PARIS--(BUSINESS WIRE)-- Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today disclosed that it has sold its shares in PregLem Holding SA to Gedeon Richter Plc, as have all PregLem’s other shareholders.
In June 2007, the Group spun off to PregLem, then a newly-formed, privately held Swiss biopharmaceutical company, a sulfatase inhibitor and a somatostatin analogue (PGL1001 and PGL2001, respectively), patents and know-how for use in the field of human reproductive medicine. In parallel, Ipsen subscribed to newly issued shares of Preglem, representing a c.15 % minority interest in its share capital.
PregLem’s lead product, PGL4001 (Esmya™), successfully completed Phase III clinical trials in June 2010 for the treatment of uterine myoma.
Ipsen will receive initial proceeds of CHF 6 million from the sale of its PregLem shares. Ipsen may also receive progressive additional payments of up to CHF 25 million, contingent upon the achievement of certain business development and regulatory milestones for EsmyaTM. The impact of this transaction will be recorded as financial income in Ipsen’s accounts.
Additionally, subject to PGL1001 and PGL2001 being granted marketing approvals, Ipsen will notably receive mid single digit royalties on PregLem’s future net sales of these products.
Christophe Thurieau, Ipsen’s Vice-President Scientific Affairs and former Director of PregLem, said: “The acquisition of PregLem by Gedeon Richter illustrates the quality and medical value of sulfatase inhibitors originating from Ipsen's research. This transaction validates our strategy to focus on our four targeted disease areas (oncology, endocrinology, neurology and hematology) while maximizing the value of our R&D pipeline by out-licensing promising compounds outside of our core focus. ”
PGL1001 is a somatostatin antagonist (SST-ATG) with the potential to modulate the ovarian follicular reserve so that more follicles are responsive to gonadotrophin stimulation and can produce an oocyte (egg). PGL1001 is the first product which has the potential to address age-related infertility in patients with a diminished ovarian reserve, who undergo Assisted Reproductive Techniques (“ART”).
PGL1001 is currently in the pre-clinical phase of development.
PGL2001 is an oral once-a-week steroid sulfatase inhibitor (STS) being developed for the management of endometriosis. Steroid sulfatase enzyme is an enzyme expressed in reproductive tissues (uterus & breast) which produces locally, bioactive estrogens. The therapeutic strategy is to reduce lesion exposure to estrogens by blocking their local production. PGL2001 has the potential to be the first of a new class of products for the treatment of endometriosis and other benign gynecological conditions. PGL2001 is currently in Phase Ib for the treatment of endometriosis with results expected in mid 2011.
Ipsen is a global biopharmaceutical group, with sales exceeding 1 billion euros in 2009. The Group has total worldwide staff of more than 4,400 employees, of which nearly 900 contribute to the discovery and development of innovative drugs for patient care. Ipsen’s development strategy is based on fast growing specialty care drugs in oncology, endocrinology, neurology and hematology, and on primary care drugs. This strategy is supported by an active policy of partnerships. Ipsen’s research & development (R&D) centers and its peptide & protein engineering platform give the Group a strong competitive edge. In 2009, R&D expenditure totaled close to €200 million, representing nearly 20% of Group sales. 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 our website at www.ipsen.com.
Ipsen forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Notably, future currency fluctuations may negatively impact the profitability of the Group and its ability to reach its objectives. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties. The Group does not commit nor gives any guarantee that it will meet the targets mentioned above. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.
For further information:
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