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More News on Biogenerics Medical News

Ed Vawter — Mon, 04 Aug 2008 19:55:27 +0000

After being away for sometime for a variety of reasons including a pinched nerve in my neck, I’m finally back and hoping to post to this blog several times a week, although I doubt I will be able to get back to posting daily due to work and other issues.

I did find the following article I found recently interesting as it talks about differences in Congress regarding biogenerics.

AMNews: Aug. 11, 2008. Disagreements slow progress on biogenerics legislation … American Medical News:

I think the point about the period of exclusivity is a valid point and where I think the the greatest debate will occur. While it may take a while to get compromise I think something will indeed happen on this front in the next year. It may not be a great bill but at least it will be something
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E.U. raids Major Drug Companies

Ed Vawter — Thu, 17 Jan 2008 23:00:54 +0000

Wow! I read today that the EU performed raids on almost all the major drug companies on Wednesday. This includes Pfizer, Sanofi-Aventis, GlaxoSmithhKline, Astrazeneca, Merck, and Johnson & Johnson.

E.U. raids drug companies in broad inquiry

The authorities are looking for evidence of abuse of patents and illegal deals to keep cheaper generics off the market. Here is a quote form the article.

The raids will help establish if companies created barriers to competitors, whether they misused patent rights or engaged in “vexatious litigation” and if some firms abused their dominance of the market.

It will be interesting to see what comes of this if anything. I’ll but we don’t hear anything else about this for months but I’ll certainly be keeping my eyes open for further information.
Technorati Tags: GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Sanofi-Aventis

PBS Frontline: The Medicated Child

Ed Vawter — Tue, 15 Jan 2008 21:22:56 +0000

I Tivo’ed Frontline’s “The Medicated Child” recently and finally got around to watching it the other night. This is a follow up from an episode they did on this back in 2001. You can watch and read about it online. It was somewhat disturbing at parts especially when they mentioned a young child who was on several atypical anti-psychotics at the age of four! Here are some of the interesting points brought up:

1. There has been a 4,000% increase in diagnosis of psychiatric problems in young children over the last ten years

2. Although doctors do not agree about bipolar in young children many kids are being diagnosed as being bipolar at ages as young as four years old.

3. There is a growing number of strip mall places offering “brain scans” looking at blood flow to the brain to give a diagnosis. The company featured was co-founded by a social worker and she was the one featured giving the family the diagnosis of the problem. To me this edges on the verge of giving medical advice but not being a medical doctor.

4. In one case they highlighted it was teachers who told the parents their child had ADHD. I know teachers and I do not envy their job but I think suggesting an actual diagnosis is inappropriate.

5. Another big problem mentioned only in passing on the program was that many of these children are being treated by family pediatricians and not by child psychiatrists.

I’m not always a fan of highlighting individual cases which may or may not be typical. However, these do pull on our heart strings and it does highlight how desperate these families become when dealing with “the problem child”. I truly feel for these parents who are trying everything to help their child but nothing seems to work. Just take a look at the discussion page and read what some of these folks have gone through. This situation is what leads to some of these snake oil salesmen mentioned in point 3 above.

Part of the problem is the whole quick fix attitude especially in the US and the resulting expectation (re-inforced by the pharmaceutical industry) that a few pills can solve all your problems. I have always believed that in the case of mental issues that medication and therapy together are much more beneficial than drugs along.

I really liked the program and highly recommend it. You can watch it for free online and they also have lot of information and further interviews with experts here. There is also a Parents Guide.

I personally look forward to the day when we can run a blood test or do a brain scan and come up with a definitive diagnosis and be able to confidently prescribe medications that will solve the problem >90% of the time. Unfortunately, I don’t know if this will occur in my lifetime. This is one situation where I truly hope I am wrong.

Technorati Tags: medicated child

Spending on marketing vs R&D

Ed Vawter — Tue, 15 Jan 2008 19:17:19 +0000

The subject of pharma spending on R&D versus Marketing is one that comes up frequently. Recently FierceBiotech has had an article on this.

Drug industry spends nearly twice as much on marketing than on research and development - FierceBiotech - Biotechnology Articles, Biotech Industry News, FDA Approval News:

Here is the link to the PLoS Medicine journal they refer to.

