Biotech company news

Noven expands pipeline with $125M JDS buyout

Tue, 10 Jul 2007 00:01:37 -0400

Noven Pharmaceuticals is paying $125 million in cash and assuming $10 million in debt to clinch a deal to acquire New York-based JDS Pharmaceuticals. Noven, which makes drug patch products, bags two products on the market and a pipeline of experimental therapies for psychiatry and women's health. JDS's two approved drugs are Lithobid for bipolar disorder and Pexeva for depression. If all goes according to plan, Noven says the acquisition will add more than $500 million in new sales by 2012. JDS' co-founder Phillip Satow is set to join the board after the deal closes in August.

- see the release on the buyout
- check out the AP report on the buyout

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Biotech start-up pockets $8.7M in venture cash

Tue, 10 Jul 2007 00:01:34 -0400

Cellumen says it will use an $8.7 million injection of venture capital to begin its commercialization efforts. The company specializes in cellular systems biology for drug discovery work. Safeguard Scientifics provided $6 million of that while PA Early Stage Partners put up $2 million.

- see the release
- read the the Pittsburgh Business Journal report

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Roche harnesses Alnylam's RNAi tech in $1B deal

Mon, 09 Jul 2007 00:01:38 -0400

Demonstrating once again the powerful pull of RNAi, Roche has agreed to pay $331 million up front--including an equity payment--and up to a billion dollars overall for the nonexclusive licensing rights to Alnylam's gene silencing technology. Roche winds up with a 5 percent stake in the company. It's a huge deal for Alnylam, which recorded about $27 million in revenue last year. Alnylam's stock soared 61.6 percent on the news. The package includes a $15 million payout to acquire Alnylam's German research center, which employs some 40 people.

"This technology has the potential of fundamentally treating disease in a new way," said Alnylam CEO John Maraganore. "That type of option, given the level and significance of human disease that is unsatisfactory today, that level of impact is profound."

- see the release on the deal
- here's the AP report
- and check out the Wall Street Journal's report (WSJ sub. req.)

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Pfizer, BMS report Phase II clotting trial success

Mon, 09 Jul 2007 00:01:36 -0400

More on the clotting drug race: Bristol-Myers Squibb and Pfizer announced that their oral anti-clotting therapy--apixaban--demonstrated comparability to the current standard of care that relies on an injectable combined with a drug that includes warfarin. The experimental pill hit its endpoints in a mid-stage study for the rates of blood clots and dangerous bleeding. The researchers say that a comparable therapy would allow patients to bypass a standard approach that includes harsh side effects and regular injections. Apixaban doesn't require close monitoring or dose adjustments.

- read the report from CNNMoney

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Pfizer partners with BMS in $1B deal. Report

BioVex raises $22M for ongoing cancer trial

Mon, 09 Jul 2007 00:01:35 -0400

Woburn, MA-based BioVex--which is working to develop new therapies for cancer and infectious diseases--has raised $22 million in the first close of its fifth round. Medical Ventures led the round. New Science Ventures joined as a new investor along with existing investors such as ABN Amro (Forbion), Avalon Ventures, Credit Agricole Private Equity, GeneChem Management of Montreal, Innoven Partners and Scottish Equity Partners.

"Building on the impressive data that has recently been generated with our lead cancer product, OncoVEX GM-CSF, in the clinic, the funds raised in this round will allow us to complete our Phase II program and to complete preparations to advance OncoVEX GM-CSF into a registration study in metastatic melanoma," said BioVex CEO Philip Astley-Sparke. "The funds will also be used to progress our lead infectious disease candidate, a vaccine for genital herpes, through to Phase II. "

- see the release on the new round

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Silence shouts about $400M AstraZeneca deal

Fri, 06 Jul 2007 00:01:38 -0400

Silence Therapeutics has partnered up with AstraZeneca in the early stage identification and development of short interfering RNA (siRNA) molecules in a deal that has a potential payoff of up to $400 million. Silence gets $15 million of that up front in access and equity payments that give AstraZeneca a 2.94 percent stake in the company. In turn AstraZeneca gets a license to Silence's siRNA technology, which has become a red-hot technology approach in biotech.

"We look forward to working with AstraZeneca to develop new RNAi therapeutics for the treatment of respiratory diseases, whilst concurrently continuing to create further significant shareholder value via the development of our proprietary oncology pipeline," Silence's chairman Iain Ross said.

- see Silence's announcement about the deal
- here's the report from Hemscott

Genzyme diarrhea drug fails Phase III

Fri, 06 Jul 2007 00:01:37 -0400

Genzyme shares took a nasty hit after researchers announced that its once promising diarrhea drug tolevamer failed to prove superior to standard therapy in a late-stage trial. The drug proved well tolerated and safe, but not as effective as vancomycin. The news triggered a 5 percent decline in the company's stock price.

"These are disappointing results that alter our expectations about the potential for commercializing tolevamer in the near future," said Henri A. Termeer, chairman and chief executive of Genzyme.

