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Last $71.79 USD
Change Today -1.34 / -1.83%
Volume 1.9M
As of 8:04 PM 04/24/15 All times are local (Market data is delayed by at least 15 minutes).

astrazeneca plc-spons adr (AZN) Key Developments

AstraZeneca PLC Announces Unaudited Consolidated Financial Results for the First Quarter Ended March 31, 2015; Reiterates Earnings Guidance for the Year 2015

AstraZeneca PLC announced unaudited consolidated financial results for the first quarter ended March 31, 2015. For the quarter, the company reported revenue of $6,057 million against $6,460 million a year ago. Operating profit was $933 million against $836 million a year ago. Profit before tax was $678 million against $638 million a year ago. Profit attributable to owners of the parent was $550 million against $504 million a year ago. Earnings per share basic and diluted were $0.44 against $0.40 a year ago. Net cash used in operating activities was $72 million compared with net cash from operating activities of $1,187 million a year ago. Purchase of property, plant and equipment was $227 million compared to $183 million a year ago. Purchase of intangible assets was $848 million compared to $545 million a year ago. Net debt as at March 31, 2015 was $6,373 million compared to $4,833 million as of March 31, 2014. Core operating profit was down 4% to $1,805 million. The Company reiterates the guidance for the year 2015. For the year 2015, the company’s total revenue is expected to decline by mid-single-digit percent at CER and core EPS is expected to increase by low single-digit percent at CER.

Innate Pharma and AstraZeneca Announce Global Agreement for IPH2201 in Immuno-oncology

Innate Pharma S.A. announced that it has signed a co-development and commercialization agreement with AstraZeneca, along with MedImmune, its global biologics research and development arm, to accelerate and broaden the development of Innate Pharma's proprietary anti-NKG2A antibody, IPH2201, including in combination with MEDI4736, an anti-PD-L1 immune checkpoint inhibitor developed by MedImmune. Currently in Phase II development, IPH2201 is a potential first-in-class humanized IgG4 antibody. NKG2A is a checkpoint receptor that inhibits the anti-cancer functions of Natural Killer and cytotoxic T-cells. The financial terms of the signed agreement include cash payments of up to $1.275 billion to Innate Pharma as well as double digit royalties on sales. The initial payment is $250 million, which includes a consideration for the exclusive global rights to AstraZeneca to co-develop and commercialize IPH2201 in combination with MEDI4736 and access to IPH2201 in monotherapy and other combinations in certain areas. AstraZeneca will pay to Innate a further $100 million prior to initiation of Phase III development, as well as additional regulatory and sales-related milestones of up to $925 million. AstraZeneca will book all sales and will pay Innate double-digit royalties on net sales. The arrangement includes the right for Innate to co-promote in Europe for a 50% profit share in the territory. The initial development plan includes: Phase II combination clinical trials with MEDI4736 in solid tumors; multiple Phase II trials planned by Innate to study IPH2201 both as monotherapy and in combination with currently approved treatments across a range of cancers; and the development of associated biomarkers. The combination of IPH2201 with MEDI4736 adds to the broad programme of immuno-oncology combination trials that AstraZeneca and MedImmune have planned and underway. The studies aim to address multiple immune pathways, harnessing AstraZeneca's own extensive pipeline and working in partnership to explore the significant potential of immunotherapies in transforming the way cancer patients are treated. The transaction is subject to customary terms and conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to become effective in the second quarter of 2015.

Astrazeneca Announces Positive Clinical Trial Evidence for its Investigational Non-Small-Cell Lung Cancer Treatment AZD9291

AstraZeneca announced on 17 April positive clinical trial evidence for its investigational non-small-cell lung cancer (NSCLC) treatment AZD9291. The company reported that AZD9291, which is currently studied in the Phase I/II AURA study, showed a median progression free survival of 13.5 months in NSCLC patients with advanced epidermal growth factor receptor mutation-positive who also have the T790M resistance mutation. Data were presented at the European Lung Cancer Conference 2015.

AstraZeneca PLC, Q1 2015 Earnings Call, Apr 24, 2015

AstraZeneca PLC, Q1 2015 Earnings Call, Apr 24, 2015

US Food and Drug Administration Grants AstraZeneca's MEK Inhibitor Selumetinib

AstraZeneca announced that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma. Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye. It is the most common primary intraocular malignancy in adults and comprises 5% of all melanomas. The Orphan Drug Designation programme provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. Selumetinib, originally licensed from Array BioPharma Inc., inhibits the MEK pathway in cancer cells to prevent the tumour from growing. Data from a phase III study evaluating selumetinib in combination with chemotherapy in patients with first-line metastatic uveal melanoma is expected to be available later this year. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in children with neurofibromatosis Type 1.


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