Drug Development Co. Pharma Two B Raises $8 Million
Published: Oct 23, 2012
Financing will be used to continue the development of the company's Fixed-Dose-Combination product for the treatment of Parkinson’s disease, and complete the pivotal Phase IIb clinical trial as part of the US FDA 505(b)(2) regulatory pathway the company chose to take.
"We are happy to have secured the financing that will bring our new combination drug to Phase IIb completion and to be able to offer better and safer treatment for Parkinson’s patients," said Pharma Two B Founder & Chairman Mr. Ehud Marom. “Our second round will cover our financial needs up to 2015, at which point in time we will start receiving royalties from our generic product portfolio.”
Parkinson’s disease is defined as the second most prevalent neurodegenerative disease, treated today mostly with Levodopa. Our new combination product P2B001 will fill a significant unmet need in the treatment regime for early stage Parkinson’s disease patients.
About Pharma Two B
Pharma Two B develops clinically differentiated and value-added products, based on approved drugs. The company focuses on Fixed-Dose-combinations of two or more drugs with complementary and synergistic effects, providing high clinical value and shorter regulatory pathways (US 505(b)(2) approach). The company develops products in two therapeutic areas with great unmet needs, Parkinson's disease and Cancer.
About 505(b)(2) Drug Development Pathway
The FDAs 505(b)(2) is a drug approval pathway that enables the use of data from clinical investigations that were not conducted by the applicant and for which the applicant does not have right of reference. The process is applicable in the cases of changes to a previously approved drug, including changes in dosage form, formulation, strength, route administration, dosing regimen, active ingredient (e.g. different salt) and indication.
About Crossroad FCP-FIS
Crossroad is a regulated foreign venture capital/private equity fund focusing on the Israeli high-tech industry, in which the Italian insurance group Generali is investing. Crossroad is independently managed by Allegro S.à r.l., a Luxembourg-based management company and advised by Bit Enterprises Ltd.
About JK&B Capital (www.jkbcapital.com)
Founded in 1996, JK&B Capital is a Chicago-based venture capital firm with more than $1.1 billion under management which focuses on Information Technologies, healthcare and communications. JK&B then provides these companies with financial support, strategic guidance and most importantly technical guidance to help them grow and prosper.
About Michael Mittelman
Mr. Mittelman, a long standing industrialist focused on the food industry and a private investor in Pharmaceutical formulation companies.
Pharma Two B Ltd.
Irit Zalayet, CFO, +972-8-9472672