GB Sciences and Catalent tackle the first-ever formulations of APIs containing up to nine cannabinoids and terpenoids for
the treatment of Parkinson's disease
SWINDON, U.K., and LAS VEGAS, Sept.
26, 2018 /PRNewswire/ -- 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.
About Catalent
Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and
consumer health products. With over 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.
Forward-Looking Statements
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 US Food and Drug Administration for
medicinal benefits, are not permitted under federal laws as they presently exist.
Contact Information
Corporate:
GB Sciences, Inc., 3550 West Teco Ave., Las Vegas, NV 89118
866-721-0297, or
Tom Arcuragi, EVP, tom@gbsciences.com
Catalent Pharma Solutions, 14 Schoolhouse Road, Somerset, NJ 08873
+1 (732) 537 6200, or
Chris Halling, Director, Global Communications and Marketing, +44 (0)7580 041073,
chris.halling@catalent.com
Richard Kerns, +44 (0) 161 728 5880, richard@nepr.eu
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SOURCE GB Sciences, Inc.