Four-strain flu vaccine approved in UK

by JoelLane 4. April 2013 14:19

cold-flu-virus A new quadrivalent (four-strain) vaccine for seasonal influenza has been approved by the MHRA for use in the UK.

Fluarix Tetra from GSK, which has also been approved for use in Germany, is the first vaccine of this type to gain regulatory approval in Europe.

The vaccine is approved by the MHRA for the immunisation of adults and children aged over three years, and was approved in the US in December 2012.

It offers protection against two subtypes of the influenza A virus and two of the B virus, widening the scope of the trivalent flu viruses currently in use.

GSK commented: “As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine.”

The new vaccine is expected to be available to the NHS by autumn 2013, the start of the flu vaccination season.

Sanofi Pasteur and Novartis are both working on quadrivalent flu vaccines, while AstraZeneca has one on the market in the US.

New global leader at MedImmune

by JoelLane 30. January 2013 12:02

Bahija Jallal, Medimmune (web) Biotechnology giant MedImmune has appointed Bahija Jallal, its current Executive Vice President for R&D, as its new President.

The former President of the Maryland-based company, Peter Greenleaf, will take over leadership of parent company AstraZeneca’s (AZ) Latin American business.

The transition accompanies the formal designation of MedImmune as the global biologics division of AZ, which acquired it for $15.6bn in 2007.

Bahija Jallal is a former researcher at the Max-Planck Institute of Biochemistry in Germany. While VP of Drug Assessment and Development at Chiron, she was headhunted by MedImmune in 2006, becoming its Head of Translational Science.

Commenting on that appointment, Jallal said: