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Rite Aid completes debt buyback program

BY Alaric DeArment

CAMP HILL, Pa. — Rite Aid has finished a buyback program for more than $800 million worth of debt using proceeds from a sale of notes that allow the company to borrow at a lower interest rate, the retail pharmacy chain said Tuesday.

Rite Aid said it has finished a cash offer for $810 million in senior notes with a 9.5% interest rate due 2017, funded with proceeds from a previous sale of $810 million worth of 6.75% senior notes due 2021.

The company said that as of 5 p.m. Monday, $739.6 million worth of the 9.5% notes were put up for sale. The new offer will expire at midnight on July 16.

 

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Sandoz starts clinical trial of Enbrel biosimilar

BY Alaric DeArment

HOLZKIRCHEN, Germany — Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

Sandoz, the generics arm of Swiss drug maker Novartis, said it had started a phase-3 trial of biosimilar etanercept, a knock-off version of Amgen’s Enbrel, used to treat chronic plaque-type psoriasis.

"Sandoz has a strong track record in developing and commercializing biosimilars around the world," Sandoz head of biopharmaceuticals and oncology injectables Ameet Mallik said. "We will leverage this experience and our industry-leading capabilities to bring a biosimilar version of etanercept to patients and physicians around the world."

Sandoz has made biosimilars for the European market for several years, alongside competitors Teva Pharmaceutical Industries and Hospira. In the United States, the Patient Protection and Affordable Care Act of 2010 included amendments to create an abbreviated regulatory approval pathway for biosimilars, but the Food and Drug Administration has yet to finish drafting regulations, and will likely be a few years before biosimilars approved under the abbreviated pathway become available. In the meantime, several companies have sought approval for biosimilars using the normal three-phase clinical trial process and approval pathway in place for novel biotech drugs, and it is expected that the abbreviated pathway will include clinical trial requirements as well.


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Sandoz launches generic rosacea drug

BY Alaric DeArment

PRINCETON, N.J. — Sandoz has launched a generic topical drug for rosacea, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the launch of metronidazole 1% topical gel, calling it the first generic version of Galderma Labs’ Metrogel. The drug is indicated for treating inflammatory lesions of rosacea, estimated to affect about 16 million Americans.

Metrogel had sales of about $110 million during the 12-month period that ended in April, according to IMS Health.

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