Save Hoffman La Roche from itself
Robert Waldmann
Zenapax world supplies at risk – well basically nonexistent.
I was thrilled when my father, Thomas Waldmann won a Service to America award in large part for his contribution to the development of Daclizumab, that is, Zenapax TM, a humanized monoclonal antibody which inhibits the immune response. Zenapax is approved for sale for the prevention of rejection of transplanted kidneys. It is also demonstrably beneficial for people who suffer from auto-immunse diseases including Mutliple Schlerosis Uveitis
(the reason Braille was blind) and inflamatory bowel disease and is key to a promising approach to treatment of Hodgkin’s lymphoma in the numerous minority of cases in which standard therapies fail .
The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.
However, Hoffman La Roche pharmaceuticals has decided to stop making Zenapax for uhm no comprehesible reason. I quote “This decision has been taken in view of available alternative treatments and the diminishing market demand for ZENAPAX and is not due to any safety issue.
This decision makes no business sense. It casts doubt on the question of whether managers of Hoffman La Roche pharmaceuticals are up to the task of making decisions which affect thousands of lives. By law Hoffman La Roche is not allowed to advertize uses of Zenapax other than the one for which it was approved. No law prevents them from forecasting demand based on the evidence, published in top peer reviewed journals, that Zenapax has many other uses and that demand for the antibody will increase.
Obviously the decision is reversible. I am going to try to convince Hoffman La Roche to not kill the goose that will lay golden eggs.
update: Now I understand. Hoffman La Roche does not completely own all of the rights to daclizumab= Zenapax. The drug will imply huge profits for someone, but not for them even if they make it, because they didn’t buy the rights to use it for purposes other than preventing transplant rejection. It’s too late to save Hoffman La Roche from itself (also I exagerated since they are making plenty of profits from other drugs).
“No comprehensible reason.”
This decision has been taken in view of available alternative treatments and the diminishing market demand for ZENAPAX and is not due to any safety issue.
It’s right there! They aren’t making any money on this drug, because people don’t take it for transplant rejection, they take the more effective oral therapies. No demand. They is a lot of competition in those other areas, too. And Zenapax is an IV, in a doctor’s office. Why IV when you can take a pill or subcutaneous injection?
Plus, it’s a biologic, so it is more difficult (expensive) to manufacture.
This is not a good drug. Your insurance company won’t want to pay. Neither will your government.
Dear makes sense to me. I agree that given the currently approved use Zenapax is not a big money maker. However, there are not good treatments for Hodgkin’s lymphoma which has returned after say 10 or so courses of treatment (the current choices are take Zenapax or die for sure). Similarly people who have no problem with MS treated with other drugs are … not all of them. It has been demonstrated that Zenapax is an effective treatment for many diseases such that there is no other effective treatment.
That means money.
Clearly you haven’t clicked the links. You will find peer reviewed articles reporting the results of clinical trials with human subjects. Such trials are not allowed if there are acceptable alternative treatments. The reported results demonstrate that Zenapax works for many patients who have no alternative.
If you choose to dismiss results in the peer reviewed scientific literature, you should, at least, read the papers.
This *is* a question of life and death. You should not be so flippant.
I am sorry to disapoint you, but Roche terminated the product because it was a loser for them.
Makes Sense To Me highlights several good reasons.
But, if you are so confident in the product, I suggest you think of this as an opportunity rather than a defeat.
If it has all the potential you believe then you will have no problem finding investors who would be interested in buying the marketing rights, leasing the manufacturing capabilities, developing a marketing plan, applying for and receiving all of the manufacturing and marketing approvals, negotiating pricing with every payer in the EU and the USA, hiring a marketing team and a sales force, developing and receiving regulatory approval for a marketing plan, and taking this product back to market!
Be sure you check the remaining patent life on the product, however, as the EU and USA are currently working on a “solution” to bring generic biologics to market.
Oh, and one more thing. The UK and EU may have some interesting positions on your pricing – i.e., it will start low and go down every year from there – so be sure to ask about that when you are doing your due diligence.
Of course, if all this sounds like a lot to do and a lot of risk – especially given the product’s poor performance to date and the availability of therapuetic alternatives – then perhaps you now have a better understanding of why Roche declined to continue selling this drug.
Mr. Waldmann
My appologies for being cynical and sarcastic in my previous response, as I can see that you are sincere in your beliefs.
Where I believe you are mistaken is “that means money”. In the current regulatory and payer environment there is little interest among pharma and biotech companies to pursue expensive, high risk clinical programs for indications in small patient populations, especially where there are potential clinical alternatives. (The case of Avastin and Lucentis sealed that forever). Furhermore, the legal risks of widespread use for off-label indications is too great.
