BUSINESS INSIGHTS, PHARMA TECH
Koneksa | January 18, 2023
On January 17, 2023, Koneksa, a healthcare technology company that develops evidence-based validated digital biomarkers, announced the beginning of a clinical study that will compare the treatment effect of at-home mobile spirometry using digital biomarkers versus in-clinic spirometry in patients who have moderate asthma and are receiving long-acting beta-agonist (LABA) treatment.
The LEARN study is a single-arm interventional trial that compares the identification of treatment effects in people with moderate asthma using at-home mobile spirometry by utilizing an ultrasonic spirometer and a smartphone compared to in-clinic spirometry. Up to 60 people with mild, uncontrolled asthma who already use inhaled corticosteroids (ICS) will take part in the study. Besides, it will also cover those who need to take LABA medication for a six-week treatment period.
In-clinic spirometry can be performed at home with the same or higher accuracy compared to in-clinic and potentially less strain on the patient. The study will analyze the LABA treatment impact in clinic and mobile spirometry along with assessing the association between different readouts of mobile spirometry, in addition to evaluating asthma control as determined by the ACQ-6, a patient-reported outcome questionnaire. Other goals include assessing patient and site-specific satisfaction with mobile spirometry technology.
Chris Benko, CEO & Founder, Koneksa, stated, “This study builds on Koneksa's prior work demonstrating that mobile spirometry has the potential to detect clinically meaningful changes in very small cohorts of asthma patients on standard of care.” He further added, “The LEARN study will evaluate whether at-home mobile spirometry can detect treatment effects of a known positive control (LABA) in a significantly smaller population than would traditionally be assumed for an in-clinic proof-of-concept study.”
(Source – Business Wire)
About Koneksa
Based out of New York, Koneksa is a patient-centric digital biomarker firm that develops end-to-end solutions for remotely obtained clinical data to expedite clinical research and guide decision-making in drug development and market strategy for the pharmaceutical and biotechnology industries. It seeks to revolutionize effect detection in clinical research by providing integrated solutions for efficient trial designs that yield more meaningful data. Its evidence-based biomarker solutions allow for more efficient clinical trial designs, allowing novel medicines to reach patients sooner.
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BUSINESS INSIGHTS, PHARMA TECH
Indivior | March 06, 2023
Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl.
Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023.
OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA).
About Indivior
A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.
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BUSINESS INSIGHTS, PHARMA TECH
West Pharmaceutical Services | February 13, 2023
West Pharmaceutical Services, Inc., a leading global innovative injectable drug administration solutions provider, recently announced the expansion of its remarkable collaboration with Corning Incorporated, which now includes exclusive distribution rights for Corning Valor® Glass vials as well as the launch of its first product, West Ready Pack™ with Corning Valor® RTU Vials employing SG EZ-fill® technology.
The West Ready Pack™ with Corning Valor® RTU Vials integrates West's highest quality NovaPure® stoppers, Flip-Off® CCS (Certified, Clean, Sterilized) seals and Corning's best-in-class Valor® RTU Vials with SG EZ-fill® technology into a complete containment solution to assist in the introduction of parenteral drugs and diagnostics to the market.
West announced its agreement with Corning in January 2022, which includes a multimillion-dollar investment to develop Corning's Valor® Glass technology to improve patient safety and increase access to life-saving therapies. This strategic alliance provides premier elastomer-glass system solutions for injectable drug storage and delivery. In addition, West and Corning intend to collaborate to develop the next generation of integrated packaging and delivery system solutions.
Valor® RTU Vials with SG EZ-fill® technology improve medication storage and distribution, enable more reliable access to important medicines for public health, and maximize production efficiency. This pharmaceutical glass was explicitly created to handle the problems of modern industrial procedures.
The Ready Pack™ mixture of NovaPure® stoppers, Flip-Off® CCS seals, and Valor® RTU Vials with SG EZ-fill® technology offers drug developers the following advantages
Proven Container Closure Integrity (CCI), which includes the ability to sustain cold storage CCI when cooled to and kept at -80 degrees Celsius;
Ready-to-use sterile format that may be introduced immediately into filling operations, avoiding the requirement for component preparation;
Premium components with the most stringent particle requirements available from West; and
Availability in volumes appropriate for small-scale filling operations with continuity to quantity alternatives for large-scale commercial operations.
About West Pharmaceutical Services
Founded in 1923, West Pharmaceutical Services, Inc. is a leading high-quality, innovative injectable solutions and services provider. It is a trusted partner to both established and emergent drug producers and contributes to the safe, effective containment and delivery of life-enhancing and life-saving medications to patients. West supports its clients by supplying over 45 billion components and devices each year, with a team of approximately 10000 members spread across 50 facilities globally. Headquartered in Exton, Pennsylvania, the company has been operating for over a century and achieved $2.83 billion in net sales in the fiscal year 2021.
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