FDA releases prescription user fee plan
WASHINGTON The Food and Drug Administration has released its Prescription Drug User Fee Act IV Information Technology Plan, according to published reports.
The agency’s intent is to provide regulated industry and other stakeholders with information on its vision for improving the automation of business processes and maintaining information technology systems that support the review of human drug applications.
The Food and Drug Administration Amendments Act of 2007 was enacted in September and reauthorized the Prescription Drug User Fee Act, which shortens the approval time for new drug and biologics approvals, among other changes in agency operations. The new law also includes information technology goals to support upgrading FDA’s drug safety program in four categories: objectives; communications and technical interactions; standards and information technology plan; and metrics and measures.
Aricept patent is still intact after lawsuit, says Eisai
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.
Bentley to spin off CPEX as independent drug delivery company
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.