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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

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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

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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

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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

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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

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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

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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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