This week, AstraZeneca AZN reported disappointing fourth-quarter results. Meanwhile, Novartis’ NVS new eye drug, Beovu and Pfizer’s PFE rare disease drug, Vyndaqel were approved by the European Commission. Sanofi SNY and J&J JNJ announced deals with BARDA, part of U.S. Department of Health and Human Services, for accelerated development of a vaccine for the newly found coronavirus.
Recap of the Week’s Most Important Stories:
AstraZeneca’s Disappointing Q4 Results: AstraZeneca missed estimates for both earnings and sales in the fourth quarter. Its product sales rose 9% at CER to $6.25 billion. In 2020, the company expects total revenues to grow by high single-digit to a low double-digit range and core EPS to increase by a mid- to high-teens percentage. Importantly, the company said it expects the coronavirus outbreak in China to hurt its profits in 2020.
Novartis Gets EU Approval for Wet AMD Drug Beovu: The European Commission (EC) granted approval to Novartis’ wet age-related macular degeneration (AMD) drug, Beovu. The approval was based on findings from the phase III, global, head-to-head HAWK and HARRIER studies, wherein Beovu demonstrated non-inferiority to Regeneron/Bayer’s market-leading drug, Eylea (aflibercept), in mean change in best-corrected visual acuity from baseline to year one.
The approval was expected as in December the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had given a positive opinion recommending approval of Beovu. The drug was approved by the FDA in October 2019.
Pfizer’s Vyndaqel Gets Approved in Europe: The EC also granted approval to Pfizer’s Vyndaqel (tafamidis) capsule (61 mg) to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), a rare and fatal illness associated with progressive heart failure. Vyndaqel is already marketed in Europe since 2011 for the treatment of transthyretin amyloid polyneuropathy (ATTR-PN) in adult patients with stage I symptomatic polyneuropathy to delay peripheral neurologic impairment. Vyndaqel and Vyndamax, two oral formulations of tafamidis, were approved in the United States in May last year for ATTR-CM. The drugs were off to a strong start and recorded sales of $473 million in 2019.
Sanofi, J&J Sign Deal With BARDA for Coronavirus Vaccine: Sanofi signed a deal with with BARDA to quickly advance development of a vaccine for COVID-19, the disease caused by the novel coronavirus, also called 2019-nCoV. Sanofi will advance the development of the vaccine by leveraging work on a pre-clinical vaccine candidate for SARS, which it had started to develop when the SARS coronavirus emerged in 2002.
J&J also expanded its partnership with BARDA to accelerate development of potential treatments for COVID-19. Following this partnership, J&J and BARDA will mobilize resources to screen potential compounds with promising antiviral activity against 2019-nCoV. To do so, J&J will work with the Rega Institute for Medical Research in Belgium. Earlier this month, J&J had said that BARDA will share the R&D costs and provide funds to rapidly advance its COVID-19 vaccine development program into phase I clinical studies.
FDA Rejects Merck’s Six-Week Dosing Option of Keytruda: The FDA granted a complete response letter to Merck’s MRK supplemental biologics license application (sBLA) seeking approval for an improved dosing schedule of its blockbuster anti-PD-1 therapy, Keytruda. Merck is looking for approval of a six-week 400 mg dosing option of Keytruda for multiple indications, which will be delivered as an intravenous infusion over 30 minutes and will provide greater flexibility than the currently approved dose of 200 mg every three weeks infused over 30 minutes. The 400-mg six week dosing option was approved in Europe in March 2019.
FDA’s Priority Review to Roche’s Tecentriq sBLA: The FDA accepted Roche’s RHHBY sBLA seeking approval of Tecentriq monotherapy as a first-line treatment for PD-L1-selected patients with advanced non-squamous or squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations. With the FDA granting priority review to the sBLA, a decision is expected on Jun 19. The sBLA is based on data from the phase III IMpower110 study.
The NYSE ARCA Pharmaceutical Index declined 0.8% in the last four trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last four trading sessions.
Last week, while Merck rose the most (0.6%) Pfizer declined the most (2.9%).
In the past six months, Bristol-Myers has risen the most (36.2%) while Merck declined the most (4.9%).
(See the last pharma stock roundup here: ABBV, AGN Post Q4 Results, Another Alzheimer’s Study Fails)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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