Sorrento Establishes Business Unit to Address Market Opportunity for Proprietary Water Soluble Cannabidiol (CBD) Formulations...
16 Abril 2019 - 10:00AM
Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announced
today that it has established a new business unit to focus on the
market potential for its innovative water soluble cannabidiol (CBD)
formulation technology.
Cannabidiol (CBD) has been under consideration within the
pharmaceutical side of Sorrento for its interesting pharmacological
properties and potential clinical benefits in multiple central
nervous system, autoimmune or inflammatory disease and pain related
indications.
Current CBD products face the limitations of oil-based
formulations. Available oral CBD products, formulated in sesame or
olive oil, can be associated with gastro-intestinal intolerance
(diarrhea). It is anticipated that aqueous formulations would
overcome this inconvenient characteristic. The challenge so far has
been to achieve comparable concentrations between oil or water
based formulations given the lipophilic properties of CBD.
Sorrento scientists have extensive experience developing
innovative drug formulations to solubilize otherwise insoluble
pharmaceutical compounds, utilizing GRAS (generally recognized as
safe) excipients. Multiple promising water soluble formulations are
currently in stability studies for the drug development program.
Safety assessment and pharmacokinetic studies in animals are under
way to support water soluble human CBD drug development (IND
enabling studies). If bioequivalence is confirmed in animal
studies, the selected water-based formulation would be eligible for
further human studies towards an FDA approval using the 505(b)(2)
pathway for any indication currently approved for CBD.
Some Sorrento pharmaceutical formulations have been identified
as highly scalable and therefore great candidates for a consumer
application. Sorrento scientists have also worked towards achieving
formulations that are preservative free and with no known
impurities. These pharmaceutical standards are often lacking in CBD
consumer business products.
The Sorrento consumer-targeted CBD concentrate could range
anywhere from 5% to 10% (50 - 100 mg/ml). This concentration range
is believed to be among the highest in the industry, and
potentially the highest concentration achieved for a water soluble
formulation.
The Company has initiated discussions with global food and
beverage producers that have a strong interest in non-oil based CBD
concentrate products. Sorrento is also in the process of securing
exclusive supply agreements with hemp growers and CBD purification
facilities in preparation for significant demand of high quality
hemp plant materials and water soluble and purified CBD.
“Without distracting from our pharmaceutical business, we have
the ability to leverage another Sorrento innovative technology –
this time from our formulation experts – and make it available to
the broader consumer market” stated Dr. Henry Ji, CEO and Chairman
of Sorrento Therapeutics. “Longer-term, we may consider spinning
off our CBD consumer business into an independently operated
company if appropriate, while our research and clinical development
team continues to explore the potential pharmaceutical applications
of cannabidiol (CBD) for the medical markets”.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
Sorrento's multimodal multipronged approach to fighting cancer is
made possible by its extensive immuno-oncology platforms, including
key assets such as fully human antibodies (“G-MAB™ library”),
clinical stage immuno-cellular therapies (“CAR-T”), intracellular
targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”),
and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer
patients and Osteoarthritis (OA) patients is also demonstrated by
its effort to advance Resiniferatoxin (“RTX”), a first-in-class
(TRPV1 agonist) non-opioid pain management small molecule, ZTlido®
and SP-102, a non-opioid corticosteroid gel. Resiniferatoxin is
completing a Phase 1b trial in terminal cancer patients and a Phase
1b trial for OA. ZTlido was approved by US FDA on 02/28/18. SP-102
(Semdexa™) is in Phase 3 pivotal study for the treatment of lumbar
radicular pain/sciatica.
For more information visit www.sorrentotherapeutics.com
More information on Sorrento clinical trials can be found at
www.clinicaltrials.gov
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting contain forward-looking statements related
to Sorrento Therapeutics, Inc., under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995
and subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward-looking
statements include statements regarding the expectations for
Sorrento's and its subsidiaries' technologies and product
candidates, including, but, not limited to, Cannabidiol (CBD), the
potential markets for CBD, expected concentration ranges,
Sorrento’s discussions with global food and beverage producers,
hemp growers and CBD purification facilities and any spinoff of
Sorrento’s CBD consumer business unit. Risks and
uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
related to Sorrento's and its subsidiaries' technologies and
prospects, including, but not limited to, CBD consumer business and
potential spinoffs; risks related to securing exclusive supply
arrangements with Hemp growers and CBD production facilities,
regulatory approvals for pharmaceutical CBD and conducting and
obtaining results of clinical trials, the clinical and commercial
success of CBD, including water soluble formulations; the viability
and success of using CBD for consumers and other risks that are
described in Sorrento's most recent periodic reports filed with the
Securities and Exchange Commission, including Sorrento's Annual
Report on Form 10-K for the year ended December 31, 2018, and
subsequent Quarterly Reports on Form 10-Q filed with the Securities
and Exchange Commission, including the risk factors set forth in
those filings. Investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date of this release and we undertake no obligation to update any
forward-looking statement in this press release except as required
by law.
Media and Investor Relations
Contact: Alexis Nahama, SVP Corporate Development
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc. ZTlido® and G-MAB™ are trademarks owned
by Scilex Pharmaceuticals Inc. and Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics
Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics, Inc.
Semdexa™ is a trademark owned by Semnur Pharmaceuticals, Inc. A
proprietary name review by the FDA is planned. All other trademarks
are the property of their respective owners.
© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.
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