Clovis Oncology Announces Notice of Allowance for Rucaparib High Dosage Strength Tablet Patent with Expiration in 2035
March 08 2018 - 8:00AM
Business Wire
• Claims to be issued cover all commercial
dosage strengths of Rubraca®
• This will be the 10th Orange Book-listed
patent for Rubraca
Clovis Oncology, Inc. (NASDAQ:CLVS) announced today that the
Company has received a Notice of Allowance from the United States
Patent and Trademark Office in United States Patent Application
14/828,065 with claims directed to high dosage strength rucaparib
camsylate formulations. The patent is expected to issue shortly
with claims that cover the commercial Rubraca product, including
all commercial dosing strengths (200, 250 and 300mg). Upon
issuance, the high dosage strength rucaparib formulation patent
will expire in 2035, and will have the longest term of the multiple
patents directed to rucaparib, rucaparib camsylate, and methods of
treatment. This will be the 10th Orange Book-listed patent for
rucaparib.
“Our development team has done a tremendous job developing high
dosage strength tablets to help ensure that patients eligible for
rucaparib are able to adhere to their daily dose in a
straightforward manner,” said Patrick J. Mahaffy, President and CEO
of Clovis Oncology. “The Notice of Allowance recognizes that work
and we expect will soon result in issuance of a patent that will
not expire until 2035, complementing our already issued camsylate
salt patents that expire in 2031. This is relevant not only to our
current indication in ovarian cancer, but also to multiple tumor
types based on our ongoing and substantial clinical development
programs.”
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in ovarian cancer as well as several
additional solid tumor indications. Studies open for enrollment or
under consideration include ovarian, prostate, breast,
gastroesophageal, pancreatic, lung and bladder cancers. Clovis
holds worldwide rights for Rubraca.
In the United States, Rubraca is approved on an accelerated
basis as monotherapy for the treatment of patients with deleterious
BRCA mutation (germline and/or somatic) associated advanced ovarian
cancer, who have been treated with two or more chemotherapies, and
selected for therapy based on an FDA-approved companion diagnostic
for Rubraca. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials. In December 2017, the U.S. Food and Drug
Administration (FDA) accepted the Company’s supplemental New Drug
Application (sNDA) for Rubraca for a second-line or later
maintenance treatment indication in ovarian cancer based on the
ARIEL3 data. The FDA granted Priority Review status to the
application with a Prescription Drug User Fee Act (PDUFA) date of
April 6, 2018. Rubraca is not a licensed medicinal product in
countries outside the US.
About Clovis Oncology
Clovis Oncology, Inc. is a biopharmaceutical company focused on
acquiring, developing and commercializing innovative anti-cancer
agents in the U.S., Europe and additional international markets.
Clovis Oncology targets development programs at specific subsets of
cancer populations, and simultaneously develops, with partners,
diagnostic tools intended to direct a compound in development to
the population that is most likely to benefit from its use. Clovis
Oncology is headquartered in Boulder, Colorado, and has additional
offices in San Francisco, California and Cambridge,
UK. Please visit clovisoncology.com for more information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis
Oncology, they are forward-looking statements reflecting the
current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Examples of forward-looking statements contained
in this press release include, among others, statements regarding
our expectation of the ultimate issuance of the patent that is
subject of the Notice of Allowance and the timing for such
issuance, and the expiration of patents in our portfolio. Such
forward-looking statements involve substantial risks and
uncertainties that could cause our future results, performance or
achievements to differ significantly from that expressed or implied
by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the actions by the United States Patent and Trademark Office
regarding final approval and issuance of such patent, and
third-party challenges to the validity, enforceability or scope of
our patents. Clovis Oncology does not undertake to update
or revise any forward-looking statements. A further description of
risks and uncertainties can be found in Clovis Oncology’s filings
with the Securities and Exchange Commission, including its
Annual Report on Form 10-K and its reports on Form 10-Q and Form
8-K.
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version on businesswire.com: http://www.businesswire.com/news/home/20180308005564/en/
Clovis Oncology, Inc.Breanna Burkart,
303-625-5023bburkart@clovisoncology.comorAnna Sussman,
303-625-5022asussman@clovisoncology.com
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