PHARMACY

Biogen Idec completes Zevalin sale to Cell Therapeutics

BY Adam Kraemer

SEATTLE Cell Therapeutics has completed its acquisition of Zevalin from Biogen Idec.

CTI will have sole responsibility for marketing, sales and development of Zevalin (ibritumomab tiuxetan) in the U.S. Zevalin, which was approved in 2002 to treat patients with relapsed indolent non-Hodgkin’s lymphoma, will be sold outside the U.S. by Bayer Schering. CTI will share the cost of certain clinical trials of Zevalin with Bayer Schering in the event such trials are undertaken, the company reported.

CTI made an initial payment of $10 million to Biogen Idec in the exchange and will pay royalties to Biogen Idec based on the net sales of Zevalin until at least December 2015. CTI has also agreed to pay up to an additional $20 million in milestone payments if the product receives approval from the FDA for certain first-line indications in NHL. 

“This acquisition puts CTI back into the commercial arena, which is a relatively exclusive space for biotech companies, and also strengthens our product pipeline,” said James Bianco, president and chief executive officer of CTI. “Adding the commercial infrastructure now may also provide a benefit to the company for future launches of other products in our pipeline. This is especially relevant to the potential launch of pixantrone and its expected synergies with Zevalin.” 

In 2006, Biogen Idec reported $16.4 million in U.S. Zevalin sales.

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Stake in drug-testing contractor purchased in $3 billion-plus deal

BY Adam Kraemer

NEW YORK In a deal worth a reported $3 billion-plus, One Equity Partners’ stake in drug trial manager Quintiles Translational is being sold to its chief executive and other buyout firms, including Bain Capital and TPG Capital, according to The New York Times.

Dennis Gillings, founder of Quintiles and its chief executive officer and chairman, has teamed up with Bain and TPG to take control of the stake from One Equity, the private equity arm of JPMorgan Chase, which also sponsored the company’s $1.7 billion buyout in 2003.

Gillings had previously offered to buy the company in 2002 for $1.3 billion, but that number was rejected as being too low.

Quintiles, based in Research Triangle Park, N.C., has more than 19,000 employees. At the time of its founding in 1982, Gillings was a professor of biostatistics at the University of North Carolina. The company went public in 1994.

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Jazz, Solvay receive approvable letter from FDA regarding extended-release Luvox

BY Adam Kraemer

PALO ALTO, Calif. The Food and Drug Administration issued an approvable letter for Jazz Pharmaceuticals’ Once-a-Day Luvox CR (fluvoxamine maleate), which the company is trying to market as an extended-release capsule indicated for the treatment of social anxiety disorder and obsessive compulsive disorder.

Jazz has teamed up with Solvay Pharmaceuticals to market the drug. The FDA earlier this month approved the regular formulation of Luvox for the treatment of OCD.

The companies are seeking clarification from the FDA and look forward to working with the FDA to resolve any issues as quickly as possible. They stressed that the approvable letter did not raise any questions related to the safety or efficacy of Luvox CR.

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