Isis Developing New IBD Medication

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The Rock
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Date Joined Nov 2014
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   Posted 1/5/2015 11:41 PM (GMT -6)   
Isis Pharmaceuticals will get $35 million upfront and potentially nearly $800 million more and royalties in a collaboration with Janssen Biotech to develop Isis' first orally active drugs.

Carlsbad's Isis will develop drugs to treat autoimmune diseases of the gut under the deal, announced Monday. The company is eligible to get nearly $800 million more in milestone payments and license fees. It will also get royalties averaging in the double digits for any products that reach the market.

Read more: http://m.utsandiego.com/news/2015/jan/05/isis-janssen-biotetch/

DMC2011
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Date Joined Jul 2011
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   Posted 1/5/2015 11:49 PM (GMT -6)   
Yay!
Left sided dx. 2011
Current med: Apriso 4 a day
Cortenema
Canasa 2 a day
Budesonide 2/day
Vsl 3 packet 1 a day
Quit LDN until I feel better/flu symptoms

Supplements: on hold
Diet: no lactose, low fat, no uncooked veggies, No honey or HFCS!! Low gluten

xy123
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   Posted 1/6/2015 12:47 AM (GMT -6)   
http://ir.isispharm.com/phoenix.zhtml?c=222170&p=irol-newsArticle&id=2002820
http://ir.isispharm.com/phoenix.zhtml?c=222170&p=irol-newsArticle&id=1289685&highlight=

Red_34
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Date Joined Apr 2004
Total Posts : 23551
   Posted 1/6/2015 7:18 AM (GMT -6)   
At first I thought you were referring to the terrorist cell! I was really confused lol
SHERRY
Moderator-Allergies/Asthma, Alzheimer's, IBS, Co-moderator-UC
Diagnosed Left sided UC '92 - meds: Apriso, Remicade (6mp discontinued due to neuropathy)*Unable to tolerate ALL mesalamines*, IBS, Diverticuliar Disease, Fibro, Sacroiilitis, Raynauds, OA, PA, Rosacea, Psoriasis, Dry Eye and allergies controlled by Zyrtec and Singular

bania
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Date Joined Dec 2003
Total Posts : 642
   Posted 1/6/2015 8:26 AM (GMT -6)   
Yeah, they really should think about changing their company name. This business deal is huge for all of us. It is a direct response to Celgene's mongersen drug - an oral antisense medication that in a phase II had a Crohn's remission rate of 65% in just two weeks! Janssen rightly sees that as a threat to three of its products - Remicade (Crohn's, UC), Simponi (UC), and Stelara (soon to be Crohn's). So it made this deal with Isis to develop its own antisense medications. Will Abbvie (maker of Humira) have to do the same? The patients are the winners here. The competition means more options and more research.
38-year-old male, Diagnosed with Crohn's in 1989 at age 12
Happy on Humira for 9 years until August 2013
Failed Remicade, Cimzia, Imuran, 6-MP, MTX
Ileostomy April 2014
Started Entyvio July 2014

fruitgirl
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Date Joined Feb 2009
Total Posts : 7150
   Posted 1/6/2015 9:12 AM (GMT -6)   
Red_34 said...
At first I thought you were referring to the terrorist cell! I was really confused lol


I thought the same thing and was wondering if it was a (fairly sick) joke!
Symptomatic remission as of 5/2009;mild flare 5/2014, quickly resolved
Colonoscopy in 10/2011 showed no inflammation
Symptoms began in 11/2008, 4 weeks after birth of first child; diagnosed with pancolitis 1/2009.
Second child born 3/2013; no post-partum flare up.
Meds: Apriso (4 0.375 g pills daily), probiotic. Used mesalamine enemas, but seem to now be intolerant.

sfc425
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Date Joined Jul 2010
Total Posts : 701
   Posted 1/6/2015 10:36 AM (GMT -6)   
Can someone explain this in lamens terms because I'm lost...

...does this mean more effective maintenance meds, treatment of severe flares or both?

