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Somatuline(R) Depot Receives FDA
Marketing Approval for the Treatment of Acromegaly
Tercica Management Will Hold a Conference
Call on August 31st at 9:00 a.m. EDT/ 6:00 a.m. PDT
BRISBANE, Calif.
August 30, 2007
Tercica, Inc. (NASDAQ:TRCA) today announced that
its partner Ipsen (Euronext:IPN) has received notice of approval
from the U.S. Food and Drug Administration (FDA) for marketing Somatuline(R)
Depot (lanreotide) injection 60, 90 and 120 mg/ml in the United
States.
Somatuline(R) Depot is indicated for the long-term
treatment of acromegaly in patients who have had an inadequate response
to
surgery
and/or radiotherapy, or for whom surgery and/or radiotherapy is
not an option. Somatuline(R) Depot will be available in a pre-filled
syringe eliminating any need for reconstitution and thus enabling
freedom of easy administration to patients. The FDA has also designated
Somatuline(R) Depot as an orphan drug for acromegaly. The Orphan
Drug Act provides a seven-year period of exclusive marketing to
the first manufacturer who obtains marketing approval for a designated
orphan product.
In October 2006, Ipsen granted to Tercica the
development and commercialization rights for Somatuline(R) Depot
in the United
States and Canada.
At the same time, Ipsen acquired a 25% stake in Tercica on a non-diluted
basis. According to the terms of the agreement, the FDA approval
of Somatuline(R) Depot triggers a EUR 30 million (approximately
$41 million) milestone payment that Tercica will pay to Ipsen
by issuing a convertible bond (converted into Tercica common stock
at a conversion price of EUR 5.92). Tercica will simultaneously
issue an additional $15 million convertible bond to Ipsen (converted
into Tercica common stock at a conversion price of $7.41), which
will be paid in cash to Tercica.
"We are delighted with the approval of Somatuline Depot. Somatuline
Depot is the only long-acting acromegaly therapy available in a
pre-filled syringe, and the only long-acting somatostatin analogue
that does not require reconstitution prior to injection. Somatuline
Depot provides a significant medical advance for the treatment of
acromegaly by offering physicians, nurses, and patients the freedom
of easy injections and ready-to-go simplicity. We expect to launch
Somatuline Depot in the U.S. in approximately eight weeks," said
John A. Scarlett, M.D., Tercica's President and Chief Executive
Officer. "The approval of Somatuline Depot represents a major
step in our goal of establishing Tercica as the leading U.S. endocrine
and metabolic company. This will be the second market introduction
of an important endocrine product made by Tercica within a two-year
period. Tercica has now become a well balanced biotechnology company
with two commercial products and an exciting pipeline that includes
our next generation growth hormone products targeting existing billion
dollar market opportunities," added Dr. Scarlett.
About Acromegaly
Acromegaly is a disorder caused
by the over-production of growth hormone usually by a benign tumor
of the anterior pituitary gland.
Acromegaly occurs in approximately 60 people per million of population.
In acromegaly patients, the pituitary gland releases too much growth
hormone into the bloodstream, the growth hormone then triggers the
liver to produce IGF-1, which in turn directly stimulates bone and
tissue growth. The most common signs and symptoms of this serious
condition include: enlarged hands, feet, and head; facial changes
such as bulging forehead, enlarged lower jaw, tongue and lips; wider
spacing between teeth; enlarged heart, liver, kidneys, spleen and
other organs; joint pain and fatigue; reduced sex drive; and loss
of concentration.
About the Marketing Approval
This decision follows
the filing by Ipsen of a New Drug Application (NDA) for Somatuline(R)
Depot in the United States in December 2006.
The effect of Somatuline(R) Depot on reducing growth hormone and
IGF-levels and control of symptoms in patients with acromegaly was
studied in two long-term, multiple-dose, randomized multicenter
studies performed in the United States and in Europe. Somatuline(R)
Depot demonstrated its ability to decrease the levels of growth
hormone and IGF-1 in the majority of patients over a one-year period.
