It is revealed that Spectrum Pharmaceuticals, Inc (NASDAQ:SPPI) has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) seeking approval for Orphan Drug – EVOMELA. The application relates to the conditioning treatment before hematopoietic stem cell transplant in patients of multiple myeloma.
Resubmission after October response
The company said that the FDA’s decision will come on May 9, 2016. The resubmission of the application follows the company’s earlier submission, for which it received a Complete Response Letter (CRL) in October this year.
Apart from this, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) has also submitted a new drug application (IND) for Poziotinib, as a part of its efforts to start Phase II Breast Cancer study at the earliest. It is noteworthy that Poziotinib has already been studied for efficacy and safety for multiple cancer types. In the phase I study, Poziotinib showed a significant response rate of 60% in patients suffering from Breast cancer.
Sale of rights
Earlier to this, the company has announced its plans to sell rights to ZEVALIN, a lymphoma med to UK-based Mundipharma. The rights have been sold in regions including Japan, Middle East, Latin America, Africa and Asia Pacific (excluding China and India). The sale of rights will fetch Spectrum an upfront payment of $15 million in addition to $5 million in profits as a result of initial ZEVALIN supply.
As per the agreement between the two companies, Mundipharma will assume operational responsibility in Japan. Meanwhile, Spectrum has decided to retain its rights in the Europe, U.S. and Canada. The company is likely to divert the proceeds from this transaction towards building resources for the development of poziotinib and SPI-2012. ZEVALIN is aimed to treat patients with relapsed low-grade or follicular B-cell non-Hodgkin’s lymphoma.
The stock of Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) was in red by 1% to $5.94 during the previous trading session.