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Eurand N.V. (Nasdaq: EURX) $12.91. Today announced data from a Phase II/III clinical study demonstrating that ZENPEP(TM) (pancrelipase) Delayed-Release Capsules significantly improves fat absorption in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis.
In a double-blind, randomized, dose-response control, crossover study conducted in 19 sites in the United States, Italy and Ukraine in 76 evaluable patients, two dosage regimens of ZENPEP were evaluated. Patients with overall mild-to-moderate EPI associated with chronic pancreatitis experienced significant improvement in fat and protein absorption and body weight with ZENPEP at both a lower dose of 35,000 lipase units/day (seven capsules of ZENPEP containing 5,000 units of lipase) and higher dose (140,000 lipase units/day (seven capsules of ZENPEP containing 20,000 units of lipase) taken with meals; e.g., two capsules per meal and one per snack. The mean CFA was 88.9% and 89.9% with the ZENPEP lower and higher dose, respectively (p < 0.001 compared to baseline). In a subgroup of patients with more severe EPI (n=33, mean baseline CFA 65.0%), the higher dose of 140,000 lipase units/day was more effective (mean CFA 84.1%) than the lower dose (mean CFA 81.1%). Both ZENPEP daily doses were safe and well tolerated. Gastrointestinal complaints, predominantly flatulence and abdominal pain, were the most common adverse events.
What They Do: Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies.
Cadence Pharmaceuticals (Nasdaq: VADX) $9.55. Today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
What They Do: Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting.
Nanometrics Incorporated (Nasdaq: NANO) $9.06. Today announced multiple orders from new and existing HB-LED customers for RPMBlue™ and IVS185™ metrology systems, which will be used for photoluminescence (PL) mapping and critical dimension and overlay control, respectively. These systems are scheduled to be delivered and qualified in the fourth quarter of this year.
What They Do: Nanometrics is a leader in the design, manufacture and marketing of high-performance process control metrology systems used primarily in the manufacturing of semiconductors, advanced wafer-scale packaging, solar photovoltaics and high-brightness LEDs, as well as by customers in the silicon wafer and data storage industries.
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