ParaPRO: Innovations in Life Sciences

ParaPRO Press Release

Date: September 21, 2007 Back
Contact: Roland Bydlon, Director of Marketing, 317-428-4597, rolandb@parapro.com

ParaPRO LLC awarded $2.1 Million Grant from State of Indiana

Carmel, IN. - ParaPRO LLC today announced that it has received a $2.1 million grant from Indiana’s 21st Century Research and Technology Fund. The grant will help ParaPRO finance the phase 3 trials for its lead investigational product, a crème rinse containing Spinosad, for the treatment of human head lice. Spinosad (pronounced "spin-OH-sid") is derived through the fermentation of a naturally occurring organism. Spinosad has been registered by Dow AgroSciences for crop protection use in more than 30 counties and has been recognized by regulatory agencies such as the U.S. Environmental Protection Agency (EPA) for its efficacy, low mammalian toxicity and low environmental impact. The EPA awarded Spinosad the Presidential Green Chemistry Challenge Award in 1999, . In 2002, Spinosad was approved by the National Organics Standards Board for use in the production of “certified organic” foods.

ParaPRO licensed Spinosad from Eli Lilly in 2002. Since then ParaPRO has developed a proprietary formulation and tested the product, tentatively branded NatrOVA™, in multiple clinical trials. ParaPRO and the FDA have reached agreement on the protocol for the phase 3 trials which are expected to begin in the next few weeks. ParaPRO has worked with several Indiana Life Science firms during product development including Anson Group of Carmel, Bioanalytical Systems of West Lafayette, and Eli Lilly, Dow AgroSciences and Concentrics Research of Indianapolis.

“This substantial grant will allow us to run two large studies simultaneously,” said Bill Culpepper, President and CEO of ParaPRO. “This will help us recruit and get patients enrolled in the study faster, submit our data package to the FDA earlier and hopefully, if the data are positive, will result in an earlier approval for the product than if we ran the studies sequentially. We would like to thank the Indiana Economic Development Corporation (IEDC) for recognizing the potential of this very exciting compound to help us grow a successful life science business here in Indiana.”

ParaPRO LLC is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the pediatric and pediatric specialty markets. ParaPRO is a wholly owned subsidiary of SePRO Corporation, www.sepro.com, a life sciences business and is located in Carmel, Indiana, a suburb of Indianapolis. For more information visit the company’s web site at www.parapro.com or call 1-877-LICE-NEWS (1-877-542-3639).

The Indiana Economic Development Corporation (IEDC) is the state of Indiana’s premier entity charged with economic development. The IEDC has a 12-member board chaired by Governor Mitch Daniels. Indiana Secretary of Commerce Nathan Feltman is chief executive officer. For more information about IEDC, visit www.iedc.IN.gov.




Ask your doctor if Natroba™ Topical Suspension is right for you or your child.

INDICATION
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients six (6) months of age and older.

ADJUNCTIVE MEASURES
Natroba™ Topical Suspension should be used in the context of an overall lice management program:
  • Wash (in hot water) or dry clean all recently worn clothing, hats, used bedding and towels
  • Wash personal care items such as combs, brushes, and hair clips in hot water
A fine-toothed comb or special nit comb may be used to remove dead lice and nits.

IMPORTANT SAFETY INFORMATION
Natroba™ Topical Suspension contains benzyl alcohol and is not recommended for use in neonates and infants below the age of 6 months. Systemic exposure to benzyl alcohol has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Most common adverse events were: application site redness (3%), eye redness (2%) and application site irritation (1%).

Consult the Patient Information, Full Prescribing Information and your doctor for more complete information on Natroba™ Topical Suspension.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.