Healthcare Industry News: Megapharm
News Release - July 15, 2008
Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement with Megapharm for IsraelSOMERSET, N.J., July 15 (HSMN NewsFeed) -- Alfacell Corporation (Nasdaq: ACEL ) today announced that it has entered into a distribution agreement with Megapharm Ltd., a leading pharmaceutical company in Israel, for the commercialization of ONCONASE® (ranpirnase) in Israel. ONCONASE, the company's lead drug candidate, recently completed an international confirmatory Phase IIIb clinical trial for unresectable malignant mesothelioma (UMM).
Under the agreement, Alfacell has granted Megapharm exclusive rights in the defined territory for the marketing, sales and distribution of ONCONASE. Alfacell will receive 50% of all sales in the territory. In addition, Alfacell will manufacture and supply the product to Megapharm, while Megapharm will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.
Miron Drucker, CEO and founder of Megapharm, said, "Having been interested observers in the development of ONCONASE, a first-in-class anti-cancer agent, we are proud to include this unique product in our oncology portfolio. We believe that ONCONASE will prove to be a promising new treatment option for patients suffering from mesothelioma."
"We are very pleased to add Megapharm to our growing list of important regional partners for ONCONASE," said Kuslima Shogen, chief executive officer of Alfacell. "Megapharm's role as a leader in biotechnology marketing in Israel provides Alfacell with an ideal partner to maximize the potential of ONCONASE in this region. We look forward to a successful collaboration with Megapharm."
ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.
ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through late-stage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic purposes while enabling the development of a new class of targeted therapies for cancer and other life-threatening diseases. Alfacell has completed Phase III clinical trials of ONCONASE in unresectable malignant mesothelioma and, in addition to ongoing efforts to complete the related rolling New Drug Application, Alfacell is currently planning for Phase II clinical trials in other oncology indications. For more information, visit www.alfacell.com.
Megapharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in Israel with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. Megapharm has demonstrated dynamic sales growth by developing a strong company presence and expertise in select therapeutic areas, and diversified segments of the healthcare business. The company also has a recognized and proven track record for obtaining reimbursement and inclusion of its products in all the health funds in Israel. For more information, visit www.Megapharm.co.il.
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, uncertainty whether the clinical trial results will allow the company to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will file or approve such application, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the company to finance research and development activities, potential challenges to or violations of patents, uncertainties regarding the outcome of clinical trials or differences of opinion in interpreting the results of clinical trials, the company's ability to secure necessary approvals from regulatory agencies, dependence upon third-party vendors, the company's ability to timely regain its compliance with NASDAQ continued listing standards and maintain such compliance, and other risks discussed in the company's periodic filings with the Securities and Exchange Commission. By making these forward-looking statements, the company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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