Dyax

Dyax shares soar on late-stage DX-88 data

John Carroll — Mon, 18 Aug 2008 12:09:48 -0400

Shares of Dyax were on a roll in pre-market trading after the company announced that its lead drug hit its primary endpoint in a late-stage trial for a genetic blood disorder. Researchers said that 93.8 percent of the volunteers taking DX-88 reported reduced symptoms of hereditary angioedema. That compared to 58.3 percent of patients in the placebo arm reporting reduced symptoms. Symptoms of the rare disease, triggered by a protein deficiency, include swelling of the face, hands and throat. And Dyax officials said that the data would allow the company to complete its application to the FDA in the fourth quarter. Its shares were up about 25 percent on the news.

"The DX-88 BLA will include the most extensive placebo-controlled assessment of any therapy for the treatment of HAE and was based on a Dyax-developed comprehensive endpoint evaluation," said CEO Henry E. Blair. "We look forward to submitting our BLA and, ultimately, commercializing this innovative therapy."

- read the press release
- check out the AP report

ALSO NOTED: Dyax to close R&D facility;Nastech sells shares; and much more...

Mon, 28 Apr 2008 06:59:50 -0400

> Dyax says it plans to close its research facility in Belgium as it focuses on commercializing DX-88 to treat hereditary angioedema. Dyax report

> Nastech Pharmaceutical plans to sell $8 million in shares to advance its RNAi programs. Report

> North Park Aesthetics says it's reached an agreement with Biophysica, Inc. and Interpharma Praha for the exclusive worldwide rights to develop and commercialize products containing fluridil, the primary ingredient in NP-619, North Park's Phase II product for pattern baldness. Release

> FDA officials say that drugmakers needed to bear the responsibility for drug safety. FDA report

> Will all medical schools bar the door to pharma giveaways? The Association of American Medical Colleges hopes so. Pharma gift report

> In another blow to the Merck/Schering-Plough joint venture, the FDA rejected a proposed allergy and asthma treatment that would have combined Schering's Claritin and Merck's Singulair into one pill. Report

> The Brazilian government recently deemed the anti-HIV med Tenofovir a "public interest." That's code for, "We're thinking about issuing a compulsory license for this drug." Brazil report

> One of the things media love to do is get two people to go head-to-head on an issue. Today's topic: Allowing drugmakers to distribute peer-reviewed journal articles in support of off-label uses for their products. On the pro side is Scott Gottlieb (photo), an ex-FDA deputy commissioner who's now at the conservative American Enterprise Institute. Former New England Journal of Medicine editor Jerome Kassirer is on the con side. Report

And Finally... Indonesia has begun to drill health workers on responding to a human outbreak of bird flu. Article

Dyax forges $231M development deal for DX-88

Thu, 24 Apr 2008 06:59:57 -0400

Cubist Pharmaceuticals has agreed to pay Dyax $15 million upfront and up to $216.5 million more in potential milestone payments for collaboration rights to Dyax's experimental therapy for the prevention of blood loss during surgery in North America and Europe. Cubist will fund development costs for an ongoing Phase II trial of DX-88. And Dyax has co-promotion rights in the U.S. and retains development rights for other indications. The first $2.5 million milestone payment will be paid this year.

"As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing blood loss and inflammation in multiple surgical indications," says Cubist CEO Mike Bonney. "There is a serious unmet medical need and a large market opportunity for a successful therapy here."

- see Cubist's release
- read the story in StreetInsider

Sanofi to pay $500M for Dyax antibody program

Tue, 12 Feb 2008 06:59:58 -0500

Sanofi-Aventis has committed up to $500 million for the worldwide rights to Dyax's DX-2240 human monoclonal antibody product. Sanofi also inked a nonexclusive license to Dyax's proprietary antibody phage display technology. Dyax pockets $25 million under the deal this year. Sanofi will be responsible for the ongoing development, commercialization and consolidation of sales of DX-2240. Dyax is retaining co-development and profit sharing rights "for certain other future antibody product candidates discovered by Sanofi-Aventis." DX-2240 is a fully human monoclonal antibody that targets the Tie-1 receptor on tumor blood vessels. In preclinical animal models, DX-2240 has demonstrated activity against a range of solid tumor types.

