This week, Allergan (AGN - Free Report) settled with two counties of Ohio for $5 million related to the upcoming multidistrict litigation for opioid-based drug abuse. The European Commission granted approvals to Merck (MRK - Free Report) and Roche’s (RHHBY - Free Report) PD-L1 inhibitors Keytruda and Tecentriq, respectively, and J&J’s (JNJ - Free Report) immunology drug Stelara for expanded use.
Recap of the Week’s Most Important Stories
Allergan Settles With Two Ohio Plaintiffs: The settlement with two Ohio plaintiffs is in connection with the upcoming October 2019 trial under the federal multidistrict litigation related to abuse of opioid-based drugs. Allergan has agreed to pay $5 million to resolve all claims pertaining to the scheduled trial. This includes payment of $1.9 million to Summit County, OH and $3.1 million to Cuyahoga County, OH. Allergan stated that it has not been actively involved in marketing or promoting opioid products since 2013. Opioid-based drug abuse came in the limelight recently with more than 2000 lawsuits being filed against pharma companies across multiple states, holding them responsible for the opioid epidemic and deaths due to opioid overdose.
EU Approval for Expanded Use of Merck, Roche & J&J’s Blockbuster Drugs: The European Commission granted approval to Merck’s main top-line driver Keytruda for expanded usein combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of advanced renal cell carcinoma (RCC), the most common type of kidney cancer. The approval was based on the results of KEYNOTE-426. Data from this study showed that Keytruda combined with Inlyta reduced the risk of death by nearly half compared to Pfizer’s another cancer drug Sutent. Keytruda was approved for the same indication in the United States in April.
The EC also granted marketing authorisation to Roche’s cancer immunotherapy — Tecentriq — in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). With this approval, Tecentriq became the first cancer immunotherapy to win an approval in the EU for the initial treatment of ES-SCLC, which is a difficult to treat cancer with limited treatment options. The approval was based on results from the phase III IMpower133 study. Tecentriq was approved for the same indication by the FDA in March.
Tecentriq was also approved by the EC in combination with Celgene’s Abraxane and carboplatin for the first-line treatment of patients suffering metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumour aberrations.
The European regulatory agency also approved J&J’s Stelara for a new indication, moderately-to-severely active ulcerative colitis. The regulatory application was based on data from the phase III UNIFI global clinical development program. A similar application is also under review in the United States. Stelara is approved in the EU for treating severe plaque psoriasis, active psoriatic arthritis and Crohn’s disease and is also being evaluated in late-stage development for axial spondylitis.
Bristol-Myers’ Opdivo Fails to Meet Co-Primary Endpoint in Brain Cancer Study: Bristol-Myers’ (BMY - Free Report) phase III study evaluating a combination of its PD-L1 inhibitor Opdivo plus standard of care to treat MGMT-methylated glioblastoma multiforme failed to meet one of its primary endpoints — progression-free survival (PFS). The phase III CheckMate -548 study did not show any statistically significant improvement in PFS in patients suffering from this aggressive and rare brain cancer. However, the study will continue as planned on recommendation of the data monitoring committee to evaluate the other primary endpoint that is, overall survival.
AstraZeneca’s Tagrisso Gets China Approval in First-Line Setting: AstraZeneca (AZN - Free Report) received a marketing approval from Chinese regulatory authorities for Tagrisso for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR mutations. The sNDA was based on data from the phase III FLAURA study. Tagrisso was approved for this indication based on PFS data from the same study in the United States and the EU in 2018. In August, AstraZeneca announced OS data from the study which showed that Tagrisso significantly improved OS. OS was the secondary endpoint in the study and AstraZeneca expects to present this data at an upcoming medical meeting.
Novartis In-Licenses Rights to Tysabri Biosimilar: Novartis’ (NVS - Free Report) generic arm Sandoz gained global commercialization rights to a proposed biosimilar of Biogen’s key multiple sclerosis medicine Tysabri (natalizumab) from a European biotech Polpharma Biologics. This is the fifth proposed biosimilar in-licensed by Sandoz in the past nine months. The biosimilar is being developed in late-stage studies.
Meanwhile, Novartis’ investigational lung cancer therapy capmatinib was granted a Breakthrough Therapy designation by the FDA for the treatment of MET-mutated advanced non-small cell lung cancer. Novartis plans to file regulatory application for capmatinib in the United States in the fourth quarter.
Breakthrough Therapy Status to J&J’s RSV Vaccine: The FDA granted a Breakthrough Therapy designation to J&J investigational prophylactic vaccine for the prevention of respiratory syncytial virus (RS”) in older adults, who are at high risk from this disease. J&J is current developing this RSV vaccine in a phase IIb proof of concept study.
The NYSE ARCA Pharmaceutical Index inched up 0.9% in the last four trading sessions.
Here is how the seven major stocks performed in the last four trading sessions.
Last week, while Pfizer rose to maximum (2.8%), AstraZeneca hit the lowest level (1.5%).
In the past six months, AstraZeneca has been the biggest gainer (7.4%) while Pfizer shed its value most (12.2%).
(See the last pharma stock roundup here: JNJ’s Opioid Lawsuit, Regulatory Nod for LLY, BMY, RHHBY Drugs)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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