Post by lakers on Nov 13, 2015 2:04:29 GMT -5
I want to share with you what I'm excited about in the pipeline. So I – just going to give you some highlights around the areas in terms of migraine, movement disorders, pain, and respi just to give you some visibility about what excites me about this.
Of course our Labrys compound, the first anti-CGRP antagonist, which has demonstrated remarkable effectiveness both in chronic and episodic migraine. We looked at many doses across two conditions. And all of these achieved outstanding significance, primary and secondary endpoints were met, and not only at 3 months, but also at 1 month of therapy. And we are the only monoclonal antibody that is separated from placebo across the entire duration of study for both primary and secondary. And we – only company that has reported results for chronic migraine. Thus far no safety concerns have emerged for us or any out of the products in this space.
When you look at this particular product, there is the potential. The race is not over. We are at mile 20 of a 26-mile marathon, but it's looking good thus far. We achieved the best results in terms of decrease in migraine at month 3, the primary endpoint, placebo subtracted. We had good results also in month 1, and in fact the effect and efficacy was seen at 1 week after therapy. And if you look at the number of patients who had actually 50% improvement, it was 44%.
Importantly and not able to be predicted we had essentially no immunogenicity, very important. And this may be the reason that we saw improved efficacy with this particular compound.
So these are all exciting results, exciting for us, but particularly important for patients who suffer from episodic and chronic migraine. When you look at the disability from episodic migraine, half patients' lives, 40 million in the United States individuals, are actually their lives are lost due to missing work, missing school, missing a family occasion as a result of episodic migraine. We've seen a major impact on disability, improving these patients' lives, and making them feel better.
Current status is that we have an outstanding end of Phase II meeting with the FDA. There was agreement and support for the CMC plan, the does, the Phase III clinical plan and strategy, total alignment with the regulatory authorities. We will be starting both single trials, pivotal trials, in chronic and episodic migraine in early 2016. And our target for BLA submission is 2018. We are making great progress with this particular program.
Importantly for us it is the product that is innovative and important that is crucial. But around this product we also are providing services and solutions. We've already started this with Zecuity. And we believe that providing services and support for patients 24/7 enhances, improves their quality of life and really is critical. As we've seen with Shared Solutions for MS, we've learned from that. And we've now established Migraine Support Solutions as a key part of our therapeutic strategy to enrich and enhance the quality of life of patients.
Let me share with you where we are. So in migraine we have the potential for being a world leader in this very important underserved space. That's one of our goals. We have Zecuity already on the market. And we're looking at deepening this portfolio and also improving this particular product in other indications in the area of migraine and headache for the future.
Teva Pharmaceutical Industries (TEVA) Erez Vigodman on Q3 2015 Results - Earnings Call Transcript $TEVA
www.seekingalpha.com/article/3622876
Of course our Labrys compound, the first anti-CGRP antagonist, which has demonstrated remarkable effectiveness both in chronic and episodic migraine. We looked at many doses across two conditions. And all of these achieved outstanding significance, primary and secondary endpoints were met, and not only at 3 months, but also at 1 month of therapy. And we are the only monoclonal antibody that is separated from placebo across the entire duration of study for both primary and secondary. And we – only company that has reported results for chronic migraine. Thus far no safety concerns have emerged for us or any out of the products in this space.
When you look at this particular product, there is the potential. The race is not over. We are at mile 20 of a 26-mile marathon, but it's looking good thus far. We achieved the best results in terms of decrease in migraine at month 3, the primary endpoint, placebo subtracted. We had good results also in month 1, and in fact the effect and efficacy was seen at 1 week after therapy. And if you look at the number of patients who had actually 50% improvement, it was 44%.
Importantly and not able to be predicted we had essentially no immunogenicity, very important. And this may be the reason that we saw improved efficacy with this particular compound.
So these are all exciting results, exciting for us, but particularly important for patients who suffer from episodic and chronic migraine. When you look at the disability from episodic migraine, half patients' lives, 40 million in the United States individuals, are actually their lives are lost due to missing work, missing school, missing a family occasion as a result of episodic migraine. We've seen a major impact on disability, improving these patients' lives, and making them feel better.
Current status is that we have an outstanding end of Phase II meeting with the FDA. There was agreement and support for the CMC plan, the does, the Phase III clinical plan and strategy, total alignment with the regulatory authorities. We will be starting both single trials, pivotal trials, in chronic and episodic migraine in early 2016. And our target for BLA submission is 2018. We are making great progress with this particular program.
Importantly for us it is the product that is innovative and important that is crucial. But around this product we also are providing services and solutions. We've already started this with Zecuity. And we believe that providing services and support for patients 24/7 enhances, improves their quality of life and really is critical. As we've seen with Shared Solutions for MS, we've learned from that. And we've now established Migraine Support Solutions as a key part of our therapeutic strategy to enrich and enhance the quality of life of patients.
Let me share with you where we are. So in migraine we have the potential for being a world leader in this very important underserved space. That's one of our goals. We have Zecuity already on the market. And we're looking at deepening this portfolio and also improving this particular product in other indications in the area of migraine and headache for the future.
Teva Pharmaceutical Industries (TEVA) Erez Vigodman on Q3 2015 Results - Earnings Call Transcript $TEVA
www.seekingalpha.com/article/3622876