AndroScience Corporation
forms Strategic Alliance with Taiwan based Orient Europharma to Develop Novel
Topical Acne Therapeutic
San Diego, CA
May 20, 2010, AndroScience Corporation (ASC) announced today the forming of a
strategic partnership with Orient Europharma Co. Ltd. (OEP) of Taiwan. The
collaborative agreement centers on the clinical development and
commercialization of ASC’s lead therapeutic candidate, ASC- J9® as a
topical anti-acne product. Under
terms of the agreement OEP is responsible for clinical study
expenses related to an ASC-J9® phase IIb multi center trial in
acne vulgaris. Scheduled to commence in September 2010, the 180 patients,
double-blinded, placebo controlled efficacy study will be jointly conducted at
clinical sites in Taiwan and
the USA. Under this agreement OEP will secure rights to the ASC-J9®
acne product as the exclusive commercialization partner for the core
territories of Taiwan, Hong
Kong, S. Korea, New Zealand,
Australia,
and other select markets served by OEP throughout Asia Pacific. ASC will
support market approval of the ASC- J9® acne product in OEP
designated territories by providing new drug approval materials following
successful regulatory submission of the product in the US or Europe. Recently, ASC has
initiated active discussions with US and European based multinational
pharmaceutical companies to license the ASC-J9® acne product in
major global markets.
Charles
Shih, PhD President, CEO and Founder of ASC stated “We are very impressed with
OEP’s robust clinical development and drug commercialization expertise.
Aligning with OEP allows access to the capital resources necessary to complete
a critical milestone towards demonstrating ASC-J9® as a safe and
efficacious acne treatment. We
maintain that ASC has secured a favorable agreement with a partner focused on
long-term strategic goals for the ASC-J9® topical acne product.”
Acne and the Androgen
Receptor (AR) as a Therapeutic Target:
Acne
represents the most common skin disease, affecting 85% of teenagers, 42.5% of
men and 50.9% of women between the ages of 20 and 30 years. Androgen (male hormone) associated with
increased of acne development, and the role of hormones as a trigger of sebum
production, sebaceous growth and differentiation are well known. However,
despite the establishment of androgen activation pathways as an attractive
therapeutic target, a topical anti-androgen based therapeutic has never been
successfully developed. ASC has discovered and developed a series of active
compounds referred as androgen receptor (AR) degradation enhancers (ARD
enhancers). ARD enhancer exerts its
function through reduction of AR and androgen function in sebaceous glands,
which leads to the reduction of sebum secretion and the manifestation of acne.
The ASC-J9®
Acne Clinical Program:
Developed
as a cream formulation for use in both men and women, ASC-J9®
represents the first topical agent directed at modulating the effect of
androgens through the AR. In a previous
phase IIa clinical trial, ASC-J9® in cream formulation lowered
lesion counts in moderate to severe acne, with the highest dose group
demonstrating the largest percent reductions from baseline at week 12 in
inflammatory lesion count and total lesion count. No side effects have been
noted in either phase I or phase IIa clinical trials. Recently ASC completed a
new formulation of ASC-J9®, which significantly enhancing dermal
penetration to improve efficacy. Upon
completion of phase IIb study the ASC-J9® acne program will require
ASC partnering with a multinational pharmaceutical company to support future
large-scale clinical trials, regulatory approval process, and product launch in
the US or EU. Business development
professionals are directed to contact ASC or evaluate the ASC corporate website
for additional information on the acne program.
Founded
in 2000, AndroScience Corporation (ASC) is developing two novel small molecule
platforms based on the therapeutic targets of the androgen receptor (AR) and
select members of the Signal Transducer and Activator of Transcription (STAT)
signaling pathway. The first patented family of compounds function through the
enhancing degradation of AR protein, a novel mechanism of action described as
AR degradation enhancers (ARD enhancers). This pipeline of drug candidates for
the androgen-related disorders includes clinical stage dermal programs in acne
and alopecia and preclinical programs in prostate cancer, liver cancer and
bladder cancer; as well as spinal bulbar muscular atrophy (Kennedy’s Disease). The second major drug development program is
based on a family of novel small molecules that function as STAT 3 and 5
transcription factors’ inhibitor.
Initiated in 2009, preclinical proof of concept data (both in vitro and
in vivo) has been obtained and efforts are underway to develop lead drug
candidates in the oncology setting for breast cancer, pancreatic cancer, colon
cancer, glioblastoma, and other metastatic disease. Additional applications in
treating immune mediated disorders are also under development using STAT 3 and
5 inhibitor drug candidates.
Orient
Europharma Co. Ltd., (OEP, Taiwan OTC : 4120) is an international publicly
traded pharmaceutical and nutritional company based in Taipei, Taiwan.
OEP specializes in research and marketing of innovative, niche-oriented
pharmaceuticals, with a strong franchise in oncology, nutritional and food
supplements, dermal-cosmetics and consumer healthcare products. OEP has a well
established marketing base in numerous Asia-Pacific countries with subsidiaries
in Singapore, Malaysia, Hong Kong, and Philippines,
being poised for significant growth.