Cydex Pharmaceuticals, Inc.
Ligand acquired CyDex Pharmaceuticals, Inc. on January 26th, 2011 and operates CyDex as a wholly-owned subsidiary of Ligand. CyDex is a specialty pharmaceutical company based in Lenexa, KS. and owns the powerful Captisol drug formulation technology platform. Captisol is currently incorporated in five FDA-approved medications and marketed by three of the company's licensees: Pfizer, Bristol-Myers Squibb and Prism Pharmaceuticals. In addition, the company is supporting drug development efforts with more than 40 other companies worldwide. The company maintains patents in the U.S. and worldwide for its Captisol technology, Captisol manufacturing and Captisol-enabled products, as well as a comprehensive Captisol Drug Master Files (DMF) that is used by partners when filing for regulatory approval with regulatory agencies.
Cydex Brings the Following into Ligand:
Significant Annual Revenue - CyDex currently generates annual revenue from royalties from five marketed drugs, material sales from the selling of Captisol, and license and milestone payments.
Onyx Collaboration - CyDex and Onyx Pharmaceuticals entered into a collaboration in 2005 (originally with Proteolix) to develop the Captisol-enabled IV formulation of Carfilzomib for refractory multiple myeloma. Onyx has recently reported positive Phase II data for this program, patent protected through 2027, and plans to file an NDA in 2011 with the FDA. CyDex is eligible to receive milestones, royalties and Captisol material sales revenue from this program.
Baxter Collaboration - Prism announced in April 2011 that it entered into a definitive agreement to be acquired by Baxter Inc. Prism Pharmaceuticals received marketing approval from the FDA for the Captisol-enabled IV form of amiodarone, marketed as Nexterone. Prism plans to launch Nexterone in the near-term. Nexterone was developed by CyDex and licensed to Prism in 2007. CyDex is eligible to receive milestones, royalties, and Captisol material sales revenue from this program.
Large Pharma Captisol-Supply Relationships - CyDex currently has multiple material sales collaborations with undisclosed large pharmaceutical companies. These collaborations have Captisol-enabled drugs in clinical development and CyDex anticipates selling Captisol to these partners in the coming years for clinical and commercial use.
Industry Recognized Captisol Technology Brand - Captisol is recognized in the pharmaceutical industry as a powerful answer to the solubility challenges frequently faced by drug-development companies. CyDex' success is primarily based on solving drug formulation problems, particularly in the area of IV and topical formulations. CyDex has also developed an extensive Drug Master File (DMF) to which its partners can refer when filing with regulatory agencies around the world, adding significant value to the Captisol brand.
Internal Pipeline of Captisol-Enabled Drugs - CyDex is currently developing two proprietary Captisol-enabled drugs for future potential licensing:
1) Melphalan IV (Captisol-enabled IV Alkeran) -Phase II for stem cell conditioning
2) Topiramate IV (Captisol-enabled IV Topamax) -Preclinical for seizures
What Is Captisol®?
Captisol is the trade name for modified β-cyclodextrin known as SBE-CD, a ring shaped sugar based molecule. Captisol has an excellent safety profile and superior drug carrier properties. Captisol cyclodextrins are a patent protected, specifically modified family of cyclodextrins designed to improve solubility, stability, bioavailability, safety and dosing of APIs. Following administration, the API separates from the Captisol molecule in the bloodstream and is delivered to the site of action. The Captisol molecule, which is inert, is then eliminated from the body.
Captisol primarily targets the multi-billion dollar solubility segment of the global drug delivery market. Captisol’s superior safety and excellent drug carrier properties make it the gold standard solubility solution. The Captisol Technology is outlicensed to third parties, such as Pfizer, Bristol-Myers Squib (“BMS”) and Onyx, while providing access to its Drug Master File (“DMF”), for use in product development. Additionally, the Company develops its own proprietary pipeline of Captisol-Enabled products targeting selected established markets. The Company has developed a broad portfolio of six product candidates utilizing its patented drug formulation technology and proprietary DMF.
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