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While Samsung is mostly know for flat screen televisions and other electronic appliances, one of South Korea’s largest companies has been quietly evaluating a play in the protein engineering and manufacturing space. For those of you who may not know, Korea possesses one of Asia’s most vibrant biotechnology industries. At present, there are over 600 Korean biotechnology companies in existence. In April 2011, Samsung created a business units called Samsung Biologics which specializes in biopharmaceutical manufacturing.

Today, Samsung formally announced that it would create a joint venture with America’s Biogen/Idec to develop market and manufacture biosimilar molecules. Under the terms of the agreement, Samsung will invest $255 million and garner a 85% stake in the venture which will be located in South Korea. Biogen/Idec will invest $45 million for a 15% stake in the joint venture. Samsung will take a leading role in developing and marketing the joint venture’s products whereas Biogen/Idec will contribute expertise in protein engineering and biomanufacturing. The joint venture will not develop biosimilar versions of Biogen/Idec’s proprietary, branded protein-based drugs which include Avonex (MS), Rituxan (oncology) and Tysabri (MS).

Biogen/IDEC is the first “big biotech” company to jump on the biosimilar train. The company joins Merck BioVentures and Sandoz (Novartis) as major players in the biosimilar marketplace. Teva, which began looking at biosimilars about eight years ago, is also widely believed to be a biosimilar player. While the financial fate of biosimilars is still uncertain in the US, these molecules are generally perceived as having a much higher financial upside in large emerging markets such as China, Korea, Brazil and Russia which are susceptible to government pricing controls.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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The conversation about follow-on biologics became extremely muted after passage of the US Healthcare Reform Act which included a 12 year period of data exclusivity for innovator company products. This provision inhibits biosimilar manufacturers from introducing generic versions of branded biologics for 12 years from the date the US Food and Drug Administration granted a license for the branded product. While this may effectively limit activity in the follow-on biologics space in the US, it didn’t stop Merck from launching its BioVentures Division (dedicated to follow-on biologics development) almost two years ago.

At the time of the announcement Merck executives in charge of the BioVentures Division divulged that its first product would be a PEGylated version of Amgen’s anemia drug Epogen (EPO). Unfortunately, a PEGylated version of EPO doesn’t qualify as a follow-on biologics because PEGylated proteins are considered new molecular entities (NMEs) by regulatory agencies. Nevertheless, Merck also said it would develop other follow-on products and that its efforts would be based primarily on the proprietary humanized yeast biomanufacturing platform it acquired after purchasing Glycofi, a New Hampshire-based biopharmaceutical company that developed the technology. Interestingly, two weeks ago Merck announced that it was abandoning the PEGylated-EPO product that it mentioned two years ago at the BioVentures kick off press conference.

It isn’t clear whether or not Merck jettisoned the project because of patent infringement litigation, regulatory concerns or possibly because of the increasingly fierce competition in the EPO space. Another possibility is that pharmaceutical companies have finally realized that biologically-active proteins are costly to manufacture and have limited therapeutic applicability as compared with monoclonal antibodies (MAbs) which are taking the biopharmaceutical industry by storm. At last count, there were over 300 MAbs in various phases of pre-clinical development with and about 125 in late stage clinical development. Last week, Teva and Lonza announced plans to develop a biosimilar version of Roche’s anti-inflammatory and cancer MAb Rituxan (rituximab)—kicking off a new era in the biosimilar industry.

For those of you who are unfamiliar with or remain interested in the follow-on biologics debate, I came across a nice PowerPoint presentation given by Teruhide Yamaguchi at the Division of Biological Chemistry and Biologicals at the National Institutes of Health.

Quality Safety and Efficacy of Follow-on Biologics

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Good Luck and Good Job Hunting!!!!!!

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At its annual business briefing, Merck’s CEO, Richard Clark, announced that the company is creating a new division called BioVentures that will develop and sell follow on biologics. Clark said that the reason for this surprising decision was based on “the arrival of the Obama administration and renewed enthusiasm on Capitol Hill for legislation that could create an easier path for generic biotech medicines.”

Merck’s new BioVentures division will be built around the humanized yeast manufacturing platform developed by Glycofi, a privately-held, company that Merck acquired two years ago. While most of big pharma and big biotech publicly lobbied against new legislation that would make follow-on biologics legal in the US, Merck was surprisingly low key on the subject (now, we know why).

I first learned about Glycofi’s technology platform shortly after the company was formed in the early 2000 and immediately recognized its implication for follow-on biologics manufacturers. I immediately contacted Glycofi’s CEO at the time to see whether or not they would hire me as a “follow-on biologics consultant.” Sadly, because cash was tight (as it always is at start ups) I didn’t get the gig but I did get to know Tillman Gerngross, one of the Glycofi’s founders and its Chief Scientific Officer. Tillman and I spent some down time together at many of the follow-on biologics conferences that I organized where he was an invited speaker.

I was glad (mostly for Tillman) when I learned that Merck was going to by Glycofi for $400 million in cash. That said, the acquisition didn’t make sense to me at the time because Merck didn’t have a biologics division (although it did have a successful vaccine division).  After today’s announcement, Merck’s decision to purchase Glycofi makes perfect scientific and financial sense to me. I wish I could have gotten a piece of Glycofi before Merck bought the company. Nevertheless, I take solace in the fact that I, like Merck’s executives, can recognize a winning technology when I see one!

Maybe Merck will turn itself around after all!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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