I realize this is life or death for affected patients, but Govt Payers don’t care (just ask NICE) and Roche shareholders are not obligated to lose money because Govt Regulators and Payers cannot create a pathway to create a viable market incentive.
I suggest you take your argument to your local Govt Agency and make the case that they should support the drug.
I can’t speak with authority on the issue but I would guess it is impossible to force a drug company to manufacture a drug if it decides not to do so. The FDA can stop a drug being sold; I doubt it can force one to be sold. Trying to do so would be an interesting test case, I would suspect.
I do not claim that Roche would make money in the UK. The populations of patients with trouble MS and irritable bowel syndrome which are not well managed by alternative therapies is not small. The risk of liability of a biological which has been used for years is — well positive but small compared to the profit opportunities.\
You seem to be assumign that H L Roche couldn’t have made a mistake. They are a firm whcih aims to make profits, therefore they have maximized their expected profits. This is not the way things work in the real world.
You discuss to other molecules which, you assert, must be relevant. Such sloppy thinking is probably much inferior to whatever reasoning that Roche used. However, the fact that someone who can write English correctly would write such a thing shows how profit opportunities can be missed. Not all biologicals are the same. For example insulin has proven to be quite useful.
It is silly to imagine that I, an economist, will find it easy to find financing if I am right about what is profitable. That’s not the way the world works. I am currently trying to convince Roche that they made a mistake. If that proves impossible I will try to convince others to buy the rights from them.
I will, of course, keep people here posted on what happens.
I see again the idea that firms don’t make mistakes — that because Roche wants profits they must know how to get them. This is not the way the world works. Aiming for a target does not meaning hitting it
Hmm there are old laws from WWII which might possibly be used to requisition the material (this was discussed with reference to AZT). In any case, if the US Federal Government were willing to buy a lot of Zenapax, Roche would be glad to make it.
Realistically, however, I think an expression of concern from a high administration official would do the trick. There are huge amounts of money at stake with public decisions about, for example, drug re-importation. The cost of making Zenapax plus liability if it suddenly shows side effects (after years of use) is nothing compared to the advantage of getting thanked by … well a fairly large number of people.
I’m quite confident that Roche made a mistake just as a business decision. However, for a pharmaceutical firm to worry about millions and ignore public relation would be such a silly mistake that I am confident they won’t make it. Obvously I am not confident that I will be able to convince anyone with any power, but anyone with a good bit of power can get it done.
I was serious about the opportunity.
Management at big companies can only focus on so many things. I could not even find this drug in the 2007 or 2008 Annual Reports for Roche, ergo it does not seem to have been that important to them. The best you can hope for is that they made a mistake (at their loss) and dropped the product because, for Sr. Management, it was just a distraction.
Their loss could be your gain, because for a smaller company this drug could potentially have value.
But I was also serious about the things that are necessary to successfully market such a product. It is not easy.
I guarantee that if you can secure a reasonable deal to have the drug manufactured, and put together a good commercial business case, that you will be able to find an interested partner.
If the drug works for IBS, contact Axcan.
Robert Waldmann – “The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.”
F. Hoffmann-La Roche Ltd (Roche) never owned the patent for Zenapax[R].
Protein Design Labs, Inc. (PDL) still owns the patent for Zenapax. The product was “exclusively licensed to Hoffmann-La Roche Inc. and its affiliates (“Roche”) and in 1998 the Company began receiving royalties from sales of Zenapax.” “Rights to daclizumab in transplantation, asthma and related respiratory diseases [were] in partnership with Roche.” Roche had already surrendered some of its Zenapax marketing rights back to PDL prior to Roche’s final announcement.
The European market had already being dumped. Roche Registration Limited withdrew Zenpax from the European market in 2008. RRL notified the the European Commission on 22 April 2008, and the Commission withdrew the marketing authorization for Zenapax effective 1 January 2009.
Meanwhile, PDL and, subsequently its spin off, Facet Biotech Facet Corporation, developed agreements with Biogen Idec to provide for “shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.” “Facet was spun off from PDL BioPharma Inc. (PDLI) a year ago in order to separate the company’s biotechnology assets from its royalty-producing assets.”
The water is muddy due to Biogen’s recent forceful attempts to take over Facet or achieve majority ownership or control of the board, all of which have failed thus far.
