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IX Biopharma will receive an initial US$9 million upfront payment Eligible for up to US$239 million in development and sales milestone payments Double digit royalties on future product sales of any licensed product IX Biopharma Ltd a specialty pharmaceutical company that develops innovative therapies using its proprietary sublingual drug delivery technology, WaferiX, announced today that it has, through its ...
  • iX Biopharma will receive an initial US$9 million upfront payment
  • Eligible for up to US$239 million in development and sales milestone payments
  • Double digit royalties on future product sales of any licensed product

IX Biopharma Ltd (SGX:42C), a specialty pharmaceutical company that develops innovative therapies using its proprietary sublingual drug delivery technology, WaferiX, announced today that it has, through its subsidiary, entered into an exclusive license agreement with Seelos Therapeutics, Inc ("Seelos") (Nasdaq: SEEL), a company focused on developing novel therapeutics for central nervous systems disorders. Under the agreement, iX Biopharma will license to Seelos its lead drug under development, Wafermine, a sublingual racemic ketamine wafer, and other products incorporating R- and S- enantiomers of ketamine utilising the WaferiX technology (the "Licensed Products").

iX Biopharma will receive a US$9 million upfront payment to be satisfied in cash and shares. iX Biopharma is also eligible for up to US$239 million in milestone payments upon achievement by Seelos of certain development milestones and product sales thresholds. iX Biopharma will also receive double digit royalties on future net sales of any Licensed Product. Seelos will fund all future development, manufacturing and commercialisation of the Licensed Products.

Eddy Lee , Chairman and CEO of iX Biopharma, said: "We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine and the other sublingual ketamine products. Licensing our WaferiX-based pharmaceutical drugs to suitable third parties for development and commercialisation is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy."

"The licensing of the WaferiX drug delivery platform for sublingual ketamine broadens Seelos' ketamine franchise with formulations that we believe will be suitable for both acute and chronic dosing. This should enable us to study additional indications beyond our current focus," said Raj Mehra, Ph.D., Chairman and CEO of Seelos. "The pharmacokinetics, pharmacodynamics and safety profile that has been demonstrated to date suggests a formulation that has the potential of being prescribed with less restrictions than current formulations. Our team is excited to be able to study additional indications with this very innovative technology."

Ketamine, a NMDA receptor antagonist, works through novel mechanisms of action compared to most currently approved therapies and has the potential to treat various conditions with significant unmet medical need, including pain and depression.

Prior to the agreement, iX Biopharma had completed Phase 2 clinical studies on Wafermine in the United States (US) which demonstrated strong analgesic efficacy, safety and tolerability in participants experiencing moderate to severe acute pain. Following that, it concluded the End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) and obtained positive Scientific Advice from the European Medicines Agency (EMA) on the Wafermine programme. The FDA has also granted iX Biopharma an orphan drug designation for ketamine for the treatment of Complex Regional Pain Syndrome (CRPS) which is a rare disorder characterised by excess and prolonged pain and inflammation usually affecting limbs, for which there is no approved drug treatment.

Under the terms of the agreement, Seelos will have exclusive worldwide rights for Wafermine except China (including Hong Kong , Macau and Taiwan ), and worldwide rights to products incorporating R- and S- enantiomers of ketamine being developed using iX Biopharma's WaferiX technology. iX Biopharma will retain exclusive rights to Wafermine in China (including Hong Kong , Macau and Taiwan ).

About the Licensed Products and WaferiX

The Licensed Products utilise iX Biopharma's patented sublingual wafer technology, known as WaferiX, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.

The Licensed Products will contain ketamine, which provides a non-opioid approach for the treatment of pain by targeting the NMDA receptor. Ketamine has tremendous prospects given its ability to address various forms of pain with significant unmet medical need. Additionally, clinical studies suggest that ketamine has the potential to be a rapid, effective treatment for depression. Current anti-depressants traditionally used in this setting are hindered by slow onset of action, often taking weeks for full therapeutic effect, adverse events and limited efficacy, where up to one in three patients are refractory to therapy. The global pain market is estimated to be valued at US$74 billion [1] and the global depression market is estimated to be valued at US$12.7 billion [2] in 2020.

About Seelos Therapeutics, Inc

Seelos Therapeutics, Inc. (Nasdaq: SEEL) is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company's robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York .

For more information, please visit: www.seelostherapeutics.com .

About iX Biopharma Ltd

iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia . The Group is focused on the development and commercialisation of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.

iX Biopharma has developed a patented drug delivery platform technology, WaferiX. WaferiX delivers drug sublingually via the mucosa for better absorption, faster onset of action and predictable effect. The WaferiX delivery platform is particularly useful for drug repurposing which is a growing trend with a global market worth over US$30 billion [3] . Drug repurposing is where existing approved drugs are developed into new drugs targeting different indications or a different route of administration, at a lower development cost and risk. Other than Wafermine, iX Biopharma's portfolio includes among others, medicinal cannabis, sildenafil and buprenorphine sublingual wafers.

