Intarcia Therapeutics

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Damn shame tell the midget with the tiny feet that his flim flam act is almost at an end

EXSCEL: No CV Benefit, but No Harm With Bydureon in Diabetes
Lisa Nainggolan

May 25, 2017


The Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial involved 14,000 people with type 2 diabetes at a wide range of cardiovascular risk, from 35 countries, and randomized them to once-weekly exenatide (2 mg subcutaneously) or placebo on top of usual care. Exenatide gent met the goal of cardiovascular safety but failed to show any cardiovascular benefit.

"Fewer cardiovascular events were observed in the Bydureon arm of the trial; however, the efficacy objective of a superior reduction in major adverse cardiovascular events did not reach statistical significance," AstraZeneca said.

It adds that the full results of EXSCEL will be reported on September 14, at the European Association for the Study of Diabetes meeting in Lisbon, Portugal.


Showing CV Benefit Is the New Norm in Type 2 Diabetes

Novo products show a statistically significant benefit in lowering cardiovascular risk and physicians want to protect their patients with drugs that actually show a benefit.

These include two with other GLP-1 agonists, the LEADER trial with liraglutide (Victoza, Novo Nordisk), a once-daily subcutaneous injection product that has been on the market for some time, and the SUSTAIN-6 trial with another Novo Nordisk GLP-1 agonist, semaglutide.

Semaglutide is a once-weekly subcutaneous injectable product that has not yet been approved; the company is also trying to develop an oral version.

In addition, the landmark EMPA-REG trial — with a different class of type 2 diabetes drug, the sodium glucose cotransporter-2 (SGLT-2) inhibitors — was the first to show a reduction in cardiovascular deaths with a diabetes drug, empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) and last December, the FDA allowed a label to be added to that product indicating that it can improve survival.

Therefore, the fact that EXSCEL has failed to show any cardiovascular benefit with exenatide when other trials of GLP-1 agonists have shown this to be the case will be viewed as somewhat disappointing. This failure is likely to reduce the use of exenatide for the treatment of diabetes.
 






anonymous said:
Managed Care will require patients to step through generic Byetta before accessing any of the longer exenatide generics like ITCA650 /QUOTE]

Byetta compliance is questionable with twice daily shots. That said there are plenty of approved and entrenched GLP1 drugs including once daily Victoza and slew of once weekly drugs. Sanofi is reported to be working on once monthly version. Rather crowded space so why would MCOs pay for Intarcia's 3/6 month implants at hell of premium?

Approved GLP-1 agonists:
  • exenatide (Byetta/Bydureon), approved in 2005/2012.
  • liraglutide (Victoza, Saxenda), approved 2010.
  • lixisenatide (Lyxumia), approved in 2016.
  • albiglutide (Tanzeum), approved in 2014 by GSK.
  • dulaglutide (Trulicity), approved in 2014—manufactured by Eli Lilly.
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Heard that Intarcia is running their own cardiovascular study albeit at much smaller scale?

Byetta compliance is questionable with twice daily shots. That said there are plenty of approved and entrenched GLP1 drugs including once daily Victoza and slew of once weekly drugs. Sanofi is reported to be working on once monthly version. Rather crowded space so why would MCOs pay for Intarcia's 3/6 month implants at hell of premium?

Approved GLP-1 agonists:
  • exenatide (Byetta/Bydureon), approved in 2005/2012.
  • liraglutide (Victoza, Saxenda), approved 2010.
  • lixisenatide (Lyxumia), approved in 2016.
  • albiglutide (Tanzeum), approved in 2014 by GSK.
  • dulaglutide (Trulicity), approved in 2014—manufactured by Eli Lilly
 






anonymous said:
I'm wide awake. Unable to sleep. Last week didn't sit right. No way we are approved this fall. Are we safe ?
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Bar to get approved is high for this implant fraught with high chance of rejection by FDA due to the very novel delivery system with outrageous claims compared to the existing injection by dime a dozen injectors. Add to this manufacturing and facility issues noted here. Going alone commercialization by building up the sales from grounds up and educating the pts and docs compound the risk of failure ever more. Anyone applying for jobs ought to weigh in the risk that you may be out of job within a year of launch and worse become laughing stock for even having worked at Intacia.
 






