Drug Pipeline Series: Approvals, Nov 6 - Nov 13, 2006

Noxafil® (Posaconazole) Oral Suspension Approved in European Union for Prevention of Invasive Fungal Infections
Schering-Plough Corporation announced that the European Commission has granted marketing approval to NOXAFIL® (posaconazole) Oral Suspension for prophylaxis (prevention) of invasive fungal infections (IFIs) in the following patients at high risk of developing these infections: patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD).

The European Commission also approved NOXAFIL for oropharyngeal candidiasis (OPC) as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. OPC is a fungal infection of the mouth and throat.

The Commission approval of the prophylaxis and OPC indications for NOXAFIL results in Marketing Authorization with unified labeling that is valid in the current European Union (EU) 25 member states as well as in Iceland and Norway. NOXAFIL was previously approved in the EU and Australia for the treatment of certain IFIs in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents.


Medicis and Dow Pharmaceutical Sciences Announce FDA Approval of Ziana (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel
Medicis and Dow Pharmaceutical Sciences, Inc. announced that the U.S. Food and Drug Administration ("FDA") has approved ZIANA™ (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel. ZIANA™ Gel is the first and only combination of clindamycin and tretinoin approved for once daily use for the topical treatment of acne vulgaris in patients 12 years or older. ZIANA™ Gel is also the first and only approved acne product to combine an antibiotic and a retinoid. ZIANA™ Gel contains clindamycin phosphate 1.2% and tretinoin 0.025%, formulated as a cosmetically elegant topical gel. ZIANA™ Gel has an alcohol-free, aqueous base. Medicis expects product supply to be available for shipping to wholesalers in the fourth quarter of 2006, and anticipates promotion and sample distribution of ZIANA™ Gel to physicians shortly thereafter.

FDA Approves MIRAPEX for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome
Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex® (pramipexole dihydrochloride) tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. While symptoms can vary from person to person, they are typically described as an urge to move the legs accompanied by burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. Symptoms begin or worsen during periods of rest or inactivity -- for example, when lying down or sitting in a movie -- and generally are worse at night. Up to ten percent of the U.S. adult population is affected by RLS.

The FDA approval was based on safety and efficacy data from four randomized, double-blind, placebo-controlled clinical trials involving approximately 1,000 patients with primary moderate-to-severe RLS who were administered MIRAPEX (0.125mg, 0.25mg, 0.5mg and 0.75mg) or placebo once daily, 2-3 hours before going to bed. In controlled clinical trials, patients were treated with MIRAPEX for periods of three weeks up to nine months. In clinical studies, patients taking MIRAPEX experienced statistically and clinically significant improvements in short- and long-term efficacy versus placebo. In three clinical studies, the mean change from baseline in total International RLS Rating (IRLS) scores for patients treated with MIRAPEX demonstrated a statistically significant greater improvement compared with placebo-treated patients. In a fourth study, efficacy was sustained with MIRAPEX over a period of nine months, including a six-month open label treatment period followed by a 12-week placebo-controlled withdrawal period.


EPIX WINS CANADIAN APPROVAL FOR VASOVIST
Epix Pharmaceuticals announced that Health Canada has approved its novel blood pool imaging agent Vasovist for marketing in Canada. Vasovist (gadofosveset trisodium injection) is indicated for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease.
Epix received a letter from the FDA in August denying the company's formal appeal to approve Vasovist and turning down its request for an advisory committee review of the agent. The company had submitted the appeal in June in response to two approvable letters for Vasovist.
The European Medicines Agency in 2005 granted marketing approval for Vasovist in all 25 members of the European Union. The agent has also been approved in Norway, Iceland, Switzerland, Australia and Canada.