PLoS Medicine - The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States

It makes for some interesting reading. I personally think that there tends to be a discussion more on what should or should not be included as “marketing expenses” and the big picture tends to get overlooked. Maybe this is the tactic that is being used to avoid talking about the real issue.

The article does a good job I feel of at least explaining how they came up with their numbers. I’m sure there will be debate on what they decided to include and some of their assumptions but the very fact that it confirms the suspicions of the public will mean it will be readily accepted.

Their figure is $57.5 billion spent on promotion or 24.4% of every dollar versus $31.5 billion for R&D or 13.4%. THis means there is almost twice as much (1.8 actually) spent on promotion over R&D.

Here is the conclusion from that article.

From this new estimate, it appears that pharmaceutical companies spend almost twice as much on promotion as they do on R&D. These numbers clearly show how promotion predominates over R&D in the pharmaceutical industry, contrary to the industry’s claim. While the amount spent on promotion is not in itself a confirmation of Kefauver’s depiction of the pharmaceutical industry, it confirms the public image of a marketing-driven industry and provides an important argument to petition in favor of transforming the workings of the industry in the direction of more research and less promotion.

The article make the point that according to their figures the industry spends twice as much on promotion as it does on R&D. This will be controversial since it is counter to the common claim made by the pharmaceutical industry and confirms some of the perceptions of the man on the street.

I personally feel and have stated here several times that the industry as a whole does not seem to take seriously the perceptions on the street and the industry’s very actions taken to counter some of these perceptions only serves to reinforce some of those negative images out there. The industry seems to forget that perception matters and can be very damaging.

Technorati Tags: drug cost, drug marketing

Dr. Jarvik, Lipitor and Ethics

Ed Vawter — Thu, 10 Jan 2008 19:49:50 +0000

This is the kind of stuff that gives the pharma industry a bad name. I’ve long had a problem with some of those on the marketing side who see

Congress questions Jarvik’s Lipitor lip service, credentials as part of celebrity-pitch probe - International
Herald Tribune:

I think the pharma industry needs to think about the “ethical” part of the name ethical pharmaceuticals, a term that isn’t used much anymore (maybe for good reason). I personally feel too many large pharma marketing departments are run by “soap and toothpaste” marketers who don’t understand (or don’t want to understand) the impact of what they are putting out there in terms of advertisements.

I feel there is too much emphasis on stretching the envelope of what is permissible and try to see what they can get away with and not enough focus on the perception of the drug industry in the eyes of the person on the street.

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin

Ed Vawter — Thu, 03 Jan 2008 05:08:42 +0000

Here is the first of what I am sure will be plenty of approvable letter from the FDA this year. Pfizer received an approvable letter for dalbavancin, a once weekly two dose antibiotic useful for methicillin resistant bacteria. Note that this drug came to Pfizer by way of their acquisition of Vicuron.

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

Technorati Tags: dalbavancin, FDA, Pfizer

Review of Important Items from Sept 17-30

Ed Vawter — Thu, 04 Oct 2007 15:00:48 +0000

Here are a few of the important articles from the last couple of weeks.

Glaxo set to axe staff as crisis hits drug - Telegraph
Generic Biotech Drugs Won’t Be in U.S. Legislation Bloomberg.com: News
The Scientist : New patent rules hurt biotech?
Chemical & Engineering News: Government & Policy - Patent Reform Inches Ahead
AstraZeneca to outsource manufacturing - Times Online
AstraZeneca To Outsource Drug Manufacturing - Contract Pharma
StockHouse.com : Encysive Pharmaceuticals Receives Written Response From FDA On
Cephalon warns over pain drug deaths| Reuters
PharmaLive: Adverse Drug Events Reported to FDA Appear to Have Increased Markedly
Sanofi-Aventis Developing New Drugs: Financial News - Yahoo!
Finance
House Passes Bill to Improve Drug Safety: Financial News - Yahoo!
Finance
Senate OKs FDA drug safety bill - washingtonpost.com
Many drugs slip through regulatory ‘black hole’ - CNN.com
Bristol-Myers to buy partner Adnexus for $430 million”>SignOnSanDiego.com >
Warning issued on Cephalon painkiller | Philadelphia Inquirer | 09/27/2007

My overall observations is that there are many factors influencing the pharma industry today and these are not likely to less anytime in the near future. It would be nice to see more positive articles but those seem to be hard to come by in the current environment.