The Rock
Regular Member


Date Joined Nov 2014
Total Posts : 155
   Posted 1/6/2015 10:44 AM (GMT -6)   
This is going to be huge for people with ulcerative colitis, it'll significantly improve things for many people that couldn't be treated with the alternatives. I can't wait for the development of antisense medication for ulcerative colitis. It feels good to know that big companies are investing in research on a large scale to improve our treatment options.
Dx: Left Sided Ulcerative Colitis
Date of Diagnosis: June 2009
Current Status: Mild Flare

Current Medications: Salofalk 500mg 8x per day, Salofalk Enema nightly
Diet: Dairy-Free, Preservative-Free, Alcohol-Free, Caffeine-Free, Low-Fat, Low-Fibre

Tunnelvisionary
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Date Joined Jul 2014
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   Posted 1/6/2015 10:49 AM (GMT -6)   
bania said...
Yeah, they really should think about changing their company name. This business deal is huge for all of us. It is a direct response to Celgene's mongersen drug - an oral antisense medication that in a phase II had a Crohn's remission rate of 65% in just two weeks! Janssen rightly sees that as a threat to three of its products - Remicade (Crohn's, UC), Simponi (UC), and Stelara (soon to be Crohn's). So it made this deal with Isis to develop its own antisense medications. Will Abbvie (maker of Humira) have to do the same? The patients are the winners here. The competition means more options and more research.


At first I couldn't bring myself to get excited about this, but after reading your post, you are definitely right. Competitors are scared. I really hope Celgene's drug's effectiveness carries throughout the rest of its clinical trials. A very effective IBD medication is definitely needed. Wish we could see more pharm news like this, instead of companies engaging in patent trickery to prevent generics or releasing me-too drugs. Competition between them is great for all of us!

bania
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Date Joined Dec 2003
Total Posts : 642
   Posted 1/6/2015 11:21 AM (GMT -6)   
sfc425, we're not sure what it means yet. Janssen signed a deal to develop up to three IBD drugs using antisense technology. They're not even drugs yet. So we don't know whether they will be great at maintenance or reducing flares, or even ever make it into production. Here's what's good about it:

1) The one antisense drug that exists for IBD was extremely effective in its phase II trial.
2) Janssen, the maker of Remicade, Simponi, and Stelara, wants to make extremely effective IBD drugs too, and is willing to pay a lot of money to do so.
3) The intent of all of these antisense drugs is to be oral medications, which is good for those of us who hate needles.
4) These new drugs will have different mechanisms of action than existing drugs. If anti-TNF's don't work for you, then maybe these will. They're not just more of the same.
5) More research is always a good thing. They'll never find the next great IBD treatment without it.
6) Drug makers want to make money. If Celgene's drug is a pill and is twice as effective as Janssen's Remicade infusion, more doctors will prescribe the pill than Remicade. This forces Janssen to develop something that is at least as effective as Celgene's pill. And from there it's game on. How many years went by where the only treatments for IBD were 5-ASA's and chemotherapy immunosuppressants? Then Remicade came on the scene, a state-of-the-art treatment specifically for IBD (at least at first). It made lots of money, and the rush to develop IBD treatments exploded - Humira, Cimzia, Simponi, Tysabri, Entyvio, Stelara. And that doesn't even include the many other treatments that never made it to approval. Even the failures are great because they advanced the research.
38-year-old male, Diagnosed with Crohn's in 1989 at age 12
Happy on Humira for 9 years until August 2013
Failed Remicade, Cimzia, Imuran, 6-MP, MTX
Ileostomy April 2014
Started Entyvio July 2014

DBwithUC
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Date Joined Feb 2011
Total Posts : 4059
   Posted 1/6/2015 11:47 AM (GMT -6)   
I agree that a new distinct class of meds is good. It will take several years of development and then several years of trials. But I am managed now, and am thinking ahead to a bad flare in 2020 ...
11/08: ischemic colitis and scope perf colon. 12cm colon/ileocecal resected. IV antib:sepsis.
01/10: Dx: Mod. UC pancolitis. Rx: Lialda 3x.
02/11: Major flare w/antib:sinus. Rx: 40mg Pred taper. 6mp.
07/11: Histol remiss rt/trans; worse sigmoid. Rx: Rowasa & hydrocort
---
Curr: 1-2 soft-formed stool, no urgency: Lialda 2x, NO PRED, probiotics, Vit-D/C

notsosicklygirl
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Date Joined Dec 2008
Total Posts : 16067
   Posted 1/6/2015 12:38 PM (GMT -6)   
I am hopeful but I feel like there are always great ideas and often they aren't as great in reality. I REALLY want to see something happen soon :(
Co-moderator: Ulcerative Colitis
Diagnosed with Pancolitis, Laryngopharyngeal Reflux & Migraines. Battling Extreme Exhaustion.
Currently: prednisone + remicade

