Hikma Acquires FDA-Approved ANDA for Trametinib from Novugen

Hikma Pharmaceuticals PLC, a global pharmaceutical company based in London, has announced the acquisition of the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Alongside this acquisition, Hikma has established a commercial agreement with Novugen, wherein Hikma will manage all sales and marketing activities for trametinib in the United States, while Novugen will handle its manufacturing and supply.

Trametinib is a kinase inhibitor taken orally and is utilized in the treatment of specific cancer types. Upon its market release, Hikma is set to enjoy a 180-day exclusivity period for the generic sale of this product in the U.S. This strategic move is part of Hikma's ongoing efforts to expand its offerings in essential medicines for the U.S. market, as emphasized by Dr. Hafrun Fridriksdottir, President of Hikma Generics. The acquisition is seen as a significant enhancement to Hikma's extensive range of essential medicines, aimed at improving healthcare accessibility for millions of Americans.

The partnership between Hikma and Novugen underscores a shared dedication to making effective and affordable cancer treatments available in the U.S. Rahil Mahmood, CEO of Novugen, highlighted that this agreement is a reflection of Novugen's commitment to innovation and regulatory excellence. Through this collaboration, both companies aim to ensure that life-changing treatments reach more patients in the U.S. Novugen is recognized for its specialization in niche, challenging-to-formulate generics and its dedication to expanding access to high-barrier pharmaceutical products.

In the twelve months ending December 2024, sales of trametinib, marketed under the brand name Mekinist®, totaled approximately $436 million in the United States, according to IQVIA. By tapping into this market, Hikma aims to bolster its presence in the North American region, where its Generics business already supplies a variety of oral, inhalation, and specialty products. Hikma is noted for its expertise in complex technologies, such as nasal sprays, where it holds the position as the largest supplier by volume in the U.S.

Hikma Pharmaceuticals has a rich history spanning over 45 years in creating high-quality medicines and making them accessible to those in need. Headquartered in the UK, Hikma operates globally with a significant presence in North America, the Middle East, North Africa, and Europe. The company's commitment to innovation and health is reflected in its broad range of branded and non-branded generic medicines, supported by a workforce of 9,500 colleagues dedicated to enhancing health outcomes worldwide.

Novugen, a subsidiary of SciTech International, is headquartered in Malaysia and is distinguished by its state-of-the-art manufacturing facilities approved by the USFDA. The company is committed to producing niche, difficult-to-formulate generics, adhering to rigorous global quality standards. Novugen's facilities are recognized for compliance with various international regulatory requirements, including those set by the USFDA, EMA, and WHO. This positions Novugen as a leader in manufacturing and exporting high-quality pharmaceutical products to the U.S. market.

By continuously pursuing innovation, Novugen seeks to lead the global pharmaceutical industry with high-quality, technology-driven products that meet the stringent needs of the healthcare sector.