Pharma Two B uses its expertise in drug pharmacology and drug delivery systems, to optimize the efficacy, safety and availability of previously approved drugs, to make better pharmaceutical products with significant benefits to the patients.
The company completed a Phase IIb study in 149 PD patients in 29 clinical sites in the US and Israel, with robust positive results.
P2B001 is now in phase III clinical trial in the US and Europe.
Pharma Two B’s pipeline is aimed at additional products in CNS and other diseases, where current treatments can be improved to address patients unmet need for optimized efficacy, safety, availability and convenience of use via 505(b)2 products.
Our Regulatory Approach
505(b)2 is one of three U.S. FDA drug approval pathways and represents an appealing regulatory strategy for appropriate drug products. A 505(b)2 candidate may be a new dosage form that acts better; a previously approved drug developed for a different indication; a novel combination of two active ingredients; or a route of administration or mechanism of drug delivery that is advantageous over the current one.
This pathway allows the applicant to rely, at least partially, on safety and efficacy findings of previously approved drugs, however requires preclinical and clinical data demonstrating the improved or new activity, as well as safety and CMC data. This approach may potentially save time and money and lower the development risk.
505(b)2 products qualify for 3-7 years of marketing exclusivity.
Pharma Two B’s products are based on previously approved drugs, however, the novel modifications, combinations and formulations used in the development, lead to innovative new products with unexpected improvements that provide basis for strong intellectual property. P2B001, a novel low dose combination product for the treatment of Parkinson’s disease, was granted a patent in 14 countries, with both harmaceutical Matter and Method of treatment patents granted in the US.
Additional patents include unique release profiles and other low dose combinations.
Strategic development approach
As we are progressing in phase III with our lead product P2B001 for early stage Parkinson’s disease treatment, we are looking for strategic partners for the worldwide marketing of this product, expected to launch is 2020.
We are currently expanding our pipeline and actively searching for in licensing projects. Our main interest is in products in CNS and other diseases, where current treatments can be improved to address patients unmet need for optimized efficacy, safety, availability and convenience of use via 505(b)2 products.