J&J (JNJ – Free Report) and Novartis (NVS – Free Report) ringed in the earnings season for the pharma space. Meanwhile, Pfizer (PFE – Free Report) and Lilly’s (LLY – Free Report) pain drug showed early positive results in a late-stage study. The FDA approved J&J’s latest HIV medicine Symtuza as well as label expansion of Pfizer’s prostate cancer drug Xtandi. In the wake of deeper political scrutiny over the high cost of prescription medicines, Novartis said it won’t raise U.S. drug prices this year while Merck (MRK – Free Report) announced price cuts of some of its drugs.
Inside J&J & Novartis’ Q2 Earnings: J&J beat the Zacks Consensus Estimate for earnings and sales in the second quarter of 2018. While Pharmaceutical segment sales rose a strong 20%, the Consumer unit lagged. J&J tightened its previously issued earnings guidance for 2018 while lowering its sales range. The guidance cut was due to less favorable currency impact owing to a strengthening dollar. However, J&J raised its 2018 operational sales and earnings growth guidance for the year.
Novartis’ earnings missed estimates while revenues beat the mark on strong Cosentyx and Entresto performance. Novartis kept its sales guidance intact.
Meanwhile, Novartis’ Kisqali gained FDA approval as a first-line treatment option (in combination with an aromatase inhibitor) for advanced breast cancer in pre-menopausal women. It was approved for the first-line treatment of postmenopausal women with HR+/HER2- advanced breast cancer in 2017. With the approval, Kisqali became the only CDK4/6 inhibitor approved as a first-line treatment (in combination with an aromatase inhibitor) for HR+/HER2- advanced breast cancer in pre-, peri- or postmenopausal women.
Top-Line Data on Pfizer/Lilly’s Pain Candidate: Pfizer and Lilly announced that a phase III study evaluating their pipeline candidate, tanezumab (subcutaneous) for the treatment of osteoarthritis (OA) pain of the knee or hip met all three co-primary endpoints. Data from the study showed that treatment with tanezumab led to a statistically significant reduction in pain and improvement in physical function compared to placebo. The patients were administered two injections of tanezumab once every eight weeks. Tanezumab is also being evaluated for chronic low back pain (CLBP) and cancer pain (due to bone metastases). (Read More: Pfizer & Lilly’s Pain Candidate Succeeds in Phase III Study)
Update on J&J’s Invokana Studies; HIV Drug: J&J announced that the FDA has delayed its decision on a supplemental new drug application (sNDA) looking for label expansion of its diabetes drug Invokana by three months. The sNDA is looking to get approval to include the cardiovascular indication on the label of Invokana. The filing was based on data from a large CANVAS outcomes program which evaluated Invokana compared with placebo on reducing CV events in type II diabetes patients who have established CV disease or are at risk for CV disease. The FDA is now expected to announce its decision in October. In the first quarter of 2018, Invokana/Invokamet sales declined 12.7% to $248 million due to higher managed care discounting and market share decline due to competitive pressure.
In a positive update on the same drug, J&J announced that the phase III CREDENCE study evaluating Invokana for slowing the progression of chronic kidney disease in patients with type II diabetes is being stopped early based on the achievement of pre-specified efficacy criteria. The decision was backed by recommendation of the study’s Independent Data Monitoring Committee (IDMC) based on an interim analysis of the data.
J&J also announced FDA approval of Symtuza, its darunavir-based once-daily single-tablet regimen for the treatment of HIVin treatment-naïve and certain virologically suppressed adults. However, the approval comes with a boxed warning regarding the risk of post-treatment acute exacerbation of hepatitis B. Symtuza was approved in the EU last September.
More on Label Expansion of Pfizer’s Xtandi: Pfizer and its Japanese partner Astellas gained FDA approval for a regulatory filing for expanding the label of its prostate cancer drug Xtandi to include an early-stage patient population. The regulatory application to add the non-metastatic Castration-Resistant Prostate Cancer (“CRPC”) indication to the drug’s label was based on the results of the PROSPER study. Xtandi was until now approved for the treatment of metastatic CRPC in patients who had previously received docetaxel. With approval for the non-metastatic patient population, the label of Xtandi now covers all patients with CRPC, metastatic as well as non-metastatic.
Pfizer also announced the initiation of a phase III study on its pipeline gene therapy for hemophilia B, SPK-9001/PF-06838435, which was originally developed by Spark Therapeutics. The gene therapy will now be called fidanacogene elaparvovec. We remind investors that following positive data from the ongoing phase I/II program on fidanacogene elaparvovec in May, Spark Therapeutics transferred the hemophilia B gene therapy program to Pfizer. Consequently, Pfizer has now assumed sole responsibility for all subsequent pivotal studies, regulatory and development activities of any products resulting from the hemophilia B gene therapy program.
Merck’s Promise of Price Cuts for Few Drugs: With the drug pricing controversy coming to the forefront after Trump attacked Pfizer for raising prices of several drugs this year, Merck said it is lowering price of hepatitis C treatment, Zepatier, by 60%. Merck also said that it will be slashing the price of several other medicines by 10% and also informed that in 2017, net price for its U.S. product portfolio declined 1.9%. It committed to limit its average price increases across its portfolio annually to the rate of inflation.
AbbVie’s Third Licensing Deal for Humira Biosimilar: AbbVie, Inc. (ABBV – Free Report) signed its third licensing deal to protect revenues from its blockbuster arthritis drug, Humira. This time the settlement is with Mylan (MYL), per which the latter will have alicense to launch its biosimilar Humira in the United States and in various other countries, excluding Europe, on Jul 31, 2023. AbbVie has similar licensing deals with Amgen, Inc. (AMGN) and Samsung Bioepis. (Read More: AbbVie Settles with Mylan to Delay Humira Biosimilar in U.S.)
Roche’s Tecentriq Hogs Limelight: Roche (RHHBY – Free Report) announced interim data from a phase III study which evaluated Tecentriq plus chemotherapy for the first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC). The study met its co-primary endpoint of progression-free survival by showing that Tecentriq plus chemotherapy reduced the risk of disease worsening or death such patients. However, statistical significance was not met for the co-primary endpoint of overall survival (OS) at the interim analysis. Final OS data will be announced next year as the study continues.
Roche also announced that the FDA has granted Breakthrough Therapy designation to a combination of its cancer drugs, Tecentriq and Avastin, for the first-line treatment of advanced or metastatic hepatocellular carcinoma (HCC) — the most common form of liver cancer.
The NYSE ARCA Pharmaceutical Index declined 0.8% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
Almost all the stocks saw slight declines, except Lilly and AstraZeneca. Lilly recorded the highest increase of 0.6%.
In the past six months, Glaxo has been the biggest gainer (5.6%) while J&J declined the most (14.9%).
(See the last pharma stock roundup here: Pharma Stock Roundup: PFE to Split Into 3 Units, J&J to Pay $4.7B in Talc Lawsuit)
What’s Next in the Pharma World?
Watch out for the earnings releases from some of the bigwigs in the pharma world like Lilly, Merck, Glaxo, Allergan and others next week.
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