omg after taking a beating in diabetes over the last 12-18 months at least Novo is profitable. I'm out it would be a disaster to jump to the pump and then have the launch take a dump
 








November 09, 2010 07:30 ET

Biolex Therapeutics Names Kurt Graves Executive Chairman as Company Prepares for Phase 3 Trials and Commercialization of Locteron® in Hepatitis C

Graves' Significant HCV Expertise Will Support Strategic Partnering and Commercialization Efforts for Locteron, Biolex's Next-Generation Interferon; Locteron's Significant Tolerability and Dosing Advantages Position It to Become the Most Combinable Interferon With Direct-Acting Anti-Virals That Together Can Raise and Redefine a New Standard of Care in HCV

PITTSBORO, NC--(Marketwire - November 9, 2010) - The Board of Directors of Biolex Therapeutics, Inc. today announced the appointment of Kurt Graves as Executive Chairman of the Board. In this newly created position, Mr. Graves will provide strategic leadership to the Board and work closely with executive management as the Company advances its potential blockbuster Locteron®, a next-generation interferon for hepatitis C (HCV), into late-stage development and prepares for strategic partnering and selection of commercialization alternatives for the product. Locteron, the only controlled-release interferon alpha, is designed to offer key advantages compared to currently marketed interferons as a core component of combination therapies for the treatment of hepatitis C, including reduced flu-like symptoms, reduced rates of depression, and a less-frequent dosing regimen with half the number of injections.

Biolex Therapeutics files for $38M bankruptcy
Jul 6, 2012, 8:07am ED

Biolex Therapeutics Inc. has filed for bankruptcy liquidation, marking an inauspicious end to $190 million that investors had poured into the Pittsboro-based company since its founding in 1997.

The company's Chapter 7 filing on July 3 cited $38 million in liabilities, including nearly $5 million owed to Intersouth Partners of Durham. Other large creditors include Clarus Lifesciences, a venture capital firm with offices in the San Francisco and Boston areas, which is owed $8.4 million, and an investment arm of the pharmaceutical giant Johnson & Johnson, which has a $3.8 million claim, according to Biolex's filing.
 






anonymous said:
Bar to get approved is high for this implant fraught with high chance of rejection by FDA due to the very novel delivery system with outrageous claims compared to the existing injection by dime a dozen injectors. Add to this manufacturing and facility issues noted here. Going alone commercialization by building up the sales from grounds up and educating the pts and docs compound the risk of failure ever more. Anyone applying for jobs ought to weigh in the risk that you may be out of job within a year of launch and worse become laughing stock for even having worked at Intacia.
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Some people even left long careers at other companies. The only way you should come to Intarcia is if you have no other choice. Don't know what people are thinking if you left a good job.
 












anonymous said:
After more than 6 months in this stupid process another delay. That was the last straw and I am out. If they can't even execute a hiring process right imagine what will happen when they launch the product (if ever). You can't keep good talent on hold for that long. I am out! Good luck but I don't think this dog will ever hunt.
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recruiter says its still on hold but supposed to open up if there is approval. I'm out.
 












Certana has a good shot at approval. The upside of a well known, well studied, thousands of patient years drug means positive things. The uphill battle is internal and in the market. Internally, Matt in Op's is totally over his head. Plus, narcissistic op's people speak with ignorant conviction and turn out a poor product. Imagine trying to work out a data issue with this guy. Jay* well if you can't make it a Sunovion, where will you go? Commercial is not ready. If you have a rep sell Certana and mentions Byetta (its Byetta not Bydureon in the tube) you will not get any office to prep a sterile field, learn buy and bill, convince a patient to have an implant, have them come back for minor surgery with a doc that doesn't even draw blood from their patients, and enjoy the patient no shows. Plus, the A1c drop isn't any better thanks to perfect compliance- remember, you get that in trials with the pen and there is no difference when its in a metal tube you feel when you rub your belly after dinner. Graves is a great artist- he raised a lot of money and should have a little more restraint spending it on the fancy art and office space. When you have nothing to lose and nothing to give, you take and spend as if there is no tomorrow.
 