Technorati Tags: Adnexus, AstraZeneca, Bristol-Myers Squibb, Cephalon, Encysive, FDA, Glaxo, GlaxoSmithKline, Sanofi-Aventis

PDL up for sale

Ed Vawter — Wed, 03 Oct 2007 19:20:59 +0000

Looks like PDL Biophrma after going through some tough times and laying-off people is finally up for sale. Here are just some of the articles recently.

PDL to lay off 250, sell four drugs, shift focus - San Francisco Business Times
PDL BioPharma up for sale - Examiner.com
San Jose Mercury News - PDL for sale; CEO quits
San Jose Mercury News - PDL BioPharma’s investors urge company’s sale, executive ousters

This is case from my perspective of poor management which went on for quite a while until finally the major investors forced the ouster of the top two officers. Now it seems that the company’s only real option is to put themselves up for sale.

This will be interesting to watch and I’m not sure how it will shake out. The latest rumors are that Roche may be interested in PDL, but they have refused to comment.

Roche declines comment on PDL BioPharma deal rumours, analysts see …

Other Resources

News
Yahoo! News Search Results for pdl biopharma
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Google Blog Search: pdl biopharma
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pdl biopharma: Blogs, Photos, Videos and more on Technorati

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Encysive, the FDA and the Dispute Resolution Process

Ed Vawter — Sat, 08 Sep 2007 22:58:32 +0000

Forbes recently had an article on fighting the FDA.

You Can’t Fight The FDA - Forbes.com

I have been watching this drama play out for sometime now and for me it is like watching a train wreck. You know what’s going to happen, you know it isn’t going to be pretty but there’s nothing you can do to stop it from happening. I’m not sure I understand Encysive’s rational for going through this dispute resolution process as it seemed doomed from the start.

Eye on FDA mentioned this in the Weekly Roundup - 9-7-07 and had a great article on this situation earlier: Eye on FDA: What’s at Stake with Formal Dispute Resolution

No Generic biologics in FDA legislation

Ed Vawter — Fri, 07 Sep 2007 21:36:26 +0000

Reuters is reporting that the new FDA legislation is unlikely to have any biogenerics in it.

UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters

I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress on how and when they will implement some kind of program.

Here is the key from my perspective.

The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

I realize that biologics are not like standard drugs in terms of generics but really think that until Congress demands that the FDA come up with some sort of plan, nothing will move forward. It is too bad that Europe will be the one taking the forefront in this movement. As an example, EMEA just approved a follow-on for EPO for Sandoz, Novartis’ generics division.

Sandoz Receives European Commission Approval for biosimilar epoetin alfa

I know there will be a lot of lobbying of Congress on this issue but think that regardless there needs to be some sort of plan put forward. Just trying to delay and avoid the issue is only going to cause more public relations problems for biotech in the future.

Other Recent Stories Related to Biogenerics

Biotech firms will soon lose patent protection - Sep. 5, 2007
Lawmakers Offer U.S. Plan for Generic Biotech Drugs
RED HERRING | Going Generic
Follow-on biologics ‘not substitutable’, says BIO
Biopharmaceuticals | Follow-on Biologics: Friend or Foe? | Pharmaceutical Manufacturing
Patent Baristas » Senate Committee Approves Follow-On Biologics Bill: Fear and Trepidation Follow
Biologics Price Competition and Innovation Act of 2007 (S. 1695)

Technorati Tags: biogenerics, biosimilars, FDA, follow-on biologics

More on Mergers

Ed Vawter — Fri, 07 Sep 2007 21:36:02 +0000

I’m not going to comment on these other than to say the merger mania continues. Here are some recent headlines.

