BT Pharma — Company Profile

BT Pharma Headquarters and Laboratories Prologue-Biotech Rue Pierre et Marie Curie BP 28262 31682 Labège-Innopole Cedex France Tel.: +33 (0)5 61 28 70 60 Fax: +33 (0)5 61 28 70 69 Email: business@btpharma.com Website: http://www.btpharma.com/

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines caused by human papillomavirus (HPV) for the treatment of cervical cancer and associated neoplasia. The company's lead candidate therapeutic vaccine, ProCervix^® is scheduled to receive approval for its first clinical trials in 2009. BT PHARMA plans to develop ProCervix^® to proof of concept stage.

The company was created in October 2001 and is based in Labège (Toulouse), France.

Corporate Profile

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines for the treatment of cervical cancer and associated neoplasia.

Cervical cancer and associated neoplasia are a major healthcare problem. They are the result of infection by the Human Papillomavirus (HPV) and are one of the most common sexually transmitted diseases affecting women.

BT PHARMA’s lead candidate therapeutic vaccine, ProCervix^® is scheduled to receive approval for its first clinical trials in 2009. ProCervix^® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV antigens needed to induce strong and specific T cell responses. BT PHARMA plans to develop ProCervix^® to proof of concept stage. The company then intends to work with an appropriate partner to further develop and commercialize this exciting new therapeutic vaccine product.

In addition, BT PHARMA has a number of other therapeutic vaccine development programs based on its CyaA vector system. These are TAAVAC, for Tumour Associated Antigen Vaccine for a range of human cancers, and DOGTAA, which targets many cancers in companion animals.

Finally, the company also has a second vaccine vector called PepTel^® which uniquely has intrinsic adjuvant ability. This promising technology platform is available for licensing.

BT PHARMA is managed by a team of experienced biotech professionals and has developed a strong network of collaborators. The company continues to work with scientists, at Institut Pasteur, who are the world leading experts in the CyaA vector technology. The company also works with leading clinicians with significant experience in conducting clinical trials with cervical cancer vaccines.

BT PHARMA started operations in October 2001 following its spin off from the Institut Pasteur. The company is headquartered in state-of-the-art facilities in Labège (Toulouse), France and employs 18 people.

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BT PHARMA enforces its alliance with the Institut Pasteur on the development of therapeutic cancer vaccines

Toulouse, 11 January 2008 — The Institut Pasteur has agreed to add a new patent under the exclusive license granted to BT PHARMA with regards to the Adenylate Cyclase vector technology. This patent has been filed in all major markets of the OECD as well as in China and India.

The patent claims a novel combination cancer treatment, which associates a chemotherapeutic agent with an immunotherapeutic agent, resulting in a dramatically improved specific immune response against the malignant tissues. In fact, the treatment induces simultaneously an adaptive cellular immune response (tumour cell specific), an amplified innate immune response and decreases the immune tolerance that tumours typically acquire. This patented combination has, for the first time in appropriate animal models, allowed to totally eliminate very large vascularized solid tumours.

The new patent reinforces BT PHARMA’s intellectual property portfolio, which consists of proprietary patents and patents exclusively in licensed from the Institut Pasteur. The results protected under this most recent patent filed by the Institut Pasteur were obtained by the team of Professor Claude Leclerc, Director of the Department for Immune Regulation and Vaccinology, INSERM U883, Institut Pasteur. Professor Claude Leclerc is also member of the Science Board of the "Cancéropôle Ile-de-France" and is a member of the Scientific Advisory Board of BT PHARMA.

« This is the second patent of the Institut Pasteur this year that BT PHARMA has integrated in its exclusive license arrangement with regards to the Adenylate Cyclase vector technology » said Benedikt Timmerman, Chief Executive Officer of BT PHARMA; « Already in May 2007, we have acquired the commercial rights to a patent filed by the Institut Pasteur, which claims the use of the Adenylate Cyclase carrying tumour-derived antigenic peptides. Together with the patent covering combination therapy of CyaA with chemotherapy, these two patents substantially reinforce BT PHARMA’s position in the domain of cancer immunotherapy ».


With regards to BT PHARMA S.A.

BT PHARMA is a bio-pharmaceutical company, spun out from Institut Pasteur incubator in 2002 (Pasteur-Biotop) and currently headquartered in Toulouse, France. The company strives to improve the well-being of people through the development of therapeutic vaccines for infection, dysplasia and cancer provoked by the Human Papillomavirus (HPV). BT PHARMA’s key technology is a recombinant protein-based antigen delivery system: the Adenylate Cyclase vector (CyaA). CyaA allows "re-educating" the immune system such that protective cellular immunity is activated against certain serious diseases, including cancer. The CyaA technology stands out because of its universal applicability, its target specificity, its potency and relative simplicity. BT PHARMA focuses on the HPV domain but invites industrial partnerships for development of vaccines against other cancers as well as preventive vaccines against infectious diseases.

