SALT LAKE CITY, December 8, 2020 / PRNewswire / – Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the US Food and Drug Administration (“FDA”) has granted interim approval to TLANDO, its testosterone product for testosterone replacement therapy (“TRT”) in adult men indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). By granting provisional approval, the FDA concluded that TLANDO has met all standards of quality, safety and efficacy required for approval, but TLANDO has not received final approval and is not eligible. for final approval and marketing in the United States until the expiration of the exclusivity. period previously granted to Clarus Therapeutics, Inc. regarding Jatenzo®, which expires on March 27, 2022. Lipocin is currently reviewing interim approval of TLANDO by the FDA and remains committed to taking the appropriate steps towards obtaining final approval to allow the launch of TLANDO. The FDA has also asked Lipocin to conduct certain post-marketing studies to (i) assess patients’ understanding of the main risks associated with TLANDO and (ii) assess the development of adrenal insufficiency with chronic treatment with TLANDO.
“We are delighted to have received this interim approval for TLANDO. The interim approval is supported by a strong clinical and CMC data set. This is an important step towards making our oral TRT option without titration available to patients. We are committed to working to obtain final approval from TLANDO, ”said Dr. Mahesh Patel, Chairman of the Board, President and CEO of Lipocine. Dr Patel added: “We believe that TLANDO represents a differentiated TRT for the treatment of hypogonadism in men, with the potential to improve both patient compliance and overcome the risks of accidental testosterone transfer. and pulmonary micro-oil embolism, effects often associated with existing non-oral risks. treatments. ”
Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocin’s clinical development pipeline includes LPCN 1144, TLANDO XR, LPCN 1148 and LPCN 1107. TLANDO, a new oral testosterone prodrug containing testosterone undecanoate, has received interim approval from the FDA for conditions associated with endogenous testosterone deficiency, also known as hypogonadism, in adult males. LPCN 1144, a bioidentical oral testosterone product, recently completed a proof-of-concept clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1144 is currently being investigated in a Phase 2 clinical study. TLANDO XR, a new oral testosterone prodrug, has been created and is under development by Lipocin as a next generation oral testosterone product with a potential administration once a day. In a phase 2 clinical evaluation, when administered once daily or twice daily, TLANDO XR met typical primary and secondary endpoints. LPCN 1148 is a targeted oral bioidentical testosterone prodrug for the treatment of cirrhosis. LPCN 1107 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm births and has received orphan drug designation by the FDA. For more information, please visit www.lipocine.com.
This press release contains “forward-looking statements” which are made in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements which are not historical facts regarding the timing and receipt of final approval of TLANDO, the expiration of the exclusive rights to third-party products, the timing of clinical trials and other studies, the regulatory approval process for our product candidates, the potential uses and benefits of our product candidates, and our efforts to product development. Investors are cautioned that all of such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not grant final approval for TLANDO, that the FDA will not approve any of our products, risks related to the exclusivity granted by the FDA to competing products, risks related to our products, expected product benefits do not materialize, clinical and regulatory expectations and plans do not materialize, new developments and regulatory requirements, risks associated with the FDA approval process, including receipt of regulatory approvals, clinical trial results and timing, patient acceptance of Lipocin products, manufacture and marketing of Lipocin products and other risks detailed in Lipocin’s filings with the SEC, including, without limitation, its Form 10-K and other reports ports on Forms 8-K and 10-Q, all of which can be obtained from the SEC’s website at www.sec.gov. Lipocine assumes no obligation to publicly update or revise any forward-looking statements contained in this press release, except as required by law.
SOURCE Lipocine Inc.