Guardian7
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Date Joined Apr 2006
Total Posts : 2682
   Posted 1/6/2015 12:57 PM (GMT -6)   
I think for a company to make profit in the long run, they have to offer some ongoing therapy plan, as opposed to something that offers a permanent solution like specialized FMTs. I wish more was invested in the latter, as we all know the importance of the microbiome on overall health.

Quite honestly, I have zero hope for the spectrum of new IBD treatments coming out, but I do have hope that some pioneering doctors (like Borody) will find it in themselves to offer tangible and permanent solutions to patients.

Best.

Dreadsteel
Regular Member


Date Joined Sep 2014
Total Posts : 345
   Posted 1/6/2015 1:06 PM (GMT -6)   
Now this makes me hopeful !!, a gene therapy can't wait to get rid of those faulty genes.

I was certain something like this would happen sooner or later, treating the problem at the source is how it should be -i hope- .

How long do you think it will take for the drug to be available ? and cost ?

A good news to start 2015 with, even though i don't think i would be able to afford it :(
27 Male UC pancolitis dx March 2013
Current Meds: Mesalamine 4gm Enema daily , 100mg Imuran, 4gm Pentasa, Parriet (nausea), Lacteol Forte, Centrum, FishOil, Boswellia, Aloe Vera Juice
Current Faecal calprotectin : ~150mg/kg , Top Score ! ~2800mg/kg Feb 2014

aguywithuc
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Date Joined Jun 2010
Total Posts : 3011
   Posted 1/6/2015 2:20 PM (GMT -6)   
Guardian7 said...
I think for a company to make profit in the long run, they have to offer some ongoing therapy plan, as opposed to something that offers a permanent solution like specialized FMTs. I wish more was invested in the latter, as we all know the importance of the microbiome on overall health.

Quite honestly, I have zero hope for the spectrum of new IBD treatments coming out, but I do have hope that some pioneering doctors (like Borody) will find it in themselves to offer tangible and permanent solutions to patients.

Best.


"Mongersen was well-tolerated, and toxicities associated with systemically active antisense therapies were not observed."

Great post, so nice to hear about something without systemic side effects, not listed as a known carcinogen and high remission rate.

From what I read this morning they paid around 700 Million for the rights on a drug that can pull in 3 Billion per year.

I could be wrong and others should check my conclusions from these sources :

newdrugapprovals.org/2014/10/22/celgene-oral-crohns-drug-ged-0301-mongersen-impresses-in-phase-ii/
www.thestreet.com/story/12919382/1/first-detailed-look-at-celgene-crohns-disease-pill-impresses.html

Just the down payment was 700M, all totaled up could be 2.6B cost. Still profitable from just one years revenue.

Article said...
"We believe at peak GED-301 [mongersen] could reach $3 billion plus in peak worldwide sales," writes Schoenebaum. "Although sell-side consensus includes very little for the drug, we believe investor expectations are much, much higher than zero. Celgene is planning to start a broad phase 3 program by 2014 year-end, putting a potential launch in the 2017-18 timeframe."

Last April, Celgene purchased mongersen from a small Irish drug maker, paying $710 million upfront. Including future milestones and sales payouts, Celgene committed $2.6 billion to acquire rights to the drug. Celgene was aware of the phase II study data before making the deal.

