Trimeris and Roche Reach Agreement on Trimeris Repayment of Deferred Marketing Expense
27 Septiembre 2010 - 7:00AM
Business Wire
Trimeris, Inc. (Nasdaq: TRMS), (“Trimeris” or the “Company”),
announced today that the Company and its partner, F. Hoffmann-La
Roche Ltd and Hoffmann-La Roche Inc. (“Roche”), have entered into
an agreement relieving Trimeris of any obligation to repay certain
deferred marketing expenses. In addition, Trimeris and Roche have
jointly settled the U.S. patent infringement suit related to
Trimeris’ and Roche’s product FUZEON® (enfuvirtide) with the
plaintiff, Novartis Vaccines and Diagnostics, Inc.
(“Novartis”).
The agreement reached today between Roche and Trimeris relates
to the parties’ collaboration for the development and
commercialization of FUZEON. Under the existing Development and
License Agreement between the parties, Trimeris and Roche had
agreed that certain expenses related to the selling and marketing
of FUZEON that were incurred by Roche in 2004 would be subject to
re-payment by Trimeris, assuming certain terms and conditions were
met. Pursuant to today’s agreement, Trimeris will no longer be
obligated to pay these deferred marketing expenses to Roche.
The re-payment obligation is recorded on the Company’s balance
sheet as a single entry under the caption “Accrued marketing
costs.” This liability was $18.7 million at June 30, 2010. The
reversal of this liability will be reflected as income on the
Company’s income statement in the third quarter of 2010.
Also, the Company announces today, that Trimeris and Roche have
signed a settlement agreement with Novartis resolving the
litigation over FUZEON currently pending in the U.S. District Court
for the Eastern District of North Carolina. Under the terms of the
settlement, the Roche and Trimeris collaboration will continue to
sell FUZEON under a license to Novartis’ U.S. patent No. 7,285,271
B1. In exchange for the grant of this license, Roche and Trimeris
have agreed to pay royalties to Novartis on net sales of FUZEON of
one and one-half percent (1.5%) on sales occurring in the U.S. and
Canada in a calendar year, and one percent (1%) on sales outside of
the U.S. and Canada in a calendar year. The royalty rate increases
to three percent (3%) in the U.S. and Canada and one and one-half
percent (1.5%) in the rest of the world on any portion of FUZEON
sales in excess of $50,000,000 in the relevant region in a calendar
year. Roche and Trimeris will share responsibility for payment of
these royalties equally.
In addition, pursuant to the terms of the settlement, Trimeris
will make an immediate payment to Novartis in the amount of
approximately $2.446 million representing Trimeris’ 50% share of
back royalties on sales of FUZEON through March 31, 2010. Trimeris
will pay an additional $133,000 to Novartis no later than October
31, 2010 representing Trimeris’ 50% share of royalties on the sale
of FUZEON for the second quarter of 2010. These payments will be
reflected as expenses on the Company’s income statement in the
third quarter of 2010.
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company
engaged in the commercialization of therapeutic agents for the
treatment of viral disease. The core technology platform of fusion
inhibition is based on blocking viral entry into host cells.
FUZEON®, approved in the U.S., Canada and European Union, is the
first in a new class of anti-HIV drugs called fusion inhibitors.
For more information about Trimeris, please visit the Company's
website at http://www.trimeris.com.
Trimeris Safe Harbor Statement
This document and any attachments may contain forward-looking
information about the Company's financial results and business
prospects that involve substantial risks and uncertainties. These
statements can be identified by the fact that they use words such
as "expect," "project," "intend," "plan," "believe" and other words
and terms of similar meaning. Among the factors that could cause
actual results to differ materially are the following: there is
uncertainty regarding the success of research and development
activities, regulatory authorizations and product
commercializations; the Company is dependent on third parties for
the sale, marketing and distribution of its drug candidates; the
market for HIV therapeutics is very competitive with regular new
product entries that could affect the sales of its products; the
results of its previous clinical trials are not necessarily
indicative of future clinical trials; and its drug candidates are
based upon novel technology, are difficult and expensive to
manufacture and may cause unexpected side effects. For a detailed
description of these factors, see Trimeris' Form 10-K filed with
the Securities and Exchange Commission on March 16, 2010.
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