Proactiveinvestors United Kingdom AstraZeneca Proactiveinvestors United Kingdom AstraZeneca RSS feed en Tue, 25 Jun 2019 16:31:19 +0100 Genera CMS (Proactiveinvestors) (Proactiveinvestors) <![CDATA[RNS press release - Bevespi Aerosphere approved by the Japanese ]]> Wed, 19 Jun 2019 07:00:04 +0100 <![CDATA[News - AstraZeneca gets EU approval for Lynparza as ovarian cancer treatment ]]> AstraZeneca PLC’s (LON:AZN) Lynparza drug will be available in the European Union as a first-line maintenance treatment for women with advanced ovarian cancer.

The approval by the European Commission, the third indication for Lynparza in the EU, will make the drug available for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response following completion of first-line platinum-based chemotherapy.

READ: AstraZeneca reports positive results from trial of pancreatic cancer treatment

While 70% of women with ovarian cancer relapse within three years of initial chemo treatment, Lynparza, which is a result of a collaboration between AstraZeneca and MSD (Merck), has been proved to significantly increase progression-free survival. 

In the Phase III SOLO-1 trial testing Lynparza as maintenance monotherapy following chemotherapy, it demonstrated a 70% reduction in the risk of disease progression or death.

Following this new approval for Lynparza, the oncology collaboration with Merck dictates that AstraZeneca will receive $30mln as ongoing collaboration revenue, which the company anticipates will be booked during the second quarter of 2019.

Sales boost

Prior to its collaboration with Merck for Lynparza, AstraZeneca had been targeting annual peak sales of $2bn for the drug, of which $400mln was from ovarian cancer.

Broker Shore Capital noted that, to date, AstraZeneca has recognised circa $2.6bn from the Lynparza collaboration out of a total deal value of circa $8.5bn, of which $140mln relates to regulatory milestones.

"We also think that for FY2019F consensus is forecasting c$600m of Collaboration Revenue from the Merck collaboration, of which $100m is a final option payment (for combo trials between Merck’s Keytruda and Lynparza) and a further $500mln relating to regulatory and sales-milestones."

Astra shares were up 1% to 6,321.86p on Tuesday morning.

Tue, 18 Jun 2019 09:20:00 +0100
<![CDATA[RNS press release - Lynparza approved in the EU for 1st-line ]]> Tue, 18 Jun 2019 07:00:12 +0100 <![CDATA[News - AstraZeneca sees further encouraging effects from leukaemia treatment Calquence ]]> An AstraZeneca PLC (LON:AZN) drug being developed to treat chronic lymphocytic leukaemia has shown that it significantly prolongs the time patients can live without the disease progressing.

An interim analysis of a phase III clinical trial has revealed that after 12 months, 88% of people who have previously treated for chronic lymphocytic leukaemia saw no progression of the disease if they were being given Calquence, compared to 68% for those patients using the physician's choice of rituximab combined with idelalisib or bendamustine.

READ: AstraZeneca drug for chronic lymphocytic leukaemia successfully navigates phase III Elevate trial

After just over 16 months of the Ascend trial, Calquence has been found to reduce the risk of disease progression or death by 69%.

Chronic lymphocytic leukaemia is the most common type of leukaemia in adults, with an estimated 191,000 new cases globally.

This trial is the first randomised test directly comparing a single drug against standard chemo-immunotherapy or idelalisib and rituximab combinations, doctors conducting the trial said. 

“These data add to the growing body of evidence to support the profile of Calquence as a selective BTK inhibitor that offers a chemotherapy-free treatment option with a favourable safety profile in chronic lymphocytic leukaemia, a life-threatening disease,” said José Baselga, executive vice president of Astra’s oncology research and development arm.

He said the Ascend data would be combined with recent positive results from other trials to serve as the foundation for regulatory submissions later this year, Baselga said.

Broker Shore Capital said the detailed data was "very promising" and "very significant" for the group's haematology franchise, but a head-to-head trial versus market leader Imbruvica was "the more likely catalyst to drive consensus upgrades upon a successful result". 

AstraZeneca shares were down 0.3% to 6,198p on Moday morning.

Mon, 17 Jun 2019 09:32:00 +0100
<![CDATA[RNS press release - Calquence significantly prolonged the time patient ]]> Mon, 17 Jun 2019 07:00:06 +0100 <![CDATA[RNS press release - Publication of a Prospectus ]]> Wed, 12 Jun 2019 16:45:04 +0100 <![CDATA[News - AstraZeneca drug for chronic lymphocytic leukaemia successfully navigates phase III trial ]]> An AstraZeneca PLC (LON:AZN) drug being developed to treat chronic lymphocytic leukaemia has successfully navigated a phase III clinical trial.

