neurology"

Amarin's future financing strategy will depend on the timing of clinical trial expenditure on Amarin's development pipeline, in particular the proposed phase III trials with MiraxionTM in Huntington's disease, plus the revenue generated from its licensing and partnering activities. As previously described, Amarin is seeking to partner the rights to its development pipeline for all indications outside neurology and for geographic markets outside the U.S. Amarin plans to directly commercialize its pipeline in the U.S. neurology market.

Amarin also announced today that the settlement agreement with Valeant Pharmaceuticals International (Valeant), announced on September 29, 2004, is now unconditional, as all conditions precedent to closing have been met.

Since September 29, 2004, Amarin has announced a number of transactions which add approximately $16 million to its shareholders' equity. The announcements are summarised as follows:

- On September 29, Amarin announced that it had reached a settlement agreement with Valeant whereby $6 million of the $8 million in contingent milestones due to Amarin from Valeant were waived. The remaining $2 million is now no longer contingent and is payable by Valeant to Amarin on November 30, 2004. After deducting $1 million due to Elan under the asset purchase agreement the net benefit to Amarin's shareholders' equity is $1 million; and

- On October 1, Amarin announced that its non-executive chairman, Mr. Thomas Lynch, had acquired Elan's entire debt and equity interest in Amarin, including the $5 million Loan Notes. Mr. Lynch has agreed to convert $3 million of the $5 million Loan Notes into ordinary shares. This debt conversion, which took place today, will improve Amarin's shareholders' equity by $3 million; and

- Today, Amarin announced the completion of a $12.75 million private placement, which will improve Amarin's shareholders' equity by approximately $12 million.

Rick Stewart continued, "Our original objective was to raise approximately $10 million, however significant investor interest increased that amount to $12.75 million. We limited the fund raising to $12.75 million in order to restrict shareholder dilution, even though we had demand in excess of this level."

Amarin had been previously informed by Nasdaq that it did not comply with the minimum shareholders' equity threshold of $2.5 million as set forth in Marketplace Rule 4310(c)(2)(B) ('the Rule'). Amarin believes that the improvement in Amarin shareholders' equity as outlined above restores Amarin's compliance with the Rule. Nasdaq will continue to monitor the Company's ongoing compliance with the Rule and, if at the time of its next relevant periodic report the Company does not evidence compliance, it may be subject to delisting.

The securities being offered have not been registered under the Securities Act of 1933, as amended and may not be offered or sold within the United States absent registration or an available exemption from such registration requirements. However, pursuant to the agreement with the investors, the Company is required to register the resale of the securities and the securities issuable upon exercise of the warrant under the Securities Act.

About Amarin Corporation

Amarin Corporation plc is a neuroscience company focused on the development and commercialisation of novel drugs for the treatment of central nervous system disorders. Miraxion is in phase III development for Huntington's disease and is in phase II development for treatment unresponsive depression.

For press releases and other corporate information, visit our website at http://www.amarincorp.com.

Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties which may cause the Company's actual results in future periods to be materially different from any performance suggested herein. Such risks and uncertainties include, without limitation, the uncertainty of entering into and consummating a definitive agreement on terms acceptable to the parties, the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products and patents, as well as other risks and uncertainties detailed from time to time in periodic reports. For more information, please refer to Amarin Corporation's Annual Report for 2003 on Form 20-F and its Form 6-Ks as filed with the U.S. Securities and Exchange Commission. The company assumes no obligation to update information on its expectations. There can be no assurance that the Company has regained compliance with Market Place Rule 4310(c)(2)(B) until the Company has received notification from Nasdaq.

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October 03, 2004

Tapestry

Tapesty Pharmaceuticals (formaly NaPro) has a paper published in the Journal of Molecular Neuroscience where they discuss their proprietary
oligonucleotides that appear to prevent the mutant huntingtin protein from 'clumping'. This could end up, one day, being an effective treatment for Huntington's disease.

Tapestry has also announced that they are starting a second mouse study (probably in preparation for an initial human study) to measure various dosing levels.

Technology Detailed in September Issue of Journal of Molecular Neuroscience

BOULDER, Colo., Sept. 30 - Tapestry Pharmaceuticals, Inc. announced today that the Company is initiating a second in vivo study to establish the dose response for its proprietary oligonucleotides in a transgenic mouse model of Huntington's disease (HD). The new in vivo study is designed to further validate the results of previous studies as to the efficacy of Tapestry's proprietary oligonucleotides. These oligonucleotides may potentially inhibit the aggregation of the huntingtin protein, which is thought to be a leading cause of neurotoxicity and neuronal cell death in HD. To date there is no effective treatment for the disease, which afflicts approximately 35,000 people in the United States.

