Gilead Sciences, Inc. and Myogen, Inc. has announced that the companies have signed a definitive agreement under which Gilead plans to acquire Myogen.
The transaction has been structured as a two-step acquisition comprised of a cash tender offer for all of the outstanding Myogen common stock at $52.50 per share, followed by a cash merger in which Gilead would acquire any remaining outstanding Myogen common stock at $52.50 per share. Upon completion of the second-step merger, Myogen will become a wholly owned subsidiary of Gilead. The value of the transaction is approximately $2.5 billion. The deal is expected to be dilutive to Gilead's earnings in 2007 and 2008, neutral in 2009 and accretive in 2010 and beyond.
Myogen's lead product candidate, ambrisentan, for the potential treatment of pulmonary arterial hypertension (PAH), is an orally available endothelin receptor antagonist. Endothelin is a small peptide hormone that is believed to play a critical role in the regulation of blood flow and cell division. Elevated endothelin blood levels are associated with several cardiovascular disease conditions, including PAH. Gilead and Myogen believe data from two completed pivotal phase III studies (ARIES 1&2) evaluating the safety and efficacy of the product, as a potential treatment for PAH would support a New Drug Application (NDA). Myogen currently expects to file an NDA with the US Food and Drug Administration as early as the fourth quarter of 2006.
Ambrisentan has been granted orphan drug status for the potential treatment of PAH in both the United States and Europe. GlaxoSmithKline holds rights to the product outside the United States.
"Myogen represents a unique scientific and strategic fit with our company, bringing to Gilead a late-stage product candidate that addresses an area of significant unmet medical need and further enhances our growing focus on pulmonology, as initially established through our recent acquisition of Corus Pharma," said John C. Martin, PhD, president and chief executive officer, Gilead Sciences. "We are excited about the potential of ambrisentan, which we believe could have important clinical benefit over existing therapies for pulmonary arterial hypertension. We look forward to welcoming Myogen's Colorado-based employees to the Gilead team. Working together, we plan to leverage both our development capabilities and experience delivering differentiated therapeutics to the medical community to make ambrisentan available for patients in need as quickly as possible."
"We are proud to join with Gilead Sciences, one of the premier biopharmaceutical companies in the world, in advancing the care of patients suffering from life-threatening diseases," said J. William Freytag, PhD, president and chief executive officer, Myogen, Inc. "Myogen was founded 10 years ago with a vision of making important contributions to the treatment of cardiovascular disorders. Through the dedication and effort of our talented employees, we have made tremendous progress. Bringing Myogen and Gilead together will allow us to build on our progress to date and expand the resources committed to that vision."