Brodalumab still in the running for psoriasis treatment

[Fred]

Following on from the announcement that Amgen had dumped Brodalumab see here: Amgen dump brodalumab after some patients had suicidal thoughts. AstraZenaca announced they have granted an exclusive license for Valeant Pharmaceuticals International, Inc to develop and commercialise brodalumab.

Quote:

---

AstraZeneca today announced that it has entered into a collaboration agreement with Valeant Pharmaceuticals International, Inc. under which it will grant an exclusive license for Valeant to develop and commercialise brodalumab.

Brodalumab is an IL-17 receptor monoclonal antibody in development for patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Under the agreement, Valeant will hold the exclusive rights to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd under a prior arrangement with Amgen Inc., the originator of brodalumab. Valeant will assume all development costs associated with the regulatory approval for brodalumab. Regulatory submission in US and EU for brodalumab in moderate-to-severe psoriasis is planned for the fourth quarter of 2015.

Under the terms of the agreement, Valeant will make an up-front payment to AstraZeneca of $100 million as well as additional pre-launch milestones of up to $170 million and further sales related milestone payments of up to $175 million following launch. After approval, AstraZeneca and Valeant will share profits.

Brodalumab is supported by data from the three AMAGINE Phase III pivotal studies1 . The results highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit and could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease. At the 210 mg dose, brodalumab was shown to be efficacious in total skin clearance of psoriasis compared to placebo and superior to ustekinumab at week 12 in two replicate comparator trials involving over 3,500 patients.

Pascal Soriot, Chief Executive Officer, said: “Our agreement will help to bring brodalumab to patients with psoriasis who need new treatment options through Valeant’s expert focus on dermatology.”

J. Michael Pearson, Chairman and Chief Executive Officer of Valeant, said, “We are delighted we were able to reach a licensing agreement with AstraZeneca to commercialize brodalumab, which is potentially the most efficacious therapy yet for moderate-to-severe plaque psoriasis. We remain fully committed to dermatology and will continue to advance our pipeline of internally developed and acquired products.”

The transaction is expected to complete in the fourth quarter of 2015, subject to customary closing conditions, and it does not materially impact AstraZeneca’s financial guidance for 2015. As AstraZeneca continues to retain a significant interest in brodalumab, the upfront payment and any potential subsequent milestone payments are expected to be reported as Externalisation Revenue.

Source: astrazeneca.com

[jiml]

I for one am glad they have pushed ahead with this drug it has proved to be very effective and an additional tool for dermatologists. I think the fear of suicidal thoughts being associated with it may put some patients off trying it, but I'm sure the dermatologists that prescribe it will be fully aware of the side effects and will hopefully monitor the recipient closely.
I hope they get approval when the drug is submitted both in the U.S. And Europe

[Fred]

I for one am glad they have pushed ahead with this drug it has proved to be very effective and an additional tool for dermatologists. I think the fear of suicidal thoughts being associated with it may put some patients off trying it, but I'm sure the dermatologists that prescribe it will be fully aware of the side effects and will hopefully monitor the recipient closely.
I hope they get approval when the drug is submitted both in the U.S. And Europe

Yes I think it's a good thing to keep the trials going, they will obviously be vigilant and keep an eye on things. Suicidal thoughts is a very serious side effect, but with close monitoring and appraisal of the patient this could be a good treatment for a lot of people.

Unfortunately Amgen felt it was to much of a risk, whether that was do to safety or shareholders we will never know. But my thoughts would be shareholders come first, would they invest in something that could cause suicidal thoughts.    

At least Valeant have the guts to give it a go.

[Quest4Cure]

I read it may be approved by the FDA in the US by Nov. 2016.

[jiml]

I read it may be approved by the FDA in the US by Nov. 2016.

So I guess they will go ahead but with a safety warning stating it can cause depression and suicidal thoughts

[Fred]

I read it may be approved by the FDA in the US by Nov. 2016.

So I guess they will go ahead but with a safety warning stating it can cause depression and suicidal thoughts

November is a long way off for any country to decide, but what I have been told investors are not keen. So it's an uphill struggle for them to get it out there.

As we have seen with Fumaderm recently it is going to get increasingly difficult to get approval. Will investors be willing to sink money into a possible or a certainty, what would you choose as an investor ?  

*For those that don't like it. Get over it. Future treatments for psoriasis are driven by money, if we get benefit then who cares. I don't care who makes money from my treatment I just want something that works for me.

[Quest4Cure]

I read it may be approved by the FDA in the US by Nov. 2016.

So I guess they will go ahead but with a safety warning stating it can cause depression and suicidal thoughts

November is a long way off for any country to decide, but what I have been told investors are not keen. So it's an uphill struggle for them to get it out there.

As we have seen with Fumaderm recently it is going to get increasingly difficult to get approval. Will investors be willing to sink money into a possible or a certainty, what would you choose as an investor ?  

*For those that don't like it. Get over it. Future treatments for psoriasis are driven by money, if we get benefit then who cares. I don't care who makes money from my treatment I just want something that works for me.

There are far too many drugs on the market that have the same side effects and a lot worse. They just post a warning in a black box on the box on each product, lets them off the hook. Is that morally correct? Or are we supposed to trust our doctors desicion that the benefits out weigh the side effects. Drug induced bipolar, drug induced MS, drug induced lymphoma. And the list goes on. Weigh the + & the - do your homework, even then it can be risky business. Big Pharma & stock ????? Here in the US the physicians association is trying to remove advertisements from drug companies from tv.
I had a friend die from a drug for RA 2 years ago. I miss him.

[Removed]

I for one am glad they have pushed ahead with this drug it has proved to be very effective and an additional tool for dermatologists. I think the fear of suicidal thoughts being associated with it may put some patients off trying it, but I'm sure the dermatologists that prescribe it will be fully aware of the side effects and will hopefully monitor the recipient closely.
I hope they get approval when the drug is submitted both in the U.S. And Europe

Yes I think it's a good thing to keep the trials going, they will obviously be vigilant and keep an eye on things. Suicidal thoughts is a very serious side effect, but with close monitoring and appraisal of the patient this could be a good treatment for a lot of people.

Unfortunately Amgen felt it was to much of a risk, whether that was do to safety or shareholders we will never know. But my thoughts would be shareholders come first, would they invest in something that could cause suicidal thoughts.    

At least Valeant have the guts to give it a go.  

Hi Fred, still trying to figure this forum thing out.  But I noticed something you said regarding amgen- and about safety or shareholders and that "we'll never know."  Why is that do you think, That we don't know?

[Removed]

I read it may be approved by the FDA in the US by Nov. 2016.

So I guess they will go ahead but with a safety warning stating it can cause depression and suicidal thoughts

Not so fast quest4cure. What makes you think that brodalumab causes depression etc. What if, at the end of the day it gets fda approval with no such warning. Afterall, let's remember that amgen was merely speculating the fda would require such a warning.

[jiml]

I read it may be approved by the FDA in the US by Nov. 2016.

So I guess they will go ahead but with a safety warning stating it can cause depression and suicidal thoughts

Not so fast quest4cure. What makes you think that brodalumab causes depression etc. What if, at the end of the day it gets fda approval with no such warning. Afterall, let's remember that amgen was merely speculating the fda would require such a warning.

I think the following quote will answer that question   Amgen dump brodalumab after some patients had suicidal thoughts.