Document 6592034
Transcription
Document 6592034
SCILEX Pharmaceuticals is a U.S. specialty pharmaceutical company committed to developing and commercializing pharmaceutical products for the treatment of pain. We use our network of global relationships to acquire high barrier-to-entry, late-stage products where we have proven expertise. Our flagship product ZTlido™ (lidocaine patch 1.8%) (Pronounced Zee’ tee’ lie’ doe) is a single layered analgesic tape. ZTlido is currently in clinical studies for post-herpetic neuralgia (PHN), or pain associated with the shingles virus. A billion dollar market opportunity has been created by the near-term patent expiry of the Lidoderm® (lidocaine patch 5%). This hydrogel patch has had rapid market acceptance since launching in 1999 for PHN. We believe that ZTlido’s potential differentiated attributes, which include its pliability, lack of water content and lower active pharmaceutical ingredient, will allow it to compete effectively against Lidoderm and its generic equivalents. The Company’s vision is to become a world-class, global pharmaceutical company that delivers the next generation of innovative products. Senior Leadership Anthony Mack, M.B.A. Co-Founder and Chief Executive Officer. Experienced pharmaceutical executive behind the successful commercialization of leading pain products. William Pedranti, J.D., Co-Founder and Chief Operating Officer. Senior executive and legal counsel for pharmaceutical and biotech companies who has helped launch commercial products and raise over $200 million through financial transactions. View the complete list of team members [clickable link]. De-risked Regulatory Path, Low Development Cost with Projected 2015 Launch. In pre-IND discussions, the FDA Division of Anesthesia and Analgesia Products agreed to a 505(b)(2) regulatory pathway to obtain market approval. To file a NDA (New Drug Application), we will complete one confirmatory pivotal pharmacokinetic study as well as several dermal safety studies. All studies have been initiated and we expect to have all studies completed in the fourth quarter of 2014. Approval and launch is anticipated in H2, 2015. CORPORATE TIMELINE Milestones Status Pre IND meeting correspondence Toxicity Study Pilot PK Study IND Submission Pivotal PK Study Photoallergy/Phototoxicity Heat Overlay Study Irritation/Sensitization/Adhesion Study NDA Submission NDA Approval Completed (April 2012) Completed Completed Completed Began May 2014 Began July 2014 Began July 2014 Began July 2014 Anticipated 4Q 2014 Anticipated 2H 2015 For more information visit www.scilexpharma.com 101 Lindenwood Drive, Suite 225, Malvern, PA 19355 P: 484.875.3032 F: 484.875.3182 www.scilexpharma.com Certain statements in this document are forward-looking statements regarding future events and the future performance of SCILEX Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. SCILEX does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. ZTlido™ is a trademark owned by SCILEX Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners. A proprietary name review by the FDA is planned. For more information contact: SCILEX Pharmaceuticals, Inc. William Pedranti 484.875.3032 [email protected] © 2014 SCILEX Pharmaceuticals, Inc. All Rights Reserved 101 Lindenwood Drive, Suite 225, Malvern, PA 19355 P: 484.875.3032 F: 484.875.3182 www.scilexpharma.com