The business office for Allendale Pharmaceuticals is Allendale, NJ.
The Today ® Spongeis manufactured at OSG Norwich Pharmaceuticals, in Norwich, NY.
Legal Form of Business
The legal form of Allendale Pharmaceuticals, Inc. is a corporation chartered in the state of Delaware. This form was chosen to facilitate the possibility of bringing the Company public and utilizing its structure for divestiture or acquisition.
With the acquisition of the Today® Sponge, the Company assumed 100% ownership of Today's WomenCare Company; formerly, VLI, Inc.
Because AlPhar is operating in the pharmaceutical industry, most products will be under the regulation of the FDA.
There can be no assurance that AlPhar's operation and profitability will not be subject to more restrictive regulation. However, Dr. Staab has expertise in worldwide regulatory affairs, clinical research, manufacturing, and quality assurance. It is anticipated the Company will have a competitive advantage in dealing with the myriad of regulatory reviews.
Since AlPhar intends to market products in the women's healthcare area, there are numerous regulations that will influence development, marketing, and operation strategies. The FDA will regulate products either through a pre-approval process (New Drug Applications ["NDA"], Abbreviated New Drug Application ["ANDA"], and Pre-market Approvals and pre-market notification for medical devices) or through compliance programs (compliance with over the counter drug monographs, good manufacturing practices, good laboratory practices, and good clinical practices.)
It will be the strategy of AlPhar to first market products with approvals already in place, e.g., over the counter monograph compliance or previously approved NDAs. This would be followed by products with more regulatory demanding paths to market.
The Company will use Dr. Staab's well-developed relationships with the FDA, National Institutes of Health and Contraceptive Research and Development Agency (CONRAD) to strengthen the approval path. Additionally, the Company will use its smaller size to advantage, as experience shows the FDA is often sensitive to a company's available resources and relationships.
Allendale Labs has often been approached to enter joint research programs using the consumer preferred ALI film. One such effort is a joint research project among ALI, the Johns Hopkins University, CONRAD, and the University of Alabama, which has not funded at this time. Allendale Labs has passed on many of these opportunities because it did not have a business arm, being just a developmental laboratory. With the formation of the Company, it will join several government-sponsored efforts to continue to test the ALI film in various delivery modes, but also to look to the Company as a partner in commercializing new products. The next efforts to be undertaken are related to the final phase clinical research on both N-9 and BZK film. CONRAD anticipates making $2.0 million available for these extensive clinical trials.