Transgene and Roche Enter Partnership on Therapeutic Vaccines Against HPV-Mediated Diseases



    Roche to Develop and Commercialize Products From Transgene's Programme

    STRASBOURG, FRANCE, April 11 /CNW/ - Roche and Transgene S.A. (Eurolist
Paris: FR0005175080) announced today that they have 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 Human Papilloma Virus (HPV) is associated with the development
of precancerous lesions and cancer of the cervix. The agreement includes
Transgene's lead therapeutic vaccine candidate TG 4001 (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 will lead worldwide development
and commercialization.
    TG 4001 has completed Phase II studies and is in planning for entry into
Phase III studies.
    'We are delighted by Roche's commitment to further develop our promising
vaccine TG 4001 in the field of HPV-mediated diseases,' said Philippe
Archinard, Chief Executive Officer of Transgene. 'Roche has broad expertise
and a leadership position in the development and marketing of first-in-class
innovative therapies. This first strategic partnership is an acknowledgement
of the validity of our technology and strategy. It is a considerable
transforming event for Transgene that we anticipate will enable us to
accelerate and broaden the development of our entire product portfolio.'
    'Transgene is an ideal strategic fit for Roche, offering a differentiated
approach to a precancerous condition with high unmet need,' said Peter Hug,
Roche's Global Head of Pharma Partnering. 'Transgene's expertise in viral
vaccine therapeutics complements our core capabilities in oncology and
virology drug development. In addition, as Roche is a leader in in vitro
diagnostics with strong capabilities in HPV detection, our collaboration with
Transgene has the potential to expand and evolve into an integrated
personalized medicine approach. We look forward to working with Transgene on
this program.'

    Terms of the Agreement

    Roche will acquire an exclusive license for TG 4001 and further
therapeutic vaccine development candidates resulting from the collaboration in
HPV-mediated diseases, and will have exclusive worldwide commercialization
rights. Roche will fund all future costs associated with the development of
TG 4001 and will lead the Phase III studies.
    Transgene will receive 13 million Euros as an upfront payment and
10 million Euros as a near-term regulatory milestone payment related to
planning the Phase III studies. Roche may pay Transgene up to 195 million
Euros, upon the achievement of certain further development and sales-based
events in various HPV-related indications. Transgene is also entitled to
double-digit escalating royalties on sales once a product is marketed.
    Roche will hold all manufacturing rights but has agreed to allocate, on
commercial terms, exclusive responsibility to Transgene for the clinical-trial
supply of TG 4001 and additional HPV products, which may be developed in the
future. This agreement will be extended to commercial-supply manufacturing for
an initial period.

    Conference Call and Webcast

    Transgene will conduct a conference call on April 11, 2007, at 10am
(French Time) in English and at 11:15am (French Time) in French. To
participate in the conference call, please log on to the Transgene website
www.transgene.fr and call one of the following numbers within 10 minutes prior
to commencement:

    +33-0-1-70-99-42-86

    +44-0-20-7138-0845


    About TG 4001

    TG 4001 therapeutic vaccine is designed to target HPV type 16 (HPV16),
known to be a high risk factor for the development of precancerous cervical
intraepithelial neoplasia and subsequently cervical cancer.
    TG 4001 (MVA-HPV-IL2) is based on a non-propagative, highly attenuated
vaccinia vector (MVA), which is engineered to express HPV16 antigens and an
adjuvant. As an immunotherapy for women diagnosed with diseases caused by the
HPV 16 infection, TG 4001 is designed to have a two-pronged anti-viral
approach: to alert the immune system specifically to HPV16-infected cells that
have started to undergo precancerous transformation (cells presenting the
HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing
activity of the immune system through an adjuvant (interleukin 2).
    In Phase II clinical trials, TG 4001 demonstrated safety and promising
clinical responses and efficacy in women with HPV16 CIN2/3. Results of a trial
in France, announced last year, of 21 women with HPV16 CIN 2/3, showed promise
as 10 women no longer had detectable levels of CIN2/3 six months after
vaccination (disappearance of the precancerous lesions and no detectable HPV16
E6/E7 mRNA). No serious side effects were observed.
    Sustainability of the response was assessed by an examination at Month 12
of the patients who did not undergo surgical excision of CIN lesions at
Month 6. No CIN2/3 relapse nor any HPV16 persistence or re-infection were
observed in these women. A placebo-controlled Phase III program is in planning
to enrol an estimated 500 patients with CIN2/3 caused by HPV16.

    About HPV-mediated diseases

    HPV 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.
    Due to the wider use of HPV testing, HPV infection is being diagnosed in
an increasing number of women, but no anti-viral treatment is currently
available. Surgical resection, currently the only therapeutic solution, is
highly effective but presents medical complications and relapses. Therefore, a
therapeutic vaccine to clear precancerous lesions and the associated HPV
infection could be an effective, non-invasive approach for the prevention of
cervical cancer.
    Roche launched the Amplicor HPV Test and the Linear Array HPV Genotyping
Test in Europe in 2004 and 2005 respectively. Both tests are currently under
review by the US Food & Drug Administration (FDA) for approval to market the
tests in the United States. The Amplicor HPV Test is designed to enable
accurate detection of 13 high-risk HPV genotypes (including HPV16) in standard
clinical samples. The Linear Array HPV Genotyping Test is designed to identify
which of 13 high-risk HPV genotypes are present in a sample. Studies worldwide
have used the research prototype of the Roche Diagnostics Linear Array HPV
Test to better understand HPV.


    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-focused healthcare groups in the fields of pharmaceuticals and
diagnostics. As one of the world's biggest biotech companies and an innovator
of products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is a world leader in
in-vitro diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as autoimmune
diseases, inflammation, metabolism and central nervous system. In 2006 sales
by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the
Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs
roughly 75,000 worldwide and has R&D agreements and strategic alliances with
numerous partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on the
Internet at www.roche.com and about Roche Diagnostics in Women's Health at
www.roche.com/med_backgr-women

    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 three compounds in Phase II trials
and one compound in Phase I studies. 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.

    All trademarks used or mentioned in this release are protected by law.


    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 into licensing
agreement, as well as to payments and other matters provided for under the
agreement. Except for the upfront payment, 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. In addition, the
agreement is subject to clearance by the U.S. Federal Trade Commission under
the Hart Scott Rodino Antitrust Improvement Act.




For further information:

For further information: Transgene's press contacts: Phone:
+33-3-88-27-91-02, email: poncet@transgene.fr, Philippe Poncet, Chief
Financial Officer; Phone: +44-20-7307-5330, Mary Clark or Halina Kukula
(Capital MS&L for Transgene)

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