U.S. FDA allows priority review to new drug application for vericiguat treating chronic heart failure

Merck | July 17, 2020

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for vericiguat, an orally administered soluble guanylate cyclase (sGC) stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), in combination with other heart failure therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Jan. 20, 2021. Vericiguat is being jointly developed with Bayer AG.

“This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We look forward to working with the FDA as they review this New Drug Application for vericiguat.”

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Astorg to Acquire Global Medical Communications and Market Access Platform OPEN Health From Amulet Capital Partners

Astorg and Amulet Capital Partners | June 01, 2022

Astorg and Amulet Capital Partners announce that they have signed a binding agreement whereby Astorg will acquire OPEN Health, a leading global provider of scientific communications and market access services to the pharmaceutical industry. Established in 2011 and headquartered in London, UK, OPEN Health is a key partner to its customers in helping them develop strategies for evidence generation and data communication by leveraging their extensive scientific knowledge and relentless focus on quality. Together, this approach consistently delivers best-in-class scientific communications, health economics and outcomes research (HEOR) and market access services to an ever-increasing audience. OPEN Health has more than 1,000 employees in 15 locations and six countries, across North America, Europe and Asia. OPEN Health serves over 170 life sciences customers, including 48 of the top 50 pharmaceutical companies. OPEN Health’s existing management team, led by CEO Rob Barker, will continue to lead the organization, building on a strong track-record of organic growth and strategic acquisitions. "We are excited to build on the momentum across our business and to continue executing with our new partners at Astorg on a shared long-term vision to bring deep scientific solutions that support our clients in driving positive health outcomes. We are grateful for the strong partnership of the Amulet team over the last three and a half years and for all that we have accomplished in expanding our industry-leading capabilities across disciplines. We continue to be very well positioned to drive innovation and growth, and we look forward to embarking on this next chapter for OPEN Health." Rob Barker, CEO, OPEN Health Building on OPEN Health’s leading service offerings, Astorg will invest in the development of the business across its main existing offerings, and beyond, to continue delivering best-in-class scientific content to OPEN Health’s customer base and help them harness the full value of their most important assets. "OPEN Health is a very impressive company. We have been following the development of the medical affairs space for a long time as the function evolved from a supportive to a central role and identified OPEN Health as a global leader in the making. We have been impressed with its outstanding reputation and the trust it benefits from its customer base,” said Judith Charpentier, Partner and Head of Healthcare, Astorg. “We look forward to supporting Rob and the OPEN Health management team in continuing to build a global leading scientific focused medical affairs platform, expanding the platform through both organic initiatives and additional strategic acquisitions,” said Olivier Lieven, Director, Astorg. Ramsey Frank, President and Managing Partner of Amulet, said, “OPEN Health was built around Amulet’s investment thesis in medical affairs: the current generation of drugs is fundamentally different from prior generations, and these therapies need to be brought to market with the support of high science communications and data analytics. We brought OPEN Health together very intentionally via three acquisitions to create a purpose-built suite of services to meet pharma’s evolving needs.” Amulet Partner Nick Amigone continued, “We could not be more grateful to Rob Barker and his team for the outstanding job they have done in building a true industry leader.” The terms of the transaction were not disclosed. The transaction is subject to customary regulatory approvals. Houlihan Lokey served as financial advisor to OPEN Health and Rothschild & Co advised Astorg on the transaction. About OPEN Health OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support our clients in improving health outcomes and patient wellbeing. We are united as one flexible organization, harnessing the power of the collective to solve complex challenges. About Astorg Astorg is a European private equity firm with over €17 billion of assets under management. Astorg works with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the US, providing them with the strategic guidance, governance and capital they need to achieve their growth plans. Enjoying a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body, Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London, Paris, New York, Frankfurt, Milan and Luxembourg. About Amulet Capital Partners, LP Amulet Capital Partners, LP is a middle-market private equity investment firm based in Greenwich, CT, focused exclusively on the healthcare sector. Amulet seeks to achieve long-term capital appreciation through privately negotiated investments in companies. Amulet Capital Partners focuses on those segments it believes have the most attractive long-term fundamentals with a target investment size generally between $25 million to $150 million.

