Mutual Pharmaceutical Company has received FDA approval of its Abbreviated New Drug Application (ANDA) for Trimethobenzamide 300mg capsules. Mutual will begin shipping its Trimethobenzamide 300mg capsules immediately.
Mutual's Trimethobenzamide 300mg capsules are AB-rated to, and therefore the generic equivalent of, King Pharmaceuticals' Tigan Capsules. The trimethobenzamide 300mg capsule market is an emerging market and is expected to reach a level in excess of $ 14MM in 2003.
United Research Laboratories/Mutual Pharmaceutical Company recently announced it is tracking to achieve a fourth consecutive year of record sales and profits. Projections based on performance through July 2003 indicate that URL/Mutual will reach sales exceeding $ 360MM, reflecting an increase of almost 25% over 2002's record sales of $ 290MM. Sales projections of $ 360MM for the Company are exclusive of any Abbreviated New Drug Application approvals or court decisions.
The Company is also engaged in the application of proprietary drug delivery and stabilization technologies to formulate and commercialize difficult-to-formulate drug products. It is currently in discussions or projects with seven of the world's fifteen largest branded pharmaceutical companies regarding the application of these proprietary technologies for product development and commercialization. The in-licensed technology applicable to improving bioavailability of New Chemical Entities (NCEs) is, in the case of one project, slated for human clinical trials, three Pharma companies have expanded the projects to include multiple NCEs, and three other projects have passed "proof of concept" with respect to pre-clinical assessments. In the field of drug stabilization, the Company is in licensing discussions with two of these seven branded pharmaceutical companies. The Company has already signed agreements with, and received payments from, two smaller to mid-sized branded companies.
United Research Laboratories/Mutual Pharmaceutical Company is engaged in the research, development, manufacturing and marketing of generic pharmaceutical products, and application of delivery and stabilization technologies to existing and future branded products.