San Diego, CA – February 10, 2014 – Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), a late-stage clinical oncology company developing new treatments for cancer and associated pain, announced today the Company has obtained exclusive rights to Cynviloq™ (marketed as Genexol-PM® in South Korea and other countries) in Australia, Canada and Mexico from Samyang Biopharmaceuticals (“Samyang”), a South Korean corporation. Sorrento already has exclusive rights from Samyang for Cynviloq in the U.S. and the 27 countries of the European Union.
“We have made significant progress carving out the clinical and regulatory path for the Cynviloq program, and we continue to build on the global commercial opportunity for this product,” said Henry Ji, Ph.D., President and Chief Executive Officer of Sorrento. “With these expanded rights, Sorrento now covers the vast majority of its targeted Cynviloq markets”.
Cynviloq (IG-001; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation for the potential treatment of metastatic breast cancer, non-small cell lung cancer, pancreatic cancer, and other solid tumors. In July 2013, the FDA Division of Oncology Products 1 agreed that the data available are supportive for a 505(b)(2) pathway, using Abraxane® and Taxol® as the Reference Listed Drugs, to pursue approval. Sorrento anticipates initiating a single Bioequivalence trial required for registration, in the first quarter of 2014.
About Sorrento Therapeutics
Sorrento is an oncology company developing new treatments for cancer and associated pain. Sorrento’s most advanced asset Cynviloq, the next-generation paclitaxel, will commence its registrational trial and be developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the National Institutes of Health to treat terminal cancer patients suffering from intractable pain. The Company has made significant advances in developing human monoclonal antibodies, complemented by a comprehensive and fully integrated Antibody Drug Conjugate (ADC) platform that includes proprietary conjugation chemistries, linkers, and toxic payloads. Sorrento’s strategy is to enable a multi-pronged approach to combating cancer with small molecules, therapeutic antibodies, and ADCs.
More information is available at www.sorrentotherapeutics.com.
This press release contains forward-looking statements under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the potential for products to be successfully developed using proprietary technologies; the synergies and prospects for a combined enterprise going forward, including the retention of key personnel; and the clinical development and commercial potential of conjugated antibodies that may be developed based on recently acquired technologies; the potential for claims from third parties regarding the use of the ADCs and related technology that may be developed; the costs and expenses associated with additional clinical development programs from successful product development efforts, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2012, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.
Genexol-PM® is a registered trademark of Samyang Corporation; Abraxane® is a registered trademark of Celgene, Inc; Taxol® is a registered trademark of Bristol-Myers Squibb, Inc.
Mr. Amar Singh
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Mr. Ian Stone
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