Tag: respira

  • Qnovia Gets $17 million for RespiRx NRT Nebulizer

    Qnovia Gets $17 million for RespiRx NRT Nebulizer

    Photo: Qnovia

    Qnovia has raised $17 million to continue development of its RespiRx nicotine replacement product, reports Richmond Business Sense.

    RespiRx is a portable, hand-held nebulizer, a powered medical device that delivers medicine as an inhaled mist and is similar to an inhaler. The device is designed to deliver a nicotine hit more quickly than existing therapies, thus enabling users to better manage withdrawals and, therefore, increase the likelihood of smoking cessation.

    Qnovia was founded in 2018 in Los Angeles by Mario Danek as Respira Technologies and rebranded in September. In May, the company appointed former Altria executive Brian Quigley as CEO and Danek as chief technology officer.

    The company also moved to Richmond, Virginia, in part because that state offers a more business friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.

    In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.

    Qnovia will use the newly raised funds to develop a proof of concept for RespiRx as a nicotine replacement therapy product and move it through an FDA approval process before the anticipated start of human clinical trials in 2023.

    The product is expected to hit the market as a prescription treatment. Qnovia is also interested in exploring how RespiRx can be used for asthma, pain management, vaccines and other uses.

  • Respira Technologies Creates Scientific Advisory Board

    Respira Technologies Creates Scientific Advisory Board

    Respira Technologies has created a scientific advisory board and appointed Jasjit S. Ahluwalia as its chair.

    According to Respira, the scientific advisory board to strengthen the company’s connection to the constantly evolving body of scientific evidence on the issues of tobacco use, harm reduction, nicotine and smoking cessation being generated by public health to guide the development of its technology and pipeline for current and future new drug applications.

    “As a biotechnology company whose goal is to end the death and disease caused by smoking through the development of a breakthrough smoking cessation therapy, we must be guided by and have a deep understanding of the constantly evolving data and science generated by public health on issues important to our business,” said Respira Technologies CEO Mario Danek in a statement.

    “We are thrilled to name Dr. Ahluwalia as Chair and the founding member of our scientific advisory board. He represents one of the best and brightest scientific minds with decades of experience in studying nicotine addiction and cessation. Having guidance and perspective from the most distinguished researchers in this space will be critical to Respira achieving its goal of contributing to eliminating preventable morbidity and mortality, and achieving health equity.”

    Ahluwalia is a leader in academic research and public health focused on studying tobacco use, nicotine addiction and smoking cessation. He is a physician and public health scientist at Brown University.

    Through his research, he has also investigated issues of health disparities and minority health broadly across multiple areas of substance use, cancer prevention and public health.

    At Brown University, he is a professor, associate director of the Legoretta Cancer Center and deputy director of the Center for Addiction and Disease Risk Exacerbation, a NIH funded Center of Biomedical Research Excellence. Ahluwalia’s work has generated over 350 publications in leading scientific journals, and he has received over $100 million in research funding as a principal and co-investigator.

    As chair of Respira’s Scientific Advisory Board, Ahluwalia will be engaged in the company’s scientific strategy, development of clinical research and leading engagement within the nicotine, addiction and cessation public health community. His broad healthcare research background will guide Respira’s current application and inform the company’s development pipeline to expand application of its proprietary drug delivery platform across a diverse spectrum of indications and patient populations.

    “I have dedicated the last 30 years of my career to understanding nicotine addiction, cessation and the complex issues they create in our society, especially among ethnic minority and other vulnerable populations,” said Ahluwalia. “Respira has the potential to create a very significant impact on this important public health crisis.  I am thrilled to be leading Respira’s scientific advisory board and look forward to assisting the company in its efforts to improve the lives of hundreds of millions of smokers looking to quit around the world.”

    Respira Technologies is preparing to submit an investigative new drug application to the U.S. Food and Drug Administration in 2022, which will allow the company to begin human clinical studies. The company is pursuing a prescription designation for its portable handheld combination drug device for the indication of smoking cessation therapy.

  • Vape Startup Said to Spread Falsehoods to Promote Product

    Vape Startup Said to Spread Falsehoods to Promote Product

    Respira Technologies is likely using a website to spread misinformation about vaping in order to promote its own product. Jim McDonald of Vaping360 reports that a website promoted by Respira contains false allegations that a scientist commissioned by Public Health England (PHE) and an author of the “vaping is 95 percent safer” than combustible cigarettes study had financial ties to the tobacco industry.

    The California-based company with plans to pursue drug approval for an inhaled nebulizer-style nicotine replacement therapy product has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration to adopt standards that would prevent most consumer vapor products from being authorized for sale, according to McDonald.

    Respira links its own website to a site called “Vaping Fact Checker” that attempts to tie nicotine vaping to the 2019 “EVALI” lung injury outbreak. A page on the site titled “EVALI Linked Products” shows Juul, SMOK and Suorin products and implies that they have caused or could cause “EVALI.”

