Glen Rock, N.J., Sept. 10, 2018 (GLOBE NEWSWIRE) -- September 10, 2018 /Globe Newswire – RespireRx
Pharmaceuticals Inc. (OTCQB: RSPI) (“RespireRx” or the “Company”), is pleased to announce that on September 4, 2018, it entered
into a dronabinol Development and Supply Agreement (“Agreement”) with Noramco, Inc. RespireRx is developing dronabinol for
Obstructive Sleep Apnea (“OSA”), a condition that affects an estimated 29.4 million Americans and for which there is no approved
pharmaceutical therapy. RespireRx believes, subject to meeting with the Food and Drug Administration (“FDA”), that dronabinol is
Phase 3 ready.
Under the terms of the Agreement, Noramco agreed to (i) provide all of the active pharmaceutical ingredient
(“API”) estimated to be needed for the clinical development process for both the first- and second-generation products (each a
“Product” and collectively, the “Products”), three validation batches for NDA filing(s) and adequate supply for the initial
inventory stocking for the wholesale and retail channels, subject to certain limitations, (ii) maintain or file valid drug master
files (“DMFs”) with the FDA or any other regulatory authority and provide the Company with access or a right of reference letter
entitling the Company to make continuing reference to the DMFs during the term of the agreement in connection with any regulatory
filings made with the FDA by the Company, (iii) participate on a development committee and (iv) make available its regulatory
consultants, collaborate with any regulatory consulting firms engaged by the Company and participate in all FDA or Drug Enforcement
Agency (“DEA”) meetings as appropriate and as related to the API.
In consideration for these supplies and services, the Company agreed to purchase exclusively from Noramco during
the commercialization phase all API for its Products at a pre-determined price subject to certain producer price adjustments, and
agreed to Noramco’s participation in the economic success of the commercialized Product or Products up to the earlier of the
achievement of a maximum dollar amount or the expiration of a period of time.
“We are very pleased and excited to enter into this development and supply agreement with Noramco, a leading
dronabinol manufacturer,” said Dr. Arnold Lippa, the Company’s Executive Chairman and Chief Scientific Officer. “There are
significant FDA and DEA regulatory and manufacturing complexities surrounding the dronabinol supply chain, considered a DEA
Schedule I drug as API and a Schedule III drug as a gel capsule. Through this arrangement with Noramco, we believe that we have
solved not only some of our regulatory concerns, but also secured appropriate manufacturing capacity. We believe that the potential
OSA market is extremely large, many times larger than the current market for dronabinol for currently approved indications, so the
commitment by Noramco to provide clinical material and to ensure commercial supply demonstrates our mutual belief that dronabinol
for OSA can be a commercial success.”
“Supplying a high-purity dronabinol to RespireRx to meet such a significant unmet medical need reflects the core
of our capability,” said Tim Jones, Director of Global Cannabinoids Portfolio, Noramco. “We appreciate that RespireRx recognizes
our ten years of experience in cannabinoids manufacture for pharmaceutical products, including the regulatory and supply chain
expertise we bring to DEA Schedule I through III APIs. We look forward to partnering with RespireRx with high-quality dronabinol as
the company moves toward regulatory approval.”
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the development of medicines for respiratory disorders and CNS
indications, with a focus on obstructive sleep apnea, attention deficit hyperactivity disorder (ADHD), spinal cord injury, other
neurological conditions and drug-induced respiratory depression. The Company holds exclusive licenses and owns patents and patent
applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the
treatment of a variety of disorders, as well as claims for novel uses of known drugs.
Cannabinoids. RespireRx is developing dronabinol, a synthetic derivative of a naturally
occurring substance in the cannabis plant, for the treatment of OSA, a serious respiratory disorder that impacts an estimated 29.4
million people in the United States according to the American Academy of Sleep Medicine (“AASM”), published in August 2016. OSA has
been linked to increased risk for hypertension, heart failure, depression, and diabetes, and has an annual economic cost in the
United States of approximately $162 billion according to the AASM. There are no approved drug treatments for OSA.
RespireRx believes, pending the outcome of an intended meeting with the FDA, that it will be able to commence a
Phase 3 clinical study for the treatment of OSA with dronabinol. The Company further believes that it would only require approval
by the FDA of a 505(b)(2) new drug application (“NDA”), an efficient regulatory pathway.
RespireRx believes that the most direct route to commercialization is to proceed directly to a Phase 3 pivotal
trial using the currently available dronabinol formulation (2.5, 5 and 10 mg gel caps) and to then commercialize a RespireRx
branded dronabinol capsule (“RBDC”).
RespireRx also believes that there are numerous opportunities for reformulation of dronabinol to produce a
second-generation proprietary, branded product for the treatment of OSA with an improved profile. Therefore, simultaneous with the
development of the RBDC, RespireRx plans to develop a proprietary dronabinol formulation to optimize the dose and duration of
action for treating OSA.
Ampakines. The second platform of proprietary medicines being developed by RespireRx are
ampakines, which act to enhance the actions of the excitatory neurotransmitter glutamate at AMPA glutamate receptors. Several
ampakines, in both oral and injectable forms, are being developed by the Company for the treatment of a variety of CNS disorders
including ADHD and spinal cord injury.
