Pipeline

Improving the Lives of Patients through Innovation

Research & Development

Our research and development team leverages its expertise across a variety of scientific disciplines to focus on identifying drug compounds for reformulation to achieve:

  • new therapeutic attributes (e.g., extended release)
  • new indications
  • bioequivalence

Our development pipeline is highlighted by two product candidates in Phase III clinical trials, arbaclofen ER, and RVL-1201, as well as multiple ANDAs pending regulatory approval and other products in various stages of development. Several of our pipeline products incorporate our proprietary Osmodex® drug delivery system.

Arbaclofen ER

Arbaclofen ER is an extended release formulation of arbaclofen, the R isomer of baclofen, that leverages our proprietary Osmodex® drug delivery system and is being studied for the treatment of spasticity resulting from multiple sclerosis.

In 2017, we initiated our second Phase III clinical trial to evaluate the efficacy of arbaclofen ER. We anticipate completing enrollment of the 510 patient trial by the end of 2018. We are also concurrently conducting a long term safety trial for arbaclofen ER.

RVL-1201

RVL-1201 is an oxymetazoline ophthalmic solution being studied for the treatment of acquired blepharoptosis, defined as the drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid.

Health care providers currently have limited options available to treat acquired blepharoptosis and, in the United States, the only approved treatment is blepharoplasty, a complex eye surgery. By contrast, RVL-1201, an eye drop administered once daily, is intended to be a simple non-invasive therapy. The drug is intended to activate the Mueller muscle at the back of the eye thereby lifting the upper eyelid 1 to 2 millimeters.

Grants Information

The mission of Osmotica's Grants and Contributions Office is to partner with the healthcare community to improve patient outcomes in areas of mutual interest through support of educational grants and investigator initiated studies (IIS).

A strong preference will be given to educational grants and IIS applications that address areas of strategic focus for the company in the fields of neurology and ophthalmology.

Interested parties may submit research ideas and educational needs by sending the completed Grants and IIS Submission Form to grants@osmotica.com.

Business Development

We seek to selectively acquire or in-license approved products and late-stage product candidates that complement our existing product portfolio, pipeline, technology or commercial infrastructure.

If you have an opportunity that you believe would be of interest to Osmotica, please contact our Business Development team at BD@osmotica.com.

Brian Markison, Chairman of the Board and Chief Executive Officer

Brian Markison has served as Chairman of the Board and Chief Executive Officer of Osmotica since 2016. Mr. Markison is a healthcare industry veteran, with more than 30 years of operational, marketing, commercial development and sales experience with international pharmaceutical companies. He has served as an advisor to Avista Capital Partners since September 2012. He previously served as the President, Chief Executive Officer and board member of Fougera Pharmaceuticals, Inc., a dermatology-focused specialty pharmaceutical company sold to Sandoz Ltd., the generics division of Novartis AG. Before leading Fougera, Mr. Markison was Chairman and Chief Executive Officer of King Pharmaceuticals, Inc., which he joined as Chief Operating Officer in March 2004. He was promoted to President and Chief Executive Officer later that year and elected Chairman in 2007. Prior to joining King Pharmaceuticals, Inc., Mr. Markison held various senior leadership positions at Bristol-Myers Squibb. He serves as Chairman of the Board of Lantheus Holdings, Inc. and is on the board of directors of Avista Healthcare Public Acquisition Corp., National Spine and Pain Centers, LLC and Braeburn Pharmaceuticals, Inc. He is also a Director of the College of New Jersey.

James Schaub, Executive Vice President and Chief Operating Officer

James Schaub has served as our Executive Vice President and Chief Operating Officer since 2016. Mr. Schaub previously served as Chief Operating Officer of Trigen Laboratories and as Vice President of M&A at Fougera Pharmaceuticals, Inc. He also held several commercial roles of increasing responsibility at King Pharmaceuticals, Inc. Mr. Schaub is a graduate of Middlebury College and holds an M.B.A. from Rutgers Business School.

Andrew Einhorn, Chief Financial Officer

Andrew Einhorn joined as Chief Financial Officer in September 2017. Mr. Einhorn has more than 15 years of experience in the pharmaceutical industry. Mr. Einhorn previously served as the Chief Financial Officer of Edge Therapeutics, Inc., a clinical-stage biotechnology company that he joined as Executive Vice President of Corporate Development in 2013. Prior to that, he was a co-founder, Executive Vice President and Chief Financial Officer at Oceana Therapeutics, Inc. Previously, Mr. Einhorn was a co-founder and Chief Financial Officer of both Esprit Pharma, Inc. and ESP Pharma, Inc. Mr. Einhorn is licensed as a Certified Public Accountant in the State of New Jersey and holds a B.S. in Finance and Accounting from American University.

