Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

Rhea-AI Summary

Ashland Inc. (NYSE: ASH) has announced that the FDA has accepted its Viatel^™ bioresorbable mPEG-PDLLA pharmaceutical excipient into the Novel Excipient Review Pilot Program. This program allows for the review of novel excipients before their use in drug formulations, aiming to enhance public health. The excipient serves as a polymeric carrier for targeted drug delivery. Ashland's participation underscores its commitment to innovation in pharmaceutical ingredients, facilitating the development of complex drug molecules for improved therapeutic outcomes.

Positive

• FDA acceptance of Ashland's Viatel^™ excipient into the Novel Excipient Review Pilot Program could expedite the development of innovative drug formulations.
• The program represents a unique opportunity for Ashland to differentiate its technology in the pharmaceutical market.

Negative

• None.

WILMINGTON, Del., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Ashland Inc. (NYSE: ASH) today announced the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel^™ bioresorbable mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA Novel Excipient Review Pilot Program.

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations^*. The pilot program which offers a new pathway to evaluate excipients could hasten important public health benefits and is available for novel excipients that have not been used in FDA-approved drug products nor have an established use in food. Ashland’s excipient is intended as a polymeric carrier for the delivery of therapeutic pharmaceuticals to target certain tissue sites within the body.

“We are continuing to demonstrate strong technology differentiation in new product innovations that are aligned with core markets and customer drivers to enable organic growth,” said Guillermo Novo, chair and chief executive officer, Ashland.

The primary functions of Ashland’s excipient could offer life-changing and transformative benefits for consumers. For customers, primary formulation formats include nanoparticles, microparticles, implants or in-situ forming drug depots.

“This prestigious opportunity to participate in the FDA pilot program shines a spotlight on Ashland’s life sciences core strategy of undiluted attention to innovation in pharmaceutical ingredients,” said Ashok Kalyana, senior vice president and general manager, life sciences, Ashland. “Working with pharmaceutical partners, we’re addressing scenarios where manufacturers and drug developers have previously cited difficulty using existing products. Ashland’s innovative excipients effectively deliver complex drug molecules where and when they're needed.”

The two-stage FDA program includes the proposal and full data package. Ashland’s submission will proceed to the second stage of the program.

For more information, visit Ashland.com/viatel

About Ashland 
Ashland Inc. (NYSE: ASH) is a global additives and specialty ingredients company with a conscious and proactive mindset for environment, social and governance (ESG). The company serves customers in a wide range of consumer and industrial markets, including architectural coatings, automotive, construction, energy, food and beverage, nutraceuticals, personal care and pharmaceutical. Approximately 3,900 passionate, tenacious solvers – from renowned scientists and research chemists to talented engineers and plant operators – thrive on developing practical, innovative and elegant solutions to complex problems for customers in more than 100 countries. Visit ashland.com and ashland.com/ESG to learn more.

*https://www.fda.gov/drugs/development-approval-process-drugs/pilot-program-review-innovation-and-modernization-excipients-prime

^™ Trademark, Ashland or its subsidiaries, registered in various countries.

FOR FURTHER INFORMATION:

Investor Relations:	Media Relations:
Seth A. Mrozek	Carolmarie C. Brown
+1 (302) 594-5010	+1 (302) 995-3158
samrozek@ashland.com	ccbrown@ashland.com

Attachment

• Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program - 20221031

FAQ

What is the significance of the FDA's acceptance of Ashland's Viatel^™ excipient?

The FDA's acceptance signifies a major step in the approval process, allowing Ashland to enhance its pharmaceutical offerings and potentially improve drug delivery methods.

How does the Novel Excipient Review Pilot Program benefit Ashland?

This program provides Ashland with a pathway to have its novel excipients evaluated before their use, potentially speeding up product development and enhancing market competitiveness.

What role does the Viatel^™ excipient play in drug formulation?

Viatel^™ serves as a polymeric carrier designed for the targeted delivery of therapeutic pharmaceuticals, improving effectiveness and precision in treatment.