Ampakines have shown potential as possible therapeutic agents for the treatment of certain neuropsychiatric and
neurological disorders. Ampakines have demonstrated statistically significant improvement of symptoms observed in a Phase 2
clinical trial of CX717 in adults with ADHD. This represents a successful translation from earlier animal and preclinical studies.
At present, the major pharmacotherapies available for ADHD are made up of two types of drugs. Stimulants, such as amphetamine,
rapidly produce robust effects, but suffer from side effects typical of stimulants, including tolerance, dependence, withdrawal and
abuse. For these reasons, stimulants are scheduled by the FDA. Non-stimulants, such as Straterra® (atomoxetine) tend to be less
effective than stimulants, with a much longer (approximately 4 – 8 week) latency to onset of action. In a number of animal and
human studies, CX717 and other ampakines did not display any stimulant properties typically associated with drugs like amphetamine.
In the Phase 2 ADHD clinical trial, statistically significant therapeutic effects were observed within one week. Therefore, we
believe ampakines may represent a novel, non-stimulant treatment for ADHD with a more rapid onset of action than alternative
non-stimulant treatment options. Additionally, in clinical studies of respiratory function, select ampakines have shown preliminary
efficacy in central sleep apnea and in the control of respiratory depression produced by opioids, without altering the opioid
analgesic effects. In animal models of spinal cord injury, an ampakine has been shown to improve motor function. In animal models
of certain orphan disorders, such as Pompe Disease, Rett’s Syndrome and perinatal respiratory distress, certain ampakines have been
shown to improve breathing function.
RespireRx owns certain composition of matter and use patents and patent applications with respect to ampakines
CX1739, CX717 and other ampakines. The Company has received notice from the University of Alberta that purports to terminate the
Company’s license in respect of patents associated with respiratory applications of ampakines. RespireRx has been in contact with
the University of Alberta and is engaging in a dispute resolution process with respect to its license with the University of
Alberta in respect to use patents associated only with respiratory applications of ampakines.
Additional information about the Company and the matters discussed herein can be obtained on the Company’s
web-site at www.RespireRx.com or in the Company’s filings with the Securities and Exchange Commission at
www.sec.gov.
About Noramco, Inc.
Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances
bulk APIs for the pharmaceutical industry. The company offers cannabinoids and APIs for use in abuse deterrence, attention deficit
disorder, pain management, and addiction management. Established in 1979, Noramco maintains production and R&D facilities in
Delaware and Georgia (USA), and Neuhausen, Switzerland. Noramco leverages decades of expertise in controlled substance development,
licensing and scale up thereby offering pharmaceutical companies a fully integrated supply chain for synthetic cannabinoid-based
APIs. Additional information about Noramco can be obtained by visiting www.Noramco.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Company intends that such forward-looking
statements be subject to the safe harbor created thereby. These might include statements regarding the Company’s future plans,
targets, estimates, assumptions, financial position, business strategy and other plans and objectives for future operations, and
assumptions and predictions about research and development efforts, including, but not limited to, preclinical and clinical
research design, execution, timing, costs and results, future product demand, supply, manufacturing, costs, marketing and pricing
factors.
In some cases, forward-looking statements may be identified by words including “anticipates,” “believes,”
“intends,” “estimates,” “expects,” “plans,” “contemplates,” “targets,” “continues,” budgets,” “may,” and similar expressions and
such statements may include, but are not limited to, statements regarding (i) future research plans, expenditures and results, (ii)
potential collaborative arrangements, (iii) the potential utility of the Company’s proposed products, (iv) reorganization plans,
(v) the clinical development, regulatory review and commercialization process, and (vi) the need for, and availability of,
additional financing.
The forward-looking statements included herein are based on current expectations that involve a number of risks
and uncertainties. These forward-looking statements are based on assumptions regarding the Company’s business and technology, which
involve judgments with respect to, among other things, future scientific, economic, regulatory and competitive conditions,
collaborations with third parties, and future business decisions, all of which are difficult or impossible to predict accurately
and many of which are beyond the Company’s control. Although the Company believes that the assumptions underlying the
forward-looking statements are reasonable, actual results may differ materially from those set forth in the forward-looking
statements. In light of the significant uncertainties inherent in the forward-looking information included herein, the inclusion of
such information should not be regarded as a representation by the Company or any other person that the Company’s objectives or
plans will be achieved.
Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies
or changes thereto, available cash, research and development results, competition from other similar businesses, interest of third
parties in collaborations with us, and market and general economic factors. This discussion should be read in conjunction with the
condensed consolidated financial statements (unaudited) and notes thereto included in Item 1 of the Company’s Quarterly Report on
Form 10-Q and the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including the section entitled
“Item 1A. Risk Factors.” The Company does not intend to update or revise any forward-looking statements to reflect new information,
future events or otherwise.
Company Contact: Jeff Margolis Senior Vice President, Chief Financial Officer, Treasurer and Secretary Telephone: (917) 834-7206 E-mail: jmargolis@respirerx.com