The Company also announced that Dr. Eric Kmiec, Professor of Biological Sciences at the University of Delaware and Senior Scientific Advisor to Tapestry, has published a paper describing the discovery of these proprietary oligonucleotides. The report, in the September issue of the Journal of Molecular Neuroscience, disclosed that the oligonucleotides were found to retard inclusion body formation in a model neuronal cell line. The in vitro assay was used in conjunction with a standardized biochemical assay to identify molecules that could disrupt the process of aggregate formation. This publication served as the basis for selection of the Tapestry oligonucleotides that are being evaluated for in vivo efficacy.

"The in vitro and preliminary in vivo data that we have gathered are important first steps and are quite encouraging. This second preclinical study will expand our experience with these molecules and provide us additional insight into the potential therapeutic benefit of our proprietary oligonucleotides in patients who are suffering with Huntington's disease," stated Anne L. Bailey, Vice President and General Manager, Genomics.

Data on earlier studies of Tapestry's proprietary oligonucleotides were presented by Dr. Kmiec at an oral session of the 2003 annual scientific meeting of the American Society of Gene Therapy. These studies described the single-stranded oligonucleotides' ability to extend the life of relevant neuronal cells by at least 40 percent in a validated cell culture model.

Huntington's disease is characterized by an expansion of a tract of CAG codons in the gene encoding the huntingtin protein. In contrast to normal, soluble huntingtin protein, mutant huntingtin protein with its expanded polyglutamine tract, aggregates with other proteins in microscopically visible intracellular inclusions. Tapestry's oligonucleotides are designed to block or retard this protein aggregation, reducing the number of inclusions, and consequently may have a potential therapeutic effect on the progression of the disease.

Citation

Parekh-Olmedo H., Wang J., Gusella J.F., Kmiec E.B. (2004) "Modified Single-Stranded Oligonucleotides Inhibit Aggregate Formation and Toxicity Induced by Expanded Polyglutamine." Journal of Molecular Neuroscience, Vol 24, pages 281-291.

About Huntington's Disease

Huntington's disease is a hereditary neurodegenerative disorder that is characterized by aggregate formation and cell death in most areas of the brain. The disease usually occurs in mid-life, and is characterized by involuntary physical movements, severe emotional disturbance and increasing cognitive decline. In the United States, the prevalence of the disease is about 10 cases per 100,000 people -- about 35,000 people in all -- with another 175,000 people genetically at risk.

About Tapestry Pharmaceuticals, Inc.

Tapestry Pharmaceuticals, Inc. is a company focused on the development of proprietary therapies for the treatment of cancer and hereditary disease.

For more information about Tapestry and its technologies, visit Tapestry's web site at http://www.tapestrypharma.com.

The statements in this press release that are not historical facts are forward-looking statements that represent management's beliefs and assumptions as of the date of this press release, based on currently available information. Forward-looking statements can be identified by the use of words such as "believes," "intends," "estimates," "may," "will," "should," "anticipates," "expected" or comparable terminology or by discussions of strategy, and include statements regarding the therapeutic potential for Tapestry's proprietary oligonucleotides, their ability to block or retard protein aggregation associated with Huntington's disease and whether the study being announced will provide sufficient insight into the potential therapeutic benefit of Tapestry's proprietary oligonucleotides in the treatment of Huntington's disease. Such statements involve risks and uncertainties, including whether Tapestry's proprietary oligonucleotides will show sufficient prospect in the treatment of disease to warrant further development, the costs of continuing development of any or all of the Company's development programs and whether the Company will have sufficient resources to pursue and complete development of the molecules, as well as other factors identified under the captions "Risk Factors," "Special Note Regarding Forward Looking Statements" or "Cautionary Note Regarding Forward Looking Statements" in the Company's documents filed from time to time with the SEC, including the Company's Current Report on Form 8-K, as amended, filed February 11, 2004, Annual Report on Form 10-K/A for the year ending December 31, 2003 filed on May 5, 2004 and Quarterly Report on Form 10-Q for the quarter ending June 30, 2004. Should one or more of these risks materialize (or the consequences of such a development worsen), or should the underlying assumptions prove incorrect, actual results could differ materially from those forecasted or expected. The Company disclaims any intention or obligation to update publicly or revise such statements whether as a result of new information, future events or otherwise.

