Medimmune

London's AstraZeneca PLC said yesterday that it will pay $15.6 billion in cash to acquire FluMist developer MedImmune Inc. in a deal that highlights how far the pharmaceutical industry is willing to go to shore up its future by tapping into biotechnology. The $58-per-share price tag is the highest paid for a Maryland-based company. And it's significantly more than most investors had predicted when MedImmune, whose headquarters is in Gaithersburg, announced this month that it was considering a sale.

Billionaire investor Carl C. Icahn dropped his plans to propose an opposing slate of directors for the board of Gaithersburg-based MedImmune Inc., noting the biotechnology company's decision to seek a buyer. Icahn, in an e-mail statement yesterday, said he urged MedImmune "several weeks ago" to put the company up for sale. He also said at the time that he intended to nominate directors at the 2007 annual meeting "whose intention it would be to accomplish this." In pulling back yesterday, Icahn said he reserved the right to pursue the proxy fight if MedImmune, Maryland's largest biotech company in sales and employment, fails to complete a sale.

A flu spray made by Gaithersburg-based MedImmune Inc. is effective for young children, the Food and Drug Administration said yesterday, signaling that the company might soon win approval to market the vaccine for use in children younger than 5. Some health experts say FluMist would be a welcome tool in combating the flu because it would help immunize children who could otherwise get the illness and spread it to others. An FDA advisory panel will take up the issue tomorrow, with the expectation that the agency will make a decision before the end of May. Approval could greatly increase sales of the nasal spray vaccine by MedImmune, which agreed last month to be purchased by London-based AstraZeneca PLC for $15.6 billion.

Facing increased competition for its main product - the HPV Test - and questions about its plans for growth, Gaithersburg's Digene Corp. agreed yesterday to be acquired by a foreign company in a $1.6 billion cash and stock deal designed to boost the local biotech firm's international sales effort and speed technology development. Under the agreement, Netherlands-based Qiagen N.V. would pay $61.25 for Digene shares - up to $880 million - on a first-come, first-served basis. That represents a 37 percent premium over Digene's $44.77 closing price Friday on the Nasdaq.

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.

MedImmune Inc. said yesterday that the sudden suspension of an AIDS drug trial by U.S. Bioscience Inc. won't scuttle its planned purchase of the Pennsylvania biotechnology company.The trial, which was being conducted in three countries, was suspended after one patient died and other problems were reported."Given what we know right now, we intend to move forward with the deal," said Lori Weiman, a MedImmune spokeswoman.Gaithersburg-based MedImmune agreed last month to purchase West Conshohocken, Pa.-based U.S. Bioscience for $477 million.

MedImmune Inc., the fast-growing Gaithersburg biotechnology company, said yesterday that it had won U.S. Food and Drug Administration approval for its $50 million manufacturing plant in Frederick.The plant, built with $13 million in state and county incentives, joins a small but growing list of Maryland biotechnology companies that manufacture drugs.MedImmune's 90,000-square-foot facility will be among the largest drug production plants in the state, employing 150 workers. To handle future MedImmune products, the plant was designed to produce several drugs at once.

Shares in MedImmune Inc. fell $5.0625, or 4 percent, to $115 yesterday after a top Merrill Lynch & Co. analyst lowered his ratings for the stock, saying the recent run-up in its price had made it overvalued. Earlier in the day, the shares were down as much as $14.125.Since mid-May, shares in the Gaithersburg-based biotechnology company, which split 2-for-1 Jan. 1, have more than doubled. MedImmune shares closed at a 52-week high of $120.625 Tuesday.Merrill Lynch biotechnology analyst Eric Hecht, whose industry ratings are closely watched, also lowered his ratings on Amgen Inc., Biogen Inc., Genzyme Corp.

For Maryland's booming biotechnology sector, 1999 should be a watershed year as a select number of companies either turn profitable or move experimental drugs and diagnostics into pivotal mid- and late-stage human trials."

MedImmune Inc. reported record revenue and earnings yesterday, the performance helped by sales of its new respiratory drug, Synagis, and a $47.4 million tax benefit.The Gaithersburg-based biotechnology company said it earned $72.7 million, or $1.34 per share, on revenue of $92.9 million in its fourth quarter, which ended Dec. 31. For the corresponding period of 1997, the company reported a profit of $3.3 million, or 7 cents a share, on sales of $53.6 million.The results include a one-time gain of $47.4 million due to a tax benefit and a one-time charge of $12.5 million due to anticipated returns of MedImmune's RespiGam, which was made obsolete by Synagis.

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...

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.

Facing increased competition for its main product - the HPV Test - and questions about its plans for growth, Gaithersburg's Digene Corp. agreed yesterday to be acquired by a foreign company in a $1.6 billion cash and stock deal designed to boost the local biotech firm's international sales effort and speed technology development. Under the agreement, Netherlands-based Qiagen N.V. would pay $61.25 for Digene shares - up to $880 million - on a first-come, first-served basis. That represents a 37 percent premium over Digene's $44.77 closing price Friday on the Nasdaq.

MedImmune Inc. failed to address multiple problems - including bacterial contamination - identified last year at a FluMist manufacturing plant in Europe, "substantially increas[ing] the risk of product failures" in batches of its nasally inhaled influenza vaccine, according to a warning letter released by the U.S. Food and Drug Administration yesterday. Last week, the Gaithersburg biotechnology company said the federal agency was withholding approval of its application to expand FluMist's use to include most children younger than age 5 until the concerns are resolved.

A flu spray made by Gaithersburg-based MedImmune Inc. is effective for young children, the Food and Drug Administration said yesterday, signaling that the company might soon win approval to market the vaccine for use in children younger than 5. Some health experts say FluMist would be a welcome tool in combating the flu because it would help immunize children who could otherwise get the illness and spread it to others. An FDA advisory panel will take up the issue tomorrow, with the expectation that the agency will make a decision before the end of May. Approval could greatly increase sales of the nasal spray vaccine by MedImmune, which agreed last month to be purchased by London-based AstraZeneca PLC for $15.6 billion.