The Rock
Regular Member


Date Joined Nov 2014
Total Posts : 155
   Posted 1/6/2015 4:04 PM (GMT -6)   
I can't believe the level of pessimism people have, it's best to hope for the best. This is as good as it gets, and that's the bottom line.
Dx: Left Sided Ulcerative Colitis
Date of Diagnosis: June 2009
Current Status: Mild Flare

Current Medications: Salofalk 500mg 8x per day, Salofalk Enema nightly
Diet: Dairy-Free, Preservative-Free, Alcohol-Free, Caffeine-Free, Low-Fat, Low-Fibre

garylouisville
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Date Joined Aug 2012
Total Posts : 9088
   Posted 1/6/2015 4:48 PM (GMT -6)   
There's more money to be made in a cure then there is in stringing us along for years and years. Just look at the new Hepatitis C drugs where it is actually a cure and costs tens of thousands of dollars, sometimes over a hundred thousand dollars. That doesn't even presume getting your name in the history books along with a Nobel prize. We need to cross our fingers on this new development but don't count your chickens yet.
Pentasa (500mg) 2 pills X 2; VSL 1 pill X 2; Prescrip Assist Probiotic 1 pill X 2; Grape seed extract (1)400mg X 2; Vitamin D3 10,000 IU; daily generic Allegra; Canasa as needed; DAO as needed due to dietary histamine intolerance; lotion daily

Gave me trouble: Zymactive, Renew Life Probiotic 80 billion, Florastor, high histamine foods

Guardian7
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Date Joined Apr 2006
Total Posts : 2682
   Posted 1/6/2015 5:00 PM (GMT -6)   
The Rock said...
I can't believe the level of pessimism people have, it's best to hope for the best. This is as good as it gets, and that's the bottom line.


I do have a lot of hope... but just not in any pharmaceutical company, given their poor track record. Borody has shown us that people on the verge of surgery can not just go on to live normal lives, but be free of medication decades after resolved UC pathology... as if the UC never existed for them.

He opened the door for many to do their own research and be their own advocates when it comes to treatments. Without his case studies, Michael (the user FecalTransplatForUC) would no longer have a colon and now he's living like the disease never existed (after 12 years of UC pathology and 3 days away from the surgery table).

So I do have hope in the microbial treatments that are coming out. I think just the fact that the mutaflor probiotic is just as effective as 5asa in treating UC is a good sign.

I just think greed corrupts even the best minds the world has to offer. Everyone has their price (doctors included), except maybe Buddhist monks.

Best.

notsosicklygirl
Forum Moderator


Date Joined Dec 2008
Total Posts : 16067
   Posted 1/6/2015 5:14 PM (GMT -6)   
The Rock said...
I can't believe the level of pessimism people have, it's best to hope for the best. This is as good as it gets, and that's the bottom line.


Yeah, I know. I hate being a pessimist but I've seen so many things come and go and people are still having surgery. I don't even have high hopes in Borody. I asked my GI about him and she said his studies are inaccurate and not well documented. She seemed like she knew quite a bit about the topic of FT and she was very informed on all of the alternatives that come up here regularly. She's quite bright and follows all different avenues, she never discourages me from asking questions, or says absolutely NO to anything I mention, but she definitely brought down my hopes on FT being a great option. I would try it regardless. Heck, anything before losing a colon and accepting pooing 6x a day. But yes, pessimist for sure. I was less so when on antidepressants.
Co-moderator: Ulcerative Colitis
Diagnosed with Pancolitis, Laryngopharyngeal Reflux & Migraines. Battling Extreme Exhaustion.
Currently: prednisone + remicade

Guardian7
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Date Joined Apr 2006
Total Posts : 2682
   Posted 1/6/2015 5:20 PM (GMT -6)   
notsosicklygirl said...
The Rock said...
I can't believe the level of pessimism people have, it's best to hope for the best. This is as good as it gets, and that's the bottom line.


Yeah, I know. I hate being a pessimist but I've seen so many things come and go and people are still having surgery. I don't even have high hopes in Borody. I asked my GI about him and she said his studies are inaccurate and not well documented. She seemed like she knew quite a bit about the topic of FT and she was very informed on all of the alternatives that come up here regularly. She's quite bright and follows all different avenues, she never discourages me from asking questions, or says absolutely NO to anything I mention, but she definitely brought down my hopes on FT being a great option. I would try it regardless. Heck, anything before losing a colon and accepting pooing 6x a day. But yes, pessimist for sure. I was less so when on antidepressants.