PDL could market Zenapax for transplantation use through its wholly-owned subsidiary, ESP Pharma, Inc.. It is also possible that Biogen may opt to secure the rights via royalty to
directly market Zenapax or daclizumab under a different name for purposes of use in transplantation and other uses for which it does not have existing marketing authority.
Robert Waldmann – “The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.”
F. Hoffmann-La Roche Ltd (Roche) never owned the patent for Zenapax [R].
Protein Design Labs, Inc. (PDL) still owns the patent for Zenapax. The product was “exclusively licensed to Hoffmann-La Roche Inc. and its affiliates (“Roche”) and in 1998 the Company began receiving royalties from sales of Zenapax.” “Rights to daclizumab in transplantation, asthma and related respiratory diseases [were] in partnership with Roche.” Roche had already surrendered some of its Zenapax marketing rights back to PDL prior to Roche’s final announcement.
The European market had already being dumped. Roche Registration Limited notified the the European Commission of its intent to withdraw on 22 April 2008, and the Commission withdrew the marketing authorization for Zenapax effective 1 January 2009.
Meanwhile, PDL and, subsequently its spin off, Facet Biotech Corporation, developed agreements with Biogen Idec to provide for “shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.” “Facet was spun off from PDL BioPharma Inc. (PDLI) a year ago in order to separate the company’s biotechnology assets from its royalty-producing assets.”
The water is muddy due to Biogen’s recent forceful attempts to take over Facet or achieve majority ownership or control of the board, all of which have failed thus far.
PDL could market Zenapax for transplantation use through its wholly-owned subsidiary, ESP Pharma, Inc.. It is also possible that Biogen may opt to secure the rights via royalty to
directly market Zenapax or daclizumab under a different name for purposes of use in transplantation and other uses for which it does not have existing marketing authority.
Robert Waldmann – “The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.”
F. Hoffmann-La Roche Ltd (Roche) never owned the patent for Zenapax [R].
Protein Design Labs, Inc. (PDL) still owns the patent for Zenapax. The product was “exclusively licensed to Hoffmann-La Roche Inc. and its affiliates (“Roche”) and in 1998 the Company began receiving royalties from sales of Zenapax.” “Rights to daclizumab in transplantation, asthma and related respiratory diseases [were] in partnership with Roche.” Roche had already surrendered some of its Zenapax marketing rights back to PDL prior to Roche’s final announcement.
The European market had already being dumped. Roche Registration Limited notified the the European Commission of its intent to withdraw on 22 April 2008, and the Commission withdrew the marketing authorization for Zenapax effective 1 January 2009.
Meanwhile, PDL and, subsequently its spin off, Facet Biotech Corporation, developed agreements with Biogen Idec to provide for “shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.” “Facet was spun off from PDL BioPharma Inc. (PDLI) a year ago in order to separate the company’s biotechnology assets from its royalty-producing assets.”
The water is muddy due to Biogen’s recent forceful attempts to take over Facet or achieve majority ownership or control of the board, all of which have failed thus far.
PDL could market Zenapax for transplantation use through its wholly-owned subsidiary, ESP Pharma, Inc.. It is also possible that Biogen may opt to secure the rights via royalty to directly market Zenapax or daclizumab under a different name for purposes of use in transplantation and other uses for which it does not have existing marketing authority.
Robert Waldmann – “The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.”
F. Hoffmann-La Roche Ltd (Roche) never owned the patents for Zenapax [R].
Protein Design Labs, Inc. (PDL) still owns the patents and all legal rights to Zenapax. The product was “exclusively licensed to Hoffmann-La Roche Inc. and its affiliates (“Roche”) and in 1998 the Company began receiving royalties from sales of Zenapax.” “Rights to daclizumab in transplantation, asthma and related respiratory diseases [were] in partnership with Roche.” Roche had already surrendered some of its Zenapax marketing rights back to PDL prior to Roche’s final announcement.
The European market had already being dumped. Roche Registration Limited notified the the European Commission of its intent to withdraw on 22 April 2008, and the Commission withdrew the marketing authorization for Zenapax effective 1 January 2009.
Meanwhile, PDL and, subsequently its spin off, Facet Biotech Corporation, developed agreements with Biogen Idec to provide for “shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.” “Facet was spun off from PDL BioPharma Inc. (PDLI) a year ago in order to separate the company’s biotechnology assets from its royalty-producing assets.”
The water is muddy due to Biogen’s recent forceful attempts to take over Facet or achieve majority ownership or control of the board, all of which have failed thus far.
PDL could market Zenapax for transplantation use through its wholly-owned subsidiary, ESP Pharma, Inc.. It is also possible that Biogen may opt to secure the rights via royalty to directly market Zenapax or daclizumab under a different name for purposes of use in transplantation and other uses for which it does not have existing marketing authority.
