U.S. Patent Trial and Appeal Board Affirms Lomitapide Patents with Favorable IPR Decisions
March 07 2017 - 08:43AM
Novelion Therapeutics Inc. (NASDAQ:NVLN) (TSX:NVLN), a
biopharmaceutical company dedicated to developing new standards of
care for individuals living with rare diseases, today announced
that the United States Patent Trial and Appeal Board (PTAB) issued
a written decision in an Inter Partes Review proceeding affirming
the patentability of all claims on U.S. 7,932,268 and U.S.
8,618,135 lomitapide dosage regimen patents.
“We believe we set forth a strong argument,
supported by expert opinions, that the step-wise titration of
lomitapide claimed in the patents was not obvious, and we are
pleased with the PTAB’s decision to uphold these patents,” said
Mary Szela, chief executive officer of Novelion Therapeutics. “We
believe we have a strong intellectual property portfolio for
lomitapide in the U.S., which includes a composition of matter
patent that expires in February 2020 and dosage regimen patents
that potentially extend our exclusivity through mid-2027.”
Of the two patents that were under review, U.S.
8,618,135 provides the potential for exclusivity until March 2025
and U.S. 7,932,268 provides the potential for exclusivity until
August 2027.
About Novelion Therapeutics
Novelion Therapeutics is a biopharmaceutical company dedicated to
developing new standards of care for individuals living with rare
diseases. Novelion has a diversified commercial portfolio through
its indirect subsidiary, Aegerion Pharmaceuticals, Inc. (Aegerion),
which includes MYALEPT® and JUXTAPID®, and is also developing
zuretinol acetate for the potential treatment of inherited retinal
disease caused by underlying mutations in RPE65 or LRAT
genes. The company seeks to advance its portfolio of rare
disease therapies by investing in science and clinical
development.
Forward-Looking Statements
Certain statements in this press release
constitute “forward-looking statements” of Novelion and constitute
“forward-looking information” within the meaning of applicable
Canadian securities laws, including statements regarding the
potential terms of exclusivity and the strength of our intellectual
property portfolio. Forward-looking statements are based on
estimates and assumptions regarding, for example, future
competitive conditions and market acceptance of our products,
expectations for the period of exclusivity our patent portfolio may
provide and the ability of our patents to withstand future
challenges, each made by Novelion in light of current conditions
and expected future developments, as well as other factors that
Novelion believes are appropriate in the circumstances. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties, many of which are beyond our control, which could
cause actual results to differ materially from those contemplated
in these forward-looking 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 risk that future challenges to our
lomitapide patents in IPR proceedings or otherwise, including
through an Abbreviated New Drug Application that could have been
filed with the FDA to market a generic of lomitapide as of December
21, 2016, may prove successful; and the risk that Aegerion's
patent portfolios and marketing and data exclusivity for lomitapide
may not be as strong as we anticipate.
For additional disclosure regarding these and
other risks we face, see the disclosure contained in the "Risk
Factors" section of Aegerion's Quarterly Report on Form 10-Q filed
on November 4, 2016, Novelion's Annual Report on Form 10-K filed on
February 25, 2016 (and amended on April 29, 2016) and Quarterly
Report on Form 10-Q filed on November 1, 2016 and each company's
other public filings with the U.S. Securities and Exchange
Commission (SEC), available on the SEC's website at www.sec.gov.
Except as required by law, we undertake no obligation to update or
revise the information contained in this press release, whether as
a result of new information, future events or circumstances or
otherwise.
Investors and others should note that we
communicate with our investors and the public using our company
website www.novelion.com, including, but not limited to, company
disclosures, investor presentations and FAQs, SEC filings, press
releases, public conference calls transcripts and webcast
transcripts. The information that we post on these websites could
be deemed to be material information. As a result, we encourage
investors, the media and others interested to review the
information that we post there on a regular basis. The contents of
our website shall not be deemed incorporated by reference in any
filing under the Securities Act of 1933, as amended.
CONTACT:
Amanda Murphy, Director, Investor Relations & Corporate Communications
Novelion Therapeutics
857-242-5024
amanda.murphy@novelion.com
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