A new orally disintegrating tablet (ODT) version of Hanmi Pharmaceutical’s hyperlipidemia treatment, Rosuzet, the market leader in outpatient prescriptions, is poised to enter the market.

On August 14th, industry sources revealed that Pharmavision is actively seeking partners for the joint development of an ODT formulation for Rosuzet, a combination drug containing rosuvastatin and ezetimibe.

The market for rosuvastatin and ezetimibe combination drugs recorded $465 million in prescription sales last year, reflecting continuous growth from $340 million in 2021 and $392 million in 2022. Hanmi’s Rosuzet has solidified its market dominance, generating $135 million in outpatient prescription sales last year alone, with $75.5 million recorded in the first half of this year. More than 50 pharmaceutical companies, including Yuhan, HK inno.N, and GC Biopharma, have introduced competing products, fueling fierce competition in the prescription market.

Pharmavision appears to be focusing on an ODT approach rather than the traditional tablet form, aiming to capture a unique market position. Although this product is a follow-up, the specialized formulation may provide a competitive edge in encouraging prescriptions.

Given the prevalence of hyperlipidemia among elderly patients, this new formulation is expected to enhance convenience, particularly for older patients and those with swallowing difficulties. Pharmavision’s analysis of the patient demographic for rosuvastatin and ezetimibe combination therapies revealed the following prescription rates: 9.4% for patients aged 40-49, 24.7% for those aged 50-59, 35.5% for those aged 60-69, 19.8% for those aged 70-79, and 8.2% for patients aged 80 and above. This data highlights that 63.5% of prescriptions target patients aged 60 and older.

Moreover, with over 20 generic versions of the rosuvastatin and ezetimibe combination already listed, the pricing falls under a tiered differential system. Pricing is set at 85% of the lower amount between the lowest-priced equivalent drug and 38.69%, irrespective of specific product requirements.

Pharmavision is positioning its ODT combination drug as a candidate for the highest allowable rate for equivalent drugs, benefiting both lead and participating developers. The company also noted that the expected pricing for its four dosage options is projected to exceed the maximum price for Rosuzet, the first-listed drug.

Having completed formulation research, Pharmavision plans to secure stability testing results within this year. The company aims to complete Phase 1 clinical trials by the first half of next year, followed by a regulatory submission. A development official from Pharmavision stated, “This could present a significant opportunity for companies struggling to compete in the Rosuzet market due to tiered pricing constraints.”