Drug Pipeline Series: Approvals, Oct. 31 - Nov 6, 2006

BioMarin Announces Marketing Approval for Aldurazyme in Japan
BioMarin Pharmaceutical Inc. announced that Japan's Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorization for Aldurazyme® (laronidase), the first specific treatment approved in Japan for patients with the genetic disease mucopolysaccharidosis I (MPS I). Aldurazyme was approved in Japan as an orphan drug.

MPS I is a progressive, debilitating and fatal genetic disease caused by a deficiency of the enzyme alpha-L-iduronidase. This deficiency leads to the accumulation of complex carbohydrates in the lysosomes of cells, leading to the progressive dysfunction of cellular, tissue and organ systems. Resulting symptoms, which span a spectrum of severity, can include impaired cardiac and pulmonary function, delayed physical development, skeletal and joint deformities, reduced endurance, and in some cases, delayed mental function. A majority of patients die before adulthood from complications of the disease.
About Aldurazyme

Aldurazyme® (laronidase) is indicated in the United States for patients with Hurler and Hurler-Scheie forms of MPS I and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Aldurazyme has been shown to improve pulmonary function and walking capacity. Aldurazyme has not been evaluated for effects on central nervous system manifestations of the disorder.

NovaDel Pharma Receives FDA Approval of NitroMist™NovaDel Pharma Inc. announced that NitroMist™ (Nitroglycerin Lingual Aerosol) has been approved by the U.S. Food and Drug Administration (FDA) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist™ is NovaDel's first product approval utilizing its proprietary oral spray technology. The North American commercial rights for NitroMist have been licensed to Par Pharmaceutical Companies, Inc. (NYSE: PRX).

Data from the NitroMist™ clinical trials demonstrate the drug's efficacy in the treatment of angina. In a double-blind, single-center, placebo-controlled, 4-period crossover study in 30 subjects with stable angina pectoris, doses of 0.2, 0.4, and 0.8 mg of nitroglycerin delivered by NitroMist™ were compared to placebo. The primary efficacy endpoint was exercise tolerance as measured by time to development of moderate angina while on an exercise treadmill. The primary endpoint was achieved with all three nitroglycerin oral spray groups demonstrating statistically significantly increase in time to angina compared to placebo (p less than or equal to 0.0003).