Friday, July 27, 2007

PharmaFraud comments on Pharmalyst among others

Thanks to Dr. Peter Rost's blog, I just became aware an interesting blog called PharmaFraud. S/he has written a rather interesting and provocative rant about some pharmablogs. About the PharmaBlogosphere s/he comments that

"Same stories as every other Blogger, shameless self promotion, a lot of stories are just copied and pasted from other sites, questionable knowledge of the Pharma Industry, would sell-out to Big Pharma in a second."

Then he proceeds to rate PharmaGossip, BrandweekNRX and Pharmalyst as "A small step above Pharmablogosphere".

To Jim Edwards (of BrandweekNRX) and Insider (of PharmaGossip): Pharmalyst is honored to be lumped together with your blogs. As for the other charges leveled, I would like to address each one of them here.
  • Shameless self promotion: Guilty as charged. I guess self promotion is always one of the many sub-conscious motivating factors influencing any blogger....and that includes you PharmaFraud.
  • Questionable knowledge of the Pharma Industry: Guilty as charged. As this post from Pharmalyst indicates, the purpose of writing this blog is to learn more about the industry through comments and e-mail from readers (many of who appear to be from the industry and have graciously shared their insights via comments and e-mails)
  • Would sell out to big-pharma in a second: You betcha. From the same post as above, Pharmalyst wants to work in business analytics or finance related fields in the pharma industry. When you have the loans and commitments that Pharmalyst has, you would sell out to big-pharma in a second. And what about you PharmaFraud? Looks like you were selling out to big-pharma till you got your gag orders and (hopefully soon) some settlement monies.....

Pharmalyst thinks that there may be a grain of truth in PharmaFraud's rant on all blogs but blogging is inherently about linking, commenting etc. Pharmalyst was also curious as to why s/he reviewed Pharmalyst and not other fine and more knowledgeable blogs like PharmaGiles, In Vivo, Pharma's Cutting Edge, Clin Psy etc etc

What about the rest of PharmaFraud's blog? Pharmalyst read a few posts and here is Pharmalyst's take.....hey everyone can be a critic sometimes...

PharmaFraud looks like a pharma insider who probably used work in the business development or wholesaler management or some such department of a big pharma (J&J or Pfizer perhaps). Looks like s/he departed after some serious litigation which is still ongoing and there is a lot of pent up angst and frustration that is all bottled up and waiting to come out. As for the posts themselves, looks like PharmaFraud is not above 'cutting and pasting' as this posting shows. Many of the other posts (like this one) appear to be a bit rambling and lack fact it almost appears that PharmaFocus knows of so much and hence knows so many problems that s/he doesn't know where to strike first. Also while some posts have lots of inner workings of the industry that people like Pharmalyst enjoy reading, many others seem to be pure vendetta (understandable given PharmaFraud's apparent situation). Most of PharmaFraud's attempts at humor also fall flat in the eyes of Pharmalyst - s/he is no PharmaGiles or PharmaGossip.

All that being said, PharmaFraud is an interesting blog that Pharmalyst will follow (and hopefully will get better once some of PharmaFraud's angst & rage subsides as whatever litigation s/he is involved in unwinds).

Alcohol addiction market

With regard to Pharmalyst's previous post regarding news articles pertaining to the use of Chantix for treating alcohol addiction market, a reader e-mails that

"my initial hypothesis is that it is a huge market that looks very attractive (large numbers etc), but that the market will be very, very challenging to commercialize. Compare the people who buy smoking cessation drugs (by choice, out of pocket) to the people who would need anti-alcoholism drugs. These patient groups are very different, leading to very different market dynamics. So I do not think the alcoholism market would be 1/4 of the smoking cessation market, even if the patient numbers give that break. If anyone could 'create the market', I suppose Pfizer could."

S/he then proceeds to note that the launch of Vivitrol by Cephalon has not followed a great trajectory. Does anyone have any further thoughts on this market? If so please comment or e-mail Pharmalyst. Many thanks in advance.

Thursday, July 19, 2007

Earnings Season

While Pharmalyst has been sampling some fine Aussie products like the ones shown, big pharma earnings season is in full swing. J&J & Novartis tempered their outlook while Abbott handily beat the street. Abbott seems to be riding the Humira wave and presumably their pipeline has other gushers or else they will be in a Pfizer like situation.

The big news appeared to be Pfizer's poor earnings. The extent of the decline of Lipitor's US sales surprised some. Time for Pfizer to move beyond Lipitor (they appear to be doing so if their new measure of earnings for non-patent expiry products per this post from Dr. Peter Rost is any indication). Dr. Rost also raises the issue of Lipitor channel stuffing by Pfizer.

