January 5, 2017
By Alex Keown, BioSpace.com Breaking News Staff
BOSTON – Bacteria never stops evolving and needs constant vigilance in order to control infections but biopharmaceutical company Paratek is using an old antibiotic, tetracycline, to find new ways to keep ahead of bacteria.That’s the central premise behind Paratek, a 20-year-old company focused on developing the next generation of antibiotics. The company was formed with the idea that researchers needs to continuously conduct solid research in order to “maintain the lead over bacteria,” Michael Bigham, Paratek’s chief executive officer told BioSpace in an exclusive interview.
When the company was founded, Bigham said it was clear that big pharma was already “getting out of the antibiotics business” and redirecting its resources to other lucrative treatment areas.
“The number of new antibiotics has dropped dramatically over the past 20 years. There’s less and less money being spent on developing the next generation of antibiotics. That’s where we want to be,” Bigham said. “There’s no better class of drugs that has had a greater impact on society than antibiotics. Before penicillin came around, infections were the number one cause of deaths.”
Paratek’s research is based on tetracycline, the 70-year-old antibiotic that is prescribed for a wide variety of uses. “We settled on this drug because it’s well known that is efficacious in a narrow setting and a broad setting. It’s also well tolerated,” Bigham said.
For the first 10 years, Paratek was focused on “blue collar chemistry,” hardcore research into tetracycline and making substitutions to the molecule to test its efficacy. From that research, which was on about 5,500 various molecules, Bigham said the company settled on two that are currently in Phase III development—sarecycline for use in skin infections and omadacycline for serious community-acquired bacterial infections like pneumonia.
Paratek has partnered with Allergan in the development for sarecycline. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains rights outside the United States.
Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration. In October, Paratek met with the U.S. Army Medical Research Institute of Infectious Diseases to discuss studying the use of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance, including the bubonic plague and anthrax.
The drug is being developed for both oral and intravenous use. If the drug pans out, he said having an oral form will be something of a “holy grail” for the military, as it will be easy to administer in combat.
Bigham said the industry and medical community has gotten complacent with antibiotics.
“The fact we’re discussing antibiotic resistance indicates the importance of innovation. The WHO (World Health Organization) says we’re in danger of going back to the pre-antibiotic environment,” Bigham said.
The last two years have been ones of explosive growth for Paratek. The company started 2015 with 15 employees and as of the end of 2016, employed 50 people. Bigham said 2017 could continue to bring strong growth as the company is expecting a “milestone heavy year.”
Bigham is expecting readouts from its two Phase III studies this year, which so far look to be promising.
If the omadacycline Phase III results are positive, the company will have to increase staff again in order to handle the New Drug Application and commercialization of the product. Bigham said Paratek would like to commercialize the drug on its own and believes it can be done in a cost-efficient manner. He said the company could hire up to 85 sales reps to handle marketing.
“We’ll start to build out the core infrastructure of commercialization in the second half of 2017,” Bigham said. If the Phase III results are positive, Bigham said the company will file the NDA by the first half of 2018 and could be ready to launch the drug at the end of the year or the beginning of 2019.
