Healthcare Industry News: osteoporosis
News Release - September 17, 2007
A Major Pharmaceutical Company Has Taken an Exclusive Option To BA058, a Compound Licensed by Ipsen to Radius in 2005BA058 Currently in Phase II for osteoporosis
PARIS--(HSMN NewsFeed)--Regulatory News: Ipsen (Paris:IPN ; Euronext: FR0010259150; IPN) today announced that Radius Health ("Radius") has granted Novartis an option to obtain an exclusive worldwide license (except Japan) to develop and commercialize all formulations of BA058. The bone anabolic candidate BA058, a PTHrP (parathyroid hormone-related protein) analogue is currently in Phase II clinical studies conducted by Radius for the treatment of osteoporosis. In September 2005, Radius acquired from Ipsen exclusive rights to BA058 (a former Ipsen proprietary compound previously referred as BIM44058,) on a worldwide basis with the exception of Japan, where Ipsen previously granted an exclusive license for BA058 to the Japanese group, Teijin.
In the event that Novartis exercises the option to license BA058, Novartis would assume the global (except Japan) clinical development, manufacturing, and marketing of BA058 and all associated costs. Radius would receive payments upon the exercise of the option and on successful completion of certain development, regulatory, and commercial milestones. These payments together could total more than $500 million. In addition, Radius would be eligible to receive royalties on product sales and has retained the option to co-commercialize BA058 in the United States. Of this amount, Radius would in turn pay to Ipsen development, regulatory and commercial milestones that could total up to $125 million, as well as royalties calculated on a pro rata sales basis. Additional terms were not disclosed.
Commenting on the agreement, Stephane Thiroloix, Executive Vice-President of the Ipsen Group, Corporate Development, stated that "As part of its strategy to maximize the value of its R&D pipeline through partnerships, outside of its own targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders), Ipsen is pleased that Radius has reached this Option Agreement to potentially partner BA058 with Novartis, a company with a world-leading franchise in osteoporosis therapy."
BA058, an analogue of human PTHrP, is currently in Phase II clinical trials conducted by Radius for the treatment of osteoporosis in postmenopausal women. PTHrP (parathyroid hormone-related protein) is a critical peptide for promoting new bone formation, with a role distinct from PTH (parathyroid hormone), which primarily regulates calcium homeostatis and bone resorption. BA058 build bone while reducing the risk of hypercalcemia or significant bone resorption. In preclinical testing it has demonstrated the potential to widen the anabolic window for bone therapeutics. This could enable improved convenience over currently available anabolic therapies, resulting in greater patient compliance and, ultimately, greater benefit to sufferers of osteoporosis.
Ipsen is an innovation driven international specialty pharmaceutical group with over 20 products on the market and a total worldwide staff of nearly 4,000. The company's development strategy is based on a combination of products in targeted therapeutic areas (oncology, endocrinology and neuromuscular disorders) which are growth drivers, and primary care products which contribute significantly to its research financing. This strategy is also supported by an active policy of partnerships. The location of its four Research and Development centres (Paris, Boston, Barcelona, London) gives the Group a competitive edge in gaining access to leading university research teams and highly qualified personnel. In 2006, R&D expenditure was EUR 178.3 million, i.e. 20.7% of consolidated sales, which amounted to EUR 861.7 million while total revenues amounted to EUR 945.3 million (in IFRS). 700 people in R&D are dedicated to the discovery and development of innovative drugs for patient care. Ipsen's shares are traded on Segment A of Eurolist by EuronextTM (stock code: IPN, ISIN code: FR0010259150). Ipsen' s shares are eligible to the "Service de Reglement Differe" ("SRD") and the Group is part of the SBF 250 index. For more information on Ipsen, visit our website at www.ipsen.com.
The forward-looking statements and targets contained herein are based on Ipsen's management's 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 Research and Development process involves several stages at each of which there is a substantial risk that the Group will fail to achieve its objectives and be forced to abandon its efforts in respect of a product in which it has invested significant sums. Therefore, the Group cannot be certain that favourable 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. Ipsen 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. Ipsen's business is subject to the risk factors outlined in its information documents filed with the French Autorite des Marches Financiers.
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