Corcept Therapeutics Files Lawsuit Against Teva Pharmaceuticals for Infringement of Korlym Patents
March 15 2018 - 5:00PM
Corcept Therapeutics Incorporated (NASDAQ:CORT), a company engaged
in the discovery, development and commercialization of drugs to
treat severe metabolic, oncologic and psychiatric disorders by
modulating the effects of the stress hormone cortisol, today
announced that it has filed a lawsuit in the U.S. District Court
for the District of New Jersey against Teva Pharmaceuticals USA,
Inc. (“Teva”) for infringement of Corcept patents covering the use
of Korlym® (mifepristone) 300 mg Tablets (“Korlym”).
Corcept filed suit in response to Teva’s
Abbreviated New Drug Application (“ANDA”), filed by Teva seeking
U.S. Food and Drug Administration (“FDA”) approval to market and
sell a generic version of Korlym prior to the expiration of
Corcept’s U.S. Patent No. 8,921,348, which expires in 2028, and
U.S. Patent No. 9,829,495, which expires in 2036. Both patents are
listed in the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations (commonly referred to as the “FDA Orange
Book”). Corcept filed the lawsuit on the basis that the use of
Teva’s proposed generic product will infringe these patents.
In accordance with the provisions of the
Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act,
Corcept’s lawsuit will automatically stay FDA approval of Teva’s
ANDA until the earlier of 30 months or a District Court decision
that the patents are invalid, unenforceable or not infringed.
About Corcept
Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in
the discovery, development and commercialization of drugs that
treat severe metabolic, oncologic and psychiatric disorders by
modulating the effects of cortisol. Korlym is the company’s
first FDA-approved medication. Corcept has a large portfolio of
proprietary compounds that selectively modulate the effects of
cortisol but not progesterone. Corcept owns extensive United States
and foreign intellectual property covering the use of cortisol
modulators in the treatment of a wide variety of serious disorders,
including Cushing’s syndrome. It also holds composition of matter
patents covering its selective cortisol modulators.
About Korlym®
Korlym inhibits the effects of excess cortisol
in patients with hypercortisolism by modulating activity at the
glucocorticoid receptor, one of the two receptors to which cortisol
binds. Korlym was the first FDA-approved treatment for patients
with Cushing’s syndrome and the FDA has designated it as an Orphan
Drug for that indication.
About Hypercortisolism
Hypercortisolism, often referred to as Cushing’s
syndrome, is caused by excessive activity of the stress hormone
cortisol. Endogenous Cushing’s syndrome is an orphan disease that
most often affects adults aged 20-50. In the United States,
an estimated 20,000 patients have Cushing’s syndrome, with about
3,000 new patients being diagnosed each year. Symptoms vary, but
most people experience one or more of the following manifestations:
high blood sugar, diabetes, high blood pressure, upper-body
obesity, rounded face, increased fat around the neck, thinning arms
and legs, severe fatigue and weak muscles. Irritability, anxiety,
cognitive disturbances and depression are also common. Cushing’s
syndrome can affect every organ system in the body and can be
lethal if not treated effectively.
Forward-Looking Statements
Statements in this press release, other than
statements of historical fact, are forward-looking statements,
which are based on our current plans and expectations and are
subject to risks and uncertainties that might cause actual results
to differ materially from those the forward-looking statements
express or imply. Forward-looking statements include those
concerning the outcome of litigation and Corcept’s intellectual
property rights, including its patents covering the use of cortisol
modulators, including Korlym, to treat patients with
hypercortisolism and other indications. These and other risks are
set forth in our SEC filings, which are available at our website
and the SEC’s website. We disclaim any intention or duty to update
forward-looking statements made in this press release.
CONTACT:Charles RobbChief Financial
OfficerCorcept
Therapeutics650-688-8783crobb@corcept.comwww.corcept.com
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