Novartis / Fingolimod (FTY720) in the news again...

An interesting article...

MS Drug Prize of $1.3 Billion Spurs Merck KGaA, Novartis Race

By Naomi Kresge

Feb. 13 (Bloomberg) -- Merck KGaA and Novartis AG are racing
to market the first multiple sclerosis pill, a prize that may
generate $1.3 billion a year in sales as patients switch from
injectable drugs.

Merck and Novartis plan to ask regulators this year to
approve tablets to fight the incurable illness. Initial test data
showed that patients who took the drugs had fewer disease flare-
ups than those who received placebo or existing treatments.

A pill may mean an end to painful injections or infusions
that can cost $28,000 a year to control multiple sclerosis, which
can rob people of their mobility and leave them with chronic
aches and depression. Merck, of Darmstadt, Germany, and Novartis,
of Basel, Switzerland, are running ahead of Teva Pharmaceutical
Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the
chase for an oral treatment. The results may shake up the $6
billion multiple sclerosis market.

“It’s going to be a neck-and-neck race between Merck and
Novartis,” said Markus Mayer, a Munich-based analyst for
UniCredit SpA, after Merck released initial data last month.

The Teva, Biogen and Sanofi pills may not reach patients
before 2012, according to Jack Scannell, an analyst for Sanford
C. Bernstein Ltd. in London. Frost & Sullivan, a research company
based in New York, predicts the market for drugs to treat early
stages of multiple sclerosis may double by 2013.

Merck fell 73 cents, or 1.1 percent, to 67.37 euros in
Frankfurt trading, while Novartis shares climbed 42 centimes, or
1 percent, to 42.51 francs in Zurich.

Cancer Cases

Merck said in January that four patients were diagnosed with
cancer during the late-stage trial of its medicine, known as
cladribine. An independent monitoring board didn’t consider the
cases a safety concern because there were too few to show a
statistical significance, said Phyllis Carter, a Merck
spokeswoman.

Conceived as both a leukemia and multiple sclerosis drug,
cladribine was approved to treat the blood cancer more than 10
years ago and has been used by doctors in injected form to treat
multiple sclerosis in so-called off-label use.

Novartis has also reported two fatal infections and seven
successfully treated cases of skin cancer in patients who took
its candidate, FTY720. Final test results later in the year will
demonstrate how safe each of the medicines is.

If the tablets aren’t linked to such side effects, either
could “revolutionize treatment,” Citigroup analyst Mark Dainty
wrote in a note to clients in January. The products may generate
a total $2.6 billion in revenue in four years’ time, according to
the analyst.

Vulnerable

Merck’s existing drug Rebif, which is injected by the
patient three times a week, had revenue of 1.22 billion euros
($1.57 billion) in 2007. Rebif loses patent protection in 2012,
leaving the German drugmaker vulnerable to generic competition.
Merck reports fourth-quarter results on Feb. 18.

Rebif vies with two other so-called beta interferons, Betaseron by Bayer AG and Biogen’s Avonex, and with a fourth injected therapy, Copaxone from Sanofi and Teva. Interferons generally cut patients’ rate of flare-ups by about 25 to 30 percent, Scannell of Bernstein said. To take over the market, the oral medicines first need to overcome safety concerns.

“Concerns over cancer and opportunistic infection are the
real barriers to what could be substantial first-line use in a
multiple sclerosis market worth around $10 billion a year,”
Scannell said in a note to clients this week.

Infection Risk

Unlike interferons -- genetically produced versions of
natural proteins that suppress the entire immune system --
cladribine and FTY720 affect only certain types of cells, said
Doug Brown, research manager for the Multiple Sclerosis Society
in London who doesn’t have financial ties to either Merck or
Novartis.

The pills work by lowering the amount of immune cells in the body, leaving patients susceptible to infections, Brown said.

Long-term side effects from cladribine are unproven because
leukemia patients took the drug on a shorter-term basis than
multiple sclerosis sufferers would do, he said.

“We don’t see anything in the study that could prevent the drug from being given to patients,” said Bruno Musch, head of global clinical development unit for neurodegenerative diseases for Merck, in an interview before the preliminary results were released last month.

Emma Delahay, 30, a multiple sclerosis patient from
Canterbury, England, who started taking injected Rebif about two
and a half years ago and has since switched to Copaxone, said she
suffered side effects, including skin rashes, while she was
adjusting to the shots.

Disruptive

A pill would end the disruptive after-dinner routine of
organizing syringes, preparing her shots and choosing a new place
to inject herself every day, she said.

