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Latest Bio-Pharma News

• Cebix raises $16M
  September 3rd, 2010, 02:47 AM (PDT)
  

  San Diego-based Cebix has raised $16 million over the last 14 months, according to filings obtained by Xconomy. The company is developing a replacement therapy based on human proinsulin C-peptide for the treatment of Type 1 diabetic neuropathy. Article

• Roche plots layoffs as it focuses on R&D
  September 3rd, 2010, 02:47 AM (PDT)
  

  Roche has confirmed that it plans to cut jobs, as reported by newspaper Sonntag earlier this week. Billing it as an "Operational Excellence initiative," Roche says it will review it structure over the coming months and make a formal layoff announcement by the end of the year. It will be implemented during 2011 and 2012. "In view of mounting pressures to curb healthcare costs--especially in the United States and Europe--together with recent developments in late-stage projects in the Roche pipeline, this initiative aims to adapt cost structures and accelerate productivity improvements Group-wide," the company says in a statement. Roche adds that it will devote more resources to treatments and diagnostic tools that will meet the needs of a changing healthcare environment.

  Although Roche CEO Severin Schwan (photo) says in a statement that the company is launching the restructuring from a "position of strength," Pharmalot notes that the Swiss drugmaker has been hit with a series of recent pipeline setbacks that have caused some concern. Roche has delayed development of its potential blockbuster Type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects. In addition, the FDA handed Roche and Genentech a refuse-to-file letter for the developers' BLA for trastuzumab-DM1. Trials of rheumatoid arthritis drug ocrelizumab were suspended, and the FDA is reviewing a breast cancer indication for blockbuster drug Avastin. "The net effect is that we have had to revise our revenue forecasts and must now adapt our business and manage our costs more carefully so as to safeguard our funding of innovation," the company says in a memo.

  Roche provided no further details on the cuts. "Cost savings could easily reach 2 billion Swiss francs ($1.9 billion) as of 2012 to 2013, which would boost our earnings per share forecast by some 10 percent," Helvea analysts Odile Rundquist and Karl-Heinz Koch tell Reuters.

  - here's Roche's release
  - check out Pharmalot's assessment
  - read the Reuters report

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  Paper: Roche mulls 'massive' worldwide job cuts
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  Roche faces long delay for diabetes drug taspoglutide
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  FDA panel votes to yank Avastin indication

• Forbion raises $240M investment fund
  September 3rd, 2010, 02:47 AM (PDT)
  

  European investment firm Forbion Capital Partners has announced the closing of a €190 million ($240m) life sciences investment fund. The VC--which has offices in the Netherlands and Germany--aims to invest most of the money in Europe and the remainder in North America and Israel. Forbion will focus its investments on private companies developing novel drugs, medical devices and diagnostics for high or unmet medical needs.

  According to Reuters, Forbion is considering an investment in Amsterdam Molecular Therapeutics, which is awaiting EMA approval of its lead product Glybera. Forbion Managing Partner Bart Bergstein also says his firm is mulling two stock listings of biotechs it had previously invested in.

  "We are very pleased to have raised such a substantial amount as fundraising conditions have never been more challenging" notes Bergstein in a statement. "Given that only few venture players have active funds to commit from, we currently see many highly attractive assets from an increasingly rich deal flow. We are therefore confident that both new funds could be at least as successful as FCF I."

  - take a look at Forbion's release
  - see the report from Reuters

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• Santhera, Ipsen ink fipamezole pact
  September 3rd, 2010, 02:47 AM (PDT)
  

  Santhera Pharmaceuticals and Ipsen have inked an agreement for fipamezole, which is being studied to treat levodopa-induced dyskinesia in Parkinson's disease.  

  Under the terms of the agreement, Ipsen will acquire the rights to fipamezole outside the U.S., Canada and Japan for an upfront payment of €13 million ($16.7 million) and additional payments contingent to future development, regulatory and sales milestones of up to €128 million ($164.6 million). Santhera also is entitled to royalty payments on Ipsen's future net sales.

  Biovail is scheduled to start Phase III testing of the product next year. Santhera granted Biovail the development and commercial rights to fipamezole in the U.S. and Canada in August 2009.

  "This agreement with Santhera will further enrich Ipsen's pipeline with a new promising first-in-class compound thus complementing our fast-growing neurology franchise, in clear medical and operational synergy with our existing portfolio," says Stéphane Thiroloix, Ipsen's executive VP, corporate development, in a statement. "We have been impressed with the scientific and development capabilities of both Santhera and Biovail. Ipsen will benefit from the Biovail development and collaborate fully to achieve regulatory filings excluding North America planned for 2015."

   - check out Santhera's release

  Related Article:
  Santhera grabs $192 million CNS licensing deal

• Pfizer returns brain cancer vax rights to Celldex
  September 3rd, 2010, 02:47 AM (PDT)
  

  Pfizer is returning the rights to rindopepimut (CDX-110), a therapeutic cancer vaccine, to Celldex Therapeutics. Pfizer, which gained rights to the drug as part of $440 million deal in 2008, says it's returning the rights because the drug is "no longer a strategic priority" for the company, raising questions about the viability of the program and sending Celldex's stock down sharply. Researchers are evaluating rindopepimut as a potential treatment for glioblastoma multiforme, a common type of brain tumor.