Pharmalyst tries to listen in on all the analyst call webcasts and did listen in on the Pfizer call day before yesterday. Many of the analyst questions were precisely regarding this issue. Unlikely that Pfizer did any channel stuffing like BMS though sure looks like they may have indirectly & unintentionally forced wholesalers to buy more by their price increase schedules etc (some analysts were asking questions around this yesterday). In any case Pfizer clearly disclosed the impact of the channel inventory in both Q1 and Q2 earnings releases and their vice chairman David Shedlarz indicated during the call yesterday that lower inventories may be a hint of wholesaler's expectations of future Lipitor sales. Can't get any clearer than that and so they can hardly be accused of channel stuffing like BMS.

Rivaroxaban, Apixaban - Meeting unmet needs and prospects (parts 2 and 3)

Pharmalyst had previously posted re oral factor Xa inhibitors. Pharmalyst had promised readers parts 2 & 3 outlining unmet needs in this market and the prospects for Rivaroxaban and Apixaban - two molecules in this class. While googling this topic, Pharmalyst found this presentation from Dr. C Michael Gibson of Harvard U which pretty much covers the above. Selected excerpts are here:...These have been removed as the site does not allow posting of the slides/excerpts. However readers can follow the link above to view the presentation.

Wednesday, July 11, 2007

Erratic posting warning

Pharmalyst is heading down under for a few days. Erratic posting ahead mates!

Making of a quiet blockbuster - New Indications?

Some of you may have read Pharmalyst's previous posts regarding the prospects of Chantix, Pfizer's drug for smoking cessation. Now ABC news and others are reporting on a new study that offers the possibility, that this could be used to treat alcohol addiction as well... and perhaps other types of addiction too.

How big could the alcohol addiction market be? Pretty big (though not as big as the smoking market). According to this source, there were an estimated 12 million alcoholics in the US in 1993. That is roughly one fourth of the number of smokers....presumably this alcohol addiction market size will be a fourth of the smoking cessation market? Though the number of alcoholics is fewer than the number of smokers, Pharmalyst thinks that the % of alcoholics who want to try Chantix will be higher than the % of smokers.....This of course supposes that the product is effective in treating alcohol addiction and that is a big if.

PAH drug pricing - update

Pharmalyst had previously posted about the wide range in the pricing of PAH drugs approved currently (summarized below).

Thanks to all the comments and some direct feedback via e-mail, there is better clarity on the issue. Here is a synopsis:

1. Flolan: Well worth its 100,000K+ costs. It is very effective and very inconvenient (frequent infusions, injection site pain etc). This class of drugs is the only deal for stage IV PAH patients.

2. Letaris & Tracleer: Comparably priced at 40K plus. Effective but has liver tox issues and needs frequent monitoring. Letaris claims much lower liver tox than Tracleer. Is effective in patients with stage II and stage III PAH.

3. Revatio: Cost wise, it can not be more than Viagra (since Revatio is same as Viagra). Common dosing is 20mg three times a day. At Viagra's cost of $8 per pill it works to approximately 10K per year. Also many physicians want to use higher doses. However safety at much higher doses and over much longer periods of time under chronic use conditions has not been studied. Suitability in more advanced stages of PAH has also not been studied.

Consensus Opinion: Revatio will be the initial choice for phase I patients. Phase II and III patients will probably use Revatio and Letaris in combination therapy. However if long term safety of Revatio in chronic and high dose setting is established, it will capture more share from Letaris and could be used as monotherapy in Phase II and Phase III patients. Other PDE 5 drugs like Cialis are also doing studies for PAH.

Monday, July 9, 2007

Lovenox's rear view mirror - "Warning: Objects are closer than they appear?"

Pharmalyst's previous post on June 30th had mentioned that Bayer/J&J's Rivaroxaban could be a looming threat to Sanofi's LMWH Lovenox (which had 06 sales of almost 3 billion Euros)

Today we read from this Reuters article that:

Bayer's blood-clot drug beats Lovenox in key study

"Sunday July 8, 3:41 am ET By Ben Hirschler LONDON (Reuters) - Bayer AG's (XETRA:BAYG.DE - News) experimental pill rivaroxaban is significantly more effective than standard injections of Lovenox in preventing blood clots after knee surgery, researchers said on Sunday.

new class of oral anticoagulants to market.

Results of a large Phase III trial showed only 9.6 percent of patients given rivaroxaban experienced venous thromboembolism (VTE), or blood clots, following total knee replacement against 18.9 percent of those on Sanofi-Aventis SA's (Paris:SASY.PA - News) Lovenox.

Major life-threatening VTE occurred in 1 percent of rivaroxaban patients against 2.6 percent for the Lovenox group."

BMS/Pfizer also had encouraging news on Apixaban. According to CNN Money:

Bristol-Pfizer anti-clotting drug clears hurdle

"July 8 2007: 7:58 AM EDT

NEW YORK (Reuters) -- An experimental anti-clotting medicine from Bristol-Myers Squibb Co. and Pfizer Inc. met its main effectiveness and safety goals in a mid-stage study, researchers said Sunday, positioning it as a future option over current popular but problematic drugs.

Patients treated with apixaban, a pill, had comparable rates in two main measures to those on the standard of care - an injected therapy plus one drug from the class that includes the widely used warfarin. The measures included rates of blood clots and dangerous bleedings."