QDIS Blog

I came across this article recently and found it thought provoking. Seems many drug industry critics are taking to YouTube to get their message out.

Big Pharma on YouTube - not a pretty picture | Trusted.MD Network:

The main video talked about in the article is one from a former Lilly sales rep who talks about what he was told to say in regard to side effects of the drug Zyprexia.

There is also a set of trailers for thr documentary “Big Bucks Big Pharma”.

Big Pharma Big Bucks pt.1
Big Pharma Big Bucks pt. 2
Big Bucks Big Pharma pt 3
Big Pharma Big Bucks 4
Big Pharma Big Bucks pt 5
Big Bucks Big Pharma 6
Big Bucks, Big Pharma Extra: Drug Costs and PR

A search of YouTube for “big pharma” comes up with 86 entries. While I didn’t watch them all, the vast majority are negative towards big pharma and all seem to get four to five stars (out of five possible)

Here is one of my favorties.

This parody of a drug commercials is humorous and well written. However, I think some people may not know the fact that it is required by law to list any and all these side effects.

I should note that I have spent my entire career of over 15 year in the pharmaceutical industry both a big pharma, at smaller companies, and biotechs. Big pharma has done a poor job of educating people about what they do and when they do come out fighting it tends to be defensive and in modes of communication that lead people to dislike them and their brand.

Another disturbing trend in my mind ids the development of vanity products for non-life threatening conditions such as wrinkles, erectile dysfunction, etc. while areas such as he development of new antibiotics is not pursued. There is good work going on in the are of anti-cancer drugs but the reason for that is the perceived lower bar to getting a drug for cancer approved.

Keep in mind pharmaceutical companies are a business and are there to make a profit. I don’t always agree with the industry’s approach I do think they serve a vital need within our society and provide great benefit to humankind. My other objection to some of the critics is they usually do not have an alternative plan that is feasible.

I think there is more wrong with the healthcare system than just the drug industry. We need to look at the whole system instead of just attacking what is an easy target.

Other Resources

big pharma - Google Video (146 entries)
Yahoo! Video search for big pharma (20 entries)
Video Search Results - big pharma - AOL Video (102 entries)
EveryZing - big pharma (162 entries)

Note many of these may be identical but it gives you an idea of the number of videos.

Technorati Tags: big pharma, YouTube

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Encysive has brought in Morgan Stanley to evaluate options. Let me translate that. They are going to be up for sale but they need to slash expenditures to make them look better.

Morgan Stanley to help Encysive evaluate options - Houston Business Journal
Here’s the interesting quote from this article.

Encysive (NASDAQ: ENCY) said it will give no more information about its review of alternatives until it agrees to a transaction, and added that there was no guarantee an alternative would be pursued.

This sort of attitude along with insisting on a formal resolution dispute I think says a lot about the companies approach. I think they will have a hard time finding suitors and if anyone is interested, it will likely be for pennies on the dollar.

Take a look at the stock price recently.

Looking at Encysive in Google trends reveals some interesting points.

There were more searches in Switzerland related to Encysive than there were in the US. Here’s why.

Thelin would go up against Allschwil, Switzerland-based Actelion Ltd.’s Tracleer (bosentan), the only approved endothelin agonist for PAH, which won clearance in Europe four years ago and was cleared in the U.S. in November 2001.

from Bioworld

I’m not sure what will happen but I can guarantee it isn’t going to be good. There will be no phoenix rising from the ashes.

Other Resources

encysive - Yahoo! Search Results
encysive - Google Search
encysive - Google Blog Search
IceRocket Blog Search: encysive
Yahoo! News Search Results for encysive
encysive - Google News

Technorati Tags: Encysive

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Encysive may have set a new record for the number of approvable letters for one single product. Recently the FDA gave them their THIRD approvable letter for the product Thelin (sitaxsentan sodium)

Press Release: FDA Issues Third Approvable Letter for Thelin - FierceBiotech:

TheStreet.com has an insightful article on this.

How Encysive Botched the FDA Game

I won’t recount the history since TheStreet.com article does an excellent job. I think companies need to keep in mind that demanding a formal review after all that has happened seems desperate at best and bull0headed at worst.

