Romark Laboratories and Lupin Pharmaceuticals Respond to Recent Cryptosporidium (Crypto) Outbreak in Dallas

TAMPA, FL and BALTIMORE, MD--(Marketwired - Jul 27, 2015) -  Two pharmaceutical companies with expertise in infectious diseases today responded to an outbreak of cryptosporidiosis (Crypto), an illness spread through swimming pools, water parks and lakes, in Dallas, Texas.

Romark Laboratories is a Tampa-based pharmaceutical company committed to the discovery, development and commercialization of innovative small molecules for treating infectious diseases, and Lupin Pharmaceuticals Inc. is the 6^th largest pharmaceutical company in the U.S. (by TRx - IMS Health, National Prescriptions Audit) with a wide portfolio of generic and branded medicines, including pediatric-branded solutions that treat infectious diseases.

Crypto is an invisible threat that can make an infected person very sick. The most common symptom of parasitic infection is diarrhea, which can last two to three weeks if left untreated. With treatment, the symptoms may lessen and disappear within four days.

"It is important for Dallas residents to know that they can seek treatment and that they do not need to suffer waiting for Crypto to run its course," said Jean-François Rossignol, Ph.D., F.R.S.C., M.D., FRCPath, Chief Medical and Scientific Officer at Romark Laboratories. "The outbreaks in Dallas remind us that Crypto is not just a third world problem. If you suspect you or your child has Crypto the most important thing you can do is see your doctor for proper diagnosis and treatment."

The Centers for Disease Control (CDC) suggests these precautionary steps to stay healthy while swimming.

• Stay out of the water if you have diarrhea
• Don't swallow the water
• Practice good hygiene. Shower with soap before swimming and wash your hands after using the toilet or changing diapers. Germs on your body end up in the water

Steven J. Czinn, M.D., Professor and Chair of the University of Maryland School of Medicine, Department of Pediatrics, believes that proper education about parasitic infections is critical.

"What's concerning is that parents may not be aware of the severity of Crypto parasitic infections," said Dr. Czinn. "Patients as well as medical care providers have a responsibility to treat parasitic infections properly."

For more information, visit www.alinia.com or www.cdc.gov/parasites/crypto/.

About Alinia ®
Alinia (nitazoxanide) for Oral Suspension, 100 mg/5 mL (patients 1 year and older) and Alinia Tablets, 500 mg (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.

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.

About Lupin Pharmaceuticals
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 across 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 6th largest and fastest growing top 6 generics player in the US (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 2015, Lupin's Consolidated turnover and Profit after Tax were Rs. 125,997 million (USD 1.99 billion) and Rs. 24,032 million (USD 381 million) respectively. Please visit http://www.lupin.com for more information.

You could also follow Lupin on Twitter - www.twitter.com/lupinlimited

Alinia is a registered trademark of Romark Laboratories, L,C. Alinia for Oral Suspension is distributed by Lupin Pharmaceuticals, Inc. under license from Romark Pharmaceuticals L.C.

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