Several large drugmakers including
Eli Lilly ( LLY Quick Quote LLY - Free Report) , Merck ( MRK Quick Quote MRK - Free Report) , Pfizer ( PFE Quick Quote PFE - Free Report) , Novartis ( NVS Quick Quote NVS - Free Report) and others released their third-quarter results. While AstraZeneca ( AZN Quick Quote AZN - Free Report) and J&J ( JNJ Quick Quote JNJ - Free Report) prepare to resume U.S. studies on their coronavirus vaccine candidates, a COVID-19 study on Lilly’s antibody candidate was ended. Recap of the Week’s Most Important Stories Pfizer’s Earnings Update: results were mixed as it beats estimates for earnings while missing the same for sales. It narrowed its financial outlook for the year as it believes that thepace of recovery from the pandemic has been slower than expected.
failed to impress with its third-quarter results, missing estimates for both earnings as well as for sales, Key drug, Trulicity’s sales slowed down. It maintained its previously issued earnings guidance.
beat estimates for both earnings and sales. The company tightened its sales guidance for 2020 to reflect continued impact of the COVID-19 pandemic. However, the company raised its guidance for adjusted earnings.
Novartis’ sales missed the Zacks Consensus Estimate while
earnings beat the same. Sales in the Innovative Medicines division rose 1% while that in the Sandoz division declined 3%. The company maintained its 2020 sales growth guidance. It raised its core operating profit outlook.
SNY Quick Quote SNY - Free Report) missed estimates for both earnings and sales. However, the company raised its earnings growth expectations for the year supported by solid sales from both Dupixent and Vaccines.
beat on third-quarter earnings while slightly missing sales estimates and maintained its adjusted earnings guidance of a decline in the range of 1% to 4% at constant exchange rate year over year J&J is preparing to resume recruitment in the large pivotal phase III study, ENSEMBLE, on its coronavirus vaccine candidate, JNJ-78436735, which was paused earlier this month. Dosing was paused in the ENSEMBLE study due to an unexplained illness observed in a study participant, which was probed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB). The DSMB has recommended resuming trial recruitment as no clear cause for the illness was determined. J&J Prepares to Re-Start COVID-19 Vaccine Study:
It was also not clear whether the unexpected serious adversity was related to the vaccine shot. Meanwhile, discussions are ongoing with other global regulatory bodies to resume the studies in those countries.
Meanwhile, J&J submitted a supplemental new drug application (sNDA) seeking approval from the FDA for expanded use of its blood thinner, Xarelto in patients with peripheral artery disease (PAD). Xarelto is currently approved to reduce the risk of major cardiovascular events, like heart attack and stroke, in people with chronic PAD. The latest sNDA seeks approval for Xarelto plus aspirin to reduce the risk of major thrombotic vascular events (such as heart attack, stroke and amputation) in patients after lower-extremity revascularization due to symptomatic PAD.
: The U.S. government’s National Institute of Health (“NIH”) has ended the ACTIV-3 study evaluating Lilly’s monoclonal antibody candidate, bamlanivimab (previously LYCoV555) and Gilead’s remdisivir in hospitalized COVID-19 patients. The study was paused earlier this month following potential safety concerns raised by the independent DSMB. The study was ended as updated data from the same showed that bamlanivimab was unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease. NIH Led Study on Lilly’s Coronavirus Antibody Candidate Ends
Lilly said that all other studies on bamlanivimab are ongoing including NIH-led ACTIV-2 study testing recently diagnosed mild to moderate COVID-19 patients as well as Lilly’s phase II BLAZE-1 study and phase III BLAZE-2 study. Last week, Lilly applied to the FDA for
Emergency Use Authorization (EUA) of bamlanivimab as a monotherapy for the treatment of higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.
Meanwhile, Lilly also signed an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (700 mg) for $375 million if the candidate gets FDA’s EUA. The deal also includes an option for purchase of an additional 650,000 vials through June 2021.
The FDA authorized AstraZeneca to resume late-stage clinical studies on its COVID-19 vaccine candidate, AZD1222, in the United States. Last month, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in U.K. suffered an unspecified illness. While studies in UK, Brazil, South Africa and Japan resumed in the weeks thereafter following regulators’ confirmation, the study in the United States remained on hold. The FDA has now reviewed all safety data from the global studies and said it is safe to re-start the U.S. study. AstraZeneca to Resume COVID-19 Vaccine Study in U.S.:
Meanwhile, the FDA granted priority review status to AstraZeneca and its Japan-based partner Daiichi Sankyo’s supplemental biologics license application (sBLA) seeking label expansion of its breast cancer drug Enhertu for HER2-positive metastatic gastric cancer. With a priority review tag, the FDA’s decision is expected in the first quarter of 2021.
Bayer bought small biotech Asklepios BioPharmaceuticals (AskBio), which makes gene therapies across multiple disease areas with high unmet need, thereby strengthening its cell and gene therapy platform. The purchase price was $2 billion upfront and up to $2 billion in success-based milestone payments. Bayer Buys Asklepios to Boost Gene Therapy Presence:
AskBio’s pipeline includes pre-clinical and clinical stage candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases. With the acquisition, Bayer also gains rights to AskBio’s revenue generating contract development and manufacturing organization (CDMO).
Sanofi and GlaxoSmithKline have agreed to provide 200 million vaccine doses of their adjuvanted, recombinant protein-based COVID-19 vaccine, if approved to the COVAX program. The COVAX program is led by Gavi, CEPI and WHO. Sanofi/Glaxo’s Supply Deal with COVAX:
Sanofi also announced an agreement with Merck to conduct a phase II study on its novel investigational candidate THOR-707 in combination with Merck’s Keytruda in patients with various cancers. THOR-707 is currently being evaluated in phase I study for the treatment of solid tumors. Sanofi will sponsor the study while Merck will provide Keytruda.
Meanwhile the European Commission approved Glaxo’s PARP inhibitor, Zejula as first-line monotherapy maintenance treatment for patients with advanced ovarian cancer, regardless of their biomarker status. The approval was based on data from the pivotal phase III PRIMA study. Zejula was approved for the same indication in the United States in April.
The European Commission accepted Glaxo’s regulatory filings, seeking approval of Nucala for three additional eosinophil-driven diseases hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilic granulomatosis with polyangiitis (EGPA). Nucala is presently approve to treat severe eosinophilic asthma in EU.
The FDA accepted and granted priority review status to Pfizer’s NDA seeking approval of its investigational oral JAK inhibitor, abrocitinib, in patients (12 years and older) with moderate-to-severe atopic dermatitis. The FDA’s decision is expected in April 2021. The EMA also accepted the marketing application in the EU for the same indication with a decision expected in the second half of 2021. FDA Give Priority Tag to Pfizer’s NDA for Eczema Candidate: Novartis announced a deal with Switzerland based Molecular Partners to develop two multi-targeted direct acting antiviral therapeutic candidates, MP0420 and MP0423 designed for potential use against COVID-19. While Molecular Partners will be responsible to conduct phase I studies expected to begin next month, Novartis will be responsible for phase II and III development, manufacturing, distribution and commercialization activities. Per the deal, Novartis will make an upfront payment of CHF 60 million, including equity. Novartis’ New COVID-19 Deal:
The NYSE ARCA Pharmaceutical Index declined almost 5% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all stocks declined with Novartis recording the maximum decrease (7.5%).
In the past six months, all stocks have declined with Lilly declining the most (13.7%).
(See the last pharma stock roundup here:
J&J’s Q3 Earnings, Pause on Coronavirus Studies & Other Updates) What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week along with earnings releases of Bayer and AstraZeneca.
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