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S1 Biopharma, Inc., and CKD Pharmaceuticals 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 hypoactive sexual desire disorder (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.”

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