Benzinga | Oct 18, 2021 07:12AM EDT

Antares Pharma Enters Into Exclusive License Agreement With Lipocine For TLANDO In U.S.; Lipocine Received An Upfront Payment Of $11M And Is Eligible For Additional Milestone Payments Up To $10M And Tiered Royalty And Commercial Milestones

Antares Pharma, Inc. (NASDAQ:ATRS) (the "Company"), a specialty pharmaceutical company, today announced that it entered into an exclusive license agreement with Lipocine Inc. ("Lipocine"), a clinical-stage biopharmaceutical company, for TLANDO(r) (testosterone undecanoate), an oral treatment for testosterone replacement therapy ("TRT") in the United States ("U.S.").

TLANDO(r) was granted tentative approval from the U.S. Food and Drug Administration ("FDA") as a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. In granting tentative approval, the FDA concluded that TLANDO(r) met all required efficacy, quality and safety standards necessary for approval and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. for JATENZO(r) on March 27, 2022.

Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, "Testosterone replacement therapy is a large and growing market, and we believe the expansion of our proprietary portfolio with TLANDO enhances our growth opportunities. Upon expiration of the JATENZO exclusivity period and anticipated final FDA approval, we are excited to be able to complement our current offering of XYOSTED with an oral formulation of testosterone to physicians and patients. Leveraging strong physician relationships, our commercial organization will continue to expand to help build upon the success we have already achieved with XYOSTED. Overall, TLANDO broadens our offerings in the TRT market to those patients seeking an oral dosage option and we look forward to the opportunity to accelerate our market share gains and revenue growth in the testosterone market."

"We believe physicians and patients prefer more than one therapy option and the addition of TLANDO highlights our commitment to the testosterone market. We expect to expand our commercial field organization and leverage our existing relationships with urologists, endocrinologists and primary care physicians in tandem with a strong clinical acumen of the testosterone market to support the anticipated U.S. launch of TLANDO. We believe our future growth will be supported by a larger commercial portfolio including TLANDO, XYOSTED and NOCDURNA," added Joseph Renda, Senior Vice President, Commercial of Antares Pharma.

Under the terms of the agreement, Lipocine received an upfront payment of $11.0 million and is eligible for additional milestone payments up to $10.0 million and tiered royalty and commercial milestones based on net sales of TLANDO(r) in the U.S.

The agreement also grants Antares the option to license and develop LPCN 1111 (TLANDO XR), an investigational product containing testosterone tridecanoate. Upon exercise of the option, Antares shall pay an additional $4.0 million in license fees in two installments. Antares shall also be responsible for additional development and commercial milestone payments as well as tiered royalties on net sales of TLANDO XR in the U.S.

TLANDO XR is a potential once daily oral testosterone product in development for the treatment of hypogonadism in adult males. Results of the Phase 2b study for TLANDO XR met its primary endpoints, including identifying the dose expected to be tested in a Phase 3 study. TLANDO XR was well tolerated with no drug-related severe or serious adverse events reported and the target Phase 3 dose also met its primary and secondary endpoints in the Phase 2b study. TLANDO XR is an investigational drug and has not been approved by the FDA.