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).
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.
BUSINESS INSIGHTS, PHARMACY MARKET
DirectRx Pharmacy | February 15, 2023
On February 14, 2023, DirectRx, a leading national specialty pharmacy committed to serving individual patients with chronic and complex health needs, announced the launch of a new website and a suite of team member training programs.
The new website emphasizes the company's dedication to working with patients and prescribers to provide the best possible care. The training programs are designed to assist team members in developing professionally.
The DirectRx website emphasizes the company's concern for patients and dedication to collaborating with doctors to offer the highest quality care. The new additions to the website consist of a Prescribers tab highlighting the key ways in which DirectRx collaborates with its prescriber partners; a manufacturers tab highlighting the company's "industry best" time-to-fill, adherence and conversion rates; and an interactive Careers tab to help grow the DirectRx team.
Additionally, DirectRx has launched new training and development programs for team members to help them improve their skill set and stay with the firm longer. The new programs include pharmacy technicians in training, account managers in training and regional patient care coordinators in training. The specialty pharmacy is also expanding its managerial positions, including a customer service manager role and others.
DirectRx's Director, Alban Ivezaj, commented, "We're very excited to launch our new website as we feel it better captures our commitment to compassionate patient care and the best-in-class services we offer to our provider partners." He added, "As a result of that commitment, DirectRx has experienced significant growth across all regions of the U.S. - including servicing all 50 states and a 26 percent increase in the number of patients we serviced in 2022."
(Source – Globe Newswire)
About DirectRx Pharmacy
Founded in 1985, DirectRx is an independent pharmacy committed to providing patients with exceptional, individualized pharmaceutical care. With the belief that communication and teamwork are crucial to achieving good treatment outcomes, the physician, patient, and pharmacist form a circle of integrated services and coordinated care, so there are no gaps in patient care between physician and pharmacist. It stands apart from the competition due to its concern and commitment to providing unmatched customer service. The company is accredited by ACHC, NABP, WBENC and URAC. Since its establishment over three decades ago, the company has expanded to 49 states.
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)
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.