Because the FMT data is scattered all over the place and quite frankly, the funding would be an issue for that kind of treatment. The recent studies all it's promising (with the patients discontinuing treatment). It's also kind of hard to show something when the right personnel aren't conducting the studies, and when they discontinue it despite showing promise.

I honestly would not trust a GI that regurgitates information that most of her peers are likely to tell her. What exactly is inaccurate about documented UC patients being free of disease after FMT? Also, personal experience triumphs most manipulated pharmaceutical data, or anything that a white coat tells you. YOU know better to trust yourself than other people, NSSG.

A locum GI (in a conventional practice) I saw opened my mind to it, as well as other treatments like LDN and tricyclics. And he actually told me to try it because of the current dismal options out there.

Marauder93
Veteran Member


Date Joined Feb 2014
Total Posts : 1185
   Posted 1/6/2015 5:22 PM (GMT -6)   
Dreadsteel said...
Now this makes me hopeful !!, a gene therapy can't wait to get rid of those faulty genes.

I was certain something like this would happen sooner or later, treating the problem at the source is how it should be -i hope- .

How long do you think it will take for the drug to be available ? and cost ?

A good news to start 2015 with, even though i don't think i would be able to afford it :(


Just for your own knowledge, antisense drugs dont even touch the genes. They only block the expression of the gene products. So if you stop the therapy, the problem comes back.

My main question is what genes will they be targeting with these therapies. Unfortunately, I feel like it will just be more generic proinflammatory cytokines and not targeted, UC specific molecules (since we dont really know what causes UC)

notsosicklygirl
Forum Moderator


Date Joined Dec 2008
Total Posts : 16067
   Posted 1/6/2015 5:26 PM (GMT -6)   
Guardian7 said...
notsosicklygirl said...
The Rock said...
I can't believe the level of pessimism people have, it's best to hope for the best. This is as good as it gets, and that's the bottom line.


Yeah, I know. I hate being a pessimist but I've seen so many things come and go and people are still having surgery. I don't even have high hopes in Borody. I asked my GI about him and she said his studies are inaccurate and not well documented. She seemed like she knew quite a bit about the topic of FT and she was very informed on all of the alternatives that come up here regularly. She's quite bright and follows all different avenues, she never discourages me from asking questions, or says absolutely NO to anything I mention, but she definitely brought down my hopes on FT being a great option. I would try it regardless. Heck, anything before losing a colon and accepting pooing 6x a day. But yes, pessimist for sure. I was less so when on antidepressants.


Because the FMT data is scattered all over the place and quite frankly, the funding would be an issue for that kind of treatment. The recent studies all it's promising (with the patients discontinuing treatment). It's also kind of hard to show something when the right personnel aren't conducting the studies, and when they discontinue it despite showing promise.

I honestly would not trust a GI that regurgitates information that most of her peers are likely to tell her. What exactly is inaccurate about documented UC patients being free of disease after FMT? Also, personal experience triumphs most manipulated pharmaceutical data, or anything that a white coat tells you. YOU know better to trust yourself than other people, NSSG.

A locum GI (in a conventional practice) I saw opened my mind to it, as well as other treatments like LDN and tricyclics. And he actually told me to try it because of the current dismal options out there.


Well yeah, you can't trust anyone. She may be tryin to push me the other way for her own benefit. I don't have a good donor anyway so FT isn't going to happen for me unless there was a clinical trial where they provided a donor stool. I see other drs, that is just one drs opinion. One of my old drs was really hopeful about worm therapy but then I have seen so many people have no luck with it that I started to doubt it as a valid option. There isn't a lot of recorded data on a lot of these things and you're right, it doesn't make financial sense for companies to invest in clinical trials of things that could make their drugs unnecessary. Even doctors, it could make them unnecessary if we can all put poop up our butts and be 100% forever.
Co-moderator: Ulcerative Colitis
Diagnosed with Pancolitis, Laryngopharyngeal Reflux & Migraines. Battling Extreme Exhaustion.
Currently: prednisone + remicade

hateuc
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Date Joined Jun 2010
Total Posts : 2344
   Posted 1/6/2015 6:46 PM (GMT -6)   
I love new ideas and approaches to IBD. This is one ISIS I can really get behind!
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