Spectrum, Hanmi’s U.S. partner, said Hanmi can secure 11.6 billion won ($9.94 million) in royalty income if the company manages to win approval for Rolontis, its neutropenia treatment, from the U.S. Food and Drug Administration.
|Hanmi headquarters in Bangi-dong, eastern Seoul.|
After the drug’s release, Hanmi will also likely receive a certain percentage of revenue annually, depending on sales.
Spectrum’s recent quarterly report, submitted to the U.S. Securities and Exchange Commission, comes after the company resubmitted the biologics license applications (BLA) for Rolontis to the FDA on Oct. 24.
The resubmission came after the company rescinded its initial BLA for the drug to accommodate the FDA’s request for more chemistry, manufacturing and control data in March. This time around, the company revised its BLA based on the data from its two clinical phase 3 trials – ADVANCE and RECOVER.
“Rolontis demonstrated safety and efficacy in 643 early breast cancer patients with neutropenia following myelosuppressive chemotherapy,” the company said. “The two phase 3 clinical trials showed non-inferiority in terms of the duration of neutropenia compared with pegfilgrastim during the four cycles of chemotherapy.”
If approved, the company expects to enter the pegfilgrastim market, which generates $ 4 billion in revenue annually, the company added.
Rolontis is a biological drug with long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi’s Lapscovery, a proprietary platform technology. In 2012, Hanmi Pharmaceuticals signed a licensing agreement with Spectrum Pharmaceuticals, giving the global rights for Rolontis except for Korea, China and Japan.
The two companies did not disclose the total contract size, including the upfront fee, when Hanmi first licensed out the treatment to Spectrum. According to Spectrum, a certain deposit was paid to Hanmi when they first signed the contract. In September 2014, after confirming the positive phase 2 clinical results and deciding to proceed with phase 3 clinical trials, the company said the terms of the contract, such as milestones and sales royalties, were modified.
Spectrum first paid Hanmi $1.9 million in the milestone when it started the ADVANCE study in the first quarter of 2016. In April of the same year, the company issued 318,750 common shares for Hanmi. Considering the stock price at that time, it was worth $ 2.3 million in cash. As of now, Hanmi owns 0.29 percent of Spectrum shares.
“In response to strategic priorities, the company submitted the BLA for Rolontis to the FDA last month,” Spectrum Pharmaceuticals President and CEO Joe Turgeon said. “The company plans to present the phase 3 clinical integration data for Rolontis, which was released at the ASCO 2019 conference, at the San Antonio Breast Cancer Symposium (SABCS) next month.”