They mislead Government officials so why would they tell us the Patients, the truth about the shortage?
April 25 2008
Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab
PRINCETON, N.J., April 25 2008 /PRNewswire-FirstCall/ -- Medarex, Inc.
(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS)data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.
As far as my research to date(10-22-2009), BMS/Medarex has not file a BLA with the FDA.
On September 12 2008 they closed the compassionate use for Ipilimumab
Your email was forwarded to us by CBER (this IND resides in the Center for Drugs Evaluation and Research). We have contacted BMS to check into the availability of ipilimumab and here is the information that BMS provided to us.
"To ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide ongoing supply to the registrational program, Bristol-Myers Squibb and Medarex have suspended enrollment of new patients into the compassionate use program, single patient exemptions and initiation of some non-registrational trials effective September 12, 2008.
Bristol-Myers Squibb and Medarex are working to manage the supply issue and may be able to re-open compassionate use in the future.
The companies are committed to providing uninterrupted treatment to patients who initiate therapy with ipilimumab. Therefore, if and when the compassionate use program reopens, it will be at such time when continuous and unconstrained supply is available."
Please let us know if you have any questions.
Sincerely,
CDER Drug Shortage Team
It Takes about a month to make a batch of monoclonal antibodies. By the time the batch is tested and packaged and approved, let us allow another two months. So in a year you should be able to make 3 to 4 batches.
Melanoma Treatment Information - Updated 09.10.09
"Ipilimumab which ASCO reported some promising results had been widely available in compassionate use trials across the county until a shortage halted the studies. Bristol Myers Squibb, is now manufacturing the drug again and there are a few small “pharmacokinetic” trials to prove the agent is the same as the previous one used in trials. Most of these trials already have waiting lists, but it may be worth checking out. Screening started August 4th and you can find the locations on www.clinicaltrials.gov."
Source:https://www.z2systems.com/np/clients/mif/news.jsp?news=381
Melanoma International Foundation
Well come to find out that BMS/Medarex is opening up new clinical trials with Ipilimumab and continue to keep the compassionate use trial closed. How ethical is that?
When big pharma is involved in clinical development, it usually means large-scale clinical trials with patients and multiple sites.
Here are the trials:
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Start Date: August 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00732186
Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Start Date: February 2009
Estimated Study Completion Date: Feb 2013
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00836407
Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma
Start Date: February 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 33
ClinicalTrials.gov Identifier: NCT00790010
Laboratory-Treated T Cells With or Without Ipilimumab in Treating Patients With Metastatic Melanoma
Start Date: February 2009
Estimated Study Completion Date: Feb 2011
Estimated Enrollment: 30
ClinicalTrials.gov Identifier: NCT00871481
Study of Immunotherapy to Treat Advanced Prostate Cancer
Start Date: May 2009
Estimated Study Completion Date: December 2012
Estimated Enrollment: 800
ClinicalTrials.gov Identifier: NCT00861614
Further study details as provided by Bristol-Myers Squibb:
These are all trials that were started after the halting of the compassionate Use. Bristol-Meyer Squibb thinks we the Melanoma Patients are expendable so they continued there quest to seek out new uses for the Drug.
Get a bigger bang for the buck.
They already know it works well with Melanoma, so why not find other uses.
Base on my calculation, 923 late stage Melanoma Patients were denied the drug while Bristol–Meyer Squibb continued to apply and start up new trials.
Bristol-Meyer Squibb Quote:
“What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”
All Lip Service!!!!!!
“Jim, thank you so much for your efforts. My father passed away this past March. He was also scheduled to start the ipi trial last year and found out the Saturday before he was to go in that the compassionate use trial was suspended. He developed 3 mets in his brain by Thanksgiving. The ipi trials with brain mets were closed to new patients by then. I've spent countless hours and days frustrated and angry, unable to express or figure out what you have with BMS and wanting to take some sort of action. I also sent letters, made phone calls, etc. One day, someone will be able to stop these drug companies from playing with our lives. Please keep me posted in your findings.”
Update on Ipilimumab
Ipilimumab is not back yet. Patients are not being encouraged to wait for Ipilimumab to become available for now. The only Ipilimumab melanoma trials currently enrolling new patients in the US are the brain metastases trial (CA-184042) and the phase 3 adjuvant trial (CA-184029) because the supply for those trials was protected in advance. Bristol Myers Squibb is working diligently to overcome the drug shortage, but can’t guarantee a time that it will return to the compassionate use setting.
Source: Melanoma International Foundation:
https://www.zsystems.com/np/clients/mif/news.jsp?news=376
Melanoma International Foundation
Response from BMS as of 10-21-2009
“Regarding compassionate use, as you are aware, the rate of enrollment in the compassionate use program for ipilimumab was greater than anticipated with 30 to 40 percent of patients continuing on therapy beyond the initial induction schedule. This demand depleted drug supply at a faster rate than anticipated. Bristol-Myers Squibb had to suspend enrollment of new patients into the compassionate use program and single patient exemptions to ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide supply for ongoing clinical studies.
We are working through the manufacturing and testing process, and continue to carefully manage the supply to enable the potential re-opening of compassionate use at the earliest possible time and when continuous supply is available.
Bristol-Myers Squibb remains committed to the development of ipilimumab and to addressing the great unmet medical need for patients with metastatic melanoma.”
As you can read, BMS is not even acknowledging that they even produced other batches.They are hiding the fact that they are back online. Their communication skills with the public/patients are NIL. Instead they are starting new protocols with Ipilimumab. Where is the FDA in al of this? Who is watching the hen house?
When I searched for drug shortages on the FDA website, Ipilimumab did not show up.
What is going on?
We the Patients deserve better, We are the ones who are taking all the risk. We should have some control in this process.
We the Patients have had to hear it from second-hand sources like the Melanoma International Foundation and Melanoma Research Foundation. I don’t believe that their ad advertisers (The Ogilvy Group Inc) can repair the public’s trust in this company. They have major issues.
This Month will be the anniversary of the discovery of Anti-CTLA-4 antibodies, celebrating ten years in the making of the drug. This is way to long for a drug to come to market. It usually takes 8.7 years for monoclonal antibodies. So what gives?
I hope see some dialog started between the patients and BMS. BMS needs somehow to regain the public's trust.
I am under the impression that greed and power-play is mixed in all of this. It all has to do with the STRING OF PEARLS intiative.
How Drugs are Developed and Approved by the FDA?
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm#
How Drugs are Developed and Approved by the FDA
Take Care,
Jimmy B
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