"“We have lent a huge amount of money to the U.S. Of course we are concerned about the safety of our assets. To be honest, I am definitely a little worried.” "

Chinese premier Wen Jiabao 12th March 2009

""We have a financial system that is run by private shareholders, managed by private institutions, and we'd like to do our best to preserve that system."

Timothy Geithner US Secretary of the Treasury, previously President of the Federal Reserve Bank of New York.1/3/2009

Wednesday, March 28, 2007

Pfizer's Exubera inhaled insulin another dog for Pfizer

Exubera is an innovative inhaled insulin technology introduced by Pfizer which has been available for the last 6 months. An rDNA insulin isomerized on 3/4 micron glass microparticles, is inhaled using the rather large EXUBERA® Inhaler (pic ) delivery device which could easily be mistaken for Austin Powers' penis pump. You can find more about it at their website and see the video with the mind boggling requirements for cleaning the device.

The prinicipal advantage is said to be to overcome resistance to using hypodermic injections ( a condition medicalized as "needle-phobia") required by Type 1 Diabetics and seriously developed Type II Diabetes. Exubera provides only fast acting relief, say before a meal and not the long term relief which is increasingly the aim of treatment to reduce the need for injections. Before launch Pfizer were telling Wall Street that Exubera "could" ultimately bring in US$2Bn annual sales. "The general consensus among analysts is that Exubera is likely to be a blockbuster" Businessweek Feb 2006.

Sales are dire. Pfizer are said to have spent US$1 BN introducing the product (Pfizer won't disclose Exubera's development costs ) and worldwide sales are in the low US$millions. Merrill Lynch are telling investors there are les than 2 thousand continuing prescriptions nationwide. Sales are not helped by Dr. John Buse, president-elect of the American Diabetes Association, who participated in Exubera's trials who has said "There is no advantage to Exubera and there may be a safety risk. I see it as my job to talk people out of (using) it." He adds the unwelcome news for investors ..""I think Pfizer will wish they had never gotten into this. I doubt they'll regain their investment," This site exubera-risks.com provides a year long tale of problems with the drug.

Pfizer needs more blockbusters. Its best-selling drug ever, the anti cholesterol agent Lipitor, loses patent protection in 2010 and development of its successor drug (torcetrapib / atorvastatin, known as torcetrapib) was scrapped last year because of safety problems (the shares dropped 11% overnight) , also their blockbuster antidepressant Zoloft lost its patent protection.

Developed with Nektar (Pfizer paid $1.4 billion to acquire rights to the device in 2006) and produce the product in a brand new US$160 Mn. plant at Terre Haute.IN, where they have so far built up nearly $800 million in Exubera inventory this year and, will have over $1.5 billion in inventory by the end of this year. Exubera was introduced last September and no sales were reported by Pfizer. Insurers don't necessarily believe Pfizer have demonstrated Exubera's value or usefulness. Well Point the US's largest health insurer estimates that Exubera costs 11 percent more than one popular brand of injected insulin (Lilly) List price of US$122 to US $140 monthly)- currently they place it in the highest tier and require co-pay (where the client pasy part of the costs) , depending on the plan.. Patients need to buy a kit which includes the device but then also need to regularly purchase blister packs and release units, which help create the mist.

On top of the consumer resistance , doctors are also concerned about potential long-term side effects from constantly inhaling the powder into patients' lungs. Pfizer has two years of data showing the drug is safe, but doctors want to see results from longer-term and larger studies. Faced with the poor results so far Exubera will be relaunched to doctors in April it will be handed over to Pfizer's cardiovascular (CV) sales force supported by a massive Direct to Consumer (DTC)ad campaign.... which some in the industry see as a last desperate throw of the dice.

Eli Lilly, the world's largest supplier of injected insulin are also working on an inhaled insulin product but it won't be on the market until 2010 at the earliest. They still have to overcome the basic problem of any such device because if the inability of an inhaled insulin product to provide and exact dose. However Lilly's new long lasting diabetic drug Byetta (exenatide) -- which patients inject twice a day - has seen take up world wide and has not met resistance from needle-phobic patients.

Irrational Exubera

New drug technology has to produce a breakthrough in treatment outcomes.

1. Pfizer has to show that the switch from injected to inhaled insulin produces an improvement in compliance -- patients keeping to their dose regime leading to significant improvements in their health.

2. Pfizer have to produce evidence that any potential improvement in compliance will be sufficiently significant to overcome concerns about long term complications of lung damage.

3. Pfizer have to show value by reducing diabetes-related complications in use - not in studies.

4. Pfizer have,somehow to justify the extra costs over the proven methods of direct injection.

5. The device is clumsy, large and imprecise in use.... they are working on that and newer version is due real soon.

Whilst Exubera is available in the UK, uptake appears to be extremely modest. For people diagnosed Type II, Janet Ruhl a fellow and articulate patient has a useful website without ads !
About Diabetes is a very helpful site with a useful e-mail newsletter.


Anonymous said...

"The world is giving us more "cheap options", and options benefit principally from uncertainty. So I am particularly optimistic about medical cures. To the dismay of many planners, there is an acceleration of the random element in medicine putting the impact of discoveries in a class of Mandelbrotian power-law style payoffs. It is compounded by another effect: exposure to serendipity. People are starting to realize that a considerable component of the gravy in medical discoveries is coming from the "fringes", people finding what they are not exactly looking for. It is not just that hypertension drugs lead to Viagra, angiogenesis drugs lead to the treatment of macular degeneration, tuberculosis drugs treat depression and Parkinson's disease, etc., but that even discoveries that we claim to come from research are themselves highly accidental, the result of tinkering narrated ex post and dressed up as design. The high rate of failure should be sufficiently convincing of the lack of effectiveness of design.

But if the success rate is very low, the more we search, the more likely we are to find things "by accident", outside the original plan — or the more an unspecified original "plan" is likely to succeed. Looking at the swelling pipeline, something tells me that the discovery of cures, or near-cures for unspecified diseases is about to happen — except that I do not know which one, nor do I know where it is coming from. More technically, I see the sign of fractal randomness in these payoffs from the fact that results are more linear to the number of investments than they are to quantities invested — thus favoring the multiplication of small bets.

All the while institutional science is largely driven by causal certainties, or the illusion of the ability to grasp these certainties; stochastic tinkering does not have easy acceptance. Yet we are increasingly learning to practice it without knowing — thanks to overconfident entrepreneurs, naive investors, greedy investment bankers, and aggressive venture capitalists brought together by the free-market system.
" by Nassim Nicholas Taleb

Anonymous said...

...which in my day they used to call "bucket chemistry" .. what would happen if ... ?

Or if a graduate with some pretensions it was called the "empirical approach".

Anonymous said...

Anon 3:54 - "bucket chemistry" - I think his critique is that combi-chem is luck ... if the med-chems new what they were doing they'd do the screening in silico and just make one molecule. Further, 'cos its getting cheaper to do combi-chem/bucket chem the chance of getting a hit increases ... sorta like the price of the lottery tickets falling year on year (and hence buying more) but the jackpot staying the same.

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