Mergers & Acquisitions News

Citeline and Norstella Merger Creates $5B Pharmaceutical Technology Company

The two companies completed their merger this month, combining their resources to simplify the clinical trial process for pharmaceutical companies and life sciences firms.

FDA Approvals, Merger, Citeline and Norstella Merger, Pharmaceutical Companies

Source: Getty Images

By Hayden Schmidt

- Norstella, a leading pharmaceutical solutions provider, completed its merger with Citeline earlier this month. As a result of the merger, Citeline will join Norstella’s group of brands, including Evaluate, MMIT, Panalgo, and The Dedham Group.

The merger combines Citeline’s solutions and analytics business for life sciences treatment development with Norstella’s drug development tools that will help clients deliver for patients and streamline the clinical trial process.

"We believe that patient access starts with identifying unmet needs and doesn't end until a patient has a therapy in hand," said Mike Gallup, CEO of Norstella. "As the industry moves toward highly targeted therapies focused on smaller patient populations, our clients need solutions that provide actionable answers to critical business questions to help bring drugs to market quicker — ultimately helping patients receive treatment sooner."

New York-based Citeline offers services that span the length of the clinical trial process, from planning and recruitment to product marketing, and will benefit from synergies between their offerings and Norstella’s broad reach.

"This union is an opportunity for both Citeline and Norstella to advance their shared mission of making therapies available to the patients who need them," said Jay Nadler, Executive Chair of Norstella, and Ramsey Hashem, CEO of Citeline. "We feel an urgency to make an impact, and we believe we can bring innovation that will change patients' lives."

Pharmaceutical companies are eager for assistance with the clinical trial process that can cost billions of dollars and isn’t guaranteed to succeed. Current estimates show that new drug development for therapeutics and biologics costs, on average, $1.1 billion, and less than 10% of drug candidates end up receiving approval. Altogether, the FDA approved just 55 novel drugs in 2021, down from 58 in 2018.

Major pharmaceutical companies are vulnerable to these failures that can delay product development and hold up treatments for patients. In early 2022, Gilead was slammed with an FDA hold on its HIV drug after it was found that their product’s vial type potentially created sub-visible glass particles.

In another instance, Bristol Myers Squibb (BMS) was issued a Refusal to File for its Biologics License Application for a cancer treatment drug after the FDA found manufacturing concerns with the product. The company had acquired the drug through a $74 billion merger with Celgene. It took BMS and its partner Bluebird Bio more than a year to amend their application and receive final approval for the drug.