About
Somatuline(R) Depot
Somatuline(R) Depot (also marketed as Somatuline(R)
Autogel(R) outside the United States) is a sustained-release formulation
for
injection containing lanreotide, a somatostatin analogue (a hormone
that inhibits the release of growth hormone). Somatuline(R) Depot
was initially developed and continues to be used mainly in the treatment
of acromegaly, a disorder caused by the over-production of growth
hormone or prolactin due to a benign tumor of the anterior pituitary
gland. This product subsequently underwent further development in
Europe in the treatment of symptoms associated with neuroendocrine
tumors (particularly of a carcinoid type). Ipsen believes that the
Somatuline(R) Depot formulation, to which it holds the patent, represents
a major technological advance. As far as Ipsen is aware, this represents
the first semi-solid formulation for injection without any excipient,
since the active substance itself controls the sustained release.
Somatuline(R) Depot releases the active substance with no excipient
other than water over a period of at least 28 days, thus requiring
just one injection per month, compared with the two or three injections
previously necessary. This product is presented in a pre-filled
syringe for easier administration.
Active Substance
The active substance in Somatuline(R) Depot is lanreotide,
which inhibits the growth and secretion of several endocrine, exocrine
and paracrine functions. It is particularly effective in inhibiting
the secretion of growth hormone.
Indications
Somatuline(R) Depot is indicated for
the treatment of acromegaly when circulating levels of growth hormone
remain high despite surgery
or radiotherapy. Somatuline(R) inhibits growth hormone release and
thus controls the therapeutic and relieves the symptoms associated
with elevated levels of this hormone.
Marketing
Long-acting lanreotide (Somatuline(R) Depot) is marketed
in almost 60 countries (including 26 in Europe) by Ipsen for the treatment
of acromegaly and neuroendocrine tumors or acromegaly alone. In
2006, more than 7,000 patients were on long-acting Somatuline(R)
therapy worldwide.
Somatuline(R) had sales of EUR 92 million (approximately
$125 million)
in 2006, out of which 68% were generated by in the major Western
European countries (France, Germany, Italy, Spain and the United
Kingdom). Long-acting Somatuline(R) accounted for 86% of total sales
of this product. Somatuline(R) products are prescribed mainly by
endocrinologists, gastroenterologists, oncologists, surgeons and
intensive care specialists.
Conference Call and Webcast Information
Tercica's
senior management team will host an investment community conference
call tomorrow to discuss the FDA approval beginning at
9:00 a.m. EDT. To access the live teleconference, please dial (888)
803-8296 (U.S.) or (706) 634-1250 (international) and reference
the conference ID# 15459858. To access the webcast, please go to
the Events page on the Investors section of the Company's Web site
at www.tercica.com.
A telephone replay will be available approximately
two hours after the call for 48 hours by dialing (800) 642-1687
from the U.S., or
(706) 645-9291 for international callers and entering reservation
number 15459858. A replay of the webcast will be available on
the Company's Web site for 21 days at www.tercica.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 pediatric and adult growth disorders,
and for adult metabolic disorders. For further information on Tercica,
please visit www.tercica.com.
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, London) gives the Group a competitive
edge in gaining access to leading university research teams and
highly qualified personnel. In 2006, Research and Development 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 "Service
de Reglement Differe" ("SRD") and the Group is part
of the SBF 250 index. For more information on Ipsen, visit its Web
site at www.ipsen.com.
Tercica's Forward Looking Statements
Except for
the historical statements contained herein, this press release contains
forward-looking statements concerning the Company's
prospects and expectations, including without limitation, that the
Company expects to launch Somatuline(R) Depot in the United States
in approximately eight weeks. 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 launch of Somatuline(R) Depot in the United States depends
on how long it will take to manufacture the new syringes and packaging
for the United States; (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 June 30, 2007 filed with
the SEC on August 2, 2007. Tercica disclaims any obligation or undertaking
to update or revise any forward-looking statements contained in
this press release.
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