In a pair of deals disclosed today and valued at a combined $1 billion-plus, Mylan moved to bolster its portfolios in women's healthcare and respiratory treatments.
Mylan said its Indian subsidiary has agreed to acquire the women’s healthcare businesses of Famy Care, which specializes in generic oral contraceptive products, for up to $800 million. Mylan said the deal will make it a leading seller of hormonal contraceptives in high-growth emerging markets worldwide, and complements the generic women’s healthcare portfolio that Mylan plans to acquire separately.
Last year, Mylan agreed to purchase Abbott Laboratories’ outside-U.S. branded generic drug business for approximately $5.3 million. In addition to accelerating its growth in women's healthcare products, Mylan said the acquisition will build on its existing partnerships with Famy Care in North America, Europe and Australia.
Mylan began partnering with Famy Care in 2008, a development CEO Heather Bresch said in a statement had significantly enhanced its presence in the women's health care segment—especially in oral contraceptive products—in the U.S. and other developed markets. Famy Care and Mylan have a U.S. portfolio of 12 approved products, with abbreviated new drug applications pending FDA approval for another 30 products.
“With today's acquisition, we are building on this successful partnership and further accelerating our global growth in this important therapeutic area. We see many opportunities to tap the large women's health care market in Europe, particularly through our pending Abbott deal; the prospect of driving additional value from this business in North America; and exciting growth potential in emerging markets,” Bresch stated.
Mylan agreed to pay Famy $750 million cash, plus up to $50 million tied to achievement of development and regulatory milestones. Famy Care will spin off its female health care businesses under a court approved de-merger plan, with Mylan set to acquire the shares of the new resulting company.
Mylan said the deal is set to close during the second half of this year, subject to regulatory approvals and customary closing conditions. Upon closing, Mylan said, the Famy acquisition is expected to immediately add to its adjusted diluted earnings per share and growth profile. The deal adds more than 900 Famy Care employees to Mylan’s workforce of more than 25,000.
Headquartered in Mumbai, India, Famy Care specializes in women's health products that include oral and injectable contraceptives, intra-uterine devices (IUDs), tubal rings and hormone-replacement therapy products. Famy Care estimates that its products are used by more than 15% of the world's women who use oral contraceptive pills, making it the world's largest producer of generic oral contraceptive products.
Founded in 1990, Famy Care has built an R&D and regulatory affairs team of more than 100 professionals that has registered some 600 products in approximately 90 countries, and built a pipeline of more than 200 filings, including more than 100 for developed markets.
Famy Care says its growth has been aided by a manufacturing base that represents one of the lowest cost and largest dedicated to oral contraceptives globally. That base includes four manufacturing facilities in India, two of which have been approved by the FDA and the European Union. Famy Care is the first generics company to have received prequalification from the World Health Organization for hormonal contraceptives.
On the respiratory front, Mylan and Theravance Biopharma—spun off last year from Theravance—have agreed to partner in the development of TD-4208, a Phase III-ready once-daily nebulized long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD) and other respiratory diseases.
The companies said TD-4208 has shown positive top-line results in COPD patients in multiple Phase II studies, and plan to launch a Phase III registrational program for the drug candidate based on a design recently approved by the FDA.
“The addition of TD-4208 to our pipeline is highly complementary with our existing respiratory portfolio, including our marketed nebulized COPD product, Perforomist® Inhalation Solution, and reinforces Mylan's leadership in nebulized respiratory therapy,” Bresch said in a statement with Theravance Biopharma. “This exciting development and commercialization collaboration leverages Mylan's expertise in manufacturing and marketing complex respiratory products and Theravance Biopharma's respiratory clinical development capabilities.
Added Rick E. Winningham, Theravance Biopharma’s chairman and CEO: “Partnering with a world leader in nebulized respiratory therapies enables us to expand the breadth of our TD-4208 development program and extend our commercial reach beyond the acute care setting where we currently market Vibativ® (telavancin),” the company’s sole approved product.
“Funding of the Phase III registrational program by Mylan strengthens our company's capital position and enhances our financial flexibility to advance other high-value pipeline assets alongside TD-4208,” Winningham added.
In addition to funding the U.S. registrational development program, Mylan will pay Theravance Biopharma an initial $15 million in cash, plus a $30 million equity investment in Theravance Biopharma through the purchase of newly issued Ordinary Shares at a price of $18.92 per share—equal to a 10% premium over the five-day trailing volume-weighted average price ending January 30.
Theravance Biopharma is eligible to receive potential development and sales milestone payments totaling $220 million—including $175 million associated with TD-4208 monotherapy and $45 million for future potential combination products.