“Even though I can inject as part of my daily routine now, it’s still having to prepare myself,” she said. “With taking an oral therapy, it would be a second. With my injection, even though it’s not that long, it’s five or 10 minutes. It’s the preparation time, making sure my injections get stored properly.”

Merck’s study results suggest cladribine and FTY720 could be
as effective as Tysabri, the newest injected multiple sclerosis
drug from Irish drugmaker Elan Corp. and Cambridge,
Massachusetts-based Biogen Idec Inc., according to Scannell.

Tysabri has been plagued by safety concerns, with Biogen and Elan pulling the drug temporarily from the market in February 2005 after two patients died of a rare brain infection, progressive multifocal leukoencephalopathy. Five patients taking Tysabri have been diagnosed with the infection since it was reintroduced to the U.S. in 2006. One patient died.

Risk-Benefit

For patients, “it will be a case of weighing up the risk-benefit,” said Brown of the U.K. multiple sclerosis group.

“Doctors and neurologists will be weighing it up as well.”

In tests, cladribine reduced the relapse rate for the disease by more than half compared with patients given a dummy pill in a two-year study, Merck said last month.

The pills, like the injected therapies, work against so-
called relapsing-remitting multiple sclerosis, the most common
form among the estimated 2.5 million people with the disease,
according to the U.S. National Multiple Sclerosis Society.
Symptoms such as loss of vision and numbness flare up and then
subside, and the likelihood of full recovery can sink with each
attack. There is no treatment for rarer forms of the disease in
which patients experience a steady decline.

$1 Billion a Year

Merck, which isn’t affiliated with U.S. drugmaker Merck &
Co., said last fall cladribine could be its next $1 billion-a-
year seller.

In December, Novartis said patients who took its candidate, known generically as fingolimod, had 38 to 52 percent fewer attacks than those on Biogen’s Avonex.

The Novartis pill may surpass $1 billion in annual sales,
Chief Executive Officer Daniel Vasella said on a conference call
with analysts on Jan. 28.

The Swiss company made its first foray into the multiple-sclerosis market this year with Extavia, an injectable interferon identical to Bayer’s Betaseron. Extavia was introduced last month in Germany and Denmark. Extavia will be important for Novartis to gain a foothold in the multiple sclerosis market before it begins selling FTY720, Vasella said.

To contact the reporter on this story:
Naomi Kresge in Zurich at
nkresge@bloomberg.net

Last Updated: February 12, 2009 18:00 EST

Suldog: Michelle Hickman Gave Me PD!

Suldog: Michelle Hickman Gave Me PD!

For all you bloggers out there who have ever taken part in the ritual of passing around the blog awards, you have GOT to read this.

Hot beverage warning level: 10

You will be erupting in uncontrollable laughter, so be forewarned. Make sure to just drink water as it cleans off your screen with no residue. For even better results, drink Windex.

FTY720 and Bone Density

So far, throughout this trial, I have done my best to keep up on breaking news about FTY720. The worst news yet came in February 08, a year ago now, when two deaths of trial patients taking FTY720 were reported.

Other news that has been reported include the fact that it has a 50% increase in relapse reduction over Avonex, and reduction in symptoms of clinical depression in MS patients.

Data from the six-month placebo-controlled Phase II study of once-daily oral FTY720 in patients with MS found that the proportion of patients with clinical depression was significantly lower in the FTY720 groups at six months compared to placebo. Depression is a common co-morbid condition in people with MS; the presence of depression in MS may reduce adherence to disease-modifying therapy and lead to higher rates of treatment discontinuation.

This is all wonderful news!

Then, this morning, as I'm sitting here reading news online due to not being able to get my TV fix of it (help! I'm being held captive in a home with a giant TV that gets no TV signal) I come across this article:

Scientists discover key factor in controlling the breakdown of bone

The chemoattractant sphingosine-1-phosphate (S1P), which is associated with the trafficking of immune cells into and out of the lymph nodes, also caused immature osteoclasts to mobilize.

That's a mouthful, no doubt, but from what I gathered after reading that paper is that they are discovering that FTY720 can play a roll in keeping the cells that cause osteoporosis from doing their dirty deed.

Hence it may someday be used as a treatment for Osteoporosis. They are testing out their theories in mouse models. Little old mice walking with canes and trying not to fall off their exercise wheels lest they break a hip, I guess.

I am so excited about this news!!

