This week, J&J JNJ received an unfavorable ruling in the litigation related to abuse of its opioid-based drugs. The FDA granted approval to Lilly’s LLY psoriasis injection for active ankylosing spondylitis (AS) while the European Commission approved Bristol-Myers’ BMY multiple myeloma drug, Empliciti and Roche’s RHHBY PD-L1 inhibitor, Tecentriq in combination use for an expanded patient population.
Recap of the Week’s Most Important Stories
Oklahoma Judge Rules Against J&J in Opioid Lawsuit: J&J was ordered by a district court in Oklahoma to pay $572 million to the state of Oklahoma in connection with a lawsuit filed by the latter. The lawsuit claimed that J&J was one of the several companies whose opioid-based drugs — Duragesic, Nucynta and Nucynta ER — were responsible for fueling the state’s opioid epidemic. However, the fine was much lower than Oklahoma state’s demand of $17 billion to be paid over 30 years by J&J. The company has decided to appeal against the ruling. The company is confident that its drugs were not responsible for the opioid crisis in the state and the ruling is inconsistent with the available facts and law. There are still a number of opioid-related lawsuits pending with about 1900 suits consolidated at the federal level in the state of Ohio, with trial set to begin in October this year.
FDA Approves Lilly’s Taltz for Ankylosing Spondylitis: Lilly gained FDA approval for its psoriasis injection Taltz for its third indication — active ankylosing spondylitis (AS). A type of spondyloarthritis, AS affects the pelvic joints and spine that can cause severe back pain. The approval was based on data from two phase III studies, COAST-V and COAST-W. Taltz is presently marketed for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Lilly’s Olumiant (baricitinib) met the primary endpoint in a phase III BREEZE-AD7 study, evaluating it in a new indication — moderate-to-severe atopic dermatitis (AD), a type of eczema. Lilly is conducting five studies on baricitinib under the AD program and BREEZE-AD7 is the third study to be completed this year. BREEZE-AD1 and BREEZE-AD2 were the other two studies wherein baricitinib 4 mg and 2 mg both met the primary endpoint. Top-line data from the remaining two studies are expected to be presented later this year or early next year.
EU Approval for Expanded Label of Bristol-Myers & Roche’s Cancer Medicines: The European Commission granted approval for label expansion of Bristol-Myers’s multiple myeloma drug, Empliciti. The drug is now approved in the EU for use in combination with Celgene’s Pomalyst (pomalidomide) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (r/rMM) in second- or later-line settings. Empliciti was approved for this combination use in the United States in November last year
The regulatory agency also gave approval to Roche’s Tecentriq in combination with Celgene’s Abraxane for the treatment of adults with PD-L1-positive, metastatic triple-negative breast cancer — a difficult-to-treat cancer. The drug was approved for the same combination use by the FDA, on an accelerated basis, in March this year. The approval was based on encouraging data from the phase III IMpassion130 study.
AbbVie Ends Rova-T Program: AbbVie ABBV discontinued development of its cancer candidate rovalpituzumab tesirine or Rova-T as the third study on the candidate, MERU, also failed. The MERU study was evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC) compared to placebo. Interim data from the study demonstrated no survival benefit for patients treated with Rova-T. The lack of survival benefit led the Independent Data Monitoring Committee to recommend terminating MERU. Rova-T was added to AbbVie’s portfolio, following the $5.8 billion acquisition of Stemcentrx in June 2016.
In December, AbbVie stopped enrollment in a pivotal phase III study —TAHOE — evaluating Rova-T in second-line SCLC. In March 2018, Rova-T fell short of expectations in a phase II TRINITY study evaluating it in third-line or later SCLC. The failure of TRINITY and the halt on TAHOE had already raised skepticism on Rova-T’s potential. Discontinuation of the candidate has now broughtinto question the viability of the Stemcentrx deal.
Several Updates from AstraZeneca: AstraZeneca’s AZN late-stage study, TULIP 2, evaluating its pipeline candidate, anifrolumab for systemic lupus erythematosus (SLE), met the primary endpoint. Top-line data from the study showed that treatment with anifrolumab plus standard of care (SOC) medicine led to a statistically-significant and clinically-meaningful reduction of disease activity based on composite lupus assessment versus placebo +SOC. This is the second phase III study on the candidate for SLE. The first study, TULIP 1, did not meet the primary endpoint, per data announced last year.
The FDA assigned Fast Track designation to AstraZeneca’s Farxiga for chronic kidney disease (CKD). The type II diabetes drug is being evaluated in the phase III DAPA-CKD study to see its effect on renal outcomes and cardiovascular (CV) mortality in patients with CKD with or without type II diabetes. DAPA-CKD is part of AstraZeneca’s DapaCare clinical program to explore the CV and renal profile of Farxiga in type II diabetes patients.
The FDA also granted orphan drug designation to AstraZeneca’s respiratory biologic Fasenra for a new indication — eosinophilic esophagitis — an allergic inflammatory disease of the esophagus.
Meanwhile, a phase III study, evaluating AstraZeneca’s fixed-dose triple combination inhaler Breztri Aerosphere (PT010) in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD) met the primary endpoint. Breztri Aerosphere was approved in Japan in June for the treatment of COPD and is under review in the United States and EU for the same indication.
Bristol-Myers Expects Celgene Acquisition to Close by Year-End: Bristol-Myers moved a step closer toward the closure of its pending acquisition of Celgene this week as the latter signed a deal with Amgen to divest global commercial rights to its blockbuster psoriasis drug, Otezla. Amgen will pay $13.4 billion in cash for the same to Celgene. Back in June, Bristol-Myers had announced plans to divest Otezla to be able to close the acquisition of Celgene on a timely basis in light of concerns expressed by the U.S. Federal Trade Commission (FTC). The sale of Otezla should now make it easier for Bristol-Myers to get FTC’s approval and will also fund a part of its massive $74 billion cost of buying Celgene. So, the deal looks like a win-win for Bristol-Myers, which expects the merger to close by the end of this year.
Novartis MS Candidate Meets Study Endpoints: Novartis’ NVS multiple sclerosis candidate, ofatumumab met the primary endpoints by reducing the annualized relapse rate compared to Sanofi’s multiple sclerosis drug Aubagio in two phase III head-to-head studies. Ofatumumab is marketed by the company for oncology indications as an intravenous infusion under the brand name, Arzerra. In the studies, the key secondary endpoints of delaying time to confirmed disability progression were also met. Novartis plans to make regulatory submissions to health authorities, seeking approval of ofatumumab for relapsing forms of MS, by the end of this year.
The NYSE ARCA Pharmaceutical Index declined 0.3% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
In the last week, while Glaxo rose the most (1.8%), J&J declined the most (2.3%).
In the past six months, AstraZeneca has been the biggest gainer (8.8%) while Pfizer lost the most (18.5%).
(See the last pharma stock roundup here: ABBV’s Rinvoq Gets FDA Nod, BAYRY to Sell Animal Health Unit)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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