FDA approval puts F.C. firm on firm ground to pursue drug

FORT COLLINS – A Fort Collins biotechnology company, best known for its work on veterinary pharmaceuticals, has made the leap into human medicine.

PR Pharmaceuticals recently obtained orphan drug status from the U.S. Food and Drug Administration for PulmoLAR, a drug the company is developing for treatment of pulmonary arterial hypertension.

The FDA grants orphan designation for drugs that target rare diseases or conditions. Orphan designation allows the drug developer market the product – once it clears final regulatory approval – exclusively for seven years.

Without such market protection, companies would be less likely to invest in research costs for products that don’t appeal to a large market, said Claude Piche, PR Pharmaceuticals’ vice president of clinical development and regulatory affairs.

Pulmonary arterial hypertension is believed to affect about 100,000 people in the United States. The disease, which Piche described as “progressive and fatal,” causes blood vessels in the lungs to thicken, restricting blood flow and leading to heart failure.

PR Pharmaceuticals started initial research with PulmoLAR three years ago. The company has since licensed the drug from the University of Pittsburgh’s School of Medicine, where PulmoLAR was developed.

PR Pharmaceuticals will likely conduct clinical testing for PulmoLAR at the University of Pittsburgh as well as the University of Colorado Health Sciences Center in Denver, which is among the leading research centers for pulmonary arterial hypertension.

On the surface, the market for PulmoLAR would seem to be crowded, given the small numbers of patients and the existence of at least four different treatments, and two more in clinical trials. Also, the makers of Viagra and Cialis are both seeking FDA approval for those drugs to be used for pulmonary arterial hypertension.

Still, one national expert on the condition thinks more is better.

“There seems to be, in each of the drugs, different mechanisms … that can bring value to patients,´ said Rino Aldrighetti, president of the Pulmonary Hypertension Association; an organization promotes awareness of the disease and funds research for a cure.

Furthermore, the costs of current approved treatments on the market range from $35,000 to $100,000 a year. If PR Pharmaceuticals can deliver a lower-cost treatment – the company’s goal, according to Piche – it could enter the market at an advantage.

Aldrighetti also thinks pulmonary arterial hypertension is widely underdiagnosed. Since the 1970s, the number of patients diagnosed increased from about 200 to 100,000. The number of physicians treating the condition increased since 2002 from 100 to 1,000, he said.

PR Pharmaceutical, with 55 employees in Fort Collins, has also started early research on a product with a distinctly larger audience. It’s in early development of a long-acting insulin injection for diabetics, which could reduce doses from once a twice a day to once a week.

To date, the company’s only products on the market are for animals, including product that helps promote growth in cattle.

“We’re trying to develop our own pipeline of human drugs,” Piche said. “We’ve shifted our focus from strictly veterinary.”

In the case of PulmoLAR, PR thinks the drug could also work in partnership with existing treatments for pulmonary arterial hypertension.

“None of the drugs approved today are cures for the disease,” Piche said. “We’re bringing something new with the mechanism of action. So maybe it will help even more in combination with another one.”

Piche also suggested PulmoLAR could have additional applications beyond pulmonary arterial hypertension, although he declined to be specific.

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