"These strategic agreements validate Dyax's capabilities to successfully discover novel antibody drug candidates utilizing our proprietary phage display technology and advance the resulting drug candidates into development," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax.

- check out the press release

ALSO: Take a look at Sanofi's pipeline. Report

Related Articles:
Sanofi: We're looking for biotech deals. Report
Sanofi underscores pipeline advances, setbacks. Report
Dyax shares skyrocket on successful Phase III. Report
Dyax pockets $30M in revenue deal. Report

ALSO NOTED: Cross Country expands research offering; Dyax prices shares; Sciele takes stake in Addrenex; and much more...

Fri, 13 Jul 2007 06:59:50 -0400

> Cross Country Healthcare is buying Assent Consulting for $19.6 million in a deal designed to expand its biotech research services. Release

> Dyax has priced a public offering of 10,500,00 shares of its common stock at $3.67 per share. Release

> Sciele Pharma has acquired a $6 million stake in Addrenex and simultaneously signed a marketing pact. Release

And Finally... For uninsured adults, reaching retirement age and qualifying for Medicare is an opportunity to start getting medical care. Article

Analysts see a continuing surge of licensing deals

Wed, 27 Jun 2007 00:01:36 -0400

Merck officials would probably be among the first to agree with Needham & Associates' conclusion that the pace of biotech partnerships shows no sign of letting up. Big Pharma and Big Biotech are both avid about doing more deals to fill their pipelines. Among some of the biggest partnership deals that are likely in the works right now, they say, is a pact for Dendreon's Provenge, Dyax's DX-88 for hereditary angioedema, and a deal for ISIS 301012.

"Isis is likely to partner the drug candidate in the second half of 2007, given the interest by big pharma in this indication as well as the advanced resources needed for Phase III development of ISIS 301012 in polygenic 'garden-variety' hypercholesterolemia," Needham analysts wrote. Panacos, La Jolla and Anesiva also made the list of likely dealmakers.

- read the report on the trend from MarketWatch

Related Articles:
Lines blur as Big Pharma crosses borders into biotech. Report
Deals and more deals. Report
Acquisition deals in biotech keep getting richer. Report

ALSO NOTED: Intradigm completes $16M Series A financing; Prana to raise $6M to fund trial; and much more...

Mon, 20 Nov 2006 19:01:30 -0500

> Intradigm Corporation has completed a $16 million Series A financing, and has also relocated company headquarters to Palo Alto, CA from Rockville, MD. Intradigm is developing RNAi technology--a hot field which has seen a number of deals as of late. Release

> Australia-based Prana Biotechnology announced that it will raise $6 million from investors to fund a trial of PBT2 in patients with Alzheimer's disease. Release

> Chutes & Ladders: SciClone Pharmaceuticals COO Dr. Alfred Rudolph has resigned. CEO Friedhelm Blobel will temporarily take over Rudolph's duties while the company searches for his successor. Report

> Dyax has completed the double-blind portion of its pivotal Phase III clinical trial for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). The FDA has also broadened the drug's Fast Track designation to include all types of HAE attacks. Release

And Finally... Decreasing lab space--and increasing rent--is pushing biotech out of Cambridge, MA and into the suburbs. Article

Jerini drug for HAE produces mixed results

Thu, 21 Sep 2006 20:01:34 -0400

Germany's Jerini is touting half of the results from two pivotal Phase III trials for Icatibant, an experimental subcutaneous treatment of hereditary angioedema (HAE). In one study, the primary endpoint was reached, showing a significant reduction in the time to onset of symptom relief. A second Phase III study, though, failed to hit its primary endpoint. The primary endpoint of median time to onset of symptom relief in the second trial was 2.5 hours for Icatibant versus 4.6 hours for placebo, which was not statistically significant. KOS Pharmaceuticals holds the North American marketing rights to the drug.

