Mikart, LLC Nano and PharmaSolutions, Inc. | October 12, 2022
Mikart, LLC a comprehensive contract development and manufacturing organization announced that it has entered into a collaboration agreement with Nano PharmaSolutions, Inc. an innovative nanotechnology company that has a proprietary NanoTransformer™ that enhances the solubility of pharmaceutical active ingredients.
"We are excited to bring this new technology from preclinical stage to a GMP clinical phase manufacturing environment. This differentiated, solvent-free, nano-granulation process for drug development and manufacturing provides our customers with an alternative solubility enhancement technology."
Nazar Elkarim, PhD, Vice President of Pharmaceutical Development Services at Mikart
Kay Olmstead, PhD/MBA, Chief Executive Officer at NPS, added, "Nano PharmaSolutions is excited for this collaboration which will provide us with GMP manufacturing capabilities for development of nanomedicines, using our NanoTransformer™ technology at Mikart's facility."
Louis Weber, Vice President of Business Development at Mikart, added, "Mikart is committed to offering innovative options for enhancing solubility and bioavailability to our customers. We feel this nanotechnology will further enhance our development, clinical, and commercial capabilities designed to bring value to our growing customer base."
About Mikart, LLC
Mikart, LLC is a privately held contract development and manufacturing organization founded in 1975. Mikart focuses on small molecules, potent compounds, solid oral, combination products, suspensions, liquids and serialized packaging services. The company has a full range of formulation, analytical, packaging and manufacturing services with a seamless development solution that minimizes the time-to-market from clinical work through commercial supply.
About Nano PharmaSolutions, Inc.
Nano PharmaSolutions, Inc. developed a NanoTransformer™ technology that generates nanoparticles of active pharmaceutical ingredients with physical vapor deposition (PVD), a nanocoating method without using any polymers or solvents. This robust and high drug loading technology increases bioavailability of poorly soluble drugs. The NanoTransformer™ Technology produces patient-centric dosage forms while accelerating drug candidates to the clinic by shrinking development time and R&D costs.
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.
Accord BioPharma | September 21, 2022
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, announced today a partnership with StoryMD. The StoryMD platform is a single, unified, personalized digital health information portfolio that curates the most relevant, visually rich content based on a patient's condition. Accord BioPharma has signed on as StoryMD's very first corporate partner, to support StoryMD's advanced prostate cancer content, allowing Accord BioPharma to provide a comprehensive, user-friendly tool to help patients and their caregivers navigate advanced prostate cancer, just in time for prostate cancer awareness month this September.
"At Accord BioPharma, we recognize the need to go beyond biology – and beyond our responsibility of drug development – to help change the clinician and patient experience at all touchpoints in the care continuum where we can," said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. "StoryMD exemplifies that mission by providing clinicians with clear, easy-to-understand visuals, videos, and health information that help their patients understand their disease journey. Partnering with StoryMD on their advanced prostate cancer content felt like a natural fit given our recent drug launch."
In March of this year, Accord BioPharma announced the U.S. launch of CAMCEVI® (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. CAMCEVI should not be used in patients with hypersensitivity to GnRN, GnRH agonist analogs as anaphylactic reactions to these drugs have been reported in the medical literature. Accord BioPharma is heading all commercial initiatives in the U.S. and Canada. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021.
Through a vast library of curated, clinically accurate disease-state information, graphics, and videos, StoryMD enables physicians to share an easy-to-understand disease journey with patients at the point of care, which can help increase patient retention of information and engagement, improve physician efficiency, and reduce the amount of misinformation patients may seek out on their own. "Accord BioPharma is making efforts to provide important patient and provider education in pursuit of our aim to offer latest treatment options to patients of advanced prostate cancer and we look forward to our collaboration with StoryMD to provide comprehensive and user-friendly tools for patients and care givers" said Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals Ltd, which is the parent company of Accord BioPharma.
"Every once in a while, you meet a person and a partner who has a vision. Chrys Kokino has that vision to go beyond drug development and sees the value in advancing technology rather than being afraid of it. And that's exactly what we want – partners who recognize the gap in communication between physicians and patients and who want to work together to close that gap and fill an unmet need."
Alexander Tsiaras, CEO and Founder at StoryMD
On the importance of prostate cancer awareness, Tsiaras said, "I have a family member who works in the medical field, and when he was diagnosed with prostate cancer, it was amazing how little he knew. Cancer is such a confusing and overwhelming disease – 'Do I wait and watch? Should I be aggressive in treatment?' So, even for the most educated among us, it is a scary moment. Accord BioPharma and StoryMD are working together to go beyond offering patients drug options to impart knowledge and serve as a trusted resource."
About Accord BioPharma
Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient's experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patient's perspective and develop high-quality therapies that impact patient's lives. The founders of Accord BioPharma have dedicated their time, passion, and resources to focusing on specialty care and treatments, proactively developing better ways of working, and delivering enhanced therapies.
CAMCEVI® injection emulsion is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels (less than or equal to 50ng/dL) after the initial injection, from Week 4 to Week 48.1 CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.