Spectrum Pharmaceuticals sold off its portfolio of approved drugs and downsized this year so it could concentrate on its development efforts. Now a manufacturing hitch is affecting the first of its pipeline products up for approval.
The Henderson, Nevada-based drugmaker said Friday that it has pulled its biologics license application for Rolontis because the FDA needs more information about the chemistry, manufacturing and controls process, and it couldn’t get that all together before the March 29 approval deadline.
“We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application,” Spectrum CEO Joe Turgeon said in a statement. “We remain confident in the Rolontis program and look forward to a successful resubmission and its ultimate approval.”
The Spectrum biologic is being manufactured in South Korea by Hanmi. If approved, it will compete with Amgen’s $4 billion seller Neulasta for reducing the duration of severe neutropenia in breast cancer patients treated with chemotherapy.
The company didn’t say in its announcement what specific information the FDA needed, but Cantor Fitzgerald analysts spoke with management about the delay. In a note, analyst Alethia Young told investors: “When we asked for clarification on the sort of new CMC data they need to generate, they noted an example around shipping validation.”
The company gave no timeframe about how long its back-and-forth with the FDA might take.
The delay comes after Spectrum in January sold its entire portfolio of seven marketed products to a subsidiary of India’s Aurobindo so that it could focus on development. It was promised $160 million upfront and up to $140 million in regulatory and sales-based milestones.
With the deal, Spectrum slashed its workforce by about 40%, an estimated 90 employees. Most of those are slated to move to Aurobindo’s New Jersey-based Acrotech Biopharma.
Analysts remain optimistic about the company. Jefferies in an investor note called Rolontis the “program that anchors the company and leverages management expertise.” It has estimated annual sales to reach $550 million.