PHARMACY

Glenmark Pharmaceuticals reports fiscal-year results

BY Allison Cerra

NEW YORK Glenmark Pharmaceuticals on Friday said its consolidated net profit for the financial year ended March 2009 stood at Rs 193.47 crore ($3.99), while it had a consolidated net profit of Rs 632.11 crore ($13.02) in the same period ended March 2008.

“The net profit figures are not comparable due to out-licensing revenue received in the last financial year 07-08 amounting to Rs 240.27 crore ($4.95) and one-time write offs taken in this financial year 08-09,” Glenmark Pharma said in a filing to the Bombay Stock Exchange.

“Due to the global financial crisis, which impacted every market in the world, one-off extraordinary items and delay in product approvals by [the Food and Drug Administration], the overall business got impacted severely in the financial year. Having said that, we began taking corrective measures in the fourth quarter itself, and you will see the impact of these initiatives in this financial year,” said Glenmark Pharmaceuticals CEO Glenn Saldanha.

Revenue increased to Rs 2,121.53 crore ($43.71) for the period ended March 2009, from Rs 19,82.06 crore ($40.84) in the same period last year.

Glenmark Generics Inc. posted revenue of Rs 733.77 ($15.12) crore for fiscal 2009 against revenue of Rs 564.02 crore ($11.62), a growth of 30% over the previous year.

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Obama administration rejects long exclusivity periods for biotech drugs

BY Alaric DeArment

WASHINGTON The Obama administration gave a boost to the generic drug industry Wednesday with a letter to Rep. Henry Waxman, D-Calif., rejecting calls by the biotech and pharmaceutical industries for guarantees of long market-exclusivity periods in biosimilars legislation.

The letter cited a recent Federal Trade Commission report saying that market exclusivity periods of 12 to 14 years were unnecessary to ensure innovation and competition, and that seven years would suffice. Signed by Office of Health Reform director Nancy-Ann DeParle and Office of Management and Budget director Peter Orszag, the letter was a response to Waxman’s June 8 letter responding to proposals for a regulatory approval pathway for biosimilars in the administration’s fiscal year 2010 budget.

The generic drug industry has welcomed the letter. “As Congress debates healthcare reform, the White House has sent a strong signal to members that it is critical to ensure that affordable, life-saving biogeneric medicines get to patients in need sooner rather than later,” Generic Pharmaceutical Association president and CEO Kathleen Jaeger stated. “In citing the recent FTC report on biogenerics, the president rejects attempts by the pharmaceutical and biotech industries to needlessly extend market exclusivity provisions to an unprecedented period of 12 to 14 years simply to maintain their monopolies on biopharmaceutical products.”

Meanwhile, the organization representing the biotech industry criticized the letter, calling seven years’ market exclusivity a “risky short cut” to biosimilars. “As we have consistently said, any pathway to biosimilars should provide a fair period of time for innovators to protect their proprietary data from competitors in order to promote the continued development of breakthrough medicines, therapies and cures,” Biotechnology Industry Organization president and CEO Jim Greenwood said. “We continue to believe that 14 years of data exclusivity will strike the appropriate, reasonable and fair balance between our common desire to expand access to breakthrough biotech medicines and the need to preserve the protections necessary to promote further biomedical advances.”

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U.S. Marshals seize drugs from Caraco Pharmaceutical Labs

BY Alaric DeArment

ROCKVILLE, Md. U.S. Marshals seized drugs made by generic manufacturer Caraco Pharmaceutical Labs Thursday at the company’s Michigian plants in Detroit, Farmington Hills and Wixom, at the request of the Food and Drug Administration.

The FDA said the seizure resulted from violations of the agency’s current Good Manufacturing Practice requirements by the company. Since January, Caraco has voluntarily recalled drugs due to potential manufacturing defects, including formulation errors and oversized tablets. The FDA found unresolved violations of cGMP requirements during an inspection of Caraco’s Detroit plant in May, the company said.

“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” FDA associate commissioner for regulatory affairs Michael Chappell stated.

In a statement on the seizure, Caraco said it had taken corrective actions and was making “continual improvements,” noting that the seizure did not affect products made outside of Michigan.

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