Date: Mar 15, 2013 Author: Bill Flook Source: bizjournals (
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Rockville biotech Sequella inc. is looking to raise at least $20 million to advance its lead antibiotic candidate through clinical trials in drug-resistant tuberculosis and the stomach bacteria H. pylori.
If there ever was a time for the company to hit the gas pedal, it's now. The resurgence of tuberculosis, especially in populous nations such as India and Russia, has brought what was thought of as a 19th century disease back into the spotlight. And the rise of multiple-drug-resistant strains of TB has made that fear very real in the mind of the U.S. consumer.
At the same time, Food and Drug Administration approval late last year of Johnson & Johnson's tuberculosis treatment Sirturo, the first such approval in four decades, has provided a clearer path forward for other drugmakers looking to navigate the regulatory process. Still more encouraging — from Sequella's perspective — Sirturo won the FDA nod on an accelerated track reserved for therapeutics addressing serious unmet medical needs.
That approval "gave us the opportunity to understand the regulatory process for a new TB drug, but also gave us the understanding of what's required for accelerated approval," said Sequella CEO Carol Nacy.
Essentially, the company now has a road map.
Sequella is now looking for at least $15 million to push its own lead drug candidate, SQ109, through late-stage pivotal trials as a multiple-drug-resistant (MDR) tuberculosis treatment, as well as submit it for FDA approval within the next few years. The company is also seeking roughly $5 million to fund midstage trials for SQ109 for use in H. pylori-related gastric diseases, according to Chief Business Officer Ralph Miller.
The company has already won millions in National Institutes of Health and European Union grants, as well as from private investors. It also has numerous pharma partnerships already in place, including one with Russian biotech Infectex.
Nacy hired Miller in large part to lead the fundraising effort, which is planned for the second and third quarters of this year.
A Cowan and Co. report forecast peak global sales for Sirturo to reach between $400 million and $500 million a year. Considering that the treatment of MDR tuberculosis will likely require a cocktail of drugs, not just one, Sequella's leaders believe the report will help them recruit investors, who haven't had a good measurement on the overall size of the market.
"The Cowan report is demonstrating that there is a large enough market for people to get the kinds of returns that they need," Miller said.
Suburban Maryland has emerged as a national hub of efforts to combat tuberculosis and its new, scarier forms. Rockville is also home to the Gates Foundation-backed Aeras Foundation. Aeras had funded a TB vaccine called MVA85A, co-developed by a team that included Rockville-based Emergent BioSolutions Inc. and the University of Oxford, which in February flunked a late-stage trial for effectiveness. MVA85A would have been the first such vaccine to hit the market since the first drug, BCG, first came into use in 1921.
That clinical failure doesn't directly impact Sequella, Nacy said, though it is bad for the broader TB community. Unlike in HIV and malaria, which have seen scores of vaccines tested, "this was the first tuberculosis vaccine that had been tried in humans in 80 some odd years."
"It would have been a miracle if the TB vaccine had actually worked," she said.
