Acella Pharmaceuticals Signs Product Development Agreement with Catalent To Bring Opioid-Abuse Deter
August 10, 2017
Acella Pharmaceuticals, LLC, a leading U.S. manufacturer of specialty pharmaceuticals across several therapeutic categories, today announced an exclusive, multi-year, multi-product development and licensing partnership with Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, to develop, manufacture, and commercialize a new portfolio of abuse-deterrent pain relief products leveraging Catalent’s OptiGel™ Lock Technology.
Abuse of prescription opioids is a very serious and rapidly growing issue, with ninety-one Americans dying every day from an opioid overdose.1-2 Since 1999, the number of overdose deaths involving opioids (including prescription opioids and heroin) quadrupled, resulting in more than a half million opioid-related overdose deaths from 2000 to 2015.1-2 With these and other statistics surrounding the issues of substance abuse, the parties anticipate an expedited review and approval by the FDA, as this agreement was executed on the heels of the FDA’s abuse deterrence initiatives announced on June 13 by FDA Commissioner Scott Gottlieb, M.D.
“OptiGel™ Lock technology has the potential to limit abuse by incorporating multi-stage levels of prevention,” commented Mr. Julien Meissonnier, Vice President, Science and Technology at Catalent. “Catalent’s OptiGel™ Lock softgel dosage form is inherently resistant to abuse and cannot be ground, blended or crushed, for inhalation or injection.”
“Through this agreement, it is our intention to support the goals of both the FDA and the pharmaceutical industry by finding a safe product solution that will continue to provide efficacious pain management options for prescribers and patients,” stated Harold A, Deas, Jr., Chief Executive Officer for Acella Pharmaceuticals. “This partnership combines the expertise of each party involved: the cutting-edge development and delivery technology from Catalent with the infrastructure, distribution and speed-to-market capabilities of Acella.”
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 10,000 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, please visit www.catalent.com.
About Acella Pharmaceuticals, LLC
Acella develops, markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of Dermatology, Women’s Health, Pediatrics and other applications. Acella specializes in identifying and bringing to market quality, affordable products to customers and patients. For additional information please contact Acella at 678-325-5189 or visit www.acellapharma.com.
REFERENCES: 1. CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016. Available at http://wonder.cdc.gov. 2. Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016.