PHARMACY

Endo Pharma, Alexza to develop inhalable pain drug

BY Adam Kraemer

CHADDS FORD, Pa. Endo Pharmaceuticals Holdings, a drug company focused on pain management, said Thursday it signed an agreement with Alexza Pharmaceuticals to develop and bring to market Alexza’s early-stage inhaled pain treatment candidate AZ-003.

Currently in Phase I clinical development, AZ-003 is a hand-held, multiple-dose inhaler designed to deliver fentanyl, a pain reliever, into the lungs. Alexza’s Staccato system vaporizes fentanyl to form a condensation aerosol that quickly gets into a patient’s system through inhalation. The drug device system is designed to treat breakthrough pain—pain that does not respond to other therapies.

“Early clinical data suggest that AZ-003 could potentially have a rapid onset of action comparable to intravenous administration,” said Endo president and chief executive Peter Lankau.

Alexza will manufacture the product for Endo and be responsible for completing development of the device. Under terms of the agreement, Endo will pay Alexza an upfront fee of $10 million, with additional payments of about $40 million upon achievement of predetermined regulatory milestones. Endo will also pay undisclosed royalties to Alexza on sales of AZ-003.

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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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