Daiichi | January 20, 2021
Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbusterland.
The FDA cleared Enhertu for HER2-positive gastric or gastroesophageal junction cancer patients who previously received Roche’s standard-of-care Herceptin, the companies said Monday.
An antibody-drug conjugate, Enhertu is the first HER2-directed therapy approved in gastric cancer in a decade, the companies said. And it earned the green light after showing—for the first time in this patient population—that an HER2 drug could top chemotherapy at helping patients live significantly longer.
In the pivotal Destiny-Gastric01 trial in Japan and South Korea, Enhertu cut the risk of death by 41% versus chemotherapy in patients who had progressed on at least two previous treatments, including Herceptin. At an interim analysis, patients on Enhertu had lived a median 12.5 months, versus 8.4 months with chemotherapy, according to data presented at the 2020 American Society of Clinical Oncology (ASCO) meeting. On the study’s primary endpoint of overall response rate, Enhertu shrank tumors in 40.5% of patients, compared with a response rate of 11.3% in the chemo arm.
Previously treated HER2-positive stomach cancer now becomes Enhertu’s second U.S. approval, on top of its original nod in third-line HER2-positive breast cancer. Both Daiichi and AZ are banking their oncology revenue growth on Enhertu.
Daiichi’s in the middle of a transformation that puts oncology front and center as the Japanese pharma pivots away from the cardiovascular and metabolic fields. As part of the overhaul, the company’s targeting JPY500 billion ($5 billion) in peak oncology drug sales. Enhertu could take about half of that load: It now bears a 2024 sales estimate of around $2.5 billion, with some bullish industry watchers projecting peak sales above $4 billion.
Novartis | January 19, 2021
Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more.
Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.”
BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely.
Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.
CareRx | January 18, 2021
CareRx Corporation ("CareRx" or the "Company") (TSX: CRRX), Canada's leading provider of specialty pharmacy services to seniors, is pleased that the Ontario Ministry of Health has announced that it will pause for one year previously scheduled changes to long-term care pharmacy funding, which were scheduled to go into effect on April 1, 2021.
Under certain amendments to the Ontario Drug Benefit Act that came into effect on January 1, 2020, the reimbursement model for long-term care pharmacies in Ontario was changed from a fee-for-service model to a fee-per-bed capitation model under which pharmacies receive a fixed professional fee for all pharmacy services provided to residents in long-term care homes. The fee for 2020, which was prescribed at $1,500, was scheduled to decline to $1,400 per bed serviced on April 1, 2021. The step-down in capitation has now been paused until April 1, 2022.
"Long-term care homes and their staff have faced unprecedented challenges during COVID-19," said David Murphy, President and Chief Executive Officer of CareRx. "This pause will ensure that pharmacies like CareRx can continue to deliver the same exceptional partnership and service offering to long-term care homes and help alleviate the burden COVID-19 has placed on home staff. We want to thank Minister Elliott, Minister Fullerton and the Ontario Government for their ongoing dialogue and commitment to protecting the wellbeing of residents in long-term care."
About CareRx Corporation
CareRx is Canada's leading provider of specialty pharmacy services to seniors. We serve approximately 50,000 residents in over 900 seniors and other communities (long-term care homes, retirement homes, assisted living facilities, and group homes). We are a national organization with a large network of pharmacy fulfillment centres strategically located across the country. This allows us to deliver medications in a timely and cost-effective manner and quickly respond to routine changes in medication management. We use best-in-class technology that automates the preparation and verification of multi-dose compliance packaging of medication, providing the highest levels of safety and adherence for individuals with complex medication regimes. We take an active role in working with our home operator partners to promote resident health, staff education, and medication system quality and efficiency.