Healthcare Industry News: Non-Small Cell Lung Cancer
News Release - January 22, 2008
Alfacell Announces ONCONASE(R) Distribution and Marketing Agreement With BL&H for South Korea, Taiwan and Hong KongSOMERSET, N.J., Jan. 22 (HSMN NewsFeed) -- Alfacell Corporation (Nasdaq: ACEL ) today announced that it has entered into a distribution agreement with BL&H Co. Ltd., a leading pharmaceutical company in Southeast Asia, for the commercialization of ONCONASE® (ranpirnase) in South Korea, Taiwan and Hong Kong. ONCONASE, the company's lead drug candidate, is currently being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a confirmatory Phase IIIb clinical trial.
Under the agreement, Alfacell has granted BL&H exclusive rights in the defined territory for the marketing, sales and distribution of ONCONASE. Alfacell has received an up-front fee of $100,000 and is eligible for milestone payments based on the achievement of certain regulatory approvals and net sales levels. Alfacell will also receive 50% of all net sales in the territory. In addition, Alfacell will manufacture and supply the product to BL&H, while BL&H will be responsible for all activities and costs related to regulatory filings and commercial activities in the territory.
"This partnership represents another important step forward in the execution of our global commercialization strategy for ONCONASE," said Kuslima Shogen, chief executive officer of Alfacell. "BL&H's extensive market knowledge, commercial capabilities, established oncology franchise and successful track record in the marketing and sales of several leading cancer therapeutics provide Alfacell with an ideal partner to maximize the potential of ONCONASE in this region. We look forward to a successful collaboration with BL&H."
D.C. Roh, president of BL&H, said, "We are pleased to enter into this agreement with Alfacell. We believe that ONCONASE will prove to be a promising new treatment option for patients suffering from mesothelioma. We look forward to working with Alfacell on a successful product launch."
ONCONASE is a first-in-class product candidate from 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 (natural death of cells) via multiple molecular mechanisms of action.
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. In addition to an ongoing Phase IIIb study in malignant mesothelioma, Alfacell is conducting a Phase I/II trial of ONCONASE in Non-Small Cell Lung Cancer (NSCLC) and other solid tumors. For more information, visit www.alfacell.com.
BL&H is a privately owned pharmaceutical company based in South Korea. BL&H was established in 1999 with the aim of becoming a leader in the delivery of pharmaceuticals and services that fulfill unmet medical needs in the Korean market. BL&H specializes in hospital-based products in hematology, oncology, rheumatology and respiratory medicines. The BL&H management team has extensive experience in the pharmaceutical and healthcare sectors and in bringing specialty products to market.
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, uncertainties involved in the outcome of clinical trials for ONCONASE, the company's ability to secure necessary marketing approvals of ONCONASE from regulatory agencies, 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, dependence upon third-party vendors, 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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