Takeda shutters Bay Area R&D shop in California shakeup

Posted under antibodies, antibody-drug conjugates, Blog, Cancer, Companies, Diagnostics, Funding, immunology, Medical Devices, Medical Supply, Pharmaceuticals, R&D, San Diego, South San Francisco, Startups, Takeda, Universities, Videos by John Carroll

Five months after Takeda announced it was formally integrating its R&D efforts in South San Francisco and San Diego into a single entity, the Japanese pharma company dropped the news that it will now shutter its Bay Area ops and move its most essential staffers and technology down south into an expanded "center of excellence."

Putting its scientists in one spot will help "enhance communication and collaboration," noted Takeda, as they pursue new antibodies and small molecules for cancer, immunology and metabolic disease. The company went on to tout its technology, boasting of X-ray crystallography work and its antibody-drug conjugates.

"This decision supports our continuous efforts to enhance the efficiency and effectiveness of Takeda's global research activities," said Paul Chapman, senior vice president of Takeda's Pharmaceutical Research Division, in a statement. "Takeda California, with its broad and flexible drug discovery capabilities, is an important asset and contributor to Takeda's productivity."

Ron Leuty at the San Francisco Business Times noted that Takeda's San Francisco chief, Mary Haak-Frendscho, recently took a new job at Compugen. There's no word on the ultimate fate of Takeda's non-essential employees, or how many will be let go in the consolidation. The Business Times noted that at one point there were 65 workers at the site, at a time when Takeda was projecting employment to hit 100. 

- here's the press release
- get the report from the San Francisco Business Times

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Lundbeck soars on PhIII success for blockbuster hopeful

Posted under Blog, Clinical Trials, Companies, depression, Diagnostics, Funding, Lexapro, Lundbeck, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Regulatory, Startups, Takeda, Universities, Videos by john

Lundbeck shares spiked 9% this morning on the news that three late-stage studies of its new depression drug had delivered the data needed to support upcoming regulatory filings. The developer badly needs new therapeutics to replace Lexapro, an antidepressant that now faces generic competition.

"Lu AA21004 statistically significantly reduced depression symptoms in patients with (major depression) compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale," the company reported. "In total, out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect of Lu AA21004. Further analysis of the data is ongoing and data are expected to be presented at upcoming medical conferences." 

Lundbeck and its partner, Takeda, now plan to jointly file for an approval in the U.S. in the second half of the year, while Lundbeck will push ahead on its own in Europe and Canada. Bloomberg notes that Lundbeck has estimated potential annual revenue from the drug at about $2 billion.

It's standard operating procedure to mount a series of clinical studies for any new depression drug, as high placebo responses have been known to torpedo studies. Takeda and Lundbeck plan to jointly continue studies examining the drug's impact on cognitive dysfunction in depression.

- here's the press release
- read the Bloomberg piece

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Takeda rebuffed (again) in long quest for FDA drug OK

Posted under Actos, alogliptin, Blog, Companies, Diabetes, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Takeda, Universities, Videos by john

Four months before Japan's Takeda will get hit with a tsunami of generic competition for the diabetes blockbuster Actos, the FDA has once again rebuffed the company's application to sell the experimental drug alogliptin. More than 5 years since it originally sought an approval, the drug giant says that the agency wants more data before it can issue an approval for the treatment, which was intended to replace Actos.

The move to re-file the drug was always considered something of a gamble. Takeda and its partner Furiex ($FURX) launched new studies after the treatment was turned down in 2009. Those trials won't be complete until 2014, though the companies had hoped that interim cardio data would suffice for an approval.

Takeda says those ongoing studies, along with data gathered in markets outside the U.S., should satisfy the regulators. "We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues," said Takeda regulatory chief Thomas Harris in a statement. "We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved."

The FDA has never been easy on diabetes drugs, and in recent years regulators have toughened up even more with demands for extensive safety data. Shares of Furiex plunged more than 20% on this latest setback.  

- get the press release
- here's the story from Bloomberg

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Affymax banks $50M milestone on ESA drug approval

Posted under Affymax, Amgen, Anemia drugs, Blog, Companies, Diagnostics, Epogen, Funding, Medical Devices, Medical Supply, Omontys, Partnering, peginesatide, Pharmaceuticals, Regulatory, Startups, Takeda, Universities, Videos by john

Affymax ($AFFY) has banked a $50 million check from its partner Takeda Pharmaceutical after they won FDA approval for peginesatide, an anemia treatment that will now compete with Amgen ($AMGN) for market share. The biotech will co-promote the treatment in the U.S., which will be sold as Omontys. Analysts expect it to earn upward of $700 million a year, much of it taken from Amgen's Epogen franchise. Release