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Astrazeneca (AZN) Presents Benralizumab Phase III Data
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AstraZeneca plc (AZN - Free Report) recently announced further results from two pivotal phase III trials on its respiratory disease candidate, benralizumab, for the treatment of severe asthma.
The positive results from the SIROCCO and CALIMA trials were presented at the European Respiratory Society (ERS) International Congress. Top-line results from the trial were reported earlier in May.
The SIROCCO and CALIMA trials are randomized, double-blind, parallel-group, placebo-controlled studies, evaluating the safety and efficacy of benralizumab as an add-on therapy in the treatment of severe uncontrolled asthma with eosinophilic inflammation in patients aged 12 years and older. The study met its primary endpoint. Data demonstrated that adding benralizumab to standard-of-care medicine led to significant reduction in the annual asthma exacerbation rate compared to placebo.
The trials also demonstrated that treatment with benralizumab can lead to improved lung function and asthma symptoms such as wheeze, cough, chest tightness and shortness of breath.
The studies evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens. All these benefits were observed in the 8-week dosing regimen while no additional benefits were seen in the 4-week regimen, suggesting that fewer doses of the drug can be effective.
AstraZeneca expects to file for regulatory approval in both the U.S. and the EU this year. Benralizumab is also being evaluated in the phase III VOYAGER program for the treatment of patients with severe COPD (both data and regulatory filings in the U.S. and the EU are expected in 2018).
AstraZeneca expects the candidate to generate peak sales of $2 billion. We remind investors that AstraZeneca has in-licensed the drug from Kyowa Hakko Kirin in all countries except Japan and some other Asian countries.
In Jul 2015, AstraZeneca inked an agreement with Kyowa Hakko Kirin for an exclusive option to commercialize the candidate in Japan, in both asthma and COPD indications.
As per the company’s press release, about 315 million individuals in the world suffer from asthma, which will likely increase to 400 million by 2020.
Zacks Rank and Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
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Astrazeneca (AZN) Presents Benralizumab Phase III Data
AstraZeneca plc (AZN - Free Report) recently announced further results from two pivotal phase III trials on its respiratory disease candidate, benralizumab, for the treatment of severe asthma.
The positive results from the SIROCCO and CALIMA trials were presented at the European Respiratory Society (ERS) International Congress. Top-line results from the trial were reported earlier in May.
The SIROCCO and CALIMA trials are randomized, double-blind, parallel-group, placebo-controlled studies, evaluating the safety and efficacy of benralizumab as an add-on therapy in the treatment of severe uncontrolled asthma with eosinophilic inflammation in patients aged 12 years and older. The study met its primary endpoint. Data demonstrated that adding benralizumab to standard-of-care medicine led to significant reduction in the annual asthma exacerbation rate compared to placebo.
The trials also demonstrated that treatment with benralizumab can lead to improved lung function and asthma symptoms such as wheeze, cough, chest tightness and shortness of breath.
The studies evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens. All these benefits were observed in the 8-week dosing regimen while no additional benefits were seen in the 4-week regimen, suggesting that fewer doses of the drug can be effective.
AstraZeneca expects to file for regulatory approval in both the U.S. and the EU this year. Benralizumab is also being evaluated in the phase III VOYAGER program for the treatment of patients with severe COPD (both data and regulatory filings in the U.S. and the EU are expected in 2018).
ASTRAZENECA PLC Price
ASTRAZENECA PLC Price | ASTRAZENECA PLC Quote
AstraZeneca expects the candidate to generate peak sales of $2 billion. We remind investors that AstraZeneca has in-licensed the drug from Kyowa Hakko Kirin in all countries except Japan and some other Asian countries.
In Jul 2015, AstraZeneca inked an agreement with Kyowa Hakko Kirin for an exclusive option to commercialize the candidate in Japan, in both asthma and COPD indications.
As per the company’s press release, about 315 million individuals in the world suffer from asthma, which will likely increase to 400 million by 2020.
Zacks Rank and Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Anika Therapeutics Inc. (ANIK - Free Report) , Geron Corporation (GERN - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>