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Bionor Pharma Announces Filing of International Patent Application for its HIV Vaccine Vacc-HIV

Oslo, 11.06.2013 - Bionor Pharma ASA (OSE: BIONOR) announced today that it has filed an International Patent Application for its HIV Vaccine, Vacc-HIV. This application gives Bionor Pharma the opportunity to obtain patent protection for Vacc-HIV in all the major international pharmaceutical markets.

Vacc-HIV, which is currently in the preclinical stage of development, is a combination of Bionor Pharma’s HIV vaccines Vacc-4x and Vacc-C5.

Vacc-4x and Vacc-C5 act in a complementary manner, as Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells whilst Vacc-C5 serves to prevent the immune activation that drives HIV disease progression.  In combination they could act synergistically and contribute  to a functional cure strategy for HIV, meaning that people can live long-term with no active HIV replication or disease progression in the absence of ongoing antiretroviral therapy (conventional HIV medication). Vacc-HIV could also potentially contribute to a preventive vaccine strategy. 

The International Patent Application filed for Vacc-HIV supplements the existing granted patents and pending patent applications that the Company holds for Vacc-4x and Vacc-C5. The term of any granted patents resulting from this application would extend until June 2033, and such patents may also be eligible for patent term extensions in countries where these are available.

The Company announced that it has also filed an International Patent Application for new peptide designs to enhance the uptake of vaccines into cells allowing them to act in an effective way to stimulate a patient’s immune system.  In addition to providing a platform for the development of new products for the treatment of viral infections, this patent application provides protection for Bionor Pharma’s Universal Influenza Vaccine, Vacc-Flu, which is in the preclinical phase of development.

Bionor Pharma ASA

Hilde Aalling Syvertsen,
-Director Communications & Corporate Affairs 

Tel +47 23 01 09 60

About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.

Global leader in the development of HIV vaccines
The Company has a leading position in the global research field for therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS. The foremost candidate, Vacc-4x, has shown a statistically significant reduction in viral load in a phase II randomized, multinational, double-blind, placebo-controlled study. The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).

Four vaccine candidates in development
HIV vaccine, Vacc-4x: 1. Clinical phase II study, combining Vacc-4x with Celgene’s immune modulator Revlimid® (Lenalidomide), to investigate whether Revlimid enhances the effect of Vacc-4x in this placebo-controlled study in HIV patients with an impaired immune system.
2. Clinical phase II study, with Reboost in patients from the previous phase II study, aimed at reducing viral load even further.

HIV vaccine, Vacc-C5: Clinical phase I/II study, to investigate safety and whether the vaccine induces antibodies against HIV in humans.

HIV vaccine, Vacc-HIV (combination of Vacc-4x and Vacc-C5): A preclinical study is in preparation. The rationale behind Vacc-HIV is that this combination should prove more efficacious than each vaccine individually.

Universal influenza vaccine, Vacc-Flu: This vaccine is in the preclinical phase of development. Vacc-Flu is designed to produce long lasting immunity, and to be effective against all seasonal variations of influenza A.

More information about Bionor Pharma is available at www.bionorpharma.com

This information is subject to the disclosure requirements of §5-12 vphl
(Norwegian Securities Trading Act).  Vacc-4x, Vacc-C5, Vacc-HIV, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are currently investigational treatments that have not been approved for marketing by any regulatory authority.  The filing of a patent application is not a guarantee that it will be granted or be enforceable.