Ittigen/Bern, Switzerland (ots) - 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®. 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.
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 Sanità (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.
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® and Inflexal® 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: www.pevion.com
Julian Wagner, PhD, Business Development