Trulance vs Linzess

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anonymous said:
Worked in this industry. Whatever you do, remember to never think for yourself. “Everything is looking great. Keep going out there. Make it happen.” Yaddayaddayadda.
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Don’t be fooled, in 3-6 months when they don’t qualify for the next tranche of funding it will be “sorry but you knew the risks” as they float safely to the ground in their golden parachutes
 




If you are unhappy, I suggest you head back to Salix and ride that ship to the bottom. Synergy has a few bumps as any new company will. Trulance is a great drug and will continue to gain share. Hate on it all you want.
 












Analog Uroguanylin (Trulance) has some impressive P2 results in its Dolcanatide formulation targeting UC, OIC & Crohn’s. It retains WW rights & has little debt. I think the game has just started.
 




anonymous said:
Analog Uroguanylin (Trulance) has some impressive P2 results in its Dolcanatide formulation targeting UC, OIC & Crohn’s. It retains WW rights & has little debt. I think the game has just started.
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Keep dreaming by then there will already be many more effective options and you’ll be hundreds of millions in debt at current burn rates.

Let’s just see if you can get enough cash to fund this money pit through 2018
 




anonymous said:
Keep dreaming by then there will already be many more effective options and you’ll be hundreds of millions in debt at current burn rates.

Let’s just see if you can get enough cash to fund this money pit through 2018
Click to expand...

Trulance sucks. These clowns tried to make a fast buck selling the company/ product, but the truth prevailed. Trulance is a shitty drug....pun intended. Bullshit company, bullshit product, bullshit “ leadership”.........it’s over. Run, don’t walk, to the nearest door, and don’t let it hit you in the ass on your way out.
 












anonymous said:
Analog Uroguanylin (Trulance) has some impressive P2 results in its Dolcanatide formulation targeting UC, OIC & Crohn’s. It retains WW rights & has little debt. I think the game has just started.
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Clearly you don’t read our own website.
https://www.synergypharma.com/research-and-development/dolcanatide

The quote above was from Jan. 2016. That was two years about and only in Phase II for OIC. Phase I (2014) is the last for Dolcanatide for UC. Listen, I am bummed too. I was sold a pile of crap. The drug is good. The company leadership is not. Game over. I am actively looking.
 




If patients are sticking with Linzess despite debilitating diarrhea, it would seem to indicate the severity of the alternative. It seems likely, though, that patients will complain about the diarrhea to their docs and that their docs, if aware of Trulance, would try it - pending insurance company approval.


I'm not sure how to evaluate the pressure from generics. From what I have been reading, a Linzess generic will be available in January 2024 at the earliest. There are different patents with different expiry dates, so its difficult to evaluate.
 




anonymous said:
If patients are sticking with Linzess despite debilitating diarrhea, it would seem to indicate the severity of the alternative. It seems likely, though, that patients will complain about the diarrhea to their docs and that their docs, if aware of Trulance, would try it - pending insurance company approval.


I'm not sure how to evaluate the pressure from generics. From what I have been reading, a Linzess generic will be available in January 2024 at the earliest. There are different patents with different expiry dates, so its difficult to evaluate.
Click to expand...

In addition to Trulance not being based on a toxin. I can only imagine the repercussions of taking Linzess for years.
 




anonymous said:
It looks like patients repeatedly treated with Linaclotide have a risk of seeking alternative drug if treatment-related Anti Drug (Linaclotide) Antibody (ADA) is produced resulting in neutralizing the drug.and render it inactive. This is behind this clinical trial as linked below. But SYGP's Trulance is happy to help out at that stage. On a second thought, why physicians shouldn't put patients on Trulance at the first place. Note that Linaclotide is a peptide mimic of endogenous guanylin and uroguanylin, meaning a foreign peptide that can be to recognized by immune system as foreign material that provoke immune rejection where the ADA concern is about. However, Plecanatide (brand name Trulance), Is nearly structurally identical to human uroguanylin. This may explain why Trulance has less side effects and has no concern for ADA issues.

