Former Pfizer Scientist Is Resurrecti...
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Jun
15
Sandeep Singh Dhillon
Former Pfizer Scientist Is Resurrecting Projects To Solve The Multidrug Resistant Bacteria Problem – Forbes
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In 2008, Pfizer decided to reduce its therapeutic area footprint and to halt R&D in a variety of areas, including infectious diseases. At the time, Dr. Michael Dunne was a vice-president at Pfizer responsible for its infectious diseases portfolio. After 16 years at Pfizer, Dr. Dunne needed to move on and became the Chief Medical Officer at Durata Therapeutics, where he was able to continue to work on his mission of developing new antibiotics.

Although he stopped working for Pfizer, Dr. Dunne didn’t forget about his former projects. One in particular captured his interest – dalbavancin, a long-acting semisynthetic lipoglycopeptide antibiotic useful as an intravenous treatment for acute skin infections caused by susceptible gram-positive bacteria. Dr. Dunne believed that dalbavancin had great potential and so Durata approached Pfizer to license the drug. Durata’s efforts were successful and Dr. Dunne was back shepherding the dalbavancin clinical program. Five years later, Durata was able to win FDA approval for this antibiotic. Shortly thereafter, Durata Therapeutics was acquired by Actavis (now Allergan) for $675 million. Dr. Dunne’s instincts concerning dalbavancin were on the money.

Despite this success, Dr. Dunne wasn’t done with Pfizer and his former anti-infective portfolio. He has joined Iterum Therapeutics as its Chief Scientific Officer and has again reached out to Pfizer, this time for a penem antibiotic, sulopenem. Here is what he has to say about his latest venture.

“Pfizer stood down from anti-infective drug development in 2008 and that included any of the ongoing work on sulopenem. Sulopenem is a penem antibiotic, similar in spectrum to ertapenem, including multidrug resistant gram negative bacteria. Its main attraction is the fact that, in addition to an intravenous preparation, it is orally available, which will allow for step-down therapy for hospitalized patients coming off their IV therapy, as well as treatment of outpatient infections due to resistant pathogens. 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.”

While this is an old compound, sulopenem has good patent protection. The IV product should garner ten years of regulatory exclusivity in the U.S. due to its status as a “Qualified Infectious Disease Product”. Given that the oral prodrug form of sulopenem is an NCE, patent protection for this version exists through 2028 with the possibility of Hatch-Waxman as well as pediatric use extensions.

But, is the commercial attractiveness of sulopenem limited given that the FDA wants to minimize the use of new antibiotics to slow down the inevitable rise of drug resistance? Dr. Dunne doesn’t think so.

“The commercial attractiveness of any new drug is directly related to the patient problem that it solves. 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. The use of sulopenem for step down therapy is perfectly aligned with good stewardship principles that get patients out of the hospital to avoid the propagation of nosocomial infections. 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%, 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.”

So, Dr. Dunne has gone back to the Pfizer well in order to bring patients much needed novel antibiotics. Hopefully, for all of our benefit, his successful track record will continue.



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