Thursday, September 18, 2008

Pro-Pharmaceuticals outlines financial strategy

By Mass High Tech Staff

Biopharmaceutical company Pro-Pharmaceuticals Inc. has announced strategic initiatives to make the struggling company financially stable.

The strategy relies mainly on an expected 505(b) New Drug Application to be approved by the U.S. Food and Drug Administration for the company’s colorectal cancer treatment drug Davanat, which would begin generating revenue for the company in 2009. Pro-Pharmaceuticals reported on Monday its New Drug Application submittal.

The company has taken steps to reduce operating expenses by reducing management compensation and non-core expenses; lowering research, development and clinical trials expenses; and reducing consulting fees and legal and accounting costs.

As a result, Pro-Pharmaceuticals is pouring much of its financial energy into the NDA-associated study to show Davanat’s effectiveness in combination with 5-FU in treating cancerous tumors. The company said that it has therefore halted its Phase 2 biliary cancer trial of Davanat.

Last week, the company sent clinical and preclinical data to the FDA for a pre-investigational new drug meeting scheduled for Oct. 8, at which the company will present its plan to develop an anti-hypoxia drug to be used in combination with Davanat and 5-FU to treat advanced solid tumors.

Late last month, the FDA granted Pro-Pharmaceuticals a new-drug application for using Davanat in combination with 5-FU to treat a breast cancer patient at the Brown Cancer Center in Louisville, Ky.

Pro-Pharmaceuticals reported a net loss of $2 million for the first quarter of 2008 on no revenue, following a net loss of $9.4 million of zero revenue in 2007.