Fim de semana é sempre assim, uma bênção. Passear no parque, ficar com meus amores, ir à igreja, não ter hora para acordar e um monte de outras atividades que surgem no meio do caminho e que eu amo. Mas passa tão rápido, que quando vejo já é domingo à noite e tenho que me preparar para segunda-feira.

A parte mais incomoda é fazer a troca de cateter da bomba de insulina. Tenho que trocar de três em três dias, e o processo às vezes é meio dolorido e chatinho. Primeiro eu devo achar um local onde vou me “furar” para ficar com o caninho. É tranqüilo depois de colocado, mas sempre tenho que levar em consideração se o local é seguro. Por exemplo, a perna é um péssimo lugar. Eu posso bater com muita facilidade e aí dói demais, além de correr o risco de me enroscar quando vou ao toiallet, no subir e baixar a “underwear”… pois é…rs, tem que pensar em tudo. Isso às vezes cansa , e dá uma saudade da insulina inalada…

Eu fiquei durante 6 anos fazendo parte do estudo da inalada, que iria se chamar Exubera. Ela chegou até ser comercializada por um tempo no Brasil, acho que por cerca de 1 ano. Entretanto, ninguém sabe e ninguém viu, proibiu. Pois é, após anos de estudo aqui e no exterior, o fabricante chegou a conclusão que este tipo de insulina não iria ser comercializada mais, pois não atingiu os objetivos esperados. Ouvi dizer que foram por questões comerciais, já que o custo dela era altíssimo, enfim o sonho de não ter que se picar mais acabou.

Glória a Deus eu tive a oportunidade de experimentar esta bênção, mas tenho que confessar que quando o estudo terminou fiquei muito muito triste, pois teria que voltar as incomodas picadas 5 vezes ao dia. Foi aí que minha médica me receitou a bomba de infusão, o que reduziria isso para apenas 1 única picada a cada três dias.. demaissss, até ver o tamanho da agulha que leva o cateter até o subcutânea da pele, mas Amém.

Vale dizer que com a inalada eu ainda me picava 1x ao dia, pois tinha que tomar a insulina lenta (que dura o dia inteiro no corpo, a Lantus). Bem, a questão é, enquanto eu não for totalmente curada por Deus, tenho que sentir ainda estas chatinhas picadas. Ele já permitiu que elas diminuíssem consideravelmente, o próximo passo agora é a cura e extinção total delas.  Vou continuar esperando e orando, pela fé chegarei lá, eu creio! Enquanto isso, eu agradeço pelos seis anos de isenção que Ele me deu desta dor, e agradeço por estes outros (até a minha cura) pela  diminuição elas.

Boa noite queridos! E que todos tenham uma semana ABENÇOADÍSSIMA!!!!

Bjus!!!

This article was sent to me by my fellow blogger, Ben who suggested that this might be an interesting article for readers. Seems so:

Pfizer Inc and said on Wednesday clinical trials of the inhaled insulin Exubera found increased cases of lung cancer, leading Nektar to stop seeking a marketing partner for the troubled product and abandon it.

I had hopes for Exubera. Did you?

According to the Indianapolis Star, Pfizer Inc. is eliminating 660 jobs at it’s plant near Terre Haute, Indiana.  This is due to poor sales of Pfizer’s inhaled insulin drug, Exubera.  Apparently this should come as no surprise to workers who have been on paid leave since production was halted in October.

Pfizer also makes the following psychotropics, or closely related drugs:  Dilantin, Navane,  and Xanax, which are not effected by the shut down.

New York, NY based Imclone (NASDAQ:IMCL) spiked 65% in 2007 on the promise of its only drug, Erbitux, which showed survival improvement in colon cancer patients when used as initial treatment, while rival drug Vectibix from Amgen, failed in a similar study. Earlier this year, raider Carl Icahn has raised its stake in Imclone and Johnson&Johnson veteran John Johnson joined as CEO.

As reported by Forbes,  the Biotech sector overall underperformed broader market indices in 2007. The NASDAQ Stock Market Biotech Index rose 5.6% while the NASDAQ composite was up 10.7% and the Dow Jones 7.2.

Along with Imclone, the big Biotech winners are Invitrogen (NASDAQ:IVGN), Gilead (NASDAQ:GILD), Millenium (NASDAQ:MLNM) and OSI (NASDAQ:OSIP). Invitrogen, based in Carlsbad, CA, is a leading supplier of Research products, including Kits for Gene Cloning. It stock went up 63% in 2007. Foster City, CA based Gilead Sciences, went up 43% on the strength of its HIV drug portfolio. Melville, NY based OSI Pharmaceuticals, went up 39% on growth of its Oncology division while still awaiting divestiture of its Ophtalmology business. Cambridge, MA based, Millenium Pharmaceuticals, rose 38% on favorable clinical results for its oncology drug Velcade.

