Heather Bresch - Mylan

A dealmaker expands Mylan's global footprint

Name: Heather Bresch
Title: CEO, Mylan 

Throughout her 20-year career with Pittsburgh-based Mylan ($MYL) in 15 different roles, Heather Bresch has made her way to the top of the third largest generics and specialty pharmaceutical company in the world.

Before becoming CEO, Bresch led the integration of Matrix Laboratories and Merck KGaA's generics business as chief integration officer. The experience obviously prepared her well to helm Mylan, which made a slew of new deals in 2013 under her guidance.

Bresch's latest deals include the $1.75 billion buyout of Agila Specialties, the specialty injectables unit from India's Strides Arcolab. The deal positions Mylan as one of the world's largest producers of sterile injectables, which treat a variety of diseases, from heart disease to cancer. But the deal stalled when the FDA issued a warning letter to one of Agila's plants. Mylan said it was holding back $250 million until the regulatory issues get resolved.

"The acquisition of Agila will create a global injectables leader, expanding and strengthening Mylan's existing injectables platform and portfolio, and providing Mylan entry into exciting, new geographic markets. We believe we can generate significant growth from this business as we maximize the capabilities of this platform and accelerate the many untapped opportunities we see ahead," Bresch said in a previous statement.

The deal means Mylan will gain 9 manufacturing facilities in India, Brazil and Poland--8 of which the FDA has approved. Combined, the deal will give more than 700 injectable products with a pipeline of 350 more to Mylan and Agila.

The Agila Specialties deal was one of many for Bresch in recent years. In 2012, the company struck a deal, along with Ranbaxy and Strides, with Gilead Sciences ($GILD) to help increase production and lower the cost of its HIV-fighting drugs in developing countries. Bresch is passionate about HIV/AIDS work, and that partnership has made Mylan a leader in the development of antiretroviral (ARV) treatment for HIV/AIDS. The company has also recently partnered up with Pfizer ($PFE) to produce branded generics in Japan.

Though Mylan reported a 25% drop in net profit and a 2% falloff in sales for its third quarter in 2013 after a dazzling earnings year in 2012, Bresch says the company will be back on the horse in 2014. And analysts say there's nothing to worry about.

Despite a 2008 controversy at West Virginia University involving allegations that she was granted an MBA without completing the required coursework, Bresch was named one of Fortune's "50 Most Powerful Women In Business" in 2012. Bresch has also been profiled by Esquire for her work that led to the passage of the FDA Safety and Innovation Act, legislation that requires foreign drugmakers that sell product in the U.S. to pay for regular facility inspections, changes the way the FDA approves clinical trials, and expands the FDA's postmarket surveillance capabilities, among other advancements. 

-- Emily Mullin (email | Twitter)

For more:
Special Report: 20 Highest-Paid Biopharma CEOs of 2012 - Heather Bresch
Mylan looks to 2014 for big growth
Mylan eyes injectables domination with $1.6B Agila buy
Mylan pledges 500 new jobs in Irish expansion
Mylan puts Bresch into CEO chair

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Heather Bresch - Mylan