AZ’s Calquence, to use the jargon, demonstrated a statistically-significant and clinically-meaningful improvement in progression-free survival. In other words it was proven to help people live longer.

READ: AstraZeneca reports positive results from trial of pancreatic cancer treatment

The primary aim of the study was to assess the treatment in harness with a targeted type of drug called a monoclonal antibody – in this case obinutuzumab.

The comparator group received the current standard of care: chemotherapy coupled with the same antibody treatment.

A secondary goal was to see if Calquence worked on its own, as what is called a monotherapy. The drug ticked both boxes.

The results will “serve as the foundation for regulatory submissions later this year", said AZ’s vice president of oncology, José Baselga.

Chronic lymphocytic leukaemia is the most common type of leukaemia in adults with an estimated 191,000 new cases globally.

Calquence, meanwhile, was granted accelerated approval by the US Food and Drug Administration in autumn 2017 for the treatment of mantle cell lymphoma who have received at least one prior therapy.

In a note to clients, analysts at City broker Shore Capital commented: “Overall, we view this data as encouraging and supportive of consensus forecasts and we look to detailed data from ASCEND and ELEVATE-TN, as well as data versus the market leader Imbruvica (ELEVATE-RR, data 2020F+), for further clarity on the competitive profile of Calquence and before unlocking further value.”

Shore Capital reiterated a ‘buy’ rating on AstraZeneca shares, which in afternoon trading were 1.2% higher at 6,029p.

 -- Adds analyst comment, share price --

Thu, 06 Jun 2019 07:59:00 +0100
<![CDATA[RNS press release - Calquence Phase III ELEVATE-TN trial met primary ]]> Thu, 06 Jun 2019 07:00:07 +0100 <![CDATA[RNS press release - Block listing Interim Review ]]> Mon, 03 Jun 2019 15:00:05 +0100 <![CDATA[News - AstraZeneca reports positive results from trial of pancreatic cancer treatment ]]> AstraZeneca PLC (LON:AZN) said its Lynparza treatment nearly doubled the life-span of patients with metastatic pancreatic cancer in a phase III trial.

The trial tested Lynparza tablets as an initial maintenance treatment for metastatic pancreatic cancer patients, whose disease had not progressed after chemotherapy.

READ: AstraZeneca gets US regulatory green light for slow-release diabetes drug

Results showed “statistically significant and clinically meaningful improvement” in the time patients could live without their disease getting worse by an average of 7.4 months on Lynparza, compared to 3.8 months for those on placebo.

More than twice as many patients showed no disease progression both at one year and two years after starting to take Lynparza.  

José Baselga, executive vice president of oncology research and development, said: "These unprecedented results raise new hope for patients that have seen little progress over a long period of time.”

He said AstraZeneca is now working with regulatory authorities to bring Lynparza to patients “as quickly as possible”.

Pancreatic cancer has the worst survival rate of the most common cancers with less than 3% of patients surviving more than five years after diagnosis.

Early diagnosis of pancreatic cancer is difficult because there are usually no symptoms until it is too late.  About 80% of patients are diagnosed at the metastatic stage.

In 2018, there were 458,918 new cases of pancreatic cancer worldwide.

Mon, 03 Jun 2019 08:35:00 +0100
<![CDATA[RNS press release - Lynparza nearly doubled time patients lived with ]]> Mon, 03 Jun 2019 07:00:09 +0100 <![CDATA[RNS press release - Pooled analyses of the roxadustat global Phase III ]]> Fri, 10 May 2019 07:00:05 +0100 <![CDATA[RNS press release - Director/PDMR Shareholding ]]> Wed, 08 May 2019 14:00:01 +0100 <![CDATA[RNS press release - Director Declaration ]]> Wed, 08 May 2019 11:00:02 +0100 <![CDATA[RNS press release - Trastuzumab deruxtecan demonstrated clinically ]]> Wed, 08 May 2019 07:00:04 +0100 <![CDATA[RNS press release - Calquence PhIII ASCEND trial met primary endpoint ]]> Tue, 07 May 2019 07:00:08 +0100 <![CDATA[News - AstraZeneca gets US regulatory green light for slow-release diabetes drug ]]> AstraZeneca PLC (LON:AZN) has received the US regulatory green light for a slow-release version of its type-2 diabetes treatment.

