Hikma Pharmaceuticals Spotlights R&D Shift, Nasal Epinephrine Filing Progress

Key Points

• Hikma is centralizing its R&D organization around three specialized platforms, with greater emphasis on global product programs and developing higher-complexity medicines across multiple markets.
• The company uses financial return metrics and development-stage reviews to prioritize projects, and may cancel programs when competition or other factors reduce their projected value.
• Hikma’s nasal epinephrine product has been accepted for U.S. review and filed in several other markets, with FDA feedback expected in the first half of 2027. The company is also advancing inhaler programs, though its Respimat project has faced technical delays.

Hikma Pharmaceuticals LON: HIK outlined a more centralized research and development strategy at the first event in its R&D Spotlight series, highlighting investments in respiratory, nasal, semi-solid and liquid products and describing its approach to developing higher-complexity medicines.

Hafrun Fridriksdottir, Hikma’s global head of R&D, said the company reorganized its R&D activities into a global structure after development work had previously been managed within separate business divisions. The new organization is built around three platforms: respiratory, nasal, semi-solids and liquids; solid oral products; and injectables. Cross-functional R&D operations and regulatory teams support the platforms.

Fridriksdottir said the structure is intended to create more specialized teams and increase the focus on products that can serve multiple markets. While Hikma will continue to pursue opportunities specific to individual markets, she said the company is placing greater emphasis on global product programs and incorporating requirements from its various markets at the outset of development.

Investment guided by returns and stage gates

The company said it uses net present value, internal rate of return and return-on-investment metrics to select and prioritize products. Fridriksdottir said Hikma’s portfolio and product-selection team works with commercial, legal, finance and R&D functions, while the executive team participates in product-selection meetings.

Products are reassessed as they progress through development stages, she said. If projected value deteriorates, including because of increased competition, Hikma may discontinue a program rather than continue to commit resources.

“We don’t hesitate to cancel the product” when its value no longer supports continued development, Fridriksdottir said. She added that cancellations occur more frequently in U.S.-focused programs, where competitive intensity can be higher, than in products being developed for Middle East and North Africa markets.

The company characterized its R&D pipeline as a mix of larger, complex programs and smaller opportunities that may require less investment but can still offer meaningful returns.

Nasal epinephrine submitted in multiple markets

Chris Edlin, Hikma’s vice president of R&D for the respiratory, nasal, semi-solids and liquids platform, said the company’s intranasal epinephrine product has been filed and accepted for review in the U.S. Hikma has also filed through the European Union’s decentralized procedure, submitted an application to the U.K.’s Medicines and Healthcare products Regulatory Agency, and filed in Canada, Jordan and Saudi Arabia.

Edlin said Hikma expects feedback from the U.S. Food and Drug Administration during the first half of 2027 but did not provide a launch-date forecast. He said the company could not disclose product data or specific commercial differentiators while the product remains under regulatory review.

The nasal epinephrine product was developed through the U.S. 505(b)(2) pathway, which Edlin described as an approach that can use existing evidence on a medicine’s safety and efficacy while supporting a new formulation or route of administration. He said epinephrine has an established clinical history and that Hikma reformulated it into a nasal dosage form intended to offer greater convenience for patients.

Fridriksdottir acknowledged that Hikma is not the first company to market nasal epinephrine, but said the company believes being a fast follower could be beneficial if earlier entrants help establish the market for the dosage form.

Respiratory programs and manufacturing capabilities

Edlin said Hikma has made progress on its Ellipta inhaler program, selecting a device partner and generating in-vitro and human in-vivo data. The company is also establishing commercial manufacturing capability in Columbus, Ohio, where much of the platform’s R&D team is based.

According to Edlin, the program can use some equipment and vendor relationships already established for Hikma’s generic Advair product. He said the company will use external partners where it lacks manufacturing capabilities or where specialized device engineering is required.

Hikma said its Respimat soft-mist inhaler program has experienced some technical challenges that delayed the anticipated submission timing. However, Edlin said the company does not believe the delay will materially affect planned launch timing around patent expiry. For pressurized metered-dose inhalers, Hikma has selected two high-volume areas and is finalizing an agreement with a third-party development partner.

Management said complex respiratory products typically have higher barriers to entry than simpler oral medicines because they require expertise in drug formulation, device interaction, clinical development and reliable high-quality manufacturing. Fridriksdottir noted that generic Advair competitors have taken substantial time to obtain approvals, illustrating the complexity of such programs.

Edlin also said Hikma is using artificial intelligence primarily as a productivity tool, including for report generation, data aggregation and analysis. He said the technology is intended to free scientists from administrative work while retaining scientific review and quality-control processes.

About Hikma Pharmaceuticals (LON:HIK)

At Hikma we help put better health within reach, every day. By creating high-quality medicines and making them accessible to the people who need them, we help to shape a healthier world that enriches all our communities. We help deliver this by living our culture, delivering our strategy, and acting responsibly. We are a trusted, reliable partner and dependable source of over 820+ (as of Feb 2026) high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, MENA and Europe.

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