Amgen and Dezima Pharma B.V. (Dezima) announced that the companies have entered into a definitive acquisition agreement under which Amgen will acquire Dezima, a privately-held, Netherlands-based biotechnology company focused on developing innovative treatments for dyslipidemia. Dezima shareholders have approved the agreement.

"With the recent launches of Repatha (evolocumab) and Corlanor (ivabradine), and today's acquisition of Dezima, Amgen is proud to be on the leading edge of an exciting new wave of treatments for cardiovascular disease, an illness impacting millions of people worldwide," said Robert A. Bradway, chairman and chief executive officer at Amgen.

Dezima's lead molecule is TA-8995, an oral, once-daily cholesteryl ester transfer protein (CETP) inhibitor. In a Phase 2b clinical trial for dyslipidemia, TA-8995 reduced low-density lipoprotein cholesterol (LDL-C) by 45 to 48 per cent compared to baseline. LDL-C reduction was consistent when TA-8995 was administered as monotherapy or in combination with statins. The most common adverse events were nasopharyngitis and headache.

"TA-8995 has demonstrated dramatic LDL-C lowering," said Sean E. Harper, M.D., executive vice president of research and development at Amgen. "With a portfolio of TA-8995 and Repatha, our recently launched LDL-C lowering PCSK9 inhibitor, we will be able to offer more treatment options with different mechanisms of action and modes of administration across varying LDL-C levels and risk profiles."

Under the terms of the agreement, Amgen will pay $300 million in cash at closing and up to $1.25 billion in additional payments if certain development and sales milestones are achieved.  Low single-digit royalties will be paid on net product sales above a certain threshold. The agreement is subject to customary closing conditions, including regulatory approvals, and is expected to close in the fourth quarter of this year. Following the completion of the transaction, Dezima Pharma, which originally licensed rights to TA-8995 from Mitsubishi Tanabe Pharma Corporation (MTPC), will become a wholly owned subsidiary of Amgen. MTPC will receive from Dezima a portion of the upfront payment, future development and sales milestone payments, and royalties on net product sales if a certain threshold is reached. MTPC will also retain development and commercialization rights to TA-8995 in certain territories in Asia, including Japan.

"We are delighted to join Amgen as the company has shown impressive leadership in the cardiovascular space by their rapid and state-of-the-art development program for Repatha, their  injectable PCSK9 inhibitor," said Rob de Ree, chief executive officer of Dezima. "Owning both Repatha and TA-8995, each innovative and complementary therapies with the potential to serve a broad range of patients with high cholesterol, will further solidify Amgen's position in the future treatment of dyslipidemia."

Covington & Burling and De Brauw Blackstone Westbroek served as legal counsel to Amgen. NautaDutilh served as legal counsel and Moelis & Company served as a financial advisor to Dezima.