Wednesday, May 02, 2007

Fierce Biotech May 2, 2007

May 2, 2007
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Today's Top Stories
1. CollaGenex halts trial after adverse reaction
2. Nabi ready for a deal after NicVAX hits endpoint
3. Patent 'cliff' looms for Big Pharma
4. Rituxan shows promise as new approach to MS
5. Cumberland Pharma looking to gin $115M in IPO

Also Noted: Spotlight On... Progenics reports positive HIV data; BMS breaks ground on $660M plant; Factive wins new indication approval; and much more...

Chutes & Ladders: Forster wins tap to run Solace

Events:
> Partnering is Now Open for the 2007 BIO Business Forum - May 6-9, Boston
> 2007 BIO International Convention, in Boston, May 6 - 9, 2007
> Feasibility in Global Trials - May 17 Audioconference
> Understanding Pharma - May 22-23, Philadelphia, PA
> C21 BioVentures - May 22-24, Monterey, CA
> Streamlining Early CMC Drug Development - May 23-24, San Diego, CA
> International Pharmaceutical Regulatory & Compliance Congress & Best Practices Forum - June 6-7, Brussels
> bioLOGIC Europe, 11 - 14 June 2007, President Wilson Hotel, Geneva, Switzerland
> Biotech Demystified: The Science Behind the Business- June 18-21, UC San Diego

Marketplace:
> Email Marketing Technology You Need. Expertise You Want.

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1. CollaGenex halts trial after adverse reaction
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Shares of CollaGenex Pharmaceuticals dipped this morning after the drug developer announced it was suspending enrollment in a mid-stage study of a new acne drug after one of the patients in the trial experienced a severe adverse reaction. One of the volunteers in the trial exhibited symptoms of phototoxicity, a condition characterized by such sensitivity to sunlight it can lead to second degree burns. The patient had been given a 40 mg dose of modified tetracycline incyclinide, an antibiotic previously linked to phototoxicity. CollaGenex shares slid 16 percent on the news.

"Our principal concern is the safety of our patients, and we are suspending further enrollment in the 40 mg cohort of this trial while we investigate this adverse event," said Colin Stewart, CollaGenex president and chief executive, in a statement. "Since we observed no adverse events at lower doses, we are continuing the Phase II dose-finding trial of incyclinide for the treatment of rosacea."

- check out the announcement from CollaGenex
- see this the AP report for more information

Related Articles:
CollaGenex touts Phase IV Oracea data. Report
CollaGenex acne drug show positive Phase II results. Report

2. Nabi ready for a deal after NicVAX hits endpoint
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Shares of Nabi Pharmaceuticals surged 18 percent this morning after researchers announced that its NicVAX vaccine hit its primary goal--eight weeks of continuous abstinence by a statistically significant number of smokers--in a mid-stage trial. The company said the "top 30 percent of antibody responders (61 of the total 201 patients receiving drug) were examined in detail. A statistically significant number of these patients...showed continuous abstinence between weeks 19-26 compared to only 13 percent for the 100 patients receiving placebo." The trial enrolled 301 heavy smokers for the test, and Nabi officials say the results sets the stage for a late-stage trial and a partnership agreement.

"We believe NicVAX is now well positioned to enter Phase III pivotal trials and to secure a strategic partner," interim President and CEO Leslie Hudson said in a statement.

- see this release on the new data

Related Articles:
FDA panel votes in favor of Nabi therapy. Report
Nabi CEO walks after hedge fund balks. Report
Nabi vows to push ahead with vaccine work. Report
Nabi to close European operations. Report

3. Patent 'cliff' looms for Big Pharma
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A new report says that the next decade will see a sharp spike in the number of generic drugs coming into the $643 billion global pharmaceutical market. Datamonitor says that knockoffs for drugs that earn $140 billion in sales will lose patent protection by 2016. Lipitor will be one of the next blockbusters to face a copycat competitor, which can reduce the price of a drug by as much as 80 percent in a matter of months. For some pharma companies, the loss of patent protection amounts to a "patent cliff" that seriously threatens the bulk of their revenue. This trend, though, has a distinct silver lining for the biotech industry. With patent deadlines looming, many of these same drug companies have been budgeting huge sums to either buy out promising developers or pay significant premiums to license key markets.

- read the AFX report on the patent trend

Related Articles:
Democrats to push for generic biotech drugs. Report
Generic competition heats up. Report
Standards on biotech patents get tougher. Report
FDA backlog slows generic drug approval. Report

4. Rituxan shows promise as new approach to MS
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Genentech and Biogen Idec say that a small mid-stage trial demonstrated that Rituxan exhibited promising efficacy as a therapy for multiple sclerosis. Rituxan is approved as a cancer therapy and has a proven ability to destroy B cells, which now appears as a promising new approach to treating MS as well.

"These Phase II results are very encouraging and suggest B-cells play a key role in MS," Stephen Hauser, MD, professor and chair, department of neurology, University of California, San Francisco. They also lend support to the concept that selective targeting of B-cells may be an important approach to treating this debilitating disease."

