AstraZenecas Farxiga pads its case for new heart-helping approval

FiercePharma | August 20, 2019

AstraZeneca is still stinging after its SGLT2 diabetes drug Farxiga was waved off by the FDA in Type 1 disease. But heres something that could ease the pain- New outcomes data showing Farxiga cut cardiovascular risks in heart failure patients with or without diabetes. In a phase 3 trial, Farxiga cut the risk of cardiovascular death or hospitalization in patients with reduced ejection fraction HFrEF, when added to standard treatments for heart failure. The data could help Farxiga score a CV risk-reduction approval, a distinction its rivals in the SGLT2 class already have. The trial, dubbed Dapa-HF, was the first to test an SGLT2 drug against heart failure in patients with or without Type 2 diabetes, the company said. It pitted Farxiga plus standard therapy against standard therapy alone. AstraZeneca plans to take the data to regulators "as soon as possible," Mene Pangalos, EVP of BioPharmaceuticals R&D, said in a statement.

Spotlight

Think you’re invincible? You’re not alone. Most working Americans drastically underestimate the odds of experiencing an income-interrupting injury or illness that will last an extended period of time. Now consider that more than one in four of today’s 20-year-olds will have their income interrupted by a disability before they retire. That’s because some top causes of long-term disabilities aren’t catastrophic accidents, but common, everyday health issues like back pain, heart disease, arthritis, cancer, even pregnancy. No matter how healthy, everybody has a risk that is too high to ignore.

Spotlight

Think you’re invincible? You’re not alone. Most working Americans drastically underestimate the odds of experiencing an income-interrupting injury or illness that will last an extended period of time. Now consider that more than one in four of today’s 20-year-olds will have their income interrupted by a disability before they retire. That’s because some top causes of long-term disabilities aren’t catastrophic accidents, but common, everyday health issues like back pain, heart disease, arthritis, cancer, even pregnancy. No matter how healthy, everybody has a risk that is too high to ignore.

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PHARMA TECH

Prescryptive Health Launches Comprehensive Pharmacy Management Platform to Expand the Scope of Community Pharmacists

Prescryptive Health | October 06, 2021

Healthcare technology company Prescryptive Health today announced that MyRx PRO is now operational nationwide. The pharmacy management platform allows pharmacists to digitize their business with new revenue opportunities through profitable clinical services and a deeper patient engagement experience. Today we change the course of the community pharmacist, by empowering them to expand their business and meet new customers through new services, all on our secure platform. Pharmacists are central to community health, and we are proud to offer a system to help them transform for the digital age. - Chris Blackley, CEO of Prescryptive Health At the core of MyRx PRO are turn-key clinical services, which build in patient engagement, inventory management, reporting, and billing all on one platform. This includes critical COVID-19 care—testing, vaccinations, and monoclonal antibody treatment—and flu services for the ongoing public health crisis. MyRx PRO pharmacists already on the platform had a lift in annual revenue up to 25%; by offering relevant services, pharmacists can grow their business while providing the healthcare needed in their local communities. New patients find these services through Prescryptive's patient-friendly mobile solution, MyRx.io. I'm getting new patients at my counter every day thanks to Prescryptive, MyRx PRO allows me to offer more services efficiently so I can focus on what matters most: patient care. - Vincent Chiffy, owner of Parkway Drugs in Utica, NY. MyRx PRO also features SmartPRICE™ with AI-driven intelligent pricing capabilities and a solution for cash-paying customers. Unlike popular cash discount cards, SmartPRICE™ saves patients up to 80% on prescriptions without exorbitant fees charged to local pharmacies by third parties. MyRx PRO is available nationwide today, with new clinical services added continually. About Prescryptive Health Prescryptive Health is a healthcare technology company delivering solutions that empower consumers. Prescryptive's secure, mobile-first products connect consumers, pharmacists, and employers, ultimately providing people with the information they need to make informed decisions and take control of their health.

