Pfizer-AZ deal could create R&D “juggernaut”

by Admin 16. May 2014 09:27

Pfizer and AstraZeneca’s complementary areas in R&D could create a pipeline with massive projected sales and a much larger oncology pipeline if the proposed deal were to go ahead.

According to research and consulting firm GlobalData, the potential consolidation of Pfizer and AstraZeneca would create a pipeline with overall projected sales of $10.8 billion in the next five years, while also creating an R&D juggernaut with aggregate expenditure of over $11 billion, overtaking current R&D spending leaders Novartis and Roche.

GlobalData says that if Pfizer’s takeover were to be successful, its position as the world’s largest pharmaceutical company would be cemented.

Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, says that this deal would be unlike any other in Pfizer’s corporate evolution up until now, as the value would lie in Pfizer’s commitment to cultivate ongoing research and development activities at AstraZeneca. 

Mr Owide said: “The proposed purchase of AstraZeneca appears to be a very complementary fit with Pfizer, especially given the latter’s plans to spin off some of the mature components of its prescription pharmaceutical business.

“AstraZeneca’s expiring drugs would meld into Pfizer’s Established Products division, and the former’s promising pipeline would bolster the other two Pfizer business units, which focus on new medications and consumer health, making them prime candidates for divestment.” 

Pfizer and AstraZeneca both have complementary areas in R&D, and a merger would give Pfizer a much larger oncology pipeline in particular, thanks to the fold-in of AstraZeneca’s late-stage, anti-cancer agents. These include moxetumomab, olaparib and tremelimumab, a candidate developed by Pfizer and licensed to MedImmune.

AstraZeneca now boasts the most promising oncology pipeline in the industry, with projected 2019 revenues of $4.7 billion, ahead of Merck & Co. and Bristol-Myers Squibb. Furthermore, AstraZeneca is currently investigating compounds in 60 oncology indications across Phase I and Phase II trials, representing a significant strategic opportunity for Pfizer as the branded oncology market is forecast to grow by annual sales of $76.7 billion between 2013 and 2019.

Mr Owide said: “The potential gain that Pfizer could extract from AstraZeneca’s pipeline, in relation to other components of the combined business, shows that any value from its deal with AstraZeneca would be heavily tied to its ability to nurture the UK giant’s emerging pipeline.”

 

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Drugs | General | News

NICE consults over fertility drug postcode lottery

by IainBate 15. May 2014 16:09

The National Institute for Health and Care Excellence (NICE) has published a set of draft statements to help the NHS eliminate the so-called ‘postcode lottery’ of treatment and support for those with fertility problems. 

Updated guidance published by NICE last year on the diagnosis, treatment and care of people with fertility problems included recommendations offering three full cycles of IVF treatment to women aged under 40 who have failed to get pregnant after two years of trying or 12 cycles of artificial insemination. It also recommended that women aged 40 to 42 should receive one full cycle if certain criteria were met. 

But Gosport MP Caroline Dinenage revealed last week that women in her area are only being offered 1 cycle of IVF treatment up to the age of 35, demonstrating that not all areas are being offered the full number of cycles.

The 10 statements are part of a draft ‘quality standard’ which highlights the key areas within which improvement is most needed. The standard has been published for consultation and supports the need to offer the full number of recommended IVF cycles. 

In addition to the statements on access to IVF treatment, the draft quality standard also says that Clinical Commissioning Groups (CCGs) should offer cryopreservation to people of reproductive age who are preparing to have treatment for cancer that is likely to give them fertility problems. 

Professor Gillian Leng, Deputy Chief Executive and Director of Health and Social Care at NICE, said: “Infertility is a recognised medical condition that can affect people of any age and has a potentially devastating effect on people’s lives. It can cause significant distress, depression and can possibly lead to the breakdown of relationships.

“Unfortunately, we know that not all areas are following our guidance to the letter. This creates variations in treatment within the NHS, which is disappointing.

”The quality standard that we are currently developing should help healthcare services to focus on the key areas of care that need to be addressed most urgently and ensure that the right support and treatment is available to those who need it.”

