Date: 2011-12-13
Type of information: Licensing agreement
Compound: octreotide product CAM2029 and the FluidCrystal® Injection depot technology
Company: Camurus (Sweden) Novartis (Switzerland)
Therapeutic area:
Type agreement: collaboration
option
licensing
Action mechanism: CAM2029 is a novel, ready-to-use, long acting octreotide product for treatment of acromegaly and carcinoid tumors. The product consists of a lipid-based liquid administered subcutaneously as a low volume injection. Once injected the lipid constituents immediately start to self-assemble into the \"active\" FluidCrystal® controlled release matrix. Therapeutic plasma levels of octreotide are thereby rapidly reached and maintained over several weeks, which suppresses the overproduction of growth hormone and gastrointestinal hormones and provides effective treatment for patients with acromegaly and NETs. The FluidCrystal® Injection depot delivers therapeutic levels of drug substance over extended periods – tunable from days to months – from a single injection. Camurus\' depot offers a liquid solution that transforms into a controlled release liquid crystal gel matrix in situ on contact with minute quantities of aqueous fluid at site of injection. The FluidCrystal® delivery system overcomes traditional side effects associated with high initial drug release on injection (drug burst) and poor drug stability by effectively encapsulating the drug compound in the nanopores of the depot matrix throughout the entire process from injection until final degradation. This, together with the ready-to-use product design, makes the system highly suitable for sustained parenteral delivery of peptides and proteins.
Disease:
Details: Camurus has granted Novartis an exclusive option to license the FluidCrystal® Injection depot technology to develop, manufacture and commercialize Camurus’ octreotide product CAM2029 and related unnamed products.
CAM2029 is a ready-to-use, long acting octreotide product being developed for treatment of patients with acromegaly, neuroendocrine tumors (NETs), and other indications. CAM2029 has received orphan drug designation by EMA for treatment of acromegaly and has been studied in two completed clinical Phase I trials assessing single and repeat dosing. A further clinical trial investigating pharmacokinetics, pharmacodynamics, and safety of CAM2029 versus an active control was recently approved and initiated. This trial is expected to be completed and reported by the third quarter of 2012.
Financial terms: According to the agreement, Novartis will pay Camurus a non-refundable option fee of $10 million. Camurus will fund, perform and retain control over the clinical development of CAM2029 until exercise of the license option. If exercised, Novartis will thereafter assume responsibility for further clinical development, including pivotal studies, product registration and worldwide commercialization. Camurus is in total eligible to payments in excess of $700 million, subject to achievement of predefined development, regulatory and commercial milestones for the various products of the agreement. In addition, Camurus is entitled to running royalties on global product sales.
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