Have Johnson & Johnson and AstraZeneca done one better than AbbVie, purchasing 55 percent of Acerta Pharma for acalabrutinib (ACP-196)?

[AussieNeil]

"Earlier this year, AbbVie won an intense bidding war for Pharmacyclics, paying $21 billion for the company and the right to split sales of its potential blockbuster blood-cancer drug Imbruvica with Johnson & Johnson. AstraZeneca may have just done AbbVie one better."

chicagobusiness.com/article...

"Acerta reported promising results from mid-phase trials of its drug last week, suggesting it may be even more effective than Imbruvica in treating relapsed chronic lymphocytic leukemia (CLL), with fewer side effects. The drug showed a 95 percent response rate (meaning the percentage of patients whose cancer shrinks or vanishes), compared to 58 percent for Imbruvica. AstraZeneca predicts peak sales of about $5 billion, compared to the $10 billion AbbVie projects for Imbruvica. "

Neil

[kathypawpaw]

Dear Neil,

This is exciting news. Thank you so much for bringing these cutting edge articles to us. Acerta is a drug to follow. A 95% response rate is impressive. I'm wondering what the % of patients that had their cancer vanish?

Thanks, this news was the nicest Christmas present I could ever receive!

Kathy

[PaulaS Volunteer in reply to kathypawpaw]

Hi Kathy, Yes it is good news!

Names can be confusing though. The drug is called Acalabrutinib (also known as ACP-196.) The company is called Acerta.

Happy Christmas,

Paula

[kathypawpaw in reply to PaulaS]

Opps...thanks Paula. I appreciate the heads up! This is a lot to absorb.

Kathy

[Cllcanada Top Poster CURE Hero in reply to kathypawpaw]

Is not a cure... CLL remains, not vanished... it will probably be a drug for life until they can run cycled trials with other combinations... but that will be some time off and there are the FDA and EMA hurdles to jump...

They will be running a head to head trial against Imbruvica (ibrutinib), which should cement their efficacy and help smooth the road to approval

[Justasheet1]

Chris or Neil,

Any rumors when this could be FDA approved?

Jeff

[Cllcanada Top Poster CURE Hero in reply to Justasheet1]

Don't know... next year...?

[Hidden]

AbbVie paid $21 billion for 1/2 the rights to imbruvica but J&J only paid $1 billion for the other 1/2 two years earlier, with most of that ear marked for funding clinical trials of it.

The average new cancer drug in the US costs about $1 billion to get to the FDA approval point. Few if any biotech start-ups can manage that without a deep pockets major firm like J&J buying into it.

[tpetro]

How exciting for us all! Any trials showing how acalabrutinib works for the treatment naive as compared to ibrutinib? Exciting times ahead…wishing all a Happy New Year! Terry

[Cllcanada Top Poster CURE Hero in reply to tpetro]

Next trials will be acalabrutinib (ACP-196) used in patients who failed Imbruvica (ibrutinib) or had side effects that caused termination of treatment...

So those patients will be 17p deleted or secondline ...

Here is the second line trial comparing the two...firstline will be some time off, likely after acalabrutinib (ACP-196) approval by FDA etc... for secondline...

clinicaltrials.gov/ct2/show...

[Ernest2]

Sorry for slowness of my reply, just catching up.

Also see (spotted for me):

dailymail.co.uk/money/marke...

I'm also wondering what AstraZenica joining the party might do to help with the pricing.

And Neil, an enormous thank-you for all your endless hard work on HU, just don't know how you all do it.

Best Wishes,

Ernest