Celgene And Agios Announce Data On Idhifa For Leukemia

Celgene Corporation (NASDAQ:CELG) and partner Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced new efficacy and safety data from the ongoing phase I dose-escalation and expansion study on experimental candidate Idhifa (enasidenib) at an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting.

The study evaluated Idhifa in patients suffering from relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-2 (IDH2) mutation The candidate, inhibitor of the mutant IDH2 enzyme, showed an overall response rate of 40.3% (the primary endpoint of the study), including a complete response rate of 19.3% in the study. A maximum tolerated dose was not reached. A total of 239 patients with advanced hematologic malignances and an IDH2 mutation were enrolled in the study, of which 176 patients had R/R AML. Median duration of response was 5.8 months for all patients who responded and 8.8 months for patients who achieved a CR.

We note that the New Drug Application (NDA) for Idhifa is currently under Priority Review in the U.S. for the treatment of patients with relapsed or refractory AML with an IDH2 mutation. The NDA has been given a Prescription Drug User Fee Act (PDUFA) action date of Aug 30.

Meanwhile, enasidenib continues to be studied in the following ongoing clinical trials IDENTIFy (phase III I study evaluating the efficacy and safety of enasidenib versus conventional care regimens in older patients with R/R AML with an IDH2 mutation), a phase Ib study of either enasidenib or Agio’s pipeline candidate ivosidenib (AG-120) in combination with standard induction and consolidation chemotherapy in newly diagnosed AML (NCT02632708) and a phase I/II study of either enasidenib or ivosidenib in combination with azacitidine in newly diagnosed AML (NCT02677922).

Celgene has been making prudent acquisitions and inking strategic deals to bolster its pipeline. We remind investors that both Celgene and Agios entered into a collaboration agreement in 2010 whereby Celgene had worldwide development and commercialization rights for Idhifa. Agios is responsible for all clinical development activities within the Idhifa development program and is entitled to receive reimbursement for those development activities and up to $95 million in miletsone payments. Both the companies plan to co-commercialize Idhifa in the U.S. Celgene will reimburse Agios for costs incurred for its co-commercialization efforts.

Celgene’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past one year. Specifically, the stock gained 9.5% during this period, against the industry’s decline of 10.4%.

Meanwhile, Celgene’s key growth driver, Revlimid, continues to outperform on the back of market share gains and increased duration. However, Otezla sales in the first quarter were impacted by managed care dynamics that drove lower total marketplace prescriptions for psoriasis therapies.

Zacks Rank & Key Picks

Celgene currently carries a Zacks Rank #3 (Hold).

Some valuable stocks woth considering in the health care sector include VIVUS, Inc. (NASDAQ:VVUS) and Zoetis Inc. (NYSE:ZTS) . VIVUS sports a Zacks Rank #1 (Strong Buy) while Zoetis carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks Rank #1 stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.

Zoetis’ earnings per share estimates increased from $2.32 to $2.34 for 2017 over the last 60 days. The company posted positive earnings surprises in all four trailing quarters, with an average beat of 9.82%.

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