Pevion Mandated Patient Survey Confirms Disease Burden of Recurrent Vulvovaginal Candidiasis (RVVC) and Indicates Public Health Problem

BERN, Switzerland, March 8, 2012 /PRNewswire/ --

• Quality of Life (QoL) is strongly diminished in RVVC patients
• Current available treatment fails in two thirds of patients
• High medical need demands novel effective treatment options

Pevion Biotech AG today announced results from a large, international survey on the Quality of Life (QoL) of recurrent vulvovaginal candidiasis (RVVC) patients. It is the first time that the overall disease burden of RVVC has been quantified by validated tools, thereby showing that QoL is strongly diminished and that RVVC has a significant impact on patients' daily activities and productivity. The survey furthermore confirmed previous findings that current use of antifungal drugs is inadequate and that it presents a therapeutic failure in more than two thirds of the RVVC patients.

"This study not only highlights the heavy burden associated with the disease, but also the very high unmet medical need," said Professor Mondher Toumi, Chair of Market Access at the University of Lyon 1, France. "The lack of effectiveness and constraint related to chronic treatment are a source of low compliance because there is low perceived benefit with current treatment. Based on cost per quality-adjusted life year (QALY) the society appears ready to pay a high price for an effective intervention in that indication."

"Pevion recently announced the outcome of the largest epidemiological survey ever performed regarding RVVC, confirming that 7% of all adult women suffer from this disease," commented Evert Kueppers, Pevion's Chief Executive Officer. "The outcome of this Quality of Life study confirms that RVVC not only is wide spread, but that it also has a significant impact on the lives of millions of women suffering from RVVC. Presently, RVVC is an under-recognized public health problem affecting mostly young and active parts of the society."

Recurrent vulvovaginal candidiasis (RVVC) is a common and moderate-to-severe chronic condition, which occurs in 7% of all adult women. To date, no study has been conducted to properly assess patients' QoL using validated questionnaires. The disease is characterized by the frequent recurrence of acute inflammations of the vagina and vulva, caused by an overgrowth of Candida albicans, and is defined as four or more acute episodes per year. Clinical symptoms cause extreme discomfort and pain and the quality of life (QoL) of patients is strongly impacted, both physically and psychologically.

Pevion has mandated a survey among more than 600 RVVC patients in the US and in the five largest European countries in order to assess the global QoL in a quantitative manner employing the validated EQ-5D and SF-36 scoring systems. The survey data show that the QoL is substantially diminished not only during an acute inflammatory episode, but also in the periods between recurrences. This reflects the maintained discomfort and stress in between acute episodes, which is accompanied by anxiety and depression in a large proportion of patients. The characteristics of a chronic disease are clearly given and the overall utility scores are significantly lower than the general population's reference value, and this, under the current standard of care. Moreover, the results show strong consistency between the six countries.

The survey revealed that there is a strong impact on patients' usual daily activities and work. A significant loss of productivity has been recorded, which represents a valuable economic damage.

The survey also investigated current treatment patterns among RVVC patients. In those patients who followed a long-term maintenance therapy with antifungal drugs, as recommended by guidelines from several medical societies, relapse occurred in two thirds of cases already within a few months. This low benefit explains why less than half of the patients actually receive such treatment.

Pevion is developing a first-in-class therapeutic vaccine, PEV7, to address this public health issue. PEV7 has recently demonstrated safety and immunogenicity in healthy volunteers.

About PEV7 therapeutic Candida vaccine

PEV7 is a clinical-stage therapeutic vaccine being developed for the treatment of recurrent vulvovaginal candidiasis (RVVC), a moderate-to-severe disease affecting 7% of all adult women. To date, there is no appropriate treatment for RVVC available. PEV7 is based on a protein antigen, Sap2, a key virulence factor of vulvovaginal candidiasis that is 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. Positive interim results have already been announced.

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^® 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 and owns the second generation of virosomes, which have an excellent stability profile through lyophilization and 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 out-licensed, and the Company's technology has been out-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 two founding companies, 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, Bachem, BB Biotech Ventures and private investors.

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

For further information, please contact:

Julian Wagner, PhD, BBA, Business Development
Phone: +41-31-550-44-44, [email protected]

SOURCE Pevion Biotech AG