A world divided
Trius Therapeutics and Bayer will collaborate on worldwide development and commercialization of Trius’ anti-infective torezolid phosphate
SAN DIEGO—Trius Therapeutics Inc. and Bayer Pharma AG havesigned an exclusive agreement to develop and commercialize Trius' lead PhaseIII antibiotic, torezolid phosphate, in China, Japan and all other countries inAsia, Africa, Latin America and the Middle East, excluding North and SouthKorea.
Under the agreement, Trius retains full development andcommercialization rights outside the licensed territory including the UnitedStates, Canada and the European Union.
In exchange for the rights in its licensed territory, Bayerwill pay Trius $25 million upfront and will support approximately 25 percent ofthe future development costs of torezolid required for global approval in acutebacterial skin and skin structure infections (ABSSSI) and pneumonia. Inaddition, Trius is eligible to receive up to $69 million upon the achievementof certain development, regulatory and commercial milestones, with about 50percent of the milestones in the precommercial phase and 50 percent aftercommercialization. The company will also receive double-digit royalties on netsales of torezolid in the licensed territory.
According to Trius President and CEO Dr. Jeffry Stein, thecompany discussed a similar collaboration with other potential partners, butchose Bayer because of its focus on emerging markets, strong sales compared toother global pharmas and the fact that it markets other anti-infectives.
"Bayer's commitment to the infectious disease area and theirdepth and breadth of experience in these markets makes them an ideal partnerfor Trius," says Stein. "At the same time, consistent with our strategy, wehave retained rights to the U.S. and EU markets where life-threateninginfections from MRSA and other gram-positive pathogens continue to be asignificant concern."
Bacterial infectious diseases represent one of the largest therapeuticareas in China and continue to grow rapidly, notes Dr. Jorg Reinhardt, chairmanof the board of management of Bayer HealthCare. Lung infections leading topneumonia represent a significant unmet need which torezolid will target. Thedrug is an IV and orally administered second-generation oxazolidinone now inPhase III clinical development for the treatment of ABSSSI, the first suchtrial to be initiated under a Special Protocol Assessment (SPA).
Torezolid is administered as a prodrug identified as TR-701that is rapidly converted in vivo byphosphatases to the active molecule TR-700. Trius' research indicates thatTR-700 is four- to eight-fold more potent in vitro and in vivo than linezolid against gram-positive pathogens, includingmethicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistantEnterococci (VRE).
"In addition," says Stein, "and unlike linezolid, torezolidas a prodrug does not react with monoamine oxidase and exhibits no pressoreffect or increase in heart rate."
Trius holds an exclusive license to torezolid phosphate forterritories outside of North and South Korea from Dong-A Pharmaceuticals.
In addition to Trius' torezolid phosphate clinical program,it is currently conducting three preclinical programs to develop antibiotics totreat infections caused by gram-negative bacteria.
The biopharmaceuticalcompany recently announced financial results for the second quarter. For thesecond quarter of 2011 and 2010, Trius reported a net loss of $10.0 million and$2.3 million, respectively. For the six months ended June 30, Trius reported anet loss of $20.1 million, compared to $6.6 million for the same period in2010. The increase in net loss during the three- and six-month periods waslargely due to increased clinical trial expenses, the company says. For thefirst halves of this year and last year, Trius reported a net loss per share of$0.82 and $7.74, respectively. The decrease in the net loss per share wasprimarily due to the increase in shares outstanding resulting from an initialpublic offering in August 2010 and private placement financing in May, Triusreports.