The full draft quality standard, including other statements, is available to view on the NICE website. The consultation will remain open on the website until Thursday 12 June 2014. The final standard is expected to be published in October 2014.


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General | News | NHS

New hope for PAH patients

by Admin 15. May 2014 13:06

Patients with pulmonary arterial hypertension (PAH) now have a new treatment option available to them.

Actelion Pharmaceuticals UK Ltd has announced that Opsumit® (macitentan) is now available to prescribe in England for PAH patients. PAH is a severe, life-threatening progressive disease with approximately 3000 people in England on disease-targeted drug therapy.

Opsumit is a novel endothelin receptor antagonist (ERA), indicated for use as a monotherapy or in combination, for the long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III. Opsumit received EU marketing authorisation in December 2013, following completion of the longest and largest clinical trial to date in PAH, the SERAPHIN study.

Dr Luke Howard, Consultant Respiratory Physician, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, said: “PAH is a chronic condition, with significant impacts on patients' quality of life, symptoms and survival. For many years, the PAH medical community and commissioners of specialised NHS services have been asking for a drug with a demonstrated benefit in reducing morbidity-mortality events, and for the first time, with macitentan (Opsumit), we have this, supported by data from SERAPHIN.” 

The efficacy of Opsumit has been shown in a PAH population including idiopathic and inherited PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. Efficacy was also demonstrated in treatment naïve patients and those already receiving PAH-specific background therapies, such as phosphodiesterase type 5 inhibitors (PDE 5i).

Robin Bhattacherjee, General Manager Actelion Pharmaceuticals UK, said: “England is one of the first countries in Europe to make Opsumit available to prescribe and we are delighted to be able to communicate this positive news for PAH patients in England. 

“This milestone further demonstrates Actelion’s ongoing commitment to the discovery, development and commercialisation of innovative treatments, which offer real benefits for patients.”

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Drugs | News

NHS England is 'failing' the dying

by Admin 15. May 2014 11:56

Experts have warned that end of life care across the NHS is failing to properly support the dying after an audit identified large variations in standards of care.

The National Care of the Dying Audit for Hospitals, which assessed the quality of care received by 6,500 patients who died in 149 hospitals across England during May 2013, identified ‘deeply concerning’ variations in care, calling for improvements to be made.

The audit, led by the Royal College of Physicians and Marie Curie Palliative Care Institute Liverpoool, found that communication with dying patients and their families was poor. Results showed that patients were usually left out of clinical discussions, with less than half of those deemed capable of understanding being informed they were dying.

During their discussions with 850 bereaved relatives, the researchers found that many felt left out of the decision-making process. A quarter reported to not feeling involved in decisions about their loved one’s care while a further quarter said they did not feel adequately supported.

The researchers also found that the levels of training were inadequate, with training for care of the dying only mandatory for doctors in 19% of trusts and for nurses in 28% of trusts.

While the research identified some good standards of palliative care, inconsistencies prompted the researchers to call for changes to improve standards and support for those dying in hospitals across the NHS.

Dr Kevin Stewart, chair of the audit’s steering group, said: “I am deeply concerned that some hospitals are falling short of the excellent care that should be provided to both dying people and those important to them.”

“It is disappointing that hospitals don’t seem to recognise this as an important issue,” he added.  

A number of recommended changes have been issued by the researchers for improvements to end of life care standards, including trust boards designating a member to lead palliative care and conducting an audit of all patients dying at the hospital.

Health and Care minister Norman Lamb welcomed the evidence of “good care” within the report but said he was “seriously concerned about the variations in care”.

“I am determined this should improve,” he said.

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News | NHS

Afatinib benefits for lung cancer patients unveiled

by Admin 15. May 2014 11:41

Boehringer Ingelheim has announced new results of a combined overall survival post-hoc analysis of two Phase III trials (LUX-Lung 3 and 6). 

The analysis showed that patients with non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations (exon 19 deletions (del 19) or exon 21 (L858R) substitutions, accounting for 90 per cent of all known EGFR mutations) lived longer if treated with first-line afatinib compared to chemotherapy. 