The big Biotech losers are Amgen, Genentech, Nektar and Vertex. Thousand Oaks, CA based Amgen (NASDAQ:AMGN) went down 31% on weak sales of its flagship drug Aranesp, which experienced label restrictions from the FDA and tighter reimbursement guidelines. South San Francisco, CA based Genentech (NYSE:DNA) fell 17% after the FDA did not approve Avastin for Breast Cancer. San Carlos, CA based Nektar Therapeutics (NASDAQ:NKTR) fell 56% after Pfizer discontinued its partnership recognizing the marketing failure of  inhaled insulin drug Exubera. Cambridge, MA based Vertex Pharmaceuticals (NASDAQ:VRTX) fell 37% in 2007 as confidence in its current and future product porfolio eroded.

The New York Times has an article about Alfred E. Mann, a billionaire who has a lot of money to spend, but he’s spending it on something I think is worthwhile. Pfizer created an inhalable insulin drug called Exubura and put it on the market earlier this year. On October 18th of this year, they decided to pull it off the market, because in their words from their website:

“This decision was not based on any safety problems with Exubera. Exubera is a safe an effective medicine and the feedback we had from Exubera patients has been very ositivy. However, Pfizer has made this decision because too few patients are taking Exubera and, since there are other medicines available that lower blood sugar, Pfizer will stop providing Exubera.”

So this is unfortunate, Pfizer looking to make money as blatantly as this. However, Mr. Mann is investing in his own pharamaceutical company in the hope that they can design a better inhaled insulin drug, they’re calling it Technosphere Insulin. Unfortunately, that sounds like something out of the 80’s.

Type I diabetes (formerly called juvenile-onset), the diabetes in which insulin needs to be injected two or more times over the course of a day, needs higher amounts of insulin, due to the pancreas shutting down. Pfizer’s Exubera worked pretty well with Type II diabetes (formerly called advanced-age onset), which is where the pancreas still makes an adequate amount of insulin butthe cells of the body have developed a resistance to it. Perhaps Technosphere Insulin can do a better job. Mann’s company, MannKind, claims that it works more quickly than previous products.

One of my friends is worried that her father is going to develop complications from his Type II diabetes because he fails to stay compliant with his treatment, and with good reason. Non-compliance is one of the biggest current problems with diabetes, with potential complications leading to coma, blindness, amputations and death. Many of the patients hate the management aspect of the disease: the daily pricks on the finger, the worrying about what you’ll eat, any perceived stigma about being diabetic. Unfortunately, the risk of developing complications seems to be tied to income and educational level. More has to be done to educate the general public about it, and I’ll be going on several rants about it

Pfizer has announced that it will drop Exubera, its poorly selling inhaled insulin developed in partnership with Nektar Therapeutics. Unfortunately a tough business orientated decision was turned into something akin to an alliance manager’s worst nightmare. It seems that something went badly wrong in the communication between the partners with Nektar Therapeutics claiming that it only learned about the decision from Pfizer’s press release.

This led Morgan Stanley analyst Jami Rubin to write in a research note that she was surprised at how Pfizer delivered the news to Nektar: “Such tactics can’t be good for your ‘partner of choice’ reputation.” Other analysts, bloggers and journalists have followed Ms Rubin’s line.

So why the breakdown in communications? Pfizer’s explanation, again communicated in a press release, was that it had withheld the news from Nektar because the announcement contained material financial information related to Pfizer’s quarterly earnings. On the face of it this explanation for the lack of communication seems a bit odd. Pfizer has dozens of alliances that are financially material and the company must be making decisions about those alliances on a daily basis. Effective communication is at the very heart of managing alliances and we would hope that they have a well-developed communication strategy with partners that balances the need to keep partners in the loop with the three month reporting cycle.

Of course it is quite possible that an executive somewhere within Pfizer made a decision about managing the exit and that there was nothing that the alliance management team could do about it except watch with horror. Or it may be that the relationship between Pfizer and Nektar had broken down to such an extent that there was no communication between the parties. It happens.

Whatever facts lie behind the breakdown in communication the events do show the importance of having a well thought out exit strategy and a strategy for handling the situation where the relationship breaks down to such an extent that the parties start trading accusations in public. For instance, which journalists and bloggers do you focus on and who handles the interviews? How are other partners to be handled? Whichever way the exit and disaster strategies are formulated communicating with partners by press release is not a good strategy.

Today’s Wall Street Journal has a front page article on Pfizer’s decision to drop Exubera. It covers some of the history of Exubera development and also points out some of it’s shortcomings

The Exubera device, which some compared unflatteringly to a bong for smoking marijuana, could also be embarrassing to use in public.

