Akorn Invalidates Durezol® Patent Via Inter Partes Review Proceeding
November 28 2016 - 5:15PM
Akorn, Inc. (Nasdaq:AKRX), a leading specialty pharmaceutical
company, today announced that on November 22, 2016, the Patent
Trial and Appeal Board (PTAB) ruled in favor of Akorn in its inter
partes review (IPR) proceeding and found all the claims of the
6,114,319 patent (“ ‘319 patent”) related to the Durezol®
formulation to be obvious. The ‘319 patent, directed to emulsions
of difluprednate, is owned by Senju Pharmaceutical Co., Ltd. and
Mitsubishi Chemical Corporation, and licensed to Alcon
Laboratories, Inc.
Raj Rai, Akorn’s Chief Executive Officer, commented, “We welcome
the PTAB’s deliberate and thorough decision which took into
consideration all the evidence presented, including evidence of
secondary considerations presented by Patent Owner. This is an
exciting opportunity for our Company as we believe we will be
eligible for sole marketing exclusivity pending receipt of final
FDA approval. This outcome will help us reach our goal of achieving
a leadership position in generic ophthalmics and further solidifies
our strategic focus on alternate dosage forms such as ophthalmics,
injectables and topicals.”
Akorn believes it is the first and only company to
file a substantially complete abbreviated new drug application
containing a Paragraph IV certification and expects to benefit from
180 days of marketing exclusivity in the U.S. upon final FDA
approval.
U.S. sales of Durezol® (difluprednate ophthalmic
emulsion) 0.05% were approximately $191 million for the 12 months
ending September 30, 2016, according to IMS Health.
About AkornAkorn, Inc. is a specialty generic
pharmaceutical company engaged in the development, manufacture and
marketing of multisource and branded pharmaceuticals. Akorn has
manufacturing facilities located in Decatur, Illinois; Somerset,
New Jersey; Amityville, New York; Hettlingen, Switzerland and
Paonta Sahib, India that manufacture ophthalmic, injectable and
specialty sterile and non-sterile pharmaceuticals. Additional
information is available on Akorn’s website at www.akorn.com.
Forward Looking StatementsThis press release
includes statements that may constitute "forward looking
statements", including statements regarding Akorn's goals and
strategy. When used in this document, the words “continue,”
“anticipate,” “plan,” “achieve,” “will,” “believe,” “estimate” and
“expect” and similar expressions are generally intended to identify
forward looking statements. These statements are made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Because such statements inherently involve
risks and uncertainties, actual future results may differ
materially from those expressed or implied by such forward looking
statements. Factors that could cause or contribute to such
differences include, but are not limited to: the susceptibility of
our generic and off patent pharmaceutical products to competition,
substitution policies and reimbursement policies of the government;
the timing and success of product launches; difficulties or delays
in manufacturing; the availability and pricing of third party
sourced products and materials; successful compliance with FDA and
other governmental regulations; the continuing consolidation of our
customer base, which could adversely affect sales of our products;
our dependence on a small number of distributors, the loss of any
of which could have a material adverse effect; changes in the laws
and regulations and such other risks and uncertainties outlined in
Akorn's public filings with the SEC. Except as expressly required
by law, Akorn disclaims any intent or obligation to update these
forward looking statements.
Investors/Media:
Stephanie Carrington
ICR, Inc.
(646) 277-1282
Stephanie.carrington@icrinc.com
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