- here's the release on the data

PLUS: News of the failure in one of Jerini's trials boosted shares of Dyax, which has a competing drug in development for hereditary angiodema. Report

DEALS: GSK, ChemoCentryx ink $1.5B pact

Wed, 30 Aug 2006 20:01:32 -0400

GSK, ChemoCentryx ink $1.5B pact

DEALS
WHO	WITH	WHAT	SCOOP
GlaxoSmithKline	ChemoCentryx	$1.5B collaboration pact	The deal revolves around developing new therapies from chemokine and chemoattractant receptors for inflammatory diseases.
Mylan Laboratories	Matrix Laboratories	$735 million acquisition	In a move to expand its reach around the globe, Mylan Laboratories has acquired a majority interest in India's Matrix Laboratories.
Infinity Pharmaceuticals	MedImmune	$500M development deal	Infinity Pharmaceuticals and MedImmune will advance new therapies for blood-related cancers and solid tumors.
Dishman Pharmaceuticals and Chemicals	Carbogen Amcis	$75M purchase	Carbogen Amcis controls three production facilities. Dishman says it expects to be able to improve margins at the contract manufacturing operation.
Dyax	Paul Capital Partners	$30M payment	Dyax receives the payment from Paul Capital Partners in exchange for a portion of the revenue generated by its Phage Display Licensing and Funded Research Program.
Isolagen	Agera Laboratories	$2.67M deal	Agera Laboratories makes clinically developed skincare products.
Orthodontix	Protalix	Merger	Once the merger is complete a small group of investors will invest $15 million in Protalix in exchange for 14 percent of the company.

Dyax pockets $30M in revenue deal

Thu, 24 Aug 2006 20:01:38 -0400

Cambridge, MA-based Dyax has snared a $30 million payment from Paul Capital Partners in exchange for a portion of the revenue generated by its Phage Display Licensing and Funded Research Program. Dyax can earn another $5 million based on revenue goals covering the next two years. In late July Dyax reported widened losses for its second quarter following the termination of its collaboration with Debiopharm.

"This financing structure allows Dyax to unlock the value of future revenues from this highly successful licensing program and receive a substantial cash infusion without a dilutive equity financing," commented Henry E. Blair, Chairman and Chief Executive Officer of Dyax. "The upfront $30 million payment will allow us to continue advancing our HAE and CABG programs and to fund other therapeutic leads from Dyax's extensive pipeline of internally discovered candidates. Furthermore, Dyax still retains a significant interest in future LFRP revenues, the value of which is now validated."

- see the release on the deal

Dyax sent back for more data on DX-88

Mon, 15 May 2006 20:01:36 -0400

The FDA wants Dyax to produce more data on its experimental therapy for hereditary angiodema. The drug developer said it would have to revise its timeline for FDA approval and will probably have to conduct a dose-ranging study of DX-88. Dyax and drug partner Genzyme say they are studying their options. A Phase III study is expected to wrap up soon.

"The FDA wants data to ensure that the current 30 mg fixed dose of DX-88 is in fact the optimal dose for subcutaneous administration," stated Tom Beck, president and chief operating officer of Dyax. "The amount of additional data and analysis that might be necessary to address this requirement is currently being discussed with the FDA. However, it should be noted that the FDA has expressed no issues or concerns with the overall safety and activity of DX-88."

- here's the UPI report for more info

ALSO NOTED: Schering cuts Angeliq forecast; Merck, Paratek to collaborate; and much more...

Thu, 09 Mar 2006 19:00:50 -0500

> Schering has cut its projected peak sales figure for the hormone replacement therapy Angeliq from €250 million per year to €150 million annually. Report

> Insmed has announced an offering of 20 million shares. Release

> Merck and Paratek have signed a deal to collaborate on the development of an antibiotic. Merck paid an undisclosed up front fee and agreed to pay up to $127 more in milestone payments for Paratek's PTK 0796, an antibiotic currently in Phase I testing. Release

> Chutes & Ladders: Allos Therapeutics has named Paul Berns as its new CEO. Report

> Massachusetts, New York, Rhode Island and North Carolina will compete for a $660 million biologics plant that has been blueprinted by Bristol-Myers Squibb. Report

> ChemDiv, a clinical research organization, has struck a deal to develop new therapies with Berlex, the U.S. affiliate of Schering. Release

> Avian flu: About one percent of the chickens sold in southern China's markets are infected with bird flu. Microbiologists gathered fecal samples from apparently healthy chickens to complete the study, which indicates a significantly higher risk of human exposure than health authorities had expected. Report

> Shares of Dyax slid after the company reported plans to sell 5.5 million shares. Report

> Evotec has achieved a second milestone in its research collaboration with Boehringer Ingelheim. Report

> Targeted Genetics has announced a $5 million offering of common stock. Release

And Finally… A new study on aging says that America's baby boomers will reach retirement age better educated and in better physical condition than earlier generations of America. That trend may have a profound impact on the healthcare industry. Article

ALSO NOTED: Roche unveils Fuzeon data; Palatin pulls agent; Acambis launches Phase II; and much more...

