Replies to post #113557 on Biotech Values

[tinkershaw]

http://www.in-thought.com/resources/GilenyaSurvey.WK.16Nov.pdf

Here is a detailed piece put out a few months ago as to anticipated mareket for Gilenya. Survey indicated that only 14% of patients are right for first line Gilenya use. These are patients that would probably go straight to tysabri or other aggressive treatment up-front anyways.

From this analysis, until more safety data is gathered (probably 3-5 years at least I would think). Report predicts $1.5 billion in sales in 2017. I don't know the cost, but using $25K per year, per patient (which is on the cheap end compared to tysabri for example) equals 60,000 patients on the drug in 2017, which would equate to about 9000 copaxone patients lost to Gilenya in that year.

It should be noted, that these patients may have been lost to tysabri or other medication anyways if they were not responding well to copaxone.

I was a bit more concerned about this myself, and the analysis can still be totally wrong and Gilenya just take over the entire market, but the drug had some serious safety issues in its clinical trials that were concerning, particularly at its more effective dosage. It does not seem to be associated with PML though, last I looked.

But that is the best information that I have on the issue. I've brought up the issue, if Teva successfully defends its patents, and MNTA can only launch copaxone in 2014-2015, what might be left for it? I like having time on my side, and since I am very confident MNTA will get copaxone approval at some point, time we do have on our side (unless copaxone fades materially away over time). It seems the chances are very high that copaxone will still be a front line drug, and in fact may grow stronger with a generic on the market, at least through the next 5-7 years.

If Teva successfully defends it patents, then that would give Teva the chance to put its new version of copaxone on the market as an alaternative, but since that is nothing more than a different dosage methodology, a generic copaxone should eat its lunch as insurance is going to be wary of paying a premium for something you can get in a cheaper generic. So time has consequences, and leave Teva with an opportunity still if they can delay things long enough.

Nevertheless, a good sized copaxone market should exist at least until MNTA can get its generic on the market, and the copaxone market will continue to grow in both users and price increases until that time. Lets give Teva credit for that!

Tinker

[jq1234]

Himalayan Fungus Boosts Mitsubishi Tanabe Sales With MS Drug Gilenya

Tetsuro Fujita’s eureka moment about a Himalayan fungus in 1985 may mean part of a $5 billion payout for Mitsubishi Tanabe Pharma Corp. a quarter-century later.

While the scientist drove over a bridge between Japan’s Shikoku and Honshu islands on his way to take up a research post for traditional herbal remedies, Fujita realized the fungus, used in a Chinese medicinal soup, must be suppressing the immune system of the insects on which it grew.

His research at Kyoto University not only helped yield Gilenya, a new treatment for multiple sclerosis -- the debilitating condition afflicting more than 2 million people worldwide -- it also promises to bring Mitsubishi Tanabe its biggest money earner. Annual sales of the pill, the first for the autoimmune disease, may exceed $5 billion, UBS AG said.

http://www.bloomberg.com/news/2011-02-02/himalayan-fungus-aids-mitsubishi-tanabe-sales-with-multiple-sclerosis-drug.html

Larva Invader

With the help of another researcher, Fujita partnered with Yoshitomi Pharmaceutical Industries Ltd. and Taito Co., now respectively part of Mitsubishi Tanabe and Mitsui Sugar Co. The scientists began studying in 1986 the Cordyceps fungus known in Chinese and Japanese as “winter insect, summer plant,” so called because it invades insect larva during winter and grows out of the host by summer.

Fujita said he was inspired by the discovery of ciclosporin, also derived from a fungus, which spurred research into how the immune system may be subdued in transplant patients. Fujita, now a professor emeritus at Kyoto University, said he was unaware the immune-modulating properties of Cordyceps could eventually help multiple sclerosis patients.

“I knew from reading the Chinese medicinal encyclopedia that the fungus feeds off the larva, lives in a symbiotic relationship for a year, and comes out of the ground in summer by growing out of the carcass,” he said. “That made me think the fungus must be suppressing the larva’s immune response.”

Centuries-Old Remedy

Used as an herbal remedy for centuries, the fungus contains an insoluble, toxic compound called myriocin, said Kenji Chiba, who worked on the project at Yoshitomi. It took scientists at least three more years before they could modify the compound into a usable form, creating fingolimod, or Gilenya.

Novartis licensed the overseas rights to fingolimod from Mitsubishi Tanabe in 1997.

“Although it took a quarter of a century, I’m happy it’s become a drug while I’m still alive,” Fujita said. “It makes me happy that something I did is making others happy.”

[jq1234]

Nice chart. See this first time. Tysabri has increasingly become last resort MS drug, probably will stay that way.

[DewDiligence]

New Gilenya data from AAN:

http://finance.yahoo.com/news/Novartis-Therapy-Gilenya-prnews-3945400636.html?x=0&.v=1

[investorgold2002]

GILENYA & Copaxone

thanks dew again for your message

try below...it says Gilenya can ramp up to 1.5 bill by 2017 if no safety issues are found in the next few years. I guess Gilenya can take marketshare from copaxone as well as the infereons...But as you pointed out due it's safety and the fact it's been in market for more than a decade now, there is really no threat to Copaxone

http://www.in-thought.com/resources/GilenyaSurvey.WK.16Nov.pdf


Then I found the below

http://www.msworld.org/forum/showthread.php?t=110680

"There hasn't been a head to head study with these 2 DMDs to date that I'm aware of. I've always heard that Copaxone and Avonex have similar efficacy rates. Gilenya was 50% more effective in reducing relapses in a head to head trial with Avonex.
"

so i guess it's the safety(risk/benefit) which gives copaxone an edge ?