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

Related Articles:
Biopharma giants call on FDA to demand tough standards for biosimilars
Abbott tries to throw up roadblock to Humira biosim
Amgen VP warns FDA about quashing manufacturing innovation of biosimilars
How much cheaper will biosimilars be?

Amgen, VC groups pump $16.5M into Sutro Biopharma

Posted under Amgen, antibodies, Blog, Companies, Diagnostics, Eli Lilly, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Sutro Biopharma, Universities, VC, Videos by rmcbride

Sutro Biopharma has reeled in more capital to back work on next-generation protein drugs. Skyline Ventures led the second $16.5 million closing of the San Francisco-based startup's Series C round, which included backing from Amgen Ventures, Lilly Ventures, Alta Partners and SV Life Sciences.

The VC units of Amgen ($AMGN) and Lilly ($LLY) joined Alta and SV in the first $20 million closing of the $36.5 million third-round financing in November 2010. Sutro, founded in 2003, says it has landed almost $60 million from investors, and the company is among of bevy of biotech startups benefitting from pharma companies' growing role the venture game.

Sutro is working on antibody-drug conjugates and bi-specific antibodies with the company's protein drug platform. Last year the company landed a research pact with Pfizer ($PFE), agreeing to work on peptide-based drugs for the drug giant. Sutro aims to land more collaboration deals with biopharma partners as well as pursue its own drug programs, according to the company's release.

"Although we generally remain cautious, especially when investing in earlier stage companies, we see the tremendous potential for antibody drug conjugates and bispecific antibodies for drug development, particularly in cancer therapy," Skyline partner Leon Chen said in a statement. "We believe that Sutro's biochemical protein synthesis platform provides a unique opportunity to rapidly identify and develop next generation therapeutics that can be manufactured utilizing the same platform in accordance with current good manufacturing practices."

- here's the release

Related Articles:
Pfizer inks peptide deal with Sutro
Sutro raises $36.5M Series C for protein drug work

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

Amgen founding CEO George Rathmann dies at 84

Posted under Abbott Laboratories, Amgen, Blog, Companies, Diagnostics, Epogen, Funding, George Rathmann, Medical Devices, Medical Supply, Neupogen, Pharmaceuticals, Startups, Universities, Videos by john

George Rathmann, the biotech pioneer who founded Amgen, has died at the age of 84. 

Credited as one of the founding fathers of the biotech industry, Rathmann was working at Abbott Laboratories ($ABT) when he was recruited to run Amgen ($AMGN), which today ranks as the largest independent biotech company in the world. In the years after he took the helm of the company Rathmann helped steer the development of Epogen and Neupogen, two anemia therapies that have continued to deliver billions of dollars of revenue for the company. Only now does Amgen face rivals to its anemia franchise.

Jack Schuler, Rathmann's boss at Abbott, told The New York Times that he told Rathman was making the mistake of a lifetime when he left for Amgen. But Abbott went on to invest in the company, later turning its $5 million stake into a $250 million return. After leaving Amgen in 1990, Rathmann tried his hand at making Icos into a big success, but failed to repeat the magic he wielded at Amgen.

Today he's best known for his role at Amgen, which today has a market value of $54 billion. 

- here's the article from The New York Times
- read the obituary from the Los Angeles Times