Romark Laboratories announced that it has entered into a strategic agreement with Lupin Limited and its subsidiaries (collectively Lupin) designed to expand promotion and distribution efforts related to its Alinia® (nitazoxanide) for Oral Suspension, 100 mg/5 mL. Under the agreement, Lupin acquired an exclusive license to promote and distribute Alinia for Oral Suspension in the United States. Lupin will promote the product using the pediatric-focused sales force of Lupin Pharmaceuticals.
"We are excited about our new partnership with Lupin and the opportunity to raise awareness of Alinia for Oral Suspension among physicians," said Marc S. Ayers, Chief Executive Officer of Romark. "Lupin has a track record in marketing pharmaceutical products for pediatric infectious diseases in the United States and has demonstrated a strong commitment to the pediatric market segment."
Alinia for Oral Suspension is approved by the U.S. Food and Drug Administration for treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 months of age and older. The product has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. It is the only product approved for treatment of diarrhea caused by Cryptosporidium parvum and the only product approved in the United States for treating diarrhea caused by Giardia lamblia in children under 4 years of age.
Cryptosporidium and Giardia are the two most common protozoan infections in the United States and worldwide. The U.S. Centers for Disease Control and Prevention (CDC) estimates that there are approximately 1.2 million cases of Giardia infection and 750,000 cases of Cryptosporidium infection annually in the United States, although most of these infections are undiagnosed.
"Alinia for Oral Suspension is an important product for diarrheal illnesses caused by Cryptosporidium or Giardia in children," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "Children are particularly vulnerable. This new collaboration will benefit children affected by these diarrheal illnesses along with their families, physicians and healthcare providers."
Romark will continue to promote and distribute Alinia (nitazoxanide) tablets, 500 mg, with its specialty sales force focused primarily on gastroenterologists and primary care physicians. The Company has recently expanded its specialty sales force from 16 to 30 representatives and plans to further expand to 50 representatives before the end of 2013.
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