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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PHARMACY MARKET, PHARMA TECH
Capsida Biotherapeutics | February 27, 2023
Capsida Biotherapeutics Inc., a fully integrated next-generation gene therapy platform company, and AbbVie, a pharmaceutical company dedicated to discovering and providing innovative medicines to address serious health issues, have recently announced an expanded strategic collaboration.
The collaboration aims to develop genetic medicines for eye diseases with high unmet needs. Capsida's novel adeno-associated virus (AAV) engineering platform and manufacturing capability will be combined with AbbVie's extensive capabilities to identify and advance three programs. This expanded collaboration builds on the neurodegenerative disease partnership established in 2021.
As per the agreement's terms, Capsida will receive $70 million, comprising upfront payments and possible equity investment. Capsida could receive up to $595 million in option fees and research and development milestones for the three programs, with the potential for further commercial milestones. Additionally, Capsida will be eligible to receive mid-to-high single-digit royalty payments on future product sales.
Capsida will be responsible for leading capsid discovery efforts for all programs, utilizing its high throughput AAV engineering platform, and will also be responsible for process development and early clinical manufacturing. AbbVie, on the other hand, will lead innovative therapeutic cargo approaches and be responsible for commercialization and development.
Capsida's CEO Peter Anastasiou commented, "AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area." He added, "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully integrated next-generation AAV engineering platform and manufacturing capabilities offers the potential to provide novel therapies enabling unprecedented benefit to patients with serious eye diseases."
(Source- PR Newswire)
About Capsida Biotherapeutics
Capsida Biotherapeutics Inc. is a leading gene therapy platform company that develops targeted, non-invasive gene therapies for patients suffering from severe and life-threatening genetic disorders. Its innovative approach allows for the treatment of rare and common diseases across all age groups. The company focuses on creating customized therapies that selectively target specific organ systems while minimizing exposure to non-targeted organs. Capsida is a fully integrated biotechnology company with proprietary adeno-associated virus (AAV) engineering, translational biology, advanced manufacturing capabilities, multi-modality cargo development and optimization, process development, as well as extensive clinical development expertise.
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BUSINESS INSIGHTS, PHARMACY MARKET
Globenewswire | March 28, 2023
EyePoint Pharmaceuticals, Inc. a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced it has completed enrollment in the Phase 2 "Durasert® and Vorolanib in Ophthalmology 2" (DAVIO 2) clinical trial evaluating EYP-1901 as a potential six-month maintenance treatment for wet age-related macular degeneration (wet AMD). The trial exceeded its original target of 144 patients, enrolling a total of 160 patients. All patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 or to an aflibercept on-label control.
“We are thrilled to announce the completion of enrollment in our oversubscribed Phase 2 DAVIO 2 trial evaluating EYP-1901 in wet AMD, marking an important milestone as we continue to advance our pipeline of innovative sustained delivery treatments for serious eye disorders,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Patients with wet AMD face an immense treatment burden, requiring monthly or bi-monthly eye injections for the rest of their lives in order to prevent severe vision loss. The high level of patient and physician interest we saw in the trial enrollment further demonstrates the great unmet need in this population for a maintenance treatment option that is safe, effective, long-lasting and convenient.”
“We look forward to reporting topline data in the fourth quarter of this year. With these data and the promising results from our Phase 1 DAVIO trial, EYP-1901 will have the largest and most robust dataset of any tyrosine kinase inhibitor (TKI) product in development for wet AMD. These data will inform the design of our pivotal Phase 3 clinical trials and provide optionality as we seek to bring this promising product to patients. I would like to thank our dedicated team of employees and clinical partners, as well as the patients who enrolled in the Phase 1 and Phase 2 EYP-1901 trials and their caregivers for advancing the development of EYP-1901,” continued Ms. Lurker.
DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with wet AMD. Originally designed to enroll 144 patients, the trial enrolled 160 patients in total due to strong investigator and patient interest. All enrolled patients were previously treated with a standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in best corrected visual acuity (BCVA) compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety.
“Our ‘Treat to Maintain’ therapeutic approach for EYP-1901 has the potential to transform the wet AMD treatment paradigm, and we are incredibly pleased to complete enrollment with more patients than planned in the DAVIO 2 clinical trial due to high demand to participate from investigators and patients,” said Jay Duker, M.D., President and Chief Operating Officer of EyePoint Pharmaceuticals. “The compelling Phase 1 DAVIO results demonstrate EYP-1901’s potential to transition a majority of patients to an every-six-month treatment for wet AMD, representing a ‘treat to maintain’ therapeutic approach that uses EYP-1901 as a baseline therapy following the use of large molecule anti-VEGFs with the goal of significantly extending the patient’s treatment interval. Based on the extensive prior clinical data evaluating Durasert in four FDA-approved indications, we are confident in EYP-1901’s ability to consistently deliver the active drug, vorolanib, with zero-order drug release kinetics using our bioerodible sustained delivery technology, Durasert® E. In addition, vorolanib brings a new mechanism of action for wet AMD patients and may have additional neuroprotective benefits. We are confident in EYP-1901’s potential to enhance treatment compliance, improve clinical experience and, ultimately, result in better patient outcomes.”
About EYP-1901
EYP-1901 is being developed as an investigational sustained delivery treatment combining a bioerodible formulation of EyePoint's proprietary Durasert® delivery technology (Durasert® E) with vorolanib, a tyrosine kinase inhibitor. Positive safety and efficacy data from the DAVIO Phase 1 clinical trial of EYP-1901 showed a positive safety profile with stable visual acuity and OCT. Further, 53% and 35% of eyes did not require any supplemental anti-VEGF injections up to six and twelve months, respectively, following a single dose of EYP-1901. Phase 2 studies are underway for wet AMD and non-proliferative diabetic retinopathy and are planned in diabetic macular edema. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products, including YUTIQ® for the treatment of posterior segment uveitis, which is currently marketed by the Company. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts.
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