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H1C

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H1C

Re: CannaZoid post# 4850

Thursday, 03/08/2018 1:33:34 PM

Thursday, March 08, 2018 1:33:34 PM

Post# of 18220
CannaZoid, IMUN's assets are its IP (patents and licenses) and human resources: the knowledge from and ongoing access it has to LDN's patent holders, except for Dr. Bihari, who passed away.

Look at the "Intellectual Property" section above on this page. IMUN bought or licensed most or all of the existing patents on Naltrexone's uses at a low dose (typically defined as 1.5 mg - 4.5 mg po qd, but I'm not certain on the exact wording as I haven't read the patent applications. But clinically that's the dosing range and use that defines the use of Naltrexone at a "low" dose). It also bought the existing patents on OGF/Metenkephalin's uses.

Is Lodonal chemically or physically different from generic LDN that you can get from a compounding pharmacy? I don't know, but probably not in any significant way, if the compounding pharmacy knows what it's doing.

The great advantage of Lodonal is the patent protection and ownership/licensing that IMUN has to those patents. I'm no lawyer, but I think if IMUN wanted to, it could send cease and desist letters to compounding pharmacies asking them to stop compounding Naltrexone in 1.5 mg - 4.5 mg doses. I don't think it would do that, though, simply not to alienate the existing LDN user base.

Could patients just get a Rx for regular, generic 50 mg Naltrexone and home-brew their own low doses? Sure, but in many cases I imagine they would not, simply for convenience's sake.

But here is the main benefit of patent protection: if and when Lodonal gets FDA, NHS, or EU approval for X, Y or Z indications, brand-name Lodonal, not generically compounded LDN, is what will be on the national health plans' or pharmacy benefit managers' formularies. In other words, prior to patent expiration, only brand-name Lodonal, not generically compounded LDN, is what will be paid for by health insurance or national health plans.

I also would not be surprised to see IMUN rolling out combination capsules or packages of Lodonal and MENK. That's not something that any compounding pharmacy can do.