RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RBCJFM is correct. Making peptides of this size is fairly standard stuff for a CMO. There is no reason a manufacturer couldnt produce a generic. Here are two public statements made at the time of the manufacturing problem.
From a press release - "
announced earlier this year, production of tesamorelin was halted using the NDA approved manufacturing process to rectify issues that were not linked to the product itself but rather related to the consistency of the lyophilization cycle. Corrective measures were developed and implemented and production resumed in May 2013. Quality issues were recently encountered with the revised manufacturing process and it was decided to carry out further development work. Until process improvement measures are completed, production will be resumed using the current NDA approved manufacturing process to produce drug product for the U.S. market."
From theratechs md&a - "
As of the date of this MD&A, there is no longer any inventory at EMD Serono’s principal distribution center. We are working with EMD Serono, our third-party manufacturer, regulatory consultants and the FDA in order to resolve the supply shortage as soon as possible. We now have a plan that is based upon temporarily reverting to the initial presentation of EGRIFTA™ (1 mg vial), which was problem free during the first two years of marketing the product. While we are supplying market demand with the 1 mg presentation, we will continue to improve our 2 mg production cycle. Once we have confidence that the cycle is robust, we will seek the approval of the FDA to bring the 2 mg presentation back to market." Neither pinpoints exactly to the problem but the second seems to suggest the problem occured due to a deliberate decision to shift from a 1mg per vial to 2mg per vial presentation and the first suggests it happened at the lyophilization stage. The thing that doesnt make sense to me is why they allowed the 1mg per vial presentation stocks to dwindle while making the 2mg vials. I know one of the criticisms of the EMA was the 1mg vials. Looks like a money saving decision that backfired to me that was in part driven by a criticism from the EMA. Whatever the reason it doesnt point to an explanation that suggests the drug is difficult to manufacture. In fact they point out the 1mg presentation was trouble-free for two years.
1998novl wrote: I disagree that Egrifta is easy to manufacture. Do you recall the manufacturing issues several years back? This issues were a result of the difficulty in manufacturing Egrifta. I suspect no generic will be interested in manufacturing Egrifta unless sales more than multiply from here.