Sandoz, the company that recently received approval for the first bio-similar human growth hormone, is pursuing new follow-on biologics in partnership with a company that specializes in analyzing and engineering the sugars that form the surfaces of proteins--a technology that promises to become a key part of analyzing the bio-equivalence of complex protein-based drugs.

The deal covers four compounds. One is a generic version of Lovenox (M-Enoxaparin), a low-weight heparain product for the treatment of deep-vein thrombosis. It has been the subject of a Sandoz/Momenta partnership since 2003 and is currently under review at FDA.

The other, undisclosed compounds, include one late-stage compounds from Momenta and two from Sandoz. Momenta could make up to $263 million on the partnership, including a $75 million equity investment from Sandoz.

Alan Crane, Momenta's president and CEO, noted that current analytical methods can assess the equivalence of small molecules, but can't compare the bio-similarity of more complex drugs. Momenta's technology can analyze how the manufacturing process changes the distribution of sugars on a protein.

Crane noted that Momenta's glycoprotein research would be "a very fundamental, central piece" of the submission package. And he added that the greater the ability to analyze and define chemical similarity, the less information FDA will need to evaluate an application for a generic biologic. 

"We're helping to bring complex drugs to market," he said.

Sandoz broke new ground in May when it received approval for Omnitrope, a human growth hormone product, using a hybrid application that was more detailed than a generic application, but less so than a new drug application.FDA has been struggling with how to approach generic biologics for some time, and has been cautious about establishing a regulatory pathway for these compounds.

"Reaching agreement on those issues is something that's going to take a lot of work and a lot of science," said David Rosen, a partner at law firm Foley & Lardner and a former FDA official. "FDA is still struggling with what should be the requirements on a gross basis."

Industry observers pointed out that human growth hormone is one of the few biologics approved under the Food, Drug and Cosmetics Act, which provides a path for generic follow-ons. Most biotech-based drugs were approved under the Public Health Services Act (PHSA), which does not. Rosen cautioned that there is some question of whether FDA even has the authority to approve generic versions of drugs approved under the PHSA.

Crane acknowledged that "Omnitrope is a relatively simple protein." But he added that Momenta?s technology would allow regulators to evaluate the chemical similarity of even more complex proteins.

In a statement, Sandoz CEO Andreas Rummelt expressed his commitment to commercializing additional follow-on proteins.

"Our intent is to set new standards for the characterization of complex drugs and for bringing follow-on versions to market as quickly as possible that will contribute to reducing healthcare costs," he said.

Sandoz declined to comment beyond the press release.

Partnership with Momenta includes technology to evaluate bio-equivalence.

Pharmaceutical Executive-08-02-2006