- see Genzyme's release
- read the AP report on the trial data

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BMS sees positive outcome for cancer drug

Fri, 06 Jul 2007 00:01:36 -0400

Bristol-Myers Squibb says its cancer drug ixabepilone has demonstrated activity in a Phase II trial for metastatic breast cancer among patients resistant to three types of chemotherapy. The trial involved 126 patients in a single-arm study.

"Drug resistance is a major concern in treating patients with advanced disease," said Renzo Canetta, vice president, Oncology Global Clinical Research, Bristol-Myers Squibb. "The results of this study are important as they provide valuable information about this investigational compound and its potential in patients with advanced breast cancer that is no longer responding to any of the current U.S. approved chemotherapy treatments."

- here's the release

ALSO: BMS has scrubbed a partnership with Medivir to develop MIV-170 for HIV. Medivir said the drug did not meet BMS' desired profile. Release

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Provenge delay triggers furor among cancer victims

Fri, 06 Jul 2007 00:01:35 -0400

The FDA's decision to delay approving Provenge until Dendreon can provide additional efficacy data has triggered intense anger among patients desperate to get the vaccine, which is designed to allow patients to live longer with advanced prostate cancer by stimulating their immune systems. The FDA's delay was at least partly attributed to the opinions of two top oncologists who questioned the drug's effectiveness. Now the experts have been exposed to threats, accusations of conflicts and the full-throated furor of cancer advocacy groups.

One other reason for all the buzz this week about Provenge: A new study is raising questions about the way cancer vaccine trials are designed. Cancer vaccines and therapeutics have been tested the same way as trials sought data related to tumor shrinkage. But vaccines can take longer to demonstrate a benefit and the study in Clinical Cancer Research suggests that the vaccines will allow patients to live longer and suffer less toxicity.

- read the article from The Washington Post
- check out the report on the new study

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Florida's $250M development cache threatened

Fri, 06 Jul 2007 00:01:34 -0400

Florida has come up with a cache of $250 million to further prod the growth of its biotech sector, but county officials say they will have trouble coming up with the matching funds needed to get access to the money. Florida has won wide acclaim for drawing in some of the world's top research institutes, and now the Max Planck Institute and New York's Rockefeller University are rumored to be interested in expanding in the sunshine state. Another big project in the works: the IBM-Scripps Florida program for influenza. If Florida can pull off any of these, it will gain another leg up on the 50-state competition for biotech projects. FierceBiotech picked Florida as one of the top five regions attracting biotech business in 2007.

- read the Palm Beach Post report

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Genaera abandons two studies in pipeline switch

Thu, 05 Jul 2007 00:01:38 -0400

Genaera has changed gears on its pipeline strategy after shuttering two mid-stage studies--one for Lomucin as a therapy for cystic fibrosis and the other for squalamine to treat prostate cancer. The Lomucin study was abandoned for "reasons of futility" while squalamine was shelved due to trouble restarting the cancer trial. Genaera will now focus on trodusquemine for obesity and the anti-IL-9 asthma program licensed to MedImmune.

"We continue to be very encouraged by the progress of the MEDI-528 Phase II program in asthma," said CEO Jack Armstrong. "This is an asset that is below the radar screen of many, and we believe has greater present and future value than is currently recognized by the market. Separately, our trodusquemine Phase 1 study in obesity is progressing nicely through the initial cohorts in Study 101 to test safety and PK.

- see the release
- check out the AP report

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Genzyme shifts focus after hylastan fails trial

Thu, 05 Jul 2007 00:01:37 -0400

Genzyme announced that it will focus its commercialization efforts in the arena of osteoarthritis pain on Synvisc-One after its experimental drug hylastan failed to achieve its primary goal in a clinical trial. Hylastan was being studied as a potentially less expensive therapy for OA pain. But researchers found no significant difference in patients' response to either hylastan or steroids. Genzyme has submitted an application to the FDA for Synvisc-One and plans to apply for a CE Mark to introduce Synvisc-One in Europe.

"We structured our development program in a way that provided us with several chances to reach our goal of introducing a single-injection product," said Ann Merrifield, president of Genzyme Biosurgery, which manufactures and markets Synvisc. "It is now clear that we will focus our efforts on bringing Synvisc-One to the market."

- check out the release for more information

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Cosmo shares buoyed by successful antibiotic data

Thu, 05 Jul 2007 00:01:36 -0400

Shares of Italy's Cosmo Pharmaceuticals were buoyed by news of positive preliminary data from a Phase II/III trial of Rifamycin for infectious diarrhea. The antibiotic hit its primary goal of the time from taking a dose to the last unformed stool. Analysts immediately leaped on the news, citing the likelihood that the company would soon take several strides forward on its development. Lehman Brothers pegged potential annual sales at $120 million.

"We believe these positive data could now enable the product to be partnered in Europe and filed in selected European countries," said Lehman Brothers. "In addition, Cosmo will now likely commence a Phase III study for U.S. regulatory filing."

