FDA approves Tetraphase's antibiotic Xerava
- The Food and Drug Administration has approved Tetraphase Pharmaceuticals' lead product candidate Xerava, an antibiotic treatment for complicated intra-abdominal infections (cIAI), the company announced Monday.
- In Phase 3 trials, the drug proved non-inferior to Merck & Co.'s Invanz (ertapenem) and AstraZeneca's Merrem (meropenem).
- Massachusetts-based Tetraphase is planning on commercially launching Xerava with a list price between $175 and $250 in the fourth quarter of 2018, company executives said on a Monday afternoon conference call.
Big pharmas backed away from antibiotics in recent years, as the challenge of counteracting "superbugs" provided a tougher path to market.
Earlier this year, for example, Allergan said it will sell off its infectious disease unit, which includes antibiotics. AstraZeneca sold its antibiotics portfolio in 2016, and Novartis reportedly exited the space earlier this year.
That's left much of the space to smaller biotechs like Tetraphase.
Tetraphase CEO Guy Macdonald told BioPharma Dive in an interview that if everything goes to plan, Xerava (eravacycline) will commercially roll out by the end of October.
Its modest price point is part of a different sales strategy that will target hospital formularies and take advantage of the drug's broader prescription indication than most other new antibiotics, Macdonald sad.
While many competitors have labels indicating use as a last resort, with prices closer to $1,000, the FDA gave Xerava a broad label for cIAI treatment with its only limitation for complicated urinary tract infections.
Tetraphase hired 35 regional account managers contingent upon the drug's approval for five different U.S. regions. The company will "hyper-target" roughly 700 tier 1 hospitals in an institution-specific approach to getting on hospital formularies, Larry Edwards, the company's chief operating officer, said on the call.
"With us having a different strategy than some of the other recently approved antibiotics, and going after the empiric market and not going after a niche market or confirmed market with a limited label," Edwards said, "we are looking to price this anywhere from $175 to $250, and we think that pricing will help us get on to formularies much quicker than other companies have seen."
As it expands its commercial approach, it will also target 1,200 tier 2 hospitals eventually, although executives skirted around providing an anticipated timetable for that ramp up.
Xerava is the company's first approved drug and will offer a new option as a first- or second-line therapy in treatment of cIAI in patients at least 18 years old.
The drug was produced through a five-year partnership with the Biomedical Advanced Research and Development Authority, or BARDA, that included funding and consultant advice. BARDA's director, Rick Bright, called the drug "a new weapon in the battle against antibiotic resistance and addresses an unmet medical need for patients suffering from multi-drug resistant infections and other serious infections."
Tetraphase also hopes to get Xerava into Europe soon. Last month, a European Medicines Agency committee adopted a positive opinion on the drug. The European Commission will make a final decision by the end of October.
One analyst who covers the company told BioPharma Dive the approval process has been "fine," noting that smaller companies can sometimes see a stock sell off upon approval of new drugs. The stock dropped about 10% in the first hour of trading Tuesday after steady climb in the weeks ahead of the decision, which had an Aug. 28 deadline.
Macdonald said he's "obviously disappointed" by Wall Street's initial reaction, but is focused on what he can control: a successful launch that proves Tetraphase can make it in the antibiotic sector.