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5	5	= Overview =
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7		-Lipocine is a specialty pharmaceutical company focused on applying its oral drug delivery technology for the development of pharmaceutical products in the area of men’s and women’s health. The company's proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. The company's primary development programs are based on oral delivery solutions for poorly bioavailable drugs. Lipocine has a portfolio of proprietary product candidates designed to produce favorable pharmacokinetic (“PK”) characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability. The company's lead product candidate, TLANDO™, is an oral testosterone replacement therapy (“TRT”) and is currently under review by the United States Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (“PDUFA”) action goal date of May 8, 2018. The FDA has deemed the resubmission a complete response to its June 2016 Complete Response Letter (“CRL”) that requested additional information related to the dosing algorithm for the proposed label. The TLANDO New Drug Application (“NDA”) is based on the results of the Dosing Validation (“DV”) study. The DV study confirmed the efficacy of TLANDO with a fixed dose regimen without need for dose adjustment. TLANDO was well tolerated upon 52-week exposure with no reports of drug related Serious Adverse Events (“SAEs”). On January 10, 2018, the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the FDA voted six in favor and thirteen against the acceptability of the overall benefit/risk profile to support approval of TLANDO as a TRT. The company continue to work with the FDA in addressing topics discussed by BRUDAC. The company may receive another CRL. This would cause delays and added expense to the process of seeking approval of TLANDO. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with the potential for once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth and has completed an End-of-Phase 2 meeting with the FDA.
	7	+Lipocine (LPCN) is a specialty pharmaceutical company focused on applying its oral drug delivery technology for the development of pharmaceutical products in the area of men’s and women’s health. The company's proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. The company's primary development programs are based on oral delivery solutions for poorly bioavailable drugs. Lipocine has a portfolio of proprietary product candidates designed to produce favorable pharmacokinetic (“PK”) characteristics and facilitate lower dosing requirements, bypass first-pass metabolism in certain cases, reduce side effects, and eliminate gastrointestinal interactions that limit bioavailability. The company's lead product candidate, TLANDO™, is an oral testosterone replacement therapy (“TRT”) and is currently under review by the United States Food and Drug Administration (“FDA”) with a Prescription Drug User Fee Act (“PDUFA”) action goal date of May 8, 2018. The FDA has deemed the resubmission a complete response to its June 2016 Complete Response Letter (“CRL”) that requested additional information related to the dosing algorithm for the proposed label. The TLANDO New Drug Application (“NDA”) is based on the results of the Dosing Validation (“DV”) study. The DV study confirmed the efficacy of TLANDO with a fixed dose regimen without need for dose adjustment. TLANDO was well tolerated upon 52-week exposure with no reports of drug related Serious Adverse Events (“SAEs”). On January 10, 2018, the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the FDA voted six in favor and thirteen against the acceptability of the overall benefit/risk profile to support approval of TLANDO as a TRT. The company continue to work with the FDA in addressing topics discussed by BRUDAC. The company may receive another CRL. This would cause delays and added expense to the process of seeking approval of TLANDO. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product with the potential for once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth and has completed an End-of-Phase 2 meeting with the FDA.{{footnote}}https://fintel.io/doc/sec-lpcn-lipocine-10k-2018-march-12-17944{{/footnote}}
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9	9	= Industry =
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189	189	The company expect to file new patent applications in the future in an attempt to further cover to various aspects of its products and product development.
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191	191	= References =
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