For further information, please contact L. Robert Cohen, Vice President, Investor Relations of Tapestry Pharmaceuticals, Inc. at 212-218-8715.

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September 29, 2004

Amarin - Definitely Under Better Management

Amarin has announced that they have reached a settlement with Valeant.

Earlier this year, and in a financial bind, Amarin sold a chunk of their assets to Valeant. There was a subsequent disagreement which is now resolved. The end result is that Amarin improved their financial situation. They were on the hook for a potential $8 million worth of payments, instead they paid $2 million now. This will help Amarin when it comes time for them to arrange more financing.

The press release:

LONDON, September 29 - Amarin Corporation plc (NASDAQSC: AMRN) today announced that it has signed a settlement agreement with Valeant Pharmaceuticals International (Valeant) (NYSE: VRX - News) resolving an outstanding dispute relating to the sale of Amarin Pharmaceuticals Inc ("API") in February 2004.

As previously announced on February 26, 2004, Amarin completed the sale of API and a majority of its U.S. products to Valeant and upon closing API became a wholly owned subsidiary of Valeant. As reported in Amarin's report on Form 20-F for the year ended December 31, 2003, the asset purchase agreement for this transaction provided for a purchase price adjustment based on variations between a pro forma balance sheet agreed between the parties and a closing date balance sheet to be prepared after the closing. Subsequent to the closing of the sale, a dispute arose relating to adjustments to the closing date balance sheet.

Under the main terms of the settlement agreement and in consideration of the mutual release of such claims, Amarin and Valeant have agreed to amend the asset purchase agreement to waive $6 million of the $8 million in contingent milestones due to Amarin from Valeant. The remaining $2 million is now no longer contingent and is payable by Valeant to Amarin on November 30, 2004. In addition, Amarin's contingent obligation to repurchase $414,000 of wholesale inventory has been waived by Valeant.

The settlement agreement is conditional upon consent to such amendment to the asset purchase agreement being given by Elan Corporation plc (or its assignees) on or before October 7, 2004. Of the $2 million payable to Amarin by Valeant on November 30, 2004, $1 million is payable to Elan as part of the original settlement between Elan and Amarin on February 25, 2004.

Rick Stewart, Chief Executive Officer of Amarin commented, "We are pleased that this dispute has been resolved amicably and that our good collaborative relationship with Valeant remains intact. The resolution of this dispute removes this uncertainty for the company and our shareholders."

About Amarin Corporation

For press releases and other corporate information, visit our website at http://www.amarincorp.com.

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September 28, 2004

Amarin Approves Purchase Of Laxdale Ltd.

It's interesting to note that in this latest press release from Amarin that Miraxion appears to not only be helpful for the treatment of Huntington's Disease, it might also be helpful for the treatment of depression.

Here's the press release:

Amarin Shareholders Approve Acquisition of Laxdale Limited

Tuesday September 28, 10:10 am ET
Amarin Receives Shareholder Approval to Purchase Laxdale Limited
Receives Authorization to Proceed With Private Offering of Shares

LONDON, September 28 Amarin Corporation plc today announced that the resolutions, as set out in Amarin's Form 6-K dated September 1st 2004, to approve the acquisition of Laxdale Limited and to authorize the equity financing, have been passed at an Extraordinary General Meeting of its shareholders held earlier today.

Rick Stewart, Chief Executive Officer of Amarin commented, "we are pleased to have received overwhelming shareholder backing for the Laxdale acquisition and the proposed equity financing and we would hope to report shortly on our progress on these and other matters".

Amarin is a neuroscience company focused on the development and commercialization of novel drugs for the treatment of neurological disorders affecting the central nervous system. Amarin's leading pipeline product, Miraxion, is in development for a number of therapeutic indications including Huntington's disease ("HD") and treatment-unresponsive depression. Amarin is listed on the Nasdaq small cap market (ticker: AMRN), has headquarters in London and a research and development facility in Stirling, Scotland.

Corporate Strategy

Amarin's goal is to capitalize on its strong reputation in neuroscience and to become a leader in the development and commercialization of novel drugs which address unmet medical needs. Amarin will develop its late-stage development pipeline initially focusing on HD and depression. Amarin will directly commercialize its neurology products in the U.S. and out-license or partner its product rights in Europe and Japan. Amarin will also out-license or partner its pipeline globally for indications outside neurology.

