PRINCETON, N.J. and
FOSTER CITY, Calif., Sept. 12, 2016 /PRNewswire/ -- Soligenix,
Inc. (OTCQB: SNGX), a late-stage biopharmaceutical company focused
on developing and commercializing products to treat rare diseases
where there is an unmet medical need, and SciClone Pharmaceuticals,
Inc. (NASDAQ: SCLN), a US-based China-focused specialty pharmaceutical
company, announced today that the companies have entered into an
exclusive license agreement granting rights to SciClone to develop,
promote, market, distribute and sell SGX942 (dusquetide), a novel,
first-in-class therapy being developed for the treatment of oral
mucositis in patients with head and neck cancer. The licensing
agreement includes the People's Republic
of China, including Hong
Kong and Macau, as well as
Taiwan, South Korea and Vietnam (the "Territory"). This exclusive
agreement builds on an existing collaboration between the two
companies, in which SciClone provided its complete oral mucositis
clinical and regulatory data library to Soligenix in exchange for
certain, previously undisclosed, commercialization rights to SGX942
in the Greater China market.
Under the terms of the agreement, SciClone will make a
$3 million upfront equity investment
in Soligenix for 3,529,412 shares of Soligenix common stock. In
addition, SciClone will be responsible for all aspects of
development, product registration and commercialization in the
Territory, having access to data generated by Soligenix. In
exchange for exclusive rights, SciClone will pay to Soligenix
royalties on net sales, and Soligenix will supply commercial drug
product to SciClone on a cost-plus basis, while maintaining
worldwide manufacturing rights.
Friedhelm Blobel, PhD, President
and Chief Executive Officer of SciClone, commented, "We believe
that SGX942 can be an excellent fit within our growing oncology
portfolio, and expands our strategy to in-license programs that can
potentially utilize accelerated development and regulatory pathways
in China. SciClone has a well
established commercial presence in China, and key to driving our long-term growth
is the expansion of our pipeline with innovative product
candidates. We believe that oral mucositis represents an unmet
medical need and is a frequent complication of anticancer
treatment, including chemotherapy and radiation therapy. We
appreciate the strong performance of the Soligenix clinical team in
advancing this potentially important therapeutic, and are looking
forward to developing SGX942 for potentially multiple Asia markets."
"We are very pleased to expand on our partnership with
SciClone," stated Christopher J.
Schaber, PhD, President and Chief Executive Officer of
Soligenix. "SciClone has a significant commercial presence
and expertise in China, and their
clinical and regulatory contribution to the dusquetide oral
mucositis program has the potential to bring high quality
development and potential commercialization of SGX942 in the
Territory. In the US, our multi-center, double-blind,
placebo-controlled, Phase 2 clinical study in oral mucositis in
head and neck cancer patients is currently ongoing with completion
of long-term follow-up expected by the end of 2016."
This exclusive license agreement builds on an existing
collaboration, wherein SciClone provided its significant oral
mucositis clinical and regulatory data library, thus increasing the
probability of success for the Soligenix SGX942 Phase 2 exploratory
clinical study. By analyzing data available from the placebo
subjects in the SciClone trials, Soligenix acquired essential
insight into disease progression, along with quantitative
understanding of its incidence and severity in the head and neck
cancer patient population. This information assisted with the
design of the SGX942 Phase 2 clinical trial, in which positive
preliminary results were announced in December 2015.
About SGX942 (dusquetide)
SGX942 is an innate defense regulator (IDR), which contains a
new class of short, synthetic peptide, having the chemical name
dusquetide. It has a novel mechanism of action in that it
modulates the body's reaction to both injury and infection towards
an anti-inflammatory and an anti-infective response. IDRs
have no direct antibiotic activity but, by modulating the host's
innate immune system responses, increase survival after infections
with a broad range of bacterial Gram-negative and Gram-positive
pathogens. It also accelerates resolution of tissue damage
following exposure to a variety of agents including bacterial
pathogens, trauma and chemo- and/or radiation therapy.
