This week marked the beginning of the fourth-quarter 2019 earnings season with J&J (JNJ - Free Report) announcing mixed results. The European Commission granted approval to two new drugs, Roche’s (RHHBY - Free Report) lymphoma drug, Polivy and Novartis’ (NVS - Free Report) Mayzent for secondary progressive multiple sclerosis (SPMS).
Recap of the Week’s Most Important Stories:
J&J’s Mixed Fourth-Quarter Earnings: J&J’s fourth-quarter results were mixed as it beat estimates for earnings but missed the same for sales. J&J’s Pharma segment performed above-market despite currency headwinds and the impact of biosimilar and generic competition on sales of some key drugs like Remicade and Zytiga. Its 2020 financial guidance was quite lukewarm. Adjusted earnings per share in 2020 are expected in the range of $8.95 - $9.10. Revenues are expected in the range of $85.4-$86.2 billion, indicating year-over-year growth of 4%-5%.
EU Approvals to Novartis & Roche’s New Drugs: The European Commission granted conditional marketing approval to Roche’s lymphoma drug, Polivy (polatuzumab vedotin-piiq). The drug has been approved in combination with bendamustine plus MabThera for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for a hematopoietic stem cell transplant. The drug was approved by the FDA in June last year, two months ahead of schedule.
The regulatory agency also approved Novartis’ Mayzent (siponimod), a next generation, selective sphingosine 1-phosphate receptor modulator for adult patients with SPMS with active disease. The drug was approved by the FDA in March last year for a similar indication.
EU Approval for Expanded Use of J&J’s Stelara & Darzalex: The European Commission also granted approval for expanded use of J&J’s blockbuster medicines, Darzalex and Stelara. The regulatory agency approved use of Darzalex in combination with Velcade (bortezomib), thalidomide and dexamethasone (VTd)) in newly-diagnosed, transplant eligible multiple myeloma patient population. The approval was based on data from a phase III CASSIOPEIA study.
The EC also approved expanded use of Stelara for the treatment of pediatric patients (ages 6–11) with moderate-to-severe plaque psoriasis. Stelara is also under review with the FDA for pediatric patients. Stelara is already marked for adolescents and adults with moderate-to-severe plaque psoriasis. Stelara is also marketed to treat adults with active psoriatic arthritis and moderate-to-severe Crohn's disease.
Meanwhile, J&J also submitted type II variation application to the European Medicines Agency (EMA), seeking expanded use of Imbruvica in combination with Roche’s Rituxan for patients with previously untreated chronic lymphocytic leukemia (CLL).
FDA Updates on AstraZeneca’s Cancer Drugs: AstraZeneca (AZN - Free Report) and Merck (MRK - Free Report) announced that the FDA has granted priority review to a supplemental new drug application, seeking label expansion approval of Lynparza in men with metastatic castration-resistant prostate cancer who have a mutation in their homologous recombination repair genes. The disease of these men had progressed on prior treatment with new hormonal agent treatments like Zytiga and Xtandi, making it difficult to treat. The FDA’s decision is expected in the second quarter of 2020. The designation was granted based on results from the phase III PROfound study.
The regulatory agency also granted Orphan Drug Designation to AstraZeneca’s PD-L1 inhibitor Imfinzi and tremelimumab, an anti-CTLA4 antibody, for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer. A phase III HIMALAYA study is presently testing Imfinzi monotherapy and Imfinzi plus tremelimumab in first-line advanced HCC setting.
The FDA accepted and granted priority review to Glaxo’s (GSK - Free Report) BLA, seeking approval for the 2.5 mg dose of belantamab mafodotin in patients with heavily pre-treated multiple myeloma. The BLA was based on data from the pivotal DREAMM-2 study, which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.
Roche’s SMA Candidate Meets Primary Goal in Study: Roche announced positive data from part 2 of the pivotal FIREFISH study, evaluating its pipeline candidate risdiplam in infants with type 1 spinal muscular atrophy (SMA). The study met its primary endpoint which was the proportion of infants sitting without support for at least five seconds at 12-months of treatment, assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). The data showed that risdiplam led to statistically significant and medically meaningful motor milestone improvement in the aforesaid infant patient population.
Meanwhile, risdiplam is under priority review with the FDA for the treatment of patients aged 2-25 years with type 2 or 3 SMA. A decision from the regulatory body is expected on May 24, 2020.
Meanwhile, a phase III study evaluating Roche’s Tecentriq for adjuvant (after surgery) monotherapy treatment of patients with muscle-invasive urothelial cancer did not meet its primary endpoint of disease-free survival (DFS).
The NYSE ARCA Pharmaceutical Index declined 0.5% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions.
Last week, Glaxo recorded the maximum gain (1.4%) while Merck declined the most (2.9%).
In the past six months, Bristol-Myers has risen the most (47.2%) while Pfizer (PFE - Free Report) lost the maximum (4.6%).
(See the last pharma stock roundup here: LLY Dermira Buyout Offer, Pipeline & Regulatory Updates)
What's Next in the Pharma World?
Watch out for fourth-quarter 2019 results of Pfizer, Novartis, Roche and Lilly and regular pipeline and regulatory updates next week.
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