Document 6592034



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
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.
Pre IND meeting correspondence
Toxicity Study
Pilot PK Study
IND Submission
Pivotal PK Study
Heat Overlay Study
Irritation/Sensitization/Adhesion Study
NDA Submission
NDA Approval
Completed (April 2012)
Began May 2014
Began July 2014
Began July 2014
Began July 2014
Anticipated 4Q 2014
Anticipated 2H 2015
For more information visit
101 Lindenwood Drive, Suite 225, Malvern, PA 19355
P: 484.875.3032
F: 484.875.3182
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
[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

Similar documents