Finally-A Reality Check at Momenta Pharmaceuticals
The Massachusetts-based biotechnology company, Momenta Pharmaceuticals, announced late yesterday that FDA refused to approve its ANDA filing for M-Enoxaparin, a generic version of Sanofi-Aventis' Lovenox®. The agency cited that Momenta had failed to provide data in its application on the potential immunogenicity of M-Enoxaparin. I find this oversight to be extremely perplexing because Momenta’s management team had to know that regulatory approval of a product –considered to be a follow-on biologic (M-Enoxaparin is a synthetic version of low molecular weight heparin which is a polysaccharide) – would require a rigorous assessment of the product's potential immunogenicity. If Momenta did not know about the immunogenicity requirements, then Sandoz (its co-development partner) had to be keenly aware of them because Sandoz had to provide immunogenicity data to FDA to garner approval last year of Omnitrope®, a follow-on version of human recombinant growth hormone (rHGH).
Although FDA’s refusal to approve M-Enoxaprin is a setback for the follow-on biologics movement in the US, it is about time, in my opinion, that Momenta’s stock price truly reflects the real market value of the company. Much to my surprise, Momenta’s stock price was over $30 a share about two years ago– presumably founded in the notion that the company’s innovative carbohydrate technology platform could be used to create a generic version of Sanofi’s multi billion dollar a year Lovenox® . I have no doubt that Momenta’s technology platform is one of the more innovative ones in the carbohydrate synthesis biz. However, as a former employee of 2 biotech companies founded on revolutionary carbohydrate synthesis platforms, I think that Momenta’s elevated stock price had more to do with the pedigree of scientists who started the company and the ROI that these scientists previously provided to the VCs who are currently backing Momenta. Further, cutting a deal with Sandoz, a company whose name is now synonymous with follow-on biologics may also have contributed to the elevated stock price.
If I was one of Momenta 100 or so employees I would be dusting off that resume right about now.
Unitl next time....
Good Luck and Good Job Hunting!!!!!!
