Ablynx and Boehringer Ingelheim announce major global strategic alliance to discover, develop and commercia...

Ablynx and Boehringer Ingelheim announce major global strategic alliance to discover, develop and commercialise novel nanobody therapeutics

Boehringer Ingelheim and Ablynx, the biopharmaceutical company focused on the discovery and development of Nanobodies®, today jointly announced a major global strategic alliance to discover, develop and commercialise up to 10 different Nanobody® therapeutics.

Ablynx expects to receive payments of EUR 75 million during the research term of the collaboration which includes EUR 15 million in a proposed equity investment by Boehringer Ingelheim in Ablynx. In addition, Ablynx will receive development milestone payments for each Nanobody® which is developed, of up to EUR 125 million as well as undisclosed royalties.

Ablynx and Boehringer Ingelheim will collaborate jointly in the discovery of Nanobodies® against agreed targets across multiple therapeutic areas including immunology, oncology and respiratory. Both parties will propose target opportunities for the collaboration with the goal of bringing Nanobody®-based products rapidly to patients in need. Boehringer Ingelheim will be exclusively responsible for the development, manufacture and commercialisation of any products resulting from the collaboration. Ablynx will have certain co-promotion rights in Europe.

Dr Edwin Moses, CEO and Chairman of Ablynx, said, “This is by far the largest financial agreement that Ablynx has signed to discover and develop innovative Nanobody® therapeutics. We are delighted to strengthen our existing relationship with Boehringer Ingelheim by working together to develop innovative products across multiple therapeutic areas, taking full advantage of the powerful Nanobody® discovery platform. This strategic alliance may provide the opportunity to grow Ablynx’s own product pipeline.”

Dr Andreas Barner, Vice-Chairman of the Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine of Boehringer Ingelheim added, “Boehringer Ingelheim looks forward to an intensified cooperation with Ablynx based on their innovative Nanobody® approach. We hope that this broad collaboration will lead to breakthroughs for patients suffering from diseases which cannot be adequately treated at present.”

About Ablynx

Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company began operations in 2001 in Ghent, Belgium and currently employs over 100 employees.

Ablynx is developing a portfolio of Nanobody®-based therapeutic programmes in a number of major disease areas, including inflammation, thrombosis, oncology and Alzheimer’s disease. Already Ablynx has generated Nanobodies® against more than 100 different disease targets. The company and its collaborators have obtained positive in vivo efficacy data from animal studies in five major therapeutic programmes in four disease areas. Importantly, Ablynx has shown the absence of any detectable immunogenicity for its Nanobody® development candidates in advanced primate studies.

Ablynx has ongoing research collaborations and significant partnerships with several major pharmaceutical companies, including Boehringer Ingelheim, Wyeth Pharmaceuticals, Novartis, and P&G Pharma. Ablynx is building a diverse and broad portfolio of therapeutic Nanobodies® through these collaborations as well as through its own internal discovery programmes. Ablynx announced interim phase I data from its first programme, an anti-thrombotic (ALX-0081) in July this year and another programme is in advanced preclinical development.

Nanobody® is a registered trademark of Ablynx NV.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and nearly 38,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine. In 2006, Boehringer Ingelheim posted net sales of EUR 10.6 billion while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.

The company`s research and development activities and production and distribution centers are spread across the entire globe. Boehringer Ingelheim’s Centers of Excellence are individual research sites that have full responsibility for specific indication areas:

- Biberach, Germany: Respiratory, Metabolic and CNS Diseases; Biopharmaceutical development and production (mammalian cell culture)
- Ridgefield, CT, USA: Immunology/Inflammation and Cardiovascular Diseases
- Laval, Quebec, Canada: Virology
- Vienna, Austria: Oncology; Biopharmaceutical development and production (microorganism fermentation)
- Vienna, Austria: Institute of Molecular Pathology, an internationally renowned basic research facility Boehringer Ingelheim is one of the leading companies for industrial customer manufacturing of Biopharmaceuticals by offering the entire production technology chain in development and production at its biopharmaceutical facilities in Biberach (Germany) and in Vienna (Austria).

The large scale manufacturing sites deliver biopharmaceutical products like therapeutic proteins, fusion proteins, protein scaffolds, monoclonal antibodies, antibody fragments and plasmid DNA. The Biberach site is specialized in highly efficient mammalian cell culture systems with yields well above industry standard in animal component free media. The Austria site offers high-expression in bacteria and yeast with exceptionally high productivities using proprietary systems. In the plasmid DNA manufacturing arena Boehringer Ingelheim in Austria has set the standard and supplies early to late-stage clinical trials with gene-therapeutics and DNA vaccines for its international clients.

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About Nanobodies®

Nanobodies® are a novel class of antibody-derived therapeutic proteins. Because of their small size, unique structure and extreme stability, Nanobodies® combine the advantages of conventional antibody therapeutics with the key features of small-molecule drugs.

Nanobodies® are antibody-derived therapeutic proteins that contain the unique structural and functional properties of naturally-occurring heavy-chain antibodies. The Nanobody® technology was originally developed following the discovery that camelidae (camels and llamas) possess fully functional antibodies that lack light chains. These heavy-chain antibodies contain a single variable domain (VHH) and two constant domains (CH2 and CH3). Importantly, the cloned and isolated VHH domain is a perfectly stable polypeptide harbouring the full antigen-binding capacity of the original heavy-chain antibody. These newly discovered VHH domains with their unique structural and functional properties form the basis of a new generation of therapeutic antibodies which Ablynx has named Nanobodies®.

Ablynx’s Nanobodies® combine the advantages of conventional antibodies with important features of small molecule drugs. Like conventional antibodies, Nanobodies® show: high target specificity high affinity for their target low inherent toxicity. However, like small molecule drugs they have the opportunity to inhibit enzymes and readily access receptor clefts. Furthermore, Nanobodies® in comparison to conventional antibodies: are extremely stable have the potential to be administered by means other than injection are easy to manufacture. Ablynx’s Nanobodies® have a high homology with the VH domains of human antibodies and can be further humanised without loss of activity. Importantly, Nanobodies® have a low immunogenic potential, which has been confirmed in primate studies with Nanobody® lead compounds.

Additional information:

Contact for further information: Boehringer Ingelheim Austria GmbH Communication Dr. Boehringer-Gasse 5 - 11, A-1121 Vienna Mag. Inge Homolka Tel. +43-1-80105-2230
mailto:inge.homolka(at)vie.boehringer-ingelheim.com Mag. Monika Primenz Tel. +43-1-80105-2742
Media Relations Ablynx Mary Clark, Director Catie Corcoran Capital MS&L Capital MS&L Tel.: +44 (0)20 7307 5336 Tel.: +44 (0)20 7255 5154 Mobil: +44 7713 335171 E-Mail: catie.corcoran(at)capitalmsl.com

The sender takes full responsibility for the content of this news item. Content may include forward-looking statements which, at the time they were made, were based on expectations of future events. Readers are cautioned not to rely on these forward-looking statements.

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