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?

Just to clarify...

The last post about being "Ticked Off" about others getting compensation was incorrect. They aren't getting compensated but reimbursed for gas money. Money's money and I haven't gotten any tho.

But I do want all you money-getting FingoHeads to know that I'm not now, nor have I ever been, ticked at you guys!! How could I possibly be ticked at the inner circle of my MS circle of friends?? We've come too far and shared too much to do anything but sit around the bonfire of our syringes aflame and sing "Kumbaya".

It's big Pharma I'm ticked at. They know who they are, and they read this blog.

"Equal pay (i.e. gas reimbursement) for everyone, I say!! Have you no soul?" said in my best protest-leading, bra-burning voice. (oh wait, that was a whole 'nother thing.)

Ticked Off

I guess I need one of these things because I'm really ticked off.

I'm not a greedy person. Well, okay, when it comes to trail mix I don't like to share much, but I'm not the gold digger type.

Without going into a lot of detail (because the yahoo group is private and it would defeat the purpose of said group to blab all the private stuff here, on my public blog) it's really been an eye opener for us all to compare notes.

Seems quite a few trial participants are getting monetary reimbursement for their participation, while others of us are not.

Not only am I not getting paid, I'm not getting gas money and I have to drive 4 hours round trip. They didn't even bother to offer gas money the one time I had to return right after my last visit because they screwed up my blood draw and had to redo it.

Okay, okay, I'm trying to calm myself down by remembering the reason I'm in the study at all...

To further the advancement toward finding a cure, or at least finding an oral drug for all of MS kind.

And to sell you a bridge...

Okay, I admit, I'm in it to get the good stuff and get to my happy place where my symptoms are so mild I can go back to my perpetual state of denial.

But when I'm sitting here broke and hearing the discussion of payment for involvement, I'm starting to think maybe I can cough up a pair of cajones next time I'm in Jacksonville and squeak out a soft plea for compensatory privileges.

Not only am I not getting paid...neither are any of the places doing the testing on me, apparently, because I am "over 30 days past due" on my last eye exam, and I just got a bill for the excision of my mole that Novartis insisted was my "pound of flesh" to part with if I wanted to stay in the extension study.

One nice lady from the University of Florida's collection department called last week to discuss the bill. I told her, in my most exasperated tone, that they bill me EVERY TIME for the eye exam and I always remind them that I am a study patient and the Research Department is supposed to be billed.

I gave her the contact names, phone numbers and the study number. She thanked me and told me she was sorry and that they would straighten it out. I told her they always say that.

I also told her that I have enough legitimate reasons for bad credit without them trying to help send my credit score into the negative numbers. She did laugh.

I laughed too. It's either that or cry. It's all worth it when I pop that pill every morning and remember what I felt like a couple years ago. You can't put a price on feeling good...

unless they start charging me for the pills.

How about this?

Can't go wrong with a shot of my own pill bottle and some cropped in actual pills now can I?

No more frilly froo froo. I took the bows out of my hair and got down to brass tacks...or Fingolimod Pills ... or whatever.

I figured I couldn't find any design more fitting that an actual photo of the pills, unless I stuck one of me on the "& Me" side of the page, but that ain't gonna happen.

That last poll is over. Now vote on the new one. And be nice...it's 2 days after my birthday. (I'm milkin' it.)

Happy Ground Hog Day

I think they say he saw his shadow and judging from the NON-Florida like weather outside my back door (in N. FL I might add) I think that's probably true.

Try explaining to a 10-year-old kid with a 147 IQ why a bunch of grownups would gather to let a caged ground hog out long enough to torture him before a crowd by holding him up and trying to determine if he sees his own shadow.

He wanted to know if it was a scientific fact that, if the animal did indeed see it's shadow, would we then have 6 more weeks of winter based solely on that evidence?

It's hard to tell a 10-year-old (who so looks up to adults as those to which he should aspire to emulate) that the aforementioned adults are all idiots who carry on a stupid tradition that makes absolutely no sense. His faith in humankind is faltering. Welcome to reality. People do stupid stuff, I tell him.

Life lesson learned.

Ground Hog day follows my birthday (a much more important day in my humble opinion) by two days.

I have my birthday on that day all the special offers from the end of the previous year expire. (Offer good until January 31st.)

It was a day like any other. My son was sick but I had only discovered this after keeping my granddaughter overnight. So I spent Saturday morning making sure they didn't get near each other and much hand washing and cough covering ensued.

I sat here at the computer for part of the day, wasting time (as evidenced by the number of "meh" votes on the new look). Then, after a boring day of being 48, I ended it all with a grand finale. I got a major sore throat.

Technically it was Feb. 1st by then as I awoke in the middle of the night with the horrible affliction after also having spent the previous hours immediately prior to the discovery sleeping with my mouth open. Oh. My. GOD. It hurt so bad I thought it would just crack and bleed.

Spent Sunday taking Motrin and bathing my throat in Cepacol while lounging on the couch and occasionally tending to my sick son as well. Oooooo! I can't take all this excitement.

While laying on the couch, I spent a tiny bit of time reminiscing about birthdays past.

It was 10 years ago to the day on my b-day that I got the most horrible stomach flu I've ever had. High fever, dizzy, vomiting, the works. I remember crawling from the toilet to the bed and collapsing. I laid there promising God anything he wanted if he'd just make it go away.

A few days after that I started itching at the base of my skull. It was a deep down itch that couldn't be satiated by scratching on the surface. It drove me nuts and I tried everything to make it go away. Itch cream, ice packs....and a heating pad. Found out later that the heating pad was probably the worst idea, for the reason I was itching was because I was suffering my first MS attack.

Within a week of the itching, I awoke with numb feet. At first I tried to blow it off, thinking maybe it was just a pinched nerve or something.

Within another week I was numb up to my waist and every step I took felt like I was slogging through mud. I got an appointment with a neuro and was soon admitted to the hospital and undergoing all the terrible, scary testing that every MS patient is familiar with.

Let me tell you, that nerve conduction study (where they juck you with 2 needles and hook you up to a car battery) can be quite painful when performed by a novice nurse who has no clue and keeps cranking up the volume in an apparent effort to see the electricity lines around me like a cartoon character, while I flail and smoke comes out my ears.

Anyhow.... I was put on high dose steroids (IVSM) and sent home after 4 days with a diagnosis of Transverse Myelitis.

As we all know, MS, by definition, has to be "Multiple" so it would be another month before my second attack and my official MS diagnosis.

A decade of change. In some ways it's like nothing is any different and I'm still basically me. In other ways, I have changed dramatically since that 38th birthday.

The only birthday I had that was worse than that one was my 18th, 30 years ago. I went outside on my birthday and called my kitty, Sunshine, an orange tabby who was everything in the world to me.

She didn't come. I ventured out farther to see if I could find her and I did. Lying in the road, flattened by traffic.

I cried all day that day.

Most people say that the birthdays that end in "0" suck. I'm starting to believe the ones that end in "8" aren't so hot in my case.

************************************

Geeze! I just re-read all that and what a downer, eh? I'm really not as mournfully depressed as that made me out to be. How about I tell a joke to end this by putting a smile on your face?

It's one my son made up:

Q. Why did the one chicken goad the other into crossing the road?

A. He wanted to "egg" him on.

Give him a break already, would ya?? He's 10 for cryin' out loud.

Ok...how about this guy then?






Go have a great day and quit worrying about me and my stupid sucky birthday. :D