Third Quarter and Recent Partner Highlights
- Ligand announced that it will receive a $2 million milestone payment from Merck, known as MSD outside the United States and Canada, under the terms of a development and license collaboration for the development of dinaciclib. This milestone payment is triggered by Merck’s initiation of a Phase 2b/3 adaptive clinical trial for dinaciclib for the treatment of patients with refractory chronic lymphocytic leukemia.
- Captisol licensee Onyx Pharmaceuticals announced that Kyprolis ™ (carfilzomib) for injection began shipping to wholesale outlets in July. Onyx previously announced receipt of accelerated approval from the U.S. Food and Drug Administration (FDA) for Kyprolis. Kyprolis is formulated with Ligand’s Captisol and is used for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
- Ligand partner Rib-X presented positive data from its completed Phase 2b study of Captisol-enabled delafloxacin in patients with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin- and quinolone- resistant Staphylococcus aureus, at the 52 nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September. Rib-X also announced that the FDA designated Captisol-enabled delafloxacin as a Qualified Infections Disease Product for ABSSSI and community-acquired bacterial pneumonia.
- Ligand entered into a Captisol license and supply agreement with MEI Pharma, Inc. for use with MEI’s two lead isovlavone-based drug compounds. Ligand received an upfront payment and will be eligible to receive milestone payments and low, single-digit royalties on net sales.
- Ligand presented data on its HepDirect technology program in September at The European Federation for Medicinal Chemistry 22 nd International Symposium on Medicinal Chemistry.
- Captisol licensee Curis Inc. announced that the first patient was dosed in a Phase 1 clinical study of an oral formulation of CUDC-101 in patients with advanced and refractory solid tumors. CUDC-101 is a first-in-class inhibitor of histone deacetylase, epidermal growth factor receptor and epidermal growth factor receptor 2, and is formulated with Ligand’s Captisol.
- Ligand partner Meridian Laboratories, Inc. announced that they are progressing toward clinical development for Captisol-enabled docetaxel for the treatment of cancer.
- Ligand entered into an option agreement with an undisclosed partner for the clinical development of an undisclosed novel inhibitor of the fructose-1,6-bisphosphatase (FBPase) enzyme for the treatment of type 2 diabetes.