On March 7, 2013 Sorrento Therapeutics reported 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 (Press release Sorrento Therapeutics, MAR 7, 2013, View Source [SID:1234500325]). 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.
The option agreement has been approved by the boards of directors of both companies and is subject to certain undisclosed closing conditions.
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