anonymous said:
Certana has a good shot at approval. The upside of a well known, well studied, thousands of patient years drug means positive things. The uphill battle is internal and in the market. Internally, Matt in Op's is totally over his head. Plus, narcissistic op's people speak with ignorant conviction and turn out a poor product. Imagine trying to work out a data issue with this guy. Jay* well if you can't make it a Sunovion, where will you go? Commercial is not ready. If you have a rep sell Certana and mentions Byetta (its Byetta not Bydureon in the tube) you will not get any office to prep a sterile field, learn buy and bill, convince a patient to have an implant, have them come back for minor surgery with a doc that doesn't even draw blood from their patients, and enjoy the patient no shows. Plus, the A1c drop isn't any better thanks to perfect compliance- remember, you get that in trials with the pen and there is no difference when its in a metal tube you feel when you rub your belly after dinner. Graves is a great artist- he raised a lot of money and should have a little more restraint spending it on the fancy art and office space. When you have nothing to lose and nothing to give, you take and spend as if there is no tomorrow.
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This whole process is littered with problems. ANY good manager they had in the mix is now out and wise to their bait and switch. Thank God this happened now because there will be more delays. I heard the new AVP in the West left a long career at BI. She had a great job and was moving her way up the company quickly and she CHOSE to come to Intarcia. She got sold a bill of goods.
 


















anonymous said:
Certana has a good shot at approval. The upside of a well known, well studied, thousands of patient years drug means positive things. The uphill battle is internal and in the market. Internally, Matt in Op's is totally over his head. Plus, narcissistic op's people speak with ignorant conviction and turn out a poor product. Imagine trying to work out a data issue with this guy. Jay* well if you can't make it a Sunovion, where will you go? Commercial is not ready. If you have a rep sell Certana and mentions Byetta (its Byetta not Bydureon in the tube) you will not get any office to prep a sterile field, learn buy and bill, convince a patient to have an implant, have them come back for minor surgery with a doc that doesn't even draw blood from their patients, and enjoy the patient no shows. Plus, the A1c drop isn't any better thanks to perfect compliance- remember, you get that in trials with the pen and there is no difference when its in a metal tube you feel when you rub your belly after dinner. Graves is a great artist- he raised a lot of money and should have a little more restraint spending it on the fancy art and office space. When you have nothing to lose and nothing to give, you take and spend as if there is no tomorrow.
Click to expand...

Certana? LOL like certain to FAIL right out of the gate? Great upside, disrupt, bla bla bla, sis boom bah! Will payers pay? Uh we sure hope so! Right, pump chumps cos you've got lot of excrements to mop up in the commercial side and armpit plant in Hayweird. Approval shoed-in? Says who? Wishes spewed in drunken stupor?

Matt and Jay are the examples of the "leadership" mired in manure that stinks up to the heaven and dirty politics to hilt. Matt is way over his head and too stupid drunk in his narcissism. Jay is red headed buffoon who should be punched in the gut to wake up from his narcissism and self proclaimed customer experience - he knows jack squat. These amateurs were too arrogant and stupid not to partner with big pharma (they weren't mesmerized by PP anyway chuckling thru the presentations). They are in DEEP shit. Graves is an interesting character who is enriching his sister the "artist"who makes bundle hand crafting key awards (butt kissers galore get some kind of popularity contest awards and oke keys trophies made by sis). New flat is over the top Taj Mahal in front of Graves arch enemy Vertex - go figure...

Good luck educating the masses and train the docs who can't even draw blood to use scalpel and perform minor surgeries in tiny exam rooms. But hey we is disrupting the Type II! No more analog as Graves says...
 






