FRAZER, Pa., Feb. 2 /PRNewswire-FirstCall/ -- Cephalon, Inc.
(Nasdaq: CEPH) today announced that the company will exercise its option to
license worldwide rights to Lupuzor(TM), an investigational medication for the
treatment of Systemic Lupus Erythematosus, based on the promising interim
results of the ImmuPharma Phase IIb study. Cephalon will assume all expenses
for Phase III studies, regulatory filings and subsequent commercialization of
the product.
ImmuPharma PLC received a $15 million upfront fee at the initiation of the
deal last year. In exercising its option, Cephalon will pay ImmuPharma a
one-time license fee of $30 million. ImmuPharma could receive future cash
milestone payments upon the achievement of certain regulatory and sales
milestones, as well as royalties on commercial sales of Lupuzor. The various
cash milestone payments (including the option and license fees) may total up
to approximately $500 million.
"We are pleased that this Phase IIb study shows a favorable efficacy and
safety profile for Lupuzor," said Dr. Lesley Russell, Executive Vice President
and Chief Medical Officer at Cephalon. "We will initiate plans to implement
pivotal Phase III clinical trials this year."
"These study results are encouraging and bring us one step closer to
providing the first specific medication for the treatment of lupus to patients
living with this chronic, potentially life-threatening disease," said Frank
Baldino, Jr., Ph.D., chairman and CEO of Cephalon. "Lupuzor recently received
a notice of allowance for its novel composition of matter patent, which will
support our development of the product. If our efforts are successful, this
product and our recent deal with Ception Therapeutics will allow us to build a
business unit focused on inflammatory diseases."
"The exercise of the option by Cephalon validates the analysis ImmuPharma
made of the interim report results," said Dr. Robert Zimmer, president and
Chief Scientific Officer at ImmuPharma. "This collaboration with Cephalon
will accelerate the Phase III program and potential commercialization of
Lupuzor thereby allowing lupus patients access to treatment as soon as
possible."
Study Results
The interim results of the Phase IIb study included 125 patients
randomized to two dosing regimens of Lupuzor or placebo. The primary efficacy
measure was a SLEDAI response; defined as a decrease of at least 4 points in
the SLEDAI-2K score, a scale generally accepted by physicians as an assessment
of the clinical status of lupus patients, a lower score representing lower
disease activity. The analysis of the data has demonstrated that the 200 mcg
Lupuzor dose regimen administered every four weeks reached statistical
significance compared to placebo (p = 0.015). Consistent with previous
studies, Lupuzor was generally well tolerated, with no significant drug
related adverse events reported.
About Lupuzor and Lupus
Lupuzor has shown that it modulates, through a unique mechanism, a
specific subset of CD4 T cells which play a critical role in the
physiopathology of Lupus. This investigational medication has the potential
to halt the progression of the disease in a substantial proportion of
patients. Patents for Lupuzor have been approved in Japan and Australia, and
the US Patent Office recently issued a notice of allowance.
Lupus is an autoimmune disease causing various effects throughout
different parts of the body. Its severity can range from very mild to
extremely serious depending on which body organs are afflicted. The Lupus
Foundation of America estimates that 1.5 million Americans have a form of
lupus. Approximately 90 percent of those diagnosed with the disease are
women. Lupus is two to three times more prevalent among people of color,
including African Americans, Hispanics/Latinos, Asians, and Native Americans.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical
company dedicated to the discovery, development, and commercialization of many
unique products in three core therapeutic areas: central nervous system, pain,
and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon
currently employs approximately 3,000 people in the United States and Europe.
U.S. sites include the company's headquarters in Frazer, Pennsylvania, and
offices, laboratories or manufacturing facilities in West Chester,
Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa.
The Cephalon European headquarters and pre-clinical development center are
located in Maisons-Alfort, France, just outside of Paris. Key business units
are located in England, Ireland, France, Germany, Italy, Spain, the
Netherlands for the Benelux countries, and Poland for Eastern and Central
European countries. Cephalon Europe markets more than 30 products in four
therapeutic areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: AMRIX(R)
(cyclobenzaprine hydrochloride extended-release capsules), TREANDA(R)
(bendamustine hydrochloride) for Injection, FENTORA(R) (fentanyl buccal
tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic
trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(R)
(armodafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate)
[C-II]. The company also markets numerous products internationally. Full
prescribing information on its U.S. products is available at
http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this
press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding timing of the Phase III
clinical study for Lupuzor, the intellectual property protection for Lupuzor,
our ability to build an inflammatory disease business unit, anticipated
scientific progress on its research programs, development of potential
pharmaceutical products, our generation of longer term growth through our
product pipeline, interpretation of clinical results, prospects for regulatory
approval (particularly for specific indications), manufacturing development
and capabilities, market prospects for its products, sales and earnings
guidance, and other statements regarding matters that are not historical
facts. You may identify some of these forward-looking statements by the use
of words in the statements such as "anticipate," "estimate," "expect,"
"project," "intend," "plan," "believe" or other words and terms of similar
meaning. Cephalon's performance and financial results could differ materially
from those reflected in these forward-looking statements due to general
financial, economic, regulatory and political conditions affecting the
biotechnology and pharmaceutical industries as well as more specific risks and
uncertainties facing Cephalon such as those set forth in its reports on Form
8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission.
Given these risks and uncertainties, any or all of these forward-looking
statements may prove to be incorrect. Therefore, you should not rely on any
such factors or forward-looking statements. Furthermore, Cephalon does not
intend to update publicly any forward-looking statement, except as required by
law. The Private Securities Litigation Reform Act of 1995 permits this
discussion.
