PHARMACY

Diabetes drug makers experience stock jump

BY Alaric DeArment

NEW YORK Shares of two large drug makers focused on diabetes increased Wednesday afternoon despite declines in the drug industry as a whole, according to published reports.

The Amex Pharmaceutical Index and Amex Biotechnology Index fell, while the Dow Jones Industrial Average increased after a fall earlier in the day.

Meanwhile, however, shares of Danish drug maker Novo Nordisk and San Diego-based drug maker Amylin Pharmaceuticals increased respectively by 4%, to $49.95, and 3%, to $12.12.

Amylin had released a study earlier in the week showing that a long-acting formulation of the diabetes drug Byetta (exenatide) that has not yet been launched outperformed Merck & Co.’s Januvia (sitagliptin) and Takeda’s Actos (pioglitazone hydrochloride) in patients with Type 2 diabetes.

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Pharmaxis announces completion of phase 3 trial for CF drug

BY Alaric DeArment

SYDNEY, Australia An Australian company announced Tuesday that it had finished the first part of an international phase 3 trial of a drug for cystic fibrosis.

Pharmaxis said the final patient in the trial of the inhaled drug Bronchitol (mannitol) had finished a final clinical visit, and the trial was running on time and on budget. Results of the trial are expected to be available later this month.

“We are very pleased to announce this major milestone for Pharmaxis and look forward to the results of the study with great interest,” Pharmaxis CEO Alan Robertson said. “It is hoped that Bronchitol will change the therapeutic landscape for people living with cystic fibrosis and provide a new therapeutic regimen that helps to prolong life.”

A second phase 3 clinical trial is recruiting in the United States, Canada, Argentina, Germany, Belgium and France, Pharmaxis said. The Food and Drug Administration and European Medicines Agency have given Bronchitol orphan drug designation due to the lack of effective treatments for cystic fibrosis.

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Court finds that Watson’s ADHD drug patent is valid

BY Alaric DeArment

CORONA, Calif. The U.S. District Court for the District of Delaware ruled Monday that Watson Pharmaceuticals’ generic version of an ADHD drug does not infringe the branded drug maker’s patent.

Watson announced the court ruling Tuesday, saying judge Joseph Farnan found that the ‘373 patent for Concerta (methylphenidate hydrochloride extended-release tablets), by ALZA Corp. and McNeil-PPC, is invalid. The ruling applies to Watson’s versions of Concerta in the 18 mg, 27 mg, 36 mg and 54 mg strengths.

“We are very pleased that the court has ruled in our favor, and we will continue to evaluate the court’s opinion as we contemplate next steps,” Watson president and CEO Paul Bisaro said. “We are currently pursuing final FDA approval of this important product.”

The two branded companies originally sued Andrx Corp. in 2005 over the drug; Watson acquired Andrx the next year.

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