Eli Lilly and Co.’s foray into combination drugs is well-timed because the company could take advantage of some the world’s most successful biotech drugs, which are about to see their patents expire.
Indianapolis-based Lilly announced June 28 that it will invest millions to double the size of its team trying to develop so-called multi-specific therapeutics—single biotech drugs that carry two medicines to treat a patient’s disease.
Such combinations could be two entirely new drugs, but more likely are mixtures of a known drug with one that’s unknown or even two that are known, said Jan Lundberg, president of Lilly Research Laboratories. They could also pair a biotech protein with a more traditionally produced small molecule drug.
Lundberg sees the potential for less resistance to medications and, possibly, fewer safety issues.
“We are expanding our capabilities to develop high-quality multi-specific agents, the combination of mechanisms of action for both large and small molecules into one therapy to better influence disease by addressing several relevant pathways and potentially also reducing resistance to treatment,” Lundberg told a meeting of investors in New York on June 30.
The known drugs could be products Lilly already has on the market, drugs from its pipeline, drugs that were tested and rejected before ever entering its pipeline, or even drugs from other companies that have gone off patent.
An example of that last possibility is Amgen Inc.’s Epogen, which treats anemia. The drug, which had worldwide sales last year of $2.5 billion, will see its U.S. patent expire in 2013.
Also, Roche’s blockbuster Rituxan, which treats non-Hodgkin's lymphoma and rheumatoid arthritis, will see its U.S. patent expire in 2015. A division of Switzerland-based Novartis is already testing a generic version of the $6-billion-a-year drug.
Such generic versions could be sold in the United States, after the 2010 health care reform law created the first pathway for approval of generic biotech drugs.
Lilly has no interest in making generic versions of biotech drugs. But it is interested in combining highly successful biotech agents, like Rituxan or other cancer drugs, with other drugs patients often take at the same time. Multiple medicines are common for patients with cancer, diabetes and autoimmune diseases.
Lilly plans to double the team of 35 to 40 people it has working on the project; half of them are in San Diego and the remainder in Indianapolis.
The company already has at least seven multi-specific drugs in the earliest stage of testing. It expects to put the first of them into human trials before year’s end.
Many other companies—including New York-based Bristol-Myers Squibb Co., Maryland-based Emergent BioSolutions, Maryland-Based Zyngenia Inc. and Switzerland-based Molecular Partners AG—are studying multi-specific therapeutics.
But since so few have even started into human testing, it’s hard to know whether the idea will prove out.
“It is certainly possible that antibodies that bind to two targets will offer a combination of efficacy and safety that will establish new therapeutic standards,” said Bernard Munos, founder of the InnoThink Center for Research in Biomedical Innovation. The former adviser in Eli Lilly and Co.’s corporate strategy group, who now speaks broadly about reinvigorating innovation in the pharmaceutical industry, praised Lilly for “taking the plunge” on this strategy.
But, Munos added, these drugs also could yield worse side effects.
“It all depends upon the number of pathways in which these targets are involved, and how great a 'commotion' will be created in the cellular machinery by interfering with them. There is no way to predict that,” he said.