There are a number of challenges that exist when biotech companies prepare to take a promising compound to a commercially viable product. 

Todd Campbell, writing for The Motley Fool has taken a look at three companies in particular, who will be facing those challenges next year. 

“It requires an entirely different set of experience to navigate the world of private and public players and a big investment in sales and marketing to convince doctors to prescribe drugs.”

The first biotech up, is Keryx Pharmaceuticals, who are based in Boston. They currently focus on developing and commercialising drugs for renal diseases. Back in 2014, the US Food and Drug Administration (FDA) approved Auryxia as a phosphorous binder for kidney dialysis patients. However, the launch was slow,  due to a number of manufacturing problems that existed in an already established market. 

In November of this year, the FDA gave them a do-over with Aurayxia. This time with the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD), not on dialysis. The regulators wanted to see if they could re-launch the drug better in a different patient population. 

“There’s some reason for optimism, given that the non-dialysis market opportunity is much bigger than the dialysis opportunity,” explained Campbell. “Keryx Pharmaceuticals’ ability to spark sales growth this year (Auryzia’s sales totaled $38.2 million through the first nine months) suggests that new insurance reimbursement is helping support prescription volume and physicians’ experience with Auryxia already could make it easier to convince them to prescribe Auryxia in its new indication.”

At the start of this year, the FDA granted approval for Synergy Pharmaceuticals Trulance, for chronic idiopathic constipation (CIC). They are currently in the waiting process, to find out whether the agency will approve the use of drug in irritable bowel syndrome with constipation (IBS-C). This will be revealed on 24 January, 2018. 

However, its worth noting that the company faces tough competition from Ironwood and Allergan’s Linzness, which is approved for both CIC and IBS-C. 

Therefore, the question remains is the market large enough for both drugs? Campbell answered, “Investors sure hope so, because Synergy Pharmaceuticals has issued a lot of stock and taken on a lot of debt in hopes that Trulance will become a winner.If an approval in IBS-C doesn’t result in a spike in sales in 2018, it could put the company and its investors under pressure. Synergy Pharmaceuticals accumulated $96m in long-term debt and it spent more than $50m on operating costs in Q3 alone.”

Last on the list, trying to make their mark on the industry is Flexion Therapuetics. Working to develop non-opioid pain killers, they are waiting to receive FDA approval for the drug Zilretta, which is for osteoarthritis (OA) of the knee. 

Flexion’s president and chief executive, Michael Clayman, commented, “We have assembled a remarkable team of Musculoskeletal Business Managers, and last week they concluded their training at the Zilretta national launch meeting. We have already begun the process of informing and educating physicians about the important role Zilretta can play in the management of OA knee pain. With its extended-release microsphere formulation, we believe Zilretta holds the potential to disrupt the current treatmentparadign, and we are thrilled that it is now broadly available for the millions of Americans confronting this relentless disease.”

It would seem that with a national opioid epidemic and medical professionals and the government urging something to be done about it, the time would seem right for Zilretta. However, Campbell argued, “There are risks to overcome for management to deliver on that market opportunity. For instance, Flexion Therapeutics has to convince providers to stockpile Zilretta without a specific Medicare reimbursement code or widespread commercial payer reimbursement. Eventually, that headwind should ease, but that could take time and push out any meaningful sales to 2019.”

To conclude, if these three biotechs are going to make it big next year, a balance needs to be formed between a fast and successful launch and using up all their cash. Although a risk is present due to none of the companies having big pharma partners, the award is just as big.