October 6, 2011
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Date Links to Topic of Interest October 2011 We have sold all Tetrahydrobiopterin tablets 10 mg and 50 mg May 2011 Pteridine price increase April 2010 Diminishing stocks of Tetrahydrobiopterin tablets January 2010 Biomarin and Merck Serono main suppliers of Tetrahydrobiopterin (Sapropterin dihydrochloride)... Nov. 2009 Dec. 2008 Biomarin starts supplying Tetrahydrobiopterin tablets as Kuvan® to USA customers.
August 2008 New Compound
We have sold October 2011
We have sold all Tetrahydrobiopterin tablets 10 mg and 50 mg. Unfortunately there is nothing we can do to change this dissatisfactory situation.
Although Schircks Laboratories sold tetrahydrobiopterin tablets on a compassionate use basis over 25 years, we did not have a marketing authorization. Orphan drug law only came into effect in 2002. Biomarin and Merck Serono could take advantage of these new laws and because they had adequate financial assets to support the clinical trials. Schircks Laboratories had no chance to compete. Biomarin and Merck Serono performed all clinical trials required to get approval for a new drug. They received marketing authorizations as an orphan drug in the USA, Japan and Europe. As a result no other company can legally sell medication containing tetrahydrobiopterin in the USA, Japan and Europe over the next 10 years.
Although we applied for a marketing authorization in Switzerland and had not much missing to receive approval here, the loss of the US, Japanese and European markets to Biomarin and Merck Serono made it impossible to remain viable.
We never and in no way whatsoever cooperated with Biomarin and Merck Serono.
We would like to thank you for the pleasant co-operation over the years.
Pteridine price increase May 2011
We have to increase our Pteridine prices because of the massive depreciation of the dollar. The prices will automatically change May 10, 2011. Diminishing stocks April 2010
We now only have a limited stock of Tetrahydrobiopterin tablets remaining. We are only accepting orders from existing customers from low income developing countries until our stock is depleted. We cannot accept orders from any new patients from any country. Taking into account that tablets from Merck Serono will be about three times more expensive than our tablets, we urge you not to start treatment of new patients with Tetrahydrobiopterin tablets until the financial side of the treatment is examined. Otherwise the relief of the strain of the diet will be replaced with bigger financial strain. Biomarin and Merck Serono January 2010
Biomarin and Merck Serono have taken over the Tetrahydrobiopterin tablet market. We have had to cease production of tetrahydrobiopterin. We now only have a limited stock of Tetrahydrobiopterin tablets remaining. We can only accept orders from low income developing countries until our stock is depleted. Unfortunately there is nothing we can do to change this situation. We would like to thank you for the pleasant cooperation through many years. Please note that the active substance (Sapropterin dihydrochloride) in Biomarin/Merck Serono`s tablets Kuvan is the same as that in Schircks Laboratories Tetrahydrobiopterin tablets. Sapropterin dihydrochloride is another name for Tetrahydrobiopterin (BH4). Please contact Biomarin/Merck Serono to ensure a continuous supply of tablets.
Tetrahydrobiopterin tablets November 2009
In November 2009 Merck Serono (www.merckserono.com) took over the market in Great Britain, France, Germany, Spain, Austria, Greek, Denmark, Hungary, Italy and Netherlands. Tetrahydrobiopterin tablets – future suppliers
December 2008
Doctors, clinics, health authorities and ethic commissions depended on the supply of tetrahydrobiopterin provided on a compassionate use / named patient basis from Schircks Laboratories over the last 28 years. Because tetrahydrobiopterin deficiency is a very rare disorder it was impossible to perform organized clinical trials.
In 1999 it was found that a larger group of PKU/HPA patients also responded to treatment with Schircks Laboratories tetrahydrobiopterin. Clinical trials were organized and data was collected by Biomarin and after FDA approval in 2007, they started to supply the US Market 2008. Tetrahydrobiopterin is an orphan drug. Special regulations apply to the sale of this product. Merck Serono received marketing authorization for the sale of tetrahyrobiopterin (sapropterin) in Europe December 2, 2008. Schircks Laboratories is legally obliged to discontinue the sale of tetrahydrobiopterin to Europe as soon as Merck Serono brings their product Kuvan on the market. We will keep you informed of changes as they come about.
Biomarin and Merck Serono will only sell unscored 100 mg sapropterin tablets.
Because there have been extensive clinical trials for their product on large groups of patients, the cost of the tablets is expected to be higher than those supplied by Schircks Laboratories.
However, it is expected that health funds are more likely to cover a product, which has a marketing authorization.
We will keep you informed of changes on our website. For updates, please check this website regularly.
New Compound
August 2008Please note that our new compound FH4·3HCl (16.208) is available. Unlike FH4, FH4·3HCl is freely soluble and therefore easy to handle. We would appreciate if you could correct your records and inform any additional members of your institutes of the changes.
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