PharmaLive: Shareholders Approve Peptech-EvoGenix Merger :
PharmaLive: Ametek Acquires Cameca SAS
PharmaLive: GeoPharma Announces Shareholder Approval of Merger with Dynamic Health Products
Meda AB to Buy MedPointe Pharmaceuticals for $800 Million in Cash, Stock - News, Search Jobs, Events

Technorati Tags: pharma M&A, pharmaceutical deals

Amgen cutting costs as key anemia drug sales fall

Ed Vawter — Mon, 20 Aug 2007 23:31:03 +0000

Amgen is now cutting jobs too and there have been several articles regarding this.

Amgen cutting costs as key anemia drug sales fall: Financial News - Yahoo!
Finance
Hometown feeling Amgen’s pain - Los Angeles Times
Amgen to Cut Up to 2,600 Jobs - washingtonpost.com
Amgen slows its Bay Area expansion - San Francisco Business Times

I’ve seen numbers up to $1 billion savings total. I’ve said it before and I’ll say it again, I think a lot of this is due to the blockbuster mentality which, while it may be changing slightly in big pharma, hasn’t changed at all for the big biotechs.

I think both big pharma and emerging biotech need to look at multiple products in the hundreds of million rather than swinging for the fences with every single drug.

Technorati Tags: Amgen

Major Job Cuts in Big Pharma

Ed Vawter — Mon, 06 Aug 2007 16:33:05 +0000

I’ve been talking about this for a while and there is finally an AP story outlining all the big pharma job cuts.

Drug Industry Sees Big Job Cuts: Financial News - Yahoo! Finance
Here is a summary:

Johnson and Johnson 4,800
Pfizer 10,000
Merck 7,000
AstraZeneca 7,600
Schering-Plough 1,100
Bristol-Myers Squibb unspecified but likely several thousand

All of these were announced last year accept for Merck and Schering-Plough.

Here is one of the more interesting quotes from this article.

Analyst Steve Brozak of WBB Securities says Wall Street is partly to blame.

By unrealistically demanding the same double-digit profit growth the industry produced through the 1990s, big investors are forcing pharmaceutical companies to scuttle external research partnerships, then reduce head count and other expenses, Brozak said.

“You’re seeing senior VPs … eliminated at these companies,” replaced by junior people with less savvy but half the salary, he said.

While I do agree with the unrealistic demands of Wall Street, I also think that big pharma did not do a good job of explaining to Wall Street the future and are responsible for allowing these unrealistic expectations to continue.

I don’t agree with the part of seeing senior VP’s losing their jobs. I’ve not actually seen that as most of the people I’ve known or heard about are at most middle management but mainly what I refer to as “workers bees” those that actually are doing the work.

And this isn’t going to improve anytime soon. The years 2010 and 2011 are going to be crucial as many blockbuster drugs come off patent including Liptor, Effexor XR, Pavix, and Zyprexa.

The article goes on to say some firms are still seeing demand but I bet if you look into the demand are from small companies and will not offset the large number of layoffs at big pharma.

Also there have been more small companies having trouble getting their drugs approved and some of them are having layoffs too although not to the same scale as the ones above. Overall it is not going to be a good time for the industry for the next five years at least.
Technorati Tags: AstraZeneca, Bristol-Myers Squibb, Johnson & Johnson, layoffs, Merck, Pfizer, job cuts, Schering-Plough

Big Pharma Job Cuts

Ed Vawter — Fri, 03 Aug 2007 23:03:16 +0000

There seems to be another round of lay-offs downsizing or whatever else they are calling it now in the pharmaceutical industry.

Johnson & Johnson Plans to Cut 4,800 Jobs - New York Times
J&J restructuring to cut up to 4,820 jobs
Alza to cut 600 jobs, exit Mountain View HQ: Financial News - Yahoo! Finance

J&J is concerned about their blockbusters expiring and declining use of drug stents. This is another reason in my opinion to get away from the blockbuster approach. This is about 4% of their total world-wide workforce.

Alza is part of J&J and will close the Mountain View CA site and laying off 600 workers there.

AstraZeneca to cut a further 4,600 jobs as costs keep rising - Independent Online Edition
AstraZeneca to slash 7,600 jobs as profits fall - Yahoo! News

AZ is cutting due to slow sales of Nexium now that it is off patent. Sales of this drug was over $5.7 billion in 2005. Again another example of the downside to the blockbuster mentality.

