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Tercica Announces Agreement with
Genentech for Worldwide Growth Hormone and IGF-1 Combination
Product Development and Commercialization
Combination Products for the Potential
Treatment of Short Stature and Adult Growth Hormone Deficiency
Tercica May Receive up to $53 Million in Equity Payments, Opt-in
Payments, R&D Reimbursement and Milestone Payments from
Genentech Pending FDA guidance, Tercica intends to initiate
Phase II Clinical Trials in 2008
BRISBANE, Calif.
July 10, 2007
Tercica, Inc. (Nasdaq:TRCA) today announced an
agreement with Genentech, Inc. for the development, manufacture
and worldwide commercialization of two products containing Genentech's
recombinant human growth hormone Nutropin AQ(R) (somatropin (rDNA
origin)) and Tercica's recombinant insulin-like growth factor-1
Increlex(R) (mecasermin (rDNA origin) injection) for the treatment
of short stature, adult growth hormone deficiency (AGHD), and potentially
other metabolic disorders. Nutropin AQ(R) and Increlex(R) were originally
designed and formulated so that the therapies could be combined
and potentially given as a single, daily injection.
Pending U.S. Food
and Drug Administration guidance and timely IND acceptance, Tercica
plans to initiate Phase II clinical development
in 2008 of one combination product for patients with low IGF-1
levels and short stature not associated with growth hormone deficiency;
and a second combination product for patients with AGHD.
"This collaboration allows us to embark on two new and exciting
development programs that each have scientific merit," said
John A. Scarlett, M.D., Tercica's President and Chief Executive
Officer. "With demonstrated synergies in pre-clinical studies,
the combination of rhGH and rhIGF-1 could have the potential for
several important therapeutic benefits compared to either rhGH or
rhIGF-1 monotherapy alone for the treatment of patients with short
stature and AGHD and potentially other adult metabolic disorders.
With our current cash position, equity sales associated with this
agreement and possible collaboration for both programs through sublicensing
of Tercica's ex-U.S. rights, Tercica continues to have profitability
in 2010 as a goal without additional equity financing unless needed
to support additional new initiatives or strategic opportunities."
Terms
of Agreement
Under the terms of the collaboration, Tercica may
be eligible to receive a total of up to $53 million in equity payments,
opt-in
payments, research and development cost reimbursement, and milestone
payments. In connection with the transaction, Genentech will purchase
708,591 shares of Tercica's common stock for $4 million.
Tercica
will fund and lead initial development efforts for both combination
products. Genentech has certain rights to opt-in to
the development programs for both products. The opt-in rights
remain open until completion of a Phase II clinical study for each
product
that is sufficient to enable a pivotal trial.
Upon exercise of
any opt-in by Genentech, Genentech shall reimburse certain incurred
research and development costs. Following such
exercise by Genentech, a cost and profit share structure will
take effect for all future development and commercial activities
of both
combination products, and Genentech will have certain commercialization
rights, including the right to co-promote both combination products
upon regulatory approval. If Genentech does not exercise any of
its opt-in rights, then Tercica will have full development and
commercialization rights to the combination products, and will owe
Genentech royalties
on worldwide sales.
Development of GH/IGF-1 Combination Product
About Increlex(R)(mecasermin (rDNA origin) injection): 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
(GH) effect on statural growth, and must be present for normal growth
of bones and cartilage in children. In Primary IGFD, children's
serum IGF-1 levels are low, despite the presence of a 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. Increlex(R) has been marketed in the United
States by Tercica 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 Nutropin AQ(R) (somatropin (rDNA origin)): Nutropin
AQ(R) (somatropin (rDNA origin) injection) is produced using recombinant
DNA technology and has the same amino acid sequence as human growth
hormone produced naturally in the human body. It is marketed as
Nutropin AQ(R) in Austria, Denmark, Finland, France, Germany, Ireland,
the Netherlands, Norway, Sweden, Portugal, Spain and the United
Kingdom. Other regulatory reviews are underway in Europe and worldwide,
excluding North America and Japan.
Nutropin AQ(R) is supplied as 10
mg of sterile liquid somatropin per cartridge for exclusive use
with the Nutropin AQ(R) Pen, a simple,
convenient, easy-to-use device for subcutaneous injection. Nutropin
AQ(R) is approved for the treatment of GHD in children and adults,
for the long-term treatment of short stature in children with
Turner syndrome, the treatment of growth failure in chronic renal
insufficiency
patients prior to transplantation and the long-term treatment
of children with idiopathic (of unknown origin) short stature (ISS).
Potential
of GH/IGF-1 Combination Product for Short Stature: One combination
product will initially be studied in patients with low
IGF-1 levels and short stature not associated with growth hormone
deficiency, for example ISS. A potential cause of short stature
in this group of patients could be a suboptimal IGF-1 secretion
in response to growth hormone stimulation alone. Pre-clinical
studies suggest that co-administration of GH and IGF-1 may increase
specific
growth responses greater than either therapy alone. Therefore,
Tercica believes that treatment with a combination of both GH
and IGF-1
may be superior to monotherapy of either component alone in
a subpopulation of children with low IGF-1 and short stature not
associated with
growth hormone deficiency.
Potential of GH/IGF-1 Combination Product
for AGHD: A second combination product will initially be studied
in the AGHD population. These
patients have abnormalities in body composition (e.g., increased
body fat and reduced lean muscle mass). Preclinical studies have
suggested that co-administration of GH and IGF-1 result in synergistic
effects on these parameters. Tercica also believes that delivered
together as a combination product, some of the negative effects
of each individual component could potentially be mitigated by
the positive effects of the other, especially their effects on glucose
metabolism. Upon review of the clinical data in AGHD, Tercica
and
Genentech will evaluate the attractiveness of this combination
product in treating other metabolic disorders.
Conference Call and
Webcast Information
Tercica's senior management team will host an investment
community conference call tomorrow to discuss the collaboration with
Genentech
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# 6557103. 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 6557103. 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 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 Tercica's
prospects and expectations, including without limitation, that Tercica:
(A) may receive from Genentech up to $53 million in equity, opt-in
and milestone payments and research and development cost reimbursement;
(B) plans to initiate Phase II clinical development of the combination
products in 2008 for both short stature and AGHD; (C) believes that
treatment with a combination of both GH and IGF-1 may offer several
important therapeutic benefits when compared with, and be superior
to monotherapy in a subpopulation of children with low IGF-1 and
short stature not associated with growth hormone deficiency, and
for patients with AGHD; (D) believes that for patients with AGHD,
delivered together as a combination product, some of the negative
effects of each individual component could potentially be mitigated
by the positive effects of the other, especially their effects on
glucose metabolism; and (E) continues to have profitability as a
goal in 2010 without the need for additional equity financing. 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) for (A) (C) (D) and (E) above, data from Tercica's
clinical trials of the combination products may not demonstrate
sufficient efficacy or safety for either clinical development or
commercial purposes or to enable Tercica to receive any financial
remuneration, and Genentech may never opt-in; (ii) for (B) above,
the FDA may have concerns or requirements that impede Tercica from
beginning the Phase II clinical trials in 2008 or cause Tercica
to stop all clinical development of the combination products; (iii)
also for (E) above, Tercica's internal projections for revenues
and costs through 2010 may be incorrect or not actually achieved,
Tercica may be unable to sublicense its ex-U.S. rights on financial
terms that it projects, or at all, and Tercica may undertake new
and costly initiatives or strategic opportunities; and (iv) for
(A) - (E) above, the risks and uncertainties of drug development
and others 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.
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