SciClone and Zensun Enter Into a Licensing Agreement for Novel Chronic Heart
Failure Drug Neucardin(TM) for the China Market
FOSTER CITY, CA -- (Marketwired) -- 05/16/13 -- SciClone
Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that the Company
has entered into an agreement with Zensun (Shanghai) Science &
Technology Co., Ltd. granting SciClone a license and the exclusive
rights in China, Hong Kong and Macau to promote, market, distribute
and sell Neucardin(TM), a novel, first-in-class therapeutic drug for
the treatment of patients with intermediate to advanced chronic heart
Neucardin is a genetically engineered recombinant peptide fragment of
neuregulin-1 that has been clinically shown to directly improve
cardiac function, reverse ventricular remodeling and increase the
survival of heart failure patients. Six Phase 2 studies with
Neucardin have been conducted in China, Australia and the United
States, including three Phase 2b studies in China. The China Phase 2b
survival study demonstrated that Neucardin was well tolerated and
showed a significant decrease in mortality and improved survival in
patients with CHF. A New Drug Application (NDA) was submitted to and
accepted by the China Food and Drug Administration (CFDA) in 2012.
Commented Friedhelm Blobel, Ph.D., SciClone's Chief Executive
Officer: "In-licensing Neucardin fulfills one of our Company's key
strategic initiatives to expand our product portfolio with
differentiated, high quality products that have significant
therapeutic advantages and near-term commercial potential, and that
can contribute to our long-term growth. Neucardin addresses a large
unmet need in the treatment of CHF, and targets an indication in
China with a significant underlying patient base. Neucardin is an
excellent fit for our Company, enabling us to leverage the deep
experience and expertise of our cardiovascular sales and marketing
team and expand our penetration into this growing market segment."
Mingdong Zhou, Ph.D., Zensun's Chief Executive Officer, stated: "We
are pleased to establish this agreement with SciClone, a company with
a stellar reputation and proven expertise in successfully selling and
promoting high-quality products in the China market. We believe that
Neucardin, a first-in-class biologic that works through a novel
mechanism of action, has the potential to bring significant benefits
to patients with CHF. We are also proud of the innovative approach
that Neucardin represents, which has enabled us to be recognized in
China's 11th and 12th five-year plans. We look forward to working
with SciClone as we move this promising new drug through the final
stages of the China regulatory process."
Under the terms of the agreement, Zensun will be responsible for the
manufacturing and supply of Neucardin, and SciClone will be
responsible for all aspects of commercialization, including the pre-and post-launch activities for Neucardin. Financial terms of the
agreement include aggregate potential milestone payments of up to
$18.5 million. The Company has agreed to make additional payments of
$10 million should Zensun receive approval of Neucardin by
subcutaneous infusion. Further indications and improved product forms
of Neucardin could result in additional payments. Also included in
the agreement is a $12 million collateralized loan facility by which
SciClone would provide a secured loan to Zensun that Zensun may use
in future. The agreement provides for the principal terms of the
arrangement between SciClone and Zensun, and the companies have
agreed to negotiate a supplemental license and supply agreement.
Cardiovascular therapeutics are a large and fast-growing market in
China. Chronic heart failure has a large underlying patient base in
China of approximately five million urban patients. It is expected
that the prevalence of CHF in China will increase to over seven
million urban patients over the next ten years, primarily due to the
growing aging population in China and urbanization.
Heart failure, or chronic heart failure, develops as a result of the
slow deterioration of cardiac muscle where the heart undergoes an
irreversible process of maladaptive remodeling. In an attempt to
compensate for impaired cardiac function, diseased hearts "remodel,"
a process that can change the heart's shape and thickness, thereby
resulting in severe cardiac dysfunction. Drugs currently treating CHF
tend to be mature products that can relieve symptoms, but none can
actually reverse the maladaptive remodeling. One of Neucardin's
potential advantages is that it is not designed to directly compete
with existing therapies, given its unique mechanism of action, but
rather it can be included as part of the comprehensive treatment of
CHF involving multiple drugs.
