Biotechnology Healthcare - July/August 2008 - (Page 8)

DRUG TRACK SELECTED FDA BIOLOGIC APPROVALS, APRIL–MAY 2008 Action date Drug name (Trade name) Sponsor Indication Dosage form New drug approval May 20, 2008 alvimopan (Entereg) Adolor New indication April 3, 2008 abatacept (Orencia) Bristol-Myers Squibb Moderate to severe polyarticular JIA IV infusion Speed gastrointestinal recovery after bowel resection Oral SELECTED FDA ACTIONS, APRIL–MAY 2008 Manufacturer Drug name (Trade name) Type of drug Indication Notes New drug application Arpida intravenous iclaprim Broad-spectrum antibiotic Severe skin and skin structure infections Accepted May 16, 2008; has fast-track status Fast-track designation Repligen RG-1068 Synthetic human secretin Improve assessment of pancreatic duct structures by magnetic resonance imaging Granted April 16, 2008 Orphan drug designation Sirtris Denials or delays Astellas tacrolimus, pro- Immunolonged relief suppressant (Advagraf) lucinactant (Surfaxin) Liquid instillate formulation Prevention of liver transplant rejection Received approvable letter April 30, 2008 Received approvable letter May 1, 2008 SRT-501 Derivative of resveratrol MELAS syndrome Granted April 1, 2008 Discovery Labs Infantile respiratory distress syndrome JIA=juvenile idiopathic arthritis, MELAS=mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes. Sources: FDA, manufacturers’ package inserts and news releases, U.S. Securities and Exchange Commission filings Other research of note Two phase 3 studies of clostridial collagenase (Xiaflex) hit their primary endpoint, a reduction in the angle of joint contracture in patients with Dupuytren’s contracture. Auxilium Pharmaceuticals will file a biologic license application for the product, the first alternative to surgical correction, in early 2009. United Therapeutics says Viveta, an inhaled version of injectable treprostinil (Remodulin), met its primary endpoint in a late-stage trial of patients with pulmonary arterial hypertension. Intermune has begun enrollment for a phase 3 program evaluating perfenidone in patients with idiopathic pulmonary fibrosis. On the basis of results from a phase 2 study of CC-10004, its experimental psoriasis treatment, Celgene is expanding dosing levels and considering other therapeutic uses for the product. Did you hear? Favrille laid off 132 of its 144 employees after a phase 3 trial of its Specifid autologous vaccine, or immunotherapy, failed to reach statistical significance. The primary endpoint had been time to progression in patients with follicular B-cell non-Hodgkin’s lymphoma. IMS Health warns that the National Eye Institute’s head-to-head comparison of Genentech’s ranibizumab (Lucentis) and bevacizumab (Avastin) in the treatment of neovascular age-related macular degeneration (AMD) could dissuade biopharma companies from undertaking comparative drug studies. If the results back the safety and efficacy of bevacizumab in treating wet AMD, it could undermine sales of ranibizumab, a blockbuster, well before its patent expires. The U.S. Food and Drug Administration is investigating the significance of scattered reports of cancer incidence in children treated with several TNF-α inhibitors for Crohn’s disease and juvenile idiopathic arthritis. The agency delayed a trial of Geron’s embryonic stem cell therapy for spinal cord injuries. No reason was immediately available. European regulators have allowed commencement of the first inhuman studies of a microRNA therapy. Santaris Pharma, of Denmark, which touts SPC3649 as a potential treatment for hepatitis C, hopes to show the utility of mRNA intervention. In this case, the therapy involves turning off the part of the genetic code that replicates HCV. 8 BIOTECHNOLOGY HEALTHCARE · JULY/AUGUST 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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