Drug Pipeline Series: Approvals Oct23-Oct30, 2006

FDA Approves New Formulation for NEXIUM
AstraZeneca announced that a new formulation for its prescription proton pump inhibitor NEXIUM ® (esomeprazole magnesium) has been approved by the US Food and Drug Administration (FDA). NEXIUM For Delayed-Release Oral Suspension is now approved for the treatment of GERD, including symptomatic gastroesophageal reflux disease, healing and maintenance of healing of erosive esophagitis (EE), and risk reduction of NSAID-associated gastric (stomach) ulcers.
Each packet of NEXIUM For Delayed-Release Oral Suspension contains either 20 mg or 40 mg of esomeprazole, the same active ingredient used in NEXIUM Delayed-Release Capsules. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form a suspension and are given by oral, nasogastric or gastric administration.
The new formulation of NEXIUM For Delayed-Release Oral Suspension will be available in the first quarter of 2007.

TYZEKA™ (telbivudine) Approved by U.S. Food and Drug Administration (FDA) as a New Treatment for Patients with Chronic Hepatitis B
Idenix Pharmaceuticals, Inc. announced the approval of TYZEKA™ (telbivudine) by the U.S. Food and Drug Administration (FDA) as a new once-a-day oral treatment, taken with or without food, for patients with chronic hepatitis B (CHB). TYZEKA rapidly and profoundly(1) suppresses the hepatitis B virus (HBV) in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Data from the pivotal phase III clinical trial, known as the GLOBE study, compared TYZEKA to lamivudine in 1,367 patients. The primary efficacy endpoint of the GLOBE study was therapeutic response at one year, a composite endpoint coupling viral suppression (serum HBV DNA suppression below 100,000 copies/mL) with either improved liver disease markers (ALT normalization) or loss of detectable hepatitis B e-antigen (HBeAg). In HBeAg-positive patients, therapeutic response was 75 percent among patients treated with TYZEKA and 67 percent for those patients treated with lamivudine, while the response for HBeAg-negative patients after one year was 75 percent vs. 77 percent, respectively. In the GLOBE study, patients who achieved non-detectable HBV DNA levels at 24 weeks were more likely to undergo e-antigen seroconversion, achieve undetectable levels of HBV DNA, normalize ALT, and minimize resistance at one year.

FDA APPROVES SCHERING'S BETASERON FOR EARLY STAGE MS
Berlex, a U.S. affiliate of Schering AG, announced that the FDA has expanded the indication of Betaseron (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaseron is the only high dose, high frequency interferon beta indicated for patients at the earliest stage of MS.
The new indication is based on results from the BENEFIT study in patients with a first clinical demyelinating event and MRI features suggestive of MS. The two-year study showed that treatment with Betaseron delayed the time to a second clinical event by one year compared with placebo. BENEFIT is the only trial to demonstrate the efficacy of a high dose, high frequency interferon beta as an effective treatment for patients with early MS. In addition to establishing efficacy in this group of patients, the study also showed that patients with early MS found Betaseron to be a safe and well-tolerated treatment, as evidenced by the findings that 93 percent of patients completed the study.
Betaseron has more than 17 years of clinical experience, with a well-established safety profile resulting from more than 700,000 patient years of treatment. A long-term follow-up study demonstrated that Betaseron remains consistently safe, effective and well-tolerated over the long term. Results of the study show that long-term continuous use of Betaseron provided 13 years of cane-free mobility, which is, on average, six years longer than when compared with untreated patients from a natural history cohort. The study also showed that patients who continuously used Betaseron experienced a significant delay in progression to secondary progressive multiple sclerosis by 6.6 years compared with patients who were not on continuous Betaseron treatment.

Pharmaxis' ARIdol Gains Swedish Approval
Pharmaceutical company Pharmaxis announced that it has received marketing approval for its asthma diagnostic and management product Aridol in Sweden, a crucial market for gaining wider European approval.
Following the Swedish registration, Pharmaxis will seek marketing of Aridol in the 27 other European Union member states via the mutual recognition procedure. Individual approvals are expected from early next year.
Aridol is Australia's first true molecule-to-market therapeutic product -- discovered, developed, manufactured and marketed over 12 years by wholly Australian interests. The exhaustive clinical trials were generously assisted by Australian Government research grants, including the current P3 Scheme.
A simple-to-use airways inflammation test, Aridol is administered as a dry powder in a hand-held inhaler. It is approved in Sweden to identify patients with asthma, determine the severity of their disease and the effectiveness of their current treatment.