Key Developments: AstraZeneca PLC (AZN.L)

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Latest Key Developments (Source: Significant Developments)

AstraZeneca PLC announces positive results from phase III
Tuesday, 13 May 2014 02:01am EDT 

AstraZeneca PLC:Announces positive results from phase III study of Saxagliptin/ Dapagliflozin combination in patients with type 2 diabetes inadequately controlled on metformin and outlines future development plans for the oral antidiabetic franchise.Study showed patients inadequately controlled on metformin achieved statistically significant reduction of HbA1c with the combination of saxagliptin and dapagliflozin versus either agent alone.Says it will commence a Phase III trial for dapagliflozin in patients with Type 1 diabetes in 2014.Results from the combination study found that patients treated with saxagliptin/dapagliflozin plus metformin achieved significantly greater reductions in HbA1c versus either agent alone plus metformin at 24 weeks.Says with an adjusted mean change from baseline HbA1c of -1.47 pct in the saxagliptin/dapagliflozin combination group compared to -0.88 pct in the saxagliptin group and -1.20 pct in the dapagliflozin group.More patients in the saxagliptin/dapagliflozin combination group (41 pct) achieved goal HbA1c levels of less than 7 pct compared to patients in the saxagliptin (18 pct) and dapagliflozin (22 pct) groups.Saxagliptin/dapagliflozin combination group achieved a significantly greater adjusted mean reduction from baseline in two-hour postprandial glucose (PPG) versus the saxagliptin group, but not the dapagliflozin group.  Full Article

AstraZeneca PLC announces results of phase IIB studies
Monday, 12 May 2014 11:00am EDT 

AstraZeneca PLC:Says two key molecules in MedImmune's Respiratory, Inflammation and Autoimmune (RIA) portfolio mavrilimumab and sifalimumab met their primary endpoints in respective Phase II studies demonstrating further pipeline progress in core therapeutic areas.Top-line results from Phase IIb study of mavrilimumab, an investigational monoclonal antibody that inhibits key pathway in development of rheumatoid arthritis (RA), achieved its primary endpoints.In Phase llb study of methotrexate inadequate responder RA population (EARTH EXPLORER-1), 326 patients with moderate and severe RA were treated for six months with either mavrilimumab (low, medium or high dose) or placebo.Says this is in addition to standard methotrexate background therapy.Co-primary endpoints of American College of Rheumatology (ACR) response of ACR20 and Disease Activity Score (DAS28) were met with all mavrilimumab doses confirming the efficacy demonstrated in the previous Phase IIa study (EARTH).  Full Article

AstraZeneca PLC announces Amgen & AZ brodalumab phase III results
Monday, 12 May 2014 02:00am EDT 

AstraZeneca PLC:Phase III AMAGINE-1TM study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses.Brodalumab is only investigational treatment in development that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor.Primary endpoints were patients achieving at least 75 pct improvement from baseline in disease severity at week 12, as measured by Psoriasis Area Severity Index (PASI 75), and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment (sPGA 0 or 1).Results showed that 70.3 pct of patients in 210 mg group and 42.5 percent of patients in 140 mg group achieved PASI 90 responses compared to placebo.  Full Article

AstraZeneca PLC initiates phase III study for MEDI4736
Thursday, 8 May 2014 07:31am EDT 

AstraZeneca PLC:Starts Phase III programme for MEDI4736, immunotherapy in development for treatment of non-small cell lung cancer (NSCLC) and other cancers.Goal of PACIFIC trial, first study in Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with locally advanced, unresectable NSCLC (Stage III).Following completion of treatment with chemoradiotherapy and no evidence of tumour progression.PACIFIC trial is first pivotal study of immunotherapy in this patient population.  Full Article

