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Afinitor success in phase III study with angiomyolipomas, associated with Tuberous Sclerosis Complex Page

A Phase III study of Afinitor (everolimus)tablets from Novartus in patients with non-cancerous kidney tumors, or angiomyolipomas, associated with tuberous sclerosis complex met its primary endpoint of best overall angiomyolipoma response rate, which includes reduction in kidney tumor size and absence of new tumors. Findings from the trial, known as EXIST-2, were presented today at the International TSC Research Conference in Belfast.Tuberous sclerosis complex is a genetic disorder that may cause non-cancerous tumors to form in vital organs, including the brain (SEGAs) and kidney (angiomyolipomas). These kidney tumors occur in up to 80% of patients, usually occurring between the ages of 15 and 30 and increasing in prevalence with age.

Surfaxin is re-filed at FDA for Respiratory Distress Syndrome Page

The FDA has accepted the re-application for the humanised surfactant Surfaxin (lucinactant) from Discovery Laboratories as a preventive therapy for respiratory distress syndrome (RDS) in premature infants as complete and has classified it as a Class 2 submission, setting 6 March 2012 as the Prescription Drug User Fee Act action date. Respiratory Distress Syndrome is a condition in which premature infants are born with an insufficient amount of their own natural pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. The condition, which affects about 90,000 premature infants annually in the US, often requires that infants receive surfactant replacement therapy along with mechanical ventilation to survive.

LB 03002 success in treatment of Growth Hormone Deficiency Page

Phase III results were announced of 24 months efficacy and safety in children with Growth Hormone Deficiency (GHD) for LB 03002, a once-a-week, sustained release recombinant human growth hormone (hGH) from Biopartners and LG Life Sciences (LGLS), at the annual meeting of the European Society for Paediatric Endocrinology. The study involved 167 paediatric patients with GHD. The data demonstrate that LB03002, using LGLS' delivery technology Biohydrix, maintained expected growth rates for patients continuously treated for 24 months as well as in patients treated for 12 months who were switched from daily therapy, according to the companies. IGF-1 levels continued to increase toward the normal range in both groups during LB 03002 treatment, a key marker of efficacy and safety in growth hormone therapy. LB 03002 was well tolerated and demonstrated a sustained growth potential without excessive bone maturation. LB03002 was originally developed by LGLS who granted Biopartners a licence to further develop and market the product in Europe, Australia, New-Zealand and several other countries. LGLS retains rights in the rest of the world including North and South America, and most Asian countries including Korea, Japan, and China.

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