Hanmi 'Rolvedon' reports US sales gain ₩18B in Q1

Emerging as stable cash cow

Assertio Holdings says "Rolvedon's sales fell due to price reduction…sales increased"

Hanmi Pharmaceutical, licensed out the drug in 2012 and obtained FDA approval in 2023…cumulative sales in U.S. amounted to KRW 194 billion

'Rolvedon,' a treatment for neutropenia that Hanmi Pharmaceutical licensed out, continues to be popular in the U.S.

 

market.

 

Although the growth trend has stalled due to price reduction in the U.S., Rolvedon recorded over US$ 10 million in sales for six consecutive years.

 

Rolvedon's cumulative sales amounted to KRW 200 billion in two years and six months since the drug launched in the U.S.

 

market.

 

According to the reports by Assertio Holdings on May 16, Rolvedon's sales for Q1 amounted to US$13.10 million (KRW 18 billion).

 

However, it decreased by 9.7% from US$14.50 million in Q1 and 14.9% from US$15.40 million in the previous quarter.

 

The company explains that despite slightly reduced sales due to Rolvedon's price reduction, increased sales partially recovered lost sales from the price reduction.

 

Rolvedon

Rolvedon is a new biopharmaceutical that Hanmi Pharmaceutical licensed to Spectrum in 2012.

 

It is administered to cancer patients receiving myelosuppressive chemotherapy for the treatment or prevention of neutropenia.

 

It belongs to the 'G-CSF' (granulocyte colony-stimulating factor) class, which stimulates granulocytes to increase neutrophil counts, showing a mechanism of action similar to Amgen's blockbuster drug Neulasta (pegfilgrastim).

 

In South Korea, Rolvedon received new drug approval from the Ministry of Food and Drug Safety in March 2021 under the product name 'Rolontis.' Spectrum was acquired by Assertio Holdings, a pharmaceutical company specializing in central nervous system disorders·pain·inflammation, in April 2023.

 

Assertio Holdings is a pharmaceutical company specializing in developing CNS and inflammation treatments.

 

The company has products such as the non-steroidal anti-inflammatory drug Indocin and buccal dissolving film Sympazan.

 

The company has succeeded in strengthening its oncology pipeline by acquiring Spectrum.

 

Assertio Holdings is responsible for clinical development, regulatory approval, manufacturing, and commercialization of Rolvedon and Poziotinib worldwide, excluding South Korea·China·Japan.

 

Rolvedon recorded its first U.S.

 

sales of US$ 10.1 million in the fourth quarter of 2022, generating revenue in the United States.

 

In December 2022, Rolvedon was included in the prevention·treatment options guideline for febrile neutropenia of the U.S.

 

National Comprehensive Cancer Network (NCCN).

 

Rolvedon posted sales of US$ 15.6 million in the first quarter and US$ 21.0 million in the second quarters of 2023, but declined to US$ 8.0 million in the third quarter.

 

It rebounded to US$ 11.0 million in the fourth quarter of 2023, surpassing US$ 10.0 million in sales for six consecutive quarters through the first quarter of this year.

 

Rolvedon's cumulative U.S.

 

sales reached US$ 138.8 million (KRW 194 billion).

 

At the San Antonio Breast Cancer Symposium (SABCS 2024) held in the United States last December, Assertio Holdings released the Phase 1 clinical trial results of the same-day administration of Rolvedon.

 

Existing neutropenia treatments, such as Neulasta, can only be administered 24 hours after chemotherapy.

 

Administering a neutropenia treatment on the same day offers the advantage of potentially reducing patients' hospital stays.

 

The clinical trial was conducted in 59 breast cancer patients, administering Rolvedon 30 minutes after chemotherapy to evaluate tolerability and safety.

 

The trial found that the average time to neutrophil count recovery with Rolvedon was 1.8 days.

 

Regarding safety, the adverse reactions observed with Rolvedon were similar to those reported in previous clinical studies.

 

Assertio Holdings said, "Rolvedon's sales exceeded our internal forecasts despite securing inventory in the fourth quarter to support first-quarter sales growth," adding, "We expect Rolvedon's sales to continue rising due to strong ongoing demand."