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MannKind Corp. Message Board

  • matese16 matese16 Apr 22, 2014 2:03 PM Flag

    Why exubera failed so miserably.....more to the story than I thought!

    Yes, I'm reading in mass, printing relevant articles, digging into any and every nook where info might be found keeping an eye on the source of the info while injecting a healthy dose of skepticism of everything I read. However, here's an except from an article written in 2007 about why exubera failed so miserably.

    "So what happened? Some blame Pfizer. The firm is struggling to replace Lipitor (atorvastatin), which loses patent protection in 2011 and accounted for $13 billion in sales last year (27% of total revenue), and observers were shocked to learn that Pfizer did not contact Nektar before issuing the Exubera news—Nektar heard it over the wire like everyone else, and that further fueled acrimony that had already spilled out previously in quarterly earnings conference calls. Others point out that Pfizer was ill-prepared to launch the product in the first place.

    “I think Pfizer felt that the drug would sell itself,” says specialty pharmaceutical analyst Jami Rubin of Morgan Stanley, in New York, who follows Nektar. Not first alerting its partner “does not speak well of Pfizer's partner-of-choice reputation,” she says. “I don't know what's happened. It could be that there's still a lot of dysfunction among the ranks of the senior management team at Pfizer.”

    The original deal between Pfizer and Nektar was signed in January 1995, three Pfizer CEOs ago. Endocrinologist Paul Norwood of the University of California at San Francisco thinks the pharma firm lost interest before Exubera was launched. “They did a poor job at marketing,” he says. “Samples were sparse, the TV ads were late, and they were too benign and not exciting.” Rubin also believes Pfizer did not chase the right market. “They did not court the nurses, the certified diabetic educators, who play an even bigger role than physicians in deciding to put patients on insulin,” she says. “They ignored them.”

    part 1 of 2

    Sentiment: Strong Buy

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    • First you had the corporate mess and lawsuit with SNY. Then you had no insurance coverage. Then the kinetics were no better than existing RAs. What did they expect. No doctor was going tp prescribe this. Then they had this little company funded by the world's greatest contributor to helping diabetics showing amazing results and a year away from approval. Once approved it would eat Pfizers lunch. Expecting Afrezza to be approved they went to the FDA and MNKD and worked a deal to put those needle phobic users on compassionate use and threw in the towel. What they did not expect was 6 more years until Affrezza being approved.

    • Thanks for posting. This was thoughtful stuff

    • part 2 of 2

      “When the product was launched at the American Diabetes Association meeting in June 2006, they didn't have the packaging facility ready in Terre Haut, Indiana, and they weren't ready to ship the product,” says specialty pharmaceutical analyst Andrew Foreman, of investment bank W.R. Hambrecht, in San Francisco. “For me, that's the most powerful evidence that within Pfizer, people who were responsible for launching this product dropped the ball because they didn't want anything to do with it.”

      It's also possible that physicians simply weren't willing to take on something new. “Most physicians are late adopters, waiting to see if someone else is using [a drug] and only then will they try it,” says Norwood. He has seven years of experience with Exubera, both in clinical trials and in use as a first-line therapy for diabetics in his private practice. “It's work to understand the mechanism of the device and the way to use it, and [the physicians] just never bothered.”

      Which brings us to the inhaler itself: the device is rather clunky—about the size of a flashlight, made larger when expanded to the ready position (see photo). The powdered insulin comes in small blister packets and the inhaler is loaded for each dose. The patient triggers a mechanism that disperses the powder into the chamber for inhalation. Although many patients embraced the technology (Box 1), some found it embarrassing to use in public—although a smaller device was in the works, the current inhaler was often compared to a marijuana bong. For that, Nektar shoulders the blame: it developed not only the powdered insulin formulation of Exubera but also the inhaler, which was an early design.

      Does Exubera's flameout mean the end for inhaled insulin? Wall Street was pleased to see the product abandoned, as Pfizer shares rose on the day of the announcement, but Rubin believes there is a market for inhaled insulin. It's “a niche opportunity,” though, and Pfizer was the wrong organization.

      Sentiment: Strong Buy

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