LEBANON, N.J.--(BUSINESS WIRE)--Update Pharma Inc. today announced that the FDA has approved Orphan Drug Status for the use of UPI-928 for the treatment of Acute Myeloid Leukemia (AML).
The FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the U.S. for the use of that product in the specified indication. The company may also be eligible to receive clinical trial tax incentives (21 CFR 316.20 and 316.21).
“The data for UPI-928 in AML was the basis for the approval of this agent in France around 25 years ago and compares quite favorably with the newer agents in development for this indication,” mentioned John Rothman, Ph.D., CEO of Update Pharma Inc. “UPI-928 is an anthracene that lacks the lifetime dosage limit associated with other anthracyclines and has been useful in the treatment of refractory or recurrent patients who were heavily pretreated with anthracyclines, which makes it a potentially meaningful drug for the treatment of AML.”
About UPI-928
UPI-928 was developed by Lederle Laboratories under the name Bisantrene. Over 2,000 patients with a variety of cancer indications were treated in a clinical program that involved 44 clinical trials. Over 70 peer reviewed clinical publications documented useful clinical activity in a number of tumor types including leukemia, lymphoma, breast and ovarian cancers. Good tolerability was reported. Bisantrene was approved in France for the treatment of AML under the trade name Zantrene, but never marketed.
At about the time of the French approval, American Cyanamid, the parent company of Lederle, experienced financial problems and pulled back on their commercial and research activities, and the Lederle drug portfolio was sold to Wyeth Pharmaceuticals, a company that had been recently restructured. Because Wyeth did not have an oncology franchise, UPI-928 was not developed subsequent to the acquisition of the Lederle portfolio. Shortly after, Wyeth was sold to Pfizer and they too did not develop this agent. UPI-928 was lost to the clinical community until last year when Update Pharma announced filed new patent claims.
About Update Pharma Inc.:
Update Pharma Inc. is a private company that is developing UPI-928 for a number of cancer indications. It is acquiring Resolute Oncology Ltd., a specialty pharma company that sells oncology drugs in the private market in Europe. Resolute also has expertise in conducting of Named Patient Programs (NPP) in Europe and elsewhere, which enable the sales of unapproved experimental drugs for patients who have exhausted all available treatment options, and for whom a physician requests the drug. This documented body of clinical literature supports the use of UPI-928 as a potentially effective agent in a Named Patient setting.
Forward-Looking Statements
Certain statements in this Press Release are "forward-looking statements" within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risk factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include the risk for the Company to complete its development work, as well as the risks inherent in commercializing a new product (including technology risks, market risks, financial risks and implementation risks, and other risks and uncertainties affecting the Company), as well as other risks that have been disclosed by us and are customarily disclosed in SEC filings of publicly traded pharmaceutical companies. We disclaim any intention or obligation to revise any forward-looking statements, including, without limitation, financial estimates, whether as a result of new information, future events, or otherwise.