EATG :: Anadys to cut jobs, end hepatitis B drug development

Anadys is cutting jobs due to the discontinued development of ANA380 a drug for hepatitis B. It was in phase II and it seems they are cutting staff early considering they still have two other drug candidates. normally this happens with phase III failures and when companies only have one real drug candidate in their pipeline. Anadys is cutting 33% of their workforce!

This brings to a total of more than 12,500 jobs lost for just this last week.

Technorati Tags: Alza, Anadys, AstraZeneca, Johnson & Johnson, AN380

Mergers & Acquisitions and Deals

Ed Vawter — Fri, 03 Aug 2007 18:06:16 +0000

I’m trying to get caught up on a lot of stuff since taking a few days of to visit family and friends. Here are some of the stories recently regarding mergers & acquisitions as well as deals.

PharmaLive: SurModics Acquires Brookwood Pharmaceuticals

Surmodics is a drug delivery company and Brookwood is also in the same drug delivery area but has experience in long acting injectable drugs. THis seems on the surface to make sense but I’ve not dug into enough to give further opinion.

Merck to buy NovaCardia: SignOnSanDiego.com
PharmaLive: Merck & Co., Inc. to Acquire NovaCardia, Inc., to Boost Clinical Pipeline of Cardiovascular Drug Candidates

Merck wants to add to its cardiovascular drug line and so is acquiring NovaCardia for its lead candidate KW-3902 for treatment of acute congestive heart failure. THe price of $350 million seems cheap if the drug lives up to all its expectations. NovaCardia had planned on an IPE and raising an estimated $86 million but Merck got to them before the IPO could happen.

Glaxo, Targacept sign $1.5 billion nicotine drug deal: SignOnSanDiego.com

Glaxo wants to get into the nicotine derived drug business by doing a deal with Targacept. It should be noted that Targacept came out of the tobacco industry in an effort to see if products derived from tobacco could serve as drugs. This area has had its share of both positive and negative results. Pfizer recently had their smoking cessation product Chantix approved. Targacept also as a deal for an Alzheimer drug deal with AstraZeneca.

Overall, I don’t expect the M&A activity or dealing making to cool of any time soon.

Technorati Tags: Brookwood Pharmaceuticals, Glaxo, GlaxoSmithKline, Merck, NovaCardia, Targacept, Surmodics

Big Pharma and YouTube

Ed Vawter — Wed, 25 Jul 2007 18:14:46 +0000

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

Encysive To Evaluate Options

Ed Vawter — Fri, 20 Jul 2007 06:20:22 +0000

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

FDA Issues Third Approvable Letter to Encysive for Thelin

Ed Vawter — Mon, 09 Jul 2007 17:50:38 +0000

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

Allos’ Brain Cancer Drug Fails Phase 3 Trials

Ed Vawter — Mon, 09 Jul 2007 17:37:35 +0000

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

Novartis in a deal with Intercell for $366 million

Ed Vawter — Mon, 09 Jul 2007 16:08:11 +0000

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

Sanofi Withdraws Obesity Pill from FDA Consideration

Ed Vawter — Fri, 06 Jul 2007 20:31:27 +0000

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

Amgen to purchase Ilypsa for $420 mln

Ed Vawter — Tue, 26 Jun 2007 05:58:04 +0000

Amgen is the latest to get into the merger mania and has offerd $420 million for Ilypsa.

Amgen to pay $420 mln cash for Ilypsa - MarketWatch

Amgen wants access to Ilypsa’a ILY101 a drug for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on hemodialysis.

Here is the press release.

Technorati Tags: Amgen, hyperphosphatemia, ILY101, Ilypsa

Amgen to Acquire Alantos

Ed Vawter — Mon, 25 Jun 2007 23:08:28 +0000

Amgen has another merger in process, now with Alantos for $300 million.

RED HERRING | Amgen to Acquire Alantos:

Now they also are purchasing Ilpysa which I posted about recently. Altantos has a phase II drug for diabetes a somewhat crowded market. I personally think they may have overpiad for what they get.

