The seven products are Fusilev (levoleucovorin), Folotyn (pralatexate injection), Zevalin (ibritumomab tiuxetan), Marqibo (vincristine sulfate LIPOSOME injection), Beleodaq (belinostat) for injection, Evomela (melphalan) for injection, and Khapzory (levoleucovorin). The seven drugs had a combined sales of $76.4 million in the first three quarters of 2018.
“This divestiture marks a major strategic shift for Spectrum to ensure laser-focus on novel, oncology drug development and commercialization,” stated Joe Turgeon, president and chief executive officer of Spectrum. “The proceeds generated by the sale will significantly strengthen the financial position of the company, providing the capital to develop and commercialize our two late-stage pipeline assets, and placing us in a solid position to evaluate additional growth opportunities.”
Acrotech is paying Spectrum $160 million in cash up front and up to $140 million in regulatory and sales-based milestones.
Spectrum is also reducing staff by about 40 percent. Turgeon noted, “Along with this divestiture, the majority of impacted staff will transition to Acrotech thereby right sizing Spectrum for our development efforts. Additionally, we are retaining a core group of commercial talent to lead the launch of Rolontis and poziotinib.”
Trading of Spectrum was halted in anticipation of the news, but stock has dropped 46.1 percent in the last year.
Posiotinib is being investigated for non-small cell lung cancer (NSCLC) in a Phase II trial, and in breast cancer in Phase Ib and Phase II trials. In September 2018, the company announced preliminary data from the Phase II NSCLC trial with the University of Texas, MD Anderson Cancer Center. The target group is breast cancer patients with an exon 20 mutation in EGFR or HER2.
“There are currently no approved targeted therapies for this hard-to-treat population,” MD Anderson’s John Heymach, chairman and professor of the Department of Thoracic/Head and Neck Medical Oncology, stated at the time. “For this reason, it is especially exciting to observe that posiotinib is highly active, with a manageable safety profile, in these heavily pre-treated patients.”
And on January 2, 2019, the company indicated that cohort 1 from the NSCLC trial of posiotinib was fully enrolled. Results from the cohort are expected by the second half of this year.
On December 27, 2018, Spectrum announced that it had submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Rolontis (eflapegrastim). The application included data from two identically designed Phase III clinical trials, ADVANCE and RECOVER, which studied the drug in early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytotoxic chemotherapy.
At the time, Turgeon stated, “Rolontis is an important and significant future growth driver for our company. Today’s milestone brings us one step closer to bringing the first novel G-CSF to healthcare providers in over 15 years in a large market that is familiar to Spectrum.”
Spectrum’s Khapzory was only approved for use in late October 2018. The drug was approved for rescue after high-dose methotrexate therapy in patients with osteosarcoma, diminishing the toxicity that comes with overdosages of folic acid antagonists or impaired methotrexate elimination, and for the treatment of patients with metastatic colorectal cancer in combination with fluorouracil.
At the time, Turgeon stated, “Khapzory is the first levoleucovorin product approved by the FDA that contains sodium in its formulation. This NDA submission was part of the lifecycle management of our legacy product, Fusilev. Our focus remains on the development of novel, targeted therapeutics including poziotinib and Rolontis.”
A Product Manager with expertise in pharma marketing and sales operations