Mon, 19 Dec 2005 19:00:50 -0500

> Roche has unveiled new data that demonstrates a significantly improved response for its HIV treatment Fuzeon. Report

> Palatin Technologies has pulled an infection diagnosing agent from the market following the deaths of two people. Release

> Acambis has become the first drug developer to begin a Phase II trial of a vaccine designed to prevent West Nile disease. Release

> New research indicates that people taking heartburn medications like Prilosec, Prevacid and Nexium are more likely to get diarrhea caused by the bacteria Clostridium difficile. Report

> Dyax and Debiopharm have restructured their development agreement on DX-890 (Depelestat), a recombinant inhibitor of humanneutrophil elastase for pulmonary disorders. Release

> CuraGen has changed the terms of its collaboration with Bayer for a new diabetes therapy. Report

> Mylan Pharmaceuticals has entered into two agreements with Ortho-McNeil Pharmaceutical and Alza Corporation relating to oxybutynin chloride extended release tablets. Release

And Finally… Despite being dealt a major setback in its effort to break Pfizer's patent on Lipitor, Ranbaxy says it has no plans to back away from its aggressive strategy of challenging patents. Article

C&L: Rastetter to retire as Biogen executive chairman

Tue, 13 Dec 2005 19:01:32 -0500

William H. Rastetter will retire as executive chairman of Biogen Idec at the end of the year. Bruce Ross, chairman of the company's compensation committee, will become non-executive chairman of the board of directors. Ross is currently president of Cancer Rx, a healthcare consulting firm.

Memry has announced the retirement of CEO James Binch. Birch served as CEO since December 1991. Robert P. Belcher, CFO and senior VP of finance and administration, has been named acting CEO.

FoxHollow Technologies announced that president and CEO Robert W. Thomas will be retiring on January 1, 2006. Chairman Dr. John Simpson will replace Mr. Thomas as interim CEO.

Pepscan Systems has named Kenneth Freeman, MBA, MPA, Ph.D., as CFO. Prior to joining Pepscan, Dr. Freeman was a co-founder and vice chairman of the supervisory board of NADAG, senior director, financial operations, and a board member of ThromboGenics.

Dyax announced several promotions. Thomas R. Beck, M.D., has been promoted to president and COO. Prior to Dyax, Dr. Beck was the director, global research and development for UCB Pharma. Clive Wood, Ph.D., has been promoted to executive VP, discovery, research and chief scientific officer. Dr. Wood spent 17 years at Genetics Institute and its successor, Wyeth Research. Ivana Magovcevic-Liebisch, Ph.D., J.D., has been promoted to general counsel and executive VP of corporate communications. Before Dyax, she served as director of intellectual property at Transkaryotic Therapies.

CardioDynamics International has appointed Donald Brooks to the position of chief technology officer and Kevin Hammond to the position of VP of sales. Most recently, Brooks served as CardioDynamics' VP of product development and oversaw the BioZ Dx development. Mr. Hammond previously led the company's sales region for 2005.

CeNeRx BioPharma has announced the addition of Atul C. Pande, M.D., as chief medical officer. He was most recently VP of neurosciences development at Pfizer.

Bruce A. Leicher joins Antigenics as general counsel. Mr. Leicher was most recently VP, chief pharmaceutical counsel and compliance officer at Millennium Pharmaceuticals.

Kereos announced that Allen Nickols, Ph.D., has been appointed VP of biology. Nickols is the former director of pharmacology and Science Fellow at Pfizer Global R&D. The company also announced that Gregory Johnson, Ph.D., John Rice, Ph.D., and Martin Sanders, M.D., have been appointed to its board.

