It's looking like it could be a bumpy day for Lipocine Inc. (NASDAQ:LPCN) following the specialty pharma saying early Wednesday morning that the U.S. Food and Drug Administration wouldn't approve its new drug application (NDA) for TLANDO, Lipocine's testosterone replacement therapy for men with hypogonadism.
The FDA issued the Salt Lake City-based company what is formally known as a Complete Response Letter, or "CRL," which identified deficiencies that the agency wants to see corrected before considering another review for possible commercialization of TLANDO, a novel oral prodrug of testosterone (T) containing testosterone undecanoate (TU).
Lipocine management said the CRL identified four problems in the NDA, all of which were within their expectations following a meeting with the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee in January.
In order to please the FDA, Lipocine needs to determinine the extent, if any, of ex vivo conversion of TU to T in serum blood collection tubes to confirm the reliability of T data; obtain definitive evidence pre-approval via an ambulatory blood pressure monitoring study as to whether TLANDO causes a clinically meaningful increase in blood pressure in hypogonadal men; verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and pre-specified Cmax secondary endpoints for TLANDO; and, determining the appropriate stopping criteria that can reproducibly and accurately identify those patients who should discontinue use of TLANDO.
In order to overcome these issues, Lipocine will seek a meeting with the FDA to dial-in a path forward. "We remain committed to work with the FDA to bring TLANDO to patients," said Dr. Mahesh Patel, a man who wears many hats at Lipocine, including president, CEO and chairman.
After falling off a precipice early in the year from around $3.50 per share to a low of $1.15 in February, shares of LPCN have been trying to recover some of the ground, including hitting $2.14 in Tuesday trading before closing the day at $1.78 (+13.4%). The stock is getting throttled Wednesday morning following the disappointing news, plunging 32.6% to $1.20 in pre-market activity.
