January 19, 2011
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In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.
The biosimilars market has also evolved in a couple of unexpected ways:
- Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
- At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”
As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.
This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.
January 18, 2010
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Another strong week for Canadian deals. Light on securities, but heavy on M&A, licensing and partnerships. MedGenesis and Cyplasin brought assets in, Canada and Australia are doing a do-sa-do (Topigen-Pharmaxis, YM-Cytopia), and Trillium Therapeutics signed an out-license to Biogen, while Medicure is shopping its lead program around. Less good news for Haemacure and Forbes Medi-Tech, but plenty of other deal info, including 7 HTX investments, to be found Read more of this post
February 25, 2009
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The question this week: a shot in the arm or a kick in the teeth?
A shot in the arm for:
- Fewer shots in the arm! (har)
- British Columbia is the first jurisdiction in North America to offer a children’s vaccine called Infanrix-hexa™, which contains six immunizations in one, resulting in three fewer needles in the overall B.C. infant vaccine schedule, and
- With the discovery of a constant region of flu virus protein hemagglutinin, a universal flu vaccine may be possible (no more yearly shots);
- The Naval Surface Warfare Center in White Oak, a suburb of Washington, where the FDA is spending $1.15 billion to consolidate its offices and labs and to anchor a new biotech hub;
- Pine Island, near Rochester, Minnesota, which could soon be the home to a new biotech research, development and manufacturing park with the help of up to $900 million in funding reportedly pledged by Steve Burrill. Funding announcements also from Maryland and Pittsburgh;
- Sustainable agriculture, when the White House announced its nominee for second-in-command at USDA: Kathleen Merrigan of Tufts University, who had been a top choice of the Cornucopia Institute to run USDA’s National Organic Program;
- The National Science Foundation, from the stimulus (a $3 billion boost) and the budget (a 6.7% increase, to $6.49 billion);
- Multiple Sclerosis, with Merck, Novartis, Teva, Biogen Idec and Sanofi Aventis all planning to release new oral therapeutics between now and 2012;
- Conflict of interest disclosure, with a new editorial in PLoS Medicine;
- Deterrence, with the arrest of four animal-rights extremists;
- Organ failure biomarkers,
- with the discovery of liver toxicity-associated MicroRNAs, and
- with the injection by Pfizer Canada of $1 million to the PROOF Centre to fund research into vital organ failure biomarkers; and
A kick in the teeth for:
February 11, 2009
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Deep Appreciation:for Phillip Terrence Ragon, founder and sole proprietor of database-software provider InterSystems who donated $100 million to establish a research institute that focuses on expediting the development of an AIDS vaccine, and to Pfizer Canada which contributed a further $2 million to British Columbia’s Center for Drug Research and Development (CDRD); and The State of Georgia is contemplating a $180 million bioscience research park.
Social Agitation: French scientists decided their street protests were their best approach to halting the government’s science and higher education reforms and rejected mediation.
Better Cogitation:Brain-Derived Neurotrophic Factor (BDNF) shows neuroprotective effects in animal models of Alzheimers’, but it won’t stop cries of ‘brain drain’ following Canada’s 2009 Budget.
Free Publication: ScienceInsider reports that Rep. Conyers’ (D-MI) bill that would eliminate free full-text publication of NIH-funded research is back on the table this session.
Self Regulation:More Pharma companies are implementing voluntary disclosure of physician payments (under threat of legislation); and some researchers are taking steps to prevent disclosures of potentially harmful research (under threat of annihilation).
Reconsideration: Researchers at Emory decided that flu pandemic deaths in 1918 may have been primarily from bacterial superinfections rather than the virus itself; Icahn decided to nominate another slate of Biogen-Idec directors; Everybody decided to take another look at their luciferase screening assay controls; and the Ontario Health Insurance Plan (OHIP) decided to take another look at payment for PSA testing for prostate cancer detection.