2009 marked a year of extremes for the biotech segment. While headlines about major workforce reductions, slashing R&D projects to save money, and heightened FDA scrutiny ran rampant, good news also caught our attention. Here are the most important stories from last year.
The New Congress
Barack Obama seems to have brought with him a renewed interest in science. The year began with the approval of the American Recovery and Reinvestment Act, which devoted $21.5 billion for science and research. In August, President Obama appointed Francis S. Collins, M.D., Ph.D., known for his leadership of the Human Genome Project, as the new director of the NIH. The President concluded the year by bringing the much debated Healthcare Reform Act closer to completion. The industry has, for the most part, been supportive of the bill but urges that innovation not be forgotten. The Senate and House are now tasked with reconciling the differences between their respective bills and trying to make sure that no one is left out.
Embryonic Stem Cells
President Obama also reversed President Bush’s ban on federal funds for embryonic stem cell research. In July, just four months after the president’s decision, NIH put forth guidelines for such funding and in December approved the first set of human embryonic stem cell lines for research under these rules. A report released toward the end of December, however, pointed out that more ethnic diversity in stem cell lines was required to enable comprehensive research. On the industry side of things, embryonic stem cells have had mixed reviews. In January Geron was given the go-ahead to begin Phase I trials with its hESC-based treatment for spinal cord injury, but new animal data prompted the FDA to place the study on hold in August. Besides these regulatory uncertainties, much remains to be done from a legal point of view to ensure a good return on investment as well as to harmonize cultural differences and morality issues.
The debate over biosimilars also heated up during 2009. Political pundits are still hashing out the details; the term for data-exclusivity, currently set at 12 years, is the major sticking point. In the meantime, the industry is clearly gearing up for the onslaught of biosimilars and will have to keep track of how legislation pans out. Merck & Co. set up a division focused on biosimilars, generic drug giant Teva Pharmaceutical is also making a play for biogenerics, and countries like India and China, where biosimilars are already common, are strategizing to expand their markets.
The so-called emerging markets certainly played a significant role last year as is evidenced by the increased interest from major players in these regions. Countries like India, China, and Brazil, which have traditionally been hubs for CROs, are now sporting companies involved in the entire life cycle of a bringing a drug to market. GlaxoSmithKline (GSK) expanded into South Africa, Pfizer formed alliances with Indian firms, Novartis bought a controlling stake in a Chinese vaccine company, and Sanofi Pasteur, Evotec, PerkinElmer, Merck KGaA, as well as Lonza each picked up Indian companies. GSK set up a joint venture in China focused on vaccines, Novartis invested $1.25 billion in new facilities in China, and Merck Serono invested almost $216 million in an R&D site to be set up in China. Novartis is also trying to gain more control of its operations in India, as are Millipore and Pfizer.
The Legalese behind Gene Patenting
As long as genes have been known to exist, there has been controversy over whether they should be allowed to be patented. Once scientists were able to isolate a gene, they won the argument that such a process was indeed patentable. In the middle of last year the American Civil Liberties Union filed a case against Myriad Genetics, challenging the patentability of the BRCA1 gene. And not suprisingly, ACLU plans to take on the issue of patenting all genes in general.
The much heralded arrival of a cancer vaccine is, well, not yet upon us but is at least closer. Dendreon and Biovest both had Phase III success with their respective vaccine candidates. However, other companies are still struggling, with Genitope's MyVax and Favrille’s mitumprotimub-1 failing in Phase III.
Besides the aforementioned biotech news highlights from 2009, we’d like to point out a few more developments that will likely serve as fodder for future trends.
