Indivior | November 21, 2022
Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company.
"Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders."
Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment
"We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose."
Roger Crystal, M.D., Opiant's President and Chief Executive Officer
Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO").
OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months.
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.
Pace® Life Sciences | September 09, 2022
Pace® Life Sciences, LLC, a full-service contract development and manufacturing organization and a subsidiary of Pace®, a science and technology company, announced today that it has acquired Biopharma Global. Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases and non-orphan products to treat indications with unmet medical needs.
"Pace® provides great value in our marketplace through our technical expertise and by meeting the strong commitments we make to our clients that rely on us to successfully advance their programs through development. The acquisition of Biopharma Global extends our reach further into regulatory strategy, guidance, and support in key therapeutic areas and greatly extends the reach of Pace® into our markets."
Eric Roman, CEO of Pace®
ABOUT BIOPHARMA GLOBAL
BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutics areas to help drug developers advance treatments for the disease communities with high unmet medical needs. We have assembled a team of globally-recognized experts in the rare diseases and other under-served disease areas, including former FDA staff, and a variety of scientists who have many successful orphan drug designations and other expedited program submissions to their credit. We maintain a completely customer-centric, transparent process through the entirety of our projects. BIOPHARMAGLOBAL.com
ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts, and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. Part of the Pace® Science and Technology Company, Pace® Life Sciences operates a network of multiple CDMO sites, FDA-registered GMP analytical testing laboratories, and regulatory and manufacturing support service centers across the United States.
Pace® makes the world a safer, healthier place. For decades, Pace® people have been committed to advancing the science of the pharmaceutical and biotechnology industries in our Life Sciences laboratories and supporting businesses, industries, consulting firms, government agencies, and more through our Analytical Services laboratories. Pace® offers local-level service backed by a national laboratory network. For customers with in-house labs, Pace® provides a range of professional services to keep their operations moving forward. Pace® people work in partnership with customers by providing the service, science, and the data they need to make critical decisions that benefit us all. Learn how Pace® people are working to advance science through sustainable practices and continuous innovation.
Ora, Inc. | September 29, 2022
Ora, Inc., the world's leading ophthalmology clinical research firm, has formally launched a revolutionary mobile research platform, Ora EyeCupTM, which promises to transform patient data capture through high-resolution imaging, artificial intelligence (AI) analysis, and real-time patient feedback. The Ora EyeCupTM, a finalist in the Most Valuable Clinical Technology Award category at the Reuters Events Pharma Awards USA 2022, will be presented by Dr. Gustavo De Moraes, Chief Medical Officer at Ora, at this year’s Eyecelerator Conference in Chicago, IL, September 29th.
The Ora EyeCupTM platform is a powerful combination of hardware and software — a smartphone attachment and software application which allows patients to take high-resolution images of their eyes and track disease signs and symptoms remotely. With over 138,000 images captured to date, 98% are considered gradable by researchers and AI. Post-capture processing utilizes AI-powered image analysis for precise clinical assessments of ocular redness, tear film stability, and corneal health. Along with this, the Ora EyeCupTM ensures protocol adherence through compliance assurance diaries for both symptom tracking and therapy dosing.
“At Ora, our technologists have spent the past two years developing this revolutionary system to capture patient data and provide a deeper understanding of therapeutic effect. The result is a trailblazing technology that captures high quality therapeutic data and improves the likelihood of study success.”
Dr. De Moraes
About Ora, Inc.
Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 55 product approvals and create vision beyond what they see. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts, R&D professionals, and operations management to maximize the value of new product initiatives. Think ophthalmology, think Ora.