We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Novartis/Amgen Migraine Drug Positive in Phase III Study
Read MoreHide Full Article
Novartis AG (NVS - Free Report) and partner Amgen Inc. (AMGN - Free Report) announced positive top-line data from the second pivotal phase III study (STRIVE) on their calcitonin gene-related peptide (CGRP) receptor, AMG 334 (erenumab), for the prevention of episodic migraine.
The multicenter, randomized 24-week, double-blind, placebo-controlled study evaluated the safety and efficacy of AMG 334 in patients with episodic migraine. Patients enrolled in the study received once-monthly subcutaneous placebo or one of two doses of AMG 334 – 70 mg or 140 mg – for six months.
Data showed that both the doses achieved the primary endpoint of demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months in comparison to placebo. The safety profile of AMG 334 was found to be comparable with placebo across both treatment arms over the six-month double-blind evaluation and consistent with the previously reported study data.
In the press release, the companies stated that additional analysis of STRIVE data is currently underway and will be submitted in a future medical conference for publication.
Earlier this year, positive data from two other studies evaluating AMG 334 – a phase III study (ARISE) for the prevention of episodic migraine and a phase II study for the prevention of chronic migraine – were announced. These data will help support discussions with regulatory authorities with filing expected in 2017.
We note that Novartis is developing AMG 334 in collaboration with Amgen. Under the collaboration agreement dated Aug 2015, the companies agreed to jointly develop and commercialize treatments in the field of Alzheimer's disease and migraine. While Amgen owns commercialization rights in the U.S., Canada and Japan, Novartis retains commercialization rights in Europe and the rest of the world.
Another migraine candidate being developed under this collaboration is AMG 301, which is currently in a phase I study.
We note that several companies, including Teva Pharmaceutical Industries Limited (TEVA - Free Report) , are looking to develop migraine treatments targeting CGRP.
Both Novartis and Amgen carry a Zacks Rank #3 (Hold).
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 18% year to date.
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>>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Novartis/Amgen Migraine Drug Positive in Phase III Study
Novartis AG (NVS - Free Report) and partner Amgen Inc. (AMGN - Free Report) announced positive top-line data from the second pivotal phase III study (STRIVE) on their calcitonin gene-related peptide (CGRP) receptor, AMG 334 (erenumab), for the prevention of episodic migraine.
The multicenter, randomized 24-week, double-blind, placebo-controlled study evaluated the safety and efficacy of AMG 334 in patients with episodic migraine. Patients enrolled in the study received once-monthly subcutaneous placebo or one of two doses of AMG 334 – 70 mg or 140 mg – for six months.
NOVARTIS AG-ADR Price
NOVARTIS AG-ADR Price | NOVARTIS AG-ADR Quote
Data showed that both the doses achieved the primary endpoint of demonstrating a statistically significant reduction from baseline in mean monthly migraine days at six months in comparison to placebo. The safety profile of AMG 334 was found to be comparable with placebo across both treatment arms over the six-month double-blind evaluation and consistent with the previously reported study data.
In the press release, the companies stated that additional analysis of STRIVE data is currently underway and will be submitted in a future medical conference for publication.
Earlier this year, positive data from two other studies evaluating AMG 334 – a phase III study (ARISE) for the prevention of episodic migraine and a phase II study for the prevention of chronic migraine – were announced. These data will help support discussions with regulatory authorities with filing expected in 2017.
AMGEN INC Price
AMGEN INC Price | AMGEN INC Quote
We note that Novartis is developing AMG 334 in collaboration with Amgen. Under the collaboration agreement dated Aug 2015, the companies agreed to jointly develop and commercialize treatments in the field of Alzheimer's disease and migraine. While Amgen owns commercialization rights in the U.S., Canada and Japan, Novartis retains commercialization rights in Europe and the rest of the world.
Another migraine candidate being developed under this collaboration is AMG 301, which is currently in a phase I study.
We note that several companies, including Teva Pharmaceutical Industries Limited (TEVA - Free Report) , are looking to develop migraine treatments targeting CGRP.
Both Novartis and Amgen carry a Zacks Rank #3 (Hold).
A Stock to Consider
Anika Therapeutics Inc. (ANIK - Free Report) is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%. Its share price has gained 18% year to date.
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>>