Neucardin has strong patent protection on a worldwide basis, with 12
issued patents and more than 30 applications pending. With its
expanding global clinical data package and worldwide patent
protection, Zensun is also actively preparing to conduct Phase 3
trials in the US in order to commercialize Neucardin beyond the China
Zensun (Shanghai) Science & Technology Co., Ltd. (www.zensun.com) is
an international biopharmaceutical company focused on the development
of innovative "first-in-class" biotherapeutic products for the
treatment of serious and life-threatening unmet medical needs. It is
focused on discovering new medicines using novel disease-specific
targets and innovative technologies. Zensun's patented discoveries
are then developed into therapies. With adherence to the tenet of
"healing for life," Zensun hopes to transform the lives of heart
failure and cancer patients by providing them with drugs that treat
their disease, not just their symptoms.
To meet the world's highest standards, incorporate international
intelligence, and expand the coverage of patients, Zensun has
infrastructure established in China, Australia, and the US. As a
globalized biopharmaceutical company, Zensun has gathered experts and
pioneers from throughout the world aiming at global commercialization
of the novel therapies, and has attracted investors with a forward
vision and broad outlook. Zensun leverages the leading technology to
best serve its patients and deliver maximum return for investors.
Zensun is a paradigm-shifting company which has led the way in novel
heart failure and cancer therapies.
SciClone Pharmaceuticals is a US-based, China-focused specialty
pharmaceutical company with a product portfolio of therapies for
oncology, infectious diseases, cardiovascular, urological,
respiratory, and central nervous system disorders. SciClone's
ZADAXIN(R) (thymalfasin) is approved in over 30 countries and may be
used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and
certain cancers, and as a vaccine adjuvant, according to the local
regulatory approvals. Besides ZADAXIN, SciClone markets about 14
mostly partnered products in China, including Depakine(R), the most
widely prescribed broad-spectrum anti-convulsant in China;
Tritace(R), an ACE inhibitor for the treatment of hypertension;
Stilnox(R), a leading hypnotic for the short-term treatment of
insomnia (marketed as Ambien(R) in the US); and Aggrastat(R), a
recently-launched interventional cardiology product. SciClone is also
pursuing the registration of several other therapeutic products in
China. SciClone is headquartered in Foster City, California. For
additional information, please visit www.sciclone.com.
This press release contains forward-looking statements regarding
expected financial results and expectations. Readers are urged to
consider statements that include the words "may," "will," "would,"
"could," "should," "might," "believes," "estimates," "projects,"
"potential," "expects," "plans," "anticipates," "intends,"
"continues," "forecast," "designed," "goal," "unaudited,"
"approximately" or the negative of those words or other comparable
words to be uncertain and forward-looking. These statements are
subject to risks and uncertainties that are difficult to predict and
actual outcomes may differ materially. These include risks and
uncertainties relating to: the clinical trial process, including the
regulatory approval and the process of initiating trials at, and
enrolling patients at, clinical sites; the effect of changes in its
practices and policies related to the Company's compliance programs.
Please also refer to other risks and uncertainties described in
SciClone's filings with the SEC. All forward-looking statements are
based on information currently available to SciClone and SciClone
assumes no obligation to update any such forward-looking statements.
Ambien, Depakine, Stilnox and Tritace are registered trademarks of
Sanofi and/or its affiliates.
Aggrastat is a registered trademark of Medicure International Inc. in
the United States, and Iroko Cardio LLC or Merck & Co., Inc. in
numerous other countries.
SciClone, SciClone Pharmaceuticals, the SciClone Pharmaceuticals
design, the SciClone logo and ZADAXIN are registered trademarks of
SciClone Pharmaceuticals, Inc. in the United States and numerous
Chief Financial Officer
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