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May 15, 2009 (Vol. 29, No. 10)

Tough Times Ratchet Up Need for Partners

From Collaborations to In-Licensing to M&A Activity, Firms Are Benefiting from Alliances

  • Biotech Firms

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    ALX-0081, Ablynx’ lead product, is an antithrombotic that targets von Willebrand factor.

    Ablynx is “one of the few biotech companies in Europe that is expanding at a fast pace now,” explained  Eva-Lotta Allan, CBO. The firm has three molecules based upon its Nanobody® platform technology in the clinic. Nanobodies are based upon the heavy chain-only antibodies produced by camelids. They can be described as “large small molecules” as they are just one-tenth the size of a conventional antibody and, as such, can penetrate tissue well. They are also resistant to degradation, Allan explained. These characteristics make them amenable to alternative delivery methods.

    Lead product ALX-0081, which recently achieved its primary endpoint in a Phase Ib study, is an antithrombotic product that targets von Willebrand factor. ALX-0081 is expected to carry a lower risk of bleeding than other antithrombotics, Allan reported. A subcutaneous version, ALX-0681, entered Phase I in December.

    Nanobodies have been validated in over 100 targets, including GPCRs, and over 25 animal models. Ablynx has validating deals with Novartis, Boehringer Ingelheim, Merck Serono, and Wyeth.

    Polyphenon Pharma is a privately held subsidiary of Misui Norin. The parent company discovered and carries out cGMP manufacture of Polyphenon E®, a defined mixture of catechin polyphenols from green tea, while Polyphenon Pharma is developing it as a pharmaceutical product for the treatment of various unmet medical needs. 

    The use of Polyphenon E in a topical formulation for the treatment of HPV-caused genital warts was licensed out to Medigene. Medigene’s topical compound Veregen®, in which Polyphenon E is the active ingredient, was reportedly the first product approved under FDA’s new botanical drug regulations.

    The science behind Polyphenon E comes from epidemiological studies indicating that green tea polyphenols can protect against cancer. One mechanism that could explain such a protective effect was recently advanced by researchers at Columbia University. They demonstrated that polyphenols disrupt the lipid raft of the cancer cell’s membrane, disrupting the activation of the EGF receptor, which increases apoptosis and decreases proliferation.

    The company is developing Polyphenon E as an oral treatment for high-grade prostatic intraepithelial neoplasia (HGPIN), a precancerous condition. If HGPIN is found in a needle biopsy, there is a 30–50% chance of the patient developing prostate cancer in the next five years, the firm reported. 

    According to Stig Ogata, Polyphenon Pharma’s COO, in an Italian study where HGPIN subjects were treated with green tea catechins, progression to prostate cancer occurred in 9 patients out of 30 in the placebo group, but in only 1 patient out of 30 in the treatment group. A Phase II trial is currently under way.

    Polyphenon  Pharma is also developing an oral treatment for chronic lymphocytic leukemia. In a Phase I study, Polyphenon E showed an excellent safety profile and indications of efficacy in reducing lymphocyte designation for this indication, Ogata added.

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