All amounts are in U.S. dollars
QUEBEC CITY, Nov. 23, 2011 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) and Hikma Pharmaceuticals PLC (LSE: HIK) (NASDAQ Dubai: HIK) announce today the signing of an exclusive commercialization and licensing agreement 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 3 programs 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, Ph.D., 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 3 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."
Mr. 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 3 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. Perifosine, 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 3 trials in both of these indications under a Special Protocol Assessment. 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 programs, with ongoing Phase 3 trials for these indications expected to be sufficient for registration in Europe. Perifosine rights have been licensed to Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) for North America, to Yakult Honsha for Japan and to Handok for Korea.
About Hikma Pharmaceuticals
Hikma Pharmaceuticals is 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. Hikma's operations are conducted through three businesses: "Branded", "Injectables" and "Generics" based principally in the Middle East and North Africa (MENA) region where it is a market leader, the United States and Europe. In 2010, Hikma achieved revenues of $731 million and profit attributable to shareholders of $99 million. As of December 2010, Hikma had 5,396 employees. For more information, please visit www.hikma.com.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, multiple myeloma, endometrial, ovarian, prostate and bladder cancer. The Company's innovative approach of "personalized medicine" means tailoring treatments to a patient's specific condition and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn from its proprietary discovery unit providing the Company with constant and long-term access to state-of-the-art therapeutic options. For more information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
SOURCE AETERNA ZENTARIS INC.