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PHARMA TECH

House Rx to Launch Specialty Drug Dispensing Inside Rheumatology Clinics By Partnering with Three Leading Practices

House Rx | August 04, 2022

House Rx, the platform for medically integrated dispensing of specialty medications, announced it has partnered with three new rheumatology clinics to integrate in-house specialty drug dispensing – also known as medically integrated dispensing (MID) – into the clinics' operations. The three practices are: Arizona Arthritis & Rheumatology Associates (AARA), Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), and Arthritis Associates of Tennessee and represent an additional 68 providers that will dispense specialty medications through the House Rx platform, bringing the total number of providers on House Rx's platform to 137. While MID has grown in oncology, House Rx's partnership with these practices is one of the first to bring the model to rheumatology care. "It's very exciting to partner with key thought leaders in rheumatology to bring medically integrated dispensing to this specialty. Each one of these practices is a leader in their region, and we look forward to partnering very closely with them to define a new standard for a better patient experience and improved outcomes for patients living with rheumatic diseases." Ogi Kavazovic, Co-Founder and CEO of House Rx By bringing specialty dispensing into the physician's office, the partnership with House Rx aims to dramatically improve the specialty medication experience for patients. The MID care model provides a seamless and efficient way for patients to receive prescribed therapies directly from their doctor – which research has demonstrated improves outcomes, including quality of life and increased survivability, when contrasted with the Pharmacy Benefit Manager-controlled specialty pharmacy approach. "This partnership will increase patient satisfaction by providing prescription medication in-house, and House Rx's technology and expertise will help us achieve this," said Prakash Viswanathan, CFO of AARA. "It is motivating to help trailblaze a new path in rheumatology and be one of the first practices to bring specialty medication dispensing under our roof, making it far easier and quicker for patients to get the medications they need." "We couldn't be more excited about this partnership, which will bring immediate benefits for our patients," said Scott Gilomen, CEO of AOCC. "Having managed an oncology practice earlier in my career, I've seen first-hand the advantages of the MID model and look forward to how House Rx's approach to MID will propel the rheumatology field forward – with our practice at the forefront." "The House Rx model will transform how rheumatology care is delivered, making it more coordinated and improving our patients' experience," said Beth Simpson, DO and managing physician partner at AATN. "We look forward to our patients not being on hold for hours on end waiting to speak with a specialty pharmacy. Instead, they'll speak immediately with House Rx's integrated team of pharmacy experts who understand their rheumatologic conditions." While the concept of dispensing specialty medications in rheumatology is not new — a handful of clinics attempted dispensing in the past but ultimately were unsuccessful due to a lack of technological and operational support — House Rx's model approaches in-office dispensing in a new way. By providing clinics with specialized technology and operational support from pharmacists and pharmacy technicians who work integrated with the clinic, practices can keep the service under their roof while reducing the heavy lifting of implementing and maintaining a successful MID program. In addition, clinics can repurpose staff resources normally spent on prior authorizations and financial assistance for patients to focus on direct patient care or other activities critical to the viability and financial independence of community rheumatology clinics. About House Rx House Rx is a healthcare technology and services company focused on making specialty medication more accessible and affordable. The company partners with specialty clinics across the country to help these community clinics offer medically integrated dispensing, bringing together clinical and pharmacy expertise to better serve patients, lower the cost of care, and create a better experience for patients and their caregivers. Learn more at www.houserx.com. About Arizona Arthritis & Rheumatology Associates With 19 physicians, 30 advanced practice providers, and 10 clinics around the state of Arizona, AARA is one of the largest rheumatology practices in the country bringing world-class expertise to patients managing autoimmune conditions. A member of the American Rheumatology Network, and always at the forefront of rheumatology care, AARA has led the way in addressing the rheumatologist workforce shortage by integrating advanced practice providers into their practice, which has allowed the practice to scale clinical operations and meet the demand of a growing patient population. About Arthritis & Osteoporosis Consultants of the Carolinas Based in Charlotte, North Carolina, AOCC has 10 physicians and 5 advanced practice providers caring for patients across two clinics. Combining years of experience in private practice, academic teaching and clinical research, the clinic staff provides highly individualized and state-of-the-art care. About Arthritis Associates Founded in 1975, Arthritis Associates has been at the forefront of rheumatological care in Chattanooga, TN and is the only practice in the area treating both adult and pediatric patients. Arthritis Associates has an excellent, experienced and knowledgeable team including skilled nurses who can administer intravenous treatments onsite, supervised by a board-certified rheumatologist.

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BUSINESS INSIGHTS

Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine,

Novavax, Inc. | August 16, 2022

Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that it submitted an application to the U.S. Food and Drug Administration for Emergency Use Authorization of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 as a homologous and heterologous booster in adults aged 18 and older. "It's important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations. Based on the data presented to the FDA's VRBPAC and the CDC ACIP, we believe our vaccine offers a broad, long-lasting immune response against a range of variants." Stanley C. Erck, President and Chief Executive Officer, Novavax Authorized Use The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. About the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) The Novavax COVID-19 Vaccine, Adjuvanted is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. About Matrix-M™ Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response. About Novavax Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 Vaccine, Adjuvanted, the company's COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including in the U.S., European Union and with the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines the Novavax COVID-19 Vaccine, Adjuvanted and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

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