Thursday, March 1, 2007

MedImmune rebuffs critics, advances product line

Biotech hires VPs, is buoyed by patent ruling

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Rendering courtesy of MedImmune
MedImmune, which has resisted calls for a sale of the company, is working on a $250 million expansion of its Frederick manufacturing plant.
It’s back to business at MedImmune.

After enduring Wall Street criticism of its management and sales figures, and turning back a stockholder’s demand to sell the company, the Gaithersburg biotech hired two new vice presidents last week to advance its product line and got a lift from the federal patent office.

The U.S. Patent and Trade Office rejected a patent of San Francisco biotech Genentech Inc. that it had claimed to cover an important drug manufacturing process used by many biotechs, including MedImmune.

For several years, the so-called Cabilly II patent has been at the center of a dispute between Genentech and MedImmune that wound up in the U.S. Supreme Court. In January, justices ruled 8-1 that MedImmune could sue Genentech on the legitimacy of the patent, essentially sending the case back to lower courts.

MedImmune wants to stop paying royalties to license the patent, which is involved in manufacturing the childhood lung infection drug Synagis, its $1 billion-a-year lead product.

MedImmune attorney William C. Bertrand Jr. said last week that the Cabilly II patent does not technically cover the Synagis process. But the company continues to pay royalties, fearing legal challenges from Genentech that could interfere with Synagis production.

‘‘Obviously from MedImmune’s perspective, we are pleased to see the re-examination result that came out of the PTO office,” Bertrand said. ‘‘But we will continue to pursue our litigation relative to the patent.”

He said the patent office ruling would probably not affect the court process because Genentech has said it will continue its appeals.

Also pleased with the patent office ruling was David A. Katz of Matrix Asset Advisors Inc. of New York, which holds 0.7 percent of MedImmune’s stock.

‘‘All good news is good,” Katz said. ‘‘We are pleased with the patent news. It is valuable.”

Katz recently asked MedImmune for the third time to consider selling itself to a large pharmaceutical company.

In a U.S. Securities and Exchange Commission filing, MedImmune said its directors had reviewed the Matrix letter, but concluded that ‘‘the best way for MedImmune to maximize value for its shareholders is to aggressively implement its business plan.”

Undaunted, Katz told The Gazette that the subsequent recent purchase of 1.17 percent of MedImmune shares by billionaire corporate raider Carl C. Icahn ‘‘shows a sentiment of a number of other shareholders. Icahn tends to speak slowly and carry a big stick. We think that Icahn will turn the heat on the company.”

Katz’s criticism echoes Wall Street’s recent disappointment with the company’s sales figures. Revenues for the fourth quarter of 2006 did not meet average expectations of $554 million by 14 analysts surveyed by Bloomberg News, while MedImmune’s revenues for all of 2006 exceeded its published guidance by $75 million.

Also following the fourth-quarter report, financial analysts at Thomas Weisel downgraded MedImmune from overweight to market weight.

‘‘Our very strong sense is that they have built a terrific product portfolio ... but they have not translated that into better product sales,” Katz said. Management has ‘‘disappointed continuously. At the same time the pharmaceutical companies have a significant slowdown in their own pipelines and are saying they have a need to acquire biotechs.”

He said interested companies would include Merck, Pfizer, Johnson and Johnson, and GlaxoSmithKline.

More than 11 percent of Matrix’s investment portfolio is in large pharma, including Pfizer, Johnson and Johnson, Wyeth and Teva Pharmaceutical Industries Ltd.

MedImmune takeover rumors ‘‘appear so regularly that you can’t get too excited about them,” said Brian Lian, a New York analyst with CIBC World Markets.

‘‘They have been fairly persistent for 12 to 18 months ... but it would bolt nicely into a company with a presence in vaccines,” Lian said. ‘‘The issue facing these potential partners is price.”

Edward T. Mathers, MedImmune’s vice president for corporate development and venture, rejected the notion of selling.

‘‘We are better off” not selling, Mathers said. ‘‘We feel good about our plan and will continue to execute on it.”

Hiring two new vice presidents this week is part of a current focus on improving the company’s commercial management organization since hiring a new head of sales and marketing a year ago, he said.

The appointments are Jamie Harrell, who will run infectious disease marketing, and Mark Stanton to manage markets.

Study: FluMist effectivefor children

A new study of 8,475 children ages six to 59 months showed that MedImmune’s FluMist nasal vaccine gives more effective protection from influenza than conventional injections.

Researchers at 249 U.S., European and Asian sites reported that the children who got FluMist had 55 percent fewer flu cases than those that got the shots.

The recently approved refrigerated version of FluMist was used in the study, which was published by the New England Journal of Medicine and was funded by MedImmune. FluMist is currently approved for healthy people 5 to 49 years old.

Jennifer Chao, a research analyst with Deutsche Bank Securities Inc., said the results point to company strength — and attractiveness as a buyout target.

‘‘Our buy rating is based on strong fundamental outlook in 2007-2009 and we see that [MedImmune] commands scarcity value, making it a top biotech takeout candidate,” Chao said.

Based on the study’s results, Chao anticipates potential approval for children ages 1 to 5 with no history of wheezing or asthma by May 28, in time for commercial launch for the 2007-08 flu season.

This report originally appeared in The Business Gazette.

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