Robert Waldmann – “The patent belongs to Hoffman La Roche Ltd whose role was basically to organize and finance the clinical trials which demonstrated the effectiveness of Zenapax in the prevention of rejection of transplanted kidneys.”
F. Hoffmann-La Roche Ltd (Roche) never owned the patents for Zenapax [R].
Protein Design Labs, Inc. (PDL) still owns the patents and all legal rights to Zenapax. The product was “exclusively licensed to Hoffmann-La Roche Inc. and its affiliates (“Roche”) and in 1998 the Company began receiving royalties from sales of Zenapax.” “Rights to daclizumab in transplantation, asthma and related respiratory diseases [were] in partnership with Roche.” Roche had already surrendered some of its Zenapax marketing rights back to PDL prior to Roche’s final announcement.
The European market had already being dumped. Roche Registration Limited notified the the European Commission of its intent to withdraw on 22 April 2008, and the Commission withdrew the marketing authorization for Zenapax effective 1 January 2009.
Meanwhile, PDL and, subsequently its spin off, Facet Biotech Corporation, developed agreements with Biogen Idec to provide for “shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases.” “Facet was spun off from PDL BioPharma Inc. (PDLI) a year ago in order to separate the company’s biotechnology assets from its royalty-producing assets.”
The water is muddy due to Biogen’s recent forceful attempts to take over Facet or achieve majority ownership or control of the board, all of which have failed thus far.
PDL could market Zenapax for transplantation use through its wholly-owned subsidiary, ESP Pharma, Inc.. It is also possible that Biogen may opt to secure the rights via royalty to directly market Zenapax or daclizumab under a different name for purposes of use in transplantation and other uses for which it does not have existing marketing authority.
Have the patents expired? If so, price pressure applied by generics may be the real reason for the change. If not, try convincing the patent owner to dedicate the patents to the public.
My guess is that the patents have expired or are close to expiring. If so, Hoffman LaRoche might make some money by licensing their trademark for the drug.
MG: I suspect this would provde a complete out for Hoffmann. If they don’t own the drug, who could force them to produce it?
Tao:
Actually, the patents for Cellcept (mycophenolate mofetil) have expired, and that is pretty much the gold standard for Xplant rejection, not Zenapax. So now, for approved usage, Zenapax is now competing with a superior, oral, generic. But I’m sure that Hoffman-LaRoche made a mistake about how to make money in that market. Sorry, that was flippant.
All:
As for IBS, just look at the list of competitiors in the link. Many with much greater long-term safety data than Zenapax. I’m sure a couple of very costly trials could get the data you need to compete with those drugs listed, many without much patent life left.
As for MS, oral cladribine and/or fingolimod will take the market for those patients that you think would benefit from Zenapax. For the more severe MS patients, alemtuzumab is on the way.
I think the only mistake being made here is someone with an incomplete picture of the data that Hoffman-LaRoche and IMS has is trying to force a business decision on them.
Robert:
Now that I have clicked the links (good call on that one, I was going on my industry knowledge), I need to say that my criticism of the drug is not an indictment of your father’s science. In fact, many scientists can’t lay claims to ever producing the science to development a drug.
Some drugs find markets. Some drugs don’t. And it is only getting harder for biologicals, especially under this payer environment.
As for your strategy for obtaining the patents, I can say that certain countries will invalidate patents if you do not provide 1) adequate supply or 2) appropriate government approved price. Canada and Brazil come to mind. Just saying.
I Take Imuran (Azathioprine) for my ulcerative colitis, and Imuran is also used to prevent Kidney transplant rejection. It is an oral mediciation. Could it be drugs like this are replacing the one your father helped create?
Azathioprine is oral and generic (and old, discovered in 1962). Costs about $1/day. Zenapax itself (not counting the Rx labor, it must be diluted before the medical professional gives you the IV) is about $600 per dose, given about every two weeks. A 5 IV course is about $3,000 for the drug alone, again not counting the labor.
Which would you choose?
Which will your insurance company or government force you to choose?
Am wondering if the IV solves the main problem with imuran, which is how soon it effects one’s system. I had to stay on prednisone for 3 months while the imuran built up in my system, perhaps an IV is faster. So there could be scenrios where it is useful, but those situations may be limited. JnJ also has some new IV based drugs that do the same thing, but not sure on cost for those.
I have been on Imuran and Cellcept and now Zenapax. Zenapax helped change my life for the better. I have no idea what I will do without it.