Replies to post #410943 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

NO because it was probably mixed to begin with.

[Doc328]

If a drug is already approved for an indication, there is an abbreviated pathway for a closely related drug to be approved. Rather than starting from scratch a related drug, one of the enantiomer (levoblarcamesine or dextroblarcamesine) has a short cut if the racemic drug, (regular blarcamesine) is already approved. So for sake of argument, let's assume blarcamesine gets approved for AD. Then, anytime later, Anavex can apply to get levo- or dextro-blarc approved with a 505(b)(2) application. They do not have to prove that the enantiomer workss in a large phase 3. Instead they can do a bridge study --- sometimes just a PK/PD fasting/fed study and other times a biomarker study. This costs 1 MM instead of 50MM and can be done in a few months at a single site. Assuming consistent data and good manufacturing data, the drug will be approved. Then the enantiomer has exclusivity for the longer of 3 years (regulatory) or the remainder of the Orange book listed enantiomer patent life (Intellectual/legal exclusivity). Generally, if the enantiomer is felt to be truly superior, the company will go for approval a few years after the first drug is approved and if fairly equivalent they will do this 12-18 month before the iroginal drug loses exclusivity.

Although the simple study is all that is required, if the enantiomer is felt to superior, the company may run a phase 3 equivalent study. As an example of the abbreviated path, Vumerity was approved for relapsing forms of MS with the 505(b)(2) pathway based on the two large Tecfidera phase 3's and a PK equivalency study on an empty stomach and with various calorie meals and alcohol (no trouble getting volunteers). However, knowing that equivalancey was not going to lead to much sales, Alkermes also did a phase 3 study comparing GI side effects for patients taking either Tecfidera or Vumerity and they showed Vumerity was better tolerated. Because Vumerity had a lot odf years remaining on the patient they received 13 years of exclusivity (rather than just the regulatory 3). Biogen then bought the drug from Alkermes. You can see the advantages of a modified (in the case of Vumerity) or an enantiomer (for blarcamesine) as part of drug life-cycle strategies.