SOMERSET, N.J., July 26 /PRNewswire-FirstCall/ -- Alfacell Corporation and US Pharmacia today announced that Alfacell has entered into a distribution agreement with USP Pharma Spolka Z.O.O. (USP Pharma), an affiliate of US Pharmacia, for the commercialization of ONCONASE(R) (ranpirnase), Alfacell’s lead drug candidate, in Eastern Europe. ONCONASE is currently being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a confirmatory Phase IIIb registration study.
Under the distribution agreement, Alfacell has granted USP Pharma exclusive rights for the marketing, sales and distribution of ONCONASE in Poland, Belarus, Ukraine, Estonia, Latvia and Lithuania for an initial term that extends for 10 years after the first commercial sale in the territory. Additionally, Alfacell and US Pharmacia have entered into a securities purchase agreement pursuant to which US Pharmacia has purchased 533,360 shares of Alfacell’s common stock at a price of $2.53 per share. Upon execution of the agreements, Alfacell received total cash payments of $1.5 million, consisting of $100,000 as an up-front signing fee under the distribution agreement and $1.4 million for the purchase of Alfacell common stock under the securities purchase agreement. Alfacell will also be entitled to receive milestone payments based on the achievement of certain regulatory approvals and certain sales goals. In addition, Alfacell will receive a transfer price for product sold as well as a significant double-digit royalty rate on net sales.
Alfacell will be responsible for making regulatory filings with and seeking marketing approval from the European Medicines Agency (EMEA) and the manufacturing and supplying of product. USP Pharma will be responsible for all commercial activities and related costs in the territory.
“We are pleased to announce our second commercial partnership,” said Kuslima Shogen, chairman and chief executive officer of Alfacell. “Poland plays an important role in our Phase IIIb clinical program. The agreement with USP Pharma represents the establishment of a key relationship in Poland and the rest of the territory designated under this agreement, where the incidence and prevalence of UMM and other cancers continues to rise, and a significant unmet treatment need exists. With its extensive market knowledge, established commercial capabilities, growing commitment to oncology and successful track record, USP Pharma is the ideal partner to maximize the marketing potential of ONCONASE in this territory.”
Katarzyna Kusmierz, chairman of US Pharmacia, said: “We are excited about the opportunity to be part of the team that brings ONCONASE to the world. ONCONASE represents a promising new treatment for UMM, a disease for which there is only one currently approved therapy worldwide. ONCONASE also has significant potential in other cancer indications. As such, we believe ONCONASE should be well-received in our markets.”
Shogen added: “Moving forward, Alfacell will continue the dialogue about ONCONASE with potential partners in the United States and other key markets. We remain committed to the transformation of Alfacell into a more fully integrated company with research, clinical and commercial dimensions.”
About ONCONASE(R)
ONCONASE is a first-in-class 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 in a manner similar to RNA interference (RNAi).
Alfacell expects to obtain data from its Phase IIIb registration study of ONCONASE in UMM later this year. Earlier in 2007, the FDA granted an orphan- drug designation for ONCONASE for the treatment of UMM. ONCONASE had previously received Fast Track status from FDA for the UMM clinical program. Alfacell is also conducting Phase I/II clinical trials of ONCONASE in non- small cell lung cancer (NSCLC) and other solid tumors.
About US Pharmacia
US Pharmacia markets, sells and distributes over-the-counter drug products in Eastern and Northern Europe, and prescription drug products in Poland with plans to expand into other countries. The company conducts activities in Poland, Ukraine, Lithuania, Russia and Bulgaria, and has U.S. offices in Rockville, Md. For more information, visit www.usp.pl/en.
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. For more information, visit www.alfacell.com.
Safe Harbor
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.
Media Contact: Investor Contact: David Schull or Wendy Lau Andreas Marathovouniotis Russo Partners Russo Partners 212-845-4271 212-845-4253 david.schull@russopartnersllc.comandreas.marathis@russopartnersllc.comwendy.lau@russopartnersllc.com
Alfacell Corporation
CONTACT: Media, David Schull, david.schull@russopartnersllc.com, WendyLau, wendy.lau@russopartnersllc.com, +1-212-845-4271, Investors, AndreasMarathovouniotis, +1-212-845-4253, andreas.marathis@russopartnersllc.com,all of Russo Partners