AstraZeneca PLC announces FDA approves EPANOVA
Tuesday, 6 May 2014 02:03am EDT 

AstraZeneca PLC:US Food and Drug Administration (FDA) has approved EPANOVA (omega-3-carboxylic acids) as adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500 mg/dL).Triglycerides are type of lipid (fat) found in blood and essential energy source for body.Some people have very high triglyceride levels (severe hypertriglyceridaemia), meaning they have too much fat in their blood which can lead to serious health complications.Nearly four million American adults currently have severe hypertriglyceridaemia and this figure continues to rise, as prevalence of associated conditions, such as obesity and diabetes, continues to grow.EPANOVA is pure, free fatty acid form that can provide physicians with option to effectively manage the condition without dramatically increasing a patient's pill burden.  Full Article

AstraZeneca PLC rejects Pfizer proposal
Friday, 2 May 2014 05:50am EDT 

AstraZeneca PLC:Financial and other terms described in Proposal are inadequate, substantially undervalue AstraZeneca and are not a basis on which to engage with Pfizer.Large proportion of consideration payable in Pfizer shares and tax-driven inversion structure remain unchanged.Accordingly, Board has rejected the Proposal.  Full Article

Pfizer Inc confirms delivery of increased proposal to AstraZeneca
Friday, 2 May 2014 02:08am EDT 

Pfizer Inc:Says having consulted with major shareholders, it has submitted a revised written proposal to AstraZeneca PLC (AstraZeneca) to make an offer to combine the two companies.Says it hopes that the increased proposal will provide the basis for AstraZeneca to engage with Pfizer and enter into discussions relating to a possible combination of the two companies.Proposes to AstraZeneca a combination of the two companies pursuant to which AstraZeneca shareholders would receive, for each AstraZeneca share, 1.845 shares in the combined entity and 1,598 pence in cash.Proposal represents an indicative value of 50.00 pounds ($84.47) per AstraZeneca share, based on Pfizer`s closing share price of $31.15 (and an exchange rate of $1.00:0.5919 pounds) on May 1.On the basis of Pfizer`s closing share price of $31.15 on May 1 and an exchange rate of $1.00:0.5919 pounds on May 1 the proposal represents a premium of about 32 pct to the unaffected closing price of 37.82 pounds on April 17;.39 pct to the closing price of 35.86 pounds on Jan. 3 being the trading day immediately prior to the date of Pfizer`s Jan proposal.7 pct to the indicative value of Pfizer`s Jan proposal of 46.61 pounds per AstraZeneca share.22 pct to AstraZeneca`s all time high closing price of 41.03 pounds since formation of the company in 1999.  Full Article

Pfizer intends to acquire AstraZeneca Plc-Reuters
Monday, 28 Apr 2014 06:49am EDT 

AstraZeneca Plc:Pfizer has contacted the British government about its desire to acquire AstraZeneca-Reuters.Pfizer said on April 28 it made a 58.8 billion pounds ($98.9 billion) bid approach to AstraZeneca in January and had contacted its British rival again on April 26 seeking further discussions about a takeover.Pfizer's original proposal, made to the board of AstraZeneca on Jan. 5, included a combination of cash and shares and would have valued AstraZeneca shares at 46.61 pounds each - a premium of around 30 percent at the time.Pfizer said it was now considering a possible transaction in which AstraZeneca shareholders would receive a significant premium above the value of their shares on April 17, before takeover rumours started.  Full Article

AstraZeneca PLC updates on dividend
Thursday, 24 Apr 2014 02:08am EDT 

AstraZeneca PLC:Announces net cash distributions to shareholders were $2,228 mln, through dividends of $2,425 mln partially offset by proceeds from the issue of shares of $197 mln.Future dividends will normally be paid as follows.First interim announced with second quarter and half year results and paid in Sept.Second interim announced with fourth quarter and full year results and paid in March.  Full Article

AstraZeneca PLC reaffirms FY 2014 guidance - Conference Call
Thursday, 24 Apr 2014 02:00am EDT 

AstraZeneca PLC:Affirms FY 2014 guidance.Continues to anticipate low to mid single-digit decline in revenue on a constant currency basis in FY 2014.Anticipates FY 2014 core EPS to decline in the teens at constant exchange rate.FY 2014 revenue of $25.31 billion and EPS of $4.29 - Thomson Reuters I/B/E/S.  Full Article

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