Qternmet XR will be prescribed alongside diet and exercise advice to people to improve glycaemic control.

America’s Food & Drug Administration gave the nod for the once-a-day treatment after the Anglo-Swedish drugs giant successfully carried out two phase III clinical trials.

Fri, 03 May 2019 07:30:00 +0100
<![CDATA[RNS press release - Qternmet XR approved in the US for type-2 diabetes ]]> Fri, 03 May 2019 07:00:03 +0100 <![CDATA[RNS press release - Total Voting Rights ]]> Wed, 01 May 2019 15:00:02 +0100 <![CDATA[RNS press release - Director/PDMR Shareholding ]]> Wed, 01 May 2019 12:00:01 +0100 <![CDATA[News - AstraZeneca’s Lynparza set for EU approval as advanced ovarian cancer maintenance treatment ]]> AstraZeneca PLC’s (LONP:AZN) Lynparza drug has been recommended for approval in the EU as a first-line maintenance treatment for women with advanced ovarian cancer.

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of the drug, meaning it will recommend that the European Medicines Agency approve it.

The recommendation is for the use of Lynparza tablets in adult women with advanced ovarian cancer who have responded to an initial round of chemotherapy.

READ: Astra sees profits double in Q1

Regulators based their opinion on data from the SOLO-1 trial, which showed the pills reduced the risk of disease progression or death by 70% compared to placebo following response to chemo.

Of those patients receiving Lynparza, 60% of women remained progression-free after three years versus 27% in the placebo arm.

“There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment,” said Astra’s oncology boss Dave Fredrickson.

“The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient's BRCA mutation status as soon as they are diagnosed.”

Chief medical officer Roy Baynes added: “If approved, this expanded indication could change the way women in Europe with BRCA-mutated advanced ovarian cancer are treated.”

In a note to clients, analysts at Shore Capital commented: "Our analysis suggests that consensus estimates for Collaboration Revenue to 2024F are covered by potential milestones from the Merck-Lynparza collaboration alone, although AstraZeneca has several agreements which can also contribute to this revenue line. Hence, we are comfortable with consensus estimates for Collaboration Revenue."

Astra shares were 1.1% to 5,857p in afternoon trade on Monday.

 -- Adds analysts comment, updates share price --

Mon, 29 Apr 2019 08:40:00 +0100
<![CDATA[RNS press release - Lynparza receives positive EU CHMP opinion for 1st ]]> Mon, 29 Apr 2019 07:00:18 +0100 <![CDATA[RNS press release - Result of AGM ]]> Fri, 26 Apr 2019 17:45:23 +0100 <![CDATA[News - AstraZeneca first-quarter profits double as product sales revival continues but cash still a worry ]]> Pre-tax profits at AstraZeneca PLC (LON:AZN) surged in the first quarter of 2019 thanks to continued growth in product sales.

The FTSE 100-pharma giant has seen billions wiped from its top line in recent years as some of its blockbuster drugs – such as the statin, Crestor, and schizophrenia treatment, Seroquel – have lost their exclusivity.

READ: Astra launches biggest cash call of the year to fund Japanese cancer deal

But it has reinvented its pipeline of late, and a wave of new drugs, including much-hyped cancer treatments Tagrisso and Lynparza, helped it to post its first annual rise in product sales for almost a decade last year.

As expected, sales have continued to grow, climbing 10% to US$5.47bn in the three months ended 31 March (Q1 18: US$4.99bn). At constant exchange rates, sales were up 14%.

Oncology driving turnaround

Tagrisso is now the company’s top-selling drug, achieving sales of US$630mln in the quarter, almost double what it raked in this time last year.

A host of other cancer drugs also made big contributions, as did its Symbicort, although sales of the asthma inhaler fell slightly year-on-year as Astra was forced to trim prices.

The strong sales growth filtered down to the bottom line, with pre-tax profits doubling to US$758mln in the period (Q1 18: US$374mln), helped by a sharp rise in margins to 20% (Q1 18: 13%).

Emerging markets growth

“Our 14% product sales growth in the quarter reflected the success of our new medicines and Emerging Markets,” said chief executive pascal Soriot.

“In Oncology, Tagrisso, Imfinzi and Lynparza continued to do well and, in BioPharma, Farxiga, Brilinta and Fasenra also grew strongly.

