3rd Jun 2014 07:08
LONDON (Alliance News) - AstraZeneca PLC Tuesday announced that its investigational drug AZD0914 for the treatment of uncomplicated gonorrhoea had been granted 'fast track' status by the US Food and Drug Administration, while also providing details of the development of its oncology pipeline.
The treatment has been granted fast tracked as gonorrhoea is becoming "increasingly resistant to existing antibiotics and poses a serious global public health threat", AstraZeneca said.
This means that the drug will be eligible for priority review from the FDA, and a five-year extension on its market exclusivity if it is approved.
After successfully rejecting a USD69.3 million takeover bid from US drugmaker Pfizer Inc, AstraZeneca has been presenting information on its oncology pipeline at the 50th American Society of Clinical Oncology Meeting in Chicago.
One of AstraZeneca's key defences for staying independent was the progression of its drug pipeline, which it argued meant that Pfizer's offer undervalued its business. AstraZeneca, like many of its peers, has been hit by the loss of exclusivity on some of its key products and is looking to replace its maturing pipeline.
The company said that it expects to file for US regulatory approval for its AZD9291 compound for the treatment of non-small cell lung cancer as early as the first quarter of 2015, or in the second half of 2015.
AstraZeneca said that data from its Phase I study of the compound showed strong activity as a once-daily mono-therapy for patients with non-small cell lung cancer who had a T790M resistance mutation, or who had previously failed with targeted therapy using tyrosine-kinase inhibitors.
Phase II study from the combination of olaparid and cediranib for the treatment of platinum-sensitive high-grade serous ovarian cancer showed that the combination nearly doubled progression-free survival and improved patients objective response rate compared to a treatment of just olaparib.
As a result, AstraZeneca is supporting the US National Cancer Institutes's plans to move the combination towards Phase III development.
In the company's Immuno-onocology pipeline, Phase I study data for its MEDI4736 treatment supported its acceleration of the treatment to Phase III clinical trials, AstraZeneca said.
AstraZeneca confirmed that it has enlarged its recruitment target for its Phase II study of mesothelioma treatment tremelimumab. Additionally, early data from a Phase I study of a combined treatment of MEDI4736 and tremelimumab for the treatment of refractory non-small cell lung cancer has shown "encouraging efficacy."
It plans to begin a Phase III study of the combination.
Shares in AstraZeneca are up 0.1% at the open Tuesday at 4,373.10 pence.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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