Sandoz, the generics business of Novartis, signed an exclusive collaboration with Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs. Both the companies plan to develop four follow-on versions of previously approved recombinant biotechnology and complex drugs.
Under the agreement, Sandoz is planning to purchase approximately 4.7 million shares of newly issued Momenta common stock for an aggregate price of USD 75 million. The investment remains subject to regulatory approvals.
The collaboration will include one late-stage compound from Momenta's pipeline and two late-stage compounds from Sandoz. It also expands an existing US collaboration on M-Enoxaparin, a complex drug based on a mixture of sugar chains, established in November 2003 to also include the European Union. M-Enoxaparin is a generic version of Lovenox a low molecular weight heparin indicated for use in treating deep vein thrombosis (DVT) and several cardiovascular conditions. It was submitted for US approval in August 2005.
Sandoz will also gain exclusive access for the four products in the agreement to the product characterization tools of Momenta, which was founded in 2001 based on technology initially developed at the Massachusetts Institute of Technology (MIT).
These tools enable the detailed chemical sequencing and analysis of complex mixtures. This capability, when combined with the global reach and manufacturing technology of Sandoz, will enhance the design of products to demonstrate their equivalence to originator products. The goal is to establish a quality-by-design approach to facilitate development and registration of biotechnology and biologic drugs. The collaboration will also leverage the global capabilities and infrastructure of Sandoz for developing, manufacturing and marketing complex drugs.
"Following the breakthrough approval of Omnitrope, Sandoz is committed to bringing other follow-on biotechnology and biologic medicines to patients worldwide following patent expiry," said Andreas Rummelt, CEO of Sandoz. "Our intent is to set new standards for the characterization of complex drugs and for bringing follow-on versions to the market as quickly as possible that will contribute to reducing healthcare costs."