This failure has led Encysive to have massive lay-offs.

Encysive to lay off most of U.S. employees
Encysive slashing 150 jobs
If you want to listen to the companies webcast on this it can be found here.

Other Resources

encysive thelin - Yahoo! Search Results
encysive thelin - Google Search
encysive thelin - Google News
Yahoo! News Search Results for encysive thelin
Google Blog Search: encysive thelin
IceRocket Blog Search: encysive thelin

Technorati Tags: Encysive, sitaxsentan sodium, Thelin

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Allos had a disappointing failure in phase III for efaproxyn for treatment of brain cancer that originated from breast cancer.

Allos’ Brain Cancer Drug Flops in Phase 3 - Health - RedOrbit:

In typical upbeat company fashion, they said they were disappointed but immediately started proclaiming their pipeline and how promising it is. This seems to be very common these days. I know there is the need to proclaim \the positive and negate the negatives but it seems to be out of balance in many of these sorts of press releases.

Technorati Tags: Allos

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Novartis has done a deal with Intercell an Austrian company for access to one of their vaccines. It is for IC31 against influenza.

Chemical & Engineering News: Latest News - Novartis expands its vaccines portfolio through a sweeping $366 million deal with Intercell:

Novartis actually has an article on this on their website now.

Novartis and leading research organizations join forces to fight Dengue fever

Intercell has an intersting portfolio. They have two candidates; one for Japanese Encephalitis which has completed phase III studies and another one that is not specifically listed on their website. They also have several preclinical vaccines under development the most interesting of which is to prevent traveler’s diarrhea

Intervcell also has the announcement:

Intercell and Novartis form world-leading strategic partnership to drive vaccines innovation

The interesting parts are quoted below.

Alliance creates opportunity for two strong innovators to combine development efforts in attractive areas
Intercell to receive upfront payment of € 270 ($ 360) million in upfront payments and equity investment granting Novartis option to non-partnered vaccine candidates and 4.8 million new shares
Pipeline to benefit from Novartis Vaccines’ phase III development capabilities and commercial strength
Exclusive Partnership for IC31® in influenza vaccines

Summary of Transaction Highlights:

€ 120 ($160) million upfront license and option fees
€ 150 million ($200) cash contribution through subscription of of 4.8 million new shares, allowing Intercell to maintain full strategic flexibility. This will increase Novartis’ equity stake from 6.1% current to 16.2% - without any controlling rights. The new shares will be issued at a price of € 31.25 ($ 41,8) per share. This represents a 30% premium to the last closing price.
An exclusive license for development of Intercell’s IC31® adjuvant in novel influenza vaccines with milestones up to approx. € 100 ($ 134) million during the development period and double-digit royalty rates tied to sales performance. In addition, Intercell will receive € 30 to € 60 ($ 40 -$ 80) million during the development period in upfront and milestones plus up to high single-digit royalties, tied to sales performance for each future license for IC31® in selected areas.
Intercell retains the right at its election either to profit-share with Novartis on, or to receive potential milestones of € 120 ($ 150) million after Phase II for the remaining development period and solid double-digit royalties tied to sales-performance, for each product for which Novartis opts in.

i do believe that if a couple fo these vaccines are successful then Novartis is likely to gobble up the rest of the company.
Other Resources

Novartis Intercell - Google News
Yahoo! News Search Results for Novartis Intercell

Google Blog Search: Novartis Intercell
IceRocket Blog Search: Novartis Intercell

Technorati Tags: Novartis, Intercell, vaccine

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Faced with an advisory panel that unanimously had safety concerns, Sanofi has decided to withdrawal their NDA for Accomplia (rimonabant).

Sanofi Withdraws Obesity Pill From FDA - Forbes.com:

Sanofi stated they had plans to resubmit the NDA at “a later date”. It should also be noted that Sanofi plans to use the name Zimulti in the US.

It will be interesting to keep an eye on this. I have my own doubts that it will ever get approved in the US.

Technorati Tags: Acomplia, Zimulti, Rimonabant, Sanofi, Sanofi-Aventis

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