When Gail Folena-Wasserman joined Gaithersburg biotechnology startup MedImmune in 1991, she was its first employee in research and development, and dreamed of what the company might be "when it grew up."
Two decades later, the senior vice president for biopharmaceutical development is helping to test new drugs at a dramatically different MedImmune. Five years since a $15 billion acquisition by British pharmaceutical giant AstraZeneca, the company is funneling a pipeline of potential therapies that has grown three times over and covers a wider spectrum of diseases.
MedImmune leaders say they are entering a prime phase in drug development, with several projects moving into final patient trials and a growing share of AstraZeneca's overall drug pipeline. Given intense competition in the industry, success will depend on how each gamble pays off in the laboratory. AstraZeneca's sales and stock prices have taken a hit because of challenges from generic drug competition, putting the pressure on MedImmune to quickly turn out new patented innovations.
Despite fears that the AstraZeneca takeover might strip Maryland of its marquee biotechnology success, MedImmune leaders said the progress might not have happened without it.
"AstraZeneca made the play for MedImmune, and I have to say this was a good strategy for the long term," said Bahija Jallal, MedImmune's executive vice president for research and development. "That long term is no longer very long. I think we're bringing that to fruition."
Yet the phrase "the next MedImmune" is never far from the lips of state and regional economic development officials eager to replicate the company's success. As the company continues to grow under AstraZeneca, biotech industry advocates say its presence still provides a boost to the region.
"They are the model company," said Aris Melissaratos, a former state economic development official who leads technology-transfer efforts as a special adviser to Johns Hopkins University President Ron Daniels. "It's a huge success case study."
The company, founded in 1988, built its reputation on Synagis, used to prevent an infant lung disease known as respiratory syncytial virus, and FluMist, a nasal-spray flu vaccine. MedImmune also contributed to successful drug products including Humira and Gardasil.
By the time AstraZeneca came courting, MedImmune had built up a 23-acre Gaithersburg campus, employed 2,500 people and stood to add $1 billion to AstraZeneca's sales. Once the deal closed, AstraZeneca melded another recent acquisition, British firm Cambridge Antibody Technology, into MedImmune with the charge of building a pipeline of medicines based in biology, as opposed to being chemically created.
At the time, MedImmune's roster of about 40 projects represented less than 25 percent of what AstraZeneca researchers were exploring, Jallal told reporters at a recent open house for news media. Today, MedImmune researchers are testing about 120 potential or proven therapies, 45 percent of AstraZeneca's drug pipeline.
"We're not going to stop at 45 percent," Jallal said.
Before the acquisition, MedImmune's most acclaimed research was in the fields of infectious and respiratory diseases, with some exploration into cancer drugs. But in the past five years its focus has expanded to include neurological, cardiovascular and gastrointestinal diseases, Jallal said.
Among the ailments that could one day be treated by drugs MedImmune is exploring are drug-resistant bacterial infections, leukemia, asthma, lupus and diabetes. Steve Projan, who heads the company's research into infectious diseases and vaccines, said he expects to file plans with the FDA by the end of the year to start clinical trials on a drug to fight the sometimes deadly Staphylococcus aureus bacteria, a form of which is better known as MRSA.
Juggling the deeper stable of projects has required some adjustments, Folena-Wasserman said.
"Our science has certainly matured a lot because of the size of the organization," she said. (There are about 1,000 more employees than five years ago.) "One of the most difficult aspects was, how do you go from a small portfolio where you know absolutely everything about every project to — which of 35 projects am I thinking about now?"
There has been a need to trim projects with a lower probability of succeeding, Jallal said. And officials recognized that the current pipeline, which is updated twice a year to the public, is heavy on relatively early-stage projects. A significant number are in Phase 1 and 2 clinical trials, being tested on small groups of patients, but none are in Phase 3 trials, when drugs are fine-tuned on larger populations. In January, a few will shift into the Phase 3 column, Jallal said.
The longer that process takes, the less profit it could mean for AstraZeneca, said Jim Pyke, a principal with Chicago-based consulting firm Bridge Strategy Group LLC. That's in part because drug companies have, at most, a 20-year window to hold a patent on a medicine, and several years to exclusively market the drug without competition from generic versions. But those periods can begin well before a drug goes to market, Pyke said.
Generic drug competition has hindered AstraZeneca's performance, as sales and profits have declined by nearly 20 percent through the first nine months of the year. The company's stock price has fallen 3 percent on the New York Stock Exchange and 5 percent on the London Stock Exchange this year, even as rivals Merck, Sanofi and Eli Lilly & Co. have posted significant gains.
Still, local biotech industry advocates have been pleased with MedImmune's performance. Although many feared job cuts when news of the acquisition broke, the opposite has occurred, said Judy Costello, deputy director of the Maryland Biotechnology Center. A recent scan of the company's online job board showed nearly 90 open positions across the company.
Company officials are also taking time to invest — both literally and figuratively — in startup biotechs striving to follow in MedImmune's footsteps.
CEO Peter Greenleaf, also chairman of the Maryland Venture Fund Authority, which is working to invest $84 million in state and private money in local technology companies, frequently lends his thoughts to business leaders at networking events, Costello said. Greenleaf joined the company just before the acquisition, helping to lead its marketing and corporate strategy before becoming CEO in 2010.
MedImmune Ventures, the company's investment arm, has $400 million under management that it has used to back startups, including Towson-based Corridor Pharmaceuticals.
MedImmune officials said the growth and reinvestment wouldn't be happening without AstraZeneca's resources. Jallal credited the acquisition for beefing up the research that is driving it all.
"We could not have done this," she said, "with the MedImmune that we were."
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