LPCN

Profile

Highlights

News

Pipeline

Chart

Management

Contacts

 

   
 
   
"LPCN 1107, is  potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA."

 

 
Approximate Financial Snapshot as of 6/19/17
Shares Outstanding 19.3M  
52 Wk Hi/Lo 7.78/

2.51

Market Cap $77M
Recent Price $4.02
 

 

 
 
   

 

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Lipocine (LPCN)

Website: www.Lipocine.com

"Developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies."


Profile

Lipocine (LPCN) Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. 

Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.  LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021 was well tolerated and met the primary efficacy end-points in Phase 3 testing with twice daily dosing.  LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed.


LPCN Investor Highlights

  • Product Development -  LPCN 1021 achieved primary endpoints confirming the efficacy of twice daily oral administration.
  • Innovation -  New Drug Application resubmission planned in the third quarter of 2017.
  • Progress: On April 24th Lipocine announced it had completed enrollment of the LPCN 1021 fixed dose trials.
  • Upcoming Milestones - Topline results from DV and DF studies for LPCN 1021 expected in June 2017.
  • Submission of LPCN 1107 Phase III protocol anticipated in 2Q:17.

Recent News and Press Releases

Lipocine (LPCN) Announces Submission Of SPA ON LPCN 1107, An Oral Alternative For The Prevention Of Preterm, Birth

Lipocine Validates “No Titration” Dosing Regimen With Positive Topline

Lipocine to Host Conference Call and Webcast to Discuss Top-Line Results From the Dosing Validation and Dosing Flexibility Studies of LPCN 1021

LPCN 1021 Readout in June; 1Q:17 R&D Costs Lower

Lipocine Announces Financial and Operational Results for the First Quarter 2017

For the latest Quote and News on LPCN Click Here.


Pipeline

LPCN 1021

LPCN 1021 is an oral testosterone replacement therapy product candidate containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN 1021 will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA "black box" warning related to inadvertent transfer of testosterone to others. Per the IMS Health database, an average of 540,000 prescriptions a month have been dispensed from January 2016 through December 2016 for testosterone products.

LPCN 1111

LPCN 1111 is a novel ester prodrug of testosterone which uses the Lip'ral technology to enhance solubility and improve systemic absorption. A Phase 1 single dose randomized, open label, crossover study in postmenopausal women has been completed and the pharmacokinetics suggested feasibility of once-daily dosing. Further, a Phase 2a study established once-daily dosing potential in hypogonadal men.

LPCN 1107

LPCN 1107 is an oral product candidate of 17-alpha hydroxyprogesterone caproate under development for the indication of prevention of recurrent preterm birth. LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.


Three Month Chart


Management

Mahesh V. Patel PH.D - Chairman, President and Chief Executive Officer

Dr. Mahesh V. Patel has more than 20 years of technology and product development experience in the area of drug discovery support, drug delivery and product line extensions. Prior to co-founding Lipocine in 1997, Dr. Patel led drug delivery research and development at Pharmacia and Upjohn in Kalamazoo, MI. He received his MS in Physical Pharmacy at the University of Cincinnati and his PhD in Pharmaceutics from the University of Utah. His areas of expertise include strategic planning, technology assessment/development, technical management and product research and development.

Morgan Brown - Executive Vice President and Chief Financial Officer

Mr. Morgan Brown has more than 20 years of finance and accounting experience with the last thirteen years servicing biotechnology, pharmaceutical, medical device and clinical research companies. Prior to joining Lipocine, Mr. Brown served in a similar capacity at Innovus Pharmaceuticals, Inc. (OTCBB: INNV), an emerging pharmaceuticals company, at World Heart Corporation (NASDAQ: WHRT), a medical device company, and Lifetree Clinical Research, a clinical research organization. During Mr. Brown's tenure at World Heart Corporation, he was involved in numerous financings in addition to the ultimate sale of World Heart Corporation to Heartware International Inc. (NASDAQ: HTWR). Previously he worked for NPS Pharmaceuticals Inc. (NASDAQ: NPSP), a biotechnology company where he served as Vice President Finance and Treasurer. During his tenure at NPS Pharmaceuticals, Inc., Mr. Brown was involved in numerous financings as well as merger and acquisition activities. Before NPS Pharmaceuticals, Inc., Mr. Brown worked for KPMG LLP in Salt Lake City for over seven years and managed multiple audit engagements, servicing private and publicly owned clients. Mr. Brown is a licensed certified public accountant in Utah. Mr. Brown earned a Master of Science degree in Business Administration from the University of Utah and a Bachelor of Science degree in Accounting from Utah State University.

Greg Bass - Excecutive Vice President and Chief Commercial Officer

Mr. Bass brings over 20 years of pharmaceutical and biotech sales, marketing, market access and operations experience to Lipocine. He has a proven track record of launching new products, improving operating performance and driving value across a broad range of therapeutic categories which includes men’s health. Most recently, he was Lipocine’s Vice President of Market Access. Prior to joining Lipocine, Mr. Bass served as the Vice President of Market Access at Merz. Previously, he held multiple senior leadership roles in marketing and market access over a 9 year period at Johnson & Johnson. Before Johnson & Johnson, Mr. Bass spent 7 years at Pfizer and held positions of increasing responsibility in sales and operations. He received his bachelor’s degree in Biology from Brandeis University in Waltham, MA.

Jykri Matilla - Exceutive Vice President and Chief Business Officer

Dr. Mattila brings over 25 years of business development, commercial and general management experience to Lipocine. Prior to joining Lipocine, Dr. Mattila served as CBO of iCeutica Operations Inc. and as President and CEO of LZ Therapeutics, Inc. Prior to these positions, Dr. Mattila was Executive Vice President of Business Development, Product Development and Technical Operations at Auxilium Pharmaceutical, Inc and President of Orion Pharma, where under his leadership several innovative products were developed, partnered and commercialized for global markets. Dr. Mattila has negotiated and closed over 50 business agreements, including licensing, co-marketing, collaboration and product acquisition arrangements. He received his M.D. and Ph.D. in Pharmacology from the University of Helsinki Medical School and an M.B.A. from the Helsinki School of Economics.


 

Contacts

Lipocine

675 Arapeen Drive
Suite 202
Salt Lake City, UT 84108

801-994-7383


 

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