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had a rough time. Nabriva Therapeutics (NASDAQ: NBRV) will try to change that trend if the FDA approves its antibiotic lefamulin for bacterial pneumonia.
The odds aren’t in Nabriva’s favor. Achaogen (NASDAQ: AKAO) went bankrupt a year after approval of its antibiotic plazomicin (Zemdri). Tetraphase Pharmaceuticals (NASDAQ: TTPH) restructured shortly after approval of its antibiotic eravacycline (Xerava), noting at the time that selling antibiotics requires “a long runway and unwavering perseverance.” Paratek Pharmaceuticals (NASDAQ: PRTK) is off to a “promising” start with omadacycline (Nuzyra), wrote SVB Leerink analyst Ami Fadia. But shares have been cut in half since Nuzyra’s approval last October.
The problem: Antibiotics are tough to make money with. They don’t get the same pricing power as, say, cancer immunotherapies. And ideally they’re used as little as possible, so bacteria don’t become resistant to them. All that leads to a business that, as this April story from Wired explains, “is broken.” That’s why Big Pharma largely exited the business.
Last week, Seema Verma, who runs the federal Centers for Medicare & Medicaid Services, proposed policy reforms to “stabilize the antibiotic development pipeline” and deal with the superbug threat. (Here’s more on Verma’s proposed policy changes.)
Amid all this uncertainty, here comes Nabriva, and it faces an uphill battle. The biotech’s shares are trading near all-time lows ($2.24) days before potential approval of its antibiotic. It also has less than a year of cash left in the bank.
The FDA has approved two cancer drugs that target a tumor’s genomic signature, no matter where in the body that tumor is found. One of those “tissue agnostic” approvals was for the immunotherapy pembrolizumab (Keytruda), which is already used to treat a slew of cancer types. Larotrectinib (Vitrakvi), from Loxo Oncology, got the second nod, prompting Eli Lilly to buy Loxo for $8 billion, even though rival Bayer held claim to the drug’s commercial rights.
[Updated with approval, price details] The third came on Thursday. Last month entrectinib (Rozlytrek) nabbed the first “tissue agnostic” approval in the history of Japan. On Thursday, the FDA followed suit and approved Rozlytrek, which Roche grabbed when it bought Ignyta for $1.7 billion. Like Viktravi, Rozlytrek is for people whose tumors have an NTRK gene that has abnormally fused to another gene. The FDA approved it for those patients, as well as for non-small cell lung cancer patients with a different fusion called ROS1.
Rozlytrek will cost about $17,050 per month for patients with Ros1-positive lung cancer, in-line with the price of crizotinib (Xalkori), the other approved drug for the disease, according to Genentech spokesperson Meghan Cox. The price for patients with NTRK fusions is based on which dose they get, but the number is “lower than” Vitrakvi, she said. (Genentech is offering support for out-of-pocket costs and free access to Rozlytrek for people who meet certain eligibility criteria, Cox said.)
The field of precision medicine, matching the right drug to the right patient, holds out the promise of less trial-and-error (and ideally, fewer side effects and more lives saved). But the commercial success of both Vitrakvi and Rozlytrek are every bit as important as touchstones for the economic viability of these drugs. Several others are in development, aiming for the same path as Vitrakvi and Rozlytrek.