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Biotech / Medical : T/FIF, a New Plateau -- Ignore unavailable to you. Want to Upgrade?

To: nigel bates who wrote (1292)	7/26/2002 1:37:56 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2243

They sounded REALLY ticked at the FDA decision. The subdued outrage had a nice, no BS ring to it. I was surprised by the FDA decision. Where did you find that news? When did it come out, before the close today?? I own a smidge (sold most after a nice, if slow, scalp..... thank's to your pointer), and I obviously noted the plus 25% today, but the modest volume made me think that it was only a reaction to the decision in Israel. quote.yahoo.com

To: nigel bates who wrote (1292)	7/26/2002 2:49:30 AM
From: scaram(o)uche	Respond to of 2243

now Zavesca (!)........ and OGSI is still a small component of "2000"...... Friday July 26, 2:00 am Eastern Time Press Release SOURCE: Oxford GlycoSciences Plc OGS and Actelion Announce Marketing and Distribution Partnership For Zavesca(TM)* in Europe OXFORD, UK, and ALLSCHWIL, Switzerland, July 26 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) and Actelion Ltd (SWX: ATLN) today announced that they have signed a binding letter of intent setting out the conditions for a European marketing and distribution partnership for Zavesca (TM). Zavesca is an oral formulation of miglustat, a small molecule developed by OGS for the treatment of type 1 Gaucher disease, and was previously known under the trademark Vevesca. OGS today received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP) recommending approval of Zavesca in the European Union (for details, see separate announcement). To ensure rapid availability of Zavesca to patients in need, Actelion will bring to this partnership its established clinical information, regulatory, marketing and distribution infrastructure. The company will also provide drug safety and post-marketing surveillance experience gained from the launch of its lead product Tracleer (TM), a dual endothelin receptor antagonist for the treatment of pulmonary arterial hypertension. Under the terms of this partnership, which will be for an initial period of five years, OGS will remain the marketing authorisation licence holder for the drug, retaining responsibility for manufacturing and regulatory activities. Actelion will be responsible for marketing and sales activities, and will handle, jointly with OGS, the post-approval pharmacovigilance specified in the CPMP positive opinion. The partnership will be managed by a joint steering committee. This committee will also decide on further development programmes of Zavesca, which will be implemented and executed by Actelion. Actelion will book sales of Zavesca and OGS will be paid an undisclosed share of the net revenues. Commenting on the agreement, David Ebsworth, Ph.D., Chief Executive Officer of OGS, said: "This partnership with Actelion is a major strategic benefit to OGS in its marketing plans for Zavesca. In addition to Actelion's solid regulatory and marketing infrastructure, its experience in pharmacovigilance will be invaluable to ensure the highest possible standard of patient monitoring post launch and to provide maximum benefits to clinicians and patients." Jean-Paul Clozel, M.D., Chief Executive Officer of Actelion, added: "OGS' expertise in the Gaucher area coupled with our experience in developing, registering and marketing innovative small molecules in highly specialised settings is a powerful combination. We believe that oral Zavesca provides an important treatment option to type 1 Gaucher patients and their treating physicians. We look forward to working with the OGS team to market the product in Europe." Note: OGS and Actelion will host a conference call for analysts today at 9.00am UK time. Please call Claire Rowell on +44 (0)20 7831 3113 for further details. About Gaucher Disease Gaucher disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, an enzyme responsible for glycosphingolipid (GSL -- a subclass of fats) metabolism. Symptoms include enlargement of spleen and liver, bone disease and anaemia. Treating Gaucher Disease with Zavesca Zavesca has a novel mode of action as an oral inhibitor of glucosylceramide synthase, a key enzyme involved in GSL biosynthesis. The rationale for the use of Zavesca is to help balance the overall level of GSLs by inhibiting their production or synthesis - termed 'substrate reduction'. Pending a final decision by the European Commission, Zavesca is an investigational drug and has not received approval for marketing in any country. About OGS OGS has developed a patented technology platform in the emerging field of proteomics, the comprehensive study of proteins, integrating proteomics with genomics to create an innovative drug discovery platform. OGS' proteomics collaborations with major pharmaceutical and biotechnology companies include Bayer, Pioneer Hi-Bred/DuPont, GlaxoSmithKline and Pfizer. OGS has drug discovery and development alliances with Medarex, NeoGenesis and BioInvent and technology development collaborations with Applera, Cambridge Antibody Technology, Packard BioScience and The Institute for Systems Biology. OGS has also entered into a joint venture, Confirmant Limited, to develop the Protein Atlas of the Human Genome (TM). OGS has drug research discovery programmes in central nervous system, cancer, infectious disease and glycosphingolipid (GSL) storage disorders. About Actelion Ltd Actelion Ltd is a biopharmaceutical company, with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug, Tracleer (TM), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer (TM) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the Swiss Stock Exchange (SWX New Market ATLN). This release contains forward-looking statements, such as the commercial potential and success of OGS' collaborations and drug candidates. Factors that could cause actual results to vary significantly from those expressed or implied by these and other forward-looking statements include the success of OGS' research and development strategies, the validity of its technologies and intellectual property position and strategies, the medical conclusions on which Zavesca (INN:miglustat) is based and uncertainties related to the regulatory process. * For commercial reasons, OGS has elected to change the trademark for this product from Vevesca to Zavesca. Zavesca will therefore be the trademark intended to be used by OGS and Actelion to market miglustat when approved. For further information please contact: Oxford GlycoSciences Plc Dr David Ebsworth, Chief Executive Officer Tel: +44 (0) 1235 208000 Actelion Ltd Roland Haefeli, Media/Investors Contact Tel: +41 61 487 34 58 +1 650 624 693 UK: Financial Dynamics Melanie Toyne-Sewell Tel: +44 (0) 20 7831 3113 USA: Feinstein Kean Michael Lawson Tel: +1 (617) 761 6765 SOURCE: Oxford GlycoSciences Plc

