AIDS patients who frequently suffer from diarrhea may now finally see some light at the end of the tunnel for a new drug developed to help them.
The U.S. Food and Drug Administration has granted priority review for Salix Pharmaceuticals‘ (NASDAQ:SLXP) crofelemer and an approval decision on the drug candidate could come by June 5. That would be almost 18 months after Salix reported positive phase 3 clinical trial results on the drug candidate that the FDA recognized could fill an unmet medical need. Besides the priority review for the crofelemer, the agency had previously placed the compound on fast-track status and gave it a special protocol assessment, which allows for an expedited regulatory review.
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Raleigh, North Carolina-based Salix had a busy 2011 and most of that activity was unrelated to crofelemer. Besides some licensing deals and acquisitions, the company has had its hands full with another gastrointestinal drug. Salix had expected approval on Xifaxan for irritable bowel syndrome in the first quarter. Instead, the company got a complete response letter and the company spent a great deal of time in 2011 figuring out what to do to get FDA approval. Salix ultimately determined it would take the time and expense to conduct another phase 3 study.
With crofelemer’s own regulatory pathway cleared of some obstacles, drug partner Napo Pharmaceuticals expected the compound to move quickly toward an approval decision. As every drug company knows, time is money. The California drug developer licensed crofelemer to Salix in 2008 and the company saw Salix’s failure to even file a new drug application after the phase 3 results as foot dragging. Napo sued Salix last year and claimed that Salix’s failure to advance the compound was a contract breach. On Nov. 4 , exactly a year after Salix reported the positive phase 3 results, Napo announced it had terminated the partnership. Napo wants crofelemer back and it claims the right to pursue development with another partner. Salix disputes Napo’s claims. Napo’s amended lawsuit against Salix, still pending in New York courts, continues to allege that Salix breached the contract and Napo seeks “tens of millions of dollars in damages” from its drug partner.
If the time Salix spent on Xifaxan drew its attention away from crofelemer, Salix has not said so. In earnings conference calls, the company has maintained that the drug figures into its plans. Crofelemer’s potential was clear to the companies and to regulators. An estimated 40 percent of HIV/AIDS patients in the United States suffer from diarrhea. But crofelemer’s potential extends to other patients as well. Napo says the compound that it invested millions of dollars to develop could have additional applications in diarrhea-predominant irritable bowel syndrome, acute infectious diarrhea and pediatric diarrhea. Crofelemer could become a blockbuster drug.
Regulatory decisions on drugs, even those under priority review, is not exactly a speedy process, but litigation is almost always slower. It’s possible a crofelemer approval could come before litigation is resolved. That would leave two drug companies fighting over the spoils of a lucrative drug that could have, and perhaps should have, reached patients sooner.
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