The committee to start the early access clinical trials for drugs and treatments for men with advanced prostate cancer has been very hard at work. Based on the leadership and tenacity of Jan Manarite of the Prostate Cancer Research Institute (PCRI) we have managed to encourage, beg and cajole a number of pharmaceutical (pharma) companies to work with the FDA to provide their investigational treatment to men in serious need of them prior to receiving FDA approval.

This is done under the auspices of gathering additional data, especially safety data for the consideration of the FDA. Since it is a clinical trial and the trial uses unapproved treatments the pharmaceutical is not able to charge for the treatment or its administration.

So, why should a pharma be willing to give away for no enumeration their drug?

First, as I mentioned they will be able to gather additional data on both safety and efficacy. Secondly, they will be able to create good will among the patient and doctor communities. The third reason is that it will broaden the communities knowledge of the treatment so that the second they receive FDA approval they will already have a market penetration. Additionally, all the companies claim that they are concerned about the patients who need their treatment to survive.

Bayer Healthcare and Algeta have one drug, radium 223 dichloride, under an Early Access Program (EAP). They were very difficult when it came to our trying to obtain their cooperation in setting up trial sites. Now we have managed to get them to set up a number of sites, but they fail on a regular basis in providing adequate supply of the radium 223. Their response has been a great disappointment.

One of the men I work with has run out of treatment options, radium 223 is the only treatment left him. When rejected from the trial because of lack of supply he wrote a letter to the pharma. He received back the following answer:

Dear Mr. XXX

I am Dr. XXXX, Vice President Medical Affairs at Bayer Healthcare. I would like to thank you for your letter dated April 19,2013, directed to Algeta which has been forwarded to me.

On behalf of Algeta and Bayer, I would like to address the status of the Expanded Access Program (EAP) for our investigational product, radium 223 dichloride.

Radium 223 dichloride is currently provided to patients through several clinical trials worldwide, including a large expanded access program (EAP). However, we are experiencing high demand worldwide from patients who need treatment, and recent demand for radium 223 dichloride has exceeded the maximum production capacity of the currently available clinical supply at the production site in Norway. We are working very hard to get another line running as quickly as possible so that we can supply this demand from patients worldwide. As a result, it will be necessary during the next few weeks to limit enrollment of new patients until we can produce sufficient quantities to accommodate additional patients. We recognize that this can be upsetting to patients, their families and health care providers. Unfortunately, due to the high demand for the product, this decision was necessary to ensure that those patients already enrolled in the EAP Program and on therapy could continue to receive their required treatments.

The production of radium 223 dichloride occurs in a Norwegian facility and the current production line, designed for clinical trials, has limited capacity. Bayer and its partner Algeta have been working diligently to initiate production of radium 223 dichloride through a new, larger manufacturing line which has substantially greater capacity than the current clinical supply line. Such a manufacturing line must undergo rigorous testing and secure the necessary worldwide regulatory approvals prior to commencement of production. We are working with the authorities to do this as quickly as possible.

While the new manufacturing line is in the final stages of securing the regulatory approvals necessary to start production, Bayer and Algeta could not be assured that this would be accomplished in time to prevent a shortfall in supply if new patients were allowed to enroll into the program. Accordingly, the companies took the difficult step of limiting enrollment into the Program until the new manufacturing line is able to produce radium 223 dichloride. We understand that this would be difficult for patients; unfortunately, we felt that we had no other option. Once the new, larger manufacturing line is producing greater quantities of radium 223 dichloride, the sites will be notified immediately and enrollment will resume so that patients can receive this new therapy. Manufacturing authorization for the new production line is expected in the near future, which will enable full production in the next few weeks.

Bayer and Algeta are deeply committed to ensuring that this treatment is available to physicians and patients through the Program and we are working to resolve this matter as quickly as possible. We recognize that many patients around the world would like treatment under the EAP program and we are working hard to make this happen. We shall ask that your center contact you as soon as additional supply of radium 223 dichloride is assured.

I do hope that this information addresses the concerns that you raised. Should you have any additional questions, please feel free to contact me.


Vice President US Medical Affairs Specialized Therapeutics

Come on Bayer, you knew of the pent up demand. I find it hard to just accept that the demand has just overwhelmed the supply. You knew this was going to happen and you made no attempt to expand production before today.

Bayer and Algeta, we have men who need this treatment NOW. For many men this is their one and only last option. How can you tell them that they have to stand on line and wait? These men will not survive long enough to see you through your failure to produce product. This line you have created is not like standing on line waiting to get into the movies or buy the popcorn.

You are making ill will in the community and you are allowing men to die sooner than they need to die!

Joel T. Nowak, M.A., M.S.W.