Miraxion(TM) and Huntington's Disease

Miraxion(TM), Amarin's lead late-stage development product, is being developed for the treatment of Huntington's disease, with phase III trials due to commence in early 2005. Miraxion for Huntington's disease has been granted Fast Track designation and received Orphan Drug designation both in the U.S. and in Europe. Huntington's disease is a genetic neurodegenerative disease characterized by movement disorder, dementia and psychiatric disturbance. It has been diagnosed in approximately 30,000 patients in the U.S. with a similar number in Europe. Additionally, over 200,000 persons in the U.S. alone are genetically "at risk" of developing the disease. Onset of symptoms is typically between 30-50 years of age with a typical life expectancy from diagnosis of 10-25 years. Patients with late stage disease require continuous nursing care, often in nursing homes, with an estimated annual cost to the U.S. economy of up to $2.5 billion. Presently, there is no effective treatment or cure for Huntington's disease.

Miraxion and Treatment-Unresponsive Depression

Phase II clinical trials have been conducted with Miraxion in treatment-unresponsive depression that concluded with statistical significance that a 1-gram per day dose of Miraxion was effective in treating depression in patients who remained depressed, despite receiving standard therapy. The results of two trials were published in the Archives of General Psychiatry in October 2002 and the American Journal of Psychiatry in March 2002.

As a result of these encouraging clinical trial results, Amarin intends to further evaluate the clinical benefits of Miraxion in this indication and will seek a development and marketing partner to accelerate the program.

About Amarin Corporation

Amarin Corporation plc is a neuroscience company focused on the development and commercialisation of novel drugs for the treatment of central nervous system disorders. Amarin's late-stage development product for Huntington's disease is in phase III clinical trials.

For press releases and other corporate information, visit our website at http://www.amarincorp.com.

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September 24, 2004

HD Research Company Teams with ImClone

Neurome, Inc. has entered into a partnership with ImClone Systems - the giant biotech company. Neurome is researching treatments for neurological diseases such as Huntington's Disease.

Here's the press release:

Neurome Announces Partnership With ImClone Systems
Thursday September 23, 10:30 am ET

LA JOLLA, Calif., Sept. 23 Neurome, Inc., a privately held biotechnology company, announced today that it has entered into a research agreement with ImClone Systems Incorporated (Nasdaq: IMCL - News), in which Neurome will apply its proprietary technologies and expertise in quantitative neuropathology to assist ImClone Systems in the discovery stage investigation of preclinical candidate molecules. Specific financial terms were not disclosed.

The partnership will leverage Neurome's extensive experience in Central Nervous System (CNS) diseases and proprietary technologies (the Neurome Technologies) to provide ImClone Systems with information on the effects of selected preclinical molecules on potential targets in the Central Nervous System.

"We are very pleased to establish a collaboration with ImClone Systems," said Floyd E. Bloom, M.D., Chairman and Founding Chief Executive Officer of Neurome and Chairman of the Department of Neuropharmacology at The Scripps Research Institute. "We believe ImClone Systems' decision to work with Neurome is an important validation of our discovery stage capabilities and proprietary technologies."

Warren Young, Ph.D., President and Chief Technology Officer of Neurome added, "ImClone Systems is a leader in the molecular oncology field, and is now clearly established and positioned to commercialize important human therapeutics. The potential benefits of combining Neurome's proprietary technologies and expertise with ImClone Systems' novel candidates are very exciting."

"ImClone Systems is dedicated to developing and commercializing novel oncology products and these efforts invariably begin with research," said Peter Bohlen, Ph.D., Senior Vice President, Research, of ImClone Systems. "We expect that our work with Neurome will help expedite our efforts in developing certain of our pre-clinical research programs and look forward to a successful collaboration."

About Neurome

Neurome, Inc. is a discovery stage biotechnology company that seeks therapeutic solutions to human neurodegenerative diseases. The company is focusing its efforts on Alzheimer's disease, Parkinson's disease, Huntington's disease, and Amyotrophic Lateral Sclerosis -- neurodegenerative disorders which are currently untreatable and share a number of characteristics which make them particularly amenable to Neurome's expertise and technologies. Since its founding in 2000, the company has developed and optimized proprietary technologies to reveal and quantify gene expression patterns and the resultant morphological details of brain structures in normal and pathological brains with an unprecedented level of sensitivity, specificity and resolution. These unique technologies to measure and assess, at the molecular, cellular and macroscopic levels, neurodegenerative processes at work, are ideally suited to identify the earliest evidence of pathology in animal models of human diseases of the CNS, and to evaluate the comparative effectiveness of candidates for intervention. The company is using these technologies to discover and develop drugs that provide effective treatments for diseases characterized by neurodegeneration. For more information, please visit Neurome's website at www.neurome.com.