https://clinicaltrials.gov/ct2/show/NCT02590432
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I’m responding as a medical professional and investor with deep knowledge of both products, their discovery and development history. Anti-drug antibody trials are usually required by the FDA from the manufacturers of any biological or peptide drugs, whether they’re administered parenterally or enterally. Trulance is not immune to it as these are post-marketing committments the manufacturers agree to meet as part of their drug approval condition, so are the pediatric study requirements that are often added to the list by the FDA. This doesn’t mean a particular drug (i.e. linaclotide) has a greater risk of being recognized by the body’s immune system than another peptide drug (i.e. plecanatide) as foreign and get eliminated even if your scientific rationale may lead you to think so. You need objective clinical evidence to make such a conclusion. FDA doesn’t know either and hence the reason for asking the manufacturers to do the study. Anti-drug antibodies are clearly the case in many biologics administered in IBD (i.e. infliximab).

Having said that, in the eyes of physicians, plecanatide has a clear safety advantage in terms of AEs. They know not to compare apples to oranges as these trials often follow wildly different protocols and requirements (pleacanatide being new, it had to follow more stringent rules), yet they primarily care about safety, then affordability. Thus formulary coverage is very important to a prescriber. In this day and age it takes 6 months to a year to get >50% of lives covered. Best strategy is to promote via sales reps in areas with coverage and postpone advertising in areas with no or poor coverage. At the end, the physician will try prescribing it a few times but they’re not going to push further if patients keep complaining of lack of coverage or pharmacy cost without insurance. Retail cost of new drugs are often shocking to most patients.

Outside of safety advantage, they can understand whether a drug is a better mimicker of body’s own fluid regulation mechanism in exocrine tissues if you are able to explain to them elegantly. In this highly regulated field, there are limits to what a sales person or a medical science liaison can say to a physician in a proactive manner no matter how much science is behind the argument. You have to stick to the label to be compliant. Allergan/Ironwood warned Synergy in the past with legal action regarding their use of “bacterial toxin vs. uroguanylin analog” story. Despite the story is being true, you do not want to jeopardize your moral high ground and risk litigation. From healthcare perspective, I’d pay more attention to whether: 1) the drug is working as advertised; 2) it is safe (or safer than alternatives with similar efficacy); 3) my patients can afford it.

Plecanatide is on a good path for success. Management needs to find financial/commercial partners with deep pockets to support a prolonged battle with Allergan/Ironwood and their financial backers. $40M/Q burn rate makes the financial future of Synergy precarious, as evidenced by today’s muted market response to label expansion into IBS-C. The best way to help your professional and financial future is to increase plecanatide prescriptions and turn this drug into a billion dollar product it will become eventually.

Some useful tips:

IBS is still a diagnosis of exlusion. Many of us underdiagnose patients. Ask us how many of our patients complain about gas, bloating, diarrhea or constipation. Half of US adult population experience frequent GI symptoms and they either self treat or live with symptoms while trying to avoid triggers. There are a lot more patients we don’t don’t even see.

Focus on safety. An analog of human peptide that regulates intestinal fluid secretion is a good story. In a way, you’re replacing what’s missing with an almost identical copy. This is routinely done in diabetes (insulin) and pancreatic insufficiency (with oral enzyme replacement).

Ask how many patients on other treatments are failing to respond to treatment after a while. This is called tachyphylaxis and we see it frequently with many drugs after 6-8 weeks of use. What percent of linaclotide patients do you think respond to treatment after two months? Physicans are hungry for information but often they are the best resource for empirical evidence. Ask probing questions and show that you’re their partner in their treatment landscape. They’ll think about your intelligent questions during their sleep, down time...

