| An SI Board Since November 2003 |
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PHRM |
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tuck
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Several posters on the Valuation thread have said they like Pharmion best of the recent crop of IPOs. Perhaps the reason might be that they actually have products? From the S-1:
>>We are creating a global pharmaceutical company focused on acquiring, developing and commercializing innovative products for the treatment of hematology and oncology patients. We have established our own regulatory, development and sales and marketing organizations covering the U.S., Europe and Australia. We have also developed a distributor network to serve the hematology and oncology markets in 19 additional countries throughout the Middle East and Asia. To date, we have acquired rights to two marketed products, Innohep® and Refludan®. We also have two products, Thalidomide Pharmion 50mg and Vidaza, in advanced stages of development that we believe represent significant market opportunities. These products were obtained through licensing arrangements with companies including Celgene Corporation, Pharmacia & Upjohn Company, now a part of Pfizer, Inc., Schering AG and LEO Pharma A/S. With our combination of regulatory, development and commercial capabilities, we intend to continue to build a balanced portfolio of approved and pipeline products targeting the hematology and oncology markets.
Our current product portfolio consists of the following four products:
• Thalidomide Pharmion 50mg (thalidomide)— Thalidomide has become a standard of care for the treatment of relapsed and refractory multiple myeloma, a cancer of the plasma cells in the bone marrow and the second most common form of cancer in the blood. We have licensed the marketing rights to thalidomide from Celgene and Penn T Limited for all countries outside of North America and certain Asian markets. We estimate that there are approximately 70,000 multiple myeloma patients in the E.U. and Australia, with approximately 22,000 new cases annually. Celgene markets Thalomid® in the U.S. and reported sales of $101 million for the six months ended June 30, 2003.
Since acquiring rights from Celgene and Penn we have made significant progress toward commercialization of thalidomide in Europe, Australia and elsewhere. We recently began selling thalidomide on a compassionate use or named patient basis under a stringent risk management program in Europe while we actively seek full regulatory approval for this drug in Europe and several additional countries. In August 2003, the Australian Drug Evaluation Committee recommended approval of Thalidomide Pharmion 50mg as a treatment for relapsed and refractory multiple myeloma and erythema nodosum leprosum, or ENL. An approval of Thalidomide Pharmion 50mg for the treatment of relapsed and refractory multiple myeloma would be the first regulatory approval of thalidomide for this indication anywhere in the world. We are currently working with the Australian regulatory agency to finalize the details for registration and labelling. To promote the safe use of thalidomide, we implemented the Pharmion Risk Management Program, or PRMP. Enrollment in the PRMP is obligatory before any patient can be given Thalidomide Pharmion 50mg and strict guidelines must be adhered to both prior to and during the course of thalidomide therapy.
• Vidaza (azacitidine)— Vidaza is the subject of a completed and published Phase III study indicating its safety and efficacy in the treatment of myelodysplastic syndromes, or MDS, a bone marrow disorder characterized by the production of abnormally functioning, immature blood cells. We obtained worldwide rights to this product from Pharmacia. According to the American Cancer Society, or ACS, the exact number of cases of MDS in the U.S. is unknown but most estimates are between 10,000 and 20,000 new cases each year. We anticipate submitting a New Drug Application to the FDA for Vidaza in and making comparable filings in Europe and Australia in . In connection with these submissions, we are currently initiating a confirmatory study of Vidaza in MDS, which will be one of the largest studies in MDS to date.
• Innohep® (tinzaparin)— Innohep® is a low molecular weight heparin approved in the U.S. for the treatment of deep vein thrombosis, or DVT, which occurs when a blood clot develops in the deep veins of the legs. We obtained the U.S. rights to this product from LEO Pharma A/S, which markets Innohep® in Europe and several additional countries. Cancer patients are particularly at risk to develop DVT, either from the disease itself or as a side effect of certain cancer treatments. We relaunched Innohep® as a treatment for DVT in cancer patients in the fourth quarter of 2002, and used this drug to establish our U.S. sales and marketing organization.
• Refludan® (lepirudin)— Refludan® is an antithrombin agent approved in the U.S., Europe and several additional countries for the treatment of heparin-induced thrombocytopenia, or HIT, an allergic, adverse immune response to heparin, resulting in an absence of sufficient cell platelets to enable blood clotting. We obtained rights to this product in all countries outside of the U.S. and Canada from Schering AG. We began selling Refludan® in Europe and Australia in the third quarter of 2002, and used this drug to establish our European and Australian sales and marketing organizations.<<
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