||October 2, 2006
||Indianapolis Business Journal (IN)
By Peter Schnitzler, email@example.com
A local pharmaceutical startup that's developing a technology licensed from Eli Lilly and Co. has reached a crucial milestone. Carmel-based ParaPRO LLC is preparing to enter phase three clinical trials for a new treatment for children's head lice. ParaPRO's remedy is built on a compound Lilly developed in the mid-1980s. That same compound-Spinosad-already is the basis of a line of insecticides sold by Indianapolis-based Dow AgroSciences that rings up annual sales approaching $200 million a year.
Now, the tiny one-man startup ParaPRO is hoping to create another bestseller from Spinosad.
"It's the old story of the dog who chased the car and caught it," said David Rowe, ParaPRO's manager and a former Dow AgroSciences executive.
Details of ParaPRO's first widespread human trial aren't decided yet, but Rowe said within the next few months it will establish its first "large" population of test subjects. He expects the research to lead directly to an application with the U.S. Food and Drug Administration.
"By the time you get to Phase 3, you clearly have something that's good and can work," said Bio Crossroads CEO David Johnson, who's not involved with ParaPRO. "Now it's just a question of how well and how big the market can be."
It will be several years before the trial results are ready. But ParaPRO is optimistic the sales potential for treating lice is similar to that of the agricultural application. According to the American Academy of Pediatrics, six million to 12 million U.S. children are diagnosed with the pesky parasites annually.
Current head lice cures vary widely. The AAP recommends Pfizer's Nix® brand cream rinse. Indianapolis Public Schools, on the other hand, advises parents to slather a liberal mixture of olive oil and mayonnaise on their child's scalp.
"It's safe, it's cheap and [with] a lot of the shampoos you have to buy over the counter, one application sometimes is not sufficient to eliminate the problem," said IPS spokeswoman Kim L. Hooper. "If they can't afford it, [parents] won't do it."
To corner the market for head lice treatment, ParaPRO is counting on parents embracing its product as the most technically superior solution available.
That's because Spinosad is based not on a synthetic compound, but on bacteria that occurs naturally in soil-the origin of its reputation for safety.
It was discovered in the Caribbean by Lilly. In 1989, when Lilly's Agricultural-Products Division formed a joint venture with Dow Chemical Co., Spinosad's insecticide applications came along. When Lilly cashed out of the venture in 1997, Michigan-based Dow renamed the business Dow AgroSciences.
ParaPRO's business plan for Spinosad mirrors that of Dow AgroSciences, which touts its green pedigree. The insecticides are certified so ecologically sound that they're used by organic farmers. Dow AgroSciences spokeswoman Kenda Resler Friend said her company began producing Spinosad-based insecticides in 1997. They're now sold in 70 countries for use on 150 crops. "You name it, Spinosad takes care of it," she said. "It's an amazingly versatile compound."
ParaPRO is a subsidiary of Carmel based SePRO Corporation, which makes herbicides and fungicides. Some are used to control aquatic weeds and algae in lakes and reservoirs. Others are applied by professional landscapers.
SePRO was founded in 1993. Rowe said the 60-employee firm has spent "several million" dollars financing Spinosad's development, including purchasing the human application rights from Lilly in 2002.
ParaPRO is controlling expenses by contracting development and trials through local partners. Lafayette-based BioAnalytical Systems Inc., for example, ran a human pediatric study on 14 subjects.
BioAnalytical Systems Chairman Pete Kissinger said Indiana is doing a better job these days commercializing technologies that major biotech companies decide not to pursue themselves.
"This is happening a lot more all over," he said. "Opportunities that might have been buried in a Dow Agro or a Lilly in 1980 now actually escape the kingdom and do some good."
Copyright, 2006, IBJ Corp. All rights reserved. Reproduced with the permission of IBJ Corp. by NewsBank, inc.
Ask your doctor if Natroba™ Topical Suspension is right for you or your child.
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients
six (6) months of age and older.
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.