STANS, Switzerland, Feb. 21, 2019 (GLOBE NEWSWIRE) -- NLS-1 Pharma (NLS), a Swiss biotech firm focusing on the development of novel treatments for Attention-Deficit/Hyperactivity Disorder (ADHD) and other cognitive disorders and impairments, today announced an exclusive license agreement to develop and commercialize its clinical-stage ADHD therapy, Nolazol® (Mazindol CR), in Central & South America (Latin America) with Eurofarma, a Brazilian pharmaceutical company with a presence in 20 Latin American countries.
“We are pleased to establish a partnership with Eurofarma, a strong partner to support the development and commercialization of Nolazol® across Latin America. We believe that there is a significant opportunity for Nolazol® for ADHD in Latin America, and with an established presence in 20 Latin American countries, we believe Eurofarma has the critical local expertise and resources to execute on regulatory approvals and commercialization for Nolazol® in this region,” says Alex Zwyer, CEO of NLS. “As a non-amphetamine molecule with stimulant-like efficacy, we believe that Nolazol® has the potential to disrupt the ADHD market by offering an effective, and importantly safer, alternative to the standard of care currently available in the region.”
The terms of the agreement have not be disclosed. Eurofarma will be responsible for seeking the required regulatory approvals and, once approved on a country-by-country basis, for commercializing Nolazol® in Latin America.
Nolazol® is a controlled release formulation of mazindol currently being developed as a non-amphetamine DEA schedule C-4 treatment option for ADHD. NLS's recent Phase II study demonstrated efficacy levels equivalent to, or greater than those previously only seen with amphetamine stimulant treatments, with no serious treatment-related adverse events. NLS is currently planning a Phase III clinical study in ADHD for Nolazol® in the U.S., which is expected to reach the U.S. market as early as 2022, pending regulatory approval and other factors.
It is estimated that only 10% of children diagnosed with ADHD in Brazil receive the correct treatment, due to parents' fear of using controlled medications1, in particular those which require medical monitoring, psychological, educational and family support. Medications currently available in the American market for treating ADHD are limited to amphetamine-based drugs or other stimulants.
Eurofarma is a Brazilian multinational pharmaceutical company, with a presence in 20 Latin American countries. The company is ranked second in medical prescriptions and the third in the generic segment in Brazil. Eurofarma operates in the areas of medical prescription, Over-The-Counter, generic, hospital, bids, oncology, veterinary and services for third parties’ segments. In Brazil, the portfolio is composed of more than 330 brands, with around 1,000 presentations covering 28 medical specialties and 48 therapeutic classes.
1 Brazilian Association of Attention Deficit (BAAD) Treatment. Available at https://tdah.org.br/tratamento/
About NLS-1 Pharma
NLS is a privately owned, Swiss-based biotech firm focusing on the development of first-in-class treatments for ADHD, sleep disorders, cognitive impairment and other neurological disorders that remain largely under-diagnosed and for which unmet medical needs are significant. NLS has built a large portfolio of promising clinical-stage compounds being developed by an experienced team of proven experts in ADHD and sleep related disorders and working closely with key opinion leaders.
About Mazindol
Mazindol is an imidazo-isoindole agent, originally developed as an appetite suppressant in the 70's, and classified at that time as a DEA scheduled C-4 controlled substance (low probability for misuse/abuse). It was withdrawn from US markets by 2002 due to commercial reasons unrelated to efficacy or safety. Mazindol controlled release is a novel formulation with a lower Cmax than the immediate release formulation and an equivalent AUC, designed for once daily dosing, which is under investigation for the treatment of ADHD and narcolepsy.
Safe Harbor Statement
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses its belief that there is a significant opportunity for Nolazol® for ADHD in Latin America and that Eurofarma has the expertise with regulatory approvals and commercialization for Nolazol® in the region, and its belief that Nolazol® has the potential to disrupt the ADHD market. These forward-looking statements and their implications are based on the current expectations of the management of NLS only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in launching and/or successfully completing its clinical trials; NLS’s products may not be approved by regulatory agencies, NLS’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with NLS’s process; NLS’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; NLS’s patents may not be sufficient; NLS’s products may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Investor relations contact
LifeSci Advisors - Daniel Ferry: +1 617-535-7746
Partnering contact
NLS-1 Pharma Alex Zwyer, CEO: +41 41 618 80 00