Sigma-Tau Pharmaceuticals, Inc. Signs Exclusive Agreement With Crosscare Limited for U.S. Marketing and Distribution License of Colief(R) Infant Drops for the Treatment of Colic-Associated Crying

GAITHERSBURG, Md. and OAKBROOK TERRACE, Ill., Aug. 11, 2014 (GLOBE NEWSWIRE) -- Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau) today announced that the Company has signed an exclusive U.S. license agreement with Crosscare of Dublin, Ireland, to market and distribute Colief® Infant Drops for the treatment of colic.

Under the multi-year license agreement, Sigma-Tau will be exclusively responsible for the sales, marketing and distribution of Colief® in the U.S. A re-launch of the product by Sigma-Tau is targeted at healthcare professionals as well as consumers, and is planned for August 2014. With the product re-launch, Colief® is expected to be available in several major pharmacy chains and retailers across the U.S. Financial terms of the agreement were not disclosed.

With about 4 million births in the U.S. each year, excessive crying, associated with colic, affects approximately one in every five infants and may be due to a number of causes including transient lactose intolerance (causing bloating and gas) (TLI). Colief® Infant Drops, an all-natural dietary supplement available over-the-counter, is supported by published research demonstrating the ability to reduce colic-related crying caused by TLI. The active ingredient in Colief® is lactase, a naturally occurring enzyme produced within the small intestine.

"We are delighted to announce this exclusive U.S. marketing and sales agreement with Crosscare," noted Dave Lemus, Chief Executive Officer of Sigma-Tau. There is a strong unmet medical need for the treatment of infant discomfort related to colic, and we are pleased to be able to offer physicians, parents and their infants, an alternative to help alleviate the underlying condition, as opposed to only treating the symptoms. Furthermore, Colief® nicely complements our existing over-the-counter pediatric product line marketed to pediatricians, including VSL#3® JUNIOR, a probiotic for the dietary management of irritable bowel syndrome and ulcerative colitis in children."

Says Jonathan Tierney, CEO of Crosscare Group,"We wanted a U.S. partner that understands the pediatric natural supplement market and has the experience, breadth and reach necessary to make Colief® as big of a success in the U.S. as it is elsewhere in the world. Sigma-Tau is such a partner, and we are thrilled to work with them to help market and sell Colief® to its potential in the U.S."

About The Crosscare Group

Founded in Ireland in late nineties, Crosscare has become a leading company in researching infantile colic in babies. Crosscare Limited manufactures and distributes healthcare products throughout the world. The company's strategy remains focused on young families and their day-to-day needs. Offering a range of products, which includes Enzyme Preparations and Creams, Crosscare is focused on providing a comprehensive consumer driven service, selling consistently high-quality safe products at a market-conscious level. Colief® Infant Drops is a registered trademark of Crosscare. Further information on the Crosscare group can be obtained at

About Sigma-Tau Pharmaceuticals, Inc.

Sigma-Tau Pharmaceuticals, Inc. is a U.S.-based, wholly owned subsidiary of the sigma-tau Group, and is dedicated to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland, and the company's marketed products are focused on cancer, kidney disease, gastrointestinal and genetic related disorders. The company also has clinical development programs focused on hematological cancer, malaria, and other areas of unmet medical need. For more information about Sigma-Tau Pharmaceuticals, Inc., visit

Contact at Sigma-Tau: Contact for Sigma-Tau: Contact at Crosscare:
Dave Lemus (CEO) Eric Goldman Jonathan Tierney
Sigma-Tau Rx Communications Group, LLC Crosscare Inc.
301-670-1522 917-322-2563 630-928-0361

Source:Sigma-Tau Pharmaceuticals