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 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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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 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

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Santhera grabs $192 million CNS licensing deal

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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