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Spectrum reports on financials, pipeline

March 9, 2017

Spectrum Pharmaceuticals, Inc. (SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today financial results for the three-month period and year ended December 31, 2016.

“We made significant advancements in our pipeline throughout 2016 and I believe we are well positioned for transformational growth,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “ROLONTIS is our highest priority drug and we are pleased that we remain on track for a BLA filing next year. Poziotinib, which is being developed for breast cancer has recently emerged as a potential treatment for a high unmet medical need in lung cancer. Data presented in December suggests that poziotinib has potential in lung cancer patients with certain genetic mutations that have poor prognosis and limited treatment options. An investigator sponsored trial of poziotinib in such patients with EGFR Exon 20 insertion mutations at MD Anderson Cancer Center could yield key results before year end. We have also obtained a new SPA for our late-stage bladder cancer drug Qapzola that significantly reduces the number of patients required for an NDA filing. Spectrum is in a unique position of having multiple opportunities to create value while benefiting patients.”

Pipeline Update:

  • ROLONTIS (eflapegrastim), a novel long-acting GCSF: A pivotal Phase 3 study was initiated under a SPA from the FDA in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer. The Company is actively enrolling breast cancer patients in the current trial, expects to initiate an additional smaller Phase 3 trial, and continues to expect to file a BLA next year.
  • Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: In collaboration with The University of Texas MD Anderson Cancer Center, an investigator sponsored trial is being initiated in non-small cell lung cancer patients with EGFR Exon 20 insertion mutations. The study is expected to yield results before year end. Spectrum is also conducting a Phase 2 breast cancer trial in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. Further, multiple Phase 2 studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture to study additional cancer indications.
  • Qapzola, a potent tumor-activated drug being investigated for non-muscle invasive bladder cancer: The Company received a new SPA from the FDA on a proposed Phase 3 study design. The Phase 3 study has been specifically designed to build on learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous study, this study will use twice the dosage of Qapzola (8 mg), will evaluate approximately 70% fewer patients (n = 425), and will evaluate time-to-recurrence as the primary endpoint compared to recurrence at 2 years.

Conference Call

Wednesday, March 8, 2017 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 67373281
International: (973) 796-5077, Conference ID# 67373281

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on March 8, 2017 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

https://yhoo.it/2lGxZ4a

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