Napo Comments on FDA Announcing Extension
of Crofelemer NDA Priority Review
May 3, 2012 - San Francisco, CA - Napo Pharmaceuticals, Inc. (Napo) has been
informed that the U.S. Food & Drug Administration (FDA) has extended the Prescription
Drug User Fee Act (PDUFA) date for the company's first in class novel drug compound,
crofelemer. The Agency's Priority Review of the New Drug Application (NDA) for
crofelemer is for the indication of chronic diarrhea in people living with HIV/AIDS who
are on anti retroviral therapy.
According to Salix Pharmaceuticals, Inc. (Salix), the PDUFA date, which was
originally set for June 5, 2012, has been extended to September 5, 2012. The FDA
apparently notified Salix that it extended the PDUFA date by three months because it
needs additional time to conduct a full review of the NDA. According to Salix, the FDA
has not requested additional studies.
Although Salix filed the NDA with the FDA for CRO-HIV, Napo discovered and
developed crofelemer and owns all the IP related to the drug. On November 4, 2011,
Napo terminated its Collaboration Agreement, dated December 9, 2008, with Salix
because Salix breached the agreement. In May 2011, prior to terminating the
Collaboration Agreement, Napo filed suit against Salix because of Salix's alleged failure
to satisfy its contractual obligations to commercialize crofelemer in a timely manner.
Crofelemer has received fast-track designation by the FDA to treat diarrhea in people
living with HIV/AIDS.
Despite the announcement of crofelemer's highly statistically significant Phase 3
ADVENT trial results for CRO-HIV on November 4, 2010, Salix did not file the NDA
with the FDA for this indication until December 2011 - after Napo filed suit against Salix
and served Salix with its notice of termination of the Collaboration Agreement.
"Our company is committed to the advancement of crofelemer," says Lisa A.
Conte, CEO of Napo. "We are optimistic about our ability to bring it to the HIV
community and the global marketplace as quickly as possible." Napo has already
invested tens of millions of dollars in the development of crofelemer.
According to the Center for Disease Control, there are 1.2 million people living
with HIV/AIDS in the United States, of which approximately 338,000 suffer from
Napo Pharmaceuticals, Inc.
Napo focuses on the development and commercialization of proprietary
pharmaceuticals for the global marketplace. The company's business model merges
traditional high-value markets in the West with the higher volume business models of
emerging and developing economies. Napo's discovery process is based on the
knowledge of traditional healers, or shamans, working in rain forest areas and provides
benefit sharing to the communities with which it works. Visit Napo at
Source: Napo Pharmaceuticals, Inc.
R.C. Auletta and Company