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(Press release, Advanced Proteome Therapeutics, MAR 14, 2013, View Source [SID:1234505240])

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Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled® Melphalan

On March 14, 2014 Spectrum Pharmaceuticals reported that the company has gained global development and commercialization rights to Ligand Pharmaceuticals’ Captisol-enabled, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma (Press release, Spectrum Pharmaceuticals, MAR 14, 2013, View Source [SID:1234502924]).

Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.

"We are pleased to add this late-stage program to our portfolio, which includes belinostat, for which we anticipate an NDA filing mid-year, and apaziquone, for which we expect to file an NDA in 2014," stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. "Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. The Captisol technology may allow longer duration of administration and slower infusion rates, potentially enabling a higher dose intensity of pre-transplant chemotherapy to optimize efficacy. We look forward to rapid progress of the program."

"We are pleased to have forged this agreement," commented John Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "Spectrum has an established oncology and hematology business, and this melphalan product is an ideal complement to their two commercial hematology products, ZEVALIN and FOLOTYN, including an expected high degree of commercial call overlap. Spectrum’s highly experienced, oncology-focused R&D team is committed to the efficient development of Captisol-enabled melphalan, and has established relationships with key investigators."

BioInvent signs deal with Bayer HealthCare for the discovery and development of therapeutic antibodies

On March 12, 2008 BioInvent reported that it has signed a deal with Bayer HealthCare related to the discovery and development of antibody products. Under the terms of the agreement, Bayer HealthCare will have a non-exclusive research licence for the use of BioInvent’s proprietary n-CoDeR library for the discovery of human monoclonal antibodies (Press release BioInvent, MAR 12, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=337691 [SID:1234500559]). BioInvent, in addition to its n-CoDeR technology, will provide at BioInvent access to an extended antibody technology suite including BioInvent’s proprietary selection processes, streamlined robotics and Immunoglobulin transient expression technology. Bayer HealthCare will fund all such activities.
As well as undisclosed license fees, BioInvent will receive additional milestone payments and escalating royalties on sales of any products commercialised. The agreement allows for up to 14 antibody products to be developed.
The n-CoDeR library contains approximately 2 x 1010 highly diverse fully human antibody fragments that have been created using BioInvent’s patented approach, generating antibodies with good affinities and selectivities.

(Press release, , MAR 11, 2013, View Source [SID:1234504106])

Sorrento Therapeutics Signs Exclusive Option to Acquire IGDRASOL

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.