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pollyvonwog

01/08/16 9:31 AM

#198877 RE: DewDiligence #198875

What's your overall thoughts on the deal and partner choice?

DewDiligence

01/09/16 2:26 PM

#198918 RE: DewDiligence #198875

Re: MYL-MNTA partnership /no Avastin FoB

The MYL-MNTA FoB partnership evidently does not include an Avastin FoB. (If the MYL-MNTA partnership did include Avastin, the companies would presumably have disclosed this insofar as MNTA previously revealed that they had completed early process-development work for an Avastin FoB codenamed M511.)

MYL-MNTA’s decision to ignore Avastin is a good one from a business standpoint, IMO. Why? Because Avastin is an infused drug that is purchased by hospitals and clinics rather than being purchased by patients at retail pharmacies.

If MNTA’s proprietary reverse-engineering technology increases the likelihood of obtaining FDA interchangeable status for their FoBs—as MNTA asserts and MYL presumably believes—then MYL-MNTA should develop FoBs for biologics that are purchased at retail pharmacies, where automatic substitution by the pharmacist is a powerful lever. On the other hand, for hospital- or clinic-administered drugs, the hospital/clinic will likely have an exclusive contract with the branded-drug supplier or one of the FoB suppliers, so interchangeable FoB status won't mean much in practice.