This week, several drugmakers — Pfizer PFE, Lilly LLY, Sanofi SNY, Glaxo GSK and AstraZeneca AZN — announced their second-quarter earnings. Pfizer and its Germany-based partner, BioNTech began a late-stage study on their coronavirus vaccine candidate. J&J JNJ started a human study on its coronavirus vaccine candidate after releasing positive pre-clinical data on the same. AstraZeneca announced its second big cancer deal with Japan’s Daiichi Sankyo.
Recap of the Week’s Most Important Stories
Earnings Update: Pfizer beat estimates for earnings while missing the same for sales. It slightly raised its earnings and sales outlook for the year. While earnings declined 2%, sales declined 1% from the year-ago quarter. Pfizer Biopharma unit’s sales grew 4% while Upjohn group’s sales declined 32%.
Lilly reported mixed second-quarter results, beating estimates for earnings while missing the same for sales. While earnings rose 26%, sales declined 2% from the year-ago quarter as the coronavirus pandemic decreased new patient starts for some of its medicines. The company raised its earnings expectations for the year while keeping its sales guidance intact.
Sanofi beat estimates for earnings while missing the same for sales. At constant exchange rates, earnings increased 4.8% while sales decreased 3.4% year over year. Pharmaceuticals segment sales declined 2% while Vaccines unit sales declined 6.8%. Despite expectations for more onerous currency headwinds, Sanofi increased its previously issued earnings growth guidance for 2020.
Glaxo missed estimates for both earnings and sales and maintained its previously issued earnings growth guidance for 2020. Second-quarter sales were hurt mainly due to reversal of COVID-19-related customer stockpiling benefits of the first quarter and adverse impact of the COVID-19 pandemic mainly on vaccine sales.
AstraZeneca beat estimates for both earnings and sales and also maintained its sales and earnings guidance for the year. Core earnings rose 31% year over at constant exchange rates while sales rose 11%.
Pfizer Begins Late-Stage Study of Coronavirus Vaccine Candidate: Pfizer/BioNTech began a large, global phase IIb/III safety and efficacy study, which will include up to 30,000 participants on its coronavirus vaccine candidate. Out of the four experimental mRNA-based vaccines being evaluated under BioNTech’s BNT162 program to prevent COVID-19, the companies selected nucleoside-modified messenger RNA (modRNA) candidate, BNT162b2 (at a 30 µg dose level in a 2 dose regimen) as the lead candidate for the late-stage study. The selection of the candidate and the dose level was done after careful evaluation of the preclinical and clinical data from phase I/II studies conducted in the United States and Germany. Pfizer expects to file regulatory applications for a COVID-19 vaccine candidate by October. Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.3 billion doses by the end of 2021.
J&J Begins Human Studies on Coronavirus Vaccine: J&J’s lead vaccine candidate, Ad26.COV2.S entered first-in-human phase I/IIa study in the United States and Belgium. The study will test Ad26.COV2.Sin over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. Also, data from pre-clinical studies on Ad26.COV2.S were published, which showed that the candidate generated a strong antibody response and provided protection against subsequent infection with a single dose. The company plans to begin a phase III study in September.
Sanofi/Glaxo Agree to Supply Coronavirus Vaccine to U.K. Government: Sanofi and Glaxo entered into an agreement with the U.K. government to supply up to 60 million doses of a COVID-19 vaccine, which the companies are developing together. Sanofi is combining its recombinant protein-based technology with Glaxo’s pandemic adjuvant technology to develop an adjuvanted COVID-19 vaccine. The vaccine candidate is expected to enter clinical studies (phase I/II) in September 2020 with a phase III study expected to start by the end of the year. The vaccine, if successfully developed, will be available in the second half of 2021. The agreement is subject to final contract.
AstraZeneca’s New Cancer Deal with Daiichi Sankyo: AstraZeneca acquired joint global (except Japan) development/commercialization rights to Daiichi’s antibody drug conjugate (ADC) DS-1062, which could be a potential medicine for lung, breast and multiple other cancers that commonly express TROP2, a transmembrane glycoprotein . For the deal, AstraZeneca will pay Daiichi an upfront amount (in staged payments) of $1 billion and up to $1 billion in regulatory milestone payments and up to $4 billion for sales-related milestones, if the candidate is eventually approved. The companies will equally share development costs and profits.
In April 2019, AstraZeneca acquired joint development and commercialization rights to the first ADC, trastuzumab deruxtecan from Daiichi. Trastuzumab deruxtecan was approved by the FDA in third-line HER2-positive metastatic breast cancer in December 2019 and immediately launched under the brand name of Enhertu.
The FDA granted approval to AstraZeneca’s triple combination therapy, Breztri Aerosphere as maintenance treatment for chronic obstructive pulmonary disease (“COPD”). Breztri Aerosphere is a combination of budesonide, glycopyrronium and formoterol fumarate.. The therapy is already approved in Japan and China, and is under regulatory review in the EU.
AstraZeneca’s Farxiga significantly reduced the worsening of renal function or risk of death in the phase III DAPA-CKD study evaluating the diabetes medicine in patients with chronic kidney disease with and without type-2 diabetes.
Meanwhile, the FDA granted Breakthrough Therapy Designation (BTD) to Tagrisso for the adjuvant treatment of patients with stage IB-IIIA EGFR-mutated lung cancer
Novartis’ Piqray Gets Approval in Europe: The European Commission granted approval to Novartis’ NVS Piqray (alpelisib) in combination with fulvestrant for the treatment of HR+/HER2- advanced breast cancer in patients whose tumor harbors a PIK3CA mutation. The approval based on data from the SOLAR-1 phase III study. Piqray (alpelisib) was approved in the United States in December 2019.
Roche’s Actemra Coronavirus Study Fails: Roche’s phase III COVACTA study evaluating Actemra/RoActemra in hospitalized patients with severe COVID-19 associated pneumonia failed to meet its primary endpoint of improving clinical status in such patients. The study also did not meet the secondary endpoint of reduced patient mortality at week four.
Meanwhile, the FDA approved Roche’s oncology drug, Tecentriq (atezolizumab), in combination with Exelixis’ Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of patients with previously untreated BRAF V600 mutation-positive advanced melanoma. The approval was based on data from the phase III IMspire150 study.
AbbVie’s Rinvoq Meets Goals in 3rd Atopic Dermatitis Study: AbbVie’s Rinvoq (upadacitinib) showed significant improvement in skin clearance and itch in the third pivotal phase III study evaluating it for moderate-to-severe atopic dermatitis in adults and adolescents. The top-line data showed that both doses of upadacitinib (15 mg and 30 mg) plus topical corticosteroids (TCS) met all primary and secondary endpoints versus placebo plus TCS.
AbbVie’s phase III study evaluating CGRP receptor antagonist, atogepant for migraine prevention met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period. Based on data from this study as well as previous phase II/III study, the company will file regulatory applications in the United States and other countries.
The NYSE ARCA Pharmaceutical Index declined 0.06% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Pfizer recorded the highest increase (4.9%) while Lilly declined the most (5.3%).
In the past six months, AstraZeneca (AZN) has risen the most (19.3%) while Novartis has declined the most (10.6%).
(See the last pharma stock roundup here: NVS, RHHBY Earnings, AZN, PFE Coronavirus Vaccine Early Data)
What’s Next in the Pharma World?
Watch out for second-quarter earnings of Merck, AbbVie, and others and regular pipeline and regulatory updates next week.
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