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.
AndroScience Corporation (www.androscience.com)
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 (OEP) of Taiwan (www.OEP.com.tw)
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.