- see the release
- here's the AFX report for more data

PDUFA debate highlights drug safety issues

Thu, 05 Jul 2007 00:01:35 -0400

The House is expected to take up PDUFA legislation soon, and that has renewed the debate over the impact of the fees and the possibility of new requirements related to pharmacovigilance. PDUFA, which has to be reauthorized every five years, has been a hot topic of late. Critics maintain that PDUFA has given the drug industry too much influence at the FDA, which is seeking an $87 million boost in the amount of money it brings in from the fees. But The Washington Post notes that the way the legislation is being molded in Congress, reauthorization this year seems highly likely. The industry has been largely satisfied with the way PDUFA, originally passed in 1992, has helped speed the drug review process.

New reports, though, have helped fuel the debate. One study shows that biopharma has profited considerably from faster approval times, but another researcher has linked faster approvals to greater safety troubles. Both of those topics will be front and center in the debate that's coming.

- read the article on PDUFA reauthorization from The Washington Post

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Bioenvision shareholders shun Genzyme takeover bid

Tue, 03 Jul 2007 00:01:38 -0400

In a rare example of investor solidarity, the shareholders in control of Bioenvision stock effectively blocked a proposed $350 million takeover by Genzyme. Only 26 percent of shares were tendered by the deadline Sunday night, far fewer than the majority Genzyme needed to complete the sale. Genzyme, an aggressive player in the M&A game, said it would extend its deadline to July 10 and would be satisfied with a large stake in the company, if it comes to that. Genzyme says there's no talk of hiking the bid.

- check out the report from The Boston Globe

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New combos of old drugs may be boon to biotech

Tue, 03 Jul 2007 00:01:36 -0400

New York Times scribe Andrew Pollack takes a careful look at the current trend of making new drugs out of combinations of old therapies. Despite reporting one trial failure last week, CombinatoRx is out in the lead on this one. Researchers at the company are systematically running through the possible combinations of 2,000 generic drugs. But Pozen, Orexigen and other biotechs have combinatorial programs in place as well.

- read the article from The New York Times

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Par strikes $65M licensing deal for antifungal therapy

Tue, 03 Jul 2007 00:01:34 -0400

Par Pharmaceutical has agreed to pay up to $65 million to license the U.S. rights to the antifungal therapy Loramyc from France's BioAlliance Pharma. The drug is in late-stage trials for oropharyngeal candidiasis, an infection common among immunocompromised patients. BioAlliance gets $15 million up front, another $20 million on the FDA's approval and up to $30 million in scheduled milestones. The drug has already been approved in France. BioAlliance has a 50-50 joint venture deal to commercialize the drug in the rest of Europe with SpeBio.

- see this release on the deal
- here's the report on the deal from Thomson Financial

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Novartis pays big for roster of new vaccines

Mon, 02 Jul 2007 00:01:38 -0400

In a strategic move aimed at swelling its pipeline of experimental vaccines in one fell swoop, Novartis has agreed to pay Intercell €270 million for an equity stake as well as an upfront fee to license more than 10 early and pre-clinical development programs. The programs include new therapies for bacterial and viral diseases as well as influenza. And Novartis obtains options on future vaccine candidates that Intercell comes up with. In the pact, Novartis will take over development and commercialization of any new product that gets past Phase II.

Among the various Intercell projects eligible to Novartis are the IC43 vaccine candidate for use in patients with hospital-acquired Pseudomonas infections, which is now in Phase II trials and will expand the range of nosocomial vaccines in the Novartis pipeline, and the pre-clinical vaccine IC47 against pneumonia infections in the elderly and infants.

- see the release
- here's the AFX report for more info

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Biogen inks $220M deal for Cardiokine drug

Mon, 02 Jul 2007 00:01:37 -0400

Biogen Idec is paying $50 million up front--and potentially $220 million in total--for the commercialization rights to Cardiokine's lixivaptan. The Philadelphia-based biotech's drug is poised to enter late-stage development for hyponatremia, a condition characterized by a lack of sodium in the bloodstream. The condition can exacerbate CHF. Cardiokine retains co-promotion rights to the drug in the U.S. Phase III trials get underway later this year.

- check out the release for more
- here's the report from the Triangle Business Journal

ALSO: Biogen CFO Peter Kellogg is leaving the company to take the same post at Merck. Release

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Newron reports positive mid-stage pain data

Mon, 02 Jul 2007 00:01:35 -0400

Italy's Newron Pharmaceuticals is reporting that its pain-killer ralfinamide significantly reduced neuropathic pain in a mid-stage trial. In addition, researchers said that the drug was well tolerated with side affects that were commensurate with a placebo. Analysts dubbed the news as an encouraging sign that the therapy merited further development, sending Newron's shares up in early trading. A Phase IIb trial is scheduled to get underway later this year. Analysts are now shifting their focus to safinamide, Newron's lead candidate for Parkinson's, which is due to deliver late-stage results.

- here's the AFX report

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