Medimmune

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.

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 Inc., a Gaithersburg-based biotechnology company, said yesterday that it has agreed to collaborate with Rockefeller University to develop a vaccine to prevent or treat illnesses caused by a virulent bacteria, Streptococcus pneumoniae.MedImmune also struck a licensing deal with the New York school for the rights to commercialize any vaccines developed from the collaboration. The two did not disclose financial details of the agreement.The bacteria MedImmune and Rockefeller have targeted is the leading cause of blood stream infections, pneumonia and ear infections in children, and the third leading cause of meningitis.

A proposal to speed the approval of new prescription drugs has patient advocates and biotech firms — including many based in Maryland — hoping that Congress will deliver a rare dose of bipartisanship this year. Lawmakers are proposing a 6 percent increase in the fees that pharmaceutical firms pay the Food and Drug Administration to offset the cost of approving new drugs. If the measure is not signed into law by the end of September, the FDA would lose the ability to charge any fees and be forced to lay off 2,000 workers, significantly slowing review times.

MedImmune Inc. said yesterday that while its revenues in the second quarter nearly doubled, its losses widened.The Gaithersburg-based biotechnology company said its revenues rose $3.8 million, to $7.9 million, in the quarter that ended June 30, mostly due to a $2.7 million increase in reimbursement payments from American Home Products, which has forged an alliance with MedImmune.It also cited a 37 percent increase in sales of CytoGam, a drug that helps kidney transplant patients. MedImmune said it sold $4.2 million worth of the drug in the second quarter.

MedImmune Inc., the Gaithersburg biotech firm, has announced that it has settled a two-year-old class-action lawsuit that claimed the company misled investors.The company said it would record a charge of $637,500 in the quarter ending Sunday. The balance of the settlement, $3,612,500, will be paid by insurers, MedImmune said."We have fully settled the lawsuit and gotten it behind the company and can move ahead," said Mark E. Kaufmann, MedImmune's manager of investor relations.Little more than a week ago, a Food and Drug Administration advisory panel recommended approval of MedImmune's most promising drug, RespiGam, for marketing.

MedImmune Inc. yesterday announced a deal with Baxter Healthcare Corp. to market the Gaithersburg company's infant pneumonia vaccine outside North America, a move that will shore up the money-losing biotechnology company's balance sheet and could make MedImmune profitable a year sooner than Wall Street had expected.As part of the alliance, Baxter will pay $9.5 million for stock that represents about a 5.6 percent stake in MedImmune, said Mark Kaufman, strategic planning manager for the Gaithersburg firm.

MedImmune Inc. of Gaithersburg saw its shares pummeled yesterday as the fledgling biotechnology company disclosed that its breakthrough drug had mixed results in its final stage of clinical trials.The stock dropped $2.75, or 23 percent, to $9.25 in extremely heavy trading after the company said its key drug worked on one set of patients but not another.RespiGam, designed to prevent a virus that causes infant pneumonia, significantly reduced hospitalization related to respiratory syncitial virus in premature infants and infants with a condition called bronchopulmonary dysplasia.

Gaithersburg-based MedImmune Inc. announced yesterday that a late-stage human trial has been launched to evaluate the effect of a treatment it has developed for the prevention of a serious respiratory disease in high-risk infants.The disease, respiratory syncytial virus, is one of the leading causes of pneumonia and bronchitis in infants and small children. In the United States, more than 90,000 children are hospitalized and 4,500 die from RSV disease annually, the biotechnology company said.

Top officers of MedImmune Inc. improperly inflated its stock price by misleading investors into believing that the budding Gaithersburg drug company's top prospect was on the verge of receiving federal approval, two class-action lawsuits charge.When that approval failed to come last week, the stock dropped nearly 50 percent in two days.After a Food and Drug Administration advisory panel voted unanimously Thursday not to recommend marketing approval of MedImmune's pneumonia and bronchitis drug, RespiGam, the company's stock fell 30 percent, to $16 a share, from $23. The next day it dropped $4.25, to close at $11.75.

Baltimore's biotechnology industry has made strides. Two biotech parks by the Johns Hopkins University and the University of Maryland now anchor the east and west sides of the city. A few dozen biotech startups have made their home here. But Baltimore's nascent biotech industry doesn't yet have a breakout company — a darling of venture capitalists and Wall Street that has grown past the risky and unprofitable startup phase to achieve a steady stream of revenue and products in the pipeline.

