Expansion for new sales force
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I also heard that one of the new managers accepted the offer then backed out already. The existing managers are trying to sell the idea that the delay is good, but who buys that? A delay is never good especially when you read the FDA concerns. I would rather the manager be honest rather then blowing smoke but the simple minded want to believe. I am not going to continue with the process. Had questions to begin with, meeting the leadership and seeing this delay confirms I need to wait on something better.
Same ol shit - at least they changed the name from Preos to Natpara
NPS drug Preos gets mixed bag from FDA
Osteoporosis treatment: Questions hold up SLC company's full approval
BY BOB MIMS
THE SALT LAKE TRIBUNE
PUBLISHED MARCH 14, 2006 12:01 AM
On the threshold of market approval, NPS Pharmaceuticals' flagship osteoporosis drug has run into government questions about a potentially worrisome side effect.
Although lauding the Salt Lake City company's Preos compound for significantly reducing fracture risks in postmenopausal women with osteoporosis, the Food and Drug Administration has raised concerns over the increased occurrence of hypercalcemia.
The FDA did issue an "approvable letter," indicating it found Preos safe and effective, with most of the major hurdles for the agency's final blessings cleared. The agency often takes this approach, identifying usually minor questions for clarification.
In some cases, the FDA may withhold final approval pending additional clinical tests. NPS spokeswoman Brandi Simpson said Monday that company representatives plan to meet soon with the agency to determine how extensive their concerns may be.
In addition to the hypercalcemia issue, the FDA wants to know more about the proposed injection device for delivery of the drug.
"We are pleased that the FDA found Preos approvable," Simpson said. "Until we have a better understanding, we can't speculate as to how serious their concerns are or what it means for the company."
Analysts were not as shy. Mark Augustine of Credit Suisse First Boston speculated that the FDA's concerns could dampen, if not ruin, Preos' eventual market debut.
"When you fail to make the primary endpoint in a clinical study, all subsequent analyses are unimportant. This is no exception," he said. "However, I compliment the company on having the brass to spin a failure into a success and to get people to continue to pay attention to it."
Augustine referred to the near-40-percent plunge NPS stock took late Friday when news of the FDA's reservations first began to circulate. Prices tumbled from $14.34 per share to $8.77 - the lowest in at least a year. However, the stock recovered some of that ground Monday, closing at $9.35, up 58 cents or 7 percent.
Michael Aberman of Morgan Stanley said that even under "a best-case scenario with existing data being sufficient" to alleviate FDA worries, Preos' launch - earlier expected by this summer - could be delayed at least six months.
"If additional clinical trials are required, which we think is most likely, we are not sure if the drug will ever make it to market," Aberman noted.
Any delays could give NPS competitor Eli Lilly a huge marketing advantage for its own osteoporosis drug, Forteo, analysts said.
"Wall Street hates uncertainty," said Adam Walsh of Jefferies Co. "The [FDA action] doesn't give us enough information to make investment decisions. . . . Additional clinical trials could mean a delay [in Preos' final approval] of possibly years.
"But it could very well be, too, that NPS has the information FDA wants in its current data," he stressed.
NPS drug Preos gets mixed bag from FDA
Osteoporosis treatment: Questions hold up SLC company's full approval
BY BOB MIMS
THE SALT LAKE TRIBUNE
PUBLISHED MARCH 14, 2006 12:01 AM
On the threshold of market approval, NPS Pharmaceuticals' flagship osteoporosis drug has run into government questions about a potentially worrisome side effect.
Although lauding the Salt Lake City company's Preos compound for significantly reducing fracture risks in postmenopausal women with osteoporosis, the Food and Drug Administration has raised concerns over the increased occurrence of hypercalcemia.
The FDA did issue an "approvable letter," indicating it found Preos safe and effective, with most of the major hurdles for the agency's final blessings cleared. The agency often takes this approach, identifying usually minor questions for clarification.