Preclinical efficacy and safety has been demonstrated in numerous
animal disease models including mucositis, colitis, melioidosis and
other bacterial infections. Some of these preclinical findings have
been published in an article entitled "A novel approach for
emerging and antibiotic resistant infections: Innate defense
regulators as an agnostic therapy" and are available at the
following link:
http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
SGX942 has demonstrated safety in a Phase 1 clinical study in 84
healthy human volunteers. Recently, SGX942 has demonstrated
preliminary efficacy and safety in an exploratory Phase 2 clinical
study in 111 patients with oral mucositis due to chemoradiation
(CRT) therapy for head and neck cancer. Consistent with
preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated
positive improvements in decreasing the duration of severe oral
mucositis by 50% overall compared to the placebo group, from 18
days to 9 days (p=0.099). In patients receiving the most
aggressive concomitant chemotherapy, the reduction in the duration
of severe oral mucositis was even more significant at 67% when
treated with SGX942 1.5 mg/kg, from 30 days to 10 days
(p=0.04). The p-values meet the prospectively defined
statistical threshold of p<0.1 in the study protocol.
Additional observations included an improved tumor response
to CRT therapy at the one month follow up visit (47% in placebo
versus 63% in SGX942 at 1.5 mg/kg), as well as decreases in
infection rate.
Dusquetide and related analogs have a strong intellectual
property position, including composition of matter.
Dusquetide was developed pursuant to discoveries made by Professors
B. Brett Finlay, PhD and
Robert Hancock, PhD of the
University of British Columbia,
Canada.
SGX942 has received fast track designation from the US Food and
Drug Administration (FDA) for the treatment of oral mucositis as a
result of radiation and/or chemotherapy treatment in head and neck
cancer patients. Fast track is a designation that the FDA
reserves for a drug intended to treat a serious or life-threatening
condition and one that demonstrates the potential to address an
unmet medical need for the condition. Fast track designation
is designed to facilitate the development and expedite the review
of new drugs. For instance, should events warrant, Soligenix
will be eligible to submit a new drug application (NDA) for SGX942
on a rolling basis, permitting the FDA to review sections of the
NDA prior to receiving the complete submission. Additionally,
NDAs for fast track development programs ordinarily will be
eligible for priority review, which imparts an abbreviated review
time of approximately six months.
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by
anticancer therapies. It can occur in any mucosal region, but
is most commonly associated with the mouth, followed by the small
intestine. It is estimated, based upon review of historic
published studies and reports and an interpolation of data on the
incidence of mucositis, that mucositis affects approximately
500,000 people in the US per year and occurs in 40% of patients
receiving chemotherapy. Mucositis can be severely
debilitating and can lead to infection, sepsis, the need for
parenteral nutrition and narcotic analgesia. The
gastrointestinal damage causes severe diarrhea. These
symptoms can limit the doses and duration of cancer treatment,
leading to sub-optimal treatment outcomes.
The mechanisms of mucositis have been extensively studied and
have been recently linked to the interaction of chemotherapy and/or
radiation therapy with the innate defense system. Bacterial
infection of the ulcerative lesions is now regarded as a secondary
consequence of dysregulated local inflammation triggered by
therapy-induced cell death, rather than as the primary cause of the
lesions.
It is estimated, based upon review of historic published studies
and reports and an interpolation of data on the incidence of oral
mucositis, that oral mucositis in head and neck cancer is a
subpopulation of approximately 90,000 patients in the US, with a
comparable number in Europe. Oral mucositis almost always
occurs in patients with head and neck cancer treated with
chemoradiation therapy and is severe, causing inability to eat
and/or drink, in >80% of patients. It is common (40-100%
incidence) in patients undergoing high dose chemotherapy and
hematopoietic cell transplantation, where the incidence and
severity of oral mucositis depends greatly on the nature of the
conditioning regimen used for myeloablation.
Oral mucositis in head and neck cancer remains an area of unmet
medical need where there are currently no approved drug
therapies.
About SciClone Pharmaceuticals, Inc.
