Lilly posts clean safety data on PhIII diabetes blockbuster hopeful

Posted under Blog, Clinical Trials, Companies, Diabetes, Diagnostics, Eli Lilly, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Startups, Universities, Videos by John Carroll

The FDA's demanding requirements on cardio safety data has made diabetes one of the most challenging diseases in the drug development world. Today, Eli Lilly ($LLY) demonstrated that its late-stage diabetes drug dulaglutide cleared an important cardiovascular safety hurdle, impressing analysts with a savvy clinical game plan on an important experimental product in its pipeline.

Eli Lilly CEO John Lechleiter has already made it clear that dulaglutide is one of the company's top blockbuster hopefuls in its late-stage pipeline. Now investigators have data from a mid-stage study of 755 patients--two thirds of whom were diagnosed as hypertensive--demonstrating that dulaglutide is comparable with a placebo in its effect on systolic blood pressure.  

In addition, Lilly reported, "the 1.5 mg dulaglutide dose significantly reduced mean 24-hour SBP (systolic blood pressure) compared to placebo." And at the end of 16 and 26 weeks the drug--a once-weekly GLP1 therapy that could end up competing with Bydureon--significantly reduced average blood glucose levels.

"We are very encouraged by these clinical trial results, in addition to the rest of the clinical trial data we've seen to date for dulaglutide," said Gwen Krivi, Ph.D., vice president of product development at Lilly Diabetes in a statement. "Dulaglutide is currently in Phase III clinical trials, where it will continue to be evaluated on its efficacy to lower blood glucose levels, overall safety, weight effects and effects on cardiovascular outcomes. We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes."

- get the press release
- here's the story from Reuters
- read the report from Dow Jones

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UPDATED: In rare slap, FDA review rips up Pfizer’s case for tafamidis

Posted under Blog, Companies, Diagnostics, familial amyloid polyneuropathy, FDA, FoldRx Pharmaceuticals, Funding, Medical Devices, Medical Supply, neurodegenerative diseases, Pfizer, Pharmaceuticals, rare diseases, Regulatory, Startups, Tafamidis, Universities, Videos by John Carroll

Pfizer gambled big when it took data from a single study to back its application for tafamidis as a treatment for a rare neurodegenerative disease. And an FDA review of the data concludes decisively that the company lost. After considering the trial's failure to meet its co-primary endpoints and questioning the data gathered at 8 sites, the agency is recommending that the experts gathering to discuss the drug's fate on Thursday reject the therapy.

"I recommend a Complete Response action, based on inadequate evidence of effectiveness," stated the FDA reviewers in a rare, outright slap at an application. The agency isn't bound by either the review or the panel vote on Thursday, but Pfizer's ($PFE) team will face an uphill struggle when it makes its case for tafamidis--a therapy for familial amyloid polyneuropathy--later in the week.

In the review, the agency investigator picks apart the data, wondering why most of the responders were clustered in one site while 7 other sites offered little by way of supporting data. "Overall, Study 005 does not have the characteristics of a single adequate and well-controlled study that could make the study adequate support for an effectiveness claim," the review states.

Pfizer, though, plans to put its case on the drug in the best light possible.

"There is currently no FDA-approved treatment designed specifically to treat TTR-FAP," Pfizer noted in a statement to FierceBiotech this morning. "If approved by the FDA, tafamidis will be the first and only medication in the U.S. to treat patients with this debilitating genetic disease. Pfizer believes that the data for tafamidis provide substantial evidence of effectiveness and meaningful therapeutic benefit where there is a high unmet medical need. We look forward to discussions with the FDA and its Advisory Committee to further the understanding of TTR-FAP and the data supporting our NDA."

Pfizer landed tafamidis when it acquired FoldRx in a buyout back in 2010 as it pushed into the rare disease field. Like other pharma companies, Pfizer was lured by the prospect of big returns for drugs that meet an urgent need in tiny patient populations. About 8,000 people around the world, including 2,500 in the U.S., suffer from the neurodegenerative disease Pfizer was focused on. But the pharma giant, which is still trying to shed its reputation as a poster child for clinical ineptitude, may be rethinking the business plan this morning.

- here's the FDA review
- read the story from Reuters

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Biotechs raise new VC rounds to back inhalable drugs, antimicrobials

Posted under asthma, Biotech Venture Capital, Blog, chronic obstructive pulmonary disorder, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Pipeline, Prosonix, Startups, Universities, Videos, Zurez Pharma by John Carroll

The Oxford, U.K.-based Prosonix has hauled in an added $9 million for its second venture round and plans to put the money to use developing a slate of inhalable drugs using its particle engineering technology. The new money brings its total B round to $27 million.

Gimv joined a slate of European venture groups already backing the biotech, which is working on development programs for an inhaled corticosteroid for asthma, a long-acting muscarinic antagonist (or LAMA) for chronic obstructive pulmonary disorder as well as combo treatments.

"Prosonix is at an important point in its development," says Gimv partner Karl Nägler in a statement. "Based on the demonstrated performance of its particle engineering platform and approach, the near-term product opportunities in its pipeline, its highly experienced team and a strong and experienced group of investors, we are confident that Prosonix can become a significant player in the area of respiratory medicines." 

In other venture news this morning, Madison, WI-based Zurex Pharma says it has raised $6.2 million in its A round, with Baird Venture Partners and the State of Wisconsin Investment Board putting up the cash. Zurex has been developing antimicrobial washes designed to prevent hospital-acquired infections. And the CEO says it hasn't been easy raising cash in this financial environment.

"We're playing our version of 'The Hunger Games' here in Wisconsin," Carmine Durham told the Wisconsin State Journal. "For a company like ours, it's probably one of the most significant series A financings done in a long time."

- read the press release for Prosonix
- here's the story on Zurex

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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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