“Emerging Markets, our largest sales region, delivered an outstanding performance with a 22% growth rate; all of its sub-regions grew strongly, including China at 28%.”

He added: “Together with this encouraging financial start to the year, our highly-productive and sustainable pipeline continued to deliver, notably with a regulatory approval for Lynparza in the EU for the treatment of metastatic breast cancer and approvals of Farxiga in type-1 diabetes.”

Cash still a worry

AstraZeneca has also been criticised for its inability to convert the top-line momentum into cold hard cash.

Net cash outflow from operating activities jumped to US$387mln in the quarter (Q1 18: US$140mln), partly as a result of increased tax payments. As a result, the amount of cash the business has on hand fell to US$4.14bn (Q1 18: US$4.83bn).

As for the rest of the year, the Anglo-Swedish company expects its cash performance to be “adversely impacted” by a number of one-off payments related to “prior business-development transactions”.

UBS analysts recently claimed that Astra would have to be generating free cash flow of more than US$8bn by 2023 to justify its current valuation, “a number we can’t see AZN delivering”.

With net debt rising to US$16.27bn come the end of March (Q1 18: US$15.42bn), the cash outflow will no doubt be of concern.

Fri, 26 Apr 2019 07:40:00 +0100
<![CDATA[RNS press release - AZN: Q1 2019 Results ]]> Fri, 26 Apr 2019 07:00:08 +0100 <![CDATA[RNS press release - Lynparza approved in EU for the treatment of germl ]]> Wed, 10 Apr 2019 07:00:03 +0100 <![CDATA[News - AstraZeneca’s new Japanese cancer drug tipped to rack up billions in annual sales ]]> AstraZeneca PLC’s (LON:AZN) recent tie-up with a Japanese drug developer could add billions to its top-line, according to analysts at Liberum.

Last week, the FTSE 100-pharma giant announced the UK’s biggest cash call so far this year, raising US$3.5bn to help fund its collaboration with Daiichi Sankyo.

The pair are working together to develop trastuzumab deruxtecan, a potential breakthrough treatment for HER-2 positive strains of cancer, such as certain forms of breast and gastric cancers.

READ: AstraZeneca launches UK’s biggest cash call to fund Japanese cancer deal

Trastuzumab deruxtecan isn’t approved for use yet, but the first regulatory submission is scheduled for later this year as a treatment for patients with advanced or hard-to-treat breast cancer.

City broker Liberum expects it to get the thumbs-up from regulators, after which analysts reckon it will go on to rack up billions of dollars in sales every year.

“We have looked at the sales potential of this drug in HER2+ cancers,” read a note to clients.

“It should be a blockbuster drug in its first indication, and has every chance of reaching US$3bn+ in sales globally.

“However, the real value in this deal will only be visible in earnings after 2023 when clinical trials open up larger patient populations.”

Liberum repeated its ‘hold’ recommendation but upped its price target to 6,400p.

In early morning trading, Astra shares were down 0.3% to 6,098p.

Fri, 05 Apr 2019 09:25:00 +0100
<![CDATA[RNS press release - Holding(s) in Company ]]> Thu, 04 Apr 2019 13:30:01 +0100 <![CDATA[RNS press release - Director/PDMR Shareholding ]]> Wed, 03 Apr 2019 10:00:02 +0100 <![CDATA[RNS press release - Total Voting Rights ]]> Tue, 02 Apr 2019 15:00:02 +0100 <![CDATA[News - AstraZeneca is still not converting top-line momentum into cash-flow, says UBS ]]> AstraZeneca PLC (LON:AZN) has been downgraded to a ‘sell’ by analysts at UBS, who claim the drugs giant’s cash generation isn’t befitting of a company with an enterprise value of almost US$120bn.

Last week, the FTSE 100 group came to market with a US$3.5bn placing – the largest so far this year by a British company.

READ: AstraZeneca launches UK’s biggest cash call of 2019

Around US$1.4bn of that will be used to fund a cancer collaboration with Japanese group Daiichi Sankyo.

The rest will be used for “general corporate purposes”, including restructuring debt, which UBS reckons is a sign that Astra is struggling to convert its top-line momentum into cash flow.

“The equity raise (US$3.5bn) that went with the license deal is also aimed at refinancing near term debt, a reflection of ongoing limited cash generation in the near term and a sign of slow margin recovery,” read a note to clients.

