Feb 13: Affymax & Takeda voluntarily recall all supplies of Omontys after the deaths of 3 pts. The FDA has received 19 reports of allergic reactions occurring within 30 minutes of a pt´s first dose. Subsequent doses have not caused problems. The overall reaction rate is about 0.2%, with about one-third of pts requiring prompt medical attention & in some cases hospitalization.
Here are some facts you should be aware of about Fersenius Dialysis centers, the centers in which the allergic reactions occurred, leading to the death of 3 patients (originally thought to be 5).
1. Most days of the week, there is no MD or DO available at the facility.
2. There are RN's, LVN's and techs at the facility.
3. When a dialysis patient comes in, the patient is weighed and depending on the increase in patients weight a preset amount of fluid will be taken off the patient and the whole blood will in essence be "cleaned" of toxins.
4. Nurses cannot make decisions on their own about the clinical care of the patient. A nurse must consult a doctor and get permission before doing anything.
5. There are exceptions to rule 4 and those are referred to as Standing Orders. In medicine Standing Order protocols are referred to as offline medical control. Under these circumstances a nurse can administer medications such as nitro for chest pain without having to contact a doctor directly.
6. Allergic reactions did occur with first time patients in Clincial Trials; however no mortality occurred in those patients due to the meticulous nature of the staff and prompt medical treatment with Epi, Benadryl, steroids, A&A treatments, IV fluids.
7. It is my assumption that patients were not treated in a timely manner and appropriately by the Nurses. The first course of medications was probably given by EMS personnel and by that time it was obviously too late.
8. Allergic reactions progress very rapidly in patients and if not treated instantly can lead to anaphylaxis and death.
AMGN briebed AFFY -CEO that is the problem ! EVERYBODY KNOWS that
Imagine A (ONE) CENTRE GET 5 REACTIONS ON SAME DAY - and AFFY CEO decides to Recall Drug. !
Even FDA say it is Voluantry Recall - AFFY managements say they follwed FDA protocol.
Protocol does not state Complete recall for ONE CENTRE INCIDENT....!!!
I keep forgetting to mention this as i have several other things on my plate and ADD is a...
Well, if you go online and search for the article written by the streetinsider dated march 18, they go into detail on the SEC filings. TAKEDA is named Co-defendent in the lawsuits.
"We and certain of our officers as well as Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development Center, Inc. have been named defendants in two lawsuits filed in February 2013 in the United States District Court for the Northern District of California, brought on behalf of stockholders of the Company that alleges violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by the defendants regarding our business practices, financial projections and other disclosures between December 8, 2011 and February 22, 2013, or the Class Period. The plaintiffs seek to represent a class comprised of purchasers of our common stock during the Class Period and seek damages, costs and expenses and such other relief as determined by the court. While we believe we have meritorious defenses and intend to defend the lawsuit vigorously, we cannot predict the outcome of these lawsuits."
So if you were in TAKEDA position, what would you be forced to do in that situation?
I would get OMONTYS back on the market, ASAP.
I would defend my company and my collaborators rigorously, and
I would not let billions of dollars worth of research and over 10 years of collaboration go to waste.
Takeda more than likely has adequate insurance. I cannot say the same for Affymax that disclosed its insurance may not be adequate. In some jurisdictions, liability is apportioned according to percentage of fault as determined by the jury according to verdict instructions. In those jurisdictions, the wise strategy is to shift the most blame on bankrupt defendants. That way the solvent defendant has less judgment exposure.
We, Longs, are truthfully thankful for your input and detailed/factual analysis. My thought is that Takeda has been working very hard to find the root cause of this problem. I am very sure that Takeda will have the same conclusions as you have indicated. Again Raj, thank you VERY MUCH for your input. Can hardly wait for the next one.
Here are the objectives, as outlined by the SEC filing:
1. To elect three Class I director nominees identified in the Proxy Statement accompanying this Notice to hold office until the 2016 Annual Meeting of Stockholders.
2. To ratify the selection of Ernst & Young LLP, as independent registered public accounting firm of the Company for its fiscal year ending December 31, 2013.
3. To approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in the Proxy Statement accompanying this Notice.
4. To conduct any other business properly brought before the meeting.
I find it curious to have such an ambiguous statement (4) in the main objectives. Clearly there are always unforeseen circumstances that may arise but it seems auspicious. Keep in mind that this research into the 3 deaths, currently being undertaken by TAKEDA is a time sensitive matter.
In my opinion by the time of the scheduled meeting, TAKEDA will announce the results of the investigation and it will be favorable news. Allergic reactions are common in the field of medicine. Virtually every other patient seems to be allergic to Morphine, Penicillin, mycin type drugs, Iodine, latex, adhesive tape, etc. The difference is that these patients are treated right away for their allergic reactions and they don't die from them
I remember the first time i had a patient with a sever allergic reaction whose tongue was so swollen that the patient could not breath. I gave a shot of epi, initiated a breathing treatment, gave IV benadryl and steroids. Even after doing all of this, i could hear Stridor (a sound you hear when there is upper airway is constricting) and it was getting worse. I had to intubate the patient but due to the swelling of the tongue it could not be done. I ended up having to do a cricothyrotomy. I was scared out of my mind but pt survived, barely. All due to a bee sting..
I believe the investigation will show, that yes OMONTYS does cause allergic reactions but the deaths could have been prevented if the patients would have been treated in a timely manner.
Then its a simple cause of testing the patient for the allergic reaction prior to given a bolus of medication and having Epi and other drugs available. Also don't forget that EPOGEN has an allergic reaction rate of 0.44% compared to 0.2% in OMONTYS.
Good post RaJ. let me quote Orwin during an interview about the volontary recall of Omontys "Our priority is to attempt to determine and appropriately address the root cause of the hypersensitivity reaction and work with the FDA to reintroduce the product to market," Orwin said."
Perhaps I should just post the entire interview i am quite optimistic that they (the team Takeda/Affy) already have an idea of the root cause. However there is an FDA SOP to follow. My estimate of the recall resolution timeframe is around.10/31/13 and 12/31/1. perhaps we will have a hint during Takeda earning call but not much details or maybe an update or conference call about the ongoing recall. I will post more about the possible unfolding scenarios as well as the EMA opinion due by the end of May.