ProCervix^®, the most advanced product candidate of the company, will enter phase I/II clinical trials in 2008. This bivalent therapeutic vaccine targets high grade neoplasia and cervical cancer provoked by Human Papillomavirus HPV16 and HPV18, which affect more than 70% of women with these indications. If effective, ProCervix^® could replace Loop Electrosurgical Excision Procedure (LEEP) or cervical conisation in millions of women infected by HPV16 or HPV18 and at risk of developing cervical cancer. Please note that preventive HPV vaccines are not proscribed for people that are already infected by the virus. On average 12% of the population is carrier of HPV, of which a fraction will develop high-grade intra-epithelial lesions that can progress to invasive cancer. It is for these people that BT PHARMA intends to provide a less invasive solution.


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BT PHARMA appoints Martin Koch as Vice President Finance and Administration

Professional in Biotech Finance brings top management and international experience to BT PHARMA &mdash forerunner in Therapeutic Vaccines

Toulouse, France — Monday September 17, 2007. BT PHARMA S.A., forerunner in the development of therapeutic vaccines for treatment of neoplasia and cancer caused by the Human Papillomavirus (HPV), announced today that Martin Koch, engineer and INSEAD MBA, has been elected to the position of Vice-President Finance and Administration.

Before joining BT PHARMA, Martin Koch had an international career in financial and operational management positions at Eli Lilly Company, Cap Gemini / Ernst & Young, Elan Pharmaceuticals, Zeneus Pharma and Cephalon Pharmaceuticals. In particular, Mr Koch was instrumental in the transaction whereby a large part of Elan’s continental European activities were spun off to Zeneus Pharma.

"We are very pleased to welcome Martin Koch who brings over 15 years of pharmaceutical industry experience to our management team", explained Benedikt Timmerman, Chief Executive Officer of BT PHARMA. "We are entering in an accelerated growth phase and the recruitment of Martin fits well in our objective to reinforce our management with executives of top management level. Martin’s experience will be of great value for BT PHARMA as we start identifying strategic partners to finance our clinical trials Phase I and II."


About BT PHARMA S.A.

BT PHARMA is a privately held biopharmaceutical company spun out of the Institut Pasteur in 2002 and registered in Toulouse, France (home of Airbus Industries). The company develops immuno-therapeutics for cervical neoplasia and cancer. BT PHARMA’s key technology is a protein-based delivery system (the Adenylate Cyclase vector) that allows inducing tailor-made and targeted T cell immune responses in the patient. BT PHARMA exploits this technology to develop innovative therapeutic vaccines in-house and in partnership with biotech and pharmaceutical companies.

The young company’s most advanced product, ProCervix^®, will enter phase I / II clinical trials in 2008. This bivalent therapeutic vaccine targets cervical neoplasia and cancer provoked by the human Papillomavirus (HPV). ProCervix^® aims to replace ablative surgery or conisation in millions of women already infected by HPV16 or HPV18 and at risk for invasive cervical cancer.

Further information: http://www.btpharma.com


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BT PHARMA successfully closes €1.3 million bridging round

Bridging funds to move candidate therapeutic vaccine up to phase I / II clinical trials for treatment of patients suffering from high-grade lesions provoked by Human Papillomavirus.

Toulouse, France — Monday, May 28th 2007.BT PHARMA is pleased to announce that it has successfully closed on €1.3 million in new investment from current shareholders and a new private investor. This bridging round will enable the Company to move its candidate therapeutic vaccine through preclinical development and up to phase I/II clinical trials for the treatment of high-grade neoplasia provoked by the Human Papillomavirus (HPV).

Dr. Benedikt Timmerman, Chief Executive comments: "This investment allows BT PHARMA to take lead candidate ProCervix^® through the entire preclinical phase and up to the next key milestone: placebo-controlled clinical trials in women bearing CIN II / CIN III lesions. We have spared no effort to render GMP production and protein purification processes of our bivalent product robust and to pharmaceutical grade. Our placebo-controlled trial is planned for the 1st trimester of 2008. The awareness of the medical need to treat infection, neoplasia and cancer provoked by Human Papillomavirus by other means than surgery has come to age. It coincides well with our clinical timelines and may allow BT PHARMA to be one of few key players in this exciting new market."

