February 13, 2013
We are writing to provide an interim update on the status of our pilot to assess the use of OMONTYS® in the FMCNA dialysis facilities. The purpose of the commercial pilot is to determine the role of OMONTYS® as an alternative Erythropoiesis Stimulating Agent (ESA) on the FMCNA Formulary. The assessment includes efficacy, safety and logistics related to this agent that was approved for use by the Food and Drug Administration at the end of March 2012.
We will now pause expansion of the pilot that began in late July 2012.
We have accumulated experience in more than 56,600 administrations in over 18,000 unique patients.
Two months into the FMCNA pilot program, the FDA released revised product information that added language similar to the prescribing information for EPOGEN® concerning the risk for allergic reactions, which we communicated to you in November 2012. To date, we have seen infrequent allergic reactions in our patient population receiving their first dose of OMONTYS®.
Most of these reactions have been mild, but a small number have been serious. The rate of allergic reactions has been on the order of 1:1000 patients receiving a first dose of OMONTYS®. The vast majority of patients who are receiving the medication on an ongoing monthly basis are tolerating it well.
Isn't this what we'd all like to see. The analysis results promised in a week or two from FMCNA.
Did they do it? If this letter was important enough to submit to the SEC where are the results?
"As we complete the analysis in the next week or two we plan to provide an update on the pilot experience and any future recommendations. I thank you for your participation in determining best protocols and practices around the use of OMONTYS® and we will update you with the analysis of our experience once complete."
Tom you raise some interesting points. I have always wondered why this letter was not more forthright in terms of laying out what exactly happened at the clinics. There are mention of severe reactions in minimal circumstances but otherwise overall well received by the vast majority of the cases. Before this came out I had taken my position down from 8,500 shares to 1,500. When I saw the market wack the stock on heavy volume and then start to rally back I added 2,000 shares, because the text of this letter did not sound that bad simply a pause while they analyzed the data. So the supposition is at this point were they worried that there was another cause at the clinic besides the drug itself? Especially since it was well tolerated by 99.98% of the patient population? I also find it interesting at this point, 8 months later, I have not heard from any law firms. I almost always get some notification if there is pending litigation as they try to sign up as many plaintiffs as possible. I am bombarded with them for any number of companies I have owned in the last few years that have dropped in price for various reasons. I lost $100k on this with the withdrawal, and yet no one has contacted me which I find odd. The law firms are as unsure about this it seems as are the people involved in the investigation. Again the shorts seems to be voting with their feet as they are covering rather quickly, despite what others who are short on this board would have you believe. Hopefully we will get some clarity before the end of the year but who knows.
Has anyone looked at the adverse incidence report for what incidences may have occurred after the fresenius letter was issued and up to the time the drug was pulled? That may be the only clue we have available if the drug was pulled because of incidents subsequent to letter issuance.
If there were no incidents reported then imo that's a major point in favor of affy not having been pulled because of any "dire circumstances" at time. I guess there's the possibility there may have been incidents which might have not been reported though i would further guess the chance of no reporting from then to now is pretty darned low.
This gwp character is actually arguing against himself. Fresenius issued the letter advocating continuing administration because no "dire circumstances" were in play at the time. If there were "dire circumstances" there's no way the letter would have been issued, unless the ceo or whomever signed it was a total fool and ignored legal advice. What chance of that? If there were no further incidents between letter issuance and pulling of the drug, no new "dire circumstances" popped up in that interval, either.
If one was an experienced health care practitioner, it was relatively easy to read this letter and comprehend that circumstances were, in fact, less than a cursory reading might suggest. Also, there is a securities class action pending and you will not be contacted until the class is certified, see Bartelt v. Affymax. The law firms are not unsure inasmuch as top tier firms are suing Affymax in the class action litigation. The products liability firms have at least 2 years to file from the date of injury.
We are now working to analyze the full set of efficacy and safety profile information and feel that the current scale of our experience with use of the drug is adequate to complete this analysis. These results will be presented to our Corporate Medical Advisory Board with follow up reporting to our medical staff. In the meantime, this communication is to inform you of our confirmation of the adjusted prescribing information and the finding that such allergic reactions can occur in patients receiving the firstdose of the drug.
For patients on OMONTYS®, we recommend continued use of the agent as it has been providing effectiveanemia management. We plan to pause the rollout to additional facilities and patients at this time until the analyses are complete and reported to our medical staff. As many of you have become quite comfortable with the medication, physicians and facilities that have been using OMONTYS® who wish to
continue prescribing it for new patients may choose to do so.
As we complete the analysis in the next week or two we plan to provide an update on the pilot experience and any future recommendations. I thank you for your participation in determining best protocols and practices around the use of OMONTYS® and we will update you with the analysis of our experience once complete.
With best regards,
Franklin W. Maddux, MD, FACP
Chief Medical Officer
Executive VP For Clinical and Scientific Affairs
Fresenius Medical Care North America
Thanks for that t0m. I think. As you know, i'm long the stock, but your posting has brought up a question for me. I go with jagan on this. In his/her post, the question is "why in the world...? I don't know if it actually was a fresenius' decision that caused the removal from market so soon after this notice or a takeda decision, and i don't know why it would have been pulled so shortly after, given the contents of this letter. I wish i could get an authoritative explanation of the true reasoning behind the decision to pull it from the market, not just speculation from bulls and bears, but i guess i can't.
Tom: Absolutely there is no doubt in my mind that O's coming back.
Did Takeda made a mistake of pulling the drug from the market place? It looks like it, however their thinking based on the circumstances, Product contamination and manufacturing issues.
If there were some Product Contamination or Manufacturing issues that would have been revealed by this time.
Secondly I did not understand why in the world FMS (after reading this letter), stopped rolling out to other patients and centers (AMGN Bullying? or internal tussle at FMS?). Probably Takeda was furious in FMS not moving forward with the drug.
All in all I don't think there is any issue with the Drug except what is stated in the Blackbox warning Label. Rejuvenated Omontys is going to hit the market with full force, it is just a matter weeks or days. I presume Takeda will take the Manufacturing too, under their control, instead of engaging third party providers.
Sentiment: Strong Buy