Avid Bioservices Inc (CDMO)

[biopharm]

Regulatory experts exwannabe BioBs etc is this scenario possible? Thanks

The part about BLA now?

MD, here is another example of the type of data that is used in a BLA and pay attention to the "that could help a significant number.." and now just realize that Garnick knows this also. The separation of curve was unfortunate (for whatever reasons : ) .. yet, Peregrine and especially Garnick, realize that all they need to show for their BLA filing is that PS Targeting helps and "that could help a significant number.." of patients. The control arm, amazingly helping this group of patients is not the norm and again, is not the norm. The norm are what the FDA has on record and what has been used for hundreds of other trials. BP's may have opened a can of worms here and a BLA filing just needs to show the MOA works, the BLA filing just needs to show "that could help a significant number.." and that is the bottom line.

Bavituximab works and works well. The BLA filing continues...and 10 months earlier than expected. I wonder if the BP's ever thought of that and it just so happens that AstraZeneca at the same time does not have to worry about Sunrise approval and can use Bavi with Durvulamab. If I remember correctly, Durvulamab was removed as a single agent and now AZ goes for combo ...

I think some BP's are in for quite a surprise that no matter what they do, Peregrine continues to trot along beside them, like that nagging fly that just can't be squashed.

The below gives a recent, clear example of exactly what the BLA requires and no where, no where in FDA guidance does it say that one can not use Phase III trial data. The circumstances that Peregrine will use it under is quite unconventional, but they have been unconventional in the past couple years already so I expect things to be this way.

Has anyone ever used data from a stopped Phase III trial for a BLA filing for their arm that performed "as expected.." ? I don't know and would say no but then again, I've never seen a small biotech do such unconventional things and keep on moving along...

interesting times for sure

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January 25, 2016

LAVAL, Quebec, Jan. 25, 2016 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) submitted by AstraZeneca in partnership with Valeant, for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate-to-severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.

The Marketing Authorisation Application (MAA) for brodalumab in psoriasis was accepted by the European Medicines Agency (EMA) in Q42015. In October, 2015, Valeant entered into a collaboration agreement with AstraZeneca under which Valeant has an exclusive license to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd.

The brodalumab BLA is supported by data from the three AMAGINE Phase III pivotal studies. The results highlighted that brodalumab has an effective mechanism of action that 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 effective in total skin clearance of psoriasis compared to placebo and superior to ustekinumab, a leading approved psoriasis treatment, at week 12 in two replicate comparator trials involving over 3,500 patients.

http://ir.valeant.com/news-releases/2016/01-25-2016-130634702