“I can teach someone how to use an insulin pen in five minutes, but it would take nearly an hour to teach a patient to use inhaled insulin,” says Anastassios Pittas, an endocrinologist at Tufts-New England Medical Center.

The article also has a pointer to a (PDF) transcript of the Pfizer conference call about its 3rd quarter earnings. The Exubera part starts on page 4 of the transcript. I’m glad to see Jeff Kindler, the Pfizer CEO say:

We remain committed to finding and developing new treatments for diabetes, which is an area of enormous unmet medical need. Our R&D portfolio in this field spans the width of the diabetes disease continuum, from genetic susceptibility at birth to the onset of devastating complications. This is also an important focus for business development. In addition, we will continue to closely monitor developments in medical practice and technology as they relate to inhalation therapies and other innovative delivery systems both for insulin and for other medicines.

Despite the problems with Exubera it was a novel treatment for diabetes that might have really helped people who fail to treat their diabetes because of their fear of injections.

And while most of us hope for and work towards a cure for diabetes, it would be nice to have new treatment options while we’re waiting.

The Wall Street Journal has an excellent health blog and their article today on Exubera had this funny photo from Pharma Giles which I reproduce below without permission.

The Good Stuff:

BMS gets approval for new oncology drug (for breast cancer) Ixempra.

Merck gets new HIV drug (Isentress) approved in the U.S. And, their Januvia diabetes drug gets new uses approved.

Abraxis gets cancer drugs approved.

J&J gets Doribax (for intra-abdominal and urinary tract infections) approved.

Bayer reports upbeat MS drug results.

Glaxo: new use of HIV drug Lexiva OK’d.

The Bummers:

Say what? Viagra and other impotence drugs may be causing hearing loss??

Pfizer pulls the plug on Exubera, lets partner Nektar know after the press release.

Novartis details job cuts, and some executive shuffling at the top. They will end a contract sales force agreement with InVentiv Health as part of the pullback.

Major job cuts at struggling Boston Scientific.

J&J’s drug biz not growing as rapidly as has been typical. Here’s why.

Genentech posts “only” 22% year over year earnings growth. This is apparently considered a disappointment…

VA scraps most use of Avandia.

Byetta and acute pancreatitis: beware!

Pfizer and Wyeth report large charges in their earnings reports (buy Lilly has good numbers)

Speculation, gossip, other stuff:

Biogen hangs out a “For Sale” sign.

Pfizer jumps into Sermo, the physician networking site. Not everyone is thrilled.

Who is Pfizer going to buy up next? Genzyme? Everyone is hot on biotech acquisitions these days…

You probably have seen the news on this from other blogs. The first I read about it today was on Scott Strumello’s blog this morning.

Exubera is the inhaled insulin that Pfizer has been has been working hard to get people with diabetes to use. And I’ve always believed this would be a hard sell. There’s not enough information about the long term consequences of inhaling this very new drug. And the inhaler itself has been commonly referred to as a bong, almost from the day it was released. This is one case where getting a true design team in to think about making something acceptable for most users would have helped a lot.

Anyway, there’s a lot of news out there about this cancellation and I wanted to point out some of them. The Wall Street Journal Health Blog has several interesting posts:

• Pfizer Gives Last Rites to Exubera
• Clouds Hang Over Inhaled Insulin After Exubera’s Demise
• With Partners Like Pfizer, Nektar Needs Dummies

And Business Week published the article Pfizer’s Exubera Flop.

Despite what I thought about the delivery mechanism, I did like the idea of a novel form of diabetes treatment. We’re treating diabetes in the same way that Banting and Best did in the 1920s. Insulin is now purer and our dosing is more accurate, but otherwise not much has changed (except for Symlin/Byetta).

I do hope that this doesn’t discourage drug makers from looking at other ways to help us treat and manage our diabetes. It would be a terrible shame if this decision by Pfizer had that kind of an effect.

Pfizer Gives Last Rites to Exubera

Posted by Scott Hensley

Pfizer admitted defeat for its inhaled insulin Exubera, the first medicine of its kind, and said it’s halting sales of the drug. Hailed by the company as a convenient and needleless alternative to insulin injection, Exubera was a flop with patients and doctors.

Sales of Exubera were just $12 million this year, Pfizer said. After the drug was approved by FDA in 2006, Pfizer said it expected Exubera to become a blockbuster by 2010, with sales exceeding $1.15 billion.

The bulky inhaler (some compared it unfavorably to a bong), tricky dosing and lingering questions about side effects in the lungs hurt the product. Skepticism by insurers about the value of the pricey alternative to injections didn’t help either.

“Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted,” Pfizer CEO Jeff Kindler said in a statement about third-quarter earnings. The company “will work with physicians to transition Exubera patients to other treatment options in the next three months.”