SciClone Pharmaceuticals is a revenue-generating, specialty
pharmaceutical company with a substantial commercial business in
China and a product portfolio
spanning major therapeutic markets including oncology, infectious
diseases and cardiovascular disorders. SciClone's proprietary
lead product, ZADAXIN® (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 an immune
system enhancer, according to the local regulatory approvals. The
Company has successfully in-licensed and commercialized products
with the potential to become future market leaders and to drive the
Company's long-term growth, including DC Bead®, a novel treatment
for liver cancer, now approved in China, and several other products in
late-stage development in China.
Through its promotion business with pharmaceutical partners,
SciClone also markets multiple branded products in China which are therapeutically
differentiated. SciClone is a publicly-held corporation based in
Foster City, California, and
trades on the NASDAQ Global Select Market under the symbol SCLN.
For additional information, please visit
http://www.sciclone.com/.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our BioTherapeutics business
segment is developing SGX301 as a first-in-class photodynamic
therapy utilizing safe visible light for the treatment of cutaneous
T-cell lymphoma, proprietary formulations of oral beclomethasone
17,21-dipropionate (BDP) for the prevention/treatment of
gastrointestinal (GI) disorders characterized by severe
inflammation including pediatric Crohn's disease (SGX203) and acute
radiation enteritis (SGX201), and our novel innate defense
regulator technology dusquetide (SGX942) for the treatment of oral
mucositis.
Our Vaccines/BioDefense business segment includes active
development programs for RiVax™, our ricin toxin vaccine
candidate, OrbeShield®, our GI acute radiation syndrome
therapeutic candidate and SGX943, our melioidosis therapeutic
candidate. The development of our vaccine programs incorporates the
use of our proprietary heat stabilization platform technology,
known as ThermoVax®. Currently, this business
segment is supported with up to $58
million in government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at http://www.soligenix.com/.
Soligenix Forward-Looking Statements
This press release may contain forward-looking statements that
reflect Soligenix, Inc.'s current expectations about its future
results, performance, prospects and opportunities, including but
not limited to, potential market sizes, patient populations and
clinical trial enrollment. Statements that are not historical
facts, such as "anticipates," "estimates," "believes," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"potential," or similar expressions, are forward-looking
statements. These statements are subject to a number of
risks, uncertainties and other factors that could cause actual
events or results in future periods to differ materially from what
is expressed in, or implied by, these statements. Soligenix
cannot assure you that it will be able to successfully develop,
achieve regulatory approval for or commercialize products based on
its technologies, particularly in light of the significant
uncertainty inherent in developing therapeutics and vaccines
against bioterror threats, conducting preclinical and clinical
trials of therapeutics and vaccines, obtaining regulatory approvals
and manufacturing therapeutics and vaccines, that product
development and commercialization efforts will not be reduced or
discontinued due to difficulties or delays in clinical trials or
due to lack of progress or positive results from research and
development efforts, that it will be able to successfully obtain
any further funding to support product development and
commercialization efforts, including grants and awards, maintain
its existing grants which are subject to performance requirements,
enter into any biodefense procurement contracts with the US
Government or other countries, that it will be able to compete with
larger and better financed competitors in the biotechnology
industry, that changes in health care practice, third party
reimbursement limitations and Federal and/or state health care
reform initiatives will not negatively affect its business, or that
the US Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. These and
other risk factors are described from time to time in filings with
the Securities and Exchange Commission, including, but not limited
to, Soligenix's reports on Forms 10-Q and 10-K. Unless
required by law, Soligenix assumes no obligation to update or
revise any forward-looking statements as a result of new
information or future events.
SciClone Forward-Looking Statements
This press release contains forward-looking statements regarding
the development of SGX942, the prospects for SGX942 in the
Territory and other matters. 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," "designed," "goal," "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 risks relating to the product development and clinical trial
process, including uncertainties regarding the time and costs
related thereto, and risks relating to performance by us and
by Soligenix of obligations under the agreement
with Soligenix, as well as well as risks and uncertainties
relating to the course, cost and outcome of regulatory matters,
including regulatory approvals and future pricing decisions by
authorities in China. 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.
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
other countries.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/soligenix-and-sciclone-establish-regional-licensing-agreement-for-sgx942-a-novel-product-candidate-for-oral-mucositis-300325787.html
SOURCE Soligenix, Inc.