Astellas, biotech VCs to pump $14M into virtual drug developer

Posted under AkaRx, Alcresta, Astellas Pharma, Blog, Companies, Diagnostics, Drais Pharmaceuticals, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, Telsar Pharma, ulcerative colitis, Universities, VC, Videos, Virtual model by rmcbride

Venture firms have teamed up with drugmaker Astellas Pharma to advance a startup called Telsar Pharma. Astellas and the venture firms, Interwest Partners and Sutter Hill Ventures, plan to invest $14 million into Telsar, which was formed to develop a drug from Astellas' pipeline for treating ulcerative colitis.

Telsar is operating virtually under the management of Drais Pharmaceuticals, which also counts InterWest and Sutter among its investors. Drais, based in Bridgewater, NJ, plans to work with Astellas to determine whether other Astellas' compounds can be pumped into Telsar's pipeline, the companies said. Telsar's first drug licensed from Astellas, ASP3291, is a melanocortin receptor agonist that could combat ulcerative colitis, a disease that causes painful inflammation in the colon and rectum.

The Drais team previously ran AkaRx, which Eisai bought in 2010 for $300 million, according to a Drais spokesperson. Astellas, InterWest and Sutter were all investors in AkaRx as well.

The virtual model has become hot. Investors are seeking efficient ways to bring biotech products to market, and rather than build new teams to develop experimental treatments, venture firms and biotech entrepreneurs have favored strategies like Telsar's that make use of existing resources. Last week, for instance, the founders and backers of drug developer Allena Pharmaceuticals revealed that they had formed a nutritional products startup called Alcresta, with the Allena team serving as the only full-time employees of Alcresta. Investors are seeking efficient ways to bring biotech products to market.  

- here's the release

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Aveo on a hiring spree as it preps for the launch of tivozanib

Posted under Astellas Pharma, AVEO Pharmaceuticals, Blog, Companies, Diagnostics, Funding, Kyowa Hakko Kirin, Medical Devices, Medical Supply, Nexavar, Pharmaceuticals, Pipeline, Startups, TIVO-1, tivozanib, Universities, Videos by john

Early this year, when Aveo Pharmaceuticals published the data from its head-to-head matchup between its experimental kidney cancer drug tivozanib and industry standard Nexavar, analysts were so unimpressed by Aveo's ($AVEO) margin of victory on disease progression that the company's shares took a beating. But the Cambridge, MA-based biotech has been consistently upbeat about its market potential in the lead-up to its regulatory filing, and Aveo is going full steam ahead on its expansion plans.

The fast-growing developer tells The Boston Globe that it plans to hire 120 new staffers this year in preparation for the likely upcoming launch of tivozanib, which delivered a median PFS rate of 11.9 months compared with Nexavar's 9.1 month rate in a late-stage study. Tuan Ha-Ngoc, president and chief executive officer of Aveo, also pronounced himself "delighted with the favorable safety profile observed in TIVO-1."

Despite the mixed reception, tivozanib remains one of the most closely watched late-stage cancer drugs in the industry. Its success at the FDA would mark a key turning point for Aveo, as it transforms itself from a developer into a more mature company with a drug to sell.

Aveo in-licensed tivozanib from Japan's Kyowa Hakko Kirin and partnered on the program with Astellas Pharma. Now it plans to file for an approval in the third quarter, setting up the prospects of a likely launch next year. At that point Aveo can find out just how well tivozanib can do against the market competition.

- here's the story from The Boston Globe

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Optimer inks $90M C. difficile drug pact with Astellas

Posted under Astellas Pharma, Blog, C. difficile, Companies, Diagnostics, Dificid, fidaxomicin, Funding, Medical Devices, Medical Supply, Optimer Pharmaceuticals, Partnering, Pharmaceuticals, Pipeline, Startups, Universities, Videos by john

Optimer is pocketing a $20 million up-front payment on a new commercial pact for its treatment for C. difficile. Astellas is paying out the cash, and promising up to $70 million more along with double-digit royalties for the right to commercialize fidaxomicin in Japan. The two are already partnered in Europe, where they recently gained marketing approval.

The deal marks another advance for Optimer ($OPTR) as it works to build revenue for the twice-daily pill. Approved by the FDA last May, fidaxomicin--sold as Dificid--has been slowly gaining traction on the sales side. 

"Japan is a key territory we have prioritized for geographic market expansion and complements nearer-term market opportunities in the U.S., Canada and the European Union as we continue to pursue additional international market opportunities," notes Optimer CEO Pedro Lichtinger.

Jefferies' Eun Yang has estimated potential U.S. sales of fidaxomicin at about $153 million. That's not a lot, but as Xconomy reported a couple of months ago, the biotech is mounting new clinical trials to demonstrate the drug's effectiveness as a preventive measure for C. difficile, a common and lethal pathogen found in hospitals. Starting with a population of at-risk bone marrow patients, Optimer is looking for the data needed to win an expanded approval, laying the foundation for as much as $380 million in added annual sales by 2020. 

- here's the release
- get the Xconomy profile from January

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Scoring winners and losers in Japan pharma M&A bout

Posted under Astellas Pharma, Blog, Companies, Diagnostics, Funding, Japan, Medical Devices, Medical Supply, Mergers and Acquisitions, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Japan's biggest pharma players have been roaming the world in recent years in a restless search for new acquisitions. They've been looking for deals to put an extra oomph into their earnings. Now The Wall Street Journal is reviewing the biggest buyers and seeing who scored the juiciest gains, and who harvested bitter losses. Astellas Pharma, which acquired OSI Pharmaceuticals in 2010, comes out on top. Story