It's even funnier when J & J talk together each desparately trying to be the best at kissin A but we have at least another year of fun. This is the best of times and endless review keeps the story going the longest. Fortunatley lots of alternatives in Boston.
 






anonymous said:
Certana? LOL like certain to FAIL right out of the gate? Great upside, disrupt, bla bla bla, sis boom bah! Will payers pay? Uh we sure hope so! Right, pump chumps cos you've got lot of excrements to mop up in the commercial side and armpit plant in Hayweird. Approval shoed-in? Says who? Wishes spewed in drunken stupor?

Matt and Jay are the examples of the "leadership" mired in manure that stinks up to the heaven and dirty politics to hilt. Matt is way over his head and too stupid drunk in his narcissism. Jay is red headed buffoon who should be punched in the gut to wake up from his narcissism and self proclaimed customer experience - he knows jack squat. These amateurs were too arrogant and stupid not to partner with big pharma (they weren't mesmerized by PP anyway chuckling thru the presentations). They are in DEEP shit. Graves is an interesting character who is enriching his sister the "artist"who makes bundle hand crafting key awards (butt kissers galore get some kind of popularity contest awards and oke keys trophies made by sis). New flat is over the top Taj Mahal in front of Graves arch enemy Vertex - go figure...

Good luck educating the masses and train the docs who can't even draw blood to use scalpel and perform minor surgeries in tiny exam rooms. But hey we is disrupting the Type II! No more analog as Graves says...
Click to expand...

It's all about the payers and that is "if" this pony ever gets approved.

http://www.mmm-online.com/payersman...-value-to-payers-analysts-say/article/683273/
 






From https://www.glassdoor.com/Reviews/Intarcia-Therapeutics-Reviews-E12851.htm

"Exciting at face value; dig deeper"
Former Employee - Anonymous Employee in Boston, MA
Doesn't Recommend
Negative Outlook
Approves of CEO
I worked at Intarcia Therapeutics full-time (More than a year)

Pros

Very promising product and stellar values (on paper), charismatic CEO, beautiful offices.

Cons

Rife with politics, nepotism and ego. Severely understaffed. Many people in power have no experience in the pharmaceutical industry. Despite millions in funding, budgets are stalled.

Advice to Management

You have only one chance to launch a product. After more than 10 years you're no longer a start-up, so don't claim to be one. Don't let your egos obstruct your stated vision. Listen to those with experience.
 






Another from https://www.glassdoor.com/Reviews/Intarcia-Therapeutics-Reviews-E12851.htm


"Intarcia grossly understaffed, can't do all it must, and far too much politics."
Former Employee - Anonymous Employee in Boston, MA
Doesn't Recommend
Positive Outlook
Approves of CEO
I worked at Intarcia Therapeutics full-time (More than a year)

Pros

The upside opportunity is tremendous in one of the world's largest pharma catagories: Type 2 Diabetes. The pipeline possibilities are similarly awesome.

Cons

They should have partnered with a Big Pharma partner, but didn't. As a result, they are struggling badly against overwhelming odds to do everything that needs to get done. As a result, employees work extraordinarily long hours all the time in a work environment aggravated by politics instead of made nicer by entrepreneurial excitement. I've never seen politics this bad in a company this tiny. It's remarkable.

Advice to Management

Quickly arrange a good partnership in the U.S. for ITCA 650 to take the undo pressure off your people, your values, and your finances. It will allow normalcy to return. You'll still have all the upside opportunity left in your rich pipeline to "go it alone" if you choose. You ran at your first product too quickly completely independently, and it is your people who are paying the price. If you continue taxing your people and allowing politics, no amount of incentive bonus can compensate for this after a year or two of having no life, and the brilliant company you could have become will never happen.
 






Hey Hey Hey whaas this about politics ? We have a very clear political policy - no blacks, no women, no gays. We are straight white males, yes my boy friend is gay but my wife knows I am straight. Not every woman goes for a midget. Did you know I was CAPTAIN OF THE FOOTBALL TEAM well actually waterboy
 






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