Sorrento Therapeutics Signs Exclusive Option to Acquire IGDRASOL

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 cancers.
 
Sorrento
Sorrento
March 7, 2013 - PRLog -- 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.

About Cynviloq™

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.

About IGDRASOL

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 within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. These statements are based on management's current beliefs and expectations and our business is subject to numerous risks and uncertainties. Some of the risks include that we have a limited operating history and limited financial resources, that our product candidates have not completed clinical development and have not received and may not ever receive regulatory approval for commercialization. As a result of risks affecting our business, actual results or events could differ materially from the plans, projections and expectations set forth in our forward-looking statements, therefore, readers are cautioned not to place undue reliance on such forward-looking statements.  We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this presentation 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.

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Tags:Biotechnology, Paclitaxel, Cancer, Chemotherapy, Personalized Medicine, Nanotechnology, Point Of Use
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Subject:Mergers
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