BUSINESS INSIGHTS

Louis Drapeau Has Resigned from the Board of Directors of Avita Medical, Inc

AVITA Medical | April 22, 2022

Louis Drapeau
Louis Drapeau has resigned from the Board of Directors of AVITA Medical, Inc. a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, effective April 29, 2022. Mr. Drapeau's resignation is not the result of a disagreement with the Company over any of its operations, policies, or procedures. Rather, he is stepping down for personal reasons.

Since January 2016, Mr. Drapeau has served as Chair of the Audit Committee and as a non-executive Director of AVITA Medical. Louis Drapeau had already stepped down as Chair of the Audit Committee as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022. James Corbett was appointed Chair of the Audit Committee in his place as of February 23, 2022, as disclosed in the Company Form 10-KT dated March 1, 2022.

We want to thank Louis for his time, dedication and contributions to AVITA Medical over the past six years. We appreciate his insights and dedication to the Company and wish him the best.”

Lou Panaccio, Chairman of the Board

Spotlight

The research-based pharmaceutical industry makes a major contribution to the prosperity of the world economy. Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, but down from recent high growth rates in 2014 and 2015, according to a recent analysis by QuintilesIMS, Outlook for Global Medicines Through 2021: Balancing Cost and Value. The global market is highly mature and consolidated. The top-10 pharmaceutical companies in this market had share of around 40% in 2016

Spotlight

The research-based pharmaceutical industry makes a major contribution to the prosperity of the world economy. Total spending on medicines is forecast to reach $1.5 trillion by 2021, up 33% from 2016 levels, but down from recent high growth rates in 2014 and 2015, according to a recent analysis by QuintilesIMS, Outlook for Global Medicines Through 2021: Balancing Cost and Value. The global market is highly mature and consolidated. The top-10 pharmaceutical companies in this market had share of around 40% in 2016

Related News

PHARMACY MARKET

Eagle Pharmaceuticals Agreed to Acquire Acacia Pharma Group plc

Eagle Pharmaceuticals, Inc. | March 29, 2022

Eagle Pharmaceuticals, Inc. reported that it had achieved an agreement with Acacia Pharma Group plc on the parameters of a plan of arrangement under Part 26 of the United Kingdom's Companies Act 2006. Acacia Pharma's current issued and to be issued, share capital is valued at approximately €94,700,000, or the equivalent of €0.90 per share, under the terms of the proposed transaction. Each Acacia Pharma shareholder would get €0.68 in cash and 0.0049 shares of Eagle common stock in exchange for each Acacia Pharma share owned. Eagle will additionally guarantee about €25.0 million of debt within the Acacia Pharma group under the proposed acquisition terms. In conjunction with the proposed transaction, the Company and Acacia Pharma entered into a collaboration agreement on March 27, 2022, and (ii) certain shareholders and directors of Acacia gave irrevocable undertakings to the Company and Acacia. The proposed deal has been authorized by the boards of directors of both businesses. It is scheduled to complete in late Q2 2022, subject to shareholder approval, approval by the High Court of England and Wales, and satisfaction of standard closing conditions for transactions of this kind. There is no guarantee that the proposed transaction will be completed on the given terms, on the anticipated schedule, or at all. The proposed transaction is expected to provide Eagle with two currently marketed acute care hospital products with the potential to disrupt the marketplace: • BARHEMSYS® is the first and only antiemetic authorized by the Food and Drug Administration (FDA) for the rescue treatment of postoperative nausea and vomiting (PONV) in the absence of prophylaxis. Eagle is now targeting healthcare providers and institutions, which account for more than 70% of the anticipated addressable market potential for BARHEMSYS. • BARHEMSYS is also licensed for the treatment and prevention of PONV in patients who have not received prophylaxis. The projected yearly addressable market for prophylaxis and rescue in the United States is $2.7 billion. • BYFAVO® is authorized for the induction and maintenance of procedural sedation in adults having operations lasting 30 minutes or less, with a total addressable market for procedural sedation in the United States estimated at more than $0.4 billion per year. “We are delighted to announce that we have agreed to terms for the proposed acquisition of Acacia Pharma. This will be a very important acquisition for us, both financially and strategically. In recent years, the pharmaceutical industry has witnessed slower uptake of new products and longer ramp periods. In the face of further challenges brought about by the COVID-19 pandemic, many smaller underfunded companies experienced significant hurdles launching products. We therefore believe that Eagle is well suited to drive uptake of these two new products, building from Acacia Pharma’s established foundation since its launch, through our experienced and specialized hospital-based sales organization with minimal additional infrastructure,” President and Chief Executive Officer of Eagle Pharmaceuticals, Scott Tarriff “We have been extremely disciplined in managing our balance sheet over the years, and we believe that the proposed acquisition is a wise use of the cash we have generated. With these two products, together with landiolol, which is on track for an NDA submission to the FDA in May of this year, Eagle will potentially have three NCEs going into their launch phase. We believe these efforts will strengthen our leadership position in the hospital and oncology space and establish a strong foundation for sustainable long-term growth and bring value to our shareholders,” concluded Tarriff. “We believe that BARHEMSYS and BYFAVO address unmet clinical needs and are nearing usage inflection points, with strong formulary acceptance, and that with our longstanding relationships in the hospital space, we can accelerate uptake and capture the commercial potential of these assets. In doing so, we strive to impact and improve the care of patients undergoing medical treatments such as surgery and invasive procedures. Additionally, their value to anesthesia providers, who are key users, is important, facilitating precision medicine for patients. We see our sales infrastructure as a strategic asset, and as we add to our commercial product portfolio going forward, we plan to expand the size of our salesforce over the next two years,” stated Executive Vice President and Chief Commercial Officer of Eagle Pharmaceuticals, Michael Moran.

