Hikma, Vectura to develop generic versions of GSK’s Ellipta portfolio
Hikma Pharmaceuticals has signed an agreement with Vectura Group for the global development and commercialization of generic versions of GlaxoSmithKlines’s Ellipta portfolio, which will utilize Vectura’s proprietary “open-inhale-close” dry powder inhaler device.
“The generic respiratory market is a key area of pipeline focus for Hikma.This agreement leverages the investment we have made and the experience we have gained through our generic Advair Diskus program,” Hikma CEO Siggi Olafsson said in a statement. “By strengthening and expanding our partnership with Vectura, we will develop a pipeline of complex respiratory products that will enable us to deliver sustainable long-term growth.”
Vectura and Hikma believe the open-inhale-close dry powder inhaler device has the potential to be developed as a drug-device combination for generic versions of the GSK Ellipta portfolio.
Net sales for Ellipta products in the United States are projected to be $4 billion by 2024 and approximately $5.5 billion globally, the company said.
The open-inhale-close dry powder inhaler program includes the development of generics of up to five GSK respiratory medicines.
Hikma and Vectura have agreed to develop and commercialize at least three of the portfolio products. A generic version of Breo Ellipta (fluticasone furoate and vilanterol trifenatate) will be prioritized for the first wave of development. Pharmaceutical and device development work has progressed in parallel with partnering discussions.
The new device, an evolution of Vectura’s lever-operated multidose device, builds on Vectura and Hikma’s shared experience with the generic Advair Diskus program, enabling accelerated development under this new agreement.
PhRMA to roll out ‘Roadmap to Health’ in NYC
The Pharmaceutical Research and Manufacturers of America, New York Health Works and assembly member Marcos Crespo announced a new mobile health screening program, the “Roadmap to Health,” which will launch in January 2019 in New York City.
Dozens of events will take place throughout the upcoming year, providing various healthcare screenings and educational resources about health and wellness.
The Roadmap to Health is a mobile health fair that will provide information and resources to New York residents to help combat chronic disease and empower individuals with knowledge about their health, initially focusing on neighborhoods in the Bronx, Brooklyn and Queens.
Biometric health screenings will be available at each event, offering such screenings as total cholesterol, HDL cholesterol, blood pressure and BMI. Blood glucose screening, vision screening and a pulmonary function test also will be available at a number of events.
An independent medical screening firm will administer and conduct all of the health screenings. At each location, screeners will be on site to provide services in Spanish and English. Individuals who are screened also will be provided information on where to seek further medical assistance within their communities, if they choose to do so. All screenings will be provided to communities free of charge. PhRMA will be working alongside legislators to make sure their constituents are aware of this important resource.
The Roadmap to Health mobile health fair aims to remove barriers to health care by partnering with community organizations, health clinics and faith-based centers and providing direct services to individuals in their own communities. Each event can be tailored to meet the needs of each organization or community. At various points throughout the program, a nutritionist will be available to advise participants about the importance of healthy eating, or a group exercise class may be offered by a community partner.
“Many communities, particularly communities of color, face barriers in accessing preventative care,” said assembly member Crespo. “The Roadmap to Health program helps break down those barriers by bringing vital services to our communities, and I’d like to thank PhRMA for launching this important program.”
“We are thrilled to sponsor the Roadmap to Health program. Regular screenings are key to detecting and treating early warning signs of chronic disease,” PhRMA vice president of medical affairs and strategic alliances Michael Ybarra said. “PhRMA supports expanding access to care, and we hope to empower the vibrant communities of New York City with information and resources to improve their health.”
FDA announces new efforts to strengthen its expanded access program
Food and Drug Administration commissioner Scott Gottlieb today outlined efforts to further strengthen the expanded access program, while noting the progress the agency has been made over the last five years.
FDA has authorized more than 9,000 applications across drugs, biologics and devices through the agency’s expanded access program, and authorized approximately 99% of all the requests it has received across all application types, Gottlieb said.
Gottlieb also highlighted key findings from the FDA’s independent assessment of the program and new steps the agency is taking to improve upon its efforts.
“The assessment found that external stakeholders’ overall perceptions of FDA’s expanded access program — and FDA’s role in administering it are very positive,” Gottlieb said. “Stakeholders across the healthcare system highlighted FDA’s commitment to expediting the review of EA applications, the FDA’s collaborative nature and our focus on continuous improvement.”
Physicians with direct experience submitting an EA application to the FDA reported positive impressions of the program, and patients and their advocates described the program as a crucial route to access investigational therapies when other alternatives have been exhausted.
“Manufacturers, patient advocates, IRB representatives and physicians all noted that FDA has taken key steps to reduce the administrative burden associated with submitting requests and recognized our commitment to facilitate medically appropriate access via the EA program,” Gottlieb said.
Stakeholders also reported some challenges across the physician and patient journey through the program, that, if properly addressed, could meaningfully enhance the program.
The assessment found that confusion with program navigation, multi-stakeholder coordination and administrative burden were the most frequently-cited challenges. The assessment recommendations include improving FDA’s public website content and investing in resources to support patient/physician program navigation.
In response to the feedback, FDA’s EA web pages will be updated to improve usability through streamlining of content and a more user-friendly organization. This includes a reduction in duplication, as well as the addition of new pages with such commonly requested information as forms and keywords.
“These updates will begin rolling out today and will continue in the future as we identify new opportunities to improve the usability of information on our EA webpages,” Gottlieb said.
FDA also plans to formally establish an agency-wide Patient Affairs Staff and Health Care Provider Affairs Program, under the oversight of the Office of Clinical Policy and Programs. “This will enhance our engagement with these important external stakeholder groups. The Patient Affairs Staff is already in place and charged with serving as the ‘home base’ and primary point of entry for patients and physicians starting the EA process and navigating them through the steps,” Gottlieb said.
The FDA already streamlined the required supporting documentation for expanded access requests submitted by a physician for access to a drug or biological for the treatment of an individual patient.
“These changes reduced the administrative burden for these physicians,”Gottlieb said. “Following these changes, we estimate that it takes about 45 minutes, on average, to complete a patient application form. That form typically requires just one attachment.”
Pointing out that the FDA also simplified the process for Institutional Review Board, or IRB review, Gottlieb said, “For single patient EA, we’ve modified the IRB review process to permit just one IRB member — the chair or another appropriate person — to concur with the treatment use rather than the entire board.”
The FDA also established an agency-wide Expanded Access Coordinating Committee, which facilitates cross-center communication and promotes discussion to rapidly address cross-cutting issues related to expanded access to promote consistency and best practices.