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Last updated on April 24, 2014 at 21:24 EDT

Pevion Grants CSL Option Right to its Therapeutic Candida Vaccine

September 1, 2011

BERN, Switzerland, September 1, 2011 /PRNewswire/ –

Pevion Biotech AG today announced that the company has granted to CSL
Limited a right of first refusal for the commercialization of its
therapeutic Candida vaccine in Australia and New Zealand. At the same time,
both companies signed a long-term supply agreement under which CSL shall
supply to Pevion components for its virosomal vaccines.

CSL, Australia’s leading biopharmaceutical company, obtained a right of
first refusal to an exclusive license for the commercialization of Pevion’s
PEV7 therapeutic vaccine in Australia and New Zealand. Further terms of the
agreement were not disclosed. PEV7 is a therapeutic candidate vaccine for
the treatment of Recurrent Vulvovaginal Candidiasis (RVVC), also known as
chronic recurrent thrush, a largely unrecognized but highly debilitating
condition, which affects 5% of adult women. PEV7 already obtained excellent
preliminary clinical results showing that the therapeutic vaccine is safe
and immunogenic in healthy volunteers.

“The novel character of PEV7, a first-in-class product, and its
commercial potential has been recognized by an industry leader, such as
CSL,” commented Evert Kueppers, CEO of Pevion. “CSL is a leading supplier of
vaccines in Australia and New Zealand and has been particularly successful
with the early development and marketing of innovative products such as
Gardasil(R). We strongly believe that CSL would be an ideal commercial
partner for our PEV7 therapeutic vaccine in these territories.”

In addition to the granting of the PEV7 option, the two companies have
signed a long-term supply agreement, whereby CSL manufactures certain
biological components that are being used by Pevion in the in vitro assembly
process of its virosomes. Virosomes are a regulatory and market-approved
vaccine technology that fulfills multiple carrier and adjuvant functions in
one. They form the basis of all of Pevion’s proprietary and partnered
pipeline products. Pevion has developed the second generation of virosomes
that allow alternative product formulations, such as capsules.

About RVVC

Recurrent vulvovaginal candidiasis (RVVC), also known as chronic
recurrent thrush, is a largely unrecognized but highly debilitating
condition, which affects 5% of adult women. It is defined as four or more
acute episodes of symptomatic vulvovaginal candidiasis within a 12 months
period. Clinical symptoms are vulvovaginal inflammation, most often
dominated by severe itching, and other symptoms causing extreme discomfort
and pain. The quality of life of RVVC patients is strongly impacted, both
physically and psychologically. A significant proportion of patients suffer
over many years without perspective for any amelioration or cure from
permanently present painful disease symptoms, impeded activities including
social life and work, partnership problems, and difficulties or
impossibility to talk about it. Over time, accumulating frustration leads to
loss of self esteem, desperation or even depression. Cure rates of RVVC with
available antifungal drug therapy remain disappointing and there is no
treatment available to prevent recurrencies.

About PEV7 therapeutic Candida vaccine

PEV7 is a therapeutic vaccine based on a protein antigen, Sap2, a key
virulence factor of vulvovaginal candidiasis, presented on the surface of
virosomes. Pevion exclusively in-licensed the Sap2 antigen from its academic
partner, the Istituto Superiore di Sanita (ISS) in Rome, Italy.

The ongoing PEV7 Phase I study is designed to assess the safety and
immunogenicity of the therapeutic vaccine candidate in healthy volunteers.
Half of the subjects will receive intramuscular injections, while the other
half will receive capsules, administered intravaginally. In total, the study
will enroll 48 healthy women of childbearing age.

About Virosomes

Virosomes are a regulatory and market-approved vaccine technology that
fulfills carrier and adjuvant functions in one. Essentially, virosomes
represent reconstituted empty influenza virus envelopes, devoid of the
genetic material of the source virus. As such, virosomes do not replicate
and are therefore an ideal combination of carrier plus adjuvant for almost
any given antigen, including peptide or protein derived antigens. The
technology enables the use of poorly immunogenic antigens and thereby
provides access to new indications and markets. Two virosome-based vaccines
(Epaxal(R) and Inflexal(R) V, marketed by Crucell Switzerland AG) are
licensed in over 40 countries, and more than 70 million doses of these
vaccines have been commercially distributed, thereby providing a solid
safety and efficacy track record. Pevion has developed the second generation
of virosomes that allow alternative product formulations, such as capsules.

About Pevion Biotech AG

Pevion Biotech AG is a fully independent Swiss vaccine company that
develops innovative vaccines for unmet medical needs based on its clinically
and commercially validated virosome technology. Its proprietary clinical
pipeline includes a first-in-class candidiasis vaccine. A clinical stage
malaria vaccine candidate has been successfully outlicensed, and the
Company’s technology has been licensed for use as an HIV vaccine currently
in human trials. Pevion has in-house development capability and expertise,
including a state-of-the-art and industrially scalable GMP manufacturing
process. Located near Bern, Pevion was established by its founding fathers,
Bachem AG (SWX: BANB) and Berna Biotech (now Crucell, a Johnson & Johnson
subsidiary). To date, Pevion has raised a total of CHF 45 million from its
founders and investors, BZ Bank, Core Capital Parnters and BB Biotech
Ventures.

        For more information visit:  http://www.pevion.com

        Julian Wagner, PhD,
        Business Development
        Phone: +41-31-550-44-44
        E-Mail: nfo@pevion.com

SOURCE Pevion Biotech AG


Source: PR Newswire