Pfizer has outlicensed exclusive worldwide rights to sutezolid, a mid-stage oxazolidinone antibiotic currently in development for tuberculosis, to Sequella.
The drug most recently completed a Phase IIa study in patients with TB in South Africa. Its potential indications include multi-drug and extensively drug resistant tuberculosis (M/XDR-TB) and HIV-associated TB.
Under the terms of the deal, Rockville, Maryland-based Sequella will be solely responsible for completing clinical development and commercialising the product globally. Financial terms have not been disclosed.
Rod MacKenzie, head of PharmaTherapeutics R&D at Pfizer, said that "we have evolved our internal infectious disease focus from treatment to prevention through our leading expertise in vaccine technology,". He added that "given the urgent patient need in TB, we sought a partner for sutezolid that would bring deep expertise and a strong commitment" to the disease.
Dr MacKenzie went on to say that "we believe Sequella meets these criteria and offers a portfolio with the important potential for combination studies". The latter's chief executive Carol Nacy noted that the firm is currently developing SQ109, which is in Phase II studies for drug-sensitive TB in Africa and in a pivotal trial for multi-drug resistant (MDR) TB in Russia.
She said that these two drugs "could potentially anchor a totally new drug combination regimen to treat all forms of active TB disease". Dr Nacy added that "we will pursue development of sutezolid under its own New Drug Application, and also plan for combination studies in subsequent clinical trials".
TB is always treated with three or more meds to reduce emergence of drug resistance, but preclinical studies performed independently by Sequella and Pfizer show SQ109 and sutezolid to each have activity as single agents, and promising additional activity when used in combination. Privately-held Sequella added that reports estimate a $400-$500 million global peak sales market for a drug to treat MDR-TB, some 5% of TB cases worldwide.