To: nigel bates who wrote (1292)	7/26/2002 2:54:57 AM
From: scaram(o)uche	Respond to of 2243

Friday July 26, 2:00 am Eastern Time Press Release SOURCE: Oxford GlycoSciences Plc OGS Announces Positive CPMP Opinion for Zavesca(TM)* for Type 1 Gaucher Disease in European Union OXFORD, UK, July 26 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) today announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of Zavesca. Zavesca is an oral formulation of miglustat, a small molecule developed by OGS for the treatment of type 1 Gaucher disease, and was previously known under the trademark Vevesca. Zavesca is indicated for the oral treatment of mild to moderate type 1 Gaucher disease. Zavesca may only be used in the treatment of patients for whom Enzyme Replacement Therapy is unsuitable. The CPMP has recommended that the Marketing Authorisation is granted under exceptional circumstances** and has requested OGS to provide follow-up safety data derived from a post- marketing surveillance programme and additional clinical information. "We are delighted to have received this positive opinion. We began the clinical investigation of Zavesca in type 1 Gaucher disease in 1998 and have now become one of the few biotech companies in the UK to achieve this important milestone," said Chris Moyses, M.D., Chief Medical Officer of OGS. "This opinion is the result of a centralised EU procedure and Marketing Authorisation can now be expected within the next few months." Today, OGS has also announced the signature of a binding letter of intent with Actelion Ltd setting out the conditions of a partnership to support the marketing and distribution of Zavesca in Europe (see separate announcement). "The combination of the positive CPMP opinion for Zavesca and our partnership with Actelion puts us in a position to expedite the delivery of this novel oral therapy to patients and physicians. In our view, this decision recognises OGS' innovative drug development expertise in the field of Gaucher disease," said David Ebsworth, Ph. D., Chief Executive Officer of OGS. Regulatory background The CPMP opinion serves as the basis for a European Commission (EC) final approval, which is typically issued in 90 to 120 days. EC approval of the centralised application for Zavesca would result in a single marketing authorisation with unified labelling valid in all 15 European Union-Member States. OGS submitted its marketing authorisation application to the EMEA in July 2001. Zavesca has been granted orphan medicinal product status in Europe, allowing for a ten-year marketing exclusivity period following approval. Gaucher Disease Gaucher disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, an enzyme responsible for glycosphingolipid (GSL - a subclass of fats) metabolism. Symptoms include enlargement of spleen and liver, bone disease and anaemia. Treating Gaucher Disease with Zavesca Zavesca has a novel mode of action as an oral inhibitor of glucosylceramide synthase, a key enzyme involved in GSL biosynthesis. The rationale for the use of Zavesca is to help balance the overall level of GSLs by inhibiting their production or synthesis - termed 'substrate reduction'. Note: OGS and Actelion will host a conference call for analysts today at 9.00am UK time. Please call Claire Rowell on +44 (0)20 7831 3113 for further details. (snip) Thanks, Nigel and Wilder, for giving us a great intro on this one.