Meet the Scientist Finding Success at Other Biotechs Working on Old Pfizer Compounds

Meet the Scientist Finding Success at Other Biotechs Working on Old Pfizer Compounds June 22, 2017
By Alex Keown, BioSpace.com Breaking News Staff

DUBLIN – Finding value in discarded drug programs is nothing new in the life sciences industry. Biotech guru Vivek Ramaswamy has built an entire business model on the concept. But one scientist, Michael Dunne, is also carving out a niche by working with his former company, Pfizer .

Following his 16 year stint at Pfizer, where he oversaw the infectious disease portfolio of drugs, Dunne served as the chief medical officer of Durata Therapeutics . While there he licensed a former Pfizer drug, dalbavancin, for the treatment of skin infections caused by susceptible gram-positive bacteria. Dunne oversaw development of the drug through approval by the U.S. Food and Drug Administration. That FDA approval led the way to Allergan snapping up Durata in 2014.

Dunne, now the chief scientific officer of Iterum Therapeutics, has turned to Pfizer for the second time to develop a shelved drug program. This time Dunne and Iterum are developing sulopenem, an oral and intravenous antibiotic, called penem, to treat Gram-negative multi-drug resistant infections.

In an interview with Forbes’ John LaMattina, Dunne explained why he returned two times to Pfizer for the cast-off therapies. Because of his familiarity with both drugs, Dunne believed they had potential to be effective treatments. Since Pfizer “stood down” from anti-infective drug development, Dunne said development of the drugs should continue because there was real value in them.

“Having worked on sulopenem while I was at Pfizer, I recognized its continued relevance to today’s problem of multidrug resistant infections. Pfizer quickly recognized it would be better to have someone continue the development efforts rather than have the drug just sit on the shelf. The license is fairly typical for these types of compounds but, unless Iterum chooses not to develop it further, there are no claw back rights,” Dunne told LaMattina.

Dunne said the drug still has patent protection, which is certainly nice for Iterum. He also said sulopenem will be effective as a “step-down therapy” as an antibacterial treatment.

“In the outpatient setting, specifically for uncomplicated urinary tract infections, we envision that most use will be for two groups of patients. The first is for those who live in regions where resistance to the standard agents now exceeds 15 – 20 percent, making them poor alternatives for empiric therapy. The second group is for those patients with infections documented to be due to multidrug resistant gram-negative bacteria,” Dunne said in his interview.

Investors must certainly agree with his reasoning. Last month, Iterum snagged $65 million in Series B funding to develop the antibiotic treatment through Phase III trials in treating patients with complicated urinary tract infections and complicated intra-abdominal infections (uUTI, cUTI and cIAI). The trials are expected to being in 2018 and if all goes well, file a New Drug Application with the FDA in 2019.

Antibiotic resistance is considered one of the biggest threats to global health today. An overuse of antibiotics is one of the causes of antibiotic resistance, which is making some infections, including pneumonia and tuberculosis, harder to treat. Despite the growing problem of antibiotic resistance, many companies do not invest in new drug development, which singles Iterum out. And Dunne seems to believe it’s the right path for the company.

“Given the medical need it addresses, we believe there is a strong and attractive business rationale for sulopenem. We are fully aligned with the idea that new and potent antibacterial agents should target patients who need them most,” he said.

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