“We estimate free cash flow of >US$8bn is required by '23 to support a current EV of US$119bn (on a sector yield), a number we can't see AZN delivering.

“We downgrade to ‘sell’ (from ‘neutral’) [and] our price target falls to 5,400p from 5,900p after scrubbing the model/CF and updating for the deal.”

Investors can’t bet on cancer success

The analysts add that Astra is trading on a forward enterprise value/ EBITDA multiple of 18x, compared to the sector average of around 10x.

“At the current valuation, the market assigns perpetuity-like positioning to the key oncology franchises, despite oncology being fast-moving and highly competitive.”

Astra shares fell 1.1% to 6,101p in mid-morning trade on Tuesday.

Tue, 02 Apr 2019 10:37:00 +0100
<![CDATA[RNS press release - Astrazeneca ]]> Mon, 01 Apr 2019 18:00:01 +0100 <![CDATA[RNS press release - Total Voting Rights ]]> Mon, 01 Apr 2019 15:00:02 +0100 <![CDATA[News - AstraZeneca granted Breakthrough Therapy Designation for rare genetic condition treatment ]]> AstraZeneca PLC’s (LON:AZN) potential treatment for a rare genetic condition called neurofibromatosis type 1 (NF1) has been granted breakthrough therapy designation (BTD) by US regulators.

The move from the US Food and Drug Administration effectively fast-tracks the regulatory review of the medicine, called selumetinib, which Astra is working on with fellow pharma giant Merck & Co Inc (NYSE:MRK).

READ: AstraZeneca launches UK's biggest cash call this year

NF1 is a rare genetic condition that causes tumours to grow along a person’s nerves which can lead to various skin issues and learning difficulties, as well as problems with the bones, eyes and nervous system.

People with NF1 also have a much higher rate of cancer and cardiovascular disease.

The BTD is based on data from a Phase II monotherapy trial last summer which showed that selumetinib can reduce pain and motor impairment.

“Selumetinib shows promise in the treatment of NF1-related plexiform neurofibromas, a rare and debilitating disease with no approved medications to date,” said Astra’s oncology R&D boss José Baselga.

“The Breakthrough Therapy Designation acknowledges the significant unmet need of these patients and the potential benefit of selumetinib in this setting.”

Mon, 01 Apr 2019 07:57:00 +0100
<![CDATA[RNS press release - Selumetinib gets Breakthrough Therapy Designation ]]> Mon, 01 Apr 2019 07:00:06 +0100 <![CDATA[RNS press release - Results of Placing ]]> Fri, 29 Mar 2019 17:15:04 +0000 <![CDATA[News - AstraZeneca launches UK's biggest cash call this year to fund £5.2bn Japanese cancer deal ]]> AstraZeneca PLC (LON:AZN) shares fell on Friday as the drugs giant came to the well with the biggest fundraiser this year by a British company.

The FTSE 100-listed firm has announced a £2.7bn share placing – cash that will be used to fund a cancer collaboration, pay down a tranche of debt and for “general corporate purposes”.

READ: AstraZeneca posts first rise in annual product sales for almost ten years

Just over £1bn will go into the commercial tie-up with Japanese group, Daiichi Sankyo, which has developed trastuzumab deruxtecan, a potential breakthrough treatment for HER-2 positive strains of the disease, such as certain forms of breast and gastric cancers.

Under the terms of the deal, which could be worth a further £4.2bn in milestones, the companies will jointly develop and commercialise the new drug everywhere except Japan.

The first regulatory submission is scheduled for the second half of 2019 for patients in advanced or hard-to-treat breast cancer.

The treatment is also being developed for HER2-mutated or HER2-overexpressing cancers such as non-small cell lung cancer, gastric and colorectal cancers.

AZ chief executive Pascal Soriot said he thought trastuzumab deruxtecan could become a “transformative new medicine” for the treatment of HER2-positive breast and gastric cancers.

Peak sales of the new product are forecast to be in the order of £3.4bn.

The financial impact of the deal will be felt from 2020 onwards, AZ said, with a “significant” effect from 2023. Earnings per share this year will be unaffected by the cash call, which has yet to be priced.

‘Relatively high-risk roll of the dice’

Nicholas Hyett, equity analyst at Hargreaves Lansdown commented: “Astra’s been thinning its portfolio for some time, as it looked to boost near term cash flows and keep the dividend ticking over while the pipeline matured.

