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Llama-Based Biotechnology Draws New Interest to Ablynx

Ablynx NV is attracting interest from potential new partners eager to join the Belgian biotech company as it tries to harness antibodies from llamas for fighting disease.

Ablynx, which already has partnerships with AbbVie Inc. and Merck & Co. in the U.S. and other companies in Europe, has caught the eye of more potential partners as the Ghent-based company uses fragments of llama antibodies to develop proprietary therapeutic proteins called nanobodies, which have the potential to attack a range of human diseases.
«There is certainly interest in a number of areas from other companies with whom we currently don’t collaborate in accessing this nanobody technology," Chief Executive Officer Edwin Moses said in an interview. «We’ll see how that develops over the rest of the year.»

Ablynx has three flagship products in development, with the most advanced being a treatment for thrombotic thrombocytopenic purpura, or TTP, a rare disease that can lead to micro blood clots and is potentially life threatening. This is set to enter the last of regulatory trials before registration in the second half of this year, and Ablynx expects to file for conditional approval in Europe in 2017 and for approval in the U.S. after completion of phase III trials.

The company is currently weighing options for marketing and selling TTP in Europe and the U.S. following approval. Ablynx hired Johan Heylen as chief commercial officer in November to head the marketing effort and expects to give an insight into its strategy when the company reports second-quarter earnings in August.

Potential Partners

Heylen is in discussions with companies experienced in marketing orphan drugs, potential partners and other agencies and contract sales forces, as well as evaluating how best to get the product to the patient. Prior to his appointment, Heylen was executive director and head of sales of cancer immunotherapeutics at GlaxoSmithKline Plc.

«The more we learn about the product and market, the more enthusiastic we are about the potential," Moses said. «I think it’s certain that we will want to be retaining quite some degree of control in the commercialization of this product, exactly how much is yet to be determined.»

Ablynx’s current partnerships also include Boehringer Ingelheim GmbH, Merck Serono and Novartis AG. The company plans on building on existing partnerships and at the same time has attracted interest from potential new partners.

Clinical Trials

«We estimate that from our partners there could be three new programs enter clinical trials» this year, Moses said. «With them come important milestones as well, so we get cash payments as those products enter phase I.»

Shares in Ablynx have risen 11 percent this year, giving the company a market value of 545 million euros ($617 million). The stock is up 44 percent since its initial public offering in 2007.
The two other flagship products in development are a treatment for respiratory syncytial virus infection, or RSV, in infants and a treatment for rheumatoid arthritis in partnership with AbbVie, both potentially representing multibillion-dollar opportunities, according to Moses.

The inhaled treatment for RSV is in phase IIa clinical trials in infants, switching between the southern- and northern-hemisphere RSV seasons, with results expected in the first half of next year. The condition hospitalizes about 300,000 children a year below the age of five in the U.S. and Europe and is the leading cause of infant hospitalization, according to the company.

Rheumatoid Arthritis

Results of the phase IIb trials of its treatment for rheumatoid arthritis are foreseen for the second half of next year. AbbVie, its development partner, is the owner of the world’s biggest selling drug in this area, Humira, which generated sales last year of $12.5 billion.
The Ablynx product will also enter clinical trials this year for systemic lupus erythematosus, a disease which can affect many parts of the body, including the skin, joints and internal organs.

Another of Ablynx’s partnerships is with Merck & Co. to develop cancer immunotherapies, or drugs to help the body fight cancer. Merck is responsible for the development, manufacturing and marketing of any products resulting from the collaboration, with Ablynx eligible to receive as much as 1.7 billion euros in potential milestone payments plus royalties.

«The discovery activities in immune oncology are one example of where our platform, the nanobodies, can do things we think that other technologies can’t," Moses said. «From an early discovery point of view, that’s an area of considerable focus for us at the moment." The nanobodies are derived from fragments of heavy-chained-only antibodies from llamas.

http://www.bloomberg.com/news/articles/2015-05-13/llama-based-biotechnology-draws-new-interest-to-ablynx

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