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Life sciences experts believe Indiana’s resume of successful pharmaceutical startups sets the stage for the next generation of young companies to follow in their footsteps; among the state’s young pharma proteges are Outpost Medicine and Acacia Pharma Inc. Indianapolis-based Outpost claimed last year’s biggest venture capital investment in the state’s life sciences sector as it nears the end of Phase 1 clinical trials. Further along the development path, Acacia Pharma believes it’s within days of earning approval from the U.S. Food and Drug Administration (FDA).

“It’s always in the FDA’s hands; there are definitely no certainties,” says Acacia Pharma Chief Commercial Officer Mike Bolinder. “We feel very confident in our chances of approval.”

Acacia is developing a drug called BARHEMSYS to be given to patients while they’re still in the hospital to treat post-operative nausea and vomiting (PONV), a common complication after surgery. The startup says the market is desperate for a solution; about 30 percent of surgical patients suffer from PONV.

“In patients’ minds, [PONV] is absolutely worse than post-op pain; it’s one of their greatest fears, in particular if they’ve had it before,” says Bolinder. “Not only are you dealing with the pain and everything you just went through surgically, but to add potential retching, nausea and vomiting is terribly debilitating. It not only affects people mentally and physically, it also delays recovery and the ability to get out of the recovery room, and ultimately, the hospital.”

Bolinder says even if patients are identified as being high-risk for experiencing PONV and are given drugs prior to surgery to help prevent the condition, about 80 percent still suffer from it.

“That’s where our drug comes into play,” says Bolinder. “We believe our drug will have a natural niche in helping those patients who have already…received that sort of generic standard of care before surgery—yet despite that, after surgery, are still experiencing nausea and vomiting or are in need of some help to alleviate that.”  

Acacia is developing a second drug, earlier in its pipeline, that uses the same active ingredient as BARHEMSYS to treat chemotherapy-induced nausea and vomiting (CINV). The startup says more than 90 percent of patients receiving highly emetogenic chemotherapy battle CINV.

Acacia is based in Cambridge (UK), however, leaders identified the U.S. as the most promising market for BARHEMSYS. At the time, Acacia had no commercial experience in the U.S., and a series of connections led them to an Eli Lilly and Company alumnus and a new home in Indianapolis.

That executive was Scott Byrd, who took the reins of Acacia’s commercialization efforts in Indianapolis in its early days. Byrd brought a second Lilly alumnus on board when Bolinder joined the Acacia team. Their collective roots and connections in Indianapolis led Byrd to serve on Acacia’s board of directors as he shifted his focus to leading another Indianapolis endeavor: Outpost Medicine.

“[Outpost Medicine] has been operating in Indianapolis for about 18 months, and it has proven to be everything we had hoped,” says Byrd, who is chief executive officer of the company. “We’ve hired several senior leaders with decades of pharmaceutical development experience, and we’re poised to bring more on board soon.  We have also benefited from the support of highly experienced local consultants and contractors that have become key partners for us with both of our programs.”

Outpost, which has raised a total of $71 million in Series A venture capital financing, is in the final stages of Phase 1 clinical trials for a drug to treat overactive bladder (OAB) and irritable bowel syndrome (IBS). The company says, in the U.S., one-third of adults age 40 or older have symptoms of OAB, and patients report limited efficacy or intolerable side effects with current treatments. 

Outpost is developing a second drug to treat various forms of incontinence disorders; it will likely begin Phase 1 clinical trials later this year.

“Indianapolis is a fantastic place for life sciences companies to grow and innovate,” says Byrd. “There is a deep pool of talent capable of supporting Outpost, and many other companies like us, far into the future.”

Indiana’s life sciences sector touted a record-breaking year in 2018 with a total of $115 million in venture capital investments. While it’s an arduous and capital-intensive journey to bring a drug to market, industry leaders are confident that today’s early-stage companies will be the next generation of success stories.

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Bolinder says he and Outpost’s Chief Executive Officer Scott Byrd are examples of how Indiana’s life sciences legacy creates and attracts startups in the pharmaceutical sector.

Bolinder says clinicians who treat surgical patients are “desperately looking forward to our [PONV] drug coming to market.”

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