Except for historical statements, this press release contains forward-looking statements involving significant risks and uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to differ materially from Neurome's current expectations. Forward-looking statements include those which express a plan, belief, expectation, estimation, anticipation, intent, contingency, future development or similar expression. Readers are cautioned that forward-looking statements are not guarantees of future performance and that undue reliance should not be placed on such statements. Forward-looking statements speak only as of the dates on which they were made. Neurome undertakes no obligation to publicly update or revise any forward-looking statements or to make any other forward-looking statements, whether as a result of new information, future events or otherwise unless required to do so by the securities laws.

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September 16, 2004

Tetrabenazine Gets 'Fast Track'

From the press release (more on Tetrabenazine here):

Tetrabenazine Receives ``Fast Track'' Designation From the FDA for Chorea Associated with Huntington's Disease

WASHINGTON--(BUSINESS WIRE)--Sept. 16, 2004--Prestwick Pharmaceuticals, Inc., a CNS specialty pharmaceutical company, announced today that tetrabenazine has been designated as a "fast track" product by the U.S. Food and Drug Administration (FDA). Also, tetrabenazine has been designated as an orphan product by the FDA. Tetrabenazine is being evaluated for the treatment of chorea associated with Huntington's disease. Currently in pivotal clinical testing in the United States, tetrabenazine is a novel dopamine depletor that works by selectively blocking the VMAT2 transporter in the CNS.

The Fast Track Program is designed to expedite the review of drug compounds for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need for new therapeutic approaches. The benefits of fast track designation provide for multiple meetings, timely comments, and a priority review at the FDA.

"This treatment addresses an unmet medical need, as there are currently no approved drugs for the treatment of chorea in Huntington's disease. The recent FDA action underscores the need for therapeutics for people with Huntington's Chorea and is most encouraging," said Kathleen Clarence-Smith, MD, PhD, Acting Chief Executive Officer, Prestwick Pharmaceuticals. "Prestwick is engaged in multiple programs to study the efficacy and safety of tetrabenazine in this patient population. We look forward to compiling the data generated from these trials and submitting it to the FDA."

Tetrabenazine is approved for use in several European countries and Australia as Xenazine(TM), and in Canada as Nitoman(TM).

About Prestwick Pharmaceuticals

Prestwick Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company that focuses on treatments for CNS disorders. The company has multiple product candidates in clinical development for Huntington's Chorea, Parkinson's disease, and schizophrenia. Prestwick is currently conducting pivotal trials in the U.S. with its lead compound, tetrabenazine, and plans to file an NDA in the very near future.

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September 01, 2004

Living Cell Technologies

From the news article:

BIOTECH company Living Cell Technologies roared on to the Australian Stock Exchange yesterday 25 per cent above its issue price.

The company is headquartered in Adelaide and raised $6.36 million from investors for more testing of its diabetes, Huntington's disease and haemophilia treatments.

It is developing three products - NeurotrophinCell to treat Huntington's disease, Fac8Cell for haemophilia and DiabeCell for diabetes.

The products use encapsulated cells that are transplanted into the patient and work by replacing and performing the functions of diseased or damaged organs.

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July 29, 2004

Amarin Update

Amarin also released their quarterly financials and they lost $3.2 million the last three months as they didn't have ANY income. (Wait, another pharmaceutical that isn't raking in the dough?) Amarin, a company that has been under disasterous management until recently, has the rights to Miraxion (LAX-101) which in going into another round of phase III drug trials for treating Hunginton's Disease.

Key phrase from the press release:

Announcement of corporate strategy - Amarin will develop its late-stage development pipeline initially focusing on Huntington's disease and treatment unresponsive depression...

The future of their company depends on Miraxion. Here's the press release:

Amarin Corporation Reports Second Quarter 2004 Financial Results
Thursday July 29, 8:18 am ET

LONDON, July 29 - Amarin Corporation plc (NASDAQ: AMRN - News) today reported a net loss for the quarter, including discontinued activities, of $3.2 million or $0.18 per American Depositary Share (ADS), compared with a net loss of $7.0 million or $0.39 per ADS in the second quarter of 2003.
Second Quarter Highlights

