product pipeline

Since adopting its new strategy in May 2008, Biovail has made strides in building a specialty CNS product-development pipeline. Today, Biovail has five such compounds in development: Staccato® loxapine for the treatment of agitation in schizophrenia and bipolar disorder patients; pimavanserin for Parkinson's disease psychosis (PDP), as adjunctive therapy in schizophrenia, and potentially Alzheimer's disease psychosis (ADP); BVF-018 (modified-release formulation of tetrabenazine) for the treatment of Tourette Syndrome; fipamezole for levodopa-induced dyskinesia, also known as Parkinson's disease dyskinesia (PDD); and CX717 for the treatment of respiratory depression.

Staccato® loxapine represents Biovail's most advanced pipeline program. Pursuant to a February 2010 collaboration and license agreement with Alexza Pharmaceuticals, Inc., Biovail has U.S. and Canadian rights to commercialize Staccato® loxapine for the treatment of agitation in schizophrenia and bipolar disorder. Agitation is estimated to affect the majority of the 8 million patients in the U.S. with these conditions. In December 2009, Alexza filed a New Drug Application (NDA) for Staccato® loxapine with the United States Food and Drug Administration (FDA). The FDA action date is October 11, 2010. Biovail intends to deploy a sales force to commercialize Staccato® loxapine in the U.S.

Pimavanserin is currently in Phase 3 development for PDP. Data from the first of two Phase 3 studies initiated by Biovail's partner ACADIA Pharmaceuticals, Inc. did not meet the study's primary endpoint. However, a signal of antipsychotic efficacy, most prominent in the U.S. centers involved in the study, was seen at the 40mg dose. Biovail intends to use the learnings from this study, in addition to those of the second trial (which was capped at the 120-patient enrolment level) to develop an enhanced study design for a new Phase 3 program. Biovail anticipates initiating such a program in the middle of 2010. PDP is estimated to affect up to 40% of the approximately 1.5 million patients with Parkinson's disease in the U.S.

Biovail is also pursuing the development of Pimavanserin as adjunctive therapy in schizophrenia. In 2007, ACADIA released data from a Phase 2 study that showed that a 20mg dose of pimavanserin in conjunction with a low dose (2mg) of risperidone was as efficacious as 6mg of risperidone, but with a better side effect profile, including a statistically significant reduction in weight gain. Biovail intends to initiate a Phase 3 program for pimavanserin as adjunctive therapy in schizophrenia in the middle of 2010. Schizophrenia is estimated to affect up to 1% of the population. In the past 12 months, over 12 million prescriptions were written for risperidone in the U.S.

BVF-018 is a modified-release formulation of tetrabenazine (an immediate-release formulation of which is currently marketed as Xenazine® in the U.S. and Nitoman® in Canada), in development for Tourette Syndrome in school-aged children, 5-16 years old. BVF-018 has been designated an Orphan Drug by the FDA, which provides seven years of market exclusivity following approval.

Fipamezole is a first-in-class compound that in a Phase 2b study displayed the potential to reduce levodopa-induced dyskinesia, which is estimated to affect approximately 250,000 patients in North America. The initiation of the Phase 3 program in the U.S. for fipamezole is anticipated in 2011. Biovail acquired U.S. and Canadian rights to develop and commercialize fipamezole from Santhera Pharmaceuticals in August 2009.

In February 2010, Biovail acquired CX717 and other AMPAKINE® compounds from Cortex Pharmaceuticals, Inc. CX717 is in development for the treatment of respiratory depression (RD) - a brain-mediated breathing disorder. The incidence of RD related to opioid administration is estimated to be up to 17% when oxygen desaturation is used as the indicator. Cortex has completed two proof-of-concept studies with an oral formulation of CX717, which demonstrated the product's ability to prevent alfentanil-induced RD while preserving the analgesic effects of alfentanil.

Biovail also has a number of development programs based on the Company's former business focus. These include BVF-324 - tramadol hydrochloride for the treatment of premature ejaculation, a sexual dysfunction believed to affect up to 30% of men of all ages. The Phase 3 program for BVF-324 in Europe, which is evaluating non-commercially available doses of tramadol, was initiated in the third quarter of 2009.

In addition, in 2008 Biovail submitted three abbreviated new drug applications to the FDA for approval. These include generic formulations of (1) fenofibrate tablets (marketed in the U.S. under the Tricor brand name); (2) quetiapine fumarate extended-release tablets (sold under the brand name Seroquel XR); and (3) venlafaxine extended-release tablets (sold under the brand name Effexor XR).

Biovail's product-development efforts are subject to the process and regulatory requirements of the FDA and the Therapeutic Products Directorate (Canada). For a chart listing our pipeline products click HERE .