Foamix Ltd. and BioMAS Ltd., announced today that the two companies will jointly develop an innovative product for the topical treatment of human papillomavirus (HPV). The product will be based on BioMAS’ proprietary organotellurium drug, AS101.
According to this agreement, Foamix will develop the topical formulations of AS101; and BioMAS will be responsible for the definitive development of the product. Additional terms were not disclosed.
Genital warts, also termed condyloma, are one of the most common sexually transmitted diseases, caused by HPV. Warts appear externally on the genitalia, in the anal area, internally in the upper vagina or cervix, and in the male urethra. Approximately 20 million Americans are currently reported as infected with HPV, and about half a million people become newly infected every year. However, it is estimated that the actual prevalence is even higher. There is currently no satisfactory cure for HPV infection, and current treatments of the lesions and warts include cryosurgery, electrosurgical excision procedure, and conventional surgery. All these suffer from limited efficacy and extremely high rate of recurrence. Topical drugs, such as Imiquimod (Aldara) are partially effective and they are known for their frequent side effects, including burning sensation, pain, inflammation, itching and erosion of the affected area.
Exploratory clinical trials, conducted by BioMAS, have shown that AS101 can be effective in the treatment of condyloma, with minimal side effects and extremely low rate of recurrence, if any. The current project is aimed to develop a final topical formulation of AS101, which will be tested in definitive Phase II and III clinical trials.
Dr. Tami Bar, CEO & President of BioMAS said, "We are very pleased to enter into this partnership with Foamix, which already has a proven track record of successfully marrying their proprietary and innovative topical delivery systems with dermatological and gynecological medications. Together we will develop a cutting-edge medicine to fill an unmet market need for an easy-to-use, effective and none-recurrent treatment for genital warts. Our collaboration with Foamix is an additional step to promote our AS101 towards advanced clinical trials”
"We are delighted to expand our project base in the gynecological field, and to provide an innovative medication to this pharmaceutical sector, together with BioMAS", said Foamix CEO Dr. Dov Tamarkin. "This partnership is a further example of our focused strategy of establishing development collaborations with pharmaceutical companies, side-by-side with our in-house product development”, he noted.
Headquartered in Rehovot, Israel, Foamix Ltd (foamix.co.il) is a clinical-stage, privately held specialty pharmaceutical company, focused on the development of proprietary topical foam and OilGel™ products for prescription, OTC and cosmetic applications. By incorporating drugs in foam and OilGel™, Foamix creates advanced, patent protected products with improved convenience, higher compliance and better efficacy. The company’s development capabilities range from initial development of the formulations to scale-up, GMP manufacturing, preclinical and clinical studies.
Foamix partners with leading pharmaceutical companies, including Intendis (Bayer’s dermatology company), Dr. Reddy's and Ferndale Laboratories.
Foamix further has an extensive in-house pipeline of dermatological and gynecological drugs. The Company’s lead product, Topical Minocycline, is currently in Phase II clinical studies in Rosacea, Impetigo and Acne patients. Topical Minocycline has further applications in the fields of ophthalmic therapy and gynecology.
To date, Foamix has 9 issued patents in the United States, covering its foam and OilGel™ technology platforms. The company has an additional 150 patents and applications worldwide, of which more than 50 applications are filed in the U.S.
Contact: Dov Tamarkin, CEO, Foamix Ltd E: dov[.]foamix.co.il.
BioMAS, a private entity established in 2000, is focusing on the development of small organic tellurium-based compounds. With its leading compound AS101,BioMAS targets its developments to various diseases and disorders.
AS101 was approved for clinical trials by the competent authorities in the US (under two FDA approved INDs), Israel, France, and other countries. Hitherto, the AS101 was applied on hundreds of patients, treated by intravenous or topical administration modes.
BioMAS enjoys the benefit of the results from its drugs development studies, which evidenced the non-toxicity and safety profile for its AS101 lead molecule, allowing relatively quick launch of clinical trials.
BioMAS has invested significant effort and expenses in creating a wide IP protection, and such portfolio that is compatible with its business strategy of maximizing the value of its compounds by out-licensing indications, or clusters of indications for each compound.