Handa Pharmaceuticals' 505(b)(2) new drug application for the smoking cessation aid HND-032 has completed experimental data on nitrosamine impurities and has recently submitted a complete response letter (CRL) supplement to the U.S. FDA. The outcome is expected as early as the fourth quarter of this year or early next year at the latest. Meanwhile, the company's U.S. antitrust case has reached a settlement with three major insurance company plaintiffs, with the settlement costs significantly lower than initially estimated, which is expected to facilitate settlements with other insurers.
In 2019, Handa, along with the original manufacturer and Par, were accused of violating antitrust laws, mainly due to Handa's patent settlement agreement with the original manufacturer, which other pharmaceutical companies argued could potentially breach the spirit of these laws. Despite favorable evidence for Handa being revealed during expert testimony, the company considered the time, manpower, and legal fees involved in the litigation and decided to pursue settlements to reduce operational uncertainties.
On the 19th, Handa announced that its subsidiary, Handa Pharmaceuticals, LLC, had reached a settlement agreement with plaintiffs HCSC, HUMANA, and AETNA. Following the plaintiffs' withdrawal of the lawsuit in the U.S. court, both parties will adhere to the agreement to cease all disputes, with the settlement amount remaining confidential. However, it is understood that the settlement cost is significantly below the budget previously allocated by Handa, which should aid in negotiating settlements with other insurers.
Additionally, Handa's subsidiary, Handa Pharmaceuticals, LLC, submitted a CRL response to the U.S. FDA for the smoking cessation aid HND-032 on July 18, addressing the complete response letter issued by the FDA in February. This supplement includes experimental data related to nitrosamine impurities at 200 ppm. According to standard FDA procedures, the company should be notified promptly upon completion of the review, with results typically expected within three to six months, implying a decision could come in the fourth quarter of this year or early next year.
HND-032 is a generic version of Pfizer Inc.'s blockbuster drug Chantix/Champix. In 2021, Chantix/Champix was found to contain excessive levels of nitrosamine impurities, leading Pfizer to urgently recall the drug. The original market value of Chantix/Champix was as high as $900 million, but the market has since been divided among several generic drugs, reducing its value to around $100 million.
Resource (mandarin): 漢達反壟斷案完成部分和解，戒菸輔助劑藥證完成補件最快Q4開牌
