PHARMACY

Addex finds GERD drug effective in clinical trial

BY Alaric DeArment

GENEVA An investigational drug in mid-stage clinical trials that is the first of its class effectively treats symptoms of gastroesophageal reflux disease, according to study results recently released by the manufacturer.

Addex Pharmaceuticals announced results of a phase 2b trial of the drug ADX10059, which the company is developing as a standalone therapy for GERD, on 103 GERD patients in Europe. The drug works by reducing activation of the protein metabotropic glutamate receptor 5, restoring normal function to the lower esophageal sphincter muscle; GERD results from the LES muscle malfunctioning to allow stomach contents to pass into the esophagus.

“We saw the number of symptom-free days increase by fivefold, an exciting and clinically meaningful effect for ADX10059 monotherapy,” Addex chief medical officer Charlotte Keywood said in a statement.

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PHARMACY

Congress investigates rising drug prices

BY Alaric DeArment

NEW YORK An article in The New York Times about rising drug prices has sparked an investigation by members of Congress, the newspaper reported Thursday.

Based on calculations by Wall Street analysts, IMS Health and AARP, the Times reported Sunday that while drug makers had promised to lower overall drug prices by $8 billion, wholesale prices of branded drugs had risen by 9%, to $10 billion. This happened despite a concurrent 1.3% contraction of the Consumer Price Index.

Now, Democratic Reps. Charles Rangel of New York, John Lewis of Georgia, Henry Waxman and Pete Stark of California and Florida Democratic Sen. Bill Nelson have asked the inspector general of the Department of Health and Human Services for “an immediate and thorough investigation into drug industry pricing and recent increases, and the extent to which these increases may affect the Medicare and Medicaid programs,” the Times reported.

The Pharmaceutical Research and Manufacturers of America, which represents the drug industry, criticized the Times’ article.

“Unfortunately, today’s New York Times only tells half a story, using selected statistics to make a flawed assumption that an increase in drug prices must somehow be tied to healthcare reform,” PhRMA SVP Ken Johnson said in a statement. “In truth, price increases are the natural result of market forces.”

Johnson said drug companies determined prices independently based on considerations such as patent expirations and research and development costs, noting that many of PhRMA’s member companies have experienced flat or negative revenue growth.

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AstraZeneca seeks approval for Brilinta

BY Alaric DeArment

WILMINGTON, Del. AstraZeneca has submitted an approval application to the Food and Drug Administration for an antiplatelet drug, the Anglo-Swedish drug maker announced Thursday.

The company said the drug, with the proposed brand name Brilinta (ticagrelor), reduces the risk of heart attacks and other cardiac events in patients with acute coronary syndrome.

The submission is based on results of a phase 3 trial comparing Brilinta with Plavix (clopidogrel), made by Bristol-Myers Squibb Co. and Sanofi-Aventis in patients also taking aspirin.

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