Another PR on the product FDA filings:
Cyplasin Biomedical Prepares A Biosimilar Pegylated Interferon-alpha (C-Pegferon(TM)) for Market Approval in the U.S., E.U. and Major Market Regions EDMONTON, June 28 /CNW/ - Cyplasin Biomedical (CPBM: OTCBB and XYI1:FRA) is a product-oriented, specialty pharmaceutical company focused on developing products for the multi-billion dollar hepatitis C virus (HCV) market. Cyplasin has amassed a portfolio of key products for the prevention and treatment of HCV infection, which affects over 4 million people in the U.S. and several hundred million people worldwide.
One such anti HCV product is known as Interferon-alpha which was approved by the FDA for treatment of HCV infection in 1997. This drug is administered to HCV-infected patients three-times-a-week by injection, for a period up to 1-2 years to achieve a clinical effect. In 2001, a newer, longer-lasting formulation of interferon-alpha called Pegylated interferon-alpha2A and -alpha2B (Roche Pegasys(R) and Schering-Plough Pegintron(R), respectively) were approved for use. The longer-acting version of interferon-alpha only needs to be administered once-per-week for 1-2 years.
Cyplasin recently signed an agreement with Minapharm Pharmaceuticals to distribute and market their version of the long-acting pegylated interferon-alpha product (to be marketed and sold under Cyplasin's brand name C-Pegferon(TM)) within the North American and South American markets as well as Mexico, Latin America, Korea, Russia, China, India and other countries. Cyplasin will be one of the first companies with a biosimilar long-acting interferon-alpha formulation for treatment of hepatitis C patients in North America. Minapharm's pegylated interferon-alpha product is currently sold in the Middle East and Northern Africa region.
The combined market for ribavirin and the long-acting interferon-alpha therapy is estimated to be over $2 Billion annually and Cyplasin now has generic versions of both drugs. Cyplasin will start the process to acquire regulatory marketing approvals to sell the generic drugs in territories outside of North America this July and expects to be on track for other regulatory approvals for the North American market by 2012.
Garth Likes, the CEO of Cyplasin, stated "There are generic drug companies, such as the Israeli company Teva and the Indian companies Dr. Reddy and Wockhardt, that have programs seeking approval of biosimilar or generic short-acting interferon-alpha. Where we can make a difference to our market and revenue stream is that we have partnered with Minapharm who are already selling a commercially viable form of the much improved, long-acting interferon-alpha product. It places us strategically well ahead of a small but elite group of companies in the hepatitis C product area. In combination with our ribavirin product, C-Virin(TM), we anticipate we will be able to start the market application process and submit our dossier to the various regulatory authorities for approval to begin selling C-Pegferon(TM) to governments and healthcare providers who are looking for more reasonably priced HCV drug products".
Mr Likes went on to state "Minapharm will also be our partner to manufacture, test and commercialize our HCV vaccine (C-Vaxin(TM)) in the same territory covered by the C-Virin(TM) distribution agreement."
The Middle East /MENA (Middle East/North Africa) territory includes: the Middle East, Africa and other industrialized regions: Afghanistan, Algeria, Armenia, Azerbaijan, Bahrain, Cyprus, Egypt, Georgia, Indonesia, Kazakhstan, Kyrgyzstan, Iraq, Iran, Israel, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Pakistan, Palestine, Qatar, Saudi Arabia, Sudan, Syria, Tajikistan, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uzbekistan and Yemen. By latest census, the MENA region comprises approximately 6 - 7% of the world's population (ca. 380 million people), a population equivalent to the European Union, or about one quarter larger than the U.S.
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