Read More

BUSINESS INSIGHTS

NAMSA Acquires Leading Clinical Research Organization Clinlogix to Enhance Therapeutic Expertise and Global Footprint

NAMSA | August 03, 2021

NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early 2021. Clinlogix, founded in 1999, is well-recognized for providing comprehensive clinical research services for novel and emerging technologies to the medical device industry. Supporting more than 500 trials across 3,500 sites worldwide, Clinlogix provides an unparalleled breadth and depth of global expertise in the areas of Cardiovascular, Neurology, Nephrology, Urology, Oncology and Venous/Wound Care clinical research. “Today is an exciting day as the Clinlogix Team joins NAMSA. We are thrilled to partner with an organization that is equally committed to client success, evidenced through Clinlogix’s consistent delivery of reliable clinical outcomes to global device Sponsors,” commented NAMSA President and CEO, Dr. Christophe Berthoux. “NAMSA’s 54-year history of providing successful development results, coupled with the clinical expertise and global reach of Clinlogix, now offers medtech innovators a clear choice when seeking safe, accelerated clinical development and commercialization of life-changing medical products,” Dr. Berthoux concluded. As the pioneer of the medical device testing industry, NAMSA provides testing services to Sponsors in addition to quality, reimbursement, clinical research and regulatory solutions. The CRO’s end-to-end development services are proven to help Sponsors successfully address varying global regulatory requirements, including recently expanded criteria for medical device and In Vitro Diagnostic research and conduct. “Clinlogix is extremely pleased to join NAMSA, an organization that shares the same patient-centric, client-focused philosophy as we do. For over 20 years, our focus has been on providing a global ‘innovation pathway’ for Clients developing novel and emerging technologies,” stated Clinlogix CEO, JeanMarie Markham. “Now together, with NAMSA, we are expanding and leveraging our respective services to truly provide end-to end development solutions to our Clients,” Markham concluded. The acquisition of Clinlogix adds to NAMSA’s rapidly growing global footprint, now serving Sponsors throughout 17 locations in Asia-Pacific, Europe, Latin America and North America. ABOUT NAMSA Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s only 100% medical device-focused, full continuum Contract Research Organization (CRO). Driven by its global expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move Clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. ABOUT CLINLOGIX Clinlogix is a global Clinical Research Organization (CRO) working to improve human quality of life by supporting and accelerating novel and emerging technologies in the life science industry. Its full suite of clinical research services supports the regulatory and clinical development pathway of medical devices, biotechnologies and pharmaceuticals from bench to bedside. The company delivers this global expertise by way of its regional office locations in the U.S., Germany, Colombia and Japan.

Read More

BUSINESS INSIGHTS

With Veeva eConsent, Celerion is changing the consent experience for clinics and patients

Veeva Systems | October 07, 2021

Veeva Systems (NYSE: VEEV ) announced that Celerion has launched Veeva eConsent , a MyVeeva for Patients solution, to provide electronic consent for its Phase I clinical trials obtain. With Veeva eConsent, Celerion is moving from manual and paper-based consent forms to a fully digital process. The company uses Veeva eConsent for several studies and has already given their consent to more than 200 test subjects. Covid-19 limited the time we could spend with attendees. So we needed new and digital ways to advance our studies while meeting regulatory requirements for proper consent, - Staci McDonald , Executive Director, Scientific Clinical Operations at Celerion . An easy-to-use solution that can keep pace with our fast-paced environment and improves the participants' understanding of the study processes. The implementation of the solution went smoothly, and the feedback from the study teams, on-site staff and participants was positive. " Celerion, a leading global provider of early clinical research services, uses Veeva SiteVault to digitally create, manage and distribute informed consent (ICF). Patients can then securely access the eConsent document and complete the consent process via a mobile device. This simplifies the comparison of documents and reduces the administrative effort for the locations. Thanks to a seamless flow of information, Celerion has a complete overview of the status of consent and can thus improve study compliance and monitoring. Celerion is driving industry collaboration by leveraging digital solutions that enable patient-centric, paperless clinical trials, Veeva eConsent improves the process of informed consent for everyone Stakeholders by providing an intuitive and digital experience for patients and easy collaboration with locations and IRBs for sponsors. - Tim Davis , vice president, MyVeeva for Patients at Veeva Systems. About Veeva Systems Veeva is the world's leading provider of cloud software for the life science industry. Veeva is committed to innovation, product quality and customer success, serving more than 1,000 customers from the world's largest pharmaceutical companies to emerging biotech companies. As a not-for-profit, Veeva is committed to aligning the interests of all stakeholders, including customers, employees, shareholders and the industries it serves.

Read More