KemPharm Announces Additional Patent Protection for Prodrug Portfolio
February 23 2017 - 7:30AM
US Patent and Trademark Office decision extends
additional patent protection to KP201 and the KP511 compound
family
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs, today announced enhancements
to its U.S. and global intellectual property estate
governing its portfolio of prodrug product candidates. The
United States Patent and Trademark Office (USPTO) issued two new
patents: 1) a “Composition of Matter” patent related to the KP511
family of compounds, and 2) a “Dosage and Formulation” patent
protection related to KP201.
“These additional patents continue to strengthen our robust
estate of intellectual property that underpins our entire prodrug
product portfolio,” said Travis Mickle, Ph.D., President and Chief
Executive Officer of KemPharm. “Our growing patent protection
portfolio extends well into the early to mid-2030’s and exemplifies
the potential of our prodrug discovery platform to address unmet
medical needs in large, established markets by improving one or
more of the attributes of approved drugs, such as susceptibility to
abuse, bioavailability and safety. We believe this protection
period provides ample marketing time following the commercial
development of our products, offering the potential of both an
immediate and a sustained value proposition.”
KemPharm was recently issued U.S. Patent No.
9,566,343 from the USPTO for its patent application
entitled “Benzoic acid, benzoic acid derivatives and heteroaryl
carboxylic acid conjugates of hydromorphone, prodrugs, methods of
making and use thereof.” The patent, which extends through 2032,
provides composition of matter protection and adds to the
intellectual property moat around KP511, KemPharm’s prodrug of
hydromorphone. The patent has issued claims for the use of a
specific hydromorphone prodrug to treat pain, as well as claims for
decreased side effects and decreased potential for intra-nasal
abuse when compared to an equivalent amount of unconjugated
hydromorphone.
The USPTO has also issued U.S. Patent No.
9,549,923, a dosage and formulation patent for a
composition of KP201, KemPharm’s prodrug of hydrocodone. This
patent also has claims to an abuse-deterrent formulation with lower
hydrocodone exposure upon intra-nasal administration as compared to
an equivalent dose of hydrocodone bitartrate.
About KemPharm
KemPharm is a clinical-stage specialty
pharmaceutical company focused on the discovery and development of
proprietary prodrugs to treat serious medical conditions through
its Ligand Activated Therapy (LAT) platform technology.
KemPharm utilizes its LAT platform technology to generate improved
prodrug versions of U.S. Food and Drug Administration
(FDA)-approved drugs in the high need areas of pain, attention
deficit hyperactivity disorder (ADHD) and other central nervous
system disorders. KemPharm’s co-lead clinical development
candidates are KP415, an extended-release prodrug of
methylphenidate for the treatment of ADHD, and KP201/IR, an
acetaminophen-free formulation of the company’s immediate release
abuse deterrent hydrocodone product, KP201. For more
information on KemPharm and its pipeline of prodrug product
candidates visit www.kempharm.com.
Caution Concerning Forward-Looking
StatementsThis press release may contain forward-looking
statements made in reliance upon the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended.
Forward-looking statements include all statements that do not
relate solely to historical or current facts, and can be identified
by the use of words such as “may,” “will,” “expect,” “project,”
“estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,”
“continue” or the negative versions of those words or other
comparable words. These forward-looking statements include
statements regarding the expected features and characteristics of
KP511 and KP201 and the sufficiency of KemPharm’s patent portfolio
to maintain exclusivity over and protection for its product
candidates. These forward-looking statements are not
guarantees of future actions or performance. These forward-looking
statements are based on information currently available to KemPharm
and its current plans or expectations, and are subject to a number
of uncertainties and risks that could significantly affect current
plans. Actual results and performance could differ materially from
those projected in the forward-looking statements as a result of
many factors, including, without limitation, the risks and
uncertainties associated with: KemPharm's financial resources and
whether they will be sufficient to meet KemPharm's business
objectives and operational requirements; results of earlier studies
and trials may not be predictive of future clinical trial results;
the protection and market exclusivity provided by KemPharm's
intellectual property; risks related to the drug discovery and the
regulatory approval process; the impact of competitive products and
technological changes; obligations to third parties regarding the
potential commercialization or sale of KP415; and the FDA approval
process, including without limitation any timelines for related
approval. KemPharm's forward-looking statements also involve
assumptions that, if they prove incorrect, would cause its results
to differ materially from those expressed or implied by such
forward-looking statements. These and other risks concerning
KemPharm’s business are described in additional detail in
KemPharm's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016, and KemPharm’s other Periodic and Current
Reports filed with the Securities and Exchange Commission.
KemPharm is under no obligation to (and expressly disclaims any
such obligation to) update or alter its forward-looking statements,
whether as a result of new information, future events or
otherwise.
Investor Contacts:
Jason Rando / Joshua Drumm, Ph.D.
Tiberend Strategic Advisors, Inc.
212-375-2665 / 2664
jrando@tiberend.com
jdrumm@tiberend.com
Media Contact:
Daniel L. Cohen
Executive VP, Government and Public Relations
KemPharm, Inc.
202-329-1825
dcohen@kempharm.com
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