TRIUS THERAPEUTICS INC.
CEO: Dr. Jeffrey Stein.
Revenue: $16.1 million for the first six months of 2012; $41 million in 2011 (all research and collaboration revenues).
Net income or loss: $22 million loss for the first six months of 2012; $18.3 million loss in 2011.
No. of local employees: 83 employees.
Headquarters: Sorrento Valley.
Year founded: 2004.
Stock symbol and exchange: NASDAQ: TSRX.
Company Description: A biopharmaceutical company focused on the discovery, development and commercialization of innovative antibiotics for life-threatening infections.
Key factors for success: Highly experienced executives from various major pharmaceutical companies have come together at Trius to bring their combined clinical, regulatory, commercial, and research experience to create truly innovative antibiotics.
Sorrento Valley-based Trius Therapeutics Inc. is cultivating tedizolid, a treatment for acute bacterial infections such as skin infections, as one solution to the growing concern over antibiotic resistance and the need to find effective replacement drugs.
Tedizolid has remarkably progressed from the lab to the presentation of Phase 3 results in less than five years.
Those results, from the first of two Phase 3 trials, were presented recently at IDWeek 2012, held in San Diego. IDWeek was the first joint meeting of the Infectious Disease Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Disease Society.
Among the data presented was a comparison of safety between tedizolid and one of several competitors, Zyvox, manufactured by Pfizer Inc. Tedizolid is a once daily, IV and orally administered treatment for serious infections, including those caused by methicillin-resistant Staphylococcus aureus, known as MRSA.
Trius Therapeutics CEO Jeff Stein said tedizolid demonstrated significantly mild impacts on key safety points, including a milder impact on blood cells as compared with Zyvox. Stein said this could have implications for anemia, particularly when used over a long course of therapy.
“Tedizolid is a lower dose and has a milder impact on blood cells, which can translate to a better safety profile,” Stein said.
Craig Thompson, chief commercial officer for Trius, said that tedizolid was offered for a shorter course of therapy — six days versus 10 to 14 days for Zyvox — and in clinical trials resulted in statistically significant lower gastrointestinal complications, such as diarrhea, nausea and vomiting.
Although tedizolid has primarily been targeted for skin infections so far, Thompson said the antibiotic shows potential for treating lung and blood infections as well.
Also presented at IDWeek was a report evaluating the dosing of tedizolid in adolescents. Stein said testing down to the age of 12 verified that teenagers could be given the same dose as an adult dose, which is a once daily 200 milligram oral tablet or 200 milligram IV infusion. The report concludes that the proposed adult dose of 200 mg produces tedizolid exposure in adolescents similar to healthy adults in both routes of administration.
“That translates to the same concentration of drug in the blood stream, so you don’t have to split pills or have a different dosage form,” Stein said.
Following the completion of the first Phase 3 trial for tedizolid, Trius Therapeutics has embarked on enrolling up to 670 patients in a second Phase 3 trial that could get under way globally, including in the U.S., South America, Europe and South Africa by the end of this year. Although Stein said the company doesn’t expect substantially different results during the second Phase 3 trial, top line data could be reported in early 2013. That would position Trius for a new drug application submission to the U.S. Food and Drug Administration during the second half of next year, and may ultimately lead to FDA approval in mid-2014.
Stein described a very large market opportunity for tedizolid, estimating 26 million patient days of therapy for MRSA infections annually in the United States. An opportunity to fill an unmet need also exists, he said, because available antibiotics are being rendered obsolete as bacterial infections adapt to antibiotics.
The necessity to develop new, innovative antibiotics has led to the recent passage of the FDA Safety and Innovation Act, which reauthorizes the Prescription Drug User Fee Act for the fifth time. A section of the PDUFA-V titled, “Generating Antibiotic Incentives Now,” or GAIN, gives pharmaceutical and biotech companies incentives to develop such new antibiotics for the treatment of life-threatening infectious diseases caused by drug resistant pathogens.
Karen E. Potts, senior vice president of regulatory affairs for Trius Therapeutics, said the GAIN Act expedites the FDA review period for qualifying companies. While a typical new drug application takes 10 to 12 months to process, she said certain companies developing antibiotics known as “qualified infectious disease products” may be granted a priority review of six months. Additionally, pharmaceutical firms and biotechs filing a new drug application that is classified as a qualified infectious disease product would be issued five years of market exclusivity on top of the standard five years of exclusivity for a new chemical entity under the Hatch-Waxman Act. The extra protection ensures competitors can’t put a generic version of the product on the market, Potts said.
Thompson said that Trius has patents in place to protect tedizolid through 2028, but the GAIN Act affords a safety net if another company decides to challenge the patent.
“We’re very well protected but there are some other companies that may benefit,” he said.