Lipocine Inc. (LPCN) stock prices were up by 8,8496% around the time market trading commenced on October 18th 2021. This brought the price per share up to USD$1.23 early on in the trading day.
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Partnership with Antares Pharma
October 18th 2021 saw LPCN stock announce having entered into an exclusive licensing agreement with Antares Pharma, Inc. The agreement is in regard to the commercialization of TLANDO in the United States. TLANDO is an oral testosterone product for testosterone replacement therapy (TRT) in adult males. The treatment is indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). The company’s proprietary TLANDO treatment has been granted tentative approval by the U.S Food and Drug Administration, as previous announced.
Details of the Collaboration
Following the expiration of the exclusivity period granted to Clarus Therapeutics and its proprietary JATENZO drug, under the Hatch-Waxman Act, TLANDO will be eligible for final approval. Clarus Therapeutic’s JATENZO drug’s exclusivity period will expire on March 27th 2022. The U.S FDA has affirmed the resubmission of a New Drug Application resubmission for the final approvement of TLANDO. It will be a Class 1 resubmission, which includes a two month review goal period by the FDA. As per the agreement, LPCN stock is set to receive an immediate upfront cash repayment of USD$11 million. An additional USD$5 million will be granted, subject to various conditions, in January of 2025. Another USD$5 million licensing payment will be due in January 2026.
LPCN Stock’s Compensation
LPCN stock will also be entitled to receive sales based commercial milestone payments over the course of the upcoming years. These will total up USD$160 million and will be contingent upon net sales of TLANDO, as well as TLANDO XR sales if Antares Pharma exercises its option. This is an addition to tiered royalty payments at rates that will range from the mid teens to up to 20% on net sales of the TLANDO treatment.
Future Outlook for LPCN Stock
LPCN stock is keen to push for the accelerated commercialization of its proprietary TLANDO treatment in the US. The company is poised to capitalize on the expanded scope of opportunities afforded to it as a result of these efforts. Current and potential investors are confident in management’s ability to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value.