AstraZeneca plc AZN came up with important announcements on both the pipeline and regulatory front.
Durvalumab Shows Clinical Activity in ATLANTIC Study
AstraZeneca provided an update on preliminary findings from the phase II ATLANTIC study on durvalumab (MEDI4736). The non-comparative, open-label, multi-center study evaluated the efficacy and tolerability of durvalumab for the third-line or later stage treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC; stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum-based chemotherapy regimen.
Durvalumab demonstrated clinical activity with durable responses and an established safety profile in these difficult-to-treat patients. However, AstraZeneca noted that in all probability the ATLANTIC study cannot be used for regulatory submission of the candidate as a monotherapy, although it will take a decision following a full analysis of the data. Currently, the complete evaluation of the data is underway and results will be presented at a scientific congress in 2016.
We note that durvalumab is being evaluated under a broad development program across multiple tumor types (including lung, bladder, head & neck and other cancers), stages of disease, and lines of therapy both as a monotherapy and in combination.
We note that AstraZeneca is aiming to bring six new cancer medicines to the market by 2020. Of late, AstraZeneca has been looking to build its immuno-oncology portfolio and pipeline with strategic licensing and acquisition deals. Last week, the company announced an agreement to invest in a majority equity stake in Acerta Pharma, a privately owned biotech company based in the Netherlands and the U.S.
The deal provides AstraZeneca with an irreversible oral Bruton's tyrosine kinase (BTK) inhibitor, acalabrutinib (ACP-196), which is currently in phase III development for B-cell blood cancers and in phase I/II studies in multiple solid tumors. The deal is slated to close by the end of the first quarter of 2016.
Gets CHMP Recommendation for 3 Drugs
AstraZeneca also announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions regarding the approval of Tagrisso, Brilique (U.S. trade name: Brilinta) and lesinurad.
Tagrisso (80 mg once daily) is recommended to be approved for the treatment of adults with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. We note that Tagrisso gained accelerated approval in the U.S. for the same indication last month.
Brilique is under review in the EU for a label expansion. AstraZeneca is looking to get Brilique (60 mg) approved for the treatment of patients with a history of heart attack and who are at a high risk of having a further atherothrombotic event. The CHMP opinion states that Brilique may be started as a continuation therapy after an initial one-year treatment with dual anti platelet therapy.
Currently, Brilique (90 mg) is approved in the EU for the reduction of the rate of cardiovascular death, myocardial infarction (also known as heart attack) and stroke in patients with acute coronary syndrome.
Lesinurad (200 mg) in combination with a xanthine oxidase inhibitor (XOI) is recommended to be approved for the adjunctive treatment of hyperuricemia in adults with gout (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a XOI alone. A decision regarding EU approval should be out in the first quarter of 2016.
We remind investors that lesinurad is under review in the U.S. for the treatment of hyperuricemia associated with gout, in combination with an XOI. A response from the FDA is expected by Dec 29, 2015.
With the CHMP in favor of approving Tagrisso, Brilique and lesinurad, we believe their chances of gaining EU approval are high.
AstraZeneca is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Mylan N.V. MYL and Anika Therapeutics Inc. ANIK. All three carry a Zacks Rank #1 (Strong Buy).
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