Patent Issued For URG 101 - Interstitial Cystitis Network Support Forum

***icnmgrjill*** · 08-21-2008, 10:36 AM

Urigen Announces Issuance of Key Patent for URG101 - A Novel Therapy to Treat Painful Bladder Syndrome/Interstitial Cystitis

Wednesday, 20 August 2008

BURLINGAME, CA, USA (Press Release) - August 19, 2008 - Urigen Pharmaceuticals, Inc. (OTC Bulletin Board: URGP, http://www.urigen.com), a specialty pharmaceutical company focused on the development and commercialization of treatments for urological disorders, today announced the U.S. Patent and Trademark Office has issued the first patent for the use of URG101, an investigational, bladder instillation treatment for Painful Bladder Syndrome/Interstitial Cystitis (PBS/IC). Patent number US 7,414,039 broadly covers the use of the URG101 product in the treatment of PBS/IC. The term of the patent extends into 2025.

"Not only does this patent establish protection for the use of URG101 in Painful Bladder Syndrome and Interstitial Cystitis; it also validates the excellent intellectual property guidance provided by Tom Jurgensen, JD of Catalyst Law and Stephen Reiter, PhD, JD of Foley & Lardner," stated William J. Garner, MD, President and CEO of Urigen. "We will continue to execute our intellectual property strategy to strengthen our proprietary position in the field of PBS/IC."

Urigen has announced positive results from a Phase 2 study of URG101. The study was a multi-center, double-blind, placebo-controlled, crossover trial. Findings from the study included:

* Primary Endpoint -- Improvement in Average Daytime Pain (p=0.03).
* Secondary Endpoints -- Improvement in Daytime Urgency (p=0.03) and Total Symptom Score (p=0.03). In addition, patients reported improved symptom relief with URG101 as measured by PORIS (p=0.01).

About URG101

URG101 is a pharmaceutical treatment for Painful Bladder Syndrome/Interstitial Cystitis that is instilled into the bladder. URG101 works with lidocaine reducing the sensations of pain, urge and muscle spasms and heparin, a glycosaminoglycan, coating the bladder wall thus augmenting the natural heparinoids.

About Painful Bladder Syndrome/Interstitial Cystitis (PBS)

Painful Bladder Syndrome/Interstitial Cystitis is a recognized medical condition with increased frequency of diagnosis. PBS/IC is characterized by bladder pain, urinary urgency and nocturia where few IC treatments exist and no approved therapies are available for PBS. Today, there are an estimated 10.5 million women and men in North America who suffer from PBS/IC.

About Urigen Pharmaceuticals, Inc.

Urigen Pharmaceuticals is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for urological disorders. Urigen's product development programs target significant unmet medical needs and major market opportunities in urology. URG101 targets Painful Bladder Syndrome/Interstitial Cystitis, which affects approximately 10.5 million men and women in North America. URG301 targets urethritis and acute urgency in patients diagnosed with an overactive bladder. For further information, please visit Urigen's website at www.urigen.com.

Urigen Pharmaceuticals, Inc.

sandymarie · 08-21-2008, 10:50 AM

Hopefully this is the thing we have all been hoping for , I am anxious to find out if I can try this and prayfully it will be a big step for us oldies. LOL You are certainly on the ball. I do want to thank you for staying on top of things for us like you do. You are an angel, with a big job and I wanted to express my appreciation for taking the time to care about those of us who are depending on this site for updated news. I just wanted you to know that you are appreciated and loved for everything you have done and are continuing to do.

May God bless you. I just hope that someday I can give back to this site as it has been a safe haven for myself and I am sure for others too. Back when I was diagnosed 35 plus years I never knew anyone had ic , but me. Thanks for making a much better place for us to go that thought we were all alone for so many years.

Many hugs and much appreciation

JJ

wolfaleena · 08-21-2008, 11:32 AM

has anyone been in any of the trials of this Urigen?
Do we know when it might be available?

Boozer05 · 02-25-2009, 10:15 AM

I know this reply is about six months late, but I have some new information about this thread...

I just talked to Bill Garner, who is one of the physicians behind this new treatment, and it looks like they are still looking for financing for the development of this drug. It sounds like the drug is ready to go, has past all the required benchmarks, etc... but due to the current economy they simply can't get the financing to move forward.

However, it sounds like this is not the miracle cure that these stories below might suggest. While this drug will probably work very well to provide temporary relief, and maybe even long-term relief in some, it is a rescue instillation designed to help you get through flares... not a long term solution on cure. If you're someone who suffers from the occasional flare, this may be the perfect solution, but if have chronic pain that never lets up, it may not be so useful.

That said, it's definitely something that could help a lot of suffers, and it deserves to be out there... hopefully they will find some financing soon.

jen74 · 02-25-2009, 11:23 AM

It sounds alot like the instills they offer already. I hope the researchers will start to look into what the cause is of IC. I am afraid they will never find a cure unless they first find the cause. I mean finding stuff that helps some with the pain in great, but lets face it, instills only help a small majority of people and also there are alot of risks with them(infections). I wish they would come up with a different oral med that could help. The only FDA approved oral med there is to treat IC is elmiron. I am suprised they have not come up with something better yet in all these years IC has been around.
Jen
Jen

mrachel · 02-25-2009, 02:13 PM

Am I correct that this is a heparine/lidicaine instill? That is what I am already getting. My instillations have heparine/marcaine/ lidicaine and bisodium carbonate in it. They help me feel better for about 4-5 hours but it doesn't last longer. I'm curious to know how this is different than what I'm already getting.