Laxdale acquisition - signature of a definitive agreement to acquire Laxdale Limited ("Laxdale"), a privately owned, neuroscience development company based in Stirling, Scotland. This transaction consolidates Amarin's position in neuroscience and represents an initial step in the implementation of its strategy to emerge as a leader in the development and commercialization of novel drugs for the treatment of neurological disorders affecting the central nervous system. In addition, the acquisition broadens Amarin's development pipeline to include rights to Miraxion for all central nervous system disorders, including Huntington's disease and treatment unresponsive depression, in the U.S., E.U. and Japan together with existing licensee relationships for the major European markets and Japan.
Miraxion progress - recent discussions with the United States Food and Drug Administration ("U.S. FDA") and with the European Medicines Evaluation Agency ("EMEA") have provided valuable information which will be used in designing the protocol for the planned phase III trials with Miraxion.
Additional positive clinical data analysis - additional analysis of the clinical data from the initial pivotal study identified a sub-set of Huntington's disease patients (with a specific gene variant) that responded to Miraxion with statistical significance at 6 months and at 12 months. This sub-set of patients represents a significant majority of the Huntington's disease patient population.
Announcement of corporate strategy - Amarin will develop its late-stage development pipeline initially focusing on Huntington's disease and treatment unresponsive depression, for which a development partner will be sought. Amarin will seek to directly commercialize its neurology products in the U.S. and out-license or partner them in Europe and Japan. Amarin will also out-license or partner its pipeline globally for indications outside neurology. Amarin intends to leverage its development capabilities by supplementing its internal development pipeline through acquiring and/or in-licensing products for direct marketing by Amarin in its core U.S. market and selected field of neuroscience.
Financial results - operating loss from continuing activities for the second quarter of 2004 of $1.6 million, compared with an operating loss of $1.9 million in the second quarter of 2003.
Commenting on the results and progress made by Amarin in the second quarter, Rick Stewart, Amarin's Chief Executive Officer said, "The completion of the Laxdale acquisition will be a major milestone for Amarin and represents a refocusing of Amarin's resources to progress Miraxion through phase III clinical trials in Huntington's disease. We are encouraged by the additional data from the initial Huntington's disease pivotal study and look forward to commencement of the phase III studies. Amarin now has a substantial development pipeline and will be seeking development partners for certain compounds outside our selected therapeutic area of neuroscience or geographic reach."

The results for the second quarter and for the six months ended June 30, 2004 are analyzed between continuing and discontinued activities and are set out in further detail in the three pages of financial tables attached. The Laxdale acquisition is contingent upon Amarin shareholder approval, completion by Amarin of a $15 million financing and other customary conditions. Amarin's reported results for the second quarter and six months ended June 30, 2004 do not include the results of Laxdale. The results of Laxdale will be consolidated with Amarin, if and when the acquisition closes later this year.

Continuing Activities

The operating loss from continuing activities for the second quarter of 2004 was $1.6 million, compared with an operating loss of $1.9 million in the second quarter of 2003. For the six months ended June 30, 2004, the operating loss from continuing activities was $3.3 million, compared with an operating loss of $3.8 million for the same period in 2003. This operating loss represents head office operating expenses, business and corporate development costs and Miraxion product rights amortization.

Discontinued Activities

The operating loss on discontinued activities for the second quarter of 2004 of $1.4 million (compared with an operating loss of $4.9 million in the second quarter of 2003) represents the cost of conducting safety studies on Zelapar. Following the sale of the majority of Amarin's U.S. operations to Valeant Pharmaceuticals International ("Valeant") in the first quarter of 2004, Amarin remains responsible for undertaking safety studies on Zelapar and is liable for up to $2.5 million of development costs. It is expected that the remaining development cost obligation of $1.1 million will be incurred in the third quarter.

Under the terms of the sale to Valeant, Amarin will be paid a contingent milestone of $3 million if the safety studies referred to above are successfully completed. Of the $3 million, Amarin would receive a net amount of $1.6 million after accounting for contingent obligations of Amarin that only arise if this milestone is earned. In addition, Amarin will be paid a further contingent milestone of $5 million if Zelapar is approved by the U.S. FDA. As discussed below, Elan Corporation plc. ("Elan") has the option to seek early repayment of its outstanding $5 million loan if Amarin receives this $5 million approval milestone from Valeant. Neither of these milestones was earned in the second quarter and will be recognized as income if and when they are achieved.

As set out in Amarin's 2003 Annual Report filed with the Securities and Exchange Commission under Form 20-F, following the sale of the majority of Amarin's U.S. operations to Valeant, Amarin and Valeant are disputing the responsibility for incremental product inventory of approximately $6 million held at wholesalers. No provision has been made with respect to this matter. It is our view that the additional inventory should not impact the consideration payable to Amarin, whether

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