Romark Laboratories, L.C. and Lupin Ltd. Reach Strategic Agreement for Promotion and Distribution of Alinia&#0174 for Oral Suspension

TAMPA, Fla., Aug. 7, 2013 /PRNewswire/ -- 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.

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"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.

About Lupin
Lupin Pharmaceuticals, Inc. is the wholly owned U.S. subsidiary of Lupin Limited. Headquartered in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines and branded formulations trusted by healthcare professionals and patients in the US and other geographies. For more information, visit http://www.lupinpharmaceuticals.com

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 positions in the Anti-TB and Cephalosporin segment.

Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).

For the financial year ended March 2013, Lupin's Consolidated turnover and Profit after Tax were Rs. 94,616 million (USD 1.74 billion) and Rs. 13,142 million (USD 242 million) respectively. Please visit http://www.lupinworld.com for more information.

About Romark Laboratories
Romark Laboratories, L.C. is a vertically integrated biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The Company markets Alinia^® (nitazoxanide) tablets, 500 mg in the United States through a specialty sales force focused on gastroenterologists and infectious disease specialists.

Romark is developing a class of small molecule drugs called thiazolides. The Company's product, NT-300 (nitazoxanide), is presently undergoing Phase 3 clinical development on a global basis for treatment of acute uncomplicated influenza. The NT-300 development program is being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services. Other new drugs from the Company's platform technology are proposed for treatment of viral diseases and cancers.

About Alinia
Alinia for Oral Suspension (patients 1 year and older) and Alinia Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Alinia for Oral Suspension and Alinia Tablets have not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.

Important Safety Information Regarding Alinia

• In clinical studies involving HIV-uninfected patients age 12 years and older receiving Alinia Tablets, the most common adverse events reported regardless of causality assessment were abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). In clinical studies involving HIV-uninfected pediatric patients receiving Alinia for Oral Suspension, the most common adverse events reported regardless of causality assessment were abdominal pain (7.8%), diarrhea (2.1%), vomiting (1.1%) and headache (1.1%). These were typically mild and transient in nature. In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo.
• Alinia Tablets and Alinia for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
• The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.
• Tizoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g. warfarin).
• It is not known whether nitazoxanide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.
• Long-term carcinogenicity studies have not been conducted.

SOURCE Romark Laboratories