PHARMACY

PhRMA: More than 50 drugs in development for COPD

BY Alaric DeArment

WASHINGTON — More than 50 drugs are under development for treating a respiratory disease that is the third-leading cause of death in the United States.

The Pharmaceutical Research and Manufacturers of America released a list Thursday of 54 drugs in clinical development for chronic obstructive pulmonary disease, or COPD.

COPD, which includes chronic bronchitis and emphysema, affects more than 13 million adults in the United States and causes obstructed airflow to the lungs, and the number of people with the disease is increasing, according to the National Institutes of Health, which estimated that 12 million may have the disease without knowing it.

"Early detection of COPD is imperative, as effective treatment can change the course and progression of this devastating disease," PhRMA president and CEO John Castellani said. "The promising new therapies highlighted in this report illustrate how emerging scientific approaches to treatment respiratory diseases, such as COPD, offer great hope to improve and save the lives of future patients."

The new drugs include a medicine that targets the underlying inflammation in COPD, a biotech drug that acts on the biological processes involved in the disease’s inflammatory component and an adult stem cell therapy that targets a protein in the blood often elevated in patients with the disease, PhRMA said.


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Mylan wins tentative approval for generic Lipitor

BY Alaric DeArment

PITTSBURGH — The Food and Drug Administration has given tentative approval to a generic cholesterol drug made by Mylan, the drug maker said Thursday.

Mylan announced that it had received tentative approval for a generic version of Pfizer’s Lipitor (atorvastatin calcium) in the 10-mg, 20-mg, 40-mg and 80-mg strengths.

A tentative approval means that the drug meets the FDA’s conditions for approval, but the agency can’t give final approval because of outstanding patent- and exclusivity-related issues. Ranbaxy Labs, which won approval for the first generic version of the drug in November, currently has the exclusive right to compete with Pfizer’s version and will until May.

Lipitor had sales of $8.2 billion in 2011, according to IMS Health.


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Walgreens fortifies its specialty pharmacy arm

BY Michael Johnsen

DEERFIELD, Ill. — Walgreens on Thursday inserted another piece into its comprehensive healthcare offering, just in time for the PBM selling season, with the acquisition of BioScrip’s community specialty pharmacies.

Walgreens and BioScrip announced that they have entered into a definitive agreement under which Walgreens will acquire certain assets of BioScrip’s community specialty pharmacies and centralized specialty and mail-service pharmacy businesses for a total deal value of approximately $225 million.

“Together, BioScrip’s clinically focused community specialty pharmacies and access to additional limited distribution drug therapies, and Walgreens existing nationwide network of retail and health system pharmacies create a strong network of support for our core drug store business to provide specialty pharmacy solutions to our patients,” stated Greg Wasson, Walgreens president and CEO. “Many of our patients will benefit from expanded access to new and limited distribution drugs for chronic conditions, such as HIV, cancer and organ transplant. This acquisition also significantly expands our nationwide reach to an additional half-million patients with chronic and complex health conditions who have strong clinical relationships with their current BioScrip pharmacy.”

BioScrip’s community specialty pharmacy business is a national network with 30 locations in 16 states across the United States and the District of Columbia. In addition to acquiring those locations, Walgreens will acquire certain assets of BioScrip’s centralized specialty pharmacy business and traditional mail-service pharmacy business that dispenses prescriptions for Drugstore.com, which was acquired by Walgreens in June 2011, among others.

Walgreens currently anticipates the transaction will not have a material impact on its earnings per share in fiscal year 2012, and expects it to be modestly accretive in fiscal year 2013.

Completion of the transaction is subject to customary conditions, including satisfaction of regulatory requirements and other closing conditions. Walgreens plans to fund the acquisition with existing cash and anticipates the transaction will close by late April 2012. The transaction was unanimously approved by both companies’ boards of directors.


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