San Diego, CA and Fountain Valley, CA – March 7, 2013 – Sorrento Therapeutics, Inc. (“STI”; SRNE: OB) today announced that it has signed an exclusive option to acquire IGDRASOL, a private company focused on the development of oncologic agents for the treatment of metastatic breast cancer (MBC), non-small cell lung cancer (NSCLC) and other cancers. If the transaction is consummated, the combined company would form an oncology franchise of potential products with Phase 2 data for multiple solid tumor indications as well as two synergistic drug discovery and development platforms.
IGDRASOL’s lead compound, Cynviloq™, is a next-generation micellar diblock copolymeric paclitaxel formulation creating a stable, easy-to-administer injectable for effective delivery of drug into tumor tissues. Cynviloq™ is currently approved and marketed in several countries, including South Korea for MBC and NSCLC under the trade name Genexol-PM®, and has completed Phase 2 testing for potential advancement into registration trials in the U.S. IGDRASOL has the exclusive U.S. distribution rights to Genexol-PM® from Samyang Biopharmaceuticals, a South Korean corporation.
IGDRASOL is preparing for an “End of Phase 2” meeting with the U.S. Food & Drug Administration (FDA) regarding Cynviloq™ targeted for the first half of 2013. As a formulation of paclitaxel, Cynviloq™ is potentially eligible for approval via FDA’s 505(b)(2) bioequivalence regulatory pathway versus albumin-bound paclitaxel (Abraxane®) in its currently approved MBC and NSCLC indications. Abraxane® recently demonstrated overall survival benefit in a pivotal phase 3 study as a first line combination therapy with gemcitabine in advanced pancreatic cancer. Abraxane® sales exceeded $400 million in MBC in fiscal 2012, and are projected to achieve peak sales over $1.6 billion in the U.S. alone.
In the transaction, STI also acquires a tocopherol polyethelyene glycol succinate (TPGS)-based drug formulation technology, which could serve as a foundation for novel, next-generation, targeted therapeutics competitive against current antibody drug conjugates (ADC). Effective immediately, STI will assume responsibility for operating expenses related to development of these next-generation antibody-formulated drug conjugates (AfDC). The transaction will enable the combined team to leverage STI’s extensive human antibody G-MAB® libraries and preclinical antibody programs, including those targeting metabolic, autoimmune and infectious diseases, together with IGDRASOL’s expertise in drug formulation and drug development to deliver a strong pipeline of targeted tumor therapies.
The transaction includes separate option, services and merger agreements as well as an asset purchase agreement for a specific asset. Upon the exercise of Sorrento’s exclusive option evidenced by closing the agreed upon merger agreement, STI will issue 76,199,171 shares of its common stock, and upon the achievement of a specified regulatory milestone a payment of an additional 32,656,788 shares of common stock will be made.
“This transaction is transformational for STI, as early- and late-stage product candidates, technologies and development expertise combine to create an oncology franchise and pipeline with tremendous value potential. This transaction also reflects our commitment to improving the lives of cancer patients worldwide through innovative medicines discovered and developed both in-house and via external opportunities,” said Henry Ji, Ph.D., president & chief executive officer of STI. “In particular, Cynviloq™ provides us with a high-value asset that has near-term revenue potential in MBC and NSCLC, and longer-term revenue potential in pancreatic, ovarian, bladder and gastric cancers. These combined addressable markets represent more than 50% of cancer cases in the U.S. Importantly, STI’s overall business model recognizes the importance of collaboration and partnering with pharmaceutical and biotechnology companies to achieve its corporate objectives.”
Dr. Ji added: “We look forward to the opportunity to collaborate with key members of the team responsible for the creation, development and commercialization of the most successful branded paclitaxel formulation to date, Abraxane®. This includes Abraxis Biosciences veterans Dr. Vuong Trieu, Dr. Kouros Motamed, Dr. Larn Hwang, and George Uy, who will give STI an outstanding core competence for the development and commercialization of its in-house lead therapeutic programs.”
“We look forward to completing this transaction and becoming part of the STI family,” said Vuong Trieu, Ph.D., chief executive of IGDRASOL. “Our experienced development and commercial team is excited to combine efforts with STI to develop and introduce a new, franchise oncology product in Cynvoloq™ as well as a next-generation of targeted drug delivery technology for unmet medical needs in cancer. Through our patented formulation technology and STI’s G-MAB® fully human antibodies, the combined entity will be well positioned for long-term growth as a targeted therapeutics company.”
The option agreement has been approved by the boards of directors of both companies and is subject to certain undisclosed closing conditions.
Cynviloq™ (or IG-001; a paclitaxel-loaded micellar diblock copolymers) is a next-generation branded paclitaxel formulation currently approved and on the market in several countries as Genexol-PM®.
About Sorrento Therapeutics, Inc.
Sorrento Therapeutics, Inc. (STI) 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.
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 next-generation paclitaxel 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). CRT Capital Group acted as the financial advisor to IGDRASOL in this transaction.
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 potential combination of STI and IGDRASOL and the synergies and prospects for a combined enterprise going forward; and the clinical development and commercial potential of Cynviloq™. 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 potential that STI and the combined company may require substantial additional funding in order to obtain regulatory approval for and commercialize any oncology products; 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; 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, Inc. Taxol® is a registered trademark of Bristol-Myers Squibb, Inc.
Contact: Mr. Jaisim Shah
Chief Business Officer
Sorrento Therapeutics, Inc.
T: + 1 (650) 996-2367