CP024 is a nasal spray formulation of somatropin (recombinant human growth hormone). Clinical proof of concept has been established for CP024 and the CriticalSorb technology. In a Phase 1 clinical trial, CP024 was shown to be well tolerated and able to induce insulin‐like growth factor 1 (IGF‐1) to the same levels as a subcutaneous injection of the marketed product. IGF‐1 is the main mediator of hGH activity in the body and a clinically relevant indicator of bioactivity. A Phase 1b clinical trial is now underway to establish the dose response of CP024 and is expected to report by May 2012.

 

Human growth hormone deficiency in children results in stunted growth and delayed muscle development and in adults in diminished lean body mass, poor bone density as well as a number of other physical and psychiatric symptoms. In addition to treating growth hormone deficiencies, somatropin is used to treat people with Turners syndrome and HARS, a syndrome associate with HIV infection, as well as certain other muscle wasting diseases due to its role in fat metabolism and muscle development. The market for somatropin products is currently estimated to be $3.1 billion annually.

 

 

 

CP016 is a long acting injection of somatropin (recombinant human growth hormone) that uses Critcal Pharmaceuticals’ proprietary CriticalMix™ drug delivery technology. It is being developed as a once every two week injection and has completed preclinical development.

 

Patients suffering from growth hormone deficiency are currently treated with a once-daily injection of somatropin, which has a considerable impact upon patients' lives. By reducing the number of injections required with CP016 compared to current medicines, we expect to improve the therapeutic outcome by increasing efficacy through improving patient compliance and reducing the side effect profile.

 

 

CP018 is a long-acting injection of risperidone that uses Critical Pharmaceuticals’ proprietary CriticalMix™ drug delivery technology. It is being developed as a once every two week injection and is about to enter preclinical development.

 

Risperidone is the most widely prescribed medication in its class for the treatment of schizophrenia and other psychiatric disorders and is the only drug approved by the FDA for the treatment of schizophrenia in adolescents. Risperidone is effective against both the positive and negative symptoms of schizophrenia and produces fewer side effects than conventional antipsychotic drugs. Schizophrenia effects more than 24 million people worldwide and global sales for risperidone is currently estimated to be $4.2 billion annually.

 

Several oral atypical antipsychotics are available for the management of schizophrenia but their benefits are limited by non-compliance. Long-acting injectable risperidone makes an important contribution to the management of schizophrenia by ensuring greater patient compliance and CP024 is an attractive alternative to current therapies.