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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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Mixed pivotal data for lung drug boosts InterMune 

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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The 2009 Biotech Graveyard
Lilly, BioMS shutter MS drug program
BioMS stocks plunge on failed trial

Germany's Cellzome has inked a second drug discovery pact with GlaxoSmithKline in the field of inflammatory disease. Under the terms of the agreement, Cellzome will receive about $44.79 million in upfront payments.

The companies will use Cellzome's Episphere technology to identify small molecule candidates against targets from four different epigenetic classes. After they identify candidates, GSK will take over all preclinical and clinical development, as well as commercialization. If all programs under the alliance are successfully developed and commercialized, additional milestone payments could exceed $645 million, according to GSK.

Cellzome and GSK signed their first inflammatory disease collaboration in September 2008. Through this partnership, the companies hope to identify and develop selective kinase inhibitors using Cellzome's Kinobeads technology. Cellzome also has partnered with Ortho-McNeil Pharmaceutical, Bayer HealthCare and Novartis on various projects.

 - read more in this report

Related Article:
GSK signs $1.5 drug dev deal with Cellzome

Publisher's Note: This article was based on an embargoed press release posted on Genetic Engineering News' site, and has since been removed. The embargo will be lifted at 12:01am on Wednesday, March 10. - Arsalan Arif

With Astellas Pharma and OSI Pharmaceuticals haggling over price, BNet Pharma wonders which biotechs could be next on the buyout menu. Mega-mergers might have been all the rage in 2009; however, with few targets left, the focus will shift to smaller acquisitions. Big Biotechs Biogen Idec and Gezyme could be on the menu, given Carl Icahn's involvement in the companies.

So which smaller developers could be targets? Here's BNet's list:

• Vertex Pharmaceuticals' promising hepatitis c drug telaprevir is in Phase III trials, and the company has a pipeline of drugs that features treatments for cystic fibrosis, epilepsy and inflammatory diseases
  
  
• GlaxoSmithKline is already partnered with Human Genome Sciences on its lupus drug Benlysta, which analysts predict could lead to $4 billion in sales.
  
  
• Alexion Pharmaceuticals boasts Soliris, the world's most expensive drug, which pulls in about $400 million a year. The developer has four Phase II trials for other indications of the drug, which is currently approved for a rare blood disorder.
  
  
• Sales of pulmonary arterial hypertension drugs Remodulin and Tyvaso have led United Therapeutics to $370 million in annual revenues.
  
  
• With $844 million in sales last year, Bayer and Onyx Pharmaceuticals' kidney and liver cancer drug Nexavar came close to the blockbuster mark. Four Phase III trials are testing the drug for additional indications
  
  
• Auxilium Pharmaceuticals is looking for more uses for its Testim testosterone gel and Xiaflex, a drug for hand contracture disease.
  
  
• Allos Therapeutics won approval last year for Folotyn as a treatment for peripheral T-cell lymphoma; trials for cutaneous T-cell lymphoma are under way.

- read the BNet article for more details

The Pulmonary-Allergy Drugs Advisory Committee is meeting today to review InterMune's NDA for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis. As a result, trading of the company's stock has been halted. InterMune release

BARCELONA - The emphasis in the European biopharma scene is squarely on finding a new equation for drug discovery that relies less on internal R&D operations and more on external drug discovery work. And the balancing act has created a lively amount of new partnering discussions here at BIO-Europe Spring.

Just in case anyone might have missed that point, AstraZeneca's Geoff Collett, a business development executive, took a moment during a presentation this morning and highlighted a quote from his boss, David Brennan, that made it crystal clear: "Externalization will be a way of life going forward."  

Got it?

The reason is simple, says Morgan Stanley's Andrew Baum. He tells the Financial Times that partnering on a drug program is less risky than relying on in-house projects and mid-stage programs Big Pharma companies collaborate on are likely to have a rate of return three times higher than the companies can earn on their own.

But even as AstraZeneca joins a long list of big companies that are reengineering their whole approach to drug development, Brennan is also cautious about how much can be cut. "You still need to have sufficient in-house staff," he tells the FT, "to scrutinize external projects."

