PHARMACY

Drug approvals down, drug warnings up

BY Drew Buono

WASHINGTON The pharmaceutical industry is headed down a rough road as drug approvals become harder to grasp and pipelines start to disappear, according to the Associated Press. As a result, drug companies, according to analysts, will move toward finding treatments for patients with rare diseases.

By doing this, drug makers won’t stand out as much to the Food and Drug Administration, which has become very sensitive to the side effects of widely prescribed medications for ailments. Companies are desperate to find relief from all the money they’re losing to generic introductions of their blockbuster drugs.

With profit growth slowing across the pharmaceutical industry, Pfizer and GlaxoSmithKline, the world’s first- and second-largest drug makers, each announced plans in 2007 to lay off thousands of employees.

The companies do have a reason to worry; in 2007, the FDA announced 69 black box warnings on approved drugs, more than twice as many as in 2004, according to the Kansas University Medical Center. In addition, the FDA has approved only 16 drug applications this year, the lowest amount in 20 years, but this also falls on the companies’ shoulders, as they haven’t been submitting as many applications for new drugs as they used to. The submission rate for new drugs has gone down from nearly 60 in 1995 to figures in the low 20s for recent years.

The upshot of all this is that drug companies will still have to conform to the regulations of the FDA, because they won’t have any other choice.

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PHARMACY

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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