SGS India Ltd.'s Chennai facility has passed an FDA inspection conducted in February 2007. It was both a pre-approval and a GMP inspection. The facility is classified as "acceptable." This was the first FDA inspection of the SGS QC testing laboratory in Chennai.

"Providing high quality analytical services in all of our QC Testing laboratories is the prime commitment to our worldwide pharmaceutical clients," said Manfred Weiler, global business manager at SGS Life Science Services. "Passing the FDA inspection is a great achievement for our Indian QC testing laboratory. It is also a result of our continuous efforts to improve and harmonize quality systems and processes throughout our network of 14 QC laboratories in North America, Europe and Asia."

The SGS Chennai site began pharmaceutical testing in 1995, and received local GMP government approval at that time. In 1997, the facility obtained ISO 17025 certification for chemical, mechanical, and biological fields. In February 2005, the Life Science Services operations moved to Ticel Biopark, a purpose-built lab facility dedicated to R&D and drug development services. SGS occupies approximately 2400 square meters of state-of-the-art lab space for chemical, microbiological and toxicological testing. The current QC testing staff consists of more than 40 employees.

The Chennai facility provides testing services in the GMP and GLP areas: raw material and finished product testing, microbiological testing, stability testing, toxicology, biotechnology and medical device testing.

Pfizer initiated a Phase III trial to evaluate the safety and efficacy of sunitinib malate, in combination with a standard chemotherapy regimen, in patients with metastatic colorectal cancer (mCRC). Also, new data from a Phase I study showed that sunitinib malate is active and generally well-tolerated in combination with a standard chemotherapy regimen, FOLFIRI, in previously untreated patients with mCRC. These data support further evaluation of sunitinib malate in mCRC in a Phase III program.

The Phase III study is currently enrolling in Europe, Canada, Asia and South America and will include more than 700 patients to evaluate the safety and efficacy of sunitinib malate combined with FOLFIRI, a standard chemotherapy regimen used in mCRC comprised of fluorouracil (5-FU), folinic acid (leucovorin), and irinotecan, compared with FOLFIRI plus placebo, in the first-line treatment of patients with mCRC.

Progenics Pharmaceuticals and Wyeth achieved positive results from a three-month open-label extension study of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation (OIC) in patients with advanced illness.

Eighty-two OIC patients completed a placebo-controlled Phase III study (MNTX 302) and participated in the three-month open-label extension study of subcutaneous methylnaltrexone. The goal of the extension study was to obtain efficacy and safety data on subcutaneous methylnaltrexone, administered as needed, for as long as three months.

Forty-two OIC patients received subcutaneous methylnaltrexone previously in MNTX 302, and then entered the open-label extension study. The mean laxation response rates were 45.5% during the first month, 57.7% in the second month, and 57.3% in the third and final month. For the remaining 40 patients who had first received placebo in the MNTX 302 study prior to this open-label extension study, laxation response rates were 48.3% during the first month, 47.6% in the second month, and 52.1% in the third and final month. Consistent with previous studies, subcutaneous methylnaltrexone was generally well-tolerated in the three-month open-label study, and the most common adverse event reported was abdominal pain which was typically mild-to-moderate in severity.