- see the data from the trial
- read the MarketWatch report on Rituxan

Related Articles:
Rituxan data encourages researchers. Report
New warning issued on Rituxan for lupus. Report
FDA approves Rituxan for rheumatoid arthritis. Report
Biogen Idec hunts for new acquisitions. Report

5. Cumberland Pharma looking to gin $115M in IPO
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Cumberland Pharmaceuticals has joined the list of developers looking to raise money in an IPO. Cumberland filed SEC papers for an offering designed to raise $115 million. UBS Investment Bank and Jefferies & Co. are leading the deal's underwriting. The Nashville-based company says it may use some of the money for new acquisitions. Its strategy has been to acquire approved or late-stage therapies. Cumberland also runs a life sciences incubator.

- read Cumberland's release
- here's the report on the IPO from the Nashville Business Journal

ALSO NOTED

TODAY'S SPOTLIGHT... Progenics reports positive HIV data
Shares of Progenics got a bump after researchers announced that a single dose of its experimental HIV therapy significantly lowered the levels of the virus that causes AIDS in an early-stage trial. Report

> Bristol-Myers has broken ground on a $660 million drug plant in central Massachusetts. Report

> Canada's Lorus Therapeutics says it has signed an agreement with6707157 Canada to recapitalize and reorganize Lorus' business which, if completed, will result in the addition of approximately $7.8 million in non-dilutive financing. Release

> Oscient Pharmaceuticals has won the FDA's approval to add a new indication for Factive. It can now be used to treat mild to moderate community-acquired pneumonia. Release

> BioServe has acquired Genomics Collaborative from SeraCare Life Sciences. Release

> Robert Bosch GmbH plans to acquire Pharmatec GmbH from Fresenius. Report

> Paladin Labs' subsidiary Squire Pharmaceuticals has inked a pact to acquire a total of eight products currently marketed in Canada by Shire BioChem. Report

> Pfizer and Eisai say that their anti-clotting drug Fragmin has been given an additional approval by the FDA to reduce blood clots in cancer patients. Release

> ThromboGenics has updated investors on its pipeline development work. Release

> India's Strides Arcolab has terminated a deal with Accu-Break Pharmaceuticals to develop generic drugs for the U.S. market. Report

And Finally... Researchers have teamed up with Google Earth to create a map that tracks the spread of avian flu. Report



Solace Pharmaceuticals has recruited Dr. Eliot Forster, most recently Pfizer's head of development for Europe and Asia, as its new CEO.

Bristol-Myers has removed "interim" from James Cornelius' title as CEO.

Anaptys Biosciences has named Tom Smart to the newly created position of chairman and CEO. Smart is the former chief business officer at XOMA Ltd.

Wyeth said CFO Kenneth Martin will leave the company at the end of June.

Compugen has appointed Ronit Lerner as CFO and Rachel Bart as general counsel.

Ligand Pharmaceuticals has named John P. Sharp vice president of finance and CFO. Sharp replaces Interim CFO Tod Mertes.

Gustav A. Christensen is joining Dyax as executive vice president and chief business officer.

Prime Therapeutics has promoted Kim Mageau to COO.

US Oncology announced that its COO, George Morgan, will retire effective June 30, 2007.

Lori A. Kunkel, M.D. has been hired as chief medical officer of Proteolix.

PTC Therapeutics has promoted Neil Almstead to senior vice president of chemistry and CMC, chemistry manufacturing and controls.

Ilypsa has promoted Paul A. Stone to the position of senior vice president, general counsel and chief patent counsel.

Viron Therapeutics has appointed Claude R. Benedict, M.D. as senior vice president, clinical development and regulatory affairs.

David A. Saperstein, M.D. will be joining QLT as a consultant and interim chief medical officer and Paul L. Kaufman, M.D. was named head of the company's Ocular Scientific Advisory Board.

Dermagenics U.S., Inc., a subsidiary of Greystone Pharmaceuticals, has named I. Kelman Cohen, M.D. chief medical director.

Medicure has named Bonnie Zell as the company's senior advisor to commercial operations.

Techne Corporation announced that Richard A. Krzyzek, Ph.D., has been appointed vice president of research for its biotechnology division, and that Dr. Monica Tsang, the company's vice president of research, has announced her intent to retire.

NicOx has recruited Sanjiv Sharma as vice president of commercial affairs.

Tengion announced that Dr. Sharon Presnell has joined the company as vice president for regenerative medicine and biology.

William Champion, M.S., has joined Critical Path Services as a senior research scientist at their analytical laboratory.

PrimeGen Biotech has named Dr. Rudolf Jaenisch, to its Scientific Advisory Board.

ImmuneRegen BioSciences has Frederick "Skip" M. Burkle, Jr. to its Bioterrorism/Pandemic Influenza Advisory Board.

SinoBiomed announced that Dr. Dicken Shiu-Chung Ko, B.SC, M.D., F.R.C.S.C., F.A.C.S, has joined SinoBiomed's Advisory Board.

