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Celgene & Acceleron Complete Enrollment on Thalassemia Drug
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Celgene Corporation and Acceleron Pharma Inc. announced that the companies have completed target enrollment in the phase III studies, MEDALIST and BELIEVE on pipeline candidate luspatercept.
Both the companies expect to report top-line results from these trials in mid-2018.
We note that the candidate is being developed to treat a range of hematologic diseases including myelodysplastic syndromes (MDS), beta-thalassemia, and myelofibrosis.
The phase III trial, MEDALIST is a randomized, double-blind, placebo-controlled, global study. The study is designed to evaluate the efficacy and safety of luspatercept in patients with ring sideroblasts (RS+), lower-risk MDS with a baseline red blood cell transfusion burden of at least 2 units per 8 weeks over the 16-week period prior to treatment. The trial has enrolled 210 patients with lower-risk MDS.
BELIEVE has enrolled 300 patients with transfusion dependent beta-thalassemia. The trials will remain blinded for both the primary and secondary endpoints until the end of the 48-week treatment period for all randomized patients.
Celgene has been making prudent acquisitions and inking strategic deals to bolster its pipeline. We remind investors that as part of the global collaboration, both Acceleron and Celgene are jointly developing luspatercept. Luspatercept is Acceleron’s lead candidate.
Both the companies are also developing sotatercept (chronic kidney disease). In Jan 2013, Celgene became responsible for the payment of all development costs related to sotatercept and luspatercept. Acceleron is eligible to receive up to $367million in development, regulatory approval and sales-based milestones and up to an additional $348 million for each of three specific discovery stage programs in the sotatercept.
Additionally, Celgene has an exclusive, worldwide, royalty-bearing license to luspatercept and future Acceleron products for the treatment of anemia. In exchange, Acceleron is eligible to receive development, regulatory approval and sales-based milestones of up to $217.5 million for luspatercept and up to an additional $170million for the first discovery stage program, $148.8 million for the second discovery stage program and $125.4 million for each additional discovery stage program thereafter.
Celgene’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past year. Specifically, the stock gained 9.2% during this period, against the industry’s decline of 12.3%.
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 in the first quarter.
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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Celgene & Acceleron Complete Enrollment on Thalassemia Drug
Celgene Corporation and Acceleron Pharma Inc. announced that the companies have completed target enrollment in the phase III studies, MEDALIST and BELIEVE on pipeline candidate luspatercept.
Both the companies expect to report top-line results from these trials in mid-2018.
We note that the candidate is being developed to treat a range of hematologic diseases including myelodysplastic syndromes (MDS), beta-thalassemia, and myelofibrosis.
The phase III trial, MEDALIST is a randomized, double-blind, placebo-controlled, global study. The study is designed to evaluate the efficacy and safety of luspatercept in patients with ring sideroblasts (RS+), lower-risk MDS with a baseline red blood cell transfusion burden of at least 2 units per 8 weeks over the 16-week period prior to treatment. The trial has enrolled 210 patients with lower-risk MDS.
BELIEVE has enrolled 300 patients with transfusion dependent beta-thalassemia. The trials will remain blinded for both the primary and secondary endpoints until the end of the 48-week treatment period for all randomized patients.
Celgene has been making prudent acquisitions and inking strategic deals to bolster its pipeline. We remind investors that as part of the global collaboration, both Acceleron and Celgene are jointly developing luspatercept. Luspatercept is Acceleron’s lead candidate.
Both the companies are also developing sotatercept (chronic kidney disease). In Jan 2013, Celgene became responsible for the payment of all development costs related to sotatercept and luspatercept. Acceleron is eligible to receive up to $367million in development, regulatory approval and sales-based milestones and up to an additional $348 million for each of three specific discovery stage programs in the sotatercept.
Additionally, Celgene has an exclusive, worldwide, royalty-bearing license to luspatercept and future Acceleron products for the treatment of anemia. In exchange, Acceleron is eligible to receive development, regulatory approval and sales-based milestones of up to $217.5 million for luspatercept and up to an additional $170million for the first discovery stage program, $148.8 million for the second discovery stage program and $125.4 million for each additional discovery stage program thereafter.
Celgene’s share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical and Genetics industry in the past year. Specifically, the stock gained 9.2% during this period, against the industry’s decline of 12.3%.
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 in the first quarter.
Zacks Rank & Key Picks
Celgene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the health care sector include VIVUS, Inc. and Zoetis Inc. (ZTS - Free Report) . While VIVUS sports a Zacks Rank #1 (Strong Buy), Zoetis carries a Zacks Rank #2 (Buy) each. 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%.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think. See This Ticker Free >>