Amid the COVID-19 pandemic and resulting quarantines, it would be easy to overlook an FDA approval of a reformulated chemotherapy drug to treat a rare cancer. But UroGen investors were certainly ready to welcome good news, and they got it yesterday evening when the FDA approved the company’s first drug, Jelmyto.
The New Jersey and Israel-based company, backed by biotech VIP Arie Belldegrun and led by Big Pharma veteran Liz Barrett, said Thursday morning that it plans to launch the upper tract urothelial cancer (UTUC) drug June 1 at a price of $21,376 per dose.
During a conference call with analysts, Barrett acknowledged that COVID-19 restrictions might complicate Jelmyto's launch, but she's determined to make good on the promise of a June 1 launch. The company has already built a sales force of 48 reps to help do the legwork, virtual or otherwise.
“Regardless of whether we’re quote-unquote back to business or not, we will be launching on June 1,” the UroGen CEO said. “It will be a potentially different type of launch, which I think we’re very prepared to do.”
Shares of UroGen were up nearly 9% in premarket trading Thursday.
UroGen’s chief commercial officer Jeff Bova said the company is preparing to make the most of technology that will allow sales reps to communicate virtually with physicians who treat UTUC.
“Many physicians have already embraced virtual technology to increase office efficiency,” Bova said. “So this approach is embedded in their offices, and we believe it will allow us to continue momentum through the launch.”
UTUC is diagnosed in an estimated 6,000 to 7,000 patients per year and typically requires multiple surgeries to treat, including kidney removal, UroGen said in a statement about the approval. Most patients are older than 70, making surgery particularly risky.
Jelmyto, by contrast, is applied to the urinary tract using a catheter and is the first non-surgical treatment approved to treat the disease.
Jelmyto was approved based on a phase 3 study in which patients received the drug once a week for six weeks. Following the treatment, 58% of participants had a complete response, and one year later, 46% of those patients were still responding.
As challenging as it will be to launch a drug during the COVID-19 shut-down, UroGen’s sales reps will face other hurdles, too. Several analysts on the Thursday morning call wondered about side effects reported during the phase 3 study, which included “ureteric obstruction,” a dangerous blockage in the tubes that carry urine from the kidneys to the bladder.
Mark Schoenberg, M.D., UroGen’s chief medical officer, said he didn’t think the side effects would deter physicians, given that they are already familiar with the general risk of swelling and other problems that can occur when they place a catheter in the urinary tract. The best way to think about side-effect risks, he said, is “best encapsulated by a response we heard from a physician who’s familiar with this product. He said, ‘look, the alternative is taking out the kidney.’”
Then there were questions about UroGen’s ability to persuade insurance companies to cover the product, both for first-time users and for patients who might have a recurrence down the road that would warrant a second round of Jelmyto doses.
“Our focus will really be on ensuring that everyone gets the [initial] six installations,” Barrett said. Any further doses would be “at a physician’s discretion,” she added, “but we do expect that it would get covered.” That said, UroGen has not discussed retreatment with payers, she said.
Barrett, the former CEO of Novartis Oncology, joined UroGen a year ago to oversee the rolling FDA submission on Jelmyto. Backed by nine years of experience at Pfizer and 13 at Johnson & Johnson, she has also been working to expand UroGen’s pipeline by applying the gel technology to other products and by bringing in additional assets via partnerships and licensing deals. The company’s pipeline includes an immuno-oncology treatment for non-muscle invasive bladder cancer.
For now, though, investors will be focused on Jelmyto and the company’s ability to bring attention to the product at a time when the medical community is laser-focused on the COVID-19 crisis. Some analysts expect the product will eventually bring in $375 million a year.
In announcing Jelmyto’s approval, the FDA vowed to continue to prioritize its review of novel cancer treatments in spite of the pandemic.
“Although our nation’s emphasis is on the need to combat COVID-19, patients with cancer and their unique needs continue to be a top priority for the FDA,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases at the FDA, in a statement. “We continue to expedite oncology product development in this critical time.”