BA058 Currently in Phase II for Osteoporosis
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."
About BA058
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.
About Ipsen
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.
Forward-looking statements
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.