Mallinckrodt/inVentiv Monday, 12-2-13, Onboarding Conference Call

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.S. Food and Drug Administration (FDA) Extends Review of Mallinckrodt’s New Drug Application for XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII)
ST. LOUIS--(BUSINESS WIRE)--Nov. 25, 2013-- Mallinckrodt (NYSE: MNK) today announced that the U.S. Food and Drug Administration (FDA) extended the review of the New Drug Application (NDA) for investigational compound XARTEMIS™ XR (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets (CII). XARTEMIS XR, previously known as MNK-795, was studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
Do you not think that they will wait until they give everybody a start date. There is still a three month review of XARTEMIS XR so I don't see anything happening for a few more months. They are not going to pay you for just sitting at home waiting for an approval.

This is an article straight from Mallinckrodt website under news::


The three-month extension from the FDA is in response to additional data submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will continue discussions regarding labeling as part of the application review throughout this period.

“If approved, we believe that XARTEMIS XR could provide an important new option as an extended-release treatment for patients with acute pain,” said Mark Trudeau, President and Chief Executive Officer, Mallinckrodt. “As a leader in pain management, Mallinckrodt remains committed to developing medications that address the needs of patients, and will work with the FDA throughout the review of the XARTEMIS XR application.”

XARTEMIS XR, an investigational, extended-release oral formulation of oxycodone and acetaminophen uses a dual layer delivery mechanism with both immediate- and extended-release components. In July, the FDA accepted for filing the NDA for XARTEMIS XR and granted priority review. There are currently no extended-release oxycodone/acetaminophen combinations on the market for the management of acute pain.
 






the only word in the previous post that stood out was "IF".......more than likely they'll 'extend' start date a couple weeks/months (unemployment time) with promise to call everybody back in "IF" product gets approved... nobody wants to pay for us to twiddle our thumbs for couple of months being a big Cost to these guys - client, (believe me inVentiv doesn't want to pay for your wait time at all)
 






Anonymous said:
the only word in the previous post that stood out was "IF".......more than likely they'll 'extend' start date a couple weeks/months (unemployment time) with promise to call everybody back in "IF" product gets approved... nobody wants to pay for us to twiddle our thumbs for couple of months being a big Cost to these guys - client, (believe me inVentiv doesn't want to pay for your wait time at all)
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you folks may be right.
i think they're going to start us as announced, on the 9th and train us and have us sell exalgo and pennsaid and lay the groundwork for xartemis.
it makes perfect sense, they have so ugh invested in the process so far. IF it doesn't get approved 3 months from now, then they will pull the plug.
in any case, we'll find out this afternoon.
 




































In the face of the FDA review extension and upcoming holiday season, the on-boarding delay makes sense.

If you are a breadwinner with a family to support and ensure health insurance coverage, how do you make a seamless transition from a current employer to inVentiv? With a January 2, 2014 start date, it's too early in the year to accrue vacation time that will allow you to overlap your stop and start dates with two different employers and obtain continous coverage without a gap.

It would be most helpful if we had a December 31, 2013 or January 1, 2014 start date so that health insurance coverage would begin January 1, 2014 (even if it means the first day of work is a holiday).

You're asking us to hang with you since Mallinckrodt is in essense being held hostage by the whims of the FDA. It is very awkward in this situation to politely and professionally give a two week resignation notice and then roll the dice that the NDA is approved, the launch is a go and then go without any health insurance for a month. Some employers have plans that cover you for the remainder of the month or pay period in which your resignation is tendered (so a January 2, 2014 resignation date ensures you are paid for the New Years holiday and your insurance coverage would continue through January 31, 2014. Know the terms of your current policy as they vary). The inVentiv plan would then kick in on February 1, 2014.

And what happens if the NDA is ultimately not received...do they terminate all the new hires?
The mid-December conference call is yet another opportunity to tweak the timeline if the FDA is still balking on the abuse deterrence language in the product labeling. This entire situation is understandable but involves a bit of risk for those currently employed and covered by health insurance. There's a lot on the line if this NDA and contract get shot down at the last minute in this challenging pharma job market.

Purdue Pharma is also rolling out abuse deterrent formulations of their CII meds:

http://finance.yahoo.com/news/fda-accepts-review-purdue-pharmas-123000245.html

http://www.drugs.com/news/fda-approves-abuse-deterrent-label-new-oxycontin-44154.html
 






Anonymous said:
I wasn't on the call because I haven't had my drug screen yet. Could someone please share what was said?
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Start date is 1/2/2014 for home study, which will be about 7 biz days. then, a meet with your new District in a meet and then training in NJ, I think. They were pretty vague about that but it makes sense. We will sell Exalgo and Pennsaid and set the cycle and set lunches for the anticipated approval of the new drug. When it gets approved, we will go to the launch, which will prob still be in Orlando.
Lot of angst out there. Listen, I think it's gonna be OK. Just a minor glitch and then we'll have a great and interesting drug to sell.
 






