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Replies to #76623 on Biotech Values
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genisi

05/05/09 3:13 PM

#77267 RE: DewDiligence #76623

Abbott Sues Johnson & Johnson Over New Simponi Drug

http://www.bloomberg.com/apps/news?pid=20601103&sid=a5rKVHzUVfbI&refer=us#

By Susan Decker and Shannon Pettypiece

May 4 (Bloomberg) -- Abbott Laboratories, the maker of the rheumatoid arthritis drug Humira, sued Johnson & Johnson’s Centocor unit over its plan to introduce a competing medicine for the crippling disease.

Abbott contends that Centocor’s new drug, to be sold under the brand name Simponi, would infringe a patent it owns that was issued in 2007. Abbott, based in Abbott Park, Illinois, wants cash and an order that would prevent further use of its invention. Centocor said it would fight the suit.

While the complaint asked for an order, called a preliminary injunction, to halt sales even before a trial is held, Abbott said it would not ask a judge to make such a ruling.

“We’re not asking the court to prevent the launch of Simponi,” said Scott Stoffel, an Abbott spokesman. “Abbott has no plans to file for a preliminary injunction or a temporary restraining order.”

Centocor is “making meaningful preparations” to sell Simponi and thus is “engaged in activities that infringe” the patent, Abbott said in the complaint, filed May 1 in federal court in Worcester, Massachusetts.

The U.S. Food and Drug Administration last month approved the sale of the medicine, whose chemical name is golimumab. The drug, to be co-marketed outside the U.S. by Schering-Plough Corp., will compete with Humira and Amgen Inc.’s Enbrel.

Biggest Seller

Humira is Abbott’s biggest drug, with $4.5 billion in 2008 global sales. Centocor and New York University sued Abbott last year, claiming they were entitled to patent royalties on Humira. That case is pending in federal court in Marshall, Texas.

Annual sales of golimumab will exceed $1 billion a year, Jeff Jonas, an analyst for Gabelli & Co. in Rye, New York, said last month.

Golimumab was also approved for use against ankylosing spondylitis, a progressive form of spinal arthritis, and psoriatic arthritis, a form of arthritis often associated with the skin condition psoriasis.

“We are currently reviewing the complaint and will vigorously contest it,” Brian Kenney, a spokesman with Centocor Ortho Biotech, said in an e-mail. “We believe we have rights to all of the intellectual property we need to market Simponi.”

J&J, based in New Brunswick, New Jersey, will sell the drug in the U.S. Schering-Plough, of Kenilworth, New Jersey, will sell it in most countries outside the U.S.

Germ Fighter

Like Enbrel, Humira, and J&J’s Remicade, the new product works by blocking TNF, or tumor necrosis factor, a germ-fighting protein that also can cause the inflammation found in rheumatoid arthritis patients.

About 1.3 million people in the U.S. have rheumatoid arthritis, according to the Arthritis Society, an Atlanta-based nonprofit group. The disease can cause long-term joint damage, resulting in chronic pain and loss of movement.

J&J rose $1.17 cents to $53.76 at 4 p.m. in New York Stock Exchange composite trading. Abbott rose $1.68 to $43.20.

The case is Abbott Biotechnology Ltd. v. Centocor Ortho Biotech Inc., 09cv40089, U.S. District Court for the District of Massachusetts (Worcester).
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DewDiligence

05/15/13 5:04 PM

#161168 RE: DewDiligence #76623

FDA approves JNJ’s Simponi for ulcerative colitis:

http://finance.yahoo.com/news/simponi-golimumab-receives-fda-approval-201500872.html

Simponi is a “second-generation” anti-TNF-alpha drug whose approved indications are a subset of those for Remicade, Enbrel, and Humira. It was approved by the FDA for its initial indications in 2009 (#msg-37306991).

The commercial rights for Simponi are divided geographically in exactly the way as the commercial rights for Remicade: JNJ has the rights in most of the world (all countries except EU, Russia, Turkey, and Japan); MRK has the rights in the EU, Russia, and Turkey; and Mitsubishi has the rights in Japan.

In 1Q13, Simponi sold at a $1B annualized rate in JNJ’s territories and a $400M annualized rate in MRK’s territories. In other words, Simponi is a decent-selling drug, but its sales are tiny compared to Remicade, Enbrel, and Humira.