QDIS Blog

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

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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.

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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.

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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.

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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

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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.

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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

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Seems three Indian companies have already moved to copy Sanofi’s Acomplia (rimonabant) before it is even for sale in Europe and the US. The companies identified are Sun Pharmaceuticals, Torrent Pharma and Zydus Cadila.

Sanofi’s Acomplia already copied in India - paper:

It should be noted that India patent law does not require them to respect patents on drugs developed prior to 1995. The claim is that these companies are only making it for the Indian market but I find this suspect. Once sold in India, it will be hard to control its sales to other countries. This is likely what these companies are betting on. They are unlikely to go head to head with Sanofi but more likely to throw up their hands and say, we only sold to distributors in India and that they have no control over what happens after that.

Sanofi is exploring legal options but it is not likely to have many from my perspective, provided these companies do only sell in India. If they sell it into other countries they are likely to face legal disputes.

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