When Opko Health bought Ireland’s EirGen in 2015, colleagues Sharon Cunningham and Orlaith Ryan wasted no time. Zeroing in on gaps in cancer care, the duo started building its own oncology company, with a focus on children’s and women’s cancers.
Now, Shorla Pharma—named for its two founders—is picking up $8.3 million to push its programs through regulatory approval and build up its technical and commercial operations ahead of its first drug launch in 2021. The company will hire “key personnel” in Ireland, Cunningham told FierceBiotech. And with the U.S. as its first market, part of the funds will go toward setting up an outpost to take care of business development and regulatory and commercialization activities stateside.
The Dublin-based company is working on three programs, all of which are improvements on established drugs, which may have a difficult-to-use formulation, not treat certain types of cancer very well or be in limited supply. Cunningham and Ryan didn’t disclose what the drugs are, beyond saying they are all “established active substances” that have been “proven from a safety and efficacy perspective.”
“We looked at areas that other people might see as a barrier to entry and saw them as an opportunity,” Ryan told FierceBiotech. “We evaluated the regulatory and clinical landscape and asked, has this drug been in shortage? … Can we take those drugs off the shortage list and create a clinical impact?”
Its most advanced assets are SH-111, a sterile injectable solution for children and adults with leukemia, and SH-105, a drug for breast and ovarian cancers. The latter is a ready-to-dilute form of a drug that was approved as a freeze-dried powder in the 1950s and hasn’t been improved since, Ryan said. The change makes it easier for doctors to handle and administer to patients.
Shorla expects to file SH-105 for FDA approval by the end of the year and SH-111 for approval early next year.
Its third program, SH-110, is a liquid version of a pill used to treat glioma, a type of brain cancer. The capsule can be difficult to swallow both for young children as well as older adults, so a “palatable oral solution simplifies the administration process.” If all goes to plan, Shorla will launch SH-110 in 2022.
After it launches its drugs in the U.S., the company will seek approvals in other markets, Cunningham said. Although its current pipeline comprises new formulations of old drugs, Shorla isn’t ruling out developing new drugs in the future.
“We have a very defined product selection strategy incorporating clinical, regulatory, technical and commercial evaluations,” Ryan said. “But we would never say never; we are constantly engaging with universities, research groups and specialized hospitals. If there is an opportunity in addressing unmet need, we absolutely want to be part of that. We intend to develop the pipeline further as the company progresses.”
The duo joined EirGen in its relatively early days and worked closely with the drugmaker’s co-founders on various deals, fundraising and other processes, Cunningham said.
“We were very lucky to get a lot of exposure to all aspects of running a pharmaceutical company,” she said.
Their biggest challenges were learning to be nimble and narrowing their focus.
“We had to learn early on the importance of being agile and having an intimate relationship with the problem, but being emotionally detached from the solution,” Cunningham said.
“We started with a long list of products we thought were going to change the world,” Ryan said with a laugh. “Early on, we had to ensure we validated our ideas, engaged key opinion leaders and considered stakeholder economics. They’re all different aspects, but ultimately critical to product development.”