ProCervix^® exploits the unique characteristics of the Adenylate Cyclase vector (CyaA) that targets tumour cell-specific antigens to antigen-presenting cells in patients in vivo and induces strong and specific cellular immune responses. This bivalent therapeutic vaccine targets cervical neoplasia and cancer provoked by HPV16 and HPV18. ProCervix^® aims to replace ablative surgery or conisation in millions of women already infected by HPV and at risk for invasive cervical cancer. The CyaA technology was exclusively licensed from the Institut Pasteur, with whom BT PHARMA has a strategic alliance. The CyaA technology, which has unique immune cell-targeting features, has since been industrialized and the patent estate broadened by newly filed proprietary patents, which cover pipeline products such as ProCervix^®.


About BT PHARMA S.A.

BT PHARMA is a privately held biopharmaceutical company incorporated in October 2001 and spun out of the Institut Pasteur in October 2002. The company headquarters and laboratories are currently based in Labège (Toulouse) France. The company strives to improve the well-being of people through the development of therapeutic vaccines for infection, dysplasia and cancer provoked by the Human Papillomavirus (HPV).


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BT PHARMA and Midi-Pyrénées Regional Council support

BT PHARMA was granted a € 460 000 risk and interest free loan from the Midi-Pyrenees Regional Council to support its ProCervix® cervical cancer programme

Labège, France — March 28, 2006. BT PHARMA, an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines in cancers, announced today that it received a zero interest financial aid of €460,000 from the Midi-Pyrenees Regional Council that is only reimbursable in case of success, for the development of its lead therapeutic vaccine candidate, Procervix^®, for the treatment of cervical precancerous lesions in patients known to be at high risk of developing cervical cancer.

Cervical cancer and its associated-dysplasia are a major healthcare problem and are the result of infection by the Human Papillomavirus (HPV), the most common sexually transmitted disease world-wide. In the US and Europe, more than 60 million women are infected and about 1 million of these develop precancerous cervical lesions each year. Despite extensive screening programmes focused on early detection, 35,000 women still die from cervical cancer in the US and Europe annually.

ProCervix^® is scheduled to receive approval for Phase I/II clinical trials before the end of 2007. ProCervix^® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV antigens needed to induce strong and specific T-cell responses. ProCervix^® is the only bivalent therapeutic vaccine being developed which targets two of the most common HPV strains infecting women, HPV16 and HPV18. These two genotypes account for 70% of all cervical cancers.

Benedikt Timmerman, CEO of BT PHARMA, commented: "We are delighted to receive this grant from the Midi-Pyrenees regional council as it will help us move our cervical cancer vaccines programme toward the clinic. BT PHARMA is one of only a handful companies in the world focused on providing therapeutic vaccine solutions to women affected with HPV-associated precancerous lesions. I am confident that when approved, our Procervix^® vaccine will provide a safe and convenient solution to this important unmet medical need."


About BT PHARMA

BT PHARMA is an emerging biopharmaceutical company focused on developing innovative therapeutic vaccines for the treatment cervical cancer provoked by the Human Papillomavirus (HPV).

The company’s lead vaccine candidate, ProCervix^®, a HPV-therapeutic vaccine targeting cervical precancerous lesions, is scheduled to receive approval for Phase I/II clinical trial before the end of 2007. BT PHARMA plans to develop ProCervix^® to proof of concept stage. ProCervix^® is based on BT PHARMA’s unique CyaA vector system which is able to deliver the appropriate HPV-antigens needed to induce strong and specific T-cell responses.

In addition, BT PHARMA has a number of other therapeutic vaccine development programmes based on its CyaA vector system. These include TAAVac, for Tumour Associated Antigen Vaccine for a range of human cancers, and DOGTAA which targets various cancers in companion animals.

The company also has a second vaccine vector called PepTel^® which has unique intrinsic adjuvant ability. This promising technology platform is available for licensing.

BT PHARMA started operations in October 2002 following its spin off from the Institut Pasteur. The company is headquartered in state-of-the-art facilities in Labège (Toulouse), France and employs 13 people.

About Midi-Pyrenees Regional Council

In February 2006, the « Région Midi-pyrénées » established a new economic policy. This new policy which is a "first" for France is based on supporting companies on a "multi-year" basis by providing support on a project and contract basis. These support contracts include a timeframe and are designed to provide a flexible tailored counsel to companies. In 2007, the "Région Midi-pyrénées" budget for economic development amounted to € 42 million, of which €17 million was directed specifically support SMEs. At the same time, the Region has increased its "research" budget for 2007 by 72%, this follows an increase of 46% in 2006. These research funds have been set up to promote the link between SMEs and academic laboratories.

The « Région Midi-pyrénées » supports also the "Cancéropôle Grand Sud-Ouest" and the "Cancéropôle" of Toulouse and has signed a protocol agreement with the "Association pour la Recherche contre le Cancer" (ARC) in 2006. This four year partnership has the objective of developing the optimal way of developing medical and biological research in the filed of cancer in the Midi-Pyrénées area.

For more information, please, see following website: www.midipyrenees.fr


Source: BT Pharma

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