Regulatory News:
Upon marketing authorization, Increlex(R) will be commercialized
in the European Union by Ipsen, Tercica's partner
Ipsen (Paris:IPN), today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMEA) adopted a positive opinion recommending marketing
authorization for Increlex(R) (mecasermin) 10 mg/ml solution for
injection. This decision follows Tercica's filing of an application
for marketing authorisation for Increlex(R) in the European Union on
December 2005. The indication recommended is for the long-term
treatment of growth failure in children and adolescents with severe
primary insulin-like growth factor-1 deficiency (severe primary IGFD),
and in children with growth hormone (GH) gene deletion who have
developed neutralizing antibodies to GH.
Based on an acceptance of the CHMP positive opinion by the
European Commission, Tercica (Nasdaq: TRCA) expects a marketing
authorization in two to three months and because Increlex(R)
previously received Orphan Drug Designation in the European Union,
this will provide ten years of marketing exclusivity for the treatment
of severe Primary IGFD. Upon marketing authorization, Ipsen expects to
pay to Tercica a milestone payment of EUR 15 million (approximately
US$20 million) under the companies' licensing agreement. Following
local pricing reviews, Ipsen will market Increlex(R) in the European
Union.
Christophe Jean, Executive Vice-President and Chief Operating
Officer of Ipsen, and Tercica's Board member, said "We are very
pleased with the CHMP's positive opinion regarding Increlex(R), a very
innovative product for the treatment of growth failure in patients
with severe primary IGFD. The addition of Increlex(R) to Ipsen's
existing global endocrinology portfolio, which also includes
Somatuline(R) and NutropinAq(R) further reinforces the company's
global franchise in this high-growth therapeutic area. Ipsen's growing
endocrinology franchise is giving to endocrinologists a comprehensive
solution to treat patients suffering from growth disorders."
About the CHMP's opinion
(CHMP press release can be accessed at http:///www.emea.europa.eu)
The CHMP's positive opinion was based on clinical data from 76
patients who were treated with Increlex(R) for up to 12.5 years. The
primary endpoint in the pivotal clinical study was height velocity,
which increased from an average of 2.8 cm per year at baseline to an
average of 8.0 cm per year (pless than 0.0001) in the first year of
treatment.
The summary of product characteristics underlying the CHMP opinion
defines severe Primary IGFD as:
-- a height standard deviation score (less than or =) -3.0,
-- basal IGF-1 levels below the 2.5th percentile for age and
gender,
-- GH sufficiency, and
-- the exclusion of secondary forms of IGF-1 deficiency, such as
malnutrition, hypothyroidism, or chronic treatment with
pharmacologic doses of anti-inflammatory steroids.
The CHMP recommended that the diagnosis be confirmed by conducting
an IGF-1 generation test.
About Increlex(R)
The active ingredient of Increlex(R) is recombinant human
insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of
growth hormone's effect on statural growth, and must be present for
normal growth of bones and cartilage in children. In severe primary
IGFD, children's serum IGF-1 levels are low, despite the presence of
normal or elevated GH level. Without adequate IGF-1, children cannot
achieve normal height. In children with this disorder, low IGF-1
levels are due to growth hormone resistance associated with mutations
in GH receptors, post-GH receptor signaling pathways, or to defects in
IGF-1 gene expression. As such, these children cannot be expected to
respond adequately to exogenous GH treatment. Some individuals may
also have a range of metabolic disorders, including lipid
abnormalities, decreased bone density, obesity and insulin resistance.
Increlex(R) has been marketed in the United States by Tercica,
Inc. since early 2006.
Exclusive rights to develop and commercialize Increlex(R) were
licensed to Ipsen in October 2006 for all regions of the world except
the United States, Japan, Canada, Taiwan and certain countries of the
Middle East and North Africa.
About Tercica
Tercica is a biopharmaceutical company committed to improving
endocrine health by partnering with the endocrine community to develop
and commercialize new therapeutics for short stature and other
metabolic disorders. For further information on Tercica, please visit
www.tercica.com.
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 Euronext(TM) (stock code: IPN, ISIN
code: FR0010259150). Ipsen's shares are eligible to the "Systeme a
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 (Ipsen)
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.
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.
Forward Looking Statements (Tercica)
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Tercica's
prospects and expectations, including without limitation, that: (A)
Increlex will receive ten years of EU orphan drug marketing
exclusivity for the treatment of severe Primary IGFD; (B) Tercica
expects to receive a marketing authorization from the European
Commission in two to three months; (C) Tercica expects to receive a
milestone payment of EUR 15 million (approximately US$20 million) from
Ipsen; and (D) Ipsen will launch Increlex in the European Union.
Because Tercica's forward-looking statements are subject to risks and
uncertainties, there are important factors that could cause actual
results to differ materially from those in the forward-looking
statements. These factors include, without limitation, risks and
uncertainties related to the following: (i) the European Commission
may not accept the CHMP opinion, issue a marketing authorization,
and/or may not issue it in two to three months; and (ii) the risks and
uncertainties disclosed from time-to-time in reports filed by Tercica,
including most recently Tercica's Form 10-Q for the quarter ending
March 31, 2007 filed with the SEC on May 4, 2007. Tercica disclaims
any obligation or undertaking to update or revise any forward-looking
statements contained in this press release.
