AstraZeneca and partner Targacept have suffered a clinical setback with the news that a mid-stage trial of their experimental compound AZD3480 failed to demonstrate effectiveness in schizophrenia patients.

The companies said that a Phase IIb study of AZD3480 did not meet the criteria for statistical significance on the primary goals of improvement on various cognitive domains. As such, the companies do not expect to put the compound into Phase III studies for CDS.

The news comes a few months after the two companies revealed that AZD3480 failed to prove effective in a Phase IIb trial of patients with mild to moderate Alzheimer's disease. AstraZeneca said that it expects to decide in the first half of next year whether to continue development of AZD3480 in Alzheimer's or attention deficit/hyperactivity disorder in adults, pending the completion of a Phase II trial of the drug in ADHD.

Bob Holland, head of neuroscience therapy at AstraZeneca, said that "while this trial outcome did not meet our objectives, we continue to pursue medicines that target neuronal nicotinic receptors (NNRs) with Targacept to treat cognitive disorders". It was noted that a Phase I trial of AZD1446 (TC-6683), a product candidate selective for the alpha4beta2 NNR will begin by the end of the year, triggering a $2 million milestone payment to Targacept.

That last piece of good news did nothing to stop a major decline in Targacept's share price which fell 30% to $2.74 in after-hours trading.

Dapagliflozin diabetes pact with B-MS now covers Japan
In better news for AstraZeneca, the firm said it is extending a development pact with Bristol-Myers Squibb on the investigational diabetes compound dapagliflozin to include Japan.

The companies have been working together elsewhere since last January on dapagliflozin, a once-daily novel selective inhibitor of the sodium-glucose cotransporter 2. The drug is currently being studied in Phase III trials in several countries, including the USA.

It is in Phase II in Japan and AstraZeneca will have “operational and cost responsibility for all development and regulatory activities on behalf of the collaboration”. The two companies will jointly market the product in Japan, sharing all commercialisation expenses and splitting profits equally. B-MS will manufacture dapagliflozin and book sales.

Bruno Angelici, executive vice president of international sales and marketing at AstraZeneca, noted the firm’s long-standing presence in Japan, adding that last year, the cost of treating and preventing type 2 diabetes in the country, where more than six million people have the disease, was more than $18.4 billion. He added that dapagliflozin has the potential to "not only help reduce this cost burden, but also reduce the impact this disease has on the country's health”.

As well as dapagliflozin, the two companies are also collaborating to develop another potential treatment for type 2 diabetes, Onglyza (saxagliptin). That deal does not include Japan.