Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ) JNJ, announced that it has submitted regulatory applications to the FDA and European Medicines Agency ("EMA"), seeking a label expansion of Darzalex Faspro (called Darzalex SC in EU). The submitted regulatory applications seek approval of Darzalex Faspro in combination with pomalidomide and dexamethasone (D-Pd) for treating patients with relapsed or refractory multiple myeloma (r/rMM) in second or later-line setting.
Please note that Darzalex Faspro is a subcutaneous formulation of J&J’s blockbuster medicineDarzalex (daratumumab). Darzalex is approved as intravenous (“IV”) formulation. The subcutaneous formulation is developed using Halozyme (NASDAQ:HALO)’s HALO ENHANZE technology. Darzalex Faspro is already approved as monotherapy for treating multiple myeloma in the United States and Europe in fourth or later- line setting and as combination regimen in second or later-line setting.
Shares of J&J have risen 1.7% so far this year compared with the industry’s rise of 1%.
Janssen filed its supplemental biologics license application (sBLA) to the FDA and Type II variation application to the EMA based on positive data from phase III study — APOLLO. Data from the study showed that D-Pd regimen improved progression-free survival significantly compared to the Pd regimen alone. We note that IV formulation of Darzalex is already approved in the United States in combination with pomalidomide and dexamethasone for treating r/rMM patients in third or later-line setting. However, the regimen is not approved for this indication in this treatment setting in Europe.
A potential approval of the recent regulatory applications for Darzalex Faspro combo regimen will significantly reduce administration time from hours to minutes, which will be beneficial for patients. This will likely drive demand of the drug in this patient population. Moreover, potential European approval will also expand patient population.
We note that Darzalex is a key drug in J&J’s portfolio. Sales of the drug rose 35.5% to $2.9 billion in the first nine months of 2020 amid COVID-19 related disruptions.
J&J’s Pharma segment is performing above-market despite currency headwinds and the impact of biosimilar and generic competition on sales of some key drugs. The sales increase is being led by the company’s oncology drugs, Imbruvica and Darzalex as well as psoriasis treatment, Stelara. Moreover, the company is making rapid progress with its pipeline and line extensions. Several pivotal data readouts and regulatory milestones are expected in the near term.
Key candidates in the company’s pipeline are niraparib for prostate cancer, JNJ-4528/BCMA CAR-T therapy for r/rMM; ponesimod is under review for relapsing forms of multiple sclerosis and others. Please note that niraparib is marketed as Zejula by Glaxo GSK for ovarian cancer but J&J owns exclusive rights to niraparib in prostate cancer.
Zacks Rank & Stock to Consider
J&J currently carries a Zacks Rank #3 (Hold). A better-ranked big biotech stock is Repligen (NASDAQ:RGEN) RGEN, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 8.6% and 12% upward for 2020 and 2021, respectively over the past 30 days.
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