RODES Signs Exclusive Captisol® Licensing Agreement with Ligand Pharmaceuticals for Three Programs
PAOLI, Pa. & SAN DIEGO-- RODES, Inc. and Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announce the signing of exclusive global license and supply agreements for three Captisol-enabled™ (CE) programs. Under the terms of the agreements, for each program Ligand will be eligible to receive development and commercial milestone payments, revenue from the sales of Captisol®, and royalties of 8% to 11% on future net sales. RODES will be responsible for all costs related to the development and commercialization of the programs.
The three programs, described in more detail below, are:
- IM/IV CE Meloxicam for patients with acute pain, potentially delaying the use of opioids with associated risk of addiction
- IM/IV CE Fosphenytoin to benefit patients with seizures, expanding the market to room-temperature access in all settings
- IN CE Budesonide + Azelastine fixed-dose combination to improve convenience and outcomes for patients with allergic rhinitis
John Sedor, Chief Executive Officer and founder of RODES, commented, “We are delighted to report the establishment of our initial portfolio of three differentiated products. We believe these new formulations of medicines will enable physicians and providers to provide effective solutions to unmet needs of patients to improve their quality of life and clinical outcomes. We are looking forward to advancing these three programs.”
“We are very pleased to be partnering with RODES for these three Captisol programs. RODES executives have three decades of expertise with biologics and pharmaceuticals, and a track record of success in bringing development-stage programs through to commercialization to benefit patients and providers,” said John Higgins, Chief Executive Officer of Ligand. “This is another example of the importance of our Captisol formulation technology to potentially enable new and differentiated drugs.”
Kaufman, Hall & Associates, LLC is acting as financial advisor to RODES and Reed Smith LLP is acting as legal counsel for RODES.
About the RODES CE Programs
Captisol-enabled™ Meloxicam is an intravenous (IV) and intramuscular (IM) version of meloxicam specifically formulated to provide an option for hospital patients suffering from acute post-surgery, trauma and cancer pain following use of IV/IM NSAIDs and in place of or delaying use of IV/IM opioids, which put patients at risk for addiction, respiratory depression, sedation and constipation. Mobic (meloxicam) is currently only available in an oral formulation. Captisol-enabled™ Meloxicam is expected to benefit from the American Society of Anesthesiologists recommendations for a “multi-modal” approach to post-surgical pain. RODES is preparing for Phase I studies.
Captisol-enabled™ Fosphenytoin is an IV and IM compound specifically formulated for patients at risk for or to control status epilepticus seizures occurring during or following neurosurgery or neurologic trauma. Cerebyx (fosphenytoin) is currently indicated in these conditions, but requires refrigerated storage. Captisol-enabled™ Fosphenytoin holds potential for onsite dispensing in vials, syringes and pre-mixed bags in emergency rooms, intensive care units, first responder vehicles or aircraft, and serial seizures in long-term care facilities. The product has completed pivotal studies.
Captisol-enabled™ Budesonide + Azelastine is a fixed-dose combination of a corticosteroid and antihistamine in an intranasal (IN) formulation for the treatment of allergic rhinitis. Compared with sequential separate intranasal dosing of these patients with similar agents, Captisol-enabled™ Budesonide + Azelastine holds potential for improved compliance in once-daily and twice-daily dosing. RODES is preparing for Phase I studies in the United States following successful Phase II proof-of-concept studies in Canada.
Captisol is Ligand Pharmaceuticals’ patent-protected, chemically modified cyclodextrin that has a chemical structure that was specifically engineered to maximize administration safety while improving solubility, stability and bioavailability of active pharmaceutical ingredients (APIs).
Given the well-established contribution of Captisol to the stability and solubility of APIs, it has been an integral part of New Drug Approval submissions for a number of established global companies in the pharmaceutical industry. Captisol has enabled the development of life-saving medicines in a variety of therapy areas including antifungals, CNS disorders, cardiovascular, and oncology. Extensive preclinical and clinical safety studies have been performed relating to Captisol and indicate that it is safe when administered parenterally, orally and in other routes of administration, and that it does not exhibit toxicities commonly associated with other cyclodextrins. Ligand maintains a large safety database for Captisol within Type IV and V Drug Master Files submitted to the FDA that contain over 200 clinical and safety studies, which Ligand’s license partners can reference for their development efforts with new Captisol-enabled medicines. There are more than 45 Captisol-enabled products currently in development.
Captisol’s broad intellectual property estate includes issued patents in over 60 countries with a potential patent term to 2033.
For more information, visit www.captisol.com.
About RODES, Inc.
Led by 30-plus year healthcare industry veteran John Sedor, RODES identifies and acquires pharmaceuticals and biologics companies and assets and applies its team’s deep development, operational, manufacturing and commercialization expertise to create value for investors. With the transaction with Ligand, RODES now has three clinical stage compounds to establish its specialty pharmaceutical platform, allowing it to develop therapeutics to provide effective solutions to currently unmet needs of patients to improve their quality of life and clinical outcomes.
About Ligand Pharmaceuticals
Ligand Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines. Over its more than 25 year history, Ligand has employed research technologies such as nuclear receptor assays, high-throughput computer screening, formulation science and liver targeted prodrug technologies to assist companies in their work toward securing prescription drug approvals. Ligand currently has partnerships and license agreements with over 72 pharmaceutical and biotechnology companies, and over 125 different programs under license with Ligand are currently in various stages of development. Ligand has contributed novel research and technologies for approved medicines that treat cancer, osteoporosis, fungal infections, low blood platelets, among others. Ligand’s partners have programs currently in clinical development targeting seizure, coma, cancer, diabetes, cardiovascular disease, muscle wasting, liver disease, and kidney disease, among others. Ligand has over 500 issued patents worldwide, and over 300 currently pending patent applications.
Follow Ligand on Twitter @Ligand_LGND.
This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand’s judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: growth in the number of products in Ligand’s portfolio, the research and development expenditures of Ligand’s partners, including RODES, Ligand’s future revenues and other projected financial measures, and the timing and results of Ligand’s clinical trials and clinical trials to be conducted by Ligand’s partners, including RODES. Actual events or results may differ from Ligand’s expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on partnered products and research and development milestone payments. Ligand and its partners, including RODES, may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand’s partners will not terminate any of its agreements or development or commercialization of any of its products. Also, Ligand and its partners, including RODES, may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit the ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand’s or its partners’ product(s) could delay or prevent regulatory approval or commercialization. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand’s public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Source: Ligand Pharmaceuticals Incorporated
Released December 8, 2015