In some cases, the FDA may withhold final approval pending additional clinical tests. NPS spokeswoman Brandi Simpson said Monday that company representatives plan to meet soon with the agency to determine how extensive their concerns may be.
In addition to the hypercalcemia issue, the FDA wants to know more about the proposed injection device for delivery of the drug.
"We are pleased that the FDA found Preos approvable," Simpson said. "Until we have a better understanding, we can't speculate as to how serious their concerns are or what it means for the company."
Analysts were not as shy. Mark Augustine of Credit Suisse First Boston speculated that the FDA's concerns could dampen, if not ruin, Preos' eventual market debut.
"When you fail to make the primary endpoint in a clinical study, all subsequent analyses are unimportant. This is no exception," he said. "However, I compliment the company on having the brass to spin a failure into a success and to get people to continue to pay attention to it."
Augustine referred to the near-40-percent plunge NPS stock took late Friday when news of the FDA's reservations first began to circulate. Prices tumbled from $14.34 per share to $8.77 - the lowest in at least a year. However, the stock recovered some of that ground Monday, closing at $9.35, up 58 cents or 7 percent.
Michael Aberman of Morgan Stanley said that even under "a best-case scenario with existing data being sufficient" to alleviate FDA worries, Preos' launch - earlier expected by this summer - could be delayed at least six months.
"If additional clinical trials are required, which we think is most likely, we are not sure if the drug will ever make it to market," Aberman noted.
Any delays could give NPS competitor Eli Lilly a huge marketing advantage for its own osteoporosis drug, Forteo, analysts said.
"Wall Street hates uncertainty," said Adam Walsh of Jefferies Co. "The [FDA action] doesn't give us enough information to make investment decisions. . . . Additional clinical trials could mean a delay [in Preos' final approval] of possibly years.
"But it could very well be, too, that NPS has the information FDA wants in its current data," he stressed.
Exactly, good point..
Current NPS ABS's must be spoiled, the grass isn't greener on the other side....crazy to be looking elsewhere being fortunate enough to have a position in such a small specialized company. There are many of us out there that would love to take your job!
Thank you for this VERY helpful information. I had no idea why NPS started in 2006 but most weren't hired till Gattex launch. Then the fact that Natpara is getting the push back from FDA was another question. Seeing that this drug has been going through the FDA approval process since 2006 and wasn't approved for the first indication definitely gives me something to pump the brakes on. Seems like this is hype to sell the company vs. a viable company to invest my future in. Super helpful. Thanks for the info!
We appreciate you moving along and taking yourself out of consideration. It will save us the trouble if letting you know you were not selected.
NPS Updates Status of PREOS(R) NDA
SALT LAKE CITY, March 29 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals,
Inc. (Nasdaq: NPSP) today provided the following update regarding the status
of its new drug application (NDA) for PREOS(R) (parathyroid hormone [rDNA
origin] for injection).
Since receiving an approvable letter from the U.S. Food and Drug
Administration (FDA) for the PREOS NDA on March 9, 2006, NPS has been in
communication with the FDA by telephone and in writing regarding the issues
raised in the approvable letter. The FDA raised two issues in the approvable
letter for PREOS: one related to the risk of hypercalcemia and the other
related to the reliability and use of the injection device for the delivery of
PREOS. The FDA has been responsive to the company's communications and has
scheduled a formal meeting with NPS for May 1, 2006 to discuss the
hypercalcemia issue. NPS has submitted questions to the FDA in preparation
for the May 1 meeting. A separate meeting is being scheduled to discuss the
injection device. Prior to both meetings with the FDA, the company intends to
submit an information package to the agency. The company expects these
meetings will be the first in a series of meetings with the FDA.
Since NPS submitted the NDA for PREOS in May 2005, the company has
analyzed different patient characteristics and various other factors from its
pivotal Phase 3 TOP study regarding the occurrence of hypercalcemia and has
gathered extensive data from these analyses. NPS intends to discuss the
results of these analyses with the FDA.
