Biotech major Amgen Inc. AMGN announced that it has submitted a supplemental biologics license application (sBLA) to the FDA for its leukemia immunotherapy Blincyto.
So far this year, Amgen’s shares are up 14.9%, better than a 4.5% increase registered by the Zacks classified Biomed/Genetics industry.
Blincyto gained accelerated FDA approval in Dec 2014 to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL.
With the latest sBLA, Amgen is looking to update Blincyto label with the overall survival data from the confirmatory phase III TOWER study. The TOWER study was conducted to support the conversion of Blincyto's accelerated approval to full approval. The study evaluated the efficacy of Blincyto versus standard of care (SOC) chemotherapy for the treatment of Ph- relapsed or refractory B-cell precursor ALL in adults.
The sBLA also includes new data from a phase II study to broaden the indication of Blincyto, a BiTE antibody for the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor ALL.
In September last year, Amgen’s sBLA for Blincyto to include new data supporting the treatment of pediatric patients with Ph- relapsed or refractory B-cell precursor ALL was approved by the FDA.
Blincyto has the potential to be developed for other hematologic malignancies as well. Phase II/III studies in patients with diffuse large B-cell lymphoma are expected to enrol patients in 2017.
Blincyto was added to Amgen’s portfolio with the Mar 2012 acquisition of biotech company, Micromet.
In 2016, Blincyto sales surged 49% from the year-ago period to $115 million, reflecting higher demand. Amgen announced fourth quarter and full year 2016 results on Feb 2. It surpassed sales and earnings expectations yet again in the fourth quarter. However, the 2017 sales outlook was somewhat unimpressive.
Concurrent with the fourth quarter results, Amgen announced that its PCSK9 inhibitor, Repatha met the primary composite endpoint as well as the key secondary endpoints in a phase III cardiovascular outcomes study (FOURIER). The highly awaited top-line data from the study showed that Repatha was effective in reducing the risk of cardiovascular events (like cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke and others) in patients with clinically evident atherosclerotic cardiovascular disease. Importantly, there was no new safety finding in the trial.
Uptake of Repatha, which gained FDA approval in Aug 2015, has not been very encouraging so far. However, the latest positive data, which clearly validates the outcomes benefit of PCSK9 inhibition in cardiovascular disease, should provide a material boost to Repatha.
Last month, Amgen announced that the U.S. District Court in Delaware granted it permanent injunction against infringement by Sanofi SNY and Regeneron Pharmaceuticals, Inc. REGN for two patents owned by Amgen for Repatha. The decision bans Sanofi and Regeneron from selling Praluent during the term of the two patents, which describe and claim monoclonal antibodies of PCSK9. Praluent’s ban could in turn drive sales of Repatha.
However, last week, Sanofi announced that the United States Court of Appeals for the Federal Circuit granted their request to suspend the permanent injunction for Praluent, pending the appeal. This means that Praluent can be sold during the appeals process. Sanofi otherwise would have been prohibited from selling Praluent in the U.S. from Feb 21, 2017.
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the Biomed/Genetics industry that can be considered is Celgene Corporation CELG with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Celgene’s share price has risen 4.5% so far this year.
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