These are lean times in the European biotech industry, but it was hard to see that in the packed presentation rooms at Bio-Europe Spring. On Tuesday morning a slate of big and small developers were on hand to provide a snapshot look at their partnering plans, and there was no shortage of would-be collaborators in the audience.

In a form of biopharma speed dating, a host of companies including Novartis, AstraZeneca and Merck offered some highlights of their partnering interests. And there's a highly ecumenical approach to deal-making these days.

"We're not married to one particular deal structure," says Collett. In this climate, it helps to keep an open mind. - John Carroll twitter | email

More from BIO-Europe:
The biotech spring arrives in Barcelona

London-based Ark Therapeutics' efforts to pioneer a gene-based brain cancer therapy in Europe hit a new hurdle today as European regulators demanded a new trial of Cerepro ahead of any approval. Ark pulled its marketing application, which had been rejected last December, and says it's considering selling the company.

An expert advisory panel for the European Medicines Agency decided at the end of last year that Cerepro failed to measure up to its efficacy standards. The therapy is Ark's lead program, and this new setback drove its shares down 15 percent, leaving the developer studying its options.

"Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value," the company says in a statement. A number of approaches have been made to the company, it added, but there's no guarantee of an offer.

- here's the press release
- here's the story from Reuters

Related Article:
Ark shares soar on gene therapy data

South San Francisco-based Exelixis is axing 270 jobs--40 percent of its workforce--as it circles its wagons around its top three cancer programs.

Citing SEC documents, the San Francisco Business Times reports that the axe will fall hardest on the company's drug discovery unit. And the developer says that slashing its budget for salaries, lab supplies and clinical trial costs will help the company save $90 million through 2011.

The spotlight now will primarily focus on three cancer programs--for XL184, XL147 and XL765--while its preclinical development program has been scaled to produce one new IND per year. Exelixis will continue development of XL888, an orally available small molecule inhibitor of HSP90 currently in Phase I, XL139 and XL413, compounds co-developed with BMS, as well as its preclinical program focused on PI3K delta

"Our priority is to see ourselves through to the anticipated filing of our first NDA for XL184 in the second half of 2011," said George A. Scangos, president and CEO of Exelixis.

- check out the Exelixis release for more information
- here's the report from the San Francisco Business Times

Related Articles:
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Exelixis, Boehringer enter $354M autoimmune pact
BMS to pay Exelixis $240M for cancer drugs
Exelixis pockets $20M in BMS cancer collaboration

America's got talent—can it keep it?

Nature Biotechnology 28, 181 (2010). doi:10.1038/nbt0310-181

To remain competitive in biotech, policymakers should pay more attention to retaining skilled foreign workers than to fixating on illegal immigration.

H1N1dsight is a wonderful thing

Nature Biotechnology 28, 182 (2010). doi:10.1038/nbt0310-182

Criticisms of the response of governments and of the pharmaceutical industry to the threat of the H1N1 epidemic are wide of the mark.

Ark's gene therapy stumbles at the finish line

Nature Biotechnology 28, 183 (2010). doi:10.1038/nbt0310-183

Author: Peter Mitchell

Monsanto's alfalfa reaches Supreme Court

Nature Biotechnology 28, 184 (2010). doi:10.1038/nbt0310-184

Author: Boonsri Dickinson

GSK/Sirtris compounds dogged by assay artifacts

Nature Biotechnology 28, 185 (2010). doi:10.1038/nbt0310-185

Author: Charlie Schmidt

US biodefense contracts continue to lure biotechs

Nature Biotechnology 28, 187 (2010). doi:10.1038/nbt0310-187

Author: Catherine Shaffer

Ride 'n Drive on government waste

Nature Biotechnology 28, 188 (2010). doi:10.1038/nbt0310-188

Melanoma vaccine for dogs

Nature Biotechnology 28, 189 (2010). doi:10.1038/nbt0310-189a

Author: Suzanne Elvidge

Biotechs go virtual

Nature Biotechnology 28, 189 (2010). doi:10.1038/nbt0310-189b

Author: Susan Aldridge

Chinese institute makes bold sequencing play

Nature Biotechnology 28, 189 (2010). doi:10.1038/nbt0310-189c

Authors: John Fox & Jim Kling