Aeterna Zentaris Inc., a late-stage oncology drug development company,  has signed an exclusive commercialization and licensing agreement with and Hikma Pharmaceuticals plc for the registration and marketing of perifosine, Aeterna Zentaris' lead anti-cancer compound, for the MENA (Middle East and North Africa) region.

Perifosine, a novel oral Akt inhibitor, is currently in two phase III programnmes for the treatment of colorectal cancer and multiple myeloma in the United States and Europe.

Under the terms of the agreement, Aeterna Zentaris is entitled to receive an upfront payment and additional payments upon achieving certain pre-established milestones in the aggregate of $2 million. Furthermore, Aeterna Zentaris will be supplying perifosine to Hikma Pharmaceuticals on a cost-plus-basis and is entitled to receive double-digit royalties on future net sales of perifosine in the MENA region. Hikma Pharmaceuticals will be responsible for the registration and commercialization of perifosine in the MENA territory.

Juergen Engel, PhD, president and CEO of Aeterna Zentaris, stated, “Hikma Pharmaceuticals has a proven track record in oncology and is a leading drug company in the Middle East and North Africa region, which is why we believe it is a perfect fit for the development and commercialization of perifosine in that part of the world. Our partnership network for perifosine now encompasses North America, Japan, Korea and the MENA region, while we still retain all rights for the rest of the world. We look forward to the phase III results in colorectal cancer during the first quarter of 2012, as we continue our quest of bringing perifosine to the market worldwide for the benefit of both patients and shareholders.”

Mazen Darwazah, vice chairman of Hikma Pharmaceuticals, commented, “Hikma is committed to improving the treatment of cancer in the MENA region through the development of its oncology product portfolio. This partnership gives Hikma access to a novel, oral anticancer treatment with excellent potential and reinforces Hikma’s commitment to developing its product portfolio through strong partnerships. We look forward to the phase III results in colorectal cancer in 2012 and are excited to work with Aeterna Zentaris to bring this critically needed therapy.”

Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. The product works by interfering with membranes of cancer cells thereby inhibiting Akt signaling which then affects cell death, growth, differentiation and survival. In combination with chemotherapeutic agents, is currently being studied for the treatment of colorectal cancer, multiple myeloma and other cancers, and is the most advanced anticancer agent of its class.

Perifosine, as monotherapy, is being explored in other indications. The FDA has granted perifosine orphan drug designation in multiple myeloma and neuroblastoma, and Fast Track designations in both multiple myeloma and refractory advanced colorectal cancer. Additionally, an agreement was reached with the FDA to conduct the phase III trials in both of these indications under a Special Protocol Assessment (SPA). Perifosine has also been granted orphan medicinal product designation from the European Medicines Agency (EMA) in multiple myeloma.

Furthermore, perifosine has received positive Scientific Advice from the EMA for both the multiple myeloma and advanced colorectal cancer programmes, with ongoing phase III trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc. for North America, to Yakult Honsha for Japan and to Handok for Korea.

Hikma Pharmaceuticals a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in licensed products.