LUND, Sweden, September 10, 2013 /PRNewswire/ --
Camurus announced today that Novartis has exercised its option to acquire an exclusive license for the further development and worldwide commercialization of CAM2029 for treatment of patients with acromegaly and neuroendocrine tumors (NETs). The license also covers additional future products based on the Camurus' FluidCrystal® Injection depot technology.
The option exercise is the next stage in the collaboration, option and license agreement between Novartis and Camurus executed in December 2011. It triggers an undisclosed milestone payment to Camurus from eligible potential payments of up to US$ 700 million, subject to achievement of predefined development, regulatory and commercial milestones for the products included in the agreement. In addition, Camurus is entitled to royalties on global product sales.
CAM2029 is a novel, long-acting octreotide product that has been developed by Camurus with the goal of easy subcutaneous administration in the treatment of patients with acromegaly and NETs. CAM2029 has received orphan drug designation by EMA for the treatment of acromegaly and has been studied in three clinical Phase I trials, assessing pharmacokinetics, pharmacodynamics and safety after single and repeat dosing. Following the option exercise, Novartis will assume responsibility for further clinical development of CAM2029, including any Phase III studies, product registration and worldwide commercialization.
"We are very proud of the successful development of our collaboration and look forward to continue assisting Novartis in the clinical development and registration efforts for CAM2029," says Fredrik Tiberg, President and CEO of Camurus. "Novartis' decision to acquire full commercialization rights to CAM2029 and related products is a key milestone for Camurus that further validates our advanced delivery technologies and clinical product development capacity. Novartis' continued investment in this program strengthens our strategic relationship and enables Camurus to expand its proprietary pipeline of new and innovative therapies for serious diseases."
Since the transaction triggers relevant value thresholds, Novartis' binding commitment to complete the exercise of the option is subject to the US's Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. §18a) (HSR).
CAM2029 is a novel, ready-to-use, long-acting octreotide product for treatment of acromegaly and neuroendocrine tumors (NETs) based on Camurus' proprietary FluidCrystal® delivery system. Octreotide chloride, the active ingredient of CAM2029 is a synthetic, cyclic octapeptide, an eight amino acid analogue of the peptide hormone somatostatin. The CAM2029 product is designed for easy and patient-friendly drug administration. While traditional depot therapeutics frequently comprise complex microsphere technology for intramuscular injection, Camurus' FluidCrystal® depot allows for subcutaneous injection of a small volume liquid that transforms into a biodegradable liquid crystal gel at the site of injection. Thereby the drug compound is effectively encapsulated, providing rapid onset and long-acting octreotide release.
Camurus is a research-based pharmaceutical company dedicated to developing innovative therapeutics for diseases with high unmet medical needs. The company's current pipeline includes products for treatment of pain, opiate addiction, cancer and for use in endocrinology. Based on its advanced nanoscale drug-delivery technology platform, FluidCrystal®, Camurus is also active in a number of development partnerships and research collaborations with international pharmaceutical and biotech companies.