San Diego, CA and Irvine, CA – May 13th, 2013– Sorrento Therapeutics, Inc. (“STI”; SRNE) and IGDRASOL announced today the acquisition of exclusive distribution rights from Samyang Biopharmaceuticals (“Samyang”), a South Korean corporation, to Cynviloq™ (marketed as Genexol-PM® in South Korea) in the 27 countries of European Union (EU). IGDRASOL had previously obtained the exclusive U.S. distribution rights to Cynviloq™ from Samyang, and with this agreement, Samyang again recognizes the ability of IGDRASOL’s management team to leverage its domain expertise in nanomedicine for the development and commercialization of Cynviloq™. STI has the right to acquire IGDRASOL pursuant to a previously-announced option agreement, entered into in March 2013.
Cynviloq™ is a next-generation, branded, micellar diblock copolymeric paclitaxel formulation currently approved and marketed in several countries, including South Korea for Metastatic Breast Cancer (MBC), Non-small cell lung cancer (NSCLC) and ovarian cancer. It has also completed Phase 2 studies for potential advancement into registration trials in the U.S. Preliminary data analysis from an ongoing MBC Phase 3 trial in South Korea has indicated a significantly improved overall response rate (ORR) for Cynviloq™ as compared to a solvent-based paclitaxel, a generic version of Taxol®. More comprehensive data analyses will be presented at future medical conferences.
“We look forward to potentially making this important drug, Cynviloq™, available to cancer patients who would greatly benefit from it – initially as an alternative to Abraxane® and potentially in the future as a treatment option for indications such as bladder and ovarian cancers” said Vuong Trieu, Ph.D., chief executive officer of IGDRASOL.
Cynviloq™ (or Genexol-PM®; a paclitaxel-loaded micellar diblock copolymer) is a next-generation branded paclitaxel formulation currently approved and on the market in several countries.
IGDRASOL’s lead therapeutic platform is Cynviloq™, a branded micellar paclitaxel formulation which is free of cremophor and human serum albumin (HSA), the excipients for Taxol® (cremophor-based paclitaxel) and albumin-bound paclitaxel (Abraxane®), respectively. Cynviloq™ combines the simplicity of manufacturing and preparation of Taxol® and potentially the albumin-mediated transport of paclitaxel. IGDRASOL intends to conduct registration trials for multiple cancer indications.
The executives of IGDRASOL are a group of pharmaceutical veterans who believe that personalized paclitaxel nanoparticle therapy will present a paradigm shift in the delivery of chemotherapeutic agents. To learn more about IGDRASOL’s mission, please visit its website (http://www.igdrasol.com).
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. (“STI”; SRNE) is a publicly-traded, development-stage biopharmaceutical company focused on the discovery, development and commercialization of novel and proprietary biotherapeutics for the treatment of a variety of disease conditions, including cancer, inflammation, metabolic and infectious diseases. STI’s objective is to identify drug development candidates derived from its proprietary human antibody libraries and, either independently or through partnerships, advance selected targets into preclinical or clinical development. In 2012, STI identified and further developed a number of potential drug product candidates across various therapeutic areas, and STI intends to select several lead product candidates to progress into preclinical development activities in 2013. More information is available at www.sorrentotherapeutics.com.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Forward-looking statements include statements about the clinical development and commercial potential for Cynviloq™ in the European Union as well as the U.S.; the domain expertise of IGDRASOL’s management; the potential combination of STI and IGDRASOL. All such forward-looking statements are based on STI’s current beliefs and expectations, and should not be regarded as a representation by STI that any of its plans will be achieved. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in STI’s and IGDRASOL’s businesses, including: whether STI will have sufficient cash and other resources to exercise the option and ultimately acquire IGDRASOL; the risk that delays in the regulatory approval or commercial launch of Cynviloq™ will enable competitors to further entrench existing products, or develop and bring new competing products to market before the approval, if any, of Cynviloq™; the scope and validity of patent protection for Cynviloq™ as well as STI’s and IGDRASOL’s platform technologies, and the risk that the development or commercialization of product candidates may infringe the intellectual property rights of others; the potential that STI and the combined company may require substantial additional funding in order to obtain regulatory approval for and commercialize Cynviloq™ or any other oncology products; and additional risks set forth in Sorrento Therapeutics’ filings with the Securities and Exchange Commission. These forward-looking statements represent Sorrento Therapeutics’ judgment as of the date of this release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and STI undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Genexol-PM® is a registered trademark of Samyang Corporation; Abraxane® is a registered trademark of Celgene Corporation, Inc.; Taxol® is a registered trademark of Bristol-Myers Squibb, Inc.
Mr. Jaisim Shah
Chief Business Officer
Sorrento Therapeutics, Inc.
T: + 1 (650) 996-2367