QLT restructures Visudyne(R) agreement
2009年10月19日 - 7:30PM
PRニュース・ワイアー (英語)
RECEIVES EXCLUSIVE U.S. RIGHTS AND WILL RECEIVE A ROYALTY ON SALES
OUTSIDE THE U.S. VANCOUVER, Oct. 19 /PRNewswire-FirstCall/ -- QLT
Inc. (NASDAQ: QLTI; TSX: QLT) ("QLT" or the "Company") today
announced that it has restructured its agreement with Novartis
Pharma AG ("Novartis") to simplify the relationship, under which,
effective January 1, 2010, it will, among other things, receive
exclusive U.S. rights to the Visudyne(R) patents to sell and market
Visudyne in the U.S. Visudyne, a photosensitizer co-developed with
Novartis, is approved worldwide for the treatment of a form of wet
age-related macular degeneration ("AMD"), the leading cause of
legal blindness in people over the age of 55 in North America and
Europe. Under the Amended and Restated PDT Product Development,
Manufacturing and Distribution Agreement (the "Amended PDT
Agreement"), QLT will have exclusive U.S. sales and marketing
rights to Visudyne, including rights to all end-user revenue
derived from Visudyne sales in the U.S. Novartis will have
marketing and sales rights in all countries outside of the U.S.
("ex-US") and will pay QLT a royalty of 20% of ex-US net sales
until December 31, 2014, and thereafter 16% of ex-US net sales
until the expiry of the Amended PDT Agreement on December 31, 2019.
QLT will continue to manufacture Visudyne and will supply the
product at a pre-specified price exclusively to Novartis for ex-US
distribution. QLT and Novartis will each be responsible for all
costs and expenses associated with marketing and sales in their
respective territories. "We are very pleased with the amended terms
of our agreement with Novartis which we expect will increase our
revenue from Visudyne and will simplify our relationship," said Bob
Butchofsky, President and Chief Executive Officer of QLT. "This
restructure will allow us to directly influence Visudyne sales in
the U.S. by establishing a small focused sales force centered on
retinal specialists." As part of the restructure, QLT and Novartis
have released each other from all open claims the parties may have
against each other, including any in connection with QLT's
litigation with Massachusetts Eye and Ear Infirmary and QLT's
litigation with General Hospital Corporation (doing business as
Massachusetts General Hospital). About Visudyne Visudyne therapy is
a two-step procedure involving the intravenous administration of
the drug into the patient's arm. A non-thermal laser light is then
shone into the patient's eye to activate the drug. This produces a
reaction that closes the abnormal leaky vessels, resulting in a
stabilization of the corresponding vision loss. Visudyne is
approved worldwide for the treatment of a form of wet AMD, the
leading cause of legal blindness in people over the age of 55, and
has been used in more than two million treatments worldwide.
Visudyne is commercially available in more than 80 countries for
the treatment of predominantly classic subfoveal CNV. In addition,
over 60 countries have approved Visudyne to treat other macular
neovascular conditions such as minimally classic and occult with no
classic AMD lesions, pathological myopia and presumed ocular
histoplasmosis. About QLT QLT Inc. is a global biopharmaceutical
company dedicated to the discovery, development and
commercialization of innovative ocular therapies. We utilize two
unique technology platforms, photodynamic therapy (used with the
Visudyne product) and punctal plugs, which are currently under
development for future product opportunities. For more information,
visit our website at http://www.qltinc.com/. Visudyne is a
registered trademark of Novartis AG. QLT Inc. is listed on The
NASDAQ Stock Market under the trading symbol "QLTI" and on The
Toronto Stock Exchange under the trading symbol "QLT." Certain
statements in this press release constitute "forward looking
statements" of QLT within the meaning of the Private Securities
Litigation Reform Act of 1995 and constitute "forward looking
information" within the meaning of applicable Canadian securities
laws. Forward looking statements include, but are not limited to:
our expectation that the restructured agreement will increase our
revenue from Visudyne; and statements which contain language such
as: "assuming," "prospects," "future," "projects," "believes,"
"expects" and "outlook." Forward-looking statements are predictions
only which involve known and unknown risks, uncertainties and other
factors that may cause actual results to be materially different
from those expressed in such statements. Many such risks,
uncertainties and other factors are taken into account as part of
our assumptions underlying these forward-looking statements and
include, among others, the following: the Company's future
operating results are uncertain and likely to fluctuate; the risk
that future sales of Visudyne may be less than expected; the
ability of the parties to successfully transition Novartis'
responsibilities in the U.S. to QLT; QLT's ability to successfully
market and sell Visudyne in the U.S.; uncertainties relating to the
timing and results of Visudyne combination therapy; the timing,
expense and uncertainty associated with the regulatory approval
process for products; uncertainties regarding the impact of
competitive products and pricing; risks and uncertainties
associated with the safety and effectiveness of products; risks and
uncertainties related to the scope, validity, and enforceability of
intellectual property rights related to our products and technology
and the impact of patents and other intellectual property of third
parties; general economic conditions and other factors described in
detail in QLT's Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q and other filings with the U.S. Securities and Exchange
Commission and Canadian securities regulatory authorities. Forward
looking statements are based on the current expectations of QLT and
QLT does not assume any obligation to update such information to
reflect later events or developments except as required by law.
DATASOURCE: QLT Inc. CONTACT: QLT Inc., Vancouver, Canada, Karen
Peterson, Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604)
707-7001; The Trout Group Investor Relations Contact: New York,
USA, Christine Yang, Telephone: (646) 378-2929; or Marcy Nanus,
Telephone: (646) 378-2927
Copyright