Outsourcer Hunts for New Uses for Old Drugs on the Cheap

I recently listened to an interview with Noel Dudley, Ph.D., co-founder at NuMedii presented by Labroots.  NuMedii, located in Menlo Park, California, is a spin-off from Atul Butte’s lab at Stanford.

What I found very interesting listening to Dudley was the very low overhead costs to running a service business like NuMedii.  Dudley said, “This is a very exciting time we live in right now.”  NuMedii is involved in drug repositioning or new uses for existing drugs.  “They use a new computational approach to look for drug repurposing opportunities,” he said.  “All you need is a bunch of guys with laptops,” said Dudley.  They have a big network of CRO’s that they leverage that they have worked with in the past.  They do not do the experiments in house.  The CRO’s cost has been driven down by pharmaceutical companies who started to use CRO’s and have really driven down the margins.  “So for very small amounts of money you have vast experimental resources,” said Dudley.  It is not necessary to have a lot of computational power in house because of cloud computing.  In addition, a lot of data can be accessed from the public domain.

According to Dudley, they have the expertise to manage everything from the informatics through the preclinical validation and experimentation — so he believes that is where NuMedii has a lot of value.

He gave an example of two drugs that could potentially be used for other indications.  Dudley said they were able to identify an anti-ulcer drug that could treat lung cancer, which again is a non-intuitive leap, and the other one was an anti-epileptic drug that could be used to treat inflammatory bowel disease (IBD).  “They can also find new indications for drugs that are in development,” he said.  This could be useful for diversifying the development of the drug.

NuMedii is a service company.  Their approach is to partner.  They set up a development partnership in which NuMedii gets access to the partner’s data.  They then go back to their partner with their findings.

Biotech Drugs Navigate Tricky Path to Fight ‘SuperBugs’

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.