ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Tuesday, May 6, 2014

It's Time For Some Three-Point Shots

For over a year I've been scratching my head about the MODDERN Cures Act.

http://als-advocacy.blogspot.com/2013/04/these-are-my-questions-du-jour-on.html

Recently an outstanding advocate/tweeter/patient/person  put me in touch with the folks at the Campaign for Modern Medicines modernmedicines.com who have gone above and beyond the call of duty to help me understand MODDERN Cures and exactly what's in it for people with ALS.  I am grateful.

As we perceived years ago, the dormant therapy features of MODDERN Cures are the most interesting for the fight against ALS.

Here is a blog from the Campaign for Modern Medicines that answers most our questions --


And here is a recap of some salient points for those interested in the fight against ALS --

Are these "dormant therapies" only things that never made it to market for another indication?
That is correct.  Think about things that didn't get through FDA approval for their original intention.  Those things that are sitting on shelves in labs somewhere could have their patent "clocks" reset so that there would be incentives for drug developers to try them on ALS.  MODDERN Cures would not apply to a lithium or a ceftriaxone, but it would apply to something that never made it through FDA approval before. 

How does it work when something is already off patent?  

There are two things that are really important in this case -- patent protection and data protection. 
The MODDERN Cures Act aligns patent protection and data protection at the date of FDA approval. 
Even if there is no patent protection left, the drug receives data protection.  A generic or biosimilar manufacturer cannot generally receive FDA approval to launch a competing product during that protection period.  If a competing manufacturer started clinical development of an off-patent molecule before the first manufacturer received FDA approval, then competing products could also be approved.

Can anybody pick up a potential drug and run with it, or does it have to be the company that owned the rights when it was on patent?

If it still has any patent life, an interested scientist would have to work with the patent holder on a license agreement; otherwise, scientists, please go for it!

OK, what happens when something has just a little patent time left?

The MODDERN Cures Act allows the patent clock to be reset during the development process and run from the date of FDA approval. This is a big incentive.

We know that it's going to take a lot of shots on goal to finally find some therapies for ALS.

We need for drug developers to make smart (and long) shots.  If something is sitting on a shelf with little or no patent protection, we owe it to people with ALS to make it viable for drug developers to pick up one of those oldies and shoot.

Many thanks to the folks at modernmedicines.com for their time and help.  If I got anything wrong, I'm all ears.  

Finally I think we have some clarity on what's in it for people with ALS.





1 comment:

  1. Note completion date:
    http://www.usaspending.gov/explore?tab=By+Prime+Awardee&typeofview=complete&fiscal_year=all&piid=HHSD200201141609C&pageno=2

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