Pretty indicative of future success when both Bydureon and Tanzeum have already crashed and burned.
Intarcia Therapeutics
- Thread starter anonymous
- Start date
-
- Tags
- None
Pretty indicative of future success when both Bydureon and Tanzeum have already crashed and burned.
LOL - heard that even the schmucks at Bill Gates Foundation were mesmerized by PP wizardry and invested in Intarcia last year. Intarcia CEO promised them the pump can be used to deliver HIV drugs.
Something interesting an insider also shared with me is that Bayer pulled the same pump which delivered 1 too many prorate cancer drug altogether 10 yrs ago due to lack of demand and Intarcia picked up the patents for a song. Anyone know when that pump goes off patent?
Apparently some investors (and employees wish) are demanding long awaited IPO especially right before the FDA approval but CEO wants to keep it private so he can run it his way whatever the hell that means.
Type II diabetes market is HUGE but there are so many good and cheap drug options out there...
At best Intarcia will be a small niche player for those who cannot swallow pills, scared of injections or forgetful with multiple trips to ER.
Add to that pricing which I understand has not been announced. Imagine selling something very expensive insurances may not cover...
Viadur was the pump for prostate cancer sold by Bayer in 2000
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf
Marketing of Viadur(R) (leuprolide acetate implant) to Phase Out by April 2008
Dec 20, 2007 10:19am
WAYNE, N.J., Dec. 20 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that after careful consideration, the company will discontinue marketing of Viadur(R) (leuprolide acetate implant) with Duros technology. Based on diminished market demand and growing manufacturing costs, Bayer HealthCare Pharmaceuticals has concluded that Viadur has limited long-term market viability. The decision to discontinue marketing of Viadur is not the result of safety or efficacy issues.
Viadur is indicated to manage the symptoms associated with advanced prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Bayer will fulfill orders until current supplies are depleted, expected by the end of April 2008. Alternative therapies are available for the palliative care of prostate cancer patients. Patients should discuss these options with their healthcare providers.
Bayer is committed to continuing patient and physician support services for current and new Viadur patients. Physicians should continue to use the current customer service hotline (800-288-8370) for orders and shipping questions. Information will also remain available at www.viadur.com.
In addition, Bayer HealthCare Pharmaceuticals has arranged for patients currently enrolled in the Viadur Continuous Care patient support program to receive an invitation to join the Us TOO International Patient Education and Support Network. Us TOO International is a grassroots, non-profit prostate cancer education and support network of 325 chapter support groups worldwide, providing men and their families with free information, materials and peer-to- peer support so they can make informed choices on detection, treatment options and coping with ongoing survivorship. More information on Us TOO can be found at www.ustoo.org.
About Viadur
Viadur (leuprolide acetate) is the first and only titanium implant drug- delivery system using Duros technology to manage the symptoms associated with advanced (stage 4) prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Viadur delivers leuprolide acetate to control the symptoms of prostate cancer with an innovative delivery system. Viadur reduces the amount of testosterone produced and circulated in the body in a continuous and steady therapy for a full 12 months.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021088s025lbl.pdf
Marketing of Viadur(R) (leuprolide acetate implant) to Phase Out by April 2008
Dec 20, 2007 10:19am
WAYNE, N.J., Dec. 20 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that after careful consideration, the company will discontinue marketing of Viadur(R) (leuprolide acetate implant) with Duros technology. Based on diminished market demand and growing manufacturing costs, Bayer HealthCare Pharmaceuticals has concluded that Viadur has limited long-term market viability. The decision to discontinue marketing of Viadur is not the result of safety or efficacy issues.
Viadur is indicated to manage the symptoms associated with advanced prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Bayer will fulfill orders until current supplies are depleted, expected by the end of April 2008. Alternative therapies are available for the palliative care of prostate cancer patients. Patients should discuss these options with their healthcare providers.
Bayer is committed to continuing patient and physician support services for current and new Viadur patients. Physicians should continue to use the current customer service hotline (800-288-8370) for orders and shipping questions. Information will also remain available at www.viadur.com.
In addition, Bayer HealthCare Pharmaceuticals has arranged for patients currently enrolled in the Viadur Continuous Care patient support program to receive an invitation to join the Us TOO International Patient Education and Support Network. Us TOO International is a grassroots, non-profit prostate cancer education and support network of 325 chapter support groups worldwide, providing men and their families with free information, materials and peer-to- peer support so they can make informed choices on detection, treatment options and coping with ongoing survivorship. More information on Us TOO can be found at www.ustoo.org.