In the combined analysis from two of the largest trials in this patient population, afatinib prolonged survival of lung cancer patients whose tumours harbour common EGFR mutations compared with standard chemotherapy by a median of 3 months, significantly reducing the risk of death by 19 per cent. The most pronounced reduction in risk of death, by 41 per cent, was noted for patients whose tumours have the common type of EGFR mutation. 

The conclusions of this analysis further substantiate earlier published results on delaying tumour growth (progression-free survival), better control of lung cancer symptoms and manageable adverse events associated with afatinib in comparison with chemotherapy.

Principal investigator Professor James Chih-Hsin Yang of the National Taiwan University Hospital in Taiwan, said: “The results of two afatinib trials independently show for the first time that despite cross-over in the subsequent treatment, frontline use of a targeted treatment can prolong overall survival in patients with del 19 EGFR mutation positive lung cancer. 

“The results add to the list of benefits already shown in these studies, which include improvements in tumour shrinkage, longer duration of disease control and life-restricting, disease-related symptoms such as cough, pain and shortness of breath.”

 

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Drugs | News

Round two for party leaders over Pfizer AZ bid

by Admin 15. May 2014 10:08

Labour leader Ed Miliband has accused Prime Minister David Cameron of being a “PR adviser for Pfizer” as they clashed again at PMQs over the US pharma company’s bid for AstraZeneca.

The prime minister rejected Mr Miliband’s accusations, reminding him of Labour’s "abject surrender" over the Kraft takeover of Cadbury when the party was in government.

Mr Cameron also accused Mr Miliband of placing the interests of the Labour party ahead of the UK after he refused an invitation to meet Ian Read, the head of Pfizer. Mr Miliband had rejected the meeting on the grounds that he was busy on the campaign trail for the local and European parliamentary elections, although he later changed his mind.

Mr Cameron urged MPs to “fight for Britain” to ensure the protection of British jobs and AstraZeneca’s development of a new research and development base in Cambridge, should Pfizer succeed in securing a deal. He also accused Mr Miliband of “playing politics”:

"The only difference between us is how do you get assurances [from Pfizer]… I say get stuck in, negotiate hard, fight for Britain. He says stand up, play politics and put that before the national interest."

Mr Miliband countered: “From Royal Mail to AstraZeneca this is a prime minister whose ideology means he cannot stand up for the national interest."


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General | News

MHRA consults on asthma inhalers in schools

by Admin 14. May 2014 16:42

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation asking for comments on providing access to salbutamol asthma inhalers and an appropriate spacer for emergency use in schools.

There is currently no provision under the current legislation for schools to hold stocks of asthma inhalers for emergency purposes because they are prescription-only medicines.

MHRA has made a recommendation to the Department of Health for the regulations to be amended to allow schools to hold a salbutamol asthma inhaler for use in emergencies. This is in response to advice from the UK’s Commission on Human Medicines (CHM) committee, following an evaluation of the risks and benefits. 

The Department of Health has developed guidance with relevant stakeholders to support schools’ use of inhalers and spacers which is included as part of this consultation, which runs until 30 May 2014.

Dr Sarah Branch, MHRA Deputy Director of Vigilance and Risk Management of Medicines, said: “The Commission has assessed the benefits and risks of allowing schools to hold a salbutamol inhaler with an appropriate spacer for use in an emergency if a child has an acute asthma attack. The Department of Health has produced guidance for schools to use.

“Our recommendation is that the UK legislation should be amended in this way to reduce distress for children suffering from asthma and make its management in schools easier.”


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Drugs | News

Janssen disappointed over NICE no-no

by Admin 14. May 2014 16:09

Janssen has expressed “disappointment” that NICE does not recommend the use of Zytiga® (abiraterone acetate).

The NICE Appraisal Consultation Document (ACD) does not recommend abiraterone acetate for the treatment of men with advanced (metastatic) hormone relapsed prostate cancer (mCRPC) who have not previously been treated with chemotherapy. Janssen says that it will now work with NICE to address the current concerns raised.

