Serious manufacturing problems are often difficult to resolve, but the Genzyme team appears determined to take the experience to new levels. The beleaguered biotech, which is now both a headache and an opportunity for Sanofi, just sent a letter to Gaucher disease patients to say that supplies of its Cerezyme medicine are being rationed on a global basis for the next four months.
"A temporary decrease in Cerezyme yields, combined with changes to our product release processes and procedures that lengthen the overall time it takes to release Cerezyme require us to change our supply projections for the next four months starting October, 2011," the letter to doctors states. "...In order to support the current level of patient demand, Cerezyme is made available as it is produced, which does not allow us to build inventory." This means that most adult Gaucher disease patients will need to change to monthly dosing rather than dosing every two weeks.
This comes on the heels of persistent difficulties in resuming full production of its Fabrazyme drug used to treat Fabry's disease. The problems supplying Fabrazyme have gotten so bad that Genzyme recently issued an apology (see this), although some patients have filed a lawsuit and are petitioning the National Institutes of Health to override the Fabrazyme patent in a bid to find another means of production (read here and here).
This latest shortage is yet another setback for Genzyme, which is now part of Sanofi. People suffering from Fabry’s disease and Gaucher's disease have suffered varying degrees of supply disruptions and shortages over the past two years thanks to a host of problems at its Allston Landing, Massachusetts facility. At one point, bits of trash were found in some products (read this). These led to a consent decree, a $175 million fine and a remediation plan that continues to miss goals.
For now, Genzyme is saying that FDA approval of its new Framingham plant in the first quarter of 2012, and that Fabrzyme production will then be shifted to the new facility. The biotech also plans to expand Cerezyme production at its Allston plant when its Framingham facility is fully functioning. Of course, this provides an opening for rivals and add further pressure on Sanofi to appease investors.
One possible beneficiary is Protalix BioTherapeutics, according to Wells Fargo Securities analyst Brian Abrahams. In an investor note, he writes that with the Cerezyme shortage "shortage occurring in the months ahead of the February PDUFA date for taliglucerase (a rival Protalix drug), this should highlight to the FDA the need for an additional enzyme supplier and perhaps increase the likelihood of approval."
pic thx to joguldi on flickr