About Viadur
Viadur (leuprolide acetate) is the first and only titanium implant drug- delivery system using Duros technology to manage the symptoms associated with advanced (stage 4) prostate cancer, including pain, urinary problems and other symptoms typical of the disease. Viadur delivers leuprolide acetate to control the symptoms of prostate cancer with an innovative delivery system. Viadur reduces the amount of testosterone produced and circulated in the body in a continuous and steady therapy for a full 12 months.
HA HA HA HA $150 million product ????
Bayer to market Alza's new prostate cancer drug in the U.S.
By Brian Reid, Bloomberg News
Published: April 5, 2000 12:00 a.m.
Mountain View, California, April 5 (Bloomberg)--Bayer AG, the company that discovered aspirin, will market Alza Corp.'s Viadur prostate cancer drug, the companies said, a move that allows Alza to concentrate its own resources on other products.
Viadur, approved by the U.S. Food and Drug Administration last month, uses leuprolide, the active ingredient in Lupron, a drug made by Abbott Laboratories and Takeda Chemical Industries Ltd. Unlike Lupron, which is injected, Viadur is delivered through a small metal implant under the skin of the upper arm that can be left in place for a year.Alza said it will focus its attention on two products: the urinary incontinence drug Ditropan XL, which the company introduced last year, and Concerta, an attention deficit/hyperactivity disorder drug being reviewed by the FDA.
"We are concentrating Alza's sales and marketing resources on supporting the Ditropan XL brand, as well as establishing a central nervous system/pediatric sales and marketing organization to launch our once-daily treatment for attention deficit/hyperactivity disorder," said Ernest Mario, Alza's chief executive, in a statement.
Bayer said it will use its experience in marketing its Cipro antibiotic to doctors to sell Viadur. Much of the promotion of Cipro has been aimed at urologists, the doctors who will prescribe Viadur. Analysts say the drug could bring in $150 million in annual sales.
Terms of the agreement were not revealed, though the companies said Bayer would have rights to the product in the U.S. until 2015. In return, Alza will receive initial payments from Bayer as well as royalty revenue from the sale of Viadur.
Bayer shares fell 1.71 euros to 45.43 in Frankfurt trading. Alza shares rose 5/8 to close at 39 3/8 yesterday.
Prostate cancer strikes about one in eight American men and is expected to kill more than 30,000 in the U.S. this year.
Bayer to market Alza's new prostate cancer drug in the U.S.
By Brian Reid, Bloomberg News
Published: April 5, 2000 12:00 a.m.
Mountain View, California, April 5 (Bloomberg)--Bayer AG, the company that discovered aspirin, will market Alza Corp.'s Viadur prostate cancer drug, the companies said, a move that allows Alza to concentrate its own resources on other products.
Viadur, approved by the U.S. Food and Drug Administration last month, uses leuprolide, the active ingredient in Lupron, a drug made by Abbott Laboratories and Takeda Chemical Industries Ltd. Unlike Lupron, which is injected, Viadur is delivered through a small metal implant under the skin of the upper arm that can be left in place for a year.Alza said it will focus its attention on two products: the urinary incontinence drug Ditropan XL, which the company introduced last year, and Concerta, an attention deficit/hyperactivity disorder drug being reviewed by the FDA.
"We are concentrating Alza's sales and marketing resources on supporting the Ditropan XL brand, as well as establishing a central nervous system/pediatric sales and marketing organization to launch our once-daily treatment for attention deficit/hyperactivity disorder," said Ernest Mario, Alza's chief executive, in a statement.
Bayer said it will use its experience in marketing its Cipro antibiotic to doctors to sell Viadur. Much of the promotion of Cipro has been aimed at urologists, the doctors who will prescribe Viadur. Analysts say the drug could bring in $150 million in annual sales.
Terms of the agreement were not revealed, though the companies said Bayer would have rights to the product in the U.S. until 2015. In return, Alza will receive initial payments from Bayer as well as royalty revenue from the sale of Viadur.
Bayer shares fell 1.71 euros to 45.43 in Frankfurt trading. Alza shares rose 5/8 to close at 39 3/8 yesterday.
Prostate cancer strikes about one in eight American men and is expected to kill more than 30,000 in the U.S. this year.