Contact for media :

Yee Chia Hsing
Director of Corporate Affairs
E: chiahsing.yee@ixbiopharma.com

Eva Tan
Chief Commercial Officer
E: eva.tan@ixbiopharma.com

Alvina Tan

Media & Investor Relations Consultant
E: alvina.tan@arkadvisors.com.sg


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SOURCE iX Biopharma Ltd

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Levitee Labs appoints Jenkins, Lahijani as directors

Levitee Labs appoints Jenkins, Lahijani as directors

Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the "Company" or "Levitee"), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce the appointment of David Jenkins and Amin Lahijani to the Board. Mr. Jenkins is a global financier who works with high-net-worth individuals. He has extensive experience in public markets and has helped secure millions of dollars in capital in private and public sectors. He is a highly regarded expert in negotiating, marketing, and advertising. Mr. Jenkins has completed hundreds of multimillion-dollar deals throughout his career, demanding top price for assets in all market conditions. Mr. Jenkins brings in-depth market knowledge and experience to the company.

Mr. Lahijani has a bachelor's from the University of Simon Fraser in Kinesiology. Mr. Lahijani has worked for multiple years as a kinesiologist specializing in injuries and recovery specifically focusing on the lower lumbar. Recently Mr. Lahijani has ventured into entrepreneurship. Mr. Lahijani Holding executive roles for 15 years with a variety of businesses with significant revenues.

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Awakn Life Sciences Signs MOU with Maps

Awakn Life Sciences Signs MOU with Maps

Agreement to Explore a Partnership for MDMA-Assisted Therapy for Treatment of Alcohol Use Disorder in Europe

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat Addiction, announced today it has signed a Memorandum of Understanding ("MOU") with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to utilize MDMA-assisted therapy to treat Alcohol Use Disorder (AUD) in Europe.

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Two thirds of physicians surveyed believe psilocybin therapy has potential benefit for patients with treatment-resistant depression

London, UK and New York, US, 19 January 2022

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, and Sermo, a global leader in physician insights, today announced findings from a survey of Sermo physician members that showed two thirds (66%) of doctors surveyed believe psilocybin therapy has potential therapeutic benefit for patients with treatment-resistant depression (TRD).

More than 320 million people globally suffer with major depressive disorder (MDD) i the leading cause of disability worldwide and one of the fastest growing mental health illnesses ii . About a third of these patients 100 million people aren't helped by existing therapies and suffer with TRD iii .

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges, including TRD. It combines the pharmacological effects of a synthesised version of psilocybin, a psychoactive substance that is an active ingredient in some species of mushrooms, with psychological support iv .

The survey of 259 Sermo member physicians, sponsored by COMPASS, was conducted in November 2021 and completed by participants from the US, the UK, France, Italy, Denmark, Spain and the Netherlands. Doctors were asked their views on the future of psychiatric therapy and the potential role of psilocybin therapy.

Key survey findings:

  • 66% of doctors surveyed believe psilocybin therapy has potential benefit for patients with TRD
  • 50% would prescribe psilocybin therapy, if it was approved; 32% are undecided
  • The greatest potential advantages to psilocybin treatment are believed to be: improved efficacy in treatment-resistant conditions (30%), rapid onset of action (26%), and different mechanism of action from existing therapies (19%)
  • The greatest potential barriers to treatment were cited as: needing a dedicated space for six to eight hours (28%), lack of trained therapists in a new model of psychological support (21%), and office infrastructure (15%)
  • Opinions on the optimal setting for psilocybin administration varied by region: 50% of European respondents said hospital; 42% of US respondents said specialised network of centres
  • Physicians also noted the need to educate healthcare professionals on the potential benefits of psilocybin therapy and on how to incorporate the therapy into their practice, if approved

"Severe mental illnesses, such as treatment-resistant depression, have affected too many people in society for too long. Physicians are looking for new approaches to accelerate the healing process, particularly for patients for whom current therapies have failed," said Murali Doraiswamy MBBS, FRCP, Professor of Psychiatry and Behavioural Sciences at Duke University School of Medicine, and an advisor to Sermo.

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: "These findings underline the fact that physicians need more options in helping patients suffering with treatment-resistant depression. COMPASS is developing COMP360 psilocybin therapy through a rigorous programme of research in the hope that we can offer just such an option. It's very encouraging to see that so many doctors see the potential that psilocybin could have and these insights will help us to understand how to introduce COMP360 psilocybin, with psychological support, into medical systems, if approved."

-Ends-

Survey methodology

The survey was designed to assess attitudes towards the use of psilocybin therapy in general, in psychiatry. The survey was conducted online via Sermo's RealTime platform and the random sample of physicians received compensation for their time and expertise. Survey limitations include sampling bias, inability to deduce causality from opinion polls, confounding variables not measured, and other factors.

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p www.compasspathways.com


Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.


Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of psilocybin therapy, including COMP360, as a treatment for depression, COMPASS's business strategy and goals, including its ability to launch and commercialise products, COMPASS's expectations for the timing of its pivotal phase III programme and the potential for that or other trials to support regulatory filings and approvals, COMPASS's ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, clinicians' perceptions of the potential advantages and efficacy of COMP360 in relation to other available therapies, including any new therapies that may be approved for the indications we are investigating, and COMPASS's expectations regarding the benefits of psilocybin therapy and the effectiveness of its executive team. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading "Risk Factors" in COMPASS's annual report on Form 20-F filed with the US Securities and Exchange Commission (SEC) on 9 March 2021 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS's current expectations and speak only as of the date hereof.

About Sermo

Sermo turns physician experience, expertise, and observations into actionable insights for the global healthcare community. Engaging with more than 1.3 million HCPs across 150 countries, the company provides physicians with a social platform and unique community that fosters impactful peer-to-peer collaboration & discussions about issues that are important to them and their patients. Sermo offers on demand access to physicians via a suite of proprietary technology to provide business intelligence that benefits pharmaceutical, healthcare partners, and the medical community at large. To learn more, visit www.sermo.com .


Enquiries

Media: Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324


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Levitee Labs Announces Non-Brokered Private Placement of up to $3,000,000

Levitee Labs Announces Non-Brokered Private Placement of up to $3,000,000

  • Offering is priced at $0.20 per offered unit, with a full warrant at $0.40 for 24 months
  • Proceeds to be used for organic and inorganic growth initiatives and refocusing the company on clinical healthcare with a focus on addiction services

Levitee Labs Inc. (CSE: LVT) (OTC: LVTTF) (FSE: 7H7) (the " Company " or " Levitee "), an integrative wellness company with a diversified portfolio of healthcare and wellness assets, is pleased to announce that it is proposing to complete a non-brokered private placement (the " Private Placement ") of up to 15,000,000 units (the " Units ") at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000. The Private Placement is subject to approval from the Canadian Securities Exchange.

Each Offered Unit will be composed of one common share of the Corporation (a " Unit Share ") and one common share purchase warrant (each whole warrant, a " Warrant "). Each Warrant will be exercisable at $0.40 per share for a period of 24 months from the date of issuance. The Company will pay a finder's fee of 8% on the gross proceeds of the Private Placement from subscribers introduced by certain finders, and will issue such number of finder's warrants (" Finder's Warrants ") as is equal to 8% of the Units sold to subscribers introduced by certain finders. Each Finder's Warrant will entitle the holder thereof to purchase one common share of the Company (a " Finder's Warrant Share ") at a price of $0.40 per Finder's Warrant Share for a period of twenty-four (24) months from the date of issuance. All securities issued under the Private Placement will be subject to a four month and one day hold period. The Offered Units are expected to be eligible for registered accounts.

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Awakn Responds to OTC Markets Request on Recent Promotional Activity

Awakn Responds to OTC Markets Request on Recent Promotional Activity

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, announces that it has been requested by OTC Markets Group Inc. ("OTC Markets") to issue this statement about certain promotional activity concerning its common stock.

On Wednesday, January 12, 2022, OTC Markets informed the Company that it became aware of certain promotional activities concerning the Company and its common stock traded on the OTCQB Marketplace, specifically the distribution of promotional emails on January 12, 2022, by third-parties discussing the growing ketamine revolution, citing the Company's potential growth in the space. Upon review, the Company determined that a third party, which was not engaged by the Company or any of its officers, directors, controlling shareholders or any third-party service providers distributed promotional emails. The Company had no editorial oversight of the promotional material or any opportunity to review in advance of the distribution; however, the Company has subsequently reviewed the specific details related to the Company that were included in such promotional emails, and has confirmed these details to be factual. The Company wishes to caution readers that the statements made in such promotional emails are speculative in nature. For more complete and specific information regarding the Company, its prospects and the risks associated with those prospects, readers should review the Company's public filings on SEDAR, its website and other reliable sources. The Company encourages investors to contact their investment advisors prior to making any investment.

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NeonMind Appoints Canadian Medical Leader in Anesthesiology, Dr. Daniel Bainbridge, MD, FRCPC to Its Specialty Clinics Advisory Board

NeonMind Appoints Canadian Medical Leader in Anesthesiology, Dr. Daniel Bainbridge, MD, FRCPC to Its Specialty Clinics Advisory Board

Dr. Bainbridge's Expertise and Network Provides Safety Best-Practices for Administration of Intravenous Ketamine (IV-Ketamine) at NeonMind Clinics

NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) ("NeonMind'' or the "Company"), an integrated drug development and wellness company, announced today the appointment of Dr. Daniel Bainbridge, MD, FRCPC, past President of the Canadian Anesthesiologists Society, Professor from the Department of Anesthesia and Perioperative Medicine at the University of Western Ontario, and Anesthesia Consultant at London Health Sciences Centre, to its Specialty Clinics Advisory Board

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