According to the firm, analyses of clinical trial data for abiraterone acetate consistently confirm the value of this medicine for patients. When compared to the standard treatment approach, abiraterone acetate delays disease progression and provides patients with a better quality of life with reduced pain.

Janssen also says that there is a major ongoing study which shows that there is a continued trend in prolonging the life of patients treated with abiraterone and prednisolone, compared with those who were treated with prednisolone alone.

Regulatory authorities in both Europe and the United States approved abiraterone acetate for this indication in December 2012.3 Since then it has been prescribed to slow the progression of the disease and delay the need for chemo in many thousands of patients across Europe and the United States, and is the second most requested treatment on the NHS Cancer Drugs Fund (CDF).

A spokesperson for Janssen said: “We believe that NICE should have made use of the flexibilities available to them under their 'end-of-life criteria' – a special consideration that has traditionally been used in assessing medicines for diseases such as cancer.

“In 2012, the ‘end-of-life’ criteria, alongside a Patient Access Scheme offered by Janssen, saw abiraterone recommended for use after chemotherapy. This PAS has been maintained in this appraisal prior to chemotherapy; however, this current decision from NICE, if it stands, would mean that men are denied the opportunity to delay chemotherapy, and furthermore denies options to those who either do not want chemotherapy, or who are unable to go through chemotherapy.”

The company expressed concerns that such patients will be left without access to any NICE approved additional active treatment options, after failure of androgen deprivation therapy, other than steroids.

Janssen maintains that the evidence presented to NICE demonstrates that abiraterone acetate meets NICE’s end of life criteria, and represents a cost-effective use of NHS resources.

 

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Drugs | News

New UK business lead for CHASE

by Admin 14. May 2014 13:53

CHASE is delighted to announce the appointment of Nick Johnson as UK Business Lead for their new Healthcare division. Nick brings over 10 years' healthcare recruitment experience to the role, both domestically and internationally. He will be driving their expansion into the dynamic UK Medical Device, Equipment and Woundcare sectors.

With a focus on sales, marketing and executive recruitment, the UK Business Lead's aim is to build a vibrant and dynamic business unit that can fulfil the huge potential that the market offers, which also complements CHASE’s highly successful pharmaceutical business.


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News | Personnel

Upgrade for electronic appointment booking

by Admin 14. May 2014 11:55

A new eReferrals Service is to be launched by NHS England to improve efficiency for both patients and clinicians.

NHS England has confirmed it will scrap the current electronic booking system in favour of a new eReferrals Service to improve efficiency and update the service with the latest technology.

The NHS eReferrals Service, to be rolled out later this year, represents an enhancement of the current Choose and Book service introduced in 2004 as a central appointments service for outpatients.

While Choose and Book was a “major step forward” in referrals and appointment booking, dealing with tens of thousands of referrals each day, the governing body accepted that the service “has worked for some and not for others” and has proposed an upgrade.

Beverley Bryant, director of strategic systems and technology for NHS England, said the new service will “build on the successes of Choose and Book and use the lessons learnt”, harnessing new technology to improve the electronic referral service.

“This isn’t about reinventing the wheel, it’s about taking the next step,” she said.

The NHS eReferrals Service will incorporate new technologies that were unavailable when Choose and Book was first developed to offer a “user-friendly” service of increased efficiency for both patients and clinicians.

“We want a system that is quick, easy and beneficial for healthcare professionals to use and ultimately improves patient experience by providing flexibility and choice around the services we offer wherever the patient is,” said Bryant.

Commenting on the plans for the new system, Robbie Hughes, CEO of software developer Quinec, said: “Technology has the power to totally re-engineer the patient journey and create more efficiencies within healthcare that benefit both patients and clinicians. But for it to succeed, it has to add value.”

“It will be interesting to see what the new system looks like and the architecture it will be built on. Fingers crossed it takes on board some important lessons and looks to the market for advice on how to do this well,” he added.

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