    Under the heading “Myth Busting,” the Vaping Fact Checker website also claims that “one of the authors” of Public Health England’s 2015 e-cigarette evidence review has “financial ties” to tobacco company Philip Morris International.

    British tobacco harm reduction advocate Clive Bates, who has followed and been part of the debate over the 2015 PHE report, is director of Counterfactual Consulting and a former director of Action on Smoking and Health (ASH) in the UK, said that it appears the author of the Vaping Fact Checker claim has (either misinformation or disinformation) confused the PHE review with a separate paper authored by a group of experts led by drug researcher David Nutt.

    “It is both offensive and preposterous to claim that the experts undertaking Public Health England’s evidence reviews were somehow compromised by tobacco industry interests,” Bates told Vaping360. “They are all scientists of the highest standing with no conflicts of interest.”

  • Respira to Submit Drug Application for Inhalable NRT

    Respira to Submit Drug Application for Inhalable NRT

    Photo: Respira

    Respira Technologies plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration in 2022 for the world’s first inhalable nicotine-replacement therapy.

    “There is a void of innovation in solving the smoking crisis from traditional healthcare companies, and as a result, Big Tobacco is trying to position itself as the solution to the problem they’ve created. At Respira, we believe only our technology can effectively help end the death and disease caused by smoking while simultaneously meeting CDER’s [Center for Drug Evaluation and Research] high standards for both safety and efficacy,” said Mario Danek, CEO and founder of Respira Technologies, in a statement.

     “We are very pleased with the productive and collaborative discussion with FDA and have confidence that FDA’s guidance will help us achieve our goal to end the death and disease caused by smoking,” said Danek. “The Pre-IND is just the first of many major milestones Respira will achieve, and we are excited to advance our plans to submit our IND to begin human clinical studies.”

    In 2020, the company said it aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Respira’s senior management includes Chief Operating Officer Brian Quigley, who spent 16 years at Altria Group where he was CEO of the smokeless tobacco business from 2012 to 2018.

  • Respira Adds Former Altria Exec to Leadership Team

    Respira Adds Former Altria Exec to Leadership Team

    Credit: Respira

    Respira Technologies has appointed Brian W. Quigley, a 16 year veteran of Altria Group, as its Chief Operating Officer effective July 1. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees, according to a press release.

    Quigley will be responsible for driving Respira’s operational strategy, regulatory strategy, and commercial efforts with a focus on disrupting the tobacco market, nicotine replacement therapy market, and developing pharmaceutical applications through partnerships.

    Respira has developed two proprietary drug delivery platforms, RespiRx, a zero heat aerosol technology, and Wave, a low heat aerosol technology. Both technology platforms are designed for safe aerosol-based delivery of drugs to patients and end users, without the creation of harmful by-products and compounds.

    The company’s device platforms have applications in nicotine replacement therapies, reduced harm tobacco products, and pharmaceutical drug delivery with a total addressable market opportunity of greater than $1 trillion, according to the release.

    Brian Quigley/Credit: Altria

     

    “We are thrilled to have Brian join the Respira team as we prepare to enter the commercial phase of our company’s growth,” said Mario Danek, Respira’s founder and CEO. “Brian’s vocal leadership for responsible industry practices and harm-reduction combined with his impressive track record of driving business performance in FDA regulated businesses make him the perfect leader for the next phase of growth for our unique product platforms.”

    Quigley said he is excited to be joining Respira Technologies at this critical moment in the company’s journey. “I look forward to working with our team, investors, and partners as we prepare to commercialize our proprietary drug delivery platforms,” said Quigley. “My goal is to help improve public health and patient outcomes across a range of inhalable therapeutic applications, including tobacco cessation and the reduction of risk associated with tobacco use.”

    Respira is backed by leading venture investment firms, including Evolution VC Partners, Poseidon Asset Management, and DG Ventures.

  • Respira to Submit Nebulizer For FDA Approval

    Respira to Submit Nebulizer For FDA Approval

    Photo: Respira Technologies

    Respira Technologies plans to submit an inhaler device to the U.S. Food and Drug Administration by late 2021 for authorization as nicotine-replacement therapy.

    The company aims to disrupt a $618 billion market dominated by decades-old gums and patches from pharmaceutical companies as well as tobacco companies’ electronic nicotine-delivery devices with a nebulizer that converts nicotine to an aerosol.

    Based in West Hollywood, California, USA, Respira Technologies says that the Covid-19 pandemic has sparked new interest in quitting, and today’s users of vapor devices and e-cigarettes need updated cessation products.

    “The reality is we have folks who are addicted to nicotine who never tried combustible products before,” Respira CEO Mario Danek told Bloomberg Technology, referring to tobacco products that are burned like cigarettes and cigars.

    “They’re used to sleeker products, and we have that design.”