Ipsen to initiate a proof-of-concept study with tasquinimod in additional cancer indications

Tasquinimod’s unique mode of action potentially attractive in multiple malignant tumors

Regulatory News:

Ipsen (Paris:IPN) (Euronext: IPN; ADR: IPSEY) today announced that it will shortly initiate a new phase II, proof-of-concept clinical trial with tasquinimod in a so-called umbrella study evaluating the compound in four different tumor types. The study will evaluate the safety and efficacy of tasquinimod in advanced or metastatic hepato-cellular, ovarian, renal cell and gastric carcinomas in patients who have progressed after standard anti-tumor therapies.

Tasquinimod’s unique mode of action is highly relevant to target multiple malignant diseases beyond prostate cancer. The compound’s immunomodulatory and anti-angiogeneic properties are believed to be pertinent in addressing unmet medical need in a broad wealth of carcinomas.

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The study is designed as a multi-center, open-label, early stopping design, proof of concept study. Tasquinimod clinical activity will be measured by the proportion of patients with progression free survival at pre-defined time-points.

In April 2011, Ipsen signed a broad co-development agreement with Active Biotech regarding tasquinimod. Active Biotech granted Ipsen the exclusive rights to commercialize tasquinimod worldwide, except for North and South America and Japan where Active Biotech retained all commercial and marketing rights. Under the terms of the agreement, both companies will co-develop tasquinimod for the treatment of cancer.

Tasquinimod has a distinct mode of action encompassing immunomodulatory, anti-angiogenic and anti-metastatic properties. Until today the development of tasquinimod was focused on the treatment of . Several clinical studies are currently ongoing:

Additionally, a previous , showed a higher fraction of patients with no disease progression during the six-month period of treatment using tasquinimod. These Phase II results were published in in September 2011. In , overall survival (OS) data was presented at ASCO (American Society of Clinical Oncology).

Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2011. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport, endocrinology / Somatuline, uro-oncology / Decapeptyl and hemophilia. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2011, R&D expenditure totaled more than €250 million, above 21% of Group sales. The Group has total worldwide staff of close to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit .

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