Be positive, exude hope. Whether you stay there or not, the drug you’re selling will stay there for the long run and will improve lives better than most others on the market. Even if you’re not happy with the management (and I would say I’m one of those), the drug you have will prove very valuable in time. That time can get shorter with your efforts. While the outcome is obvious, making the journey shorter and sweeter is at the hands of all of you at Synergy.
 




anonymous said:
I’m responding as a medical professional and investor with deep knowledge of both products, their discovery and development history. Anti-drug antibody trials are usually required by the FDA from the manufacturers of any biological or peptide drugs, whether they’re administered parenterally or enterally. Trulance is not immune to it as these are post-marketing committments the manufacturers agree to meet as part of their drug approval condition, so are the pediatric study requirements that are often added to the list by the FDA. This doesn’t mean a particular drug (i.e. linaclotide) has a greater risk of being recognized by the body’s immune system than another peptide drug (i.e. plecanatide) as foreign and get eliminated even if your scientific rationale may lead you to think so. You need objective clinical evidence to make such a conclusion. FDA doesn’t know either and hence the reason for asking the manufacturers to do the study. Anti-drug antibodies are clearly the case in many biologics administered in IBD (i.e. infliximab).

Having said that, in the eyes of physicians, plecanatide has a clear safety advantage in terms of AEs. They know not to compare apples to oranges as these trials often follow wildly different protocols and requirements (pleacanatide being new, it had to follow more stringent rules), yet they primarily care about safety, then affordability. Thus formulary coverage is very important to a prescriber. In this day and age it takes 6 months to a year to get >50% of lives covered. Best strategy is to promote via sales reps in areas with coverage and postpone advertising in areas with no or poor coverage. At the end, the physician will try prescribing it a few times but they’re not going to push further if patients keep complaining of lack of coverage or pharmacy cost without insurance. Retail cost of new drugs are often shocking to most patients.

Outside of safety advantage, they can understand whether a drug is a better mimicker of body’s own fluid regulation mechanism in exocrine tissues if you are able to explain to them elegantly. In this highly regulated field, there are limits to what a sales person or a medical science liaison can say to a physician in a proactive manner no matter how much science is behind the argument. You have to stick to the label to be compliant. Allergan/Ironwood warned Synergy in the past with legal action regarding their use of “bacterial toxin vs. uroguanylin analog” story. Despite the story is being true, you do not want to jeopardize your moral high ground and risk litigation. From healthcare perspective, I’d pay more attention to whether: 1) the drug is working as advertised; 2) it is safe (or safer than alternatives with similar efficacy); 3) my patients can afford it.

Plecanatide is on a good path for success. Management needs to find financial/commercial partners with deep pockets to support a prolonged battle with Allergan/Ironwood and their financial backers. $40M/Q burn rate makes the financial future of Synergy precarious, as evidenced by today’s muted market response to label expansion into IBS-C. The best way to help your professional and financial future is to increase plecanatide prescriptions and turn this drug into a billion dollar product it will become eventually.

Some useful tips:

IBS is still a diagnosis of exlusion. Many of us underdiagnose patients. Ask us how many of our patients complain about gas, bloating, diarrhea or constipation. Half of US adult population experience frequent GI symptoms and they either self treat or live with symptoms while trying to avoid triggers. There are a lot more patients we don’t don’t even see.

Focus on safety. An analog of human peptide that regulates intestinal fluid secretion is a good story. In a way, you’re replacing what’s missing with an almost identical copy. This is routinely done in diabetes (insulin) and pancreatic insufficiency (with oral enzyme replacement).

Ask how many patients on other treatments are failing to respond to treatment after a while. This is called tachyphylaxis and we see it frequently with many drugs after 6-8 weeks of use. What percent of linaclotide patients do you think respond to treatment after two months? Physicans are hungry for information but often they are the best resource for empirical evidence. Ask probing questions and show that you’re their partner in their treatment landscape. They’ll think about your intelligent questions during their sleep, down time...