Anonymous said:
Start date is 1/2/2014 for home study, which will be about 7 biz days. then, a meet with your new District in a meet and then training in NJ, I think. They were pretty vague about that but it makes sense. We will sell Exalgo and Pennsaid and set the cycle and set lunches for the anticipated approval of the new drug. When it gets approved, we will go to the launch, which will prob still be in Orlando.
Lot of angst out there. Listen, I think it's gonna be OK. Just a minor glitch and then we'll have a great and interesting drug to sell.
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Thank you so much!!!
 












I attempted to ask when away training was but my request must not have gone through. I know they are waiting for launch for Orlando but I will assume we will have some away training before we hit the field. Only 7 days home-study? I didn't hear them mention training in New Jersey at all, did anyone else?
 












Anonymous said:
I attempted to ask when away training was but my request must not have gone through. I know they are waiting for launch for Orlando but I will assume we will have some away training before we hit the field. Only 7 days home-study? I didn't hear them mention training in New Jersey at all, did anyone else?
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Here's what i know: Tom Bonk is a good man. I don't know any of those other people, so I can't say. He is electing to err on the side of being too informative. There are things they don't yet know so it sounds like they're holding back.
We will get the info as they get it. I believe that. This guy is an honorable man.
This is still a good gig. Hang in there or not. I have another interview tomorrow and another (zogenix) next week. I will end up with a job but this is the one I want.
 






Anonymous said:
Here's what i know: Tom Bonk is a good man. I don't know any of those other people, so I can't say. He is electing to err on the side of being too informative. There are things they don't yet know so it sounds like they're holding back.
We will get the info as they get it. I believe that. This guy is an honorable man.
This is still a good gig. Hang in there or not. I have another interview tomorrow and another (zogenix) next week. I will end up with a job but this is the one I want.
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I'm curious why you'd want this job (one that is certain to end) over one with a actual company that really is open ended???
 






Anonymous said:
Here's what i know: Tom Bonk is a good man. I don't know any of those other people, so I can't say. He is electing to err on the side of being too informative. There are things they don't yet know so it sounds like they're holding back.
We will get the info as they get it. I believe that. This guy is an honorable man.
This is still a good gig. Hang in there or not. I have another interview tomorrow and another (zogenix) next week. I will end up with a job but this is the one I want.
Click to expand...

I has nothing to do with being a good and honorable man has nothing to do with the situation. This is the world of pharma and most importantly contract pharma. This is a 3 month extension and it makes no sense to hire 160 reps to do what 200 reps have already been doing. There's things that are not known. The company states they "want to set the groundwork...how? You can't discuss the product and you shouldn't even be talking the disease state without a product. Additionally they are mixing the the territories to bring new people in to sell 2 products for a short length of time. This completely upsets the relationships that are already there. There very little coverage for pennsaid and absolutely no samples. With exalgo , it could be gone Anytime. It is a "month to month" product so it is a waste of time to train 160 new reps on it for a short term product and realign the territories. None of this makes sense. If course it did not make sense to jump the fun and hire the Inventiv team so far in advance for an "iffy" approval. They were hanging their hat on the abuse deterrent labeling and obviously did not receive it; therefore additional dTa saw probably submitted for review.
 






Anonymous said:
I'm curious why you'd want this job (one that is certain to end) over one with a actual company that really is open ended???
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the only answer i can offer is that i know the pain market. i'm trying to look 2 years into the future... based on what i know.
i might be wrong, have been wrong before or i would not be having this conversation... but i think this drug could be a winner.
 






Anonymous said:
I has nothing to do with being a good and honorable man has nothing to do with the situation. This is the world of pharma and most importantly contract pharma. This is a 3 month extension and it makes no sense to hire 160 reps to do what 200 reps have already been doing. There's things that are not known. The company states they "want to set the groundwork...how? You can't discuss the product and you shouldn't even be talking the disease state without a product. Additionally they are mixing the the territories to bring new people in to sell 2 products for a short length of time. This completely upsets the relationships that are already there. There very little coverage for pennsaid and absolutely no samples. With exalgo , it could be gone Anytime. It is a "month to month" product so it is a waste of time to train 160 new reps on it for a short term product and realign the territories. None of this makes sense. If course it did not make sense to jump the fun and hire the Inventiv team so far in advance for an "iffy" approval. They were hanging their hat on the abuse deterrent labeling and obviously did not receive it; therefore additional dTa saw probably submitted for review.
Click to expand...

wrong. it has everything to do with an honest and honorable guy at the top.
relax. quit trying to figure it all out. too many factors and too many possible scenarios.
that's where believing in the head 'honcho' comes in.
this is, and will be, a great gig.
after selling in Pain for 7 years, i know it ain't easy and if you can't handle that, go back to the POD and big Pharma advertising to pave your way.
 






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