PHARMACY

Advanced, Abbott to submit application for new antibiotic

BY Drew Buono

WOODRIDGE, Ill. Advanced Life Sciences is preparing to submit a new drug application for its antibiotic cethromycin, which it is developing with Abbott Laboratories.

The drug is used for the treatment of community acquired pneumonia and other respiratory tract infections. The drug recently completed six phase III clinical trials. The current treatments for community acquired pneumonia are zithromax and biaxin. These drugs though have shown bacterial resistance. Unlike current treatments which are a drug class known as macrolides, cethromycin is a ketolide and will fight the bacterial resistance.

In addition to treating community acquired pneumonia, cethromycin was shown to be 100 percent effective in preventing inhalation anthrax post-exposure in a study as compared to the current standard of care, cipro which demonstrated 90 percent protection. Community acquired pneumonia is the sixth leading cause of death in the U.S.

Advanced Life Sciences expects to file for regulatory approval of the drug during the first half of this year and to begin selling the medicine in 2009.

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Aricept patent is still intact after lawsuit, says Eisai

BY Adam Kraemer

NEW YORK Even after a decision by a U.S. court related to Japanese Eisai’s Alzheimer’s disease drug, Aricept, the company still insists that its patent is valid.

The U.S. District Court of New Jersey on Dec. 20 dismissed a suit filed by Eisai against Philadelphia-based Mutual Pharmaceutical Co. over the latter’s move to seek Food and Drug Administration approval for marketing a generic version of Aricept. The patent expires in three years.

Eisai Thursday said the ruling was issued on procedural grounds and doesn’t affect the validity of its Aricept patent, which the company believes remains valid through Nov. 25, 2010. Mutual Pharmaceutical still can’t sell a generic version of the drug, Eisai said.

The dismissal, Eisai stated, stemmed from the court’s decision that “there is no case or controversy between the parties, because Mutual did not make a certification challenging the Aricept patent and does not yet have U.S. Food and Drug Administration approval to market its product,” the Wall Street Journal reported.

The Japanese company also said that the U.S. company will give 45 days’ notice of any introduction of a generic version of Aricept.

Eisai this month agreed to pay $3.9 billion to buy MGI Pharma to boost its growth prospects, giving it more reach in the U.S., where Eisai also is building a research-and-development facility.

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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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