Alexza Pharmaceuticals has named three new VPs: William C. Houghton, M.D., joins the company as VP of clinical and regulatory affairs; William L. Leschensky, M.D., J.D., was promoted to VP, intellectual property; and Robert H. Strickland joins the company as VP of commercial manufacturing.

Gregory L. Bennett has been named Cholestech's VP of R&D. Mr. Bennett has been Cholestech's director of engineering since November 2003. He succeeds Dr. Thomas Worthy, who is retiring.

Alliant Pharmaceuticals has named Allen Fields, Ph.D.., as VP of R&D. The company also appointed Pete Joiner as director of national accounts.

Parextel International has appointed Todd A. Joron as corporate VP and general manager. Joron will manage Perceptive's global offerings.

Louis G. Lange, M.D, Ph.D., has been appointed to Maxygen's board of directors. Dr. Lange is a founder of CV Therapeutics and has served as chairman of the board and CEO of the company since August 1992. Previously, Dr. Lange served on the faculty of Washington University School of Medicine.

deCODE Genetics has named Dr. Linda Buck to join its board of directors. Dr. Buck received a Nobel Prize in physiology or medicine in 2004.

Robert G. Funari, chairman and CEO of Crescent Healthcare, has been elected to Beckman Coulter's board of directors.

Neurocrine Biosciences has appointed Adrian Adams to its board of directors. Mr. Adams is president and CEO of Kos Pharmaceuticals.

Auxilium Pharmaceuticals has added Al Altomari and Oliver Fetzer to its board of directors. Mr. Altomari, CFO at Barrier Therapeutics, will also serve on the audit and compliance committee, filling the seat left open after Michael Wall resigned in June.

John W. Madigan has joined Gilead's board of directors. Mr. Madigan is the retired chairman and CEO of Tribune.

ALSO NOTED: GSK to co-develop cancer therapy; Singulair approved for new use; Teva gets FDA nod; and much more...

Wed, 17 Aug 2005 20:00:50 -0400

> GlaxoSmithKline has exercised an option to help develop and market a new cancer therapy with Human Genome Sciences. Story

> The FDA has approved Merck's Singulair for indoor allergy uses. Release

> The FDA has given tentative approval to Teva's ANDA for Granisetron HCl Injection, 1 mg/mL single dose vials and Granisetron HCl Injection, 4 mg/4mL in multi-dose vials. Story

> The National Cancer Institute says that an ambitious program of earlier detection, better therapies and controls on tobacco can stop lung cancer by 2015. Report

> Dyax and Merck have inked a licensing deal for the discovery of therapeutic antibodies and peptides. Release

> Novartis has signed an agreement with SeBo of Germany to acquire the global rights for a novel oral phosphate binder in development for the treatment of elevated serum phosphate levels in late- or end-stage renal disease patients. Release

And Finally… The death rate from heart disease in New York is among the highest in the country, but health officials are at a loss to explain why. Article

ALSO NOTED: Merck scientist defends Vioxx; Taro wins FDA OK; Advanced Magnetics revises Phase III; and much more...

Wed, 10 Aug 2005 20:00:50 -0400

> Dr. Alise Reicin, VP of clinical trials for Merck, insisted in the first court case involving Vioxx that the drug had been tested in 10,000 people before being submitted for approval and was never linked to elevated cardiovascular risks. Dr. Reicin also insisted that one trial that did show a heightened risk when compared to naproxen was do to the heart-protecting qualities of naproxen and not any added risk from Vioxx -- a point that has been rigorously disputed by a number of experts. Report

> The FDA has approved Taro Pharmaceuticals' ANDA for Ciclopirox Topical Suspension USP, 0.77%. Release

> The FDA has approved Gen-Probe's Aptima Combo 2 test to detect chlamydia and gonorrhea. The two conditions are the most common bacterial sexually transmitted diseases in the US. Gen-Probe says the approval will make testing easier and less expensive. Story

> Advanced Magnetics has revised its Phase III program for ferumoxytol in IV iron replacement therapy. Release

> The FDA has cleared Halozyme Therapeutics' Chemophase Investigational New Drug application. Release

> Dyax has announced a new cancer lead. Release

And Finally… The New York City health department has launched a campaign to get its restaurants to take harmful trans fats off of the menu. Article