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Litigation Settlement Reached Between Tercica, Genentech
and Insmed
Companies Partner Through License and Development Agreement
BRISBANE, Calif. & RICHMOND, Va.
March 6, 2007
Tercica, Inc., (Nasdaq:TRCA) and Insmed Incorporated
(Nasdaq:INSM) today announced that Tercica, Insmed and Genentech,
Inc. (NYSE:DNA) have entered a Settlement, License and Development
Agreement that resolves all outstanding litigation between the companies,
including the patent infringement suits brought by Tercica and Genentech
against Insmed in the United States (N.D. Cal.) and United Kingdom,
and the unfair business practices suit (E.D. Virginia). The key
elements of this settlement are:
-- Insmed will no longer provide
IPLEX(TM) to patients with severe Primary IGF-1 Deficiency and
other short stature indications and
will withdraw its IPLEX marketing authorization application for
severe Primary IGF-1 Deficiency in the European Union.
-- Through
licensing and development rights granted by Tercica and Genentech,
Insmed will have freedom to operate regarding the
manufacture, development and commercialization of IPLEX for certain
non-short stature indications including severe insulin resistance,
myotonic muscular dystrophy and HIV associated adipose redistribution
syndrome (HARS), subject to opt-in rights and royalty provisions
for Tercica and Genentech.
-- Tercica and Genentech have waived
the damages award by the jury in the U.S. patent infringement
litigation.
In a joint statement, Dr. John A. Scarlett, Tercica's
President and Chief Executive Officer, and Dr. Geoffrey Allan,
Insmed's President,
Chief Executive Officer and Chairman of the Board of Directors,
stated, "We are very pleased with our new licensing and development
relationship. It allows Tercica to focus its efforts in the short
stature market and allows Insmed, in cooperation with Tercica and
Genentech, to focus its IPLEX development efforts in valuable non-short
stature indications."
U.S./Canada IPLEX Sales for Tercica/Genentech
Indications
As a consequence of the court's finding that Tercica's
patents were infringed, Insmed will no longer be able to provide
IPLEX in
the U.S. for severe Primary IGF-1 Deficiency and the following indications:
Primary IGF-1 Deficiency, Noonan's Syndrome, Laron Syndrome, Growth
Hormone Deficiency, and all other short stature indications; and
Adult Growth Hormone Deficiency. These indications are collectively
referred to as "the TRCA/Genentech Indications." Insmed
and Tercica will work closely together with pediatric endocrinologists
to identify therapeutic alternatives for children currently receiving
IPLEX, and where appropriate, to transition patients to Increlex(TM).
IPLEX
Worldwide License and Development Agreement
The parties will form
a joint development (and subsequently, a joint commercialization)
committee to guide the development and
commercialization of IPLEX in non-Tercica/Genentech Indications.
Tercica (along with Ipsen, for Ipsen's Increlex territory) and Genentech
will have the right to opt into Insmed's development and commercialization
of each non-Tercica/Genentech Indication up to 90 days after Insmed
provides "Phase III-enabling" clinical data. Tercica will
have the first right to opt into orphan indications, and Genentech
will have the first right to opt into non-orphan indications. If
Tercica does not opt into an orphan indication, Genentech will have
the right to opt-in. Similarly, if Genentech does not opt into a
non-orphan indication, Tercica will have the right to opt-in. In
the case of an opt-in, Insmed will retain development control prior
to approval, and Tercica or Genentech would gain commercial control
after approval.
If the opt-in is exercised by Tercica, Insmed
would be reimbursed 50% of its incurred development costs for the
indication
and further
development costs would be shared 50:50. Upon subsequent commercialization,
Insmed and Tercica will split profits 50:50 after accounting for
relevant expenses including sales-based tiered royalties of 6%-15%
to Genentech.
If the opt-in is exercised by Genentech, Insmed
would be reimbursed 50% of its incurred development costs for the
indication.
Subsequent
development costs and profits will be split 50:50, but no royalty
will be owed to Tercica.
If neither Tercica nor Genentech opts
in, Insmed will pay a 4% royalty on all commercial sales of the
approved drug to Genentech.
Worldwide Pre-Approval IPLEX Sales
Outside the
U.S. and Canada, Insmed will be permitted to continue to provide
IPLEX to physicians through its Expanded Access Program
for non Tercica/Genentech indications (excluding severe insulin
resistance) and ALS in Italy. Any cost reimbursement obtained from
this program would be subject to a tiered royalty of 4% to 15% shared
between Tercica, Genentech and Ipsen.
The Settlement, License and
Development Agreement is in effect until the later of 2018 or
the expiration of any subsequent Tercica/Genentech
issued patents that cover IPLEX or its indications.
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
Insmed
Insmed Inc. is a biopharmaceutical company focused
on the development and commercialization of drug candidates for
the treatment
of metabolic
diseases and endocrine disorders with unmet medical needs. For
more information, please visit www.insmed.com
Tercica Safe Harbor
Statement
Except for the historical statements contained herein,
this press release contains forward-looking statements concerning
prospects
and results, including statements concerning a worldwide partnership
with opt-in rights for Tercica on non-Tercica/Genentech Indications
and settlement of all outstanding litigation between Tercica, Genentech
and Insmed. 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, the risk
that none of the non-Tercica/Genentech Indications demonstrate clinically
meaningful efficacy and safety, and 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.
Insmed
Safe Harbor Statement
Statements included within this press release,
which are not historical in nature, may constitute forward-looking
statements for purposes
of the safe harbor provided by the Private Securities Litigation
Reform Act of 1995. Forward-looking statements in this press release
include, but are not limited to, statements regarding business strategies,
growth opportunities for approved or proposed products, plans and
objectives of management. Such forward-looking statements are subject
to numerous risks and uncertainties, including risks that our product
candidates may fail in clinical trials or may not be successfully
marketed, we may lack financial resources to complete development
of product candidates, we may be unable to raise additional financing
necessary to continue current operations competing products may
be more successful, demand for new pharmaceutical products may decrease
and the biopharmaceutical industry may experience negative market
trends. As a result of these and other risks and uncertainties,
actual results may differ materially from those described in this
press release. For further information with respect to factors that
could cause actual results to differ from expectations, reference
is made to reports filed by the Company with the Securities and
Exchange Commission under the Securities Exchange Act of 1934, as
amended. The forward-looking statements made in this release are
made only as of the date hereof and Insmed disclaims any intention
or responsibility for updating predictions or financial guidance
contained in this release.
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