PHARMACY

Endo bid for Canadian drug maker clears regulatory hurdle

BY Alaric DeArment

MALVERN, Pa. — Endo announced Thursday that regulatory waiting periods in the United States and Canada related to its plans to acquire a Montreal-based drug maker have been terminated.

Endo said that the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act and a similar period required under the Canadian Competition Act had been terminated, allowing it to move ahead with its purchase of Paladin Labs. The plan remains subject to additional regulatory and other conditions, including approval by the companies’ shareholders and an approval by the Superior Court of Quebec.

Endo said last month it would acquire Paladin Labs for $1.6 billion. Paladin specializes in treatments for attention deficity hyperactivity disorder, urology and other indications. The company will continue to operate under its present name after the acquisition is complete.

 

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Diplomat becomes distributor of recently approved cancer drug

BY Alaric DeArment

FLINT, Mich. — Diplomat has become a distributor of a new cancer drug made by Genentech, Diplomat said Thursday.

The specialty pharmacy company said it had received a distribution contract for Gazyva (obinutuzumab) for chronic lymphocytic leukemia, which received Food and Drug Administration approval on Nov. 1. CLL is a slowly advancing blood and bone marrow disease that, according to the National Cancer Institute, part of the National Institutes of Health, will be diagnosed in 15,680 Americans this year and cause 4,580 deaths.

"We are pleased to partner with Genentech as a specialty pharmacy provider of Gazyva," Diplomat president Gary Kadlec said. "With our extensive clinical and industry experience with new and emerging drug therapies, we are committed to providing Gazyva according to Diplomat’s high standards and industry-leading protocols, enabling patients to obtain the best outcomes possible."

The drug is administered intravenously in conjunction with chlorambucil, a chemotherapy drug also used to treat CLL. The drug’s labeling includes a boxed warning, the highest-level warning a drug can carry, due to the risk of viral reactivation in patients with hepatitis B and the risk of progressive multifocal leukoencephalopathy, or PML, a rare disorder that damages the material covering and protecting nerves in the white matter of the brain.

CORRECTION: A previous version of this story reported that Diplomat had joined a limited-distribution network for Gazyva, based on an erroneous statement in the specialty pharmacy’s press release. Gazyva is an open-distribution drug for which Diplomat has been named a distributor. This version of the story corrects the error.

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Actelion launches Valchlor

BY Alaric DeArment

SOUTH SAN FRANCISCO, Calif. – Actelion has launched a topical gel used to treat a kind of skin cancer, the company said.

Actelion announced the launch of Valchlor (mechlorethamine), which the Food and Drug Administration approved in August for treating stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma in patient who have received skin-directed therapy before. Actelion acquired rights to the drug when it merged with Ceptaris Therapeutics. Accredo Specialty Pharmacy distributes the drug in the United States.

"The availability of Valchlor is exciting news for patients and the treatment community," Stanford University School of Medicine professor and director of the school’s Multidisciplinary Cutaneous Lymphoma Clinic Youn Kim said in a statement on behalf of Actelion. "Physicians now have the option to treat appropriate MF-CTCL patients with the first formulation of topical mechlorethamine that is FDA-approved based on rigorous clinical evidence to support its use." 

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