Deal advances S1 Biopharma strategy for global commercialization of Lorexys.

NEW YORK, Dec. 8, 2015 /PRNewswire/ — S1 Biopharma, Inc. a leading developer of first-in-class drugs for the treatment of sexual dysfunction and hypoactive sexual desire disorder (HSDD) in both women and men, and CKD Pharmaceuticals, a leading pharmaceutical company in South Korea, today announced that they have entered into a commercialization agreement for Lorexys™, S1 Biopharma’s investigational therapy currently positioned to advance to a Phase 2b clinical trial for treatment of HSDD in women.

Under the terms of the agreement, CKD acquires rights to commercialize Lorexys throughout South Korea.  The terms include an upfront payment to S1 Biopharma and additional payments based on milestones as well as royalties on future product sales.  CKD also has right of first refusal for commercialization agreements related to additional potential indications for Lorexys.

“CKD is an ideal partner to help us rapidly maximize market entry and commercial opportunities for Lorexys pending regulatory approval, while this collaboration positions us to consider additional commercialization strategies in other global markets,” said Nick Sitchon, president and CEO of S1 Biopharma.  “We continue to be very encouraged by the levels of interest in the Lorexys program, and look forward to continuing to advance our global commercialization strategy in the months ahead.”

Lorexys is an oral, non-hormonal, fixed-dose therapy formulated to target HSDD in women, the most common type of female sexual dysfunction. It has a unique mechanism of action designed to restore the balance of three neurotransmitters – dopamine, serotonin and norepinephrine – that are known to regulate sexual inhibition and sexual excitation.  Lorexys has completed a Phase 2a clinical study that evaluated its safety, tolerability and pro-sexual efficacy as compared to bupropion, one of its constituent drugs.

“HSDD is an underserved market in South Korea due to lack of effective treatment options.  The promising clinical data related to Lorexys indicate that it could represent a significant advance in treatment for many women in the years ahead,” said Kim Young Joo, president of CKD.   “The combination of a promising therapy with CKD’s established presence and expertise in the South Korea market makes this a highly advantageous opportunity with major synergistic benefit potential for both companies.”

About S1 Biopharma, Inc.

S1 Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the treatment of sexual dysfunction in both women and men. The company’s development programs include first-in-class non-hormonal therapies designed to treat diminished sexual desire by restoring the natural balance of key neurotransmitters in the brain. The company’s lead product candidate, Lorexys, is currently positioned to advance to a Phase 2b clinical trial for the treatment of hypoactive sexual desire disorder (HSDD) in women. S1 Biopharma is evaluating partnerships, collaborations and out-licensing deals that will enable the company to rapidly advance its sexual dysfunction franchise as well as to accelerate the path to commercialization for its drug candidates in the U.S. and internationally. For more information, visit or follow S1 Biopharma on Facebook or Twitter (@s1biopharma).

About Chong Kun Dang Pharmaceutical Corp.

Founded in 1941, CKD is a fully integrated pharmaceutical company employing over 1,900 people. It is one of the leading local pharmas in Korea and through in-licensing and in-house R&D it has significantly contributed to improving health and quality of life of people mainly in Korea for more than 70 years. Domestically, it has a strong presence in cardiovascular and immunosuppressant health and has local offices established in Vietnam and Indonesia. As a leading pharma in Korea, CKD continues to strengthen its major therapeutic area through its R&D capability and by licensing-in innovative drugs from business partners worldwide. Recently, CKD has expanded its focus to include treatments that improve women’s health, including therapies for premenstrual syndrome (PMS) and menopause.

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