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PRACTICE MANAGEMENT

Azurity Pharmaceuticals to Acquire and Merge with Arbor Pharmaceuticals

Azurity Pharmaceuticals, Inc. | August 24, 2021

Azurity Pharmaceuticals, Inc. and Arbor Pharmaceuticals, Inc. today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from existing investors including JW Asset Management and KKR. Following the completion of the transaction, which is subject to regulatory approvals, Azurity and Arbor will merge, creating a leading company offering innovative, high-value products to meet the unique needs of patients with underserved conditions. Financial details of the transaction were not disclosed. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” “Arbor is excited to be joining forces with Azurity to further our goal of bringing innovative products to the market that improve patients’ lives,” commented Ed Schutter, CEO of Arbor. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.” The combined company, operating as Azurity, will have a portfolio of products serving the unmet needs of patients in the cardiovascular, central nervous system, endocrinological, gastrointestinal, and institutional markets. Azurity will build upon each company’s legacy of success through a distinctive portfolio of 10 exclusively promoted, FDA-approved, branded product families, more than 30 total commercialized products, and a robust pipeline of mid and late-stage products under development. Azurity will continue to develop and commercialize its portfolio of products and deliver them at the right time, in the right way, to the right patients, through a spectrum of healthcare professionals. “We are proud to continue our partnership with Azurity,” said Jeff Edwards, Partner at NovaQuest Private Equity, the majority owner of Azurity. “This combination accelerates our shared vision of building the leading patient-centric company that differentiates itself by bringing distinctive, high-value products that meet the unique needs of our patients, through state-of-the-art innovation and commercialization capabilities.” “Today is a tremendous milestone for both Arbor and Azurity, and a strong validation of the products that they provide to patients in need,” said Jason Wild, Chairman of Arbor and Chief Investment Officer of JW Asset Management. “We are proud to have supported Arbor and its management team and are excited for the company’s next phase of growth in partnership with Azurity,” added Ali Satvat, Co-Head of Americas Health Care Private Equity and Global Head of Health Care Strategic Growth at KKR. JPMorgan Chase Bank, N.A. and Truist Securities, Inc. are financing sources for the transaction for Azurity. Smith Anderson served as legal advisor to Azurity. MTS Health Partners, L.P. served as exclusive sell-side financial advisor and King & Spalding served as legal advisor to Arbor. Simpson Thacher & Bartlett LLP served as legal advisor to KKR. Pending regulatory approvals, the companies anticipate closing the transaction in September. About Azurity Pharmaceuticals: Azurity Pharmaceuticals is a privately-held, specialty pharmaceutical company focusing on the needs of patients requiring customized, user-friendly drug formulations and dosage forms. Azurity’s patient centric products span the cardiovascular, neurology, gastro-intestinal and institutional markets. Azurity’s products have benefited millions of patients for which conventional oral dosage forms are not ideal and whose needs are not served by other commercially available therapies. About Arbor Pharmaceuticals: Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company marketing FDA-approved prescription products in the neuroscience, cardiovascular, and institutional markets. In addition to an extensive pipeline, the company actively pursues growth through acquisition and licensing of late-stage development products. About NovaQuest Private Equity: NovaQuest Private Equity is a leading investor in technology and services companies in the life sciences and healthcare sectors. NovaQuest was formed in 2000 with the vision of building an investment platform to provide strategic capital and operational leverage in partnership with strong management teams. The investment team consists of highly seasoned operational and investment professionals with significant investment experience and deep life science and healthcare expertise. Furthermore, NovaQuest benefits from an extensive network of industry experts and relationships that assist in identifying, analyzing and growing NovaQuest portfolio companies and investments. About JW Asset Management: JW Asset Management is a New York based fund manager with combined assets under management in excess of $1.5 billion. Jason Wild, the firm’s founder and Chief Investment Officer, is a registered pharmacist and Chairman of Arbor Pharmaceuticals and TerrAscend Corp. JW Asset Management has a history of finding attractive investment opportunities and actively invests in both public and private markets. About KKR: KKR is a leading global investment firm that offers alternative asset management and capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of The Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries.

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RESEARCH

NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial

NRx Pharmaceuticals | August 30, 2021

NRx Pharmaceuticals announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm." NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef. "With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA." Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care. This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy About ZYESAMI™/VIP in COVID-19 ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19. About NRx Pharmaceuticals NRx Pharmaceuticals draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx currently has the BriLife for COVID-19 in phase 3 trials, and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

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