Hikma Pharmaceuticals Expands Portfolio with Novugen's Trametinib ANDA Acquisition

Hikma Pharmaceuticals PLC, a well-known player in the global pharmaceutical market, recently announced a significant acquisition. On April 17, 2025, the company confirmed it has obtained the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. This partnership marks a crucial step for Hikma as it aims to strengthen its position in the oncology market.

Trametinib is recognized for its role as an orally administered kinase inhibitor, primarily utilized in the treatment of specific cancers. Notably, upon its launch, Hikma will enjoy 180 days of exclusivity in the U.S. generic market for this product. This exclusivity can significantly influence sales, offering Hikma a competitive edge in the rapidly growing sector of oncology treatments.

Dr. Hafrun Fridriksdottir, the president of Hikma Generics, expressed enthusiasm regarding this acquisition, stating that it reflects Hikma's ongoing commitment to broadening its generics pipeline. The aim is to address pressing therapeutic needs faced by U.S. patients and healthcare providers alike. Dr. Fridriksdottir emphasized that enhancing the availability of pivotal cancer treatments aligns with Hikma's mission to improve overall health access for millions of Americans.

The partnership highlights a shared vision for accessible oncology treatments. Rahil Mahmood, CEO of Novugen, reiterated the importance of this collaboration, underlining their focus on providing effective and cost-efficient medications in the U.S. market. The agreement sees Hikma taking on full responsibility for U.S. sales and marketing of trametinib, while Novugen will handle its manufacturing and supply.

This collaboration stands as a prime example of innovation and regulatory success, showcasing both companies’ commitments to tackling significant healthcare challenges. Trametinib, previously marketed under the brand name Mekinist®, achieved U.S. sales of approximately $436 million in just the twelve months ending December 2024, according to figures from IQVIA. This striking figure underscores the market's demand and the potential financial impact of Hikma's entry into this space.

Hikma's Generics division brings a diverse portfolio, including a variety of specialized products such as oral and inhalation generics to the North American market. Their expertise in complex manufacturing technologies, particularly in nasal sprays, positions them as the largest supplier in this category in the U.S. market. Such strengths complement the new trametinib product, enhancing Hikma’s overall product offerings.

Furthermore, Novugen, a subsidiary of SciTech International, boasts over three decades of experience in the healthcare sector, specializing in niche generics particularly in the oncology field. Their stringent adherence to quality standards and capabilities in developing complex formulations position them as a leading manufacturer. Novugen maintains robust manufacturing facilities compliant with various international regulatory standards, including those of the U.S. FDA.

This strategic acquisition from Novugen not only signifies Hikma's commitment to oncology treatments but also reinforces its dedication to expanding access to high-quality medications. The collaboration will potentially make significant strides in providing much-needed therapies to a larger population of U.S. patients.

As the global fight against cancer continues, Hikma's efforts through this acquisition highlight a pathway toward improved health outcomes and the essential availability of effective treatment options. By leveraging Novugen's innovative approaches and their capabilities, Hikma is poised to successfully navigate the competitive landscape of oncology drugs, helping to ensure that vital treatments reach those in need.

In summary, the acquisition of trametinib represents a forward-thinking strategy by Hikma Pharmaceuticals, enhancing its oncology product line while also affirming its role in improving healthcare access for patients across the United States.