The Story. Spectrum Pharmaceutical (SPPI), a biotechnology firm based in Henderson Nevada, focusing on the development and commercialization of hematology and oncology therapeutics, announced today that the United States Patent Trademark Office (USPTO) has issued U.S. Patient No. 8835501 for belinostat. Selling under brand name Baleodaq, the drug now has patent coverage until October 2027, which extended from the original protection date of May 2026.

"We are pleased to have this patent extension for Beleodaq, our fifth approved drug to further lengthen our intellectual property protection," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "With the recent launch of Beleodaq, we are excited about the growth trajectory. Our objective for all our products is to continue to enhance the value of the product and benefit our shareholders."

Source: Spectrum

More Insight. Baleodaq previously has the Prescription Drug User Fee Act (PDUFA) date of August 9, 2014, in which a panel of experts – physicians, patients advocates and industry leaders – would convene to vote their approval recommendation to the U.S. Food and Drug Administration (FDA). However, Spectrum recently received belinostat's early approval by the Agency on July 3 a treatment for patients having relapsed or refractory peripheral T-cell lymphoma (PTCL).

The FDA approval decision – one that is delivering great news for shareholders and patients – was based on the highly favorable tumor rate and duration of response as reported in the BELIEF trial. The international trial is an open-label, single-arm, non-randomized study of 120 patients at 62 different centers. Patients in the treatment arm received 1,000 mg/m2 of belinostat via daily intravenous (IV) infusion on day 1-5 of a three-weeks chemo-treatment cycle.

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