The Viadur® leuprolide acetate implant was developed by Alza (now part of Johnson & Johnson) and marketed by Bayer until it was discontinued in 2007 due to generic competition. Viadur® gained FDA approval in 2000 for the treatment of prostate cancer and utilized the DUROS® platform. The DUROS®titanium implant is 4 mm in diameter by 45 mm in length and provides osmotically driven, zero-order drug delivery (Fig. 9) [71,72]. The implant is placed under the skin on the inside of the upper arm with the aid of a trocar. At the end of the one year delivery duration, the empty system is explanted. Viadur® delivered leuprolide (370 mg/ml leuprolide in dimethyl sulfoxide) continuously over 1 year at ~120 μg/day (0.4 μl/day) from a 150 μl drug reservoir [73]. In vitro and in vivo (rats and beagles) release rate data demonstrated zero-order delivery for 1 year [72,74]. Serum testosterone and leuprolide levels were also monitored and showed steady release rates for 12 months.
Fig. 9
Diagram of a DUROS® osmotic implant. Reproduced with permission from Fig. 1 in [72] (©2001 Elsevier).
Durect Corp. licensed the DUROS® platform from Alza for pain indications. The CHRONOGESIC®reservoir contained ~155 μl sufentanil in benzyl alcohol and provided zero-order release at 5 μg/hr [75]. Durect initiated Phase 3 trials with sufentanil for moderate to severe chronic pain. However, the trial was suspended in 2003 due to premature shutdown of devices [76].
Intarcia Therapeutics uses the DUROS® implant for the delivery of exenatide (type 2 diabetes) and ω-interferon (Hepatitis C) [77]. Exenatide was formulated for a 6 month (45 μg/day), 9 month (30 μg/day), and 12 month (10 μg/day) duration and showed good stability at 25°C and 37°C for 12 months [78]. Furthermore, exenatide was dosed at 20-80 μg/day for 6 months in Phase 2b trials [79]. Intarcia also has ω-interferon in Phase 1b (25 μg/day and 50 μg/day) for Hepatitis C [80,81]. ω-interferon was formulated as a suspension and showed good stability for 2 years at 30°C. The protein was delivered from the device at 9 μg/day and 22 μg/day for 6 months at 37°C.
Adv Drug Deliv Rev. 2012 Nov; 64(14): 1590–1602.
Published online 2012 Feb 21. doi: 10.1016/j.addr.2012.02.005
PMCID: PMC3430809
NIHMSID: NIHMS360102
Reservoir-Based Drug Delivery Systems Utilizing Microtechnology
Cynthia L. Stevenson,a John T. Santini, Jr.,a,* and Robert Langerb
Fig. 9
Diagram of a DUROS® osmotic implant. Reproduced with permission from Fig. 1 in [72] (©2001 Elsevier).
Durect Corp. licensed the DUROS® platform from Alza for pain indications. The CHRONOGESIC®reservoir contained ~155 μl sufentanil in benzyl alcohol and provided zero-order release at 5 μg/hr [75]. Durect initiated Phase 3 trials with sufentanil for moderate to severe chronic pain. However, the trial was suspended in 2003 due to premature shutdown of devices [76].
Intarcia Therapeutics uses the DUROS® implant for the delivery of exenatide (type 2 diabetes) and ω-interferon (Hepatitis C) [77]. Exenatide was formulated for a 6 month (45 μg/day), 9 month (30 μg/day), and 12 month (10 μg/day) duration and showed good stability at 25°C and 37°C for 12 months [78]. Furthermore, exenatide was dosed at 20-80 μg/day for 6 months in Phase 2b trials [79]. Intarcia also has ω-interferon in Phase 1b (25 μg/day and 50 μg/day) for Hepatitis C [80,81]. ω-interferon was formulated as a suspension and showed good stability for 2 years at 30°C. The protein was delivered from the device at 9 μg/day and 22 μg/day for 6 months at 37°C.
Adv Drug Deliv Rev. 2012 Nov; 64(14): 1590–1602.
Published online 2012 Feb 21. doi: 10.1016/j.addr.2012.02.005
PMCID: PMC3430809
NIHMSID: NIHMS360102
Reservoir-Based Drug Delivery Systems Utilizing Microtechnology
Cynthia L. Stevenson,a John T. Santini, Jr.,a,* and Robert Langerb
Something interesting an insider also shared with me is that Bayer pulled the same pump which delivered 1 too many prorate cancer drug altogether 10 yrs ago due to lack of demand and Intarcia picked up the patents for a song. Anyone know when that pump goes off patent?