BT2008 · 03-09-2009, 12:02 AM

I just went to the Urigen website looking for the amount of Heparin included in their combo version, and I can't find it anywhere.

I am currently using Heparin 40,000 units along with Marcaine (plus Kenalog and Sod Bicarb) in each of my instills -- twice per week.

My insurance covers the Heparin and I only have to pay a $20 co-pay; and while my insurance does not cover the Marcaine, it is only around $10.00 for a 100mL bottle which provides for 10 instills (five weeks worth).

I can't help but wonder if/when this drug becomes available whether or not the price will be jacked up to a higher price/co-pay because of the patent rights that allow for a much higher price for a "name brand" drug.

From my experience, it would be no more trouble to load a syringe from two different bottles than it would from just one. Therefore, it may turn out to be much less expensive to buy the drugs separately, rather than already mixed. Could this be a "packaging ploy"...??? (Or am I already so jaded that I don't trust very easily anymore???)

Does anyone have any thoughts on this?

~Beth

p.s. I also posted this same reply on the other thread about URG101...

BT2008 · 03-09-2009, 12:13 AM

Quote:

Originally Posted by mrachel

Am I correct that this is a heparine/lidicaine instill? That is what I am already getting. My instillations have heparine/marcaine/ lidicaine and bisodium carbonate in it. They help me feel better for about 4-5 hours but it doesn't last longer. I'm curious to know how this is different than what I'm already getting.

I agree. I get maybe 4-6 hours of relief after each instill, most of the time; sometimes I don't even get that much.

While I am still hoping that the heparin is working over time to repair my bladder lining (and the Kenalog to keep the inflammation under control), even as a "rescue instill" it is not a miracle by any means -- Not for me anyway! If it is for some, that's GREAT! But, that still leaves some of us untreated and desperately needing help!

I think we need a new approach or new drug altogether instead of just a re-working of the same drugs we are already using! But that is just my take on it!

~Beth

***ICNDonna*** · 03-09-2009, 03:27 AM

Beth, I noticed that you have stopped taking elmiron --- how long did you take it before stopping?

Donna

jen74 · 03-09-2009, 06:36 AM

I agree with you Beth. I would like to see these pharmaceuticals come up with a different approach, or a different drug. I was reading my latest issue from the ICA and all it talks about is bladder instillations and not much else! I sure wish these guys would start looking into a cause instead of this same song and dance they always seem to stay on.
I am afraid I also have to agree about the supposed new bladder instill. It is the same old stuff, heparin,lidocaine etc.... but like you said, they will likely charge Alot more for it since it is likely to be pre-mixed. Just another way to make more money off of sick people who are desperate for some help.
Jen

wolfaleena · 03-09-2009, 07:48 AM

yes, maybe they will be able to get more funding for finding the Cause of the disease, thus getting closer to a cure... President Obama signed the legislation today for federal funding for embryonic stem cell research. I know it is a controversial subject.... but it may allow some scientists and researchers to find a cause and cure for this "curse" that we live with day in and day out

BT2008 · 03-10-2009, 07:23 AM

Quote:

Originally Posted by ICNDonna

Beth, I noticed that you have stopped taking elmiron --- how long did you take it before stopping? Donna

Hey Donna,

I took Elmiron (100mg 3xday) from mid-September 2008 until early February 2009. So, about five months? I do remember my urologist saying that it didn't appear to be working, so he said to stop taking it after I started the Heparin instills. I also remember the two overlapping for a few weeks to finish out my last Elmiron script.

~Beth

BT2008 · 03-10-2009, 07:47 AM

Quote:

Originally Posted by wolfaleena

President Obama signed the legislation today for federal funding for embryonic stem cell research. I know it is a controversial subject.... but it may allow some scientists and researchers to find a cause and cure for this "curse" that we live with day in and day out

My husband and I discussed this last night. And yes, even though it is a very controversial subject, it seems logical to both of us that this option might provide a way "to regenerate" our bladder linings. I even put this question on my list of Q's to take to my next uro appt on the 23rd.

Moreover, even though the science behind the research suggests that embryonic stem cells work much better in regeneration, we were also wondering if adult stem cells would work? Such an idea certainly sounds promising, in theory anyway.

Does anyone know whether this potential has been explored?

~Beth

BT2008 · 03-10-2009, 07:48 AM

Quote:

Originally Posted by wolfaleena

President Obama signed the legislation today for federal funding for embryonic stem cell research. I know it is a controversial subject.... but it may allow some scientists and researchers to find a cause and cure for this "curse" that we live with day in and day out

My husband and I discussed this last night. And yes, even though it is a very controversial subject, it seems logical to both of us that this option might provide a way "to regenerate" our bladder linings. I even put this question on my list of Q's to take to my next uro appt on the 23rd.

Moreover, even though the science behind the research suggests that embryonic stem cells work much better in regeneration, we were also wondering if adult stem cells would work? Such an idea certainly sounds promising (in theory anyway).

Does anyone know whether this potential has been explored?

~Beth