Hanmi Pharmaceutical and its U.S. partner Spectrum have completed preparations to launch Rolontis in the U.S. market by confirming the product’s American name and beefing up local sales and marketing personnel.

Hanmi Pharmaceutical completed the U.S. FDA’s due diligence inspection of its Pyeongtaek Bio Plant in June and is awaiting the regulator’s marketing approval of Rolontis by Sept. 9.
Hanmi Pharmaceutical completed the U.S. FDA’s due diligence inspection of its Pyeongtaek Bio Plant in June and is awaiting the regulator’s marketing approval of Rolontis by Sept. 9.

They expect Rolontis, or Rolvedon in U.S., will win the FDA’s approval on Sept. 9.

“The FDA completed its due diligence inspection of our Pyeongtaek Bio Plant, which will produce Rolontis' undiluted solution, in June without much comment. We are awaiting the FDA’s market approval decision,” a Hanmi Pharmaceutical official said Tuesday.

Rolontis is Korea's 33rd new drug used to treat or prevent severe neutropenia in cancer patients receiving chemotherapy. In addition, Rolontis is the first product to receive marketing approval by applying Hanmi Pharmaceutical's proprietary platform technology, "LAPSCOVERY,” which increases the medicinal effectiveness of bio-medicine.

Rolontis is spread in the bone marrow through the pharmacological characteristics of the LAPSCOVERY platform technology. It has excellent hematopoietic stem cell differentiation and proliferation efficacy compared to existing neutropenia products.

Hanmi and Spectrum are actively promoting Rolontis as a next-generation treatment. Spectrum's sales professionals are increasing contact with key cancer centers in the U.S. with support from Hanmi in establishing a marketing strategy for the U.S. market.

Under the U.S. Prescription Drug User Fee Act, the FDA will decide whether to allow Rolontis to begin marketing before Sept. 9. Rolontis won approval as the 33rd new drug from the Korean regulator in March last year and has been prescribed since the fourth quarter of last year through code-in procedures at Korean hospitals.

"Rolontis is the first global new drug released by Hanmi Pharmaceutical, a key business item of the group,” a company official said. “We will focus our capabilities to ensure it generates real results in the field of neutropenia therapeutics, which forms a market of about 3 trillion won ($2.2 billion) in the United States alone."

Hanmi plans to expand Rolontis’ usage so that physicians can inject Rolontis immediately after or within hours of their patients’ taking anticancer drugs by securing convenience in use compared to existing treatments through additional trials, the official added.

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