ParaPRO: Innovations in Life Sciences

ParaPRO Press Release

Date: June 24, 2009 Back
Contact: Bill Culpepper III, President, 317-216-8166, billc@parapro.com

Kerry Mettert Joins ParaPRO as Director of Quality Assurance and Regulatory Affairs

CARMEL, IN – ParaPRO LLC announced today that it has hired Kerry Mettert to serve as Quality Assurance and Regulatory Affairs Director. ParaPRO, based in Carmel, Indiana, is a new pharmaceutical enterprise and a wholly-owned subsidiary of the SePRO Corporation. ParaPRO previously submitted to the FDA for review a New Drug Application for NatrOVA™ brand (Spinosad), for the treatment of pediculosis capitis (Head Lice).Mettert’s responsibilities include overseeing ParaPRO’s Quality System, preparing for regulatory inspections/interactions and conducting internal and external compliance audits.

Mettert brings over 20 years of experience in the Biologics and Pharmaceutical industries.  Prior to joining ParaPRO, Mettert invested 14 years with the American Red Cross Biomedical Division. In the past six years, he has led quality assurance and regulatory affairs for two independent blood centers and most recently provided regulatory-compliance consulting for a medical device company in New Jersey.

Mettert holds a bachelor’s degree in Biology from Anderson University in addition to an MBA from Indiana Wesleyan University. Mettert is also a certified Medical Technologist with the American Society of Clinical Pathologists.

ParaPRO President William Culpepper noted the importance of Mettert’s position when asked about the company’s forthcoming entry into the marketplace. “As we look to move ahead with the regulatory protocol and quality control of NatrOVA, a new product that we are very excited about for treatment of head lice on humans, the experience and knowledge that Kerry Mettert brings to ParaPRO will be essential to both our initial and continued success,” said Culpepper.

About Spinosad
Spinosad, the active ingredient upon which NatrOVA™ is based, is a non-synthetic, fermentation product of the soil bacterium Saccharopolyspora spinosa. Several products containing Spinosad have been approved by the U.S. Environmental Protection Agency (EPA) for use on agricultural crops and by the Organic Materials Review Institute for use on organically grown crops. The Spinosad technical bulletin provides an extensive overview of Spinosad.

About ParaPRO LLC
ParaPRO LLC was founded in 2002 when SePRO Corporation of Carmel, IN purchased the worldwide rights to develop and market Spinosad for the control of lice in human health from Eli Lilly and Company. The compound is currently in clinical trials at multiple sites across the United States. More information on ParaPRO can be found at www.parapro.com.




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.