Posted on November 14, 2007 by BioJobBlogger

Another Bad Investment for Pfizer -Inhaled PEGylated Human Growth Hormone

I was reading a post about the Exubera deal that Pfizer cut with Nektar the other day and I stumbled upon this tidbit–“The two companies will continue to jointly develop an inhaled formulation of PEGylated recombinant human growth hormone (rHGH) to treat growth problems”.

For those of you who may not know, protein PEGylation–developed about 30 years ago by Frank Davis and Abe Abuchowski at Rutgers University– involves chemically attaching polyethylene glycol (PEG) to proteins. PEGylated proteins are less immunogenic and circulate longer in the bloodstream than native, unPEGylated proteins. Protein PEGylation has revolutionized the biopharmaceutical industry because it reduces immunological side effects, improves clinical efficacy and enhances patient compliance (by reducing the number of injections that are required) for many protein-based drugs. Several companies including Schering Plough, Roche and Amgen have used protein PEGylation to create multibillion blockbuster a year biotechnology products like PEG-Intron, Pegasys and Neulasta.

Like most protein-based products, rHGH needs to be injected daily to achieve its desired clinical effects. At present, there are no fewer than 8 rHGH products on the market that are used to treat pediatric and adult growth hormone deficiencies. The holy grail of the growth hormone market is to develop a sustained-release version of rHGH so that daily injections are no longer necessary. To that end, several companies, including Nektar, have developed PEGylated versions of rHGH which are in various stages of clinical development. These products should hit the markets in Europe and the US within the next few years.

Although Pfizer is in the rHGH biz, it is puzzling (to me) why any company would consider developing an inhaled form of PEGylated rHGH –given all of the regulatory hurdles and exhorbitant development costs-when an injectable form of PEGylated rHGH would be far superior and offer greater patient benefits than any of the currently marketed rHGH products? Maybe I am missing something here. That said, the larger question is: Why hasn’t Pfizer learned that the inhaled protein market is a dicey one at best?  Maybe that's why Pfizer is still Pfizer!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

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Posted on November 7, 2007 by BioJobBlogger

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!!!!!!

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