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MannKind Corp. Message Board

  • rapp78 rapp78 Jun 25, 2013 4:28 PM Flag

    Affinity 1 fails, Afrezza still a blockbuster in 2014.

    If Affinity 1 results are negative and are currently being leaked, I believe this could create a significant buying opportunity for MNKD shares.

    Lets assume Affinity 1 proves bio-equivalence between the two inhalers, but either fails to achieve non-inferiority or achieves non-inferiority with so many hypos that the FDA fails to recognize Afrezza's clinical utility for Type 1's. Even so, MNKD could still solicit favorable partnership terms this year, obtain FDA approval for the Dreamboat inhaler in Type 2's in the spring, and be a blockbuster by 2014/15.

    All MNKD needs from Affinity 1 is bioequivalence. The success or failure of MNKD rests with the Type 2 market and the Dreamboat inhaler, not the Type 1 market. Affinity 2 is likely to exceed expectations. Titration isn’t required for Type 2s like it is for Type 1's. I will post later why Affinity 1 results may underwhelm.

    Type 2’s make up 95% of diabetics and consume over 70% of total insulin. More important, over 70% of Type 2’s don’t take insulin. It’s this group which will make up the bulk of Afrezza’s sales. IMO, the target market should be early Type 2’s, not just late stage who are failing metformin. Regardless, Afrezza doesn’t need Type 1's to be a huge success.

    Amylin was bought out for $7 billion with virtually no Type 1 product. Amylin’s three products, Byetta, Bydureon and Symlin had about $500 million in sales in 2012. Symlin, the only product out of the three that was approved for Type 1, had less than 15% of those sales. Novo’s GLP-1 product, Victoza, which has 55% of the total GLP-1 market is only approved for Type 2's. Novo has only recently started trials for Type 1's. Smart.

    MNKD is wise to release the results together as Affinity 1 may underperform, while Affinity 2 may exceed expectations. Luckily for MNKD, Type 2's make up 90% of the market and MNKD will be well equipped after August results and FDA approval to tap into that huge market, regardless of Affinity 1.

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