Christopher Klein, General Counsel and Secretary

Christopher Klein has served as our General Counsel and Secretary since December 2013. Mr. Klein previously served as the General Counsel of Fougera Pharmaceuticals, Inc. and as Deputy General Counsel at King Pharmaceuticals, Inc. Mr. Klein spent six years in senior legal roles with Bristol-Myers Squibb Company. Mr. Klein holds a B.A. in Biology from Adelphi University, an M.A. in Education from Columbia University and a J.D. from Fordham University.

Tina deVries, Ph.D., Executive Vice President, Research and Development

Tina deVries, Ph.D. became our Executive Vice President, Research & Development in May 2016. Dr. deVries most recently served as the Principal of TM deVries Consulting, LLC. She was previously Vice President of Nonclinical and Clinical Pharmacology at Actavis plc following its 2013 acquisition of Warner Chilcott plc where she served as the Vice President of Clinical Pharmacology. Dr. deVries holds a B.S. in Pharmacy and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from The Ohio State University.

Lynn Palmer, Senior Vice President, Technical Operations

Lynn Palmer has served as our Senior Vice-President, Technical Operations since June 2017. Prior to that, he served as Vice-President, Manufacturing from February of 2016. Before Osmotica, Mr. Palmer served as Executive-Vice-President, Engineering at King Pharmaceuticals for six years. Previously Mr. Palmer led Engineering at Mallinckrodt Inc. (a division of Tyco Healthcare), and served as Vice-President, Production at Inbrand Corporation. Prior to Inbrand, he served in progressive manufacturing management roles at Kimberly-Clark Corporation from 1982-1996. Mr. Palmer holds a Bachelor of Applied Science in Paper Science and Engineering from Miami University.

Jarret Miller, Executive Vice President, Human Resources

Jarret Miller has served as our Executive Vice President, Human Resources since January 2016. Mr. Miller has more than 20 years of Human Resources experience in various roles of increasing responsibility. He previously served as the Head of Human Resources Operations and Services for the Americas at Teva Pharmaceuticals, Inc. Prior to that, he held the positions of Vice President, Human Resources at ConvaTec, Inc. and Senior Vice President, Human Resources at King Pharmaceuticals, Inc. Mr. Miller holds a B.S. in Statistics and Biometry from Cornell University.

David Burgstahler

David Burgstahler has been a director since 2016. Mr. Burgstahler is the President and Co-Managing Partner of Avista Capital Partners and is the Chief Executive Officer of Avista Healthcare Public Acquisition Corp. Mr. Burgstahler was a founding partner of Avista Capital Partners in 2005 and since 2009, has been President of Avista Capital Partners. Prior to forming Avista Capital Partners, Mr. Burgstahler was a partner of DLJ Merchant Banking Partners. Previously, Mr. Burgstahler worked at Andersen Consulting (now known as Accenture plc) and McDonnell Douglas (now known as The Boeing Company). Mr. Burgstahler currently serves as a director of Avista Healthcare Public Acquisition Corp., Inform Diagnostics, Inc., Kramer Laboratories, Inc., United BioSource Corporation and WideOpenWest, Inc. He is also a Trustee of the Trinity School in New York City. Mr. Burgstahler holds a B.S. in Aerospace Engineering from the University of Kansas and an M.B.A. from Harvard Business School.

Sriram Venkataraman

Sriram Venkataraman has been a director since 2016. He is a Partner of Avista Capital Partners, having joined in 2007. Prior to joining Avista Capital Partners, Mr. Venkataraman was a Vice President in the Healthcare Investment Banking group at Credit Suisse Group AG. Previously, he worked at GE Healthcare (formerly known as GE Medical Systems). He currently serves as a director of OptiNose, Inc., Inform Diagnostics, Inc. and National Spine & Pain Centers Holdings, LLC and previously served as a director of AngioDynamics, Inc., Lantheus Holdings, Inc. and Zest Anchors, Inc. Mr. Venkataraman holds an M.S. in Electrical Engineering from the University of Illinois, Urbana-Champaign and an M.B.A. from The Wharton School at the University of Pennsylvania.

Daniel Sielecki

Daniel Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki has worked at Laboratorios Phoenix S.A since 1975 and currently serves as a director of Simali S.A., Petroquımica Cuyo S.A and PEPCA S.A. He previously served as a director of Disprofarma S.A.

Carlos Sielecki

Carlos Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki currently serves as a director of Simali S.A. and holds a degree in architecture from the University of Buenos Aires.

Juan Vergez

Juan Vergez became a director in 2016. Mr. Vergez served as the President of Osmotica Argentina from November 2010 to May 2016, and as the New Business Director of Osmotica Argentina from May 2016 to December 2017. Mr. Vergez previously served as a director of Nutrifoods, S.A. and has more than 40 years of experience in the pharmaceutical industry.