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FDA Finally Gives Tentative Approval To Lipocine's Oral Testosterone Replacement Therapy

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Lipocine Inc.'s (LPCN) Tlando, an oral testosterone product, which failed to get the FDA nod thrice, has finally passed muster. But there is a caveat.

The approval for Tlando is tentative and it will be eligible for final approval and marketing in the U.S. only when the exclusivity period previously granted to rival product Jatenzo, developed by Clarus Therapeutics, expires on March 27, 2022.

Lipocine is required by the FDA to conduct certain post-marketing studies to assess patient understanding of key risks relating to Tlando and evaluate development of adrenal insufficiency with chronic Tlando therapy.

What is Tlando indicated for?

Tlando is indicated for conditions associated with a deficiency or absence of endogenous testosterone - primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

What is hypogonadism?

Testosterone, often called the "fountain of youth", is the major sex hormone in men. The level of this hormone declines with age. The condition in which the body doesn't generate enough testosterone is known as hypogonadism or simply, Low T, and is associated with specific signs and symptoms, including diminished sex drive and sense of vitality, erectile dysfunction, mood disturbances, fatigue and osteoporosis.

Although hypogonadism is more common among men aged between 40 years and 79 years, it can also occur at any age, and that can be due to inherited conditions, disease, injury, drugs, and certain types of cancer.

Testosterone replacement therapy (TRT) is often recommended to provide and maintain a normal level of testosterone. TRT is available in several forms like skin patch, gels, mouth patch, injections and subcutaneous implants.

In March 2019, the FDA approved Clarus Therapeutics' Jatenzo, a new oral testosterone capsule for treatment of men who have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland. Jatenzo, the first new oral testosterone replacement product in over 60 years, has a 3-year market exclusivity granted by the FDA, which as mentioned above expires on March 27, 2022.

AbbVie's AndroGel; Eli Lilly's Axiron; Pfizer's Depo-Testosterone; Actavis' Androderm; Valeant Pharmaceuticals' Android; Auxilium Pharmaceuticals' Strian and Endo Pharmaceuticals' Fortesta are some of the other leading prescription testosterone drugs.

The global testosterone replacement therapy market, valued at $1.61 billion in 2018, is expected to expand at a CAGR of 4.4% from 2019 to 2027, according to a recent report compiled by Transparency Market Research.

Commenting on the FDA approval of Tlando, Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine, said, "We believe that TLANDO represents a differentiated TRT for treating hypogonadism in men, with the potential to both improve patient compliance and overcome inadvertent testosterone transference and pulmonary oil micro-embolism risks, effects often associated with existing non-oral treatments."

In a recent SEC filing, Lipocine had revealed that it is exploring the possibility of licensing Tlando to a third party should it receive approval, although no licensing agreement has been entered into by it yet.

H.C. Wainwright analyst Oren Livnat expects Tlando to achieve peak sales of over $275 million, with a potential to earn royalties of around $50 million for Lipocine.

Patent suit - What's the status?

Lipocine and Clarus are embroiled in a patent dispute since 2016.

In 2016, Clarus filed a patent suit against Lipocine in the U.S. District Court in Delaware alleging that LPCN-1021, now known as Tlando, infringes Clarus' '428 patent. The Court dismissed the lawsuit that year saying that there was no immediate reason to hear the case as Tlando was not approved then.

Last April, Lipocine hit back filing a suit against Clarus Therapeutics in the US District Court (Delaware) alleging that Clarus' Jatenzo infringes six of Lipocine's US patents - '858; '057; '690; '390; '463; and '988. In a bid to streamline the dispute, Lipocine, on February 11, 2020, voluntarily dismissed allegations of patent infringement for expired U.S. Patent Nos. '463 and '988. The Court has scheduled a five-day jury trial beginning on February 8, 2021.

Furthermore, in April of this year, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the Patent Trial and Appeal Board ("PTAB") canceling all the claims of the Clarus '428 Patent.

What's up next after Tlando?

The most-advanced product candidate in the pipeline now is LPCN 1144, an oral prodrug of bioidentical testosterone that is being developed as a treatment of non-alcoholic steatohepatitis (NASH).

LPCN 1144 is currently being studied in a phase II trial in confirmed pre-cirrhotic NASH subjects, dubbed LiFT.

Top-line results for change in liver fat data measured by MRI-PDFF (primary endpoint) are expected in January 2021 and 36-week biopsy and MRI-PDFF data are expected mid-2021.

The market opportunity for NASH is enormous and there are currently no approved therapeutic options yet. If all goes well as planned, Lipocine will also be a player in this multi-billion market.

Key Financial Metrics:

As of September 30, 2020, the company had an accumulated deficit of $167.5 million and cash balance of $18.8 million.

LPCN has traded in a range of $0.30 to $2.39 in the last 1 year. The stock closed Tuesday's trading at $1.68, down 0.59%.

With a couple of catalysts lined up, i.e., the LiFT primary endpoint results in January, the oral jury hearing in February and the biopsy data from the LiFT trial in July, it will be interesting to watch how Lipocine stock plays out in the coming months.

For comments and feedback contact: editorial@rttnews.com

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