Neos Therapeutics Announces Issuance of New U.S. Methods of Use Patent for N-desethyloxybutynin
April 09 2020 - 8:00AM
Neos Therapeutics, Inc. (NASDAQ: NEOS), a commercial-stage
pharmaceutical company developing and manufacturing central nervous
system-focused products, today announced that the United States
Patent and Trademark Office (USPTO) has issued U.S. Patent No.
10,610,507, which is directed to methods of treating sialorrhea by
administering N-desethyloxybutynin, the active pharmaceutical
ingredient in NT0502. NT0502 is currently in Phase 1 clinical
development for the treatment of sialorrhea in patients with
neurological conditions. The patent, assigned to Neos Therapeutics,
is not expected to expire before November 2032.
“We are very pleased to have secured this important method of
use patent from the USPTO. The issuance of this patent further
supports our efforts to explore the potential of NT0502 to treat
sialorrhea in patients with neurological disorders, particularly
Parkinson’s Disease, given the significant psychosocial and medical
impact they experience,” said Jerry McLaughlin, President and Chief
Executive Officer. “We remain on track to initiate a Phase 1 single
ascending and multiple ascending dose clinical trial of NT0502 in
the second half of 2020, and look forward to reporting the data
from this trial.”
About NT0502NT0502 (N-desethyloxybutynin) is a
new chemical entity being developed as an oral, once- or
twice-daily treatment to reduce chronic sialorrhea in patients with
neurological and other conditions associated with excess saliva and
drooling. Based on preclinical data, the company believes that
NT0502 offers the potential for an improved tolerability profile
and an easier-to-dose oral formulation, without the need for
complex titration, compared to existing treatment options.
N-desethyloxybutynin is an active metabolite of oxybutynin, an
approved drug to treat a urological condition.
About Sialorrhea Sialorrhea is defined as
prevalent and excessive drooling from the mouth as a result of
limitations in a person’s ability to control and swallow oral
secretions1,2. Sialorrhea can lead to significant physical and
psychosocial complications, including perioral chapping,
aspiration, dehydration, infection, foul odor, stigmatization, and
increased dependency and level of care, all of which can create an
additional burden for these medically complicated patients1,3. In
the U.S., more than 1.4 million patients – including those
suffering from Parkinson’s disease4,5, cerebral palsy6,7,
stroke8,9, traumatic brain injury10, ALS11 and other neurological
conditions12,13 – experience sialorrhea due to
neuromuscular/sensory dysfunction. Many of these patients
remain untreated today because existing non-selective
anticholinergic agents are associated with treatment-limiting side
effects and cumbersome dosing schedules.
About Neos Therapeutics Neos Therapeutics,
Inc. (NASDAQ: NEOS) is a commercial-stage pharmaceutical
company utilizing its novel microparticle delivery technology to
develop and manufacture central nervous system (CNS)-focused
products. Adzenys XR-ODT® (amphetamine) extended-release
orally disintegrating tablets (see Full Prescribing
Information, including Boxed WARNING), Cotempla
XR-ODT® (methylphenidate) extended-release orally
disintegrating tablets (see Full Prescribing
Information, including Boxed WARNING), and
Adzenys-ER® (amphetamine) extended-release oral suspension
(see Full Prescribing Information, including
Boxed WARNING), all for the treatment of ADHD, are three approved
products utilizing the Company’s novel microparticle delivery
technology. Additional information about Neos is available
at www.neostx.com.
Forward-Looking StatementsCertain statements in
this press release constitute “forward-looking statements” within
the meaning of The Private Securities Litigation Reform Act of
1995. Forward-looking statements may involve statements about
future expectations, plans and prospects for the Company, including
statements about the Company’s strategy, future operations,
commercial products, clinical development of its therapeutic
candidates, plans for potential future product candidates,
financial condition and outlook, intellectual property, and other
statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “suggest,” “target,” “potential,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: the impact of COVID-19,
including with respect to the clinical development of NT0502; the
status, timing, costs, results and interpretation of the Company’s
clinical trials or any future trials, including whether the Company
will initiate a Phase 1 ascending dose study of NT0502 in the
second half of 2020; the uncertainties inherent in conducting
clinical trials, including any potential impact on timing resulting
from COVID-19; expectations for regulatory interactions,
submissions and approvals; the financial condition and outlook for
the Company; availability of funding sufficient for the Company’s
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; uncertainties related to the Company’s
intellectual property, including with respect to the U.S. patent
covering methods of treating sialorrhea; other matters that could
affect the availability or commercial potential of the Company’s
commercial products or therapeutic candidates, including whether
NT0502 offers the potential for an improved tolerability profile
and an easier-to-dose oral formulation, without the need for
complex titration, compared to existing treatment options; and
other factors discussed in the Risk Factors set forth in the
Company’s Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings the Company makes with the SEC from time to time. In
addition, the forward-looking statements included in this press
release represent the Company’s views only as of the date hereof.
The Company anticipates that subsequent events and developments may
cause the Company’s views to change. However, while the Company may
elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to do so,
except as may be required by law.
References
- Hockstein NG, et al. Sialorrhea: a management challenge. Am Fam
Physician. 2004; 69: 2628-34.
- Chou KL, et al. Sialorrhea in Parkinson’s Disease: a review.
Movement Disorders. 2007; 22(16): 2306-2313.
- Bavikatte G, et al. Management of drooling of saliva. Br J Med
Practitioners. 2012; 5(1): a507.
- Marras C, et al. Prevalence of Parkinson’s disease across North
America. npjParkinson’s Disease. 2018; 4(21): 1-22.
- Kalf JG, et al. Prevalence and definition of drooling in
Parkinson’s disease: a systematic review. J Neurol. 2009; 256:
1391-1396.
- Maenner MJ, et al. Prevalence of cerebral palsy and
intellectual disability among children identified in two US
National Surveys, 2011-2013. Ann Epidemiol. 2016; 26(3):
222-226.
- Reid SM, et al. Prevalence and predictors of drooling in 7- to
14-year-old children with cerebral palsy: a population study. Dev
Med Child Neurol. 2012; 54: 1032-1036.
- Mozaffarian D, et al. Heart disease and stroke statistics –
2016 update. Circulation. 2016; 133: e38-e360.
- Cohen DL, et al. Post-stroke dysphagia: a review and design
considerations for future trials. Int J Stroke. 2016; Jun:11(4):
399-411.
- Alhashemi HH. Dysphagia in severe traumatic brain injury.
Neurosciences. 2010: 15(4): 231-236.
- Garuti G, et al. Sialorrhea in patients with ALS: current
treatment options. Degenerative Neurol Neuromuscular Dis. 2019; 9:
19-26.
- McGrath J, et al. Schizophrenia: a concise overview of
incidence, prevalence, and mortality. Epidemiol Rev. 2008; 20:
67-76.
- Maher S, et al. Clozapine-induced hypersalivation: an estimate
of prevalence, severity, and impact on quality of life. Ther Adv
Psychopharmacol. 2016; 6(3): 178-184.
Contacts:
MediaJennifer GuinanSage Strategic
Marketing610.410.8111jennifer@sagestrat.com
InvestorsRichard Eisenstadt Chief Financial
Officer Neos Therapeutics 972.408.1389 reisenstadt@neostx.com
Sarah McCabe Stern Investor Relations, Inc.
212.362.1200sarah.mccabe@sternir.com
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