Omeros, one of Seattle’s biggest biotech companies, may have its hands on a lucrative new drug — but questions about the drug and how it has been studied, first raised by an anonymous report, continue to dog the company.
The success of the drug, called OMS721, is important for the company’s future. Its direct competitor, Soliris, hit $2.8 billion in worldwide sales in 2016 and Omeros investors are betting on a similar success. However, a report this week from STAT News questioned the company’s claims about the drug and concluded Omeros may have “oversold” it.
The drug is aimed at treating rare blood and kidney diseases and is currently being studied in a phase 3 clinical trial, having completed several phase 1 and 2 trials.
Questions about it first surfaced in June, when a group of Omeros stockholders using the name Art Doyle released an anonymous report online. In it, the group alleged that Omeros hasn’t provided the scientific evidence necessary to support the claims it was making about the drug. The group also shared that it had a short option on the company’s stock and would gain money if the company’s stock fell — which it did, by 9 percent.
— Art Doyle (@ArtDoyle2017) June 28, 2017
Omeros took the anonymous group to court and a judge ordered the report be taken down by the service hosting it. The legal action is ongoing, but STAT News journalist Adam Feuerstein wasn’t satisfied with the company’s response.
— Art Doyle (@ArtDoyle2017) July 6, 2017
He continued to ask Omeros for key data on the drug that didn’t seem to add up — for instance, how many patients had been treated with it? And importantly, can it be administered under the skin instead of through an IV drip, what Omeros was touting as the drug’s main selling point?
In a piece published this week, Feuerstein wrote that several points in the drug’s development don’t add up to the company’s claims and that he believes the company may have oversold the drug.
Omeros said 54 patients have taken the drug over the course of its clinical trials, but Feuerstein could only find public data on 27 patients. If 54 patients have indeed taken the drug, the data from the remaining patients is critically important because the sample size is so small.
Omeros did not comment for Feuerstein’s story, but in a press release, it reaffirmed that 54 patients have taken the drug.
“In addition, like most biopharmaceutical companies, Omeros does not routinely release all clinical data as they are generated,” the company said. This is true, but withholding 50 percent of data is rather extreme. Omeros did not address the amount of data it withheld.
Omeros has also touted how the drug is administered: it says that, unlike its competitor Soliris, the drug can be taken through injections under the skin (subcutaneous injections) instead of intravenous injections.
But Feuerstein couldn’t find any public evidence that patients have taken the drug this way. Omeros has said the subcutaneous injection has been studied in “subjects,” assumedly healthy people, and that the subjects showed biomarkers of the drug working.
That means there is no public evidence that actual patients have taken the drug this way and seen positive therapeutic effects.
After Omeros doubled down on its claims in the press release Wednesday, Feuerstein fired back with another piece pointing out that the company hadn’t actually answered any of the ongoing questions about the drug.
Omeros raised $68.3 million in a public stock offering Monday, with the plan to put the money towards fueling OMS721 through its clinical trials and FDA approval. Its stock has been holding relatively steady this week, sitting at $20.93 per share as of publishing.