Pfizer’s new CFO Frank D’Amelio detailed the financial damage. Pfizer, he said in the statement, will take “pre-tax charges of $2.8 billion related primarily to the write-off of assets associated with” Exubera. That’s got to make it one of the most expensive failures in pharma history. The financial hit breaks down as “$1.1 billion of intangible assets, $661 million of inventory, $454 million of fixed assets and $584 million of other exit costs.”

Earlier this year, John Buse, a president of the American Diabetes Association, told the AP: “I think Pfizer will wish they had never gotten into this. I doubt they’ll regain their investment.” He explained:”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.”

In a chat with the Health Blog at the time, Buse said his concerns were centered mostly on younger patients, whose blood sugar can be harder to control and whose lungs are more vulnerable. For these patients, Buse said, “I’m going to make it sound pretty bad: ‘A., You may have to take it for a long time and we only have three-year safety data. B. You’re going to carry this crazy thing (picture, upper left) that’s the size of a can of Coke. You’re going to be mixing packets before meals. People are going to think you’re doing drugs. Why would you do that?’ ”

Until the end, Pfizer proclaimed its confidence in Exubera, even telling analysts in January that it would bring “a full court press,” including consumer advertising, to bear in marketing the drug this year.

Nektar Therapeutics (NASDAQ:NKTR) is seeing shares hitting 52-week lows after its pharmaceutical partner Pfizer Inc. (NYSE:PFE) unexpectedly said it would end its involvement in inhaled diabetes drug Exubera and return the licensing rights to Nektar.  Nektar had been receiving a 15% royalty on sales of Exubera since early 2006.

Shares are trading down almost 15% at $6.90, well under the $7.59 lows of the last year.  This actually takes Nektar back to lows not seen since 2003.  The good news is that Nektar won’t be a biotech zombie and it has a partnered product portfolio comprising of Neulasta for neutropenia, PEGASY for Hepatitis-C, Somavert for Acromegaly, PEG-INTRON for Hepatitis-C, Macugen for age-related macular degeneration, Cimzia for Crohn’s disease, and MIRCERA for renal anemia.  It also has many other products in various trial stages.

The bad news is that this was one of the big hypes and big hopes for the company that at one point was being touted as a potential blockbuster drug (over $1 Billion in annual sales).  When the partnership first launched, Business Week had noted that inhaled insulin products could have worldwide sales of $4.8 Billion annually by 2010.  Even in late 2006 there were calls that Exubera wasn’t living up to expectations and some of the issue was blamed on the fact that physicians and patients had to be trained to use the device.  Another critical issue the cost factor, with Exubera being considered more costly than other diabetes treatments.

Analysts were not expecting Nektar to be profitable this year nor in 2008, but now you’ll likely see some strong downward revisions to forward numbers.  Without Pfizer selling this it looks like those losses are going to be worse.

Jon C. Ogg
October 18, 2007

With all of the advertising I see about Exubera I felt the need to provide a comprehensive list of all the relevant Exubera information that I could find.

Exubera: Is an inhaled Insulin that is produced by drug manufacturer Pfizer. Exubera is a fast acting insulin that can start working faster than traditional insulin injections. While it Exubera may help to eliminate the need for insulin injections. It by no means eliminates the need for insulin injects in diabetic patients.

Exubera Information:

http://www.drugs.com/exubera.html

http://www.rxlist.com/cgi/generic/exubera_ad.htm

http://www.nytimes.com/

http://medguides.medicines.org.uk

What seemed, at first, to be a terrific marketing idea ended in disaster this week, when, in the dead of night, a life-sized Hexubera “bong” was installed to replace the Leaning Tower of Pisa.

“We thought they were just putting up a banner or something,” howled Guido Marchesi, curator of the Pisa site, who thought that a promotional tie-in with another towering design fluke would bring some much-needed new revenue. “Instead, I come this morning and some massive bong has replaced my Tower. Although, I must say, my blood sugar level today seems better.”

According to N. Hale Sulin, Brand Manager for Hexubera, “Perhaps we were a bit over-the-top with this one, but hey, the dimensions were about the same for the Tower and for our delivery mechanism, and no-one can deny that the old relic needed some updating. Why not replace it with a modern example of remarkable design? Plus, we’ve got a few extra of these beasts in inventory – we’re checking with NASA now about first stage rocket needs.”

Local residents displayed a mixture of curiosity and outrage, some of them attempting to scale the massive bong in order to activate its insulin spray. After a few successes, a curious layer of snowy material covered the site, leading to a world-first insulin snowball-throwing contest.

“Wait ’til you see what the Lipitor brand manager has in mind for the LaBrea tar pits,” hinted Sulin. “We’ll be taking on that sticky cholesterol stuff once and for all…”

(credit to Pharma Giles for the idea on take-offs of the Exubera bong…)

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The Pharma Side
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