I find it interesting that now even the biotechs are getting into the acquisition mania. It wouldn’t surprise me if Genetech starts on a buying binge just to keep pace.

Technorati Tags: Amgen, Ilypsa, Alantos

Dr. Reddy’s To Market Generic Ambien

Ed Vawter — Sat, 16 Jun 2007 17:15:58 +0000

Since I use Ambien on occasion it was good to hear Dr. Reddy’s Lab is no approved to sell generic Ambien.

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, Sanofi-Aventis, zolpidem tartrate

Biotech drugs contribute heavily to Big Pharma sales

Ed Vawter — Sat, 02 Jun 2007 23:56:03 +0000

CNN Money had an article back in late May that discusses how the major pharma companies are becoming more like biotechs.

Biotech drugs contribute heavily to Big Pharma sales - May. 29, 2007:

This isn’t too surprising if you consider the fact that biologic drugs have no generic competition. It only makes good business sense to be looking at products have a much longer life-cycle. In 100 years or so, I think it will be difficult to differentiate biotech from pharm in the way we think of them today. I don’t think the small molecule discovery and development will ever go away but I do think you will see budget decisions geared more towards the development of biologicals.

Dendreon will delay Provenge, cuts jobs

Ed Vawter — Tue, 29 May 2007 23:27:12 +0000

Dendreon hit a major snag last week when the FDA declined to approve the drug without further data. THese are somewhat misleadingly called “approvable letters. For more on approvable letters see What Do Approvable Letters Mean? from Mark over at Ee on FDA.

Dendreon will delay Provenge, cuts jobs:

This led to a major drop in stock price and Denreon announcing it will lay off 400 workers mainly those geared towards commercialization of Provenge. If things go well, the company said it could launch the drug as soon as 2008 but it could be as late as 2010.

What is surprising in this case is the the advisory committee unanimously voted (17-0 on safety and 13-4 on efficiency) to approve the drug and it is rare that the agency would then not approve it. Looks like the FDA may be getting more cautious or has access to information that wasn’t know to the committee.

For another look at this see Eye on FDA: Dendreon Gets Complete Response Letter

Technorati Tags: Dendreon, Provenge

AMRI Acquires Manufacturing Facilities in India

Ed Vawter — Tue, 29 May 2007 14:54:50 +0000

Contract Pharma has an article on Albany Molecular purchasing manufacturing facilities in India.

AMRI Acquires Manufacturing Facilities in India - Contract Pharma

What is surprising to me is how little they paid for it; $11 million for these assets which earned $5 million in revenue last year!

It is interesting that some contract manufacturers are buying facilities in India to get access to cheap labor and that Indian companies are buying European and North American companies for name recognition and established clients.

Avandia and Heart Risk

Ed Vawter — Fri, 25 May 2007 22:34:30 +0000

Avandia, the diabetes drug has been in the news quite a bit recently due to it possibly raising the risk of heart attack.

UPDATE 1-EU agency says already aware of Avandia heart risk
| Reuters

FDA study said to show Avandia risk - Yahoo! News

While I appreciate the information, I think it is interesting to note that the well respected cardiologist Steve Nissen is again involved in this. He was one of the key folks involved in the Vioxx analysis that showed it increased the risk of heart attack.

I can’t help but wonder though if you are a cardiologist and you are looking for cardiac events, if you night not be predisposed to finding such events. I’m not saying that is what happened but it struck me that we all view life through our own experiences and this creates a sort of lens through which we interpret life’s events.

for mre on this story look at some of the links I have listed below. Don’t trust me, read what others are saying and come to your own conclusions.

Other Resources

Yahoo! News Search Results for Avandia
Avandia - Google News
Blog Results

Google Blog Search: Avandia
avandia - IceRocket Tag
Individual Blogs
More Avandia, And More on Marketing. In the Pipeline: (great discussion on that blog on this)
‘Round the Sphere: Health Care Renewal Rebuffed by In the Pipeline on Avandia
Health Care Renewal: Expanded Avandia Story Now Echoes Familiar Themes

Technorati Tags: Avandia, GlaxoSmithKline, Steven Nissen