PHARMACY

Some companies see 2008 as make-or-break time

BY Drew Buono

WASHINGTON

The new year will be a year of last resorts for some companies, as they hope to receive approval for some of their drugs, according to the Washington Post.

MiddleBrook Pharmaceuticals is expecting the Food and Drug Administration to approve its once-daily antibiotic amoxicillin. The company has invested a good deal of money on the drug, which has seen failed late-stage testing and therefore has left the company low on cash.

Vanda Pharmaceuticals is expecting approval from the FDA in August for its schizophrenia drug, iloperidone, which it acquired from Novartis in 2004 for $500,000. The drug is part of Vanda’s concept to take abandoned drugs from other companies and either start testing them again or find new uses for them. Vanda is also expecting final testing results this year on an insomia drug that it bought from Bristol-Myers Squibb.

United Therapeutics plans to seek approval for an inhaled version of a drug to treat pulmonary hypertension and it will also release final testing results for a pill version of a pulmonary hypertension treatment.

Human Genome Sciences plans on selling its first product, a drug called ABThrax, which would be used to treat anthrax exposure. The company is also developing drugs for lupus and hepatitis. By the end of this year, Human Genome Sciences plans to release results of the first of two pivotal tests for the hepatitis drug, which it is partnering with Novartis to develop. If certain milestones are hit, the company could receive $507 million from Novartis.

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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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