Salix Pharmaceuticals (Nasdaq: SLXP) has filed a new drug application for the use of the drug Crofelemer to fight HIV-related diarrhea even as it is involved in a fight with Napo Pharmaceuticals, the company from which it licensed the drug.

Salix disclosed the NDA filing before the markets opened Wednesday.

“Napo has purported to terminate the license due to Salix’s alleged failure to develop Crofelemer and other alleged breaches of the parties’ collaboration agreement,” Salix said in the announcement. “As Salix has previously explained, Napo’s purported termination of the license is groundless and without merit.”

Salix has the rights to develop Crofelemer for a variety of treatments in numerous markets.

In November, Napo said it had terminated the collaboration agreement between the two companies over Salix’s failure to advance the drug fast enough for the California company.
Napo said the termination leaves it free to find another partner or develop on its own what could become a blockbuster drug.

Salix paid Napo $4.5 million up front plus a $500,000 equity investment in the company in 2008. Napo stood to gain up to $300 million in additional milestone payments, according to MedCity News.

Crofelemer was being studied to treat chronic diarrhea for people who have HIV/AIDS. Napo said that an estimated 40 percent of HIV/AIDS patients in the United States suffer from diarrhea. Besides HIV-associated diarrhea, the compound also has potential applications in diarrhea-predominant irritable bowel syndrome, acute infectious diarrhea and pediatric diarrhea, MedCity News reported.

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