August 7, 2013
Announces Acquisition of Exclusive US Rights to Alinia® for Oral Suspension
Pharmaceutical Major, Lupin Ltd. and its US subsidiary, Lupin Pharmaceuticals Inc. (collectively Lupin) announced today that it has signed a strategic licensing agreement with US pharmaceutical company Romark Laboratories, L.C. (Romark) which grants Lupin exclusive rights to promote, distribute and market Alinia® (nitazoxanide) for Oral Suspension in the US.
Alinia® (nitazoxanide) is the first thiazolide approved by the FDA for the treatment of diarrhea caused by Cryptosporidium and Giardia and is the only FDA-approved treatment for Cryptosporidium. Alinia® for Oral Suspension is indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 1 year of age and older. These are the two most common protozoal causes of diarrhea in the developed and developing world.
Use of Alinia® suspension in children is facilitated by relatively simple dosing and administration; a strawberry flavored suspension given twice a day for three days (100mg BID for ages 1 - 3 and 200mg BID for ages 4 - 11).
According to the Centers of Disease Control & Prevention (CDC) it is estimated that there are 1.2 million cases of Giardiasis and 750,000 cases of Cryptosporidiosis in the US annually, although many cases go undiagnosed. Cryptosporidium is one of the most frequent causes of waterborne disease among humans in
the United States
. Pediatric diarrhea is a major complaint in more than 10% of office visits for children less than 3 years of age, says the American Academy of Pediatrics (AAP). Over 300,000 children under five years of age are hospitalized with gastroenteritis annually. Pediatric diarrhea is often left untreated based on limited treatment options (no other product is indicated for children < 3 years of age). Older children are sometimes treated with flouroquinolones (e.g., CIPRO), cephalosporins (e.g., SUPRAX) and metronidazole. The cost of care for diarrhea-related illness exceeds
USD 2 billion
each year according to AAP.
Alinia® for Oral Suspension will not only enable Lupin to strengthen its existing Brand portfolio but also expand its offering specifically, but not limited to the US Pediatrics segment. Key prescribers for Alinia® include pediatricians, pediatric, gastroenterologists and primary care physicians which are strategic customer groups for Lupin, so we are well positioned to capitalize on this opportunity. Lupin's current 160+ strong brands sales force will promote Alinia® for Oral suspension in the US market. The product will be marketed along with Lupin's Suprax® and Antara®.