WP Remix
Find Where the Flu Heading to
15
March

For much of 2009, the swine flu was the biotech industry’s cash cow. The virus’s sudden contagion last spring spread rapidly and lucratively to the local life sciences community, where a handful of companies scrambled to assemble enough money and staffers to launch studies, conduct research and shape products to respond to the first documented flu pandemic in 40 years.

Their battle against the H1N1 virus generated millions of dollars in revenue and lifted some stock prices to new yearly highs, with some leaping as much as 700 percent over the course of last year.

But the pandemic’s relatively light impact — only 16,455 people died worldwide, compared with 1 million to 50 million deaths in past flu pandemics — and a shorter-than-expected flu season has brought some of those biotechs, not to mention their stock prices, back to earth. The companies are now evaluating their performance and lessons learned last year to push for improving flu vaccine technology in time for the next outbreak.

“The opportunity for a specific product for the swine flu has essentially passed,” said Frank Malinoski, a former MedImmune executive who spent most of last year consulting for the Centers for Disease Control and Prevention and small companies preparing for pandemic diseases. “The companies in the area now are either concentrating on how they can be part of the seasonal flu market or how they can prepare for the next pandemic.”

The swine flu frenzy touched several local biotechs in different ways.

One local behemoth, MedImmune, won a contract for up to $453 million to manufacture and deliver its FluMist vaccine to the federal government, boosting its parent company’s revenue and stock price. At least two other companies, Novavax Inc. and Cel-Sci Corp., sped up flu-related vaccine research. While they did not recognize any sales revenue from the pandemic, both companies watched their stock prices soar.

Though, MedImmune and its parent, London pharmaceutical giant AstraZeneca PLC, are now unlikely to see another federal dollar from contracts for their widely used FluMist vaccine tailored to guard against H1N1.

Last year, the government paid $389 million for FluMist, the first vaccine to reach the clinic shelves. The unanticipated income helped convert a potential 5 percent slide in AstraZeneca’s U.S. revenue into a 4 percent bump in the fourth quarter and turn what would have been a roughly 2 percent revenue increase into a 9 percent jump for of 2009.

But now the Department of Health and Human Services will likely leave $64 million of that original $453 million contract with MedImmune on the table. With 74 million unused H1N1 vaccine doses of its own, the department plans to redirect those toward the next seasonal flu vaccine, which will include the H1N1 strain. Overall, the feds spent $1.6 billion on flu vaccines last year.

Although MedImmune spokeswoman Karen Lancaster said the H1N1 revenue injection was always understood to be a “one-time event,” the loss of that money this year is already having an impact on the parent company. AstraZeneca said it expects a mid-single-digit decline in this year’s revenue compared with last year.

Cel-Sci, another company that positioned itself at the center of the swine flu stage last year, watched its stock price swell from an 18-cent low to a $2.10 high in seven months.

In that time, the company announced each step of a process that revived its longtime immune-system-modulating technology for a potential H1N1 treatment and tested it on blood samples of up to 40 total enrollees at the Johns Hopkins University School of Medicine. The company seized the opportunity to collect more than $20 million in a stock sale to put toward a cancer drug waiting in the wings for years to enter new trials.

But as the number of swine flu patients continues to wane, Cel-Sci’s stock is now trading around 70 cents, and a company official said a much-touted trial remains in a holding pattern with no more than a half-dozen blood samples at hand.

“The H1N1 this year has turned out to be a real enigma — it’s bamboozled everybody,” said Dan Zimmerman, Cel-Sci’s senior vice president of research for cellular immunology, who was rehired full-time last November to head these trials, which he said took “substantial” company financial and personnel resources. “We’re doing what we can, but we have not had the number of patients we really need to be able to evaluate this.”

Novavax perhaps shone most brightly in the swine flu spotlight last year. The Rockville company had been working for years on high-tech methods that would lead to faster production of vaccines, and it sped up those efforts last year amid the swine flu hysteria. For much of last year, it trumpeted two major endeavors: the largest clinical trial of its H1N1 vaccine candidate in Mexico and negotiations with Rovi Pharmaceuticals Laboratories of Madrid, Spain, to test and produce its seasonal and pandemic flu vaccine technology in Europe.

The biotech saw its shares swing from its yearly low of 52 cents to its yearly high of $7.79 in a five-month span last spring and summer, and national media from Bloomberg TV to Time magazine were quoting CEO Rahul Singhvi. By year’s end, the previously cash-hungry Novavax was $21 million richer from a major stock sale.

Now, however, the company’s shares are trading below $2.50, and talks with Rovi have ground to a halt.

Yet Novavax remains intent on convincing the U.S. government that its vaccine versions are faster, cheaper and still effective. The company recently announced that it finished enrollment of its pivotal H1N1 vaccine trials in Mexico, and it hopes the trials will help fine-tune a vaccine production method that uses only lab-created chunks of a virus rather than a full, live strain.

“There is a need for new technologies in spite of very valiant efforts of companies,” Singhvi said. “If the pandemic was any worse, then it could have been a very tragic situation.”

While Novavax concentrates on using virus-like particles, another small Rockville company, Bacilligen Inc., is working on assembling genetic sequences of the flu virus pieces responsible for immunity to draft a vaccine manufacturing manual of sorts.

Bacilligen CEO Steve Bende describes his company’s chosen method, funded by a National Institutes of Health grant, as even faster than that of purifying virus-like particles, aiming to take 70 days from strain discovery to patient injection.

National experts say that race to fashion newer, faster vaccines is the key to winning future pandemic battles, as the industry mulls options to replace its roughly 70-year-old vaccine production-process: growing each live virus strain in one or two chicken eggs that must also have matured within an all-too-specific time frame. It was that combination that helped lead to delayed deliveries and long patient waiting lines last year.

“It’s not so much about the strain as it is about the platform — how it’s made and what’s in it,” said Lisa Beth Ferstenberg, chief medical officer for Accelovance Inc., a Rockville contractor that conducts vaccine clinical trials for other drug developers. “Anything we can do to create an alternative to poultry eggs is helpful.”


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