FRAZER, Pa. and LONDON, Nov. 25 /PRNewswire-FirstCall/ -- Cephalon, Inc.
(Nasdaq: CEPH) and ImmuPharma PLC (LSE: IMM), a European pharmaceutical
company, today announced that the companies have signed an Option Agreement
providing Cephalon with an option to obtain an exclusive, worldwide license to
the investigational medication Lupuzor(TM) for the treatment of Systemic Lupus
Erythematosus. ImmuPharma is now conducting a large Phase IIb study of
Lupuzor in patients in Europe and Latin America.
Under the terms of the option agreement, Cephalon will pay ImmuPharma a
$15 million upfront option payment. If the Phase IIb studies are successful
and if the option is exercised then the parties enter into an exclusive
worldwide license agreement and ImmuPharma will receive a one-time license
fee, milestone payments upon the achievement of regulatory milestones and
royalties on commercial sales of Lupuzor. The various milestone payments
which include sales milestones may total up to $500 million. Upon exercise of
the option, Cephalon will assume all expenses for Phase III studies and
subsequent commercialization of the product.
"We are excited about entering another specialty market and the potential
Lupuzor presents for us to further diversify our product portfolio and to
bring 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. "Our current cash position
has created the opportunity to make this type of deal, which helps to position
Cephalon and our pipeline for longer term growth."
"We are truly delighted to have this agreement with Cephalon and believe
they would be a great partner to take Lupuzor forward. It represents an
important landmark for the company and secures the future for our most
advanced asset. Importantly, we have appreciated the positive chemistry
between Cephalon and ourselves and believe we would work well together," said
Dimitri Dimitriou, CEO of ImmuPharma.
About Lupuzor and Lupus
Lupuzor is a first-in-class immune modulating treatment that has shown,
through a unique mechanism, to modulate a specific subset of CD4 T cells which
has been shown to play a critical role in the physiopathology of Lupus. This
experimental medication has the potential to halt the progression of the
disease in a substantial proportion of patients. Composition of matter
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 four core therapeutic areas: central nervous system, pain,
oncology and addiction. A member of the Fortune 1000, 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. The company's European
headquarters are located in Maisons-Alfort, France.
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, VIVITROL(R) (naltrexone for extended-release injectable
suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (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.
About ImmuPharma PLC
ImmuPharma PLC is a drug discovery and development company headquartered
in London, UK and quoted on AIM of the London Stock Exchange (LSE: IMM). It
has research operations in France (ImmuPharma (France) SA) and Switzerland
(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,
largely based on peptide therapeutics, to treat serious medical conditions
such as autoimmune diseases characterised by: blockbuster potential in niche
markets; low promotional costs in few specialised physicians and centres; and
lower risk of drug development and lower development costs.
ImmuPharma is a currently developing drug candidates for five different
medical conditions, each of which would represent a significant breakthrough
in its field. The furthest advanced drug candidate targets Lupus, a disease
for which there is currently no cure or specific treatment. The other four
address 1) cancer, 2) moderate to severe pain (such as that experienced by
cancer sufferers and post-operative patients), 3) MRSA and similar severe
hospital-acquired resistant infections and 4) inflammation.
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 anticipated scientific
progress on its research programs, development of potential pharmaceutical
products, interpretation of clinical results, prospects for regulatory
approval, 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.
