Target Health is pleased to announce that it was the e*CRO for the entire program for the development, and now NDA approval, of a novel product for the treatment of head lice. Our congratulations to Mike Precopio, President of Summers Laboratories, for his vision, and for the dedication and commitment of the excellent staff at Target Health Inc.

Target Health joined the program at the pre-IND stage and took the product from IND to NDA with a true partnership with Summers Laboratories. Target Health managed the toxicology program with our good friend and colleague, Colleen Johnson of Reno and Associates. Dr. Glen Park, Sr. Director of Clinical and Regulatory Affairs at Target Health, ran the clinical operations and all interactions with the FDA, including the NDA preparation and submission with a terrific team. Yong Joong Kim, Sr. Director of Data Management and Application Development at Target Health, directed his excellent data management team, and Joonhyuk, Choi Director of Application Development at Target Health, together with his dedicated and extraordinary programming team, implemented Target e*CRF® for the EDC trials. Leigh Ren, Associate Director of Biostatistics at Target Health, prepared the SAP and ran all of the statistical analyses. Daisy Sun, Clinical Manager at Target Health, wrote all of the Clinical Study reports. Dr. Mitchel, President of Target Health did the original negotiations with FDA, submitted the IND and “gave advice from time to time.“

The approval of the Summers Laboratories’ NDA comes on the heels of the approval of Ferring’s Degarelix in December 2008 and SyntheMed’s PMA earlier this year. All three programs used Target e*CRF® for the Phase 2 and Phase 3 clinical trials. There are now 16 FDA approvals that used Target e*CRF for EDC (4 NDAs, 1 BLA, 10 PMAs and 1 510(k). Two additional NDA submissions will occur this year and we expect 1 MAA (Europe) approval this year.

For more information about Target Health and any of our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors

The FDA has approved a new prescription medication for the treatment of head lice (Pediculosis capitis) infestation. Benzyl Alcohol Lotion, 5%, received full market approval as a prescription medication, for use in patients 6 months of age and older. Benzyl Alcohol Lotion, 5%, is the first head lice product approved by the FDA with benzyl alcohol as the active pharmaceutical ingredient. “Head lice are a problem that impacts more than a 1 million children each year and is easily transmitted to others,“ said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “This drug is an effective first line treatment to eliminate lice infestation, and minimize disruption in the daily routines of families.“ The safety and effectiveness of Benzyl Alcohol Lotion, 5%, was demonstrated in two studies of 628 people, 6 months of age and older, with active head lice infestation. The subjects received two, 10-minute treatments of either Benzyl Alcohol Lotion or a topical placebo, one week apart. Fourteen days after the final treatment, more than 75 percent of the subjects treated with Benzyl Alcohol Lotion, 5%, were lice free. Common side effects of the medication include irritations of the skin, scalp, and eyes, and numbness at the site of application. As with all medications, it is important to use benzyl alcohol, 5%, as labeled to maximize benefits and minimize risks. The product should be applied only to the scalp or the hair attached to the scalp. It is not approved for use in children younger than six months. Use in premature infants could lead to serious respiratory, heart- or brain-related adverse events such as seizure, coma, or death. Benzyl Alcohol Lotion, 5%, was developed by Summers Laboratories, and is distributed by Sciele Pharma Inc., a subsidiary of Atlanta-based Shionogi Company.

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TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

One traditional bad breath cure which is backed up by modern research is yogurt. Yogurt has always been used to combat 1) ___ infections and anaerobic bacterial infections because the ‘good’ bacteria in yogurt compete with the pathogens and actively destroy them. Now research backed by the International Association For Dental Research shows that eating plain live yogurt for six weeks can reduce levels of oral 2) ___ by up to 80%. In the 83rd General Session of the International Association for Dental Research held in Baltimore, US and Japanese scientists presented the results of a study that says eating sugar-free yogurt is good for people suffering from bad 3) ___. Oral bad odor or so called bad breath is caused by harmful bacteria and sulfide compounds like hydrogen sulfide. The study revealed that volunteers who had sugar-free and natural forms of yogurt for six weeks, reported less mouth odor. There was a reduction of 80% of the volatile hydrogen sulfide in the mouth cavity. Also, the plaque and 4) ___ indices were considerably lower for volunteers who ate yogurt versus those with bad breath who did not. The reason for this may be due to the bacteria present in the yogurt called lactobacillus bulgaricus and 5) ___ thermophillus which wages a war against the harmful and odor causing bacteria and chemicals in the mouth. The researchers are of the opinion that eating traditional yogurt or curd may help in oral 6) ___ by reducing oral bad breath and harmful bacteria. The scientists of the Tsurumi University, Yokohama, Japan, conducted the research

ANSWERS

1) yeast; 2) bacteria; 3) breath; 4) gingival; 5) streptococcus; 6) hygiene

Researchers have developed a novel technique to separate and analyze all the proteins found in human saliva, not just the soluble ones, providing an approach that may reveal protein markers for oral and other disorders in the 1) ___ cavity. Saliva contains an abundance of 2) ___ that could be used to screen for diseases, particularly oral diseases. Until now, though, studies have only focused on the small subset of free-floating saliva proteins. Far more proteins are present inside of oral cells, and Timothy Griffin, Nelson Rhodus and colleagues developed a method, called three-step peptide fractionation, to look at those understudied proteins. They analyzed saliva samples from four oral cancer patients and identified over 1000 human proteins, including many known cancer associated proteins. In addition, they separated out proteins from over 30 different 3) ___, many of which have not been previously found in saliva, and several of which may also have possible cancer links. The researchers note that the mortality rate for oral cancer has hardly declined over the past 30 years; their technique, providing the first description of using whole cells to identify the vast array of human and bacterial proteins in saliva, may help identify new markers for oral 4) ___ progression. This research was recently published in the journal Molecular and Cellular Proteomics.

ANSWERS

1) oral; 2) proteins; 3) bacteria; 4) cancer