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VIRPAX Pharmaceuticals

A company focused on the development and commercialization of late-stage transdermal and liposomal products with a main focus on the treatment of pain.

Presenter: Tony Mack MBA, Chairman and CEO

 

Monday, September 11, 2017

Embassy Suites, Chesterbrook, Pennsylvania (directions)

 

About

 

VIRPAX Pharmaceuticals Inc. is a privately held specialty pharmaceutical company focused on the development and commercialization of late-stage transdermal and liposomal products with a main focus on the treatment of pain. Virpax has the exclusive global rights to a proprietary patented delivery technology for use in developing a Diclofenac- based product candidate and is negotiating both for the right to apply this technology to a Lidocaine-based product candidate and to acquire the rights to a alternative delivery technology that it will use to develop a Bupivacaine-based product candidate. Virpax will utilize these delivery technologies (collectively, the “Technologies”) to selectively develop a portfolio of patented 505(b)(2) candidates with unique delivery systems for commercialization, partnering and out-licensing opportunities.

 

VIRPAX will enter the prescription analgesic/pain market with its lead product, DSF100, a novel NSAID topical spray film and, subject to obtaining the necessary rights, LSF60 a patented proprietary anesthetic topical spray film. Our pain franchise represents a $5+ Billion-dollar global (annual peak sales) opportunity. In 2015, more than 32 billion transdermal products were sold in the US. Pain made up 23% of the total transdermal market. VIRPAX seeks to obtain FDA approval for DFS100 for the treatment of acute musculoskeletal pain and, subject to obtaining the necessary rights, LSF60 for the management of Neuropathic pain. There are an estimated 100 million people affected by chronic pain annually. VIRPAX entered an agreement for the exclusive rights to the Spray Film Platform for use with its Diclofenac- based product candidate and plans to negotiate for the rights to apply this technology to range of additional product candidates to build a portfolio using this highly efficient transdermal film delivery system with non-opioid molecules for the treatment of low back pain, osteoarthritis, and other acute and chronic pain conditions as well as for other CNS (i.e. migraine) and inflammatory diseases. VIRPAX has executed a term sheet that provides it the exclusive right to negotiate an agreement for the rights to develop LBL100, a sustained-release 96-hour formulation of local anesthetic conjugate. LBL100 will compete with an FDA-approved liposomal bupivacaine for post-surgical analgesia.

 

 

3 Major Issues

 

  1. Our first product is a Topical Spray Film technology.  What would be the optimal regulatory strategy to implement to achieve the optimal value for the application and greatest probability of success?  What would be a potential cost and timing of such a program?
  2. Our second product candidate will use an injectable liposomal delivery technology for postoperative pain management.  Should we focus on our first program and dedicate our resources to meeting milestones or diversify the risk by expending resources to initiate this program?  Which strategy would be best received by Investors?
  3. VIRPAX has Global rights to all its product candidates.  One commercial strategy is to engage a Contract Sales Organization to launch the first product in the U.S. and seek a commercial partner for OUS.  Would it be better to seek commercial partners for global rights for restricted indications or first get approval in the U.S. and initiate sales then seek partnerships.  Is it even advisable for a start-up to consider a limited internal commercial launch?

 

Program:

 

6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Tony Mack MBA, Chairman and CEO, will deliver Greene Street's "Elevator" Pitch to the Group

8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests

 

 

Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.

 

Slides

None available at this time

Audio

None available at this time

Video

None available at this time

Webcast

None available at this time

 

Contact Info:

 

 

Our Sponsors

EisnerAmperGlaxoSmithKlineKEH Insurance Agency
New Jersey Institute of Technology
Science CenterWhite and Williams

 

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Questions or Coments?

Contact: Peter van der Kam,

peter@rxpcci.com | (610) 296-8086

 

 

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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