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.
Alimentiv Inc. | October 06, 2022
Alimentiv Inc. Satisfai Health, Inc and Virgo Surgical Video Solutions, Inc. announced a strategic partnership to revolutionize central reading, data capture, decision support, and patient recruitment in the clinical trial domain for Inflammatory Bowel Disease and allied GI conditions. Satisfai, a global leader in developing artificial intelligence solutions for gastroenterology, and Virgo, an industry leader in endoscopy video capture technology, will leverage their combined strengths to work in partnership with Alimentiv, a leading CRO in gastroenterology, to realize the full potential of AI-powered precision imaging in the GI clinical trials space.
"This synergy of Satisfai and Virgo with Alimentiv is a positive development for patients with IBD and the drug development space. Clinical trials have many pain points, and this strategic partnership will enable advances in improving the efficiency of clinical trials and make some significant changes to how trials are run. We are delighted to enter this arrangement to bring the next generation of imaging technology to clinical trials in gastroenterology."
Jeff Smith, CEO of Alimentiv
"Artificial Intelligence in medicine is being increasingly adopted across various clinical specialties, with gastroenterology being one key field of use, particularly endoscopy," said Dr. Michael Byrne, CEO and founder of Satisfai Health, Clinical Professor of Medicine and gastroenterologist in Vancouver. "Working with Virgo, we are excited to bring AI-driven solutions to the IBD clinical trials arena. To be able to do so with Alimentiv — a leading Gastroenterology and imaging CRO—is a great opportunity. Our clear ambition is to change the clinical trial paradigm for IBD and other disease states such as Eosinophilic Esophagitis. As three groups working together, we are confident we can do so."
"Combining Satisfai's marquis AI solutions with Virgo's HIPAA and SOC 2 compliant automated cloud video capture technology and Alimentiv's 21CFR11 compliant solutions, expansive site community, and imaging expertise is very powerful. We truly look forward to realizing this vision and bringing real-time, in-line AI solutions to GI clinical trials worldwide," said Matthew Schwartz, CEO and co-founder at Virgo.
This partnership will facilitate Alimentiv's continued leadership in GI Clinical Trials through exclusive access to Satisfai's SmartScore Central Reading tool and Virgo's fully integrated, hands-free, cloud-based high-definition video-capture fleet. In addition, this will provide pharmaceutical and biotech sponsors with access to the ongoing development of novel endpoints, scoring methodologies, and scalable solutions geared toward bringing novel therapies to market faster.
About Alimentiv Inc.
Alimentiv is a global contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization's unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in IBD. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and partners with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance IBD research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society.
About Satisfai Health
Satisfai is a leading medical solutions provider specializing in AI applications applied to large addressable markets in gastroenterology. Satisfai's solutions deliver real-time medical imagery analysis, providing clinicians with decision support intelligence that dramatically improves patient outcomes. Satisfai is supported by a highly respected board of medical clinicians and key opinion leaders who operate at the top of their fields in the many areas of gastroenterology. Satisfai enjoys a strong voice on academic panels, leading GI societies, and direct access to prominent industry players seeking to adopt new AI technologies in gastroenterology.
Virgo provides the leading cloud video capture, management, and artificial intelligence analysis platform for endoscopic medicine. Academic, integrated, and private practice healthcare providers use the Virgo platform to advance patient care through video-based research and training initiatives. Since launching, Virgo has helped physicians capture over 400,000 endoscopy procedures using industry-leading HIPAA, HITRUST, and SOC 2-compliant cloud service providers. Virgo also supports integration with all leading electronic health records systems. In 2021, Virgo launched a suite of tools called VirgoTrials, which help pharmaceutical trial sponsors and their participating trial sites accelerate patient recruitment and shorten the overall enrollment period for trials.
Jacobio Pharma | October 13, 2022
Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®.
This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement.
"Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck,"
Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio
JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab.
ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells.
ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.
Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.