Amgen pushes agenda for biosimilars on the FDA

Posted under Amgen, Aranesp, biosimilars, Blog, Cancer, Companies, Diagnostics, Enbrel, Epogen, FDA, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos, Watson Pharmaceuticals by rmcbride

Amgen ($AMGN) has some concerns as the U.S. progresses toward a regulatory pathway for biosimilars development. As one of the largest biotech drugmakers, the company plans to advise the FDA today to adopt standards to guard the safety, supply chain and understanding of the copycat biologics.

The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars. Dr. Joseph Miletich, Amgen's senior vice president of R&D, plans to speak on behalf of his company, which is a major player in the biosimilars game. Besides the company's tie-up with Watson to advance cancer biosimilars, Amgen faces competition from knockoff versions of its biologics.

In a release this morning, Amgen revealed that Miletich plans to push for the agency to adopt rules which would put tracking systems in place and distinguish biosimilars from the originals, make clear to doctors and others that biosimilars aren't substitutes for the real thing unless the FDA deems them interchangeable, and keep high quality standards for production of biosimilar products.

Amgen clearly has an interest in protecting the company's franchise of biotech drugs such as Enbrel, Epogen and Aranesp. The company's deal with Watson excludes development of biosimilar versions of Amgen drugs. Yet there are literally hundreds of companies chomping at the bit to develop copycat version of biologics, if not in the U.S., than in emerging markets. And many have already debuted biosimilar products. 

Biogen Idec ($BIIB), Novartis ($NVS) and other large drugmakers are also investing in biosimilars but have an interest in safeguarding their intellectual property for biologics. Biosimilars are much larger and complex molecules than small-molecule generics, and there are major challenges to developing a copycat version of a biologic with the same properties and risk/benefit profile as the original.

"The biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances," Miletich said in a statement. "It will be essential for FDA to clearly communicate to all stakeholders what biosimilar products are and are not."

- here's Amgen's release

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PRA snags Amgen’s PhIII biosimilars contract

Posted under Amgen, biosimilars, Blog, Clinical Trials, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Partnering, Pharmaceuticals, Phase III, PRA, Startups, Universities, Videos, Watson Pharmaceuticals by john

PRA has snagged an exclusive deal to run Amgen's worldwide Phase III biosimilar studies. The contracting coup comes four months after Amgen ($AMGN) tied up with Watson ($WPI) on an ambitious pact to develop biosimilars of some leading cancer therapies. Watson signed on with a capped investment of $400 million over the next 7 years, while Amgen has an open-ended commitment to the deal. And analysts were intrigued by the notion of a leading biologics company jumping into an arena that has already attracted a lineup of Big Pharma players like Merck ($MRK) as well as a group of multinationals. Story

Columbia Labs axing 42% of jobs after FDA shoots down drug application

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, FDA, Funding, layoffs, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaginal gel, Videos, Watson Pharmaceuticals by Ryan McBride

Fresh off the setback of an FDA denial, Columbia Laboratories ($CBRX) will cut deeply into its workforce and let go 42% of its employees, the company said. The drug developer expects to shave $1.5 million from its annual expenses and plod forward with partner Watson Pharmaceuticals ($WPI) to advance a vaginal progesterone gel that recently failed to gain FDA approval. 

In the meantime, Columbia is weighing "all strategic options moving forward," the company said.

Livingston, NJ-based Columbia is sending pink slips to 10 of its 24 workers, with the majority of the cuts made to jobs in research and development and administration, according to the company's release. The leaner workforce of 14 employees plans to forge ahead with the company's programs, which make use of its bio-adhesive drug delivery technologies.

The layoffs come after the company's announcement on Monday that the FDA handed Columbia and Watson a complete response letter for their application for approval of the progesterone gel for lowering risk of preterm births. U.S. regulators told the companies that more data on the efficacy of the treatment was needed before it could be considered for approval again.

"Our action today is difficult, particularly because we greatly appreciate the contributions of those we must let go," Columbia CEO Frank Condella said in a statement. "However, it is a step we must take to streamline operations and secure the company's positive financial position."

- here's the release

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FDA rejects Columbia Labs’ gel to prevent preterm births

Posted under Blog, Columbia Laboratories, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaginal gel, Videos, Watson Pharmaceuticals by John Carroll

Just weeks ago, after FDA regulators and agency experts lined up squarely against an approval for a vaginal gel from Columbia Laboratories ($CBRX) and Watson Pharmaceuticals to reduce the risk of preterm birth, Columbia's CEO declared himself convinced of the justification for a formal approval. This morning, when the company revealed that the FDA had rejected the application, Columbia announced that it had been handed a complete response letter "as expected."

The company stood by its complaint that regulators had zeroed in on something they never expected: The robustness--or lack thereof--of the sub-cohort of U.S. patients in the study. The agency has made it officially clear now that it wants more clinical evidence of efficacy for Prochieve before it hands out an approval.

"Watson will work directly with the FDA to address items raised in the complete response letter regarding the approvability of progresterone vaginal gel 8% for reduction of preterm birth. We have formally requested an end of review meeting with FDA to determine if a viable path forward can be established for this application," said Paul M. Bisaro, Watson's CEO. "We believe that there is a significant unmet medical need for a safe and effective treatment of patients at risk for preterm birth which affects approximately one-in-eight live-born infants in the U.S."

The writing on the wall for this treatment started last summer, when Columbia failed to achieve a priority review for the treatment. Then in January regulators flatly stated that investigators never presented sufficient data to make their case, and the experts agreed days later.

Evidently the rejection still caught a few people by surprise. Columbia's shares fell another 8% in premarket trading.

- here's the press release

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