This week’s Innovation Partners BioBlog contains several updates from major players in the pharmaceutical industry. Novartis’ sales dropped in the second quarter after early pandemic drug stockpiling boosted Q1 sales. The company is also struggling with unanticipated and serious side effects reported for its macular degeneration drug, Beovu. Pfizer and BioNTech are preparing for late-stage human testing in July of their mRNA-based COVID-19 vaccine. And the FDA is considering batch-testing for COVID-19. More in this week’s Innovation Partners BioBlog.
Pfizer, BioNTech ink U.K. supply pact for 30M COVID-19 vaccine doses
Pfizer and BioNTech are expected to begin late-stage human testing this month on their mRNA-based COVID-19 vaccine. To keep things moving quickly, the companies have already signed a deal with the U.K. government to supply 30 million doses over the next two years. The U.K. pact is part of Pfizer and BioNTech’s goal to produce 100 million doses of an effective and approved vaccine within the year and eventually produce 1.3 million doses by the end of 2021. The company hopes for regulatory review by October, with emergency authorization for approval following regulatory review.
NowRx, Medly Pharmacy land new funding as demand for digital pharmacies grows
Digital pharmacy startups are securing significant capital in their quest to take on industry giants such as CVS and Walgreens. New York City-based Medly Pharmacy scored a $100 million series B funding round co-led by growth equity firm Volition Capital and venture capital firm Greycroft with the participation of Horsley Bridge and Lerer Hippeau. Medley works with five pharmacies in New York, New Jersey, Pennsylvania, Maryland, and Miami, Florida. The investment provides growth capital for the company to expand into most major cities over the next 18 months.
FDA opens door to ‘batch testing’ for COVID-19 with new green lights for Quest Diagnostics
The FDA has authorized the first batch COVID-19 testing. The test collects samples from a related group, such as family members, pools the samples, and runs the tests. If all are negative, all are cleared, but one shows positive, all must be retested individually to screen for the subject with positive results. FDA Commissioner Dr. Scott Hahn stated that the pooled tests will be especially crucial as infection rates decrease, and larger groups in the general population need to be tested.
Exelixis Announces Initiation of CONTACT-03 Phase 3 Pivotal Trial of Cabozantinib in Combination With Atezolizumab in Previously Treated Metastatic Renal Cell Carcinoma
Exelixis, Inc. announced the start of CONTACT-03, a global phase 3 pivotal trial of cabozantinib (CABOMETYX®) in combination with atezolizumab (TECENTRIQ®) in patients with inoperable, locally advanced or metastatic renal cell carcinoma (RCC) who progressed during or following treatment with an immune checkpoint inhibitor as the immediate preceding therapy. CONTACT-03 is part of a clinical trial collaboration between Exelixis and Roche. The trials include two additional phase 3 pivotal trials that were both initiated in June 2020. CONTACT-03 is a global, multicenter, randomized, phase 3, open-label study that aims to enroll approximately 500 patients. Patients will be randomized 1:1 to the experimental arm of cabozantinib combined with atezolizumab or the control arm of cabozantinib alone.
Pandemic hits Novartis sales with eye meds, Cosentyx suffering from slowdown
Although a surge in sales at the start of the pandemic looked hopeful for Novartis, the global shutdown has slowed sales of many of its products. Sales of eye medications, psoriasis medication, and other sales decreases contributed to the 4% sales decline in Q2 2020. Other problems included their newly launched drug, Beovu, a drug to treat age-related macular degeneration. Beovu added a new safety risk of retinal vasculitis and retinal vascular occlusion that may result in severe vision loss. Although these are setbacks, Novartis stated it remains committed to Beovu and has convened a panel of 25 experts to review the root causes, risk factors, and other data related to Beovu.
FiercePharmaPolitics—States still exploring drug pricing despite congressional gridlock
Although drug pricing legislation hasn’t progressed in Congress, there’s work being done at the state level. Deloitte analysis found that several states have passed or sought to pass bills related to transparency requirements for price increases, importation, value-based contracting, etc. In Congress, lawmakers are readying drug pricing legislation in the event they can insert them into COVID-19 legislation.