Pfizer PFE, Merck MRK, Bristol-Myers BMY, Sanofi SNY, Glaxo GSK and Bayer released their third-quarter results this week. In other important news, AstraZeneca’s first-line lung cancer study on Imfinzi showed positive results and J&J’s JNJ new tests revealed no asbestos in its baby powder.
Recap of the Week’s Most Important Stories:
Earnings Update: Pfizer, Merck, Bristol-Myers and Glaxo beat estimates for both earnings and sales. Higher sales of some of Pfizer’s key brands like Eliquis, Ibrance, Inlyta and Xeljanz were offset by lower sales of Lyrica due to loss of exclusivity in July 2019 in the United States. Merck’s blockbuster cancer drug, Keytruda continued its robust performance on strong demand. Both Merck & Pfizer raised their earnings guidance for 2019 while tightening the same for revenues. Strong performance of relatively newer vaccine and respiratory products boosted Glaxo’s sales. Glaxo raised its 2019 adjusted earnings growth expectations to around flat at CER from a decline of 3% to 5% expected previously.
Bristol Myers’ sales growth of 6% was led by robust sales of Eliquis and Sprycel while sales growth of its PD-1 inhibitor, Opdivo was weak. The company raised its guidance range for earnings.
Sanofi’s third-quarter 2019 results were mixed as it beat estimates for earnings but missed the same for sales. Double-digit growth in Sanofi’s Specialty Care unit was offset by a weak performance in the Consumer Healthcare and Vaccines units in the quarter.
Bayer’s sales increased 5.4% on an organic basis in the quarter. All the three segments, Crop Science, Pharmaceuticals and Consumer Health, witnessed higher sales.
AstraZeneca’s Imfinzi Combo Meets Goal in First-Line Lung Cancer Study: AstraZeneca’s phase III POSEIDON study evaluating Imfinzi plus platinum-based chemotherapy or the triple combination of Imfinzi plus tremelimumab and chemotherapy in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) met the primary endpoint. Imfinzi plus multiple choices of chemotherapy regimens led to a statistically significant and clinically meaningful improvement in the final progression-free survival (PFS) analysis in such patients versus chemotherapy alone, thereby meeting the study’s primary endpoint. The triple regimen of Imfinzi plus tremelimumab and chemotherapy also met the key secondary endpoint by demonstrating a statistically significant and clinically meaningful PFS improvement versus chemotherapy alone. The study continues to assess the co-primary endpoint of overall survival with data expected to be presented next year.
AstraZeneca also announced an agreement to sell rights to Seroquel and Seroquel XR, a treatment for schizophrenia and bipolar disease, in Europe and Russia to Cheplapharm Arzneimittel GmbH.
J&J Says Tests Find No Asbestos in Baby Powder: J&J announced that 15 new tests conducted on the same bottle of Johnson’s Baby Powder that was previously tested by the FDA, found no asbestos, a known carcinogen. The product is the subject of numerous lawsuits, which claim that J&J’s talc-based products contain asbestos that causes cancer. Earlier this month, J&J announced a voluntary recall of one lot of its Johnson’s Baby Powder. The recall was initiated following a test done by the FDA, which revealed traces of asbestos in samples from one bottle purchased online. J&J also said that an additional 48 independent third-party lab tests of samples from the same lot that was recalled also confirm that the talc does not contain asbestos.
Pfizer Gets EU Nod for Bavencio+Inlyta Combo in Kidney Cancer: Pfizer and partner Merck KGaA gained approval from the European Commission for Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer. The combination of Bavencio and Inlyta received approval in the United States for a similar indication in May. In January, a similar application had been submitted in Japan.
Glaxo Begins Phase III Program on New Antibiotic: Glaxo announced initiation of patient dosing in a phase III program on its investigational oral antibiotic, gepotidacin, which Glaxo claims has mechanism of action distinct from any currently approved antibiotic. The program will comprise two studies with one evaluating the use of gepotidacin for uncomplicated urinary tract infection and the other for urogenital gonorrhea, a common sexually transmitted infection.
Meanwhile, the European Commission gave approval to the intravenous formulation of Benlysta for systemic lupus erythematosus in children aged five years and above. The intravenous formulation is already approved in EU as well as the United States for adults while it was approved in the United States for children in April.
AbbVie’s Rinvoq Meets Goal in Psoriatic Arthritis Study: AbbVie’s ABBV phase III study evaluating Rinvoq (upadacitinib) for active psoriatic arthritis in adult patients who had an inadequate response to other bDMARDs met the primary endpoint. Top-line data from the study (SELECT-PsA 2) showed that both doses of Rinvoq (15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response or at least a 20% reduction in the number of both tender and swollen joint counts, at week 12 versus placebo. After 12 weeks of treatment, the ACR20 response (primary endpoint) was achieved in 57% of the patients receiving the 15 mg oral once-daily dose of upadacitinib and 64% of the patients taking the 30 mg dose versus 24% for patients in the placebo group. In addition, patients treated with Rinvoq (both doses) achieved significantly greater responses for all ranked secondary endpoints compared to placebo. Rinvoq was approved for the treatment of moderate-to-severe rheumatoid arthritis in August.
FDA Puts Hold on Novartis’ AVXS-101 Intrathecal Studies: The FDA placed a partial clinical hold on studies testing intrathecal administration of its newly approved spinal muscular atrophy (SMA) treatment, Zolgensma (AVXS-101) based on findings of a small pre-clinical animal study. Zolgensma is presently available as an intravenous administration after FDA granted approval in May this year for pediatric SMA patients. Novartis said that the clinical hold has no impact on intravenous Zolgensma.
FDA and EMA Accept Roche’s Applications for Satralizumab: Roche’s marketing applications for satralizumab developed to treat neuromyelitis optica spectrum disorder were accepted for review by the European Medicines Agency and FDA. The regulatory applications were based on data from two studies, SAkuraStar and SAkuraSky.
The NYSE ARCA Pharmaceutical Index rose 3.3% in the last five 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 five trading sessions.
Last week, all the stocks were in the green supported by strong third-quarter results of most companies in the sector. Lilly was the biggest gainer (5.6%).
In the past six months, AstraZeneca has risen the most (30.3%) while J&J lost the most (6.5%) mainly due to its litigation issues.
(See the last pharma stock roundup here: LLY, NVS, AZN’s Q3 Earnings, Updates From FDA
What's Next in the Pharma World?
Watch out for third-quarter results of Novo Nordisk and Allergan and regular pipeline and regulatory updates next week.
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