Omnaris is gone for a while, manufacturing problem. If the new product doesn't get approved, we are all screwed. Good thing is, the grade book will be thrown in the garbage along with all of the omnaris. Read my lips, No New Taxes(pips)
Recall of Omnaris Nasal Spray 50mcg due to quality defect (with photo) ********************************************************** The Department of Health (DH) today (November 16) endorsed the voluntary recall of one batch (Batch number: 137930) of a pharmaceutical product called Omnaris Nasal Spray 50mcg (Omnaris) (Registration number: HK-59322) from shelves by a licensed drug wholesaler, Nycomed (Hong Kong) Limited (Nycomed), in view of a quality defect. The DH received notification from the company that the product's German manufacturer, Nycomed Gmbh, conducts a worldwide recall of affected batches as the manufacturer discovered pinhole or leakage in some of the pouches which might affect the product quality. According to the manufacturer, the defects in the pouches might lead to oxygen ingress to the pouch from ambient air and lead to a decrease of the preservative and an increase of its degradation product. Omnaris contains ciclesonide which is a steroid indicated for treatment of nasal symptoms associated with allergic rhinitis. It requires doctors' prescription and can only be sold in a pharmacy under the supervision of a pharmacist. The affected batch was manufactured in August 2010. A total of 9,807 boxes were imported and supplied to hospitals under the Hospital Authority (HA), private hospitals, private doctors, pharmacies and exported to Macao. According to the information from Nycomed so far, no batches manufactured since January 2011 showed pinhole defects of the pouches. DH's investigation continues. So far no adverse reports have been received. Nycomed has set up a hotline 2133 9800, operating from 9am to 5pm from Monday to Friday, to answer related enquiries. DH has already alerted the HA, private hospitals, professional healthcare bodies and the Macao authority about the matter and will closely monitor the recall. "Members of the public should check the pouches of the product before use. If they feel unwell, they should stop using the drug and consult their healthcare providers. "Here, contravention of Section 52(1) of the Public Health and Municipal Services Ordinance Cap 132, selling any drug not of the nature, substance or quality demanded by the purchaser, might have occurred. The maximum penalty involved is $10,000 and three months' imprisonment. On completion of our investigation, we will consult the Department of Justice for advice regarding prosecution," the spokesman said. Ends/Wednesday, November 16, 2011 Issued at HKT 21:31 NNNN
Bull, you are just trying to cause trouble. Manufacturing issue has nothing to do with selling rights
I think there is more than meets the eye going on with Omnaris. Nycomed was not happy with Sepracor's/Sunovion's performance with Omnaris Nasal Spray. I have a friend that was in management with them (lost their job when Takeda bought them out) and it was no secret that they were unhappy with sales, the amount of samples we bought from them was insufficient (so they thought), nor were they happy with the number of P1 details for the product. They thought we should have done much better with it than we did. I wish they were still there because I want answers to the following questions, and I doubt we will get them from our management team. The launch of Omnaris HFA means a significant milestone payment (about $100 million) would be due to Nycomed, and now I assume Takeda. Could the curious timing have something to do with the fact we will owe lots of bucks at a time when Xopenex is coming off patent, and our other brands are struggling in a generic marketplace. How many of the $280 million in milestone payments have we made? Is it worth making those payments when we haven't sold that much product, much less come anywhere close with the profit derived from the ciclesonide molecule. Just curious.
Funny about that recall -- I cannot find any US sources for that, only the one from Southeast Asia. It references only one batch (lot number) that was manufactured in 2010. I know we just went through that a couple of months ago. Are there any Dear Doctor letters going out to inform physicians what is going on, or is the product being left in limbo? I agree with the last poster, that there is more going around in the dark in the Marlborough offices than Santa Claus.
Very Subtle. You and I both know exactly what is going on and it has absolutely nothing to do with manufacturing. The lack of a Press Release is telling.
I think you guys may be on to something. I looked at the copy of that news release posted earlier. The date was November 16th. Isn't that a month before they fired Summit? And it says no problem with batches manufactured after January 2011 ( a year ago!) were affected. So, why are we in this crisis now? I think it is time for the management team to grow some testicles and become leaders--be honest and up front, no matter how alien it seems to be to them.
Just do a search and you will see where Takeda has taken over rights to promote a prod from Nycomed/Merck. Similar to Nycomed Sunovion agreement.
Hit the nail pretty close. New CFO from Japan is asking lots of hard questions about the way we do/have done business, and is not liking what he is hearing. Not only is Omnaris deal being scrutinized, but Stedesa cost/projected return is also being closely looked at. Iwicki is on the hot seat right now. He may be retained to save face, but real power will be shifted to DSP
I am still unable to get my Rx filled-The doctor hasn't advised me of any problem. Is the company going under?
