Summer Brings Fun in the Sun but Threats Lurk Beneath the Water's Surface

BALTIMORE, MD and TAMPA, FL--(Marketwired - May 18, 2015) - Romark Laboratories, a Tampa-based pharmaceutical company committed to the discovery, development and commercialization of innovative small molecules for treating infectious diseases, and Lupin Pharmaceuticals Inc., the 6^th largest pharmaceutical company in the US (by TRx - IMS Health, National Prescriptions Audit) with a wide portfolio of generic and branded medicines, including pediatric-branded solutions that treat infectious diseases, are working together to raise awareness of the parasites Cryptosporidium (Crypto) and Giardia, which can cause Recreational Water Illnesses (RWIs), that are spread through swimming pools, water parks and lakes.

Crypto and Giardia are invisible threats 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 three days or less. According to the Centers for Disease Control and Prevention (CDC), approximately 750,000 cases of Crypto and 1.2 million cases of Giardia are estimated annually in the U.S. Rates of Crypto have increased almost 300 percent over the past 10 years.

"Crypto and Giardia are more common than you think. The risk of contracting these parasitic infections increase during the summer months when people around the country return to swimming in community pools," said Jean-François Rossignol, M.D., Ph.D., F.R.S.C., Chief Science Officer at Romark Laboratories. "It's important that swimmers take precautions in the pool and seek proper treatment from a doctor if they suspect that they are infected with Crypto or Giardia."

Contrary to popular belief, swimming in properly chlorinated pools does not necessarily eliminate the risk of parasitic infections. An infected person can spread the parasite at alarming rates by swimming in community pools. You can become infected after accidentally swallowing water that contains Crypto. While the parasite most often affects the small intestine, it can also affect other parts of the digestive tract and respiratory tract in immunocompromised people. Over-the-counter antidiarrheal medications offer limited support to Crypto and Giardia infections and therefore it's important that adults and children see their doctor for proper treatment. If left untreated the parasites may return and can leave lasting gastrointestinal damage on the infected patient.

Alinia® is the only FDA-approved treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia in persons 1 year of age and older. Alinia is available in three-day doses for both adults and children.

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 and Giardia parasitic infections," said Dr. Czinn. "These invisible threats can wreak havoc on a person's GI system as well as ruin summer plans. For this reason, if you suspect that you or your child has swallowed pool water in any amount and has become sick, contact your doctor immediately."

The Centers for Disease Control (CDC) suggests all swimmers take these precautionary steps to stay healthy while swimming this summer.

• 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.
  
  

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

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 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

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.
Long-term carcinogenicity studies have not been conducted.

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