BELLPORT, N.Y.--(BUSINESS WIRE)--Feb. 23, 1998-- Biopharmaceutics, Inc. (BOPM: OTCBB) and ABS Group Inc. (ADBS: OTCBB) announced that on Friday, February 13, 1998, the Companies' joint venture, DBD Company, LLC., Project Director, Dr. Stewart Ehrreich and several medical advisory team members met with the Food and Drug Administration (FDA) to discuss the clinical trial data for Mitolactol, the Companies' drug for the treatment of both brain and cervical cancer. The meeting helped clarify a plan which may in the opinion of management allow DBD Company, LLC to file a New Drug Application (NDA) for Mitolactol by 1999. |
Dr. Stewart Ehrreich, Project Director and a former Deputy Division Director of the FDA stated, "The results of the meeting couldn't have been more encouraging. The FDA accepted much of our rationale for presenting the analysis of the available clinical data for Mitolactol. They have requested that we complete and provide a clinical Pharmacokinetic Study before preparing and filing the NDA. Such a study can be completed while we are assembling the other data required for the NDA filing. Provided the results of the Pharmacokinetic Study support the already available clinical data, I feel that we may be able to obtain an approval for Mitolactol within three years."
Edward Fine, President of Biopharmaceutics, Inc. stated, "We have been advised by one of our medical experts that each year there are approximately 80,000 new cases of brain cancer of which Mitolactol may be usable to treat between 5,000 and 10,000 patients, when and if a New Drug Application is approved. The Companies' present pricing plans are to charge $4,000 to $5,000 per patient for a treatment course. This is competitive with other pricing plans for other cancer treatments. Dr. Ehrreich and the medical team have done an excellent job in preparing and analyzing all of the available clinical data."
Emanuel A. Floor, President of ABS Group Inc., stated, "ABS is the financial partner in the Venture. We continue to be impressed with the quality and professional work of our consultants and managing partner. The results reported from the FDA meeting are excellent and we hope that the long-term benefits in the treatment of forms of Cancer with our drug will be significant when the NDA is approved."
This news release contains forward looking statements that involve risk and uncertainties including but not limited to, product demand, market acceptance, changing economic conditions, risks in product and technology development and regulatory approvals.
Biopharmaceutics, Inc., Bellport
Stuart Fine, 516/286-5800
ABS Group Inc.
Emanuel Floor, 801/521-8000