I have bone loss due to excessive steroid use during the first 8 years of my MS since Copaxone sucked for keeping my MS under control. I can't tell you how many times I have had IVSM, but I do know that I have shrunk in height by 1.5" and that's nothing to sneeze at, lest I break something.

I'm not always so good about remembering to take my Calcium with D pills, but I have only ever missed 2 Fingolimod capsules in the past 18 months (and that's only because I went out of town on both occasions and didn't remember until I was too far away from my pill bottle).

Maybe the FTY720 might be helping my bone density, maybe not. They didn't say if it at all affected the bone density of those who damaged their bones with steroid use. At least it wasn't bad news.

Until they try out FTY720 on those mice they gave experimental allergic encephalomyelitis (EAE) (which is the mouse equivalent of MS) who have also undergone repeated treatments with steroids, I guess we'll never know.

The sound of silence or Dish Network sucks at customer service

I was sitting here pounding out that last post when all of a sudden the TV went quiet and some swearing erupted from the living room in the general vicinity of John.

"Did you pay the satellite bill???"

"um, I dunno."

"Well, until you go pay it online, it's been shut off. There's a big message on the screen."

Crap. I knew there was a bill I forgot about...and after inspecting our online account, I apparently have forgotten about it since December.

We owe $403.

There is no way I can justifying forking out $403 right this second in one big lump to pay for TV when I'm trying to scrape together the mortgage payment.

I call them up hoping to arrange maybe 1/2 now and 1/2 in 2 weeks because John (who was out of work for a whole year) just got a good job and we will be able to make that payment with his first check, expected in 2 weeks.

Nope. No dice. Bruce from Dish Network informed me that my account has been "reviewed by a supervisor and it was determined that in order to restore service, payment must be made in full."

I say "ok Bruce, then can I speak to your supervisor?"

"Well, it's a funny thing about that. I'm not authorized to transfer you to a supervisor unless you make payment in full right now. Then I would be happy to transfer you."

I said "Here's the thing about that, Bruce. When a customer is unhappy with the only arrangements the operator is authorized to provide, it is customary for the customer to ask for said operator's name and ID number and then be transferred to their supervisor in hopes of speaking with someone who DOES have authorization to make other arrangements."

He did not flinch.

"What I have read in the handbook is that I am to tell you that in order to be transferred to a supervisor, I must require you to make payment in full first."

"You're missing the WHOLE POINT, Bruce! If I COULD make payment in full, and had no reason to try and negotiate other arrangements to restore my service, then why would I even WANT to speak to the supervisor??"

"I can give you my name and Operator ID".

I took it down.

And then it dawned on me. Who am I going to complain to? He can't transfer me and the number I could call is top secret. If he told me he'd have to kill himself or be fired.

So here we sit. My keyboard has never resounded so loudly in my ears before. I've always had background noise to block it out.

The refrigerator hums louder than I remember, and the clock on the wall actually makes a ticking sound. Who knew?

Not quite "silent" but too close for my comfort level.

John, the real TV junky, is busily trying to remember how to hook up the DVD player and instructing me that I am to make a run by McD's where the Red Box is and get SOMETHING to watch.

I thought all this scraping to try and make ends meet and keeping all the bills paid and trying to stay afloat was working. I could see the light at the end of the tunnel because he had this job and everything was going to be okay....

Personally, I was brought up on a sailboat where we didn't even have electricity, much less TV. We heated, lighted and cooked with kerosene and entertained ourselves by using our imagination. I have the tools to survive and after a day of withdrawal I'm sure I'll be fine.

John on the other hand, will be a basket case in no time and THAT I'm not ready to deal with.

A happy John is worth the $403, trust me.

The one thing I hate about FTY720

I got this head cold on my birthday, Jan. 31st (I'll take belated gifts, btw). Everyone else I know that had it, got over it in a day or three.

I thought I was getting over it as well, but then it set up house in my chest, just like in those weird Mucinex commercials. I think they're hanging pictures on the walls of my lungs and everything.

I cough all night long and I'm really phlegmy (Flemish?). I never used to be like this with colds. I've always had a pretty top notch immune system that would efficiently kick a head cold's butt in 72 hours with all signs of any illness erased like it never even happened.

But since this trial I have had a LOT of upper respiratory infections. During the first winter of the study I had 6 URIs in the span of 4 months. And I read in the Informed Consent that URIs were a known side effect.

So, even though I can't say enough good things about Fingolimod, it sure sucks to have a head cold that won't go away.

Pass the Kleenex, would ya?