With regard to the issues raised by the FDA related to the reliability and
use of the injection device for the delivery of PREOS, NPS has performed a
variety of tests, including those specified by the International Organization
for Standardization (ISO), which support the reliability of the device
proposed for commercial use.
NPS believes that the analyses it is supplying to the FDA should form the
basis for a Class 1 resubmission, which under the Prescription Drug User Fee
Act would be considered a minor re-analysis and clarification of existing data
and would commit the FDA to a two-month review period upon receipt of the
completed resubmission. However, the company emphasizes that the FDA will
determine whether the information NPS provides in response to the approvable
letter will qualify as a Class 1 resubmission. The agency might also require
a resubmission which would involve significant new data, including a new
clinical trial, which would constitute a Class 2 resubmission.
About PREOS
PREOS is recombinant human parathyroid hormone (PTH). NPS has studied
PREOS in a number of clinical settings to document its safety and effects on
bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with
PTH), was a multi-center, randomized, double-blind and placebo-controlled
clinical trial designed to evaluate the potential of PTH to reduce the risk of
first and subsequent vertebral fractures in post-menopausal women.
In the TOP study, PREOS demonstrated a statistically significant reduction
in the risk of new vertebral fractures in women with and without pre-existing
osteoporosis-related fractures. Results from the TOP study have been the
foundation of both the E.U. and the U.S. marketing authorization applications.
SALT LAKE CITY, March 29 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals,
Inc. (Nasdaq: NPSP) today provided the following update regarding the status
of its new drug application (NDA) for PREOS(R) (parathyroid hormone [rDNA
origin] for injection).
Since receiving an approvable letter from the U.S. Food and Drug
Administration (FDA) for the PREOS NDA on March 9, 2006, NPS has been in
communication with the FDA by telephone and in writing regarding the issues
raised in the approvable letter. The FDA raised two issues in the approvable
letter for PREOS: one related to the risk of hypercalcemia and the other
related to the reliability and use of the injection device for the delivery of
PREOS. The FDA has been responsive to the company's communications and has
scheduled a formal meeting with NPS for May 1, 2006 to discuss the
hypercalcemia issue. NPS has submitted questions to the FDA in preparation
for the May 1 meeting. A separate meeting is being scheduled to discuss the
injection device. Prior to both meetings with the FDA, the company intends to
submit an information package to the agency. The company expects these
meetings will be the first in a series of meetings with the FDA.
Since NPS submitted the NDA for PREOS in May 2005, the company has
analyzed different patient characteristics and various other factors from its
pivotal Phase 3 TOP study regarding the occurrence of hypercalcemia and has
gathered extensive data from these analyses. NPS intends to discuss the
results of these analyses with the FDA.
With regard to the issues raised by the FDA related to the reliability and
use of the injection device for the delivery of PREOS, NPS has performed a
variety of tests, including those specified by the International Organization
for Standardization (ISO), which support the reliability of the device
proposed for commercial use.
NPS believes that the analyses it is supplying to the FDA should form the
basis for a Class 1 resubmission, which under the Prescription Drug User Fee
Act would be considered a minor re-analysis and clarification of existing data
and would commit the FDA to a two-month review period upon receipt of the
completed resubmission. However, the company emphasizes that the FDA will
determine whether the information NPS provides in response to the approvable
letter will qualify as a Class 1 resubmission. The agency might also require
a resubmission which would involve significant new data, including a new
clinical trial, which would constitute a Class 2 resubmission.
About PREOS
PREOS is recombinant human parathyroid hormone (PTH). NPS has studied
PREOS in a number of clinical settings to document its safety and effects on
bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with
PTH), was a multi-center, randomized, double-blind and placebo-controlled
clinical trial designed to evaluate the potential of PTH to reduce the risk of
first and subsequent vertebral fractures in post-menopausal women.
