PHARMACY

Bentley to spin off CPEX as independent drug delivery company

BY Adam Kraemer

EXETER, N.H. Bentley Pharmaceuticals announced Friday that it had filed with the Securities and Exchange Commission to spin off its new subsidiary CPEX Pharmaceuticals as an independent, publicly traded company.

As an independent company, CPEX will focus on drug delivery systems research and marketing. Upon completion of the plan, Bentley will focus on the generics pharmaceutical business, though it will provide CPEX with transitional services, including managerial, operational and administrative support, for a period of up to 24 months.

“Filing the Form 10 with the SEC is an important milestone for the planned spin-off of CPEX,” said James Murphy, chairman and chief executive officer of Bentley. “We are pleased with our progress and believe we are on track to complete the spin-off in a timely manner.”

CPEX drug delivery technology, CPE-215 permeation enhancement, has been validated through commercialization of Testim, a testosterone gel marketed by Auxilium Pharmaceuticals, and is also currently being used to develop Nasulin, an intranasal insulin product.

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Congress passes bill giving $1.73 billion to FDA

BY Adam Kraemer

WASHINGTON Congress last week passed a consolidated appropriations bill, giving, among other things, nearly $1.73 billion to the Food and Drug Administration, more than $79 million over the president’s budget request.

In addition, the bill also gives the Center for Drug Evaluation and Research more than $682 million, of which $41.9 million is available for the Office of Generic Drugs, while the Center for Biologics Evaluation and Research would receive more than $236 million.

On Dec. 17, the House passed H.R. 2764 by a vote of 214–189, and the following day, the Senate passed a revised version by a vote of 76–17, The House agreed to send the revised version to the president, increasing 2007’s FDA funding by $145 million.

In addition, the committees encouraged the FDA to limit “to the greatest extent possible” granting financial conflict-of-interest waivers to advisory committee members, which has been a hot topic recently. While the committees were encouraged by the FDA’s announcement earlier this year that it would limit the number of waivers, they said the agency should do more.

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Cubist acquires Illumigen in potential $341.5 million deal

BY Adam Kraemer

SEATTLE and LEXINGTON, Mass. Cubist Pharmaceuticals may pay up to $341.5 million to buy Illumigen Biosciences, adding an experimental treatment for hepatitis C, a blood-borne virus that can damage the liver, to its pipeline.

Lexington, Massachusetts-based Cubist, the maker of the skin-infection drug Cubicin, will pay $9 million to acquire Seattle-based Illumigen, plus a potential $332.50 million in regulatory and drug development payments, the companies said today in a statement.

The purchase of Illumigen will add an experimental HCV treatment, called IB657, to Cubist’s portfolio of infection-fighting medicines. The HCV market, the companies said in a statement, was $2.2 billion in 2005 and is expected to reach $4.4 billion in 2010.

Cubist will make payments during the development of IB657 for hepatitis of up to $75.5 million and an additional $117 million if Cubist develops Illumigen products for other viruses, the companies said. The company will pay up to $140 million in milestone payments once products reach the market.

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