Novartis has put up $10 million and promised up to €700 million more in milestones in exchange for an option on Transgene's promising, late-stage cancer immunotherapy.

France's Transgene will hold on to control of the upcoming Phase IIb/III pivotal trial of TG4010, which is slated to get underway by the end of this year after enrolling about a thousand patients with non-small cell lung cancer. Once Novartis gets its hands on the IIb portion of the data, the pharma giant will have 90 days to decide whether or not it will exercise its option on the program. The data is scheduled to arrive in early 2012.

If Novartis decides to pull the trigger on the option--a deal structure that is growing increasingly common in drug development--Transgene will get a fee plus milestones along with co-promotion rights in a list of countries that includes France and China. Novartis will gain control of the program and take responsibility for further costs.

"We believe this agreement represents the best way to accelerate development and create long term value for our shareholders," said Transgene CEO Philippe Archinard. "It is also consistent with the company's goal of becoming a fully integrated biopharmaceutical company as under this agreement Transgene will maintain certain commercialization and manufacturing rights."

- check out the press release
- here's the Reuters story

An FDA expert panel voted 9-3 Tuesday in favor of InterMune's Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on the condition that there will be a post-marketing period during which the drug won't be widely available until further data are available.

Not all the panelists were convinced of the drug's efficacy; however, most voted that the potential benefits of the drug outweighed these concerns. "I voted yes because I've been straight down the middle the entire time. I didn't see substantive evidence of efficacy per the FDA regulations but there was clinical meaningful effect on the disease. You need to offer patients hope. If this offers a smidgen of hope, then it is worth approving," one panelist said, according to TheStreet's Adam Feuerstein. Added another, "I voted yes, opposite of my vote on the question of substantial efficacy because I don't believe there is substantial evidence of efficacy; but if I got this disease, I'd be on the next Delta flight to Japan." 

The FDA doesn't have to follow the panel's recommendations, but it usually does. In a conference call, CEO Dan Welch said that if the drug is approved, it may take the company some time to ramp up production. "We chose not to make certain investments in commercial or other areas of the company until we had visibility from this meeting. So one should not expect that Esbriet would be available immediately after the approval."

During the call, analysts also attempted to suss out how InterMune would price the biologic if approved. InterMune also manufactures Actimmune, a treatment for chronic granulomatous disease that's been used off-label for the treatment of IPF. On-label, Actimmune runs in the range of $8,000 to $20,000 per year. When used off-label for IPF patients, the annual cost price per year shoots up to $50,000. "I don't know what you draw from that," noted Welch, unwilling to reveal the possible price of Esbriet. A final decision is expected May 4.

- check out InterMune's release
- read TheStreet's live blog on the panel meeting

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Abbott has succeeded where Biogen Idec once failed. The company announced late Tuesday that it's purchasing Facet Biotech for $450 million, or $27 a share. That's 67 percent premium over the biotech's closing price of $16.21 earlier today.

Abbott says the acquisition will boost its early- and mid-stage pharmaceutical pipeline. The developer has its eyes on two primary therapeutic areas--immunology and oncology. The highest-priority program is daclizumab, a Phase II biologic for multiple sclerosis that will move into Phase III trials in Q2 of 2010. Facet is already partnered with Biogen Idec on the compound. The biotech also has oncology compounds for multiple myeloma and chronic lymphocytic leukemia in early to mid-stage trials.

Last year Biogen attempted to purchase Facet, eventually making a "best and final offer" of $430 million after its initial $356 million bid was deemed hopelessly unrealistic based on the developer's cash position and pipeline. But with the support of two major investors, Facet was able to fend Biogen off, while at the same time noting that it would be open to more substantial bids from other companies. Biogen will owe Facet a big milestone on the launch of a late-stage study for daclizumab.

"This acquisition will further strengthen Abbott's biologics capabilities and pharmaceutical pipeline," says John Leonard, M.D., senior vice president, global pharmaceutical research and development, Abbott. "Daclizumab is a promising treatment for multiple sclerosis, a disease that has a significant unmet medical need, and has the potential to become an important treatment option for patients. We continue to explore multiple mechanisms to treat autoimmune diseases and cancer with both biologic and small molecule approaches."

Abbott has been on a buying spree as of late. It spent $10 billion on new acquisitions last year, paying $3 billion for Advanced Medical Optics and $6.6 billion for the prescription drug business of Solvay.

- here's Abbott's release
- read the BusinessWeek article for more

Related Articles:
Facet seeks new bids after Biogen offer flops
Biogen ups the ante for Facet
Biogen turns hostile in $356M bid to acquire Facet
Abbott CEO White still interested in fresh acquisitions

 @FierceBiotech: Between 4Q07 and 4Q09, 25 percent of US public biotechs disappeared (half via M&A), says BIO. | Follow @FierceBiotech

 @JohnCFierce: For sale: Ark Therapeutics. Willing to consider any serious offer. Buyer must be willing to mount new Ph3 for lead drug. Follow @JohnCFierce

> San Diego-based Tocagen has raised almost $7.8 million from 75 investors in a Series D round of financing. Article

> The FDA has granted ISTA Pharmaceuticals NDA for XiDay a PDUFA date of October 16, 2010. The company's request for a shorter, six-month priority review is still under consideration by the agency. ISTA release

> INSYS Therapeutics announced positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. INSYS release

> Amgen plans to sell $1 billion of senior notes in a two-part sale, reported IFR, a Thomson Reuters service. Report

> Stirling Pharma, an Australian group, has taken over North Sydney-based Keata Pharma for about $3.6 million. Report

And Finally... More than 100 researchers teamed up over two years pieced together a genetic blueprint of the bacteria that's found in the human digestive tract. Article

After considering all of its options, Pasadena, CA-based AutoImmune has decided to liquidate its assets and to dissolve the company. The developer had been working on products to treat autoimmune and other cell-mediated inflammatory conditions. The company ran into trouble after the Phase III failure of multiple sclerosis drug dirucotide, a treatment it had been developing with BioMS. In October, AutoImmune retained Junewicz & Co. to explore its strategic options. Shuttering its operations proved to be the best course, and the company plans to distribute all available cash to stockholders.

"After evaluating the Company's strategic options, the Board of Directors reached the conclusion that it is in the best interest of stockholders to liquidate and dissolve the Company," says CEO Robert Bishop in a statement. "In connection with the Company's plans to liquidate, we have begun the orderly wind down of the Company's operations, including seeking purchasers for the Company's intellectual property and other tangible and intangible assets and providing for the Company's outstanding and potential liabilities."

- here's AutoImmune's release

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