Hikma secures exclusive rights to $436M cancer drug in deal with Novugen

Hikma Pharmaceuticals has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen, positioning itself to enter the US market with exclusive generic rights to the high-value oncology treatment.

Hikma Pharmaceuticals PLC has announced the acquisition of Novugen’s FDA-approved ANDA for trametinib tablets, a kinase inhibitor used in targeted cancer therapy. The deal also includes a commercial arrangement where Novugen will manufacture the product while Hikma will manage sales and marketing activities across the United States. The agreement grants Hikma 180 days of generic market exclusivity in the US once trametinib is launched, providing a strong commercial head start in the oncology segment.

Trametinib is used primarily to treat specific types of melanoma and is marketed under the brand name Mekinist®, owned by Novartis Pharma AG. According to IQVIA, US sales for Mekinist® reached approximately $436 million in the 12 months ending December 2024, indicating strong market potential for its generic counterpart.

How will the acquisition impact Hikma’s oncology pipeline in the US?

The deal enhances Hikma’s pipeline of complex generics, particularly in oncology—an area with high barriers to entry and significant unmet medical demand. Dr. Hafrun Fridriksdottir, President of Hikma Generics, said the acquisition aligns with Hikma’s broader strategy to scale its generics portfolio through targeted development and strategic licensing, especially for treatments addressing critical healthcare needs.

Hikma’s Generics business currently spans a diverse range of oral, inhalation, nasal spray, and specialty medications in the US. With nasal sprays, the company remains the largest supplier by volume in the country, according to IQVIA MAT data as of December 2024. The trametinib acquisition allows Hikma to leverage its established commercial infrastructure to expand into oncology-based therapies with strong revenue potential.

Why is trametinib a strategic win for both Hikma and Novugen?

The agreement provides clear mutual benefit. For Novugen, a wholly owned subsidiary of UAE-based SciTech International, the deal showcases its ability to bring complex, niche generics to regulatory approval in major global markets. As the first Malaysian pharmaceutical company with a USFDA-approved oncology manufacturing facility, Novugen’s supply-side role in this partnership reinforces its positioning in the global generics space.

Novugen’s CEO Rahil Mahmood said the transaction represents the company’s continued commitment to expanding access to high-barrier products that lack generic alternatives. He also highlighted that the partnership with Hikma offers an ideal commercial synergy—combining Novugen’s regulatory and manufacturing expertise with Hikma’s deep-rooted sales network in the US.

What are the regulatory implications and commercial limitations?

While the trametinib ANDA has been approved for US marketing by the FDA, Hikma clarified that the approval is geographically restricted. The company does not hold rights to sell the drug outside of the United States, thereby maintaining regional exclusivity as per the original product’s global licensing held by Novartis.

The 180-day exclusivity window is expected to deliver substantial early-mover advantage to Hikma in the US generics market. This exclusivity is granted under the Hatch-Waxman Act as a reward for being the first generic applicant to challenge the branded drug’s patents and successfully gain FDA approval.

What does this deal signal for broader industry trends?

The transaction comes at a time when pharmaceutical companies are increasingly prioritizing complex generics, oncology products, and strategic collaborations to address pricing pressures and regulatory challenges. With competition intensifying in traditional generic segments, companies like Hikma are shifting towards high-barrier, differentiated products that offer limited competition and higher margins.

From a supply chain perspective, Novugen’s vertically integrated operations—from R&D to manufacturing—allow it to deliver FDA-compliant products at scale. Its facilities in Malaysia are approved by leading global regulators, including the EMA, WHO, and USFDA, allowing the company to deliver oncology drugs that meet global compliance standards.

Sentiment analysis and stock outlook for Hikma Pharmaceuticals

Hikma Pharmaceuticals PLC (LSE: HIK) currently trades on the London Stock Exchange and NASDAQ Dubai, and is rated BBB-/Stable by S&P and BBB-/Positive by Fitch. The company has demonstrated solid financial performance in recent quarters, bolstered by its growing Generics and Injectables businesses. The latest trametinib deal adds a high-value oncology drug to its pipeline, which could positively impact revenue growth and profit margins in the medium term.

Market analysts see this as a “buy” or “hold” scenario depending on the investor’s exposure to generic pharmaceuticals and appetite for oncology-based growth strategies. Institutional interest in high-barrier generics has increased amid margin compression in commodity generics. Hikma’s ability to secure exclusivity for trametinib indicates strong regulatory and commercial execution.

With US oncology spending expected to cross $80 billion by 2026, according to IQVIA forecasts, the addition of trametinib to Hikma’s portfolio reflects a broader industry pivot toward specialty medicines with fewer competitors and higher entry thresholds.