USFDA APPROVES CROFELEMER 125 MG DELAYED-RELEASE TABLETS FOR THE SYMPTOMATIC RELIEF OF DIARRHEA IN PATIENTS WITH HIV/AIDS ON ANTI-RETROVIRAL THERAPY (ART)

Glenmark  has  exclusive  Crofelemer rights for diarrhea indications in 140 countries including India and the approval will accelerate filing and launch preparations across its territories.

This will be the first NCE(New Chemical Entity) launch by an Indian company across multiple geographies

Glenmark is the sole API supplier globally for Crofelemer (ex-China) 
Mumbai, India, January 2, 2013 – Glenmark Pharmaceuticals Limited announced today that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited for  Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV)/ acquired immune deficiency syndrome (AIDS) on antiretroviral therapy (ART)

“The  USFDA approval of Crofelemer for HIV associated diarrhea will pave the wave to launch Crofelemer across our territories. This is a significant approval milestone  and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications,” said Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals Limited. He  added “Crofelemer,  a locally-acting, minimally-absorbed drug  is believed to  act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea. It is this secretion that is believed to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency.

About Crofelemer
Crofelemer is a first-in-class, gastrointestinal agent derived on a sustainable basis from the Croton lechleri plant, native to northwestern South America.  Crofelemer acts as an antisecretory, anti-diarrheal agent that works locally in the GI lumen and exhibits minimal systemic absorption. At the recommended dose of one 125 mg delayed-release tablet taken orally, twice daily, Crofelemer works to inhibit both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (C1-) channel, and the calcium-activated C1- channels (CaCC).

Inhibiting CFTR and CaCC reduces the secretion of chloride ions, along with the water that enables  their transport, out of the circulatory system and into the intestinal lumen. The secretion of chloride ions has been shown to cause diarrhea, with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. Unlike other anti-diarrheal agents,  Crofelemer does not  appear to  affect gut motility.