On October 26, 2011, I attended the BIO Investor Forum in San Francisco. The Therapeutic Workshop about Infectious Disease, titled “Resistance is Futile—SuperDrugs for SuperBugs.” Moderator Susan Schaeffer, Sr. Editor at BioCentury Publications said that the economics are unique in this category. Antibiotics can get developed and approved, but then they sit on a shelf. The problem is real, but it has to be resolved through price, which is tricky, Schaeffer said.
Urgent Need for Antibiotics
According to David Perry, CEO at Anacor Pharma, Inc. there is an urgent need for antiobiotics to fight certain gram-negative bacteria. Mark Leuchtenberger, President at Rib-X Pharma. Inc. told a sad story about a man with a congenital heart defect who was in the hospital and the MRSA he contracted mutated 35 times before he died. Jeffrey Stein, President and CEO at Trius Therapeutics, Inc. said they have a gram-negative program just started. They also have gram-positive program. He believes that the gram-negative market is underserved. He also said that anti-infective companies are tapping into government contracts. The government is partnering with VCs. They are looking for dual-use compounds (anthrax).
Antibiotics Are Big In China
According to Stein, there is a rise of MRSA in China. Unlike the U.S., antibiotics are the largest growing class in China. China is big into IV treatment for infections. They are big on IV treatments for a lot of things. Perry said that for some reason money is not flowing into antibiotics. He gave some reasons such as the time lag is so long and regulatory hurdles. He said there is only 5 percent resistance now.
New FDA Guidance Adds Clarity
Stein told a story about FDA’s new guidance right before the company went on its roadshow, which delayed their IPO. They had to adjust their protocols according to the new guidance. The FDA has finally given clarity and it has pretty strict outcome priorities. One of them is fever. However, Stein believes that the FDA probably will remove this as a criteria outcome. He said he is looking for rational thinking from the FDA. The FDA actions have been unexpected in past, said Stein. The Generating Antibiotic Incentives Now (GAIN) Act is a bill that has been introduced to provide incentives for the development of new antibiotics needed to treat new and emerging resistant bugs.