- Genzyme was hit by contamination issues in one of its bioreactors in July. The resulting shortfall of the firm’s therapy for Gaucher disease, which is also the only available treatment for the disease, created a unique opportunity for competitors with Phase III candidates, namely Shire and Protalix. It also created a buzz around rare diseases, which have traditionally been scorned by bigger pharmaceutical companies, so much so that Pfizer bought global rights to Protalix’ drug. Additionally, Genzyme’s cell-culture production problems triggered a renewed interest in plant-based methods. Here are some related links:
Genzyme Temporarily Halts Production at Plant in Massachusetts (June 16, 2009)
Genzyme Plant Shutdown Could Mean up to $300M in Lost Sales (July 2, 2009)
Companies Step In to Fill Gap in Enzyme Replacement Therapy for Gaucher (July 24, 2009)
Shire Reports Positive Data from First Phase III Study of Gaucher Disease Therapy (Aug. 3, 2009)
EMEA Issues Treatment Recommendations to Preserve Supply of Genzyme’s Gaucher Drug (Aug. 14, 2009)
Restart of Genzyme’s Allston Landing Production Plant Has Been Completed (Sep. 23, 2009)
Protalix’ Gaucher Therapy Demonstrated Positive Results in Phase III (Oct. 15, 2009)
Refocusing on Therapeutic Protein Production in Plants (Nov. 20, 2009)
Big Pharma Adopting Orphan Drug Strategy (Dec. 14, 2009)
- Obesity has become an equal, if not greater, contributor to the burden of disease, according to a report to be published in February issue of the American Journal of Preventive Medicine by researchers from Columbia University and The City College of New York. We thus believe we’ll see more basic research and drug development activity in this space in coming years. Here are some of the top obesity stories from 2009:
The Obesity Epidemic—It's Your Fault (and Yours, and Yours...) (Dec. 7, 2009)
Obesity Therapies Show Lackluster Efficacy Results (Dec. 3, 2009)
Amylin to Receive $75M in Obesity Alliance with Takeda (Nov. 2, 2009)
Arena Reports Positive Data from Phase III Trial with Obesity Therapy (Oct. 26, 2009)
Orexigen’s Obesity Therapy Shows Promise in Phase III (July 20, 2009)
Merck & Co. Pays Galapagos €1.5 million to Kick Off Diabetes and Obesity Alliance (Jan. 9, 2009)
- Last year’s biggest acquisitions included Pfizer’s $68 billion purchase of Wyeth, Merck & Co.’s $41.4 billion buyout of Schering-Plough, and Roche’s $46.8 billion offer for the 44.1% of Genentech it didn’t already own. The Roche/Genentech consolidation is significant for a few different reasons. It marks the world’s second largest pure biopharmaceutical company being gobbled up, and begs the question: Are others like Amgen, Genzyme, and Gilead Sciences next? It also makes one wonder what Genentech’s future holds. The company is known for its strong research model and oncology focus but has already begun to diversify into other diseases. Here are some related links:
How Biotech Unions Could Save Companies and Revitalize Pipelines (Nov. 17, 2009)
This Year’s Major Mergers—What Makes Sense and What Doesn’t (July 17, 2009)
Pfizer to Pony Up $68B for Wyeth (Jan. 26, 2009)
Merck to Pony Up $41.4B for Schering-Plough (Mar. 9, 2009)
Genentech Goes Beyond Antibodies with Bayhill Therapeutics Diabetes Deal (June 19, 2009)
Roche Wins Over Genentech with $46.8B Offer (Mar. 12, 2009)
Roche Sweetens Its Bid for Genentech Offering $45.7B (Mar. 9, 2009)
Roche Cuts Acquisition Offer for Genentech to Roughly $42.47B (Jan. 30, 2009)
Genentech Believes that It Is Worth More than the $43.7B Roche Is Offering (Aug. 13, 2008)
Roche Makes $43.7B Bid for Genentech (July 21, 2008)
- Of course, any discussion of medical issues in 2009 would be incomplete without a mention of swine flu. While it turned out to be much more manageable than was presumed, it did instigate a wave of influenza research. With swine flu expected to surge again this year, we believe R&D interest in this space will continue. Check out some related stories:
Researchers Reveal Major Differences between Current H1N1 Strain and Other Recent Flu Strains (Nov. 17, 2009)
Novartis’ Swine Flu Vaccine Effective at Half the Current Antigen Dose (Nov. 17, 2009)
FDA Clears CSL's Seasonal and Swine Flu Vaccines for Pediatric Populations (Nov. 12, 2009)
FDA Grants Emergency Use Authorization to Gen-Probe's PCR Test for the H1N1 Flu (Oct. 29, 2009)
Blog: Killer Vaccines and Deadly Viruses on the Rampage!!! (Aug. 31, 2009)
FDA Okays Vaccines for 2009 H1N1 Influenza Virus (Sep. 16, 2009)
Swine Flu’s Ability to Attach to Lung Receptors Increases Chance of Respiratory Problems (Sep. 10, 2009)
Inovio and NIH Vaccines Research Center Ally on Swine Flu and Universal DNA Vaccines (Aug. 10, 2009)
NIH to Evaluate Novavax Vaccine Candidate for Novel H1N1 Strain (June 4, 2009)
Blog: Swine Flu fear Boosts Biotech Stocks (Apr. 27, 2009)