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JB3729

06/29/16 7:51 AM

#66255 RE: blu_1 #66241

I find it odd that Anavex was able to secure patent protection on A2-73 until 2035 after a patent on A2-73 was issued in 1997.

The PR stated -

Additional U.S. patent applications filed for pharmaceutical composition of matter for ANAVEX 2-73 will, if granted, provide further patent protection until at least 2035. An additional patent application on file for ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil, if granted, will provide protection for composition of matter until at least 2033.

It's going to be interesting to find out what these "Additional U.S. patent applications" cover.

The 8/12/15 PR -

NEW YORK, NY, August 12, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for U.S. Pat. App. No. 14/205,637 related to ANAVEX 2-73. Upon issuance, the patent will provide intellectual property (IP) protection until at least 2035. ANAVEX2-73 is the subject of an ongoing Phase 2a clinical trial for the treatment of Alzheimer’s disease.

The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.

“This patent is a valuable addition to our IP portfolio and covers innovations we have made in our development efforts for ANAVEX 2-73 and beyond,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We have filed numerous patent applications to cover promising compositions and therapies, including those pertaining to ANAVEX 2-73, in keeping with our commitment to a comprehensive IP protection strategy.”

Additional U.S. patent applications filed for pharmaceutical composition of matter for ANAVEX 2-73 will, if granted, provide further patent protection until at least 2035. An additional patent application on file for ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil, if granted, will provide protection for composition of matter until at least 2033.

The USPTO issues a Notice of Allowance after it determines that a patent should be granted for a claimed invention that is novel in comparison to all known technology in existence. Based on the timing of this Notice of Allowance, Anavex expects the patent to be issued by the end of 2015.

orveko_inc

06/29/16 8:53 AM

#66263 RE: blu_1 #66241

It is complex and there are many possible futures, but please know that no scenario exists where generic drug makers will be able to swoop in if and when A2-73 sees FDA approval.

A2-73 is currently covered by one patent as a combination therapy for the treatment of melanoma (PR'd last year). There are also several patent applications that would cover it as combination therapies for the treatment of Alzheimer's, epilepsy, and more. The patents and published applications are all public - you just need to read through the claims to discern the scope.

Bottom line: this is a developmental stage company. The science is being validated in the clinic and the IP is being validated in the patent offices.