Be positive, exude hope. Whether you stay there or not, the drug you’re selling will stay there for the long run and will improve lives better than most others on the market. Even if you’re not happy with the management (and I would say I’m one of those), the drug you have will prove very valuable in time. That time can get shorter with your efforts. While the outcome is obvious, making the journey shorter and sweeter is at the hands of all of you at Synergy.
Click to expand...

Thank you for your very insightful info.
Most of us don’t want to continue suffering through the growing pains . The only way this crap will ever start paying the bills is if we are bought by a company that knows what the they're doing. A lot of drugs are around for a long time collecting dust.
 




anonymous said:
If patients are sticking with Linzess despite debilitating diarrhea, it would seem to indicate the severity of the alternative. It seems likely, though, that patients will complain about the diarrhea to their docs and that their docs, if aware of Trulance, would try it - pending insurance company approval.


I'm not sure how to evaluate the pressure from generics. From what I have been reading, a Linzess generic will be available in January 2024 at the earliest. There are different patents with different expiry dates, so its difficult to evaluate.
Click to expand...

Generics tier one, brands, tier 3. Patient makes the choice. That choice will tell how debilitating the diahrrea actually is .
 




Im not sure what else needs to be said to these Trulance reps....

Linzess TRX VOL CHANGE FOR Q4 2017 WAS 19% INCREASE YEAR OVER YEAR. This kind of growth for a drug that has been out since OCTOBER of 2012 tells the story. Its not about dollars, its about RX's GROWTH.

WAKE UP. EFFICACY TRUMPS LOOSE STOOL SO KEEP TALKING ABOUT DIARRHEA. YOU SYNERGY REPS ARE SELLING LINZESS FOR US......:)
 




satisfiedyet said:
Im not sure what else needs to be said to these Trulance reps....

Linzess TRX VOL CHANGE FOR Q4 2017 WAS 19% INCREASE YEAR OVER YEAR. This kind of growth for a drug that has been out since OCTOBER of 2012 tells the story. Its not about dollars, its about RX's GROWTH.

WAKE UP. EFFICACY TRUMPS LOOSE STOOL SO KEEP TALKING ABOUT DIARRHEA. YOU SYNERGY REPS ARE SELLING LINZESS FOR US......:)
Click to expand...

Nothing. They’re all retread losers who couldn’t find a real job in pharma, who took the bait, and now await their fates.
 




satisfiedyet said:
Im not sure what else needs to be said to these Trulance reps....

Linzess TRX VOL CHANGE FOR Q4 2017 WAS 19% INCREASE YEAR OVER YEAR. This kind of growth for a drug that has been out since OCTOBER of 2012 tells the story. Its not about dollars, its about RX's GROWTH.

WAKE UP. EFFICACY TRUMPS LOOSE STOOL SO KEEP TALKING ABOUT DIARRHEA. YOU SYNERGY REPS ARE SELLING LINZESS FOR US......:)
Click to expand...

STAY WOKE
 




anonymous said:
Thank you for your very insightful info.
Most of us don’t want to continue suffering through the growing pains . The only way this crap will ever start paying the bills is if we are bought by a company that knows what the they're doing. A lot of drugs are around for a long time collecting dust.
Click to expand...

Which drug is best when administered PR? It might be type to start pulling the drug where it belongs, up the buttt
 




Ironwood Pharmaceuticals, Inc. and Allergan plc have reached an agreement with wholly owned subsidiaries of Sun Pharmaceutical Industries Ltd. resolving patent litigation brought in response to Sun Pharma’s abbreviated new drug application (ANDA) seeking approval to market a generic version of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents.

Pursuant to the terms of the settlement, Ironwood and Allergan will grant the wholly owned subsidiaries of Sun Pharma a license to market a generic version of Linzess in the United States beginning on February 1, 2031 (subject to U.S. FDA approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur.

As a result of the settlement, all Hatch-Waxman litigation between the companies and Sun Pharma regarding Linzess patents will be dismissed. Additional details regarding the settlement were not disclosed.
 




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