Replies to post #7163 on Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

tinker

good find.
I think there is a difference. PDLI's technology and licensing of it is not mandatory to make human anti-bodies. There are other ways to make human antibodies as in other MAB's that have not in-licensed PDLI.

However, making ANY biogeneric would require selection of host line and that involves careful selection/calibration and if MNTA's patent on that covers that(that have already find numerous relation b/w host line and resulting protein structure- see example below), then I am hypothesizing that ANY future biogeneric player will need to license that testing/selection patent from MNTA

Eg: http://www.nature.com/nbt/journal/v28/n11/abs/nbt1110-1153.html

Even so, it is generally accepted that CHO cells lack the biosynthetic machinery to synthesize glycoproteins with a-Gal antigens5. Contrary to this assumption, we report here the identification of the CHO ortholog of N-acetyllactosaminide 3-a-galactosyltransferase-1, which is responsible for the synthesis of the a-Gal epitope. We find that the enzyme product of this CHO gene is active and that glycosylated protein products produced in CHO contain the signature a-Gal antigen because of the action of this enzyme. Furthermore, characterizing the commercial therapeutic protein abatacept (Orencia) manufactured in CHO cell lines, we also identified the presence of a-Gal. Finally, we find that the presence of the a-Gal epitope likely arises during clonal selection because different subclonal populations from the same parental cell line differ in their expression of this gene

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http://pdl.com/technology-products/what-are-humanized-monoclonal-antibodies/


http://pdl.com/about/
Antibodies are proteins in the immune system that help the body defend against foreign invasion, particularly from pathogens and toxins. As such, a human-engineered therapeutic monoclonal antibody is a protein that has the ability to combine specifically with a target protein that plays a role in a disease process. With this unique ability to specifically target disease-related cells while leaving healthy cells unaffected, monoclonal antibodies can serve to diagnose and treat a wide range of medical conditions. Examples include Genentech/Roche’s Avastin®, Herceptin®, and Lucentis® and Elan/Biogen Idec’s Tysabri®, which are all produced using PDLI’s antibody technology and together made up more than 80% of the company’s royalty revenue in 2008.

It is relatively easy for a biotech company to make a mouse or chicken antibody. However, these animal antibodies may be seen by the human body as foreign substances triggering an immune response. Therefore humanized antibodies, which are more difficult to produce, are preferred. PDL licenses the technology to produce humanized antibodies to other pharmaceutical and biotech companies in exchange for royalty payments. Since 2004 PDLI’s revenues have averaged year-over-year growth rates of more than 20%, predominantly as a result of royalty payments from pharmaceutical companies that use PDLI’s antibody humanization technology to make treatments for cancer as well as autoimmune and infectious diseases.

[DewDiligence]

…bring to market drugs. Far more profitable the protected drug market vs. a royalty or licensing fee.

Quite so. MNTA certainly does not intend to become the Rambus of the follow-on-biologics universe.

Insofar as most prospective players in the US FoB arena are intending to develop non-substitutable biosimilars via the 351(k) pathway or the conventional BLA pathway, it’s not even clear that MNTA’s patents on cell lines would be able to block anybody else’s products from reaching the market.