Catalent Pharma Solutions today announced that GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences’ proprietary active pharmaceutical ingredients (“APIs”) for its Parkinson’s disease therapies.
SWINDON, U.K., and LAS VEGAS, September 26, 2018– GB Sciences, Inc. (OTCQB: GBLX) and Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that GB Sciences has selected Catalent to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences’ proprietary active pharmaceutical ingredients (“APIs”) for its Parkinson’s disease therapies. A proof of concept study will be conducted by Catalent at its Swindon, U.K. facility to evaluate GB Sciences’ clinical candidates GBS101, GBS102, and GBS103 using Catalent’s proprietary Zydis® Orally Disintegrating Tablet (ODT) technology.
GB Sciences’ three patent-pending APIs for Parkinson’s disease are complex mixtures containing up to nine individual components that function synergistically. Preclinical studies have shown that these cannabinoid-containing complex mixtures are more potent than would have been predicted by combining the activity of each individual compound.
“To prepare our Parkinson’s disease formulations for human clinical trials, we wanted the ease-of-use offered by Zydis ODTs for our Parkinson’s patients, many of whom may have difficulties in swallowing. Catalent’s proprietary delivery method also potentially offers consistent dosing for our complex cannabinoid- and terpenoid-containing APIs,” explained Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences. “The creation of GB Sciences’ proprietary APIs in Zydis ODT formulations is a very important step towards readying them for our Exploratory IND filing and planned phase zero human trial for patients with mild to moderate Parkinson’s disease.”
Jonathan Arnold, President of Oral Drug Delivery at Catalent, added, “Dissolving rapidly in the mouth, ODTs are convenient and ease administration, offering an alternate dosage form for patients who have difficulty swallowing, as is sometimes the case with Parkinson’s disease, as well as with geriatric or pediatric patients.”
GB Sciences selected Catalent as its development partner due to its expertise in tackling formulation challenges, and ability to achieve the stability and dosing necessary for these novel complex mixtures. In addition to its Zydis technology, Catalent has early development and oral drug delivery solutions available for the efficient delivery of GB Sciences’ proprietary APIs.
+44 (0)7580 041073
+44 (0) 161 728 5880
Tom Arcuragi, EVP
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With 85 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 over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal 2018 generated approximately $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.
More products. Better treatments. Reliably supplied.™
About GB Sciences, Inc.
GB Sciences, Inc. (OTCQB: GBLX) is a diverse cannabis company, focused on standardized cultivation and production methods; as well as biopharmaceutical research and development. The company’s goal is creating safe, standardized, pharmaceutical-grade, cannabinoid therapies that target a variety of medical conditions. To learn more about GB Sciences, Inc., go to: http://gbsciences.com.
This press release may contain statements relating to future results or events, which are forward-looking statements. Words such as "expects", "intends", "plans", "may", "could", "should", "anticipates", "likely", "believes" and words of similar import may identify forward-looking statements. These statements are not historical facts, but instead represent only GB Sciences’ or Catalent Pharma Solutions’ belief regarding future events, many of which, by their nature, are inherently uncertain and outside of their respective control. It is possible that actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further, information concerning each of GB Sciences and Catalent and each of their respective businesses, including factors that potentially could materially affect the their business and financial and other results, are contained in their respective filings with the Securities and Exchange Commission, available at www.sec.gov. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
Note: Although GB Sciences’ research and development activities are not illegal, the production and sale of cannabis products in the United States, except as otherwise approved by the U.S. Food and Drug Administration for medicinal benefits, are not permitted under federal laws as they presently exist.
GB Sciences, Inc., 3550 West Teco Ave., Las Vegas, NV 89118
Tom Arcuragi, EVP, firstname.lastname@example.org
Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, NJ 08873+1
(732) 537 6200, or
Chris Halling, Director, Global Communications and Marketing, email@example.com