  Celldex will regain full worldwide rights to develop and commercialize rindopepimut. The company says it plans to move ahead with more trials of the drug. TheStreet notes that as of June 30, Celldex had $65.8 million in its coffers; it will have to draw upon that nest-egg to fund late-stage trials of rindopepimut.

  The general prognosis for anyone diagnosed with malignant glioma is poor, and patients generally have up to three years to live following diagnosis. "There is a significant need for new therapies for GBM and we are fully committed to developing rindopepimut for the patients who suffer from this fatal disease," says Celldex President and CEO Anthony Marucci. "[T]he program has advanced significantly, including the completion of a multi-center Phase II study, the development of a diagnostic companion product, the manufacture of drug supply for clinical studies, and the execution of discussions with regulatory agencies on the design of a global controlled study."

  - check out Celldex release
  - read TheStreet article for more

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• UAB spin-off's tech could shorten drug dev to 6 weeks
  September 3rd, 2010, 02:47 AM (PDT)
  

  Findings from research at the University of Alabama at Birmingham has helped create a company--Soluble Therapeutics--that specializes in protein-based drugs and vaccines. The spin-off has created technology that speeds the production of protein-based products used in insulin production and blood clot treatments. Drug development that used to take 12 to 18 months could be shortened to as little as six weeks with the new technology, CEO Joseph Garner explains.

  The company has orders to fill for the remainder of the year and has been looking to expand, Garner says. "We hope in the next couple of months to be adding to the work force as there is gained interest in this form of technology," he adds.

  Soluble is the second biotechnology company to spin off from UAB research and incorporate this year, the other being VIPAAR, the Birmingham Business Journal reports. In addition, it is one of about 40 entities to spin off from the school's R&D since the UAB Research Foundation formed more than 20 years ago, according to the foundation's website.

  - get more from the Birmingham Business Journal

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• Submit your candidate for the Fierce 15
  September 2nd, 2010, 02:47 AM (PDT)
  

  As we first noted yesterday, FierceBiotech will reveal the 2010 class of Fierce 15 companies later this month, and readers are being offered a chance to nominate a drug developer for this special report. So if you know of a biotech company with great science, a great staff and enormous potential, here's a chance to put them in the spotlight. Click the link to fill out the form. - John Carroll (twitter | email)

• Antibiotic gets positive FDA staff assessment
  September 2nd, 2010, 02:47 AM (PDT)
  

  Shares of Forest Laboratories jumped on the news that FDA staffers found that their new antibiotic ceftaroline appears to be an effective therapy for skin infections and pneumonia. The staff review comes in advance of a key panel vote on the new antibiotic. Analysts have estimated that ceftaroline could garner $361 million in sales by 2014. Story

• Analysts: New FDA rules inspire tougher drug reviews
  September 2nd, 2010, 02:47 AM (PDT)
  

  The analysts at Concept Capital did the math on this year's decisions by FDA expert panels and reached the disturbing conclusion (for biotech execs, anyway) that the numbers clearly indicate that the panels are getting tougher.

  On 23 tries related to new chemical entities and major new indications, developers won 12 votes in favor of recommendation--a 52 percent rate of approval. "The percentage of 'yes' recommendations is down significantly compared to 2009 and 2008, when 75 percent and 80 percent of drugs received positive recommendations," Ramsey Baghdadi, an analyst with Concept Capital, tells Adam Feuerstein at TheStreet, which has the full story.

  What's behind the new level of intensified criticism? New rules require a review now for most new therapies, which is triggering more votes. And the analysts insist that tougher conflict-of-interest rules are forcing the agency to pick less experienced people for the panel. That could be bitter news for anyone up for a review. A negative vote can torpedo a new drug's chances at the agency.

  - here's the story from TheStreet

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• Nobel Prize-winner finds new path for Alzheimer's drug
  September 2nd, 2010, 02:47 AM (PDT)
  

  After 25 years of ongoing research, Nobel Prize-winning scientist Paul Greengard is unveiling a new pathway at work in Alzheimer's--a discovery likely to trigger a fresh burst of R&D work around a new therapy for the mystery disease.

  Alzheimer's has proved a vexing target for drug developers. Eli Lilly was bitterly disappointed to learn that its drug candidate actually appeared to make the disease worse in trial participants. And Medivation's Dimebon was scuttled by a failed late-stage study.

  As the New York Times explains in its feature on Greengard's work, Lilly's scientists had focused on shutting down gamma secretase, which is needed to make beta amyloid, a common marker for the disease. But gamma secretase does more than generate the brain plaque, and drug developers who block it entirely may well hurt patients.

  Greengard, though, found a protein that is needed by gamma secretase to produce beta amyloid--and only beta amyloid. A variation of Gleevec that can remain in the brain--something the current formulation can't accomplish--may be just what's needed.

  "You could use Gleevec as a starting molecule," Harvard Alzheimer's expert Rudolph Tanzi tells the Times. "You could change the structure a little bit and try analogs until you get one that does what Gleevec does and does not get kicked out of the brain. That's possible."

  - read the NYT story

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