Expansion for new sales force

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Anonymous said:
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 :)
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While interviewing is still going on in hopes of approval in January, hiring is not. A buyout puts a new sales force at risk in that those that buy a companh are buying it for the drug and they want the rights to the drug to be sold by their existing sales force.

That being said, since Natpara (under a different name) hasn't been approved for a previous indication (2006) and now delayed due to serious questions regarding efficacy and long range safety this go round, why does this still seem appealing to anyone? I would question the motivation of a sales person leaving an existing job and coming to this company with all of this being public knowledge. I would wonder if they were on a performance improvement plan or had horrific numbers for them to jump to an unstable place. Just my thoughts.
 


















I agree with the statement of whether it makes sense to interview. The interviews are still on going but I don't quite get who would be interested? Then again, they may be holding out for a launchin 2015 (certainly a possibility) and so they will move forward with interviews since there are RBDs on payroll who need to be busy, right?
 












Anonymous said:
I agree with the statement of whether it makes sense to interview. The interviews are still on going but I don't quite get who would be interested? Then again, they may be holding out for a launchin 2015 (certainly a possibility) and so they will move forward with interviews since there are RBDs on payroll who need to be busy, right?
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Who would be interested?

Someone who wants to launch a drug into the endocrine space for a rare disease, for one.

The management team is comprised of great people...at least the folks with whom I met. I'd work for any one of them.

Benefits are average for the industry...nothing special, but not lacking in any way.

Equity is OK, too. Not great, but fair. ESPP is standard.

We'll see what the salaries and comp plan look like, but I'm interested so far.
 
























could be a fast growing product right from the git go - just replace the Forteo and BAM !

http://www.parathyroid.com/hypoparathyroidism.htm

FORTEO (teriparatide). Forteo is a genetically engineered man-made hormone that is composed of the first 34 amino acids of the human PTH molecule (about 1/2 of the molecule, but it works like the entire molecule). Lily is the pharmaceutical company that makes this hormone and their name for this is "Forteo" (the generic name for this hormone molecule is "teriparatide" (tare-ree-PAIR-ah-tide)). Because this molecule is a hormone (a protein with a very specific size and shape), it must be given with a shot under the skin just like insulin. And, like most other hormones, it has a short lifespan in the body (half-life) so that it needs to be given at least once per day. In fact, some would suggest that taking the shots twice per day will work better and use less hormone than taking it once per day. A lot of hypOparathyroid patients are now taking Forteo or have tried it in the past to help them cope with the loss of their own parathyroid glands. Some patients have found that it makes their disease much more manageable, wile others simply say that the drug makes them feel worse or doesn't help at all. It is important to remember... there is not much known yet about using this drug for hypOparathyroidism, as no good medical studies have been done yet. This drug was made for the treatment of osteoporosis in post-menopausal women (this is a MUCH BIGGER market for the drug companies than is the rare condition of hyp0parathyroidism). It is used in post-menopausal women who are at high risk of having fractures, have had fractures, or who cannot use other osteoporosis treatments. This medicine increases bone mass and bone strength, thereby decreasing the chance of getting a fracture. HOWEVER, for patients with hyp0parathyroidism, the issue is to replace the hormone that has been removed with the parathyroid glands. Lilly will still be using this drug for severe cases of osteoporosis, but for now the use of this drug in patients with hyp0parathyroidism is at the discretion of your endocrinologist, provided the endocrinologist tells you about the potential risks of this drug (some tests showed that this drug caused bone cancer in the lab animals that they were giving it to). Although the doses of the hormone that they were giving to the experimental animals was MUCH higher than would be given to a human for hyp0parathyroidism, it did cause the bone cancer so Lilly stopped the clinical trials in humans with hypoparathyroidism). This does not mean that you should not take this drug... but it is not FDA approved for use in hypoparathyroidism. I regularly recommend this drug for patients with hypoparathyroidism that are referred to me--and if the patient feels that the drug helps, then I recommend they stay on it. There are some very specific patients that should never take Forteo (those at risk for osteosarcoma: e.g. Paget's disease, prior radiation therapy, bone metastases, open epiphyses, etc). As a side note, Dr Norman is NOT a fan of Forteo for osteoporosis. He's not sure it actually works and thinks most doctors who give it have no idea what they are doing. This is an editorial, and an opinion based on observations but not on actual studies.

IMPORTANT. If you are one of the rare patients that has had all your parathyroid glands removed and a part of one transplanted in your arm (almost never appropriate for primary hyperparathyroidism, but done regularly for hyperparathyroidism due to renal failure) and you have hypoparathyroidism immediately after the surgery... you should NOT take Forteo in the first 3-4 months. It is possible that your transplant will begin to make hormone after a few months... but if you take Forteo you could suppress the parathyroid cells that are trying to grow and doom your transplant. If the transplant is making little or no parathyroid hormone after 4 months, it will likely never make sufficient (any??) hormone and Forteo may be tried. You can read more about Forteo here.
 






























Read the study, read the FDA reply after the BLA, learn about the PDUFA delay, realize this product was initially for another indication around 2006 and it didn't get approved then. You do the math.
 






Anonymous said:
Read the study, read the FDA reply after the BLA, learn about the PDUFA delay, realize this product was initially for another indication around 2006 and it didn't get approved then. You do the math.
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So you're saying that because Natpara wasn't approved for osteoporosis in 2006, it won't get approved for hypoparathyroidism in 2014?
 






Anonymous said:
So you're saying that because Natpara wasn't approved for osteoporosis in 2006, it won't get approved for hypoparathyroidism in 2014?
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I said read the study that was submitted for approval. 53% efficacy? No dosing regime determined?? You think this is only a 3 month delay or will this require additional studies? Just to many questions from the FDA.
 






Anonymous said:
I said read the study that was submitted for approval. 53% efficacy? No dosing regime determined?? You think this is only a 3 month delay or will this require additional studies? Just to many questions from the FDA.
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Read the manuscript, genuis.

Primary endpoint was 48-1 in favor of Natpara. Secondary endpoint was 36-2. And this was after an optimization phase that ensured patients were receiving the optimal levels of Ca and Vitamin D prior to randomization.

And what's a dosing regime, anyway? If you meant regimen, most patients were escalated to 100ug during the titration phase.

Didn't do too well on the simulation, did you?

If you're not impressed, why are you posting?
 






I just double checked the data - were you referring to the control of hypercalcuria and hypocalcemia ?? My source must be confused it says that placebo patients did better than the treatment arm.
 






Anonymous said:
I just double checked the data - were you referring to the control of hypercalcuria and hypocalcemia ?? My source must be confused it says that placebo patients did better than the treatment arm.
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You suggest "read the study" then blame your bullshit comment on your "source"?

Bombed the simulation, did you?
 






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