QDIS Blog

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
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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.

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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
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