In the TOP study, PREOS demonstrated a statistically significant reduction
in the risk of new vertebral fractures in women with and without pre-existing
osteoporosis-related fractures. Results from the TOP study have been the
foundation of both the E.U. and the U.S. marketing authorization applications.
Thank you, again. Excellent information. I have been told I am a "top candidate" (recruiter's statement) for the area I live in and would interview in the next wave in Chicago but this is just not sounding so great. I appreciate that you are providing true data vs simply being a dick like the person was above.
Heard that too about a manager leaving already. And I think the guy even knew the NSD or the President or something.
http://www.ema.europa.eu/ema/index....9/human_med_000984.jsp&mid=WC0b01ac058001d124
The marketing authorisation for Preotact has been withdrawn at the request of the marketing authorisation holder.
Information
Generic Name:
parathyroid hormone (pth 1-84)
Trade Name: Preotact (EU), Natpara (US)
Synonym: NPSP558
http://www.outsourcing-pharma.com/C...into-fill-finish-problems-as-BLA-filing-nears
Due to a technical production issue, Takeda is presently unable to have batches of finished product manufactured that are consistently within specification and we have been informed that as a result Takeda is experiencing an out-of-stock situation for Preotact which began in certain countries in August 2012. We understand that Takeda has taken a number of actions to resolve the manufacturing issue and to accelerate a return to normal supply situation. It is our understanding that Takeda is no longer selling Preotact in their territories and we have not received any information as to when or if Takeda will re-introduce Preotact in the future
The marketing authorisation for Preotact has been withdrawn at the request of the marketing authorisation holder.
Information
Generic Name:
parathyroid hormone (pth 1-84)
Trade Name: Preotact (EU), Natpara (US)
Synonym: NPSP558
http://www.outsourcing-pharma.com/C...into-fill-finish-problems-as-BLA-filing-nears
Due to a technical production issue, Takeda is presently unable to have batches of finished product manufactured that are consistently within specification and we have been informed that as a result Takeda is experiencing an out-of-stock situation for Preotact which began in certain countries in August 2012. We understand that Takeda has taken a number of actions to resolve the manufacturing issue and to accelerate a return to normal supply situation. It is our understanding that Takeda is no longer selling Preotact in their territories and we have not received any information as to when or if Takeda will re-introduce Preotact in the future
When are offers going out?
I'm coming over from shire so I'm pretty much guaranteed a spot. Unless I mess up the interview.
I'm coming over from shire so I'm pretty much guaranteed a spot. Unless I mess up the interview.
I'm coming over from Celgene - this is a better growth opportunity
Is NPS still moving forward with hiring a sales force in light of the 3 month delay?
So what does this mean? Is there only a limited supply of Natpara available? Having worked with a company when drug supply was halted was bad news. What more can you share about this?
Believe there is a hiring freeze for the foreseeable future. Rumor mill is going crazyb internally that we will be sold by end of year. Not a place you want to be because whether or not we get approval, we will be sold. Sorry for the bad news but best you look elsewhere.
This company is toast. Many of the managers here are struggling getting good people. People don't want to bounce around these days. Looking for their security, not just receive a paycheck and wonder if they have a job in a few months.
Good stop posting then you punk. You're scared to compete against others so you make up stories. If I ever see you, I will beat your a%%!!!!!
why act like an a-hole to someone who is trying to help you?
1. Was at Amgen when the FDA delayed approval of Denosomab (Prolia) because they needed more information - not the end of the world by any means.
2. Hiring is still going on @ NPS.......despite the rumor mill speaking of a buyout.
3. A buyout may actually give NPS more clout to compete so not all together a bad thing.
Am sure I will pissed off a few folks with those comments
2. Hiring is still going on @ NPS.......despite the rumor mill speaking of a buyout.
3. A buyout may actually give NPS more clout to compete so not all together a bad thing.
Am sure I will pissed off a few folks with those comments