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www.fdanews.com/articles/73924-biotechs-helping-big-pharma-fill-pipelines

BIOTECHS HELPING BIG PHARMA FILL PIPELINES

July 1, 2005

Roughly half of the products large drugmakers receive approval for today are generated from in-licensed molecules, according to an industry expert, who said drugmakers can find particularly high value in acquisitions of large-molecule biologic products.

In-licensed products acquired by large drugmakers succeed on average more than 33 percent more frequently than internally developed products, said Roger Longman, founder of the business information firm Windhover Information, during a recent session at the Biotechnology Industry Organization's (BIO) annual conference in Philadelphia.

This high success rate is especially prevalent in large-molecule biologics because most candidates are aimed at unvalidated disease targets, Longman noted. A large molecule product targeting an unvalidated disease has a greater chance of being approved than a small molecule product going after a completely validated target, he said.

Demand for such innovative products is changing the face of R&D, according to one pharmaceutical executive. "The model for R&D is different today, and largely that is because 'me-too drugs' are not going to be accepted in the marketplace," said Harlan Weissman, executive vice president of R&D at Johnson & Johnson (J&J).

"What's going to be driving value in the marketplace is innovation, and innovation is going to occur through a combination of novel targets and improvements to drugs that go after existing targets," he said.

New drugs that follow others into a class, however, will have to show substantial improvements over the existing therapies, he said. One way to do this is through new delivery systems, Weissman said, pointing to J&J's pain drug Duragesic (fentanyl transdermal system), which

delivers an established drug through a patch.