QDIS Blog

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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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

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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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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

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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

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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

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