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)forOral Suspension in theUS.
Alinia® (nitazoxanide) isthe 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 twomost 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 forthree days(100mg BIDfor ages 1 ‐ 3 and 200mg BIDfor 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 Cryptosporidiosisin 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 visitsfor children lessthan 3 years of age,saysthe 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 productisindicated for children < 3 years of age). Older
children are sometimestreated with flouroquinolones(e.g., CIPRO), cephalosporins(e.g., SUPRAX) and metronidazole. The cost of care for diarrhea‐related illness exceedsUSD2 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 groupsfor Lupin,so we are well positioned to capitalize on this opportunity. Lupin’s current 160+ strong brandssalesforce will promote Alinia® forOralsuspension in the USmarket. The product will bemarketed along with Lupin’s Suprax® and Antara®.
“We are very excited with the addition of Alinia® forOral Suspension to our Brands portfolio. The agreement demonstrates Lupin’s commitment to grow its brand franchise in the US and bring meaningful productsto the Pediatric community. Our sales and marketing efforts will commence immediately and we are optimistic that Alinia will contribute to our growth and
profitability in the coming quarters and years.” said Vinita Gupta, CEO, Lupin Pharmaceuticals Inc. and Group President, Lupin Limited.
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti‐Infective and NSAID space and holds global leadership
positionsin the Anti‐TB and Cephalosporin segment.
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