Diffusion Pharmaceuticals has named the following to its new Scientific Advisory Board: John L. Gainer, Ph.D. (Chair); Stuart A. Grossman, M.D.; John A. Jane, M.D., Ph.D., FRCS; and David E. Longnecker, M.D., FRCA.

The chairman of the board of directors of Epix Pharmaceuticals, Christopher F. O. Gabrieli, has decided to retire from the EPIX board.

INNOVIVE Pharmaceuticals has named Philip Frost, M.D., Ph.D., to the company's board of directors.

Oragenics announced that George Hawes is leaving his position as a member of the board.

Kyphon announced the appointment of D. Keith Grossman to its board of directors.

pSivida announced that Dr. Roger Aston, who joined the board as a non-executive director in December 2006, has resigned to focus on other activities including his role as the CEO of his new Australian based company, HalcyGen Pharmaceuticals Limited.

Adolor Corporation has elected Georges Gemayel, Ph.D. to its board of directors.

ImmunoGen has added Stephen C. McCluski to the company's board of directors.

Keryx Biopharmaceuticals has named Kevin J. Cameron to its board.

Allos Therapeutics has named Dr. Jeffrey R. Latts to its board.

Oculus Innovative Sciences has named Jay E. Birnbaum, Ph.D., to its board.

Bionovo has appointed Dr. Mimi Hancock to the company's board of directors.


EVENTS


* Post an Events Listing: Click here.
* General ad info: Click here.

> Partnering is Now Open for the 2007 BIO Business Forum - May 6-9, Boston

The 2007 BIO Business Forum offers an unparalleled opportunity for biotech and pharmaceutical companies, academic research institutions, and investors from around the world to gather in one place to learn about each other and to schedule private one-on-one meetings to discuss business opportunities of mutual interest. Click here for more information.

> 2007 BIO International Convention, in Boston, May 6 - 9, 2007

20,000 professionals from around the world and 1,900 exhibiting companies converge for the most important scientific breakthroughs, trends, and business opportunities in medicine, energy, agriculture, and materials. For more information and to register please visit www.bio2007.org

> Feasibility in Global Trials - May 17 Audioconference

Learn from an expert how to perform global feasibility to aid in planning and conducting clinical trials both time - and cost-effectively. For more information, go to http://www.fxtrans.com/resources/ac/future/ac20070517.htm.

> Understanding Pharma - May 22-23, Philadelphia, PA

Now available as an interactive two-day course! Based on one of the industry's best-selling books of 2006, Understanding Pharma provides the first practical, end-to-end perspective on how pharmaceutical and biotech companies really work. Ideal for industry veterans, individuals who support the industry, and those who are new to the industry or transitioning into new roles. Groups discounts available. Call (877)923-5600 or visit us online

> C21 BioVentures - May 22-24, Monterey, CA

The ninth annual C21 BioVentures offers the best opportunities to private emerging life science companies in the areas of partnering, investing, and networking. Produced by Technology Vision Group LLC, C21 BioVentures offers a relaxed and casual atmosphere to create deals and make new connections. For more information, visit www.techvision.com/c21.

> Streamlining Early CMC Drug Development - May 23-24, San Diego, CA

A 2-day comprehensive educational program: Understanding and Interpreting current FDA and EU regulations to Facilitate Approval of IND and CTA IMPD regulatory submissions. To register or for more information, visit http://bernsteincmc.com or call 510-658 - 3334 / email david@bernsteincmc.com.

> International Pharmaceutical Regulatory & Compliance Congress & Best Practices Forum - June 6-7, Brussels

Featuring INSEAD Professor Reinhard Anglemar; Peter Arlett, MDPrincipal Administrator, Pharmaceuticals Unit, European Commission; Nicola Bonucci, OECD Director of Legal Affairs; Christian Coquoz, Federal Prosecutor, Switzerland; Sir Christopher Gent, Chairman, GlaxoSmithKline; Peter Hustinx, European Data Protection Supervisor, European Union; Mark Mendelsohn, Esq., Deputy Chief, Fraud Section, US Department of Justice. Visit www.InternationalPharmaCongress.com, email register@internationalpharmacongress.com, or call +32.2.467.00.59.

> bioLOGIC Europe, 11 - 14 June 2007, President Wilson Hotel, Geneva, Switzerland

bioLOGIC Europe focuses on the strategic elements of biopharmaceutical operations and manufacturing. Don't miss this year's premier opportunity to meet the key biomanufacturing and biotech industry figures. Book today by calling +44 (0) 207 242 2324 or register online at www.lifescienceworld.com/2007/biologic

> Biotech Demystified: The Science Behind the Business- June 18-21, UC San Diego

Strengthen your company's competitive position, market growth and financial performance by mastering the science behind the biotech and pharmaceutical industries. Join industry leaders including Craig Venter and Chester Meyers at this popular, intensive 4-day course offered at UC San Diego, one of the premier research universities in the world. Additional details and information: http://www.rady.ucsd.edu/exec/programs/open/biotech/index.html?source=FierceBT


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