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Tercica Reports Somatuline(R)
Autogel(R) NDA for Acromegaly Accepted for Filing
by FDA
Somatuline(R) Autogel(R) Now Available in Canada
BRISBANE, Calif.
January 16, 2007
Tercica, Inc. (Nasdaq:TRCA) today reported that
its partner IPSEN (Euronext; IPN) received notice that the U.S.
Food and Drug Administration (FDA) has accepted the filing of its
New Drug Application (NDA) for Somatuline(R) Autogel(R) (60, 90,
120 mg) in the United States as a 28-day sustained-release formulation
to treat patients with acromegaly. Pursuant to Prescription Drug
User Fee Act (PDUFA) guidelines, Tercica expects the FDA will complete
its review or otherwise respond to the Somatuline(R) Autogel(R)
NDA by August 30, 2007.
Somatuline(R) Autogel(R) has already received
a marketing approval in Canada and is currently being launched
by Tercica under its distribution
license agreement with Ipsen. Subject to approval by the FDA,
Tercica will also market Somatuline(R) Autogel(R) in the United
States.
About Somatuline(R) Autogel(R)
Somatuline(R) Autogel(R)
is an injectable sustained-release formulation containing lanreotide,
a somatostatin analogue. Somatuline(R) was
initially developed and continues to be used in the treatment of
acromegaly (a disorder caused by the over-production of growth hormone
secondary to a benign tumor of the anterior pituitary gland) and
is also approved, outside of North America, for the treatment of
symptoms associated with neuroendocrine tumors (particularly of
carcinoid type). Somatuline(R) Autogel(R) formulation does not contain
any excipient other than water and releases lanreotide over a period
of at least 28 days. The product is conditioned in a pre-filled
syringe for convenient administration. In acromegaly, Somatuline(R)
is used primarily when circulating levels of growth hormone remain
elevated following surgery or radiotherapy, and lowers growth hormone
and IGF-1 levels, thus controlling disease progression and relieving
the symptoms associated with active acromegaly.
At December 31, 2005,
Somatuline(R) and Somatuline(R) Autogel(R) had marketing authorizations
in over 50 countries (including 26
in Europe) for the treatment of acromegaly and neuroendocrine
tumors and in six countries (including 2 in Europe) for the treatment
of
acromegaly alone.
According to epidemiology data (source: Alexander
L, Clin Endocrinol 12:71-79, 1980 & Bengtsson BA, Acta Med
Scan 223:327-335, 1988), acromegaly affects approximately 15,000
people
in the United States
and Canada and is most commonly found in middle-aged adults. Studies
estimate an all-cause mortality rate associated with acromegaly
of at least twice the normal population, and a reduction in life
expectancy of 5 to 10 years.
About Ipsen
Ipsen is a European 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 R&D
centers (Paris, Boston, Barcelona and London) gives the Group a
competitive edge in gaining access to leading university research
teams and highly qualified personnel. In 2005, Research and Development
expenditure reached EUR 169 million, i.e. 20.9% of consolidated
sales, which amounted to EUR 807 million in the Group's pro forma
accounts set up according to the IFRS. Nearly 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 (stock code: IPN, ISIN code: FR0010259150). Ipsen's
internet website is www.Ipsen.com.
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.
Safe
Harbor Statement
Except for the historical statements contained
herein, this press release contains forward-looking statements concerning
prospects
and results, including statements that: (1) Tercica expects the
FDA will complete its review or otherwise respond to the Somatuline(R)
Autogel(R) NDA by August 30, 2007; (2) subject to approval by the
FDA, Tercica will market Somatuline(R) Autogel(R) in the United
States; and (3) acromegaly affects approximately 15,000 people in
the United States and Canada. 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, that: (i) the FDA may not grant a marketing
approval or grant a marketing approval covering so few patients
that it is not commercially reasonable for the company to launch
the product; (ii) there may be fewer patients than Tercica estimates;
and (iii) the risks and uncertainties disclosed from time to time
in reports filed by Tercica with the SEC, including most recently
Tercica's Form 10-Q for the quarter ended September 30, 2006 filed
with the SEC on November 3, 2006.
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