November 25, 2006

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Could Pfizer’s Exubera Sales Force Quash The Inhaled Insulin

If compensation is what motivates any sales force worth its salt — whether it’s selling  prescription drugs or Ferraris — then Pfizer, Inc. (NYSE:PFE) might be facing an uphill challenge selling its Exubera inhaled insulin.

Anonymous posts on CafePharma’s message boards suggest that Pfizer’s drugs sales team isn’t motivated to sell Exubera because (if they’re to be believed) they aren’t getting paid or motivated to sell the inhaled insulin.

One supposedly anonymous Pfizer rep recently complained that Exubera “is quite possibly the worst producd launch in Pfizer history.”

Another alleged Pfizer sales rep complains that the drug sales force isn’t being compensated for the time and energy expected of them to sell Exubera:

There is NO commission for a product that we are launching. (And don’t call it bonus. If it’s based on performance, it’s a commission. That $1500 they keep waving in our face for visiting pharmacists is a “bonus”)

What a joke.

It also appears that Pfizer reps are trying to convince clinical diabetes educators (’CDEs’) that inhaled insulin will be good for their patients, but that this amounts to a lot of effort that could detract from sales of two of Pfizer’s highly profitable drugs, Celebrex and Lyrica:

According to one anonymous CafePharma poster, Pfizer’s sales of Celebrex and Lyrica “would falter if the reps continued spending endless hours with CDEs”

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November 14, 2006

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Company That Consulted For Nektar on Exubera Will Discuss Pfizer Deal

Robert P. Moran, the President of Plexus Ventures, LLC, a Philadelphia-based pharmaceutical business development consultantcy, will give a presentation focusing on Exubera at the upcoming Drug Delivery Partnerships Conference in Las Vegas.

Plexus represented Nektar Therapeutics (NASDAQ:NKTR) in the drug delivery company’s negotiations with Pfizer, Inc. (NYSE:PFE) to conclude a worldwide development and commercialization agreement for Exubera inhaled insulin. According to Plexus, major “insulin companies” weren’t interested in Nektar’s inhaled insulin technology before Pfizer came along.

Moran’s Exubera presentation is titled “Exubera®: The Improbable but Successful Collaboration between Device (Nektar) and Pill (Pfizer) Companies.”

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November 9, 2006

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Researcher: Exubera May Be Effective, But Expresses “Worrisome Concern” That Exubera May Have On Lung Function

The results of a new study by researchers at the Tufts-New England Medical Center (Meta-Analysis: “Efficacy and Safety of Inhaled Insulin Therapy in Adults with Diabetes Mellitus”) raise new questions about the safety of Exubera, the inhaled insulin developed by Pfizer, Inc. (NYSE:PFE) and Nektar Therapeutics (NASDAQ:NKTR). While researchers concluded that the diabetes drug offers an alternative treatment over injectable insulin for some diabetics, they also raised important questions about the drug’s long-term safety.

The study’s lead author, Dr. Lisa Ceglia, recently cautioned WebMD that:

For the time being, the most worrisome concern is the effect inhaled insulin may have on lung function.

Once again, the concern about Exubera’s potential long term safety risks has been on the minds of many endocrinologists and diabetics. As this latest study shows, the long-term safety of the inhaled insulin is still being questioned, even for doctors whose studies that suggest that the insulin may be effective for some patients.

This blog has continued to report on the safety concerns raised by doctor’s about Exubera’s safety. Here are just a few examples:

  • A Cleveland Clinic pulmonologist and member of the FDA’s Endocrinology and Metabolism Advisory Committee has serious concerns about the likelihood that
    “patients with undiagnosed [Chronic Obstructive Pulmonary Disease], asthma, interstitial lung disease, or lung cancer” will use Exubera.
  • A co-author of this new Tufts-NEMC Study, Dr. Anastassios Pittas, is a Boston endocrinologist who decided to take a wait-and-see approach before prescribing Pfizer’s new Exubera inhaled insulin: “I would like to see people using it for five or 10 years before I give it to my patients,” he told The Boston Globe.
  • Two N.Y.C. endocrinologists at the Oppenheimer Diabetes Conference in September had mixed feelings about prescribing Exubera for their patients. One of them, Dr. Jerome Tolbert of Cabrini Medical Center in Manhattan cautioned that doctors should not necessarily rush to prescribe Exubera, noting that the “FDA feels it is a safe drug, but we still have to be careful with this medication.” He believes that “[t]here is a niche for this drug. I will use it, but it will be on selected patients until I feel very, very comfortable about it.The other endorcrinologist, Dr. David Bloomgarden, estimated that maybe 5 - 10% of diabetics will be using Exubera in 2 years. Tolbert is not rushing to prescribe it, howoever, he said that this practice “could change’ if sees good results by diabetics using the inhaled insulin.

Readers of this blog should remember that when the FDA approved Exubera in January 2006, its approval was effectively conditioned upon Pfizer agreeing to do long-term safety research on the inhaled insulin for almost another decade.

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November 3, 2006

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Nektar’s 3Q Results: Heavy Reliance on Exubera Shown

The co-developer of Exubera inhaled insulin, Nektar Therapeutics (NASDAQ:NKTR), reported it’s Third Quarter results today. It’s clear from the regulatory filing and press release that Nektar has been, and will continue to rely, on income generated from manufacturing Exubera for Pfizer, Inc. (NYSE:PFE), as well as Pfizer’s sale of the diabetes drug.

Significant reported Nektar expenses include:

  • A $17.7 million litigation settlement with the University of Alabama at Huntsville over Exubera. The original patent lawsuit sought $197 million in damages. The university’s claims were based on one of Nektar’s founders, Dr. Milton Harris, having worked at UAB for nearly two decades where he was alleged to have developed the PEGylation technology
    that reportedly helps protect the inhaled insulin from a diabetic user’s autoimmune system that could attack the drug.
  • $16.4 million in severance ‘charges’ (i.e., pay for letting people leave the company, including executives)

Nektar’s Expected 2007 Exubera Income

Next year Nektar plans to rely heavily on income from Exubera sales to diabetics generated by Pfizer. According to regulatory filings with the SEC, Nektar expects to generate:

Total revenue for 2007 in the range of $210 to $250 million, including Exubera revenue of $110 to $130 million, with most of the estimated Exubera revenue based on estimated manufacturing sales of Exubera to Pfizer.

That’s some pretty heavy reliance on one drug. Pfizer’s numerous delays of Exubera sales in July ‘06 and again in October ‘06 have probably not helped Nektar. It certainly doesn’t seem to have helped Pfizer.

Only a month before the most recent Exubera delay announcement, Pfizer’s CEO Jeffrey Kindler spoke at a Bank of America investment conference where he told analysts, doctors, and other attendees that Pfizer’s education programs of Exubera inhaled insulin were “expanding value” for doctors, insurance companies, and patients who use the inhaled insulin.

Given the delays and ongoing Exubera safety concerns by some physicians, it appears really unclear how reliable Pfizer’s and Nektar’s predictions of drug sales are.

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Disclaimer: This blog contains news and information about Exubera inhaled insulin,
but is neither written by nor on behalf of Pfizer and Nektar Therapeutics, Exubera inhaled insulin's makers. All
trademark rights to Exubera are owned by Pfizer and/or Nektar Therapeutics, and no express or implied rights to such
are claimed by this blog.

Medical warning: No medical advice is offered by this blog. All persons reading this blog,
whether diabetic or not, must consult with their respective doctors and medical
professionals for diabetes advice and insulin treatment options. If you believe that you are experiencing a medical emergency, call 911 and/or seek medical help immediately.

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