Lipocine Inc. (NASDAQ: LPCN) and Antres Pharma Inc. have signed an exclusive licensing agreement for the commercialization of TLANDO in the US. TLANDO is a testosterone replacement therapy for treating adult males with conditions associated with endogenous testosterone deficiency or absence, such as hypogonadotropic hypogonadism or primary hypogonadism.
TLANDO has provisional approval in the US
TLANDO received provisional approval from the US FDA, as previously disclosed. The drug will be eligible for final approval once the exclusivity term given to Clarus Therapeutics, Inc. under the Hatch-Waxman Act with respect to its medicine, JATENZO®, expires on March 27, 2022. The agency has confirmed that the NDA resubmission for TLANDO’s final approval will be classified as a Class 1 resubmission, with a goal period of two months for FDA review.
According to agreement terms, Lipocine will receive an $11 million payment upfront, an additional $5 million licensing payment by January 2025, and another licensing payment of $5 million by January 2026. Also, the company will be entitled to sales-based milestone payments of up to $160 million based on net sales of TLANDO. Liposcine will retain TLAND rights for all ex-US jurisdictions and for non-TRT indications. On the other hand, Antres Pharma will be responsible for commercial and post-marketing roles in the US.
Lipocine bringing TLANDO for TRT in the US
Liipocine CEO and President Mahesh Patel said, “We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space. Our agreement with Antares Pharma demonstrates our commitment to ensure efficient and effective patient access to TLANDO in the U.S. We are confident in Antares Pharma’s capabilities, given its established marketing experience and demonstrated success in the TRT space. Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet need.”
