It was good week for the pharma space with Bristol-Myers (BMY - Free Report) , AstraZeneca (AZN - Free Report) , Roche (RHHBY - Free Report) and Glaxo (GSK - Free Report) reporting better-than-expected results and boosting their guidance for the year. Meanwhile, the FDA granted approval to Lilly’s (LLY - Free Report) glucagon nasal powderto treat severe hypoglycemia in diabetes patients. Bristol-Myers’ late-stage study evaluating its blockbuster PD-L1 inhibitor, Opdivo, for the lucrative indication of first-line non-squamous non-small cell lung cancer (NSCLC) failed to meet the endpoint.
Recap of the Week’s Most Important Stories
Earnings Update: Glaxo, Bristol-Myers and AstraZeneca beat the Zacks Consensus Estimate for both earnings and sales in the second quarter of 2019. Roche also reported better-than-expected results for the first half of 2019.
Strong performance of new drugs led both AstraZeneca and Roche to raise their full-year forecast for sales. While AstraZeneca raised its product sales growth guidance to a range of low double-digit percentage versus prior expectation of a high-single digit percentage, Roche raised its sales growth view for the second time this year from a range of low to mid-single digits to a mid- to high single-digit range.
Glaxo also provided an improved earnings guidance for 2019. Its earnings are expected to decline 3-5% at CER in 2019 compared with the previous expectations of a decline of 5-9%.
Bristol-Myers increased its adjusted earnings per share guidance range from $4.10-$4.20 to $4.20-$4.30.
FDA Approves Lilly’s Glucagon Nasal Powder for Hypoglycemia: The FDA gave approval to Lilly’s investigational nasal glucagon (3 mg) to treat severe hypoglycemia in diabetes patients aged four years and older. Nasal glucagon, to be marketed by the trade name of Baqsimi, is the first and only nasally administered glucagon approved by the FDA. It is a different low blood sugar rescue treatment for type I and II diabetes patients as it is delivered as a puff in the nose instead of the currently available injection options. Baqsimi is expected to be available in U.S. pharmacies within a month at a list price of $280.80 for one pack and $561.60 for a double pack.
Bristol-Myers’s Opdivo Fails in a Lung Cancer Study: Bristol-Myers’ late-stage study evaluating the survival benefit of a combination of Opdivo plus chemotherapy for first-line treatment of patients with NSCLC, regardless of their PD-L1 status, did not meet the primary endpoint. Data from part 2 of the phase III CheckMate -227 study showed that in patients treated with Opdivo plus chemotherapy, the median overall survival (OS) was 18.83 months versus 15.57 months for the chemotherapy arm. Moreover, the one-year landmark OS in the non-squamous NSCLC patient population was 67.3 percent in Opdivo plus chemotherapy arm versus 59.2 percent in chemotherapy. Bristol-Myers announced that part 1 of the study, however, met the co-primary endpoint of OS, with low-dose Yervoy and Opdivo demonstrating superiority to chemotherapy in patients whose tumors express PD-L1 of more than 1%.
FDA Approves Pfizer’s Rituxan Biosimilar: The FDA approved Pfizer’s (PFE - Free Report) biosimilar version of Roche’s blockbuster drug, Rituxan, to be marketed by the trade name of Ruxience. It is approved for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). This is Pfizer’s third oncology biosimilar product to get approval by the FDA. Pfizer’s biosimilar versions of Roche’s cancer drugs Herceptin (trade name: Trazimera) and Avastin (trade name: Zirabev) were approved by the FDA in March and June, respectively.
Allergan Recalls Biocell Textured Breast Implants: Allergan announced a worldwide recall of its Biocell brand of saline-filled and silicone-filled textured breast implants and tissue expanders. The voluntary recall was initiated following updated safety information from the FDA regarding the incidence of breast implant-associated anaplastic large cell lymphoma. The company stated that Biocell will not be distributed or sold in any market where it is presently available.
Novartis Begins Study on Biosimilar Denosumab: Novartis’ generic division, Sandoz announced that the first patient has been enrolled in a phase I/III study for a proposed biosimilar version of denosumab. The candidate is marketed as Prolia and Xgeva by Amgen. While Prolia is indicated for postmenopausal women with osteoporosis at high risk for fracture, Xgeva is indicated for prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.
Sanofi Buys U.S. OTC Rights to Roche’s Flu Treatment, Tamiflu: Sanofi signed a deal to buy exclusive U.S. over-the-counter (OTC) rights to Roche’s antiviral medicine Tamiflu, which is marketed for the prevention and treatment of flu. Tamiflu is presently sold in the United States by Roche for prescription use. Sanofi will be responsible for leading FDA negotiations for the switch of Tamiflu to OTC and for leading the clinical program and funding all studies needed to support the same.
Third Breakthrough Therapy Designation for Keytruda/Lenvima Combo: Merck (MRK - Free Report) and its Japanese partner Eisai announced that the FDA has granted Breakthrough Therapy designation to a combination of Merck’s Keytruda and Eisai’s Lenvima for first-line treatment of advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment. This marks the third Breakthrough Therapy Designation to Keytruda/Lenvima combo. Merck has an ongoing collaboration with Eisai to evaluate Keytruda plus Lenvima across a number of different types of cancer.
J&J’s Multiple Sclerosis Study Meets Main Goal: J&J’s late-stage head-to-head study evaluating its investigational product, ponesimod, for the treatment of relapsing multiple sclerosis, met its primary and most secondary endpoints. Ponesimod was added to J&J’s pipeline with the June 2017 acquisition of Swiss biotech, Actelion. The OPTIMUM study compared the efficacy and safety of ponesimod to Sanofi’s Aubagio in the abovementioned patient population.
The NYSE ARCA Pharmaceutical Index declined 0.4% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
AstraZeneca recorded the highest rally (4.7%) while Merck declined the most (1.1%)
In the past six months, AstraZeneca has been the biggest gainer (20.2%) while Bristol-Myers declined the most (6.1%).
(See the last pharma stock roundup here: JNJ & NVS’ Q2 Earnings, Pipeline/Regulatory Updates in Focus)
What's Next in the Pharma World?
Watch out for second-quarter earnings of Lilly, AbbVie, Merck, Pfizer and others and regular pipeline and regulatory updates next week.
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