Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S.

Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute treatment
of agitation associated with schizophrenia and bipolar disorder

Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd (TEVA), and Alexza Pharmaceuticals, Inc. (ALXA) announced today that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.

Published: 08 May 2013
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Transition Therapeutics Announces Results of Clinical Study of Type 2 Diabetes Drug Candidate TT-401

Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) announced the results of a five-week proof of concept clinical study of TT-401 in type 2 diabetic and obese non-diabetic subjects.  In the study, TT-401 a once-weekly administered peptide, demonstrated significant improvements in glycemic control and reductions in body weight.

The study enrolled diabetic patients at five dosing levels and non-diabetic obese patients at one dose level.  All dosing cohorts received five doses over a five week period.  Diabetic patients were on stable doses of metformin.  At the end of the treatment period, TT-401-treated patients in the three highest dose groups experienced statistically significant reductions in mean fasting plasma glucose relative to placebo.

Published: 30 April 2013
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FDA Advisory Committee recommends approval of BREO™ ELLIPTA™ for the treatment of COPD

 GlaxoSmithKline plc (GSK.L) and Theravance, Inc. (THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of  BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)*. 

BREO™ ELLIPTA™, is the proposed proprietary name for FF/VI 100/25 mcg, a combination of the inhaled corticosteroid (ICS) fluticasone furoate "FF" and the long acting bronchodilator (LABA) vilanterol "VI" (FF/VI).

Published: 18 April 2013
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Alkermes Announces Positive Results from Phase 2 Clinical Study of ALKS 5461 for Major Depressive Disorder

–– Significantly Improved Depression Scores in 142-Patient Study Testing Novel Mechanism of Action for Once-Daily, Oral Medication ––
–– Company Plans to Initiate Pivotal Development Program ––
–– Data to be Presented at NCDEU Conference in May ––

Alkermes plc (ALKS) today announced positive preliminary topline results from a phase 2 study of ALKS 5461, its novel drug compound for major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. ALKS 5461 reflects a new approach to the treatment of MDD based on modulation of opioid receptors in the brain and is designed as a non-addictive, oral, once-daily medicine.

Published: 17 April 2013
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ACADIA Pharmaceuticals Announces Expedited Path to NDA Filing for Pimavanserin Following Meeting with FDA

Single Pivotal Phase III -020 Study and Other Supportive Data Sufficient for Future NDA Filing for the Treatment of Parkinson’s Disease Psychosis

ACADIA Pharmaceuticals Inc. (ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has agreed that the data from the pivotal Phase III -020 study, together with supportive data from other studies with pimavanserin, are sufficient to support the filing of a New Drug Application (NDA) for the treatment of Parkinson’s disease psychosis (PDP). As a result, ACADIA will no longer conduct the Phase III -021 study that was planned as a confirmatory trial and was scheduled to be initiated later this month.

Published: 11 April 2013
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