DUROS Leupolid implants named as Viadur was approved as the first implantable osmotic pump for humans in USA in the year 2000. In 2001, patent was granted for dosage form comprising of liquid drug formulation that can emulsify to enhance the solubility, dissolution and bioavailability of the drug. First report of floating osmotic pump was given in 2003. This proves that the controlled delivery of drug through osmotic pump systems is a successful method to deliver the drugs which has been investigated and studied since past three decades and is still continuing to develop and mature to provide a controlled release of drugs in a zero order fashion for a prolonged period of time making it independent of the various physiological factors in the human body
patents should be expiring over the next 2-3 years
DUROS Leupolid implants named as Viadur was approved as the first implantable osmotic pump for humans in USA in the year 2000. In 2001, patent was granted for dosage form comprising of liquid drug formulation that can emulsify to enhance the solubility, dissolution and bioavailability of the drug. First report of floating osmotic pump was given in 2003. This proves that the controlled delivery of drug through osmotic pump systems is a successful method to deliver the drugs which has been investigated and studied since past three decades and is still continuing to develop and mature to provide a controlled release of drugs in a zero order fashion for a prolonged period of time making it independent of the various physiological factors in the human body
patents should be expiring over the next 2-3 years
Unless Intarcia can extend it which is common and often desperate lame attempts made by pharma companies.
Anyway the ride is going to up in 3 yrs folks as you all know what happens when the generics come marching in - that is IF Intarcia can get their act together and get it approved this year.
Good luck finding patients, the guinea pigs, willing to put strange object in their body not to mention additional cost associated with even out patient surgery = EXPENSIVE therapy payers will balk at.
On track for approval soon since NDA filed in late 2016.
Unless they get the dreaded CRL (complete response letter) from FDA which may push out the approval to 6 to 18 months. Heard Hayward factory in pretty fucked up based on glassdoor.com reviews which universally say in disarray...
Watch out on glassdoor - please notice that the company pays to provide information like "annual revenue" and other stuff. Absolutely the comments there are the tip of the ice burg most of us talk about how long we have to find something before this place blows up.
Is it possible to tell people that re-launching a generic is actually making it into a "new drug" ?
Bydureon/Byetta GLP-1 class volumes grew by 25% during the quarter and continues to be the fastest-growing class for patients with type-2 diabetes. Combined sales for Bydureon/Byetta were $197m, with Bydureon sales, up 11%, representing approximately 69% of total Bydureon/Byetta sales. Byetta sales declined by 30% to $62m with the Company’s focus switching to Bydureon. In the US, Bydureon sales were $108m, an increase of 2% despite increased competition from new market entrants. Sales in Europe were $23m
Who will pop the hype bubble ?
Bydureon/Byetta GLP-1 class volumes grew by 25% during the quarter and continues to be the fastest-growing class for patients with type-2 diabetes. Combined sales for Bydureon/Byetta were $197m, with Bydureon sales, up 11%, representing approximately 69% of total Bydureon/Byetta sales. Byetta sales declined by 30% to $62m with the Company’s focus switching to Bydureon. In the US, Bydureon sales were $108m, an increase of 2% despite increased competition from new market entrants. Sales in Europe were $23m
Who will pop the hype bubble ?
This is about the future of delivery systems for chronic diseases. Diabetes being the first of many disease states that can be looked at for new long term delivery systems. Lifelong, crippling diseases that allow for steady state consistent blood levels will lead to better outcomes. As nonotechnology continues to develop cures may not be at hand but long term treatments will provide better outcomes, improved quality of life, and cost less healthcare dollars over time. Quit thinking about what can't happen and think about the future with new and improved delivery systems. If not this one, then the next generation. At least Intarcia is moving toward the future not staying locked in the past with an X-R tablet or long acting injectable decanoate.
Happy Independence Day to all Americans!
Happy Independence Day to all Americans!
then why did Bayer discontinue your super pump if it is so good ?
I stared at my key this morning. The break was nice but the reflection has left me feeling weighted down, like moving in molasses. Politics, back stabbing, kissing ass- when did my life take a wrong turn to end up here.
#37- I feel your pain. I think it's life in the good ole USA in 2017. Add to that working in Pharma today with no job security and mindless tasks by our work pods when one can do the job. The industry lost its way and we as employees have suffered the consequences. However the money is good and we look for new opportunities while we are employed. Good Day to you!
Yeah well be quiet. Keep your pain to yourself and spend time looking. Escape may be possible if we slip out before the crash.
Cos piss poor sales due to the HIGH price, tons of better and CHEAPER drugs to treat and no additional need for SURGICAL procedure.
Oh wait - same challenges in the Type II diabetes market! LOL