“That strategy seems to have paid off, with product sales showing signs of long term growth last year. However, Astra clearly felt that pipeline was need of a shot in the arm, and this deal represents a major boost to the oncology portfolio.”

However, he added: “It's a higher risk deal though, the drug in question has yet to make it out of the labs and hasn’t been approved in any markets.

“There’s always the risk that the drug falls at the final hurdle and ends up being worth nothing at all, but then that’s a fundamental part of the pharmaceutical industry.”

Hyett concluded: “The risk of failure probably goes a long way to explaining why Astra have decided to fund the deal with an equity raise rather than debt, there’s no obligation to pay shareholders if things don’t work out as expected, whereas lenders demand their pound of flesh regardless.”

“Ultimately this is a relatively high-risk roll of the dice, only time will tell whether it it’s a stroke of genius or leaves shareholders nursing a hangover.”

In late morning trading in London, AstraZeneca shares were 5.3% lower at 6,150p.

 -- Adds analyst comment, share price --

Fri, 29 Mar 2019 07:42:00 +0000
<![CDATA[RNS press release - AZ and Daiichi Sankyo enter collaboration in novel ]]> Fri, 29 Mar 2019 07:00:07 +0000 <![CDATA[RNS press release - Forxiga approved in Japan for type-1 diabetes ]]> Wed, 27 Mar 2019 07:00:05 +0000 <![CDATA[News - AstraZeneca wins regulatory approval for Europe's first type-1 diabetes drug taken by mouth ]]> AstraZeneca PLC (LON:AZN) has won regulatory approval for a breakthrough diabetes drug with its new product Forxiga becoming the first oral treatment for the type-1 form of the disease in Europe.

It will be used as an “adjunct” to insulin for people whose glucose levels are not adequately controlled with the hormone alone.

“We look forward to bringing Forxiga to a patient population that has not had any approved oral medicines available before," said Elisabeth Björk, AZ’s head of cardiovascular, renal and metabolism.

It is estimated that there are just over 300,000 UK sufferers of type-1 diabetes, a chronic disease that means pancreas produces little or no insulin.

The condition is caused by an autoimmune reaction that destroys the beta cells in the pancreas, which make insulin.

Mon, 25 Mar 2019 07:56:00 +0000
<![CDATA[RNS press release - Forxiga approved in Europe for type-1 diabetes ]]> Mon, 25 Mar 2019 07:00:12 +0000 <![CDATA[RNS press release - US FDA grants saracatinib ODD for IPF ]]> Mon, 18 Mar 2019 07:00:05 +0000 <![CDATA[RNS press release - Notice of AGM ]]> Thu, 14 Mar 2019 12:00:02 +0000 <![CDATA[RNS press release - Director/PDMR Shareholding ]]> Tue, 12 Mar 2019 12:00:01 +0000 <![CDATA[RNS press release - Filing of Form 20-F with SEC ]]> Wed, 06 Mar 2019 07:00:04 +0000 <![CDATA[RNS press release - Annual Financial Report ]]> Tue, 05 Mar 2019 11:00:02 +0000 <![CDATA[RNS press release - Holding(s) in Company ]]> Mon, 04 Mar 2019 16:04:36 +0000 <![CDATA[RNS press release - Total Voting Rights ]]> Fri, 01 Mar 2019 15:00:01 +0000 <![CDATA[RNS press release - Lynparza receives positive EU CHMP opinion ]]> Fri, 01 Mar 2019 13:45:01 +0000 <![CDATA[News - AstraZeneca reports pancreatic cancer trial success for Lynparza ]]> AstraZeneca PLC (LON:AZN) has claimed the first positive result by a Parp-1 inhibitor as a treatment for one type of pancreatic cancer.

Pancreatic cancer is one of the hardest to treat as it is very hard to spot and patients often only become aware of the disease when it is too late for effective treatment.

READ: AstraZeneca rises as Brilinta medicine meets goal in Phase III clinical trial

Lynparza though showed significantly increased rates of survival in the phase III POLO trial.

José Baselga, Astra's head of oncology research, said: "This is the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need.

Parp-1 inhibitors stop cancer cells repairing themselves while BRCA-1 and -2 genes are the body's tumour suppressants and mutations of these can significantly increase the risk of occurrence.

"The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these results with global health authorities as soon as possible," added Baselga.

Lynparza is being developed jointly by Astra and US group Merck.

"The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer," said Roy Baynes, Merck's head of global clinical development.

Tue, 26 Feb 2019 07:54:00 +0000