CPD AND LEARNING
Miravo Healthcare | March 16, 2023
Nuvo Pharmaceuticals Inc., which operates as Miravo Healthcare (Miravo), and Searchlight Pharma Inc., a Canadian specialty firm, have recently announced the closing of the previously announced plan of arrangement of Miravo with Searchlight. As per the arrangement terms, Searchlight acquired all the outstanding common shares of Miravo in exchange for $1.35 per share in cash, and the Miravo common shares will be removed from the Toronto Stock Exchange. Miravo will also apply to cease being a reporting issuer in each of the Canadian provinces.
The registered shareholders of Miravo must complete, sign and return the letter of transmittal and share certificate(s) to TSX Trust Company, the depositary, to receive their compensation under the arrangement. Non-registered shareholders will receive their compensation through their intermediary.
Before the Arrangement, Searchlight did not possess any Company Shares. Searchlight bought 11,388,282 Company Shares, representing 100% of the issued and outstanding Company Shares, for $1.35 per Company Share in conjunction with the arrangement.
Searchlight Pharma Inc., President and CEO, Mark Nawacki, commented, "Today marks the beginning of a new chapter for Miravo as it officially combines with Searchlight and continues as a private company." He further emphasized, "Searchlight plus Miravo will be a diversified, large and strong company – based on IQVIA CDH sales data, we will rank in the top three of Canadian specialty pharma companies – and this positions us well to continue to execute our successful business model and to deliver on our leadership objective in the sector. On behalf of the Searchlight team, I express our thanks to all Miravo stakeholders for their cooperation throughout this acquisition process, and I warmly welcome our new Miravo colleagues to the Searchlight family."
(Source – Business Wire)
About Miravo Healthcare
Miravo Healthcare, formerly known as Nuvo Pharmaceuticals Inc., is a Canadian specialty pharmaceutical company that focuses on developing and commercializing innovative therapies. Its mission is to improve patient's quality of life by providing them with safe and effective treatments for chronic conditions such as pain, inflammation, and addiction. Miravo Healthcare's portfolio includes a range of prescription drugs, over-the-counter products, and medical devices used in various therapeutic areas, including pain management, dermatology, and women's health. The company's flagship product is Pennsaid, a topical non-steroidal anti-inflammatory drug (NSAID) used to treat knee osteoarthritis. It is committed to sustainability and social responsibility, and the company's initiatives include reducing its environmental footprint, supporting local communities, and promoting diversity and inclusion. With a focus on innovation and patient care, it continues making significant contributions to the pharmaceutical industry in Canada and beyond.
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PHARMA TECH
Globenewswire | June 01, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
“The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”
The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1
The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST.
“This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.”
About Ciltacabtagene Autoleucel (cilta-cel)
Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5
Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9
In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13
About the Janssen Pharmaceutical
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
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PHARMA TECH
Globenewswire | May 12, 2023
SERB Pharmaceuticals, a global specialty pharmaceutical company, and SFJ Pharmaceuticals, a global drug development company, announce that SERB has acquired exclusive US rights to the ticagrelor reversal agent bentracimab from SFJ.
Bentracimab is a novel, monoclonal antibody fragment designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor, marketed by AstraZeneca as Brilinta®, is a reversible oral P2Y12 platelet inhibitor for patients who have suffered a heart attack or stroke, or who have acute coronary syndromes or coronary artery disease (CAD). Bentracimab, if approved by the FDA, could allow these patients to benefit from the antithrombotic effect of ticagrelor, preventing vascular events and reducing risk of death, while giving physicians a way to control bleeding in rare emergency situations such as surgery or a major bleeding event.
SFJ will remain responsible for the ongoing clinical trials of bentracimab and will work in collaboration with SERB to submit the Biologics License Application (BLA) to the US Food and Drug Administration (FDA), which they expect to file later this year.
Jeremie Urbain, Executive Chairman of SERB Pharmaceuticals, said: “The acquisition of bentracimab marks a significant step in our strategy to grow through investment in innovative, biologic products for critical care conditions and leverages our existing commercial and technical capabilities. We're excited to partner with SFJ, recognized leaders in late-stage drug development, to bring this life-saving medicine to healthcare professionals and the patients they treat.”
Robert DeBenedetto, Chief Executive Officer of SFJ, said: “We are pleased to partner with Jeremie and the entire SERB team on this important step to help advance bentracimab to patients. Bentracimab has recognized potential benefits and we have confidence that SFJ in collaboration with SERB will be able to expeditiously and efficiently see bentracimab through the approvals process by the US FDA.”
Bentracimab binds ticagrelor and its major active metabolite with high affinity and specificity. A prespecified interim analysis of the ongoing Phase 3 trial REVERSE-IT published in the New England Journal of Medicine Evidence demonstrated that bentracimab immediately and sustainably reversed the antiplatelet effects of ticagrelor, and was generally well tolerated, with only minor adverse events reported. In 2019 bentracimab received Breakthrough Therapy Designation from the FDA, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
The companies did not disclose specific financial terms. Leopoldo Zambeletti acted as advisor for SFJ, and Evercore acted as advisor for SERB.
About SERB Pharmaceuticals
SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB has the broadest antidote portfolio in the world, including medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. SERB operates in the US as BTG Pharmaceuticals.Learn more at https://SERB.com.
About SFJ Pharmaceuticals®
SFJ is a global drug development company, which provides a unique and highly customized clinical development partnering model for the world's top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ's mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life-enhancing drugs for the benefit of physicians and the patients they serve. www.sfj-pharma.com
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