Severstal plans improvement Russian steelmaker OAO Severstal, which closed on an $810 million deal to buy Sparrows Point in May with promises to invest significantly in the steel plant, said its first major project will be to upgrade the blast furnace. The $10 million renovation will begin in late summer and the blast furnace, which creates raw steel from ore, would be shut down for about 14 days. Court rules in Grace case The U.S. Supreme Court has refused an appeal to limit the asbestos-related criminal charges against Columbia's W.R. Grace & Co. and six former executives.

After 16 years of guiding MedImmune Inc. from a struggling Gaithersburg biotech to one of the world's most profitable, Chief Executive David M. Mott is stepping down for personal reasons, the company's London-based parent, AstraZeneca PLC, said yesterday. Tony Zook, CEO of AstraZeneca's North American business based in Wilmington, Del., will succeed Mott when he leaves at the end of July. The announcement surprised local biotech representatives, who look to Mott, 42, as a role model in an industry the state considers among its best hopes for economic growth.

When Gaithersburg-based MedImmune Inc. first introduced a needle-free flu vaccine five years ago, shareholders were as excited as the kids who needed it. So far, the product has fallen short of expectations. But that could change after a federal panel that advises the U.S. Centers for Disease Control and Prevention recommended yesterday that all children, from six months of age to 18, be vaccinated for the flu. If adopted by the CDC, an additional 30 million children would need immunizations.

MedImmune has been able to double the number of potential products in development to 100 since the Maryland biotech was acquired last spring by drug giant AstraZeneca, David M. Mott, MedImmune's president and chief executive officer, said yesterday. Since AstraZeneca agreed to pay $15.6 billion for MedImmune in April, the Gaithersburg biotech has been put in charge of the British firm's biologics units -- Cambridge Antibody Technology in England and a research facility in Hayward, Calif.

The U.S. Food and Drug Administration said yesterday that MedImmune has addressed problems at its FluMist manufacturing plant in Europe. The move clears the way for the agency to also consider an application requesting that a new version of the influenza vaccine be approved for use in children younger than 5. In May, the FDA sent a warning letter to the Gaithersburg company and said it would withhold approval of the drug for younger children until problems...

NEW YORK -- Shares of Gaithersburg-based MedImmune Inc. plunged more than 30 percent yesterday in frenzied trading after a Food and Drug Administration advisory panel concluded that the company needed to do further clinical trials on its respiratory virus drug Respivir.The stock price tumbled $7, to close at $16. With more than 4 million shares traded, it was the most active issue on the Nasdaq.The FDA is certain to follow the committee's recommendation, which is sure to cause a substantial delay in the product's launch.

Gaithersburg-based MedImmune Inc. said yesterday that it lost $10.2 million, or 47 cents a share, in its third quarter, which ended Sept. 30, compared with a loss of $3.8 million for the same quarter of 1995.The promising young biotechnology company, which has yet to turn a profit, will launch its second product, RespiGam, a drug to fight infant pneumonia, in the fourth quarter of this year."We should see a significant increase in sales in the fourth quarter," said Mark E. Kaufmann, associate director of strategic planning and investor relations at MedImmune.

Maryland : Biotechnology MedImmune licenses `reverse genetics' MedImmune Inc. has licensed its "reverse genetics" technology to Novartis, a Swiss company that owns flu-shot manufacturer Chiron. Novartis will use the technique to create seasonal and pandemic influenza vaccines. Reverse genetics is thought to be a faster and safer means of vaccine production than the current standard. In late 2005, Gaithersburg-based MedImmune acquired the final exclusive license to the last of four intellectual property portfolios that govern the use of reverse genetics in making human flu vaccines, which means anyone else who wants to get in on it has to get the company's permission first.

After years of failing to attract a big pharmaceutical presence to the state - and losing the competition for a Novartis AG plant to North Carolina last summer - it's time for Maryland economic developers to shift gears in biotechnology, according to a study being released online today. The Economic Alliance of Greater Baltimore spent the past six months compiling data and interviewing company representatives to create the Biosciences Report, a 40-page assessment of the local industry and its growth potential (available at www.greaterbaltimore.