PHARMACY

Avicena gets patent for experimental ALS drug

BY Allison Cerra

WASHINGTON The U.S. Patent and Trademark Office has granted the Avicena Group a patent for its amyotrophic lateral sclerosis drug candidates.

The contenders, which will treat ALS types AL-02 and AL-08, have undergone several trials as part of an extensive body of clinical research.

ALS, also known as “Lou Gehrig’s disease,” is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord, according to the Amyotrophic Lateral Sclerosis Association. The illness attacks the body’s motor neurons, which reach from the brain and spinal cord to the muscles throughout the body. The degeneration eventually leads to death.

The pooled analysis of these studies showed the median survival time, which determines the effectiveness of a treatment, revealed an increase of 1.47-fold compared with patients taking a placebo, Avicena said.

Portions of these data have been presented to the FDA and formed the basis for the company’s plans to start a Phase 3 trial in 2008.

Avicena, a late-stage biotechnology company, develops central nervous system therapeutics for neurodegenerative diseases, including ALS and Parkinson’s disease.

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Cephalon submits application to FDA for supplemental uses of Fentora

BY Drew Buono

FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.

Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.

In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.

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Reverse-payment bill held up in Congress by pharmaceutical lobbying

BY Drew Buono

WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.

The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.

An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.

More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.

And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.

“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”

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