Pfizer’s (PFE - Free Report) strong second-quarter results stole the show this week. Other than that, the European Commission approved Pfizer’s first oncology biosimilar and a second indication for its JAK inhibitor, Xeljanz and Bristol-Myers’ (BMY - Free Report) Opdivo for a melanoma indication. Meanwhile, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave its opinion recommending/not recommending approval of several drugs in Europe.
Recap of the Week’s Most Important Stories
Pfizer’s Q2 Strong, Mixed Results for Sanofi: Pfizer beat estimates for both earnings as well as revenues in the second quarter. Pfizer’s total sales rose 4% as higher sales of key brands Ibrance, Eliquis and Xeljanz made up for loss of exclusivity of some products, lower sales of legacy Established Products in developed markets and continued supply shortage in legacy Hospira products.
Meanwhile, while Pfizer raised its earnings expectations for 2018, it slightly lowered the revenue guidance due to less favorable currency impact owing to a strengthening dollar. (Read more: Pfizer Beats on Q2 Earnings & Sales, Ups Profit View).
Sanofi (SNY - Free Report) beat earnings but missed sales estimates in the second quarter of 2018 owing to currency headwinds. At constant currency rates, Sanofi’s sales were almost flat.
CHMP Gives Positive Opinion to Several Drugs: Glaxo’s (GSK - Free Report) drug, Nucala, gained a positive CHMP opinion, recommending approval as an add-on treatment for severe refractory eosinophilic asthma in the pediatric patient population in Europe. The CHMP also gave a nod to AstraZeneca’s (AZN - Free Report) Imfinzi for an early-stage lung cancer indication based on positive progression free survival data from the phase III PACIFIC study. Imfinzi is already approved for this indication in many countries including the United States.
Novartis’ (NVS - Free Report) combination regimen of Tafinlar and Mekinist also received CHMP nod for adjuvant treatment of BRAF V600 mutation-positive melanoma. Meanwhile, Bayer gained CHMP nod for a new indication for oral Factor Xa inhibitor, Xarelto for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischaemic events.
Merck’s (MRK - Free Report) application seeking approval for Keytruda in combination with Lilly’s Alimta (pemetrexed) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic non-squamous NSCLC was also given a positive opinion by the CHMP. The final decision by the European Union on these products is expected in the coming months.
European Approval for Pfizer and Bristol-Myers’ Medicines: Pfizer announced European approval for Trazimera, its biosimilar version of Roche’s cancer drug, Herceptin. This is Pfizer’s first approved oncology biosimilar. The biosimilar is yet to gain approval in the United States and a regulatory application is under review. Pfizer also gained approval from the European Commission for a new indication of its JAK inhibitor, Xeljanz for moderately to severely active ulcerative colitis (UC). The approved dose of Xeljanz is 10 mg twice-daily (BID) for at least eight weeks, followed by Xeljanz 5 mg BID or 10 mg BID. Xeljanz was approved for the UC indication in the United States in May this year. In the second quarter, Xeljanz sales rose 37% to $463 million.
Bristol-Myers’ Opdivo was granted approval by the European Commission for the adjuvant treatment of adult patients with complete resected melanoma with involvement of lymph nodes or metastatic disease. With this latest approval, Opdivo is now approved for eight indications across six distinct tumor types in the European Union. In the United States, Opdivo was approved for the same indication in December last year.
Merck’s Keytruda Combo Gets Breakthrough Therapy Designation: Merck and Japanese partner Eisai announced that the FDA granted Breakthrough Therapy designation to a combination of their cancer drugs. A combination of Keytruda, Merck’s PD-L1 inhibitor and Lenvima, Eisai’s tyrosine kinase inhibitor, have been given this designation for previously treated patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma (EC).
In March 2018, Merck formed a deal with Eisai to co-develop and commercialize Lenvima, both as a monotherapy as well as in combination with Keytruda, for several types of cancer. In the second quarter, Merck recorded Lenvima alliance revenues of $35 million.
The NYSE ARCA Pharmaceutical Index rose 1.3% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
All the stocks recorded an increase with Lilly recording the highest gain of 4.5%.
In the past six months also, Lilly has been the biggest gainer (28.4%) while Bristol-Myers declined the most (2.8%).
(See the last pharma stock roundup here: Pharma Stock Roundup: LLY, AGN Post Solid Q2 Results, ABBV’s Elagolix Gets FDA Nod)
What's Next in the Pharma World?
Watch out for several pipeline and regulatory updates next week
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