Despite recession, bioscience sector sees gains
HGS, others mark commercial, research success
While the recession continued to put a damper on the venture capital lifeline for Maryland's bioscience industry, a few companies celebrated some significant advances, both financial and scientific.
In the first half of the year, Human Genome Sciences posted $162.4 million in sales of its anthrax treatment, ABthrax, to the U.S. Strategic National Stockpile. Then, in July, the Rockville biotech secured a new federal purchase order for 45,000 doses to be delivered over the next three years. But the company hit a snag when a Food and Drug Administration advisory panel, in considering HGS's application for marketing approval, questioned the treatment's effectiveness in animal studies.
Yet HGS also racked up victories with successful results from clinical trials of two treatments: Zalbin for treating hepatitis C and Benlysta for lupus, for which no new treatment has been approved by the FDA in 50 years. The company has applied for FDA marketing approval for Zalbin, which it is developing with Novartis; the Swiss pharma giant has already paid HGS $207.5 million in their collaboration, with total payments potentially reaching $507.5 million. HGS plans to seek FDA marketing approval for Benlysta next year.
Meanwhile, United Therapeutics of Silver Spring continued to win FDA approval for new products to treat pulmonary arterial hypertension. This year, the FDA approved its inhaled Tyvaso treatment two months after the agency approved the company's Adcirca oral treatment for the same condition. Company officials expect annual sales upward of $300 million from Adcirca, which is the same compound as Eli Lilly's erectile dysfunction drug, Cialis. The company already marketed two other treatments for the disease.
The H1N1 pandemic was a boon for MedImmune, the Gaithersburg division of AstraZeneca, as the federal government bought about a half-billion dollars' worth of the company's nasal vaccine to fight the flu.
Another Maryland biotech, Novavax of Rockville, actively pursued its development of an alternative flu vaccine, one which was based on genetic material rather than the actual virus. The company says such vaccines can be safer, more effective and more quickly produced than conventional vaccines.
And another Rockville company, Nabi Biopharmaceuticals, may have hit the half-billion-dollar jackpot when it agreed to license its nicotine vaccine candidate to GlaxoSmithKline. Nabi will receive an upfront fee of $40 million, with other fees and milestone payments potentially reaching $500 million. The company's NicVax is designed to treat nicotine addiction and prevent smoking relapse.
Vanda Pharmaceuticals, also of Rockville, scored when the FDA approved its schizophrenia treatment and struck a commercialization deal with Novartis, from which Vanda recently received $200 million. The achievements meant a $530,400 bonus for CEO Mihael Polymeropoulos.
Many small bioscience businesses contracted out this year, cutting staff, salaries and research activities. But Clinical Trials & Surveys, a Baltimore company that helps manage clinical trials and lab studies, is expanding. Citing increased demand, this year it added three Ph.D. biostatisticians and said it plans to almost double its staff, from more than 35 now to 60, by February.
In late June, representatives of dozens of Maryland biotechs took their sleeping bags to Baltimore, where some camped out for as long as five days to apply for this year's round of biotech investment tax credits.
The early lineup surprised officials from the Maryland Department of Business and Economic Development, which oversees the $6 million first-come, first-served tax credit program that started in 2006.
"We expected people to start lining up Monday, but not last Friday," said Karen Glenn Hood, a DBED spokeswoman.
"For people to wait so long, that shows how important the program is to the community," said Marty Zug, CFO of Rockville biopharmaceutical company Sequella.
Biotech center opens in
Montgomery, Baltimore
State officials this year opened the Maryland Biotechnology Center at the Shady Grove Innovation Center in Rockville and World Trade Center in Baltimore. The center is one of the first initiatives of the 10-year, $1.3 billion BioMaryland 2020 strategic plan for the biotech industry, fine-tuned by the Maryland Life Sciences Advisory Board.
Montgomery County officials also said they are working on what could be one of the first local biotechnology investment tax credits in the nation. The credit will be similar to the state one, a $6 million annual program that formed in 2006, County Executive Isiah Leggett (D) said. He planned to forward the measure to the council early next year and hoped it could become effective in early 2011.
State bills that would have implemented county biotech investment tax credits in both Montgomery and Baltimore counties failed earlier in 2009. But Leggett said the new measure would require approval by only the county council, not the state.
The local biotech tax credit was one of many recommendations of the county's Biosciences Task Force to reinvigorate the biotech industry. Other recommendations included the formation of a public-private partnership to advance the county's program that aids developing businesses with a heightened accelerator concept. The accelerator initiative could be modeled after those in Seattle and Cleveland, to improve commercialization of area research and enhance bioscience educational programs.
RNL Biostar, a subsidiary of Korean biotechnology company RNL Bio, is among the county's growing biotech companies. RNL is investing $6 million in a stem-cell research and manufacturing facility at the county's Germantown Innovation Center incubator, with plans to create 50 new, full-time positions within the next four years.