Hikma acquires Novugen's FDA-approved ANDA for trametinib

Rhea-AI Summary

Hikma Pharmaceuticals has acquired the FDA-approved ANDA for trametinib tablets from Novugen, securing 180 days of US generic market sales exclusivity. The agreement positions Hikma to handle US sales and marketing while Novugen manages manufacturing and supply.

Trametinib, an oral kinase inhibitor for cancer treatment, generated approximately $436 million in US sales under the brand name Mekinist® in the 12 months ending December 2024. This strategic acquisition strengthens Hikma's generics portfolio in oncology and expands its pipeline of essential medicines.

The partnership aims to increase access to cost-efficient cancer treatments in the US market, where Hikma maintains a strong presence in complex generic technologies, including being the largest supplier by volume of nasal sprays.

Positive

• Secured 180-day exclusivity period for generic trametinib in US market
• Target product has significant market value ($436M in annual sales)
• Expands presence in high-value oncology market
• No upfront manufacturing investment required (Novugen handles production)

Negative

• Additional marketing and sales expenses required
• Dependency on Novugen for manufacturing and supply
• Competition from brand name product (Mekinist®) may affect market share

Insights

Pharmaceutical Industry Analyst

Hikma's acquisition of trametinib ANDA offers 180 days of exclusivity for a $436M product, significantly boosting revenue potential in high-value oncology market.

Hikma's acquisition of the FDA-approved trametinib ANDA from Novugen represents a strategically significant move with substantial revenue implications. The deal grants Hikma exclusive first-to-file status with 180 days of US market exclusivity - the most valuable period in any generic product lifecycle. With the branded version (Mekinist) generating $436 million in annual US sales, this represents a meaningful commercial opportunity.

The partnership structure is particularly efficient: Hikma leverages its established commercial infrastructure while Novugen handles manufacturing. This allows each company to focus on core competencies without Hikma needing to invest in additional manufacturing capabilities for this complex oncology product.

Trametinib, an orally administered kinase inhibitor, strengthens Hikma's position in the high-value oncology market. Generic oncology medications typically maintain higher margins than conventional generics while improving treatment affordability. This aligns perfectly with Hikma's stated strategy of expanding in growing therapeutic areas with high patient need.

First-to-market generic entrants typically capture substantial market share during exclusivity periods, often with less price erosion than seen with multiple competitors. While the article doesn't specify the launch timeline, this acquisition positions Hikma to capitalize on a significant market opportunity while diversifying its product portfolio in the complex generics space where they already have established expertise.

Oncology Market Expert

Trametinib acquisition strengthens Hikma's oncology portfolio with 180-day exclusivity for a targeted therapy with $436M annual sales and strategic market positioning.

Hikma's acquisition of the trametinib ANDA represents a valuable addition to the oncology generics landscape. Trametinib is a MEK inhibitor primarily used in treating BRAF-mutated melanoma and certain other cancers, often as part of combination therapy regimens. As a targeted therapy, it commands higher reimbursement and stronger patient adherence compared to conventional chemotherapies.

The 180-day exclusivity period is particularly valuable in the oncology space where prescribers tend to be more reluctant to switch patients between manufacturers once treatment has begun. This creates a sustained advantage beyond the exclusivity window as patients often remain on the initial generic version.

With reference brand Mekinist generating $436 million in annual US sales, this represents one of the larger oncology generic opportunities in the near-term pipeline. Kinase inhibitors like trametinib typically face less immediate competitive pressure than other generic categories because of their manufacturing complexity and specialized handling requirements.

For patients, this generic entry will improve affordability for a critical cancer therapy. For Hikma, it establishes stronger relationships with oncology prescribers and payers, potentially creating pathways for future oncology product launches. The partnership with Novugen balances risk appropriately, allowing specialized manufacturing while leveraging Hikma's established commercial infrastructure in the US market.

LONDON, April 17, 2025 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma.

Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product.

"Hikma's Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans."

"As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen's innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma's strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy."

According to IQVIA, US sales of trametinib, sold under the brand name Mekinist^® (trametinib) Tablets, were approximately $436 million in the 12 months ending December 2024.

Hikma's Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US¹. 

¹IQVIA MAT December 2024, volumes by eaches

Mekinist^® is a registered trademark of Novartis Pharma AG

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

Enquiries

Hikma Pharmaceuticals PLC

Susan Ringdal EVP, Strategic Planning and Global Affairs	+44 (0)20 7399 2760/ +44 7776 477050
Steven Weiss US Communications	+1 732 788 8279

About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch)

Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

About Novugen
Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of expertise in the healthcare industry. The company has successfully ventured into strategic healthcare businesses and developed world-class healthcare facilities worldwide. Driven by a passion for science and a bold global strategy, Novugen specializes in niche, difficult-to-formulate generics across various therapeutic areas, including general and oncology pharmaceuticals, while adhering to stringent global quality standards. With vertical integration from research and development to manufacturing in Malaysia, Novugen maintains full control over its supply chain. Its state-of-the-art manufacturing facilities, comply with USFDA, EMA, PIC/S, and WHO regulatory requirements. Novugen is also the first in Malaysia and the only in Southeast Asia with USFDA-approved pharmaceutical manufacturing facilities dedicated to oral solid dosage forms for general medicines and highly potent oncology drugs. This accreditation positions Novugen as the first in Malaysia to manufacture and export high-quality medicines for the U.S. market. Novugen is committed to expanding early access to complex pharmaceutical products that often lack robust generic alternatives. Through continuous innovation, we strive to lead the way in delivering high-quality, technology-driven pharmaceuticals globally.

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SOURCE Hikma Pharmaceuticals USA Inc.

FAQ

What is the market value of trametinib (HKMPY) that Hikma acquired from Novugen?

US sales of trametinib (Mekinist®) were approximately $436 million in the 12 months ending December 2024.

How long will Hikma have exclusive generic market rights for trametinib in the US?

Hikma secured 180 days of US generic market sales exclusivity for trametinib.

What is the strategic importance of the trametinib ANDA acquisition for HKMPY?

The acquisition strengthens Hikma's US pipeline of essential medicines and expands its oncology portfolio with a high-value cancer treatment.

What are the roles of Hikma and Novugen in the trametinib partnership?

Hikma will handle US sales and marketing, while Novugen will manufacture and supply the product to Hikma.