STRASBOURG, France, June 1 /PRNewswire-FirstCall/ -- Transgene S.A. announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have reviewed the proposed plan to initiate Phase III studies of TG 4001 / R3484 (MVA-HPV-IL2) for the treatment of high grade cervical intraepithelial neoplasia (CIN 2/3). A EUR 10 million payment associated with this milestone should be received by Transgene from Roche before the end of June 2007. Under the collaboration agreement between Roche and Transgene, Roche is responsible for the ongoing development and commercialization of TG 4001 / R3484.
About the agreement with Roche:
On April 11th, 2007, Transgene and Roche entered into an exclusive worldwide collaboration agreement to develop and commercialize products from Transgene's therapeutic vaccine program against Human Papilloma Virus-mediated diseases. The agreement, which was subject to clearance by the U.S. Federal Trade Commission under the Hart Scott Rodino Anti-trust Improvement Act, has become effective as from May 23rd, 2007. In addition to a EUR 13 million upfront payment and the EUR 10 million near-term regulatory milestone payment related to planning the Phase III studies, Roche may pay Transgene up to a total of EUR 195 million, upon the achievement of certain further development and sales-based events in various HPV-related indications. In addition, Transgene is entitled to double-digit escalating royalties on sales once a product is marketed.
The agreement includes Transgene's lead therapeutic vaccine candidate TG 4001 / R3484 (MVA-HPV-IL2), currently in clinical development to treat high grade cervical intraepithelial neoplasia (CIN2/3), a precancerous cervical abnormality which can lead to cervical cancer. Under the agreement, Roche is responsible for leading the worldwide development and commercialization. TG 4001 / R3484 has completed Phase II studies and is in planning for entry into Phase III studies.
Roche holds all manufacturing rights but has agreed to allocate, on commercial terms, exclusive responsibility to Transgene for the clinical-trial supply of TG 4001 / R3484 and additional HPV products, which may be developed in the future. This agreement will be extended to commercial-supply manufacturing for an initial period.
About TG 4001
TG 4001 therapeutic vaccine is designed to target Human Papilloma Virus type 16 (HPV16), known to be a high risk factor for the development of precancerous cervical intraepithelial neoplasia and subsequently cervical cancer.
About HPV-mediated diseases
Human Papilloma Virus infection is recognized as the necessary cause of precancerous cervical lesions and cervical cancers and is the most common sexually transmitted disease affecting about 400 million women worldwide. Most infections are spontaneously eliminated in less than one year. In the remaining cases, persistent HPV infection can lead, after several years or decades, to precancerous lesions of the cervix - called cervical intraepithelial neoplasia of grades 2 and 3 (CIN 2/3) - and eventually to cervical cancer. Worldwide, new cases are reported at a yearly rate of around 1.4 million for CIN 2/3 and 500,000 for cervical cancer, of which approximately 50% are linked to HPV16. The HPV16 genotype, along with HPV18, 31 and 33 genotypes, have the highest risk of transforming infected cervical cells into cancerous cells.
About Transgene
Transgene is a France-based biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases. The company has one product which has completed Phase II trials (TG 4001), two compounds in Phase II trials (TG 4010 and TG 1042) and one compound in Phase I studies (TG 4040). Transgene has concluded a strategic partnership agreement with Roche for the development of its TG 4001 therapeutic vaccine to treat HPV-mediated diseases. Transgene has bio-manufacturing production capacities for viral-based vectors and technologies available for out-licensing. Additional information about Transgene is available on the Internet at www.transgene.fr.
Cautionary comments regarding forward-looking statements
This press release contains forward-looking statements referring to the anticipated development and commercialization of one of Transgene's therapeutic product candidates pursuant to a recently entered licensing agreement, as well as to payments and other matters provided for under the agreement. Except for the upfront and near-term regulatory milestone payments, all other payments to Transgene by Roche under the agreement are subject to the occurrence of certain events that are dependent on regulatory approvals and further clinical testing, as well as for marketing, demonstrated product efficacy and success in broad clinical studies, and market demand and sales levels, none of which can be assured at this time. For further information on the technical, regulatory and competitive risks and uncertainties involved in the development and commercialization of product candidates, see Transgene's Document de reference on file with the French Autorite des marches financiers.
Transgene S.A.CONTACT: Transgene's press contacts: Philippe Poncet, Chief FinancialOfficer, Transgene, Phone: +33-3-88-27-91-02, email: poncet@transgene.fr;Mary Clark or Halina Kukula, Capital MS&L, Phone: +44-20-7307-5330
