Emerging Drug Developer: Cytochroma

Cytochroma plans to grow as it advances vitamin D work

The business case for Cytochroma is built around the shortcomings of two lead therapies for hyperparathyroidism in patients with chronic kidney disease; Hectorol and Zemplar. 

"These two products properly control hyperparathyroidism in 10 percent of treated patients," says Cytochroma CEO Charles Bishop. "There's an enormous opportunity for better therapies for the disorder." 

Bishop is in a good position to know. He was a senior manager at Bone Care and helped get the NDA approval for Hectorol. Later, he co-founded Proventiv Therapeutics, which was sold to Cytochroma two years ago--a deal which provided two of its top three development programs. And Cytochroma is now moving into a critical phase, providing the data to prove the biotech is on the right path to better treatments. 

The company is advancing three therapies in the clinic: CTA018 and CTAP201 for secondary hyperparathyroidism and CTAP101 for the treatment of vitamin D insufficiency. 

The first set of Phase II data should come in around the middle of next year, says the CEO. The first safety and efficacy trial lies ahead for 201 and 101 should be in a mid-stage trial by the end of the year. 

The biotech's work has attracted a long lineup of financial backers as well as its first development partner. Mitsubishi Tanabe Pharma Corporation led the $45 million (Canadian) Series C, supported by Vengrowth Advanced Life Sciences Fund, Caisse de Dépôt et Placement du Québec, Novo A/S, Canadian Medical Discoveries Fund Inc., T2C2/Bio 2000 Limited Partnership, GrowthWorks Canadian Fund Ltd., BDC Capital Inc., and VentureLink Brighter Future Fund Inc. 

On the same day the Series C was announced, Mitsubishi Tanabe and Cytochroma heralded a $105 million (Cdn) licensing pact--including both an upfront payment and milestones--outlining a joint promotion deal for the U.S. as well as Asian rights for 018.  

Cytochroma is expanding its staff to advance its mid-stage work. By the end of this year, says Bishop, the company will likely grow from its current staff of 45 to about 75. Most of these new workers will be engaged in clinical and product development, with some regulatory experts added to the mix as they start to get closer to late-stage negotiations with the FDA. And later, adds Bishop, Cytochroma plans to build a sales team to ramp up commercialization efforts--a team that could potentially field a number of new therapies. 

While 201 and 101 were both acquired in the buyout of Proventiv, 018 was in-licensed from Johns Hopkins along with a significant lineup of additional compounds to explore. 

"We have a portfolio of 225 vitamin D compounds in-licensed from Johns Hopkins," says Bishop. "That portfolio will provide this company with a formidable pipeline." 

In an increasingly hot field. 

The sun provides a free source of vitamin D, but there's been a growing body of literature that links insufficient levels of the steroid hormone vitamin D turns into in the body with a long list of ailments, including cardiovascular disease and many cancers. (You can find a recent Wall Street Journal report here [1].)

"You see so much in the published press about vitamin D and increased cancer risk," says Bishop. "Cytochroma is really well positioned by virtue of our vitamin D technology. There's lots of enthusiasm to drive additional products and an enormous opportunity." 

Whether the company goes on to pursue its development work independently or gets bought out by a larger company pushing into the same field won't be determined for some time. But the CEO's job is to keep both eyes open to the best opportunity to boost shareholder value.  

"All of us are aware of the stats of what happens to companies like Cytochroma. Our intention is to drive value for shareholders," says Bishop.