Transgene to Receive First Milestone Payment of EUR 10 Million From Roche Following FDA and EMEA Review of TG 4001 (R3484) Phase III Studies Plan

    STRASBOURG, France, June 1 /CNW/ - Transgene S.A. (Eurolist Paris:
FR0005175080) 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

    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

    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.

For further information:

For further information: Transgene's press contacts: Philippe Poncet,
Chief Financial Officer, Transgene, Phone: +33-3-88-27-91-02, email:; Mary Clark or Halina Kukula, Capital MS&L, Phone:

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890