Pfizer Inc. PFE came up with a couple of announcements related to its breast cancer drug, Ibrance and PF-06438179, a biosimilar version of Johnson & Johnson’s JNJ blockbuster drug, Remicade (infliximab).
Ibrance a Step Closer to EU Approval
Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion in favor of the approval of the company’s marketing authorization for Ibrance. Ibrance is under review in the EU for the treatment of women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer. The CHMP has indicated that Ibrance is to be used in combination with an aromatase inhibitor as well as in combination with Faslodex (fulvestrant) in women who have received prior endocrine therapy.
The favorable opinion of the CHMP will now be reviewed by the European Commission (EC). With the CHMP in favor of approving Ibrance, we believe chances of gaining EU approval are high. A decision should be out by year end.
Approval would make Ibrance the first CDK 4/6 inhibitor to be approved by the EC.
We note that Ibrance is already approved in the U.S. for the treatment of HR+/HER2- advanced or metastatic breast cancer in combination with Novartis AG’s NVS Femara (letrozole) as initial endocrine-based therapy in postmenopausal women or Faslodex in women with disease progression following endocrine therapy. The indication in combination with Femara was cleared in the U.S. under accelerated approval.
Ibrance has received broad patient and physician acceptance with an encouraging feedback, and the company plans to continue to build momentum in the U.S. by penetrating all lines of therapy. The drug has recorded sales of $942 million in the first half of 2016 since its launch in Feb 2015.
Approval in the EU would boost the commercial potential of the drug significantly. Meanwhile, Pfizer is also working on expanding Ibrance’s label by targeting different segments of breast cancer patients.
Biosimilar Remicade Hits Phase III Primary Endpoint
Pfizer announced positive top-line data from a phase III confirmatory study – REFLECTIONS B537-02 on PF-06438179 (infliximab-Pfizer). The multi-national, randomized, double blind, two-arm, parallel group phase III study evaluated the efficacy, safety, and immunogenicity of PF-06438179, against Remicade in combination with methotrexate when administered intravenously for the treatment of patients with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to methotrexate therapy.
The study hit the primary endpoint and showed that PF-06438179 demonstrated similar efficacy to Remicade as measured by the American College of Rheumatology-20 response at Week 14 of study treatment.
PF-06438179 is presently in development for all currently approved indications of Remicade. We note that Pfizer had divested in Feb 2016 the rights to the development, commercialization and manufacture of PF-06438179 in the European Economic Area (EEA) to Novartis’ generic arm, Sandoz. Pfizer, on the other hand, retains the commercialization and manufacturing rights to PF-06438179 in all countries outside the EEA.
We remind investors that Celltrion Inc.’s biosimilar version of Remicade, Inflectra (infliximab-dyyb), had gained FDA approval earlier this year in April. Pfizer has exclusive commercialization rights to Inflectra in the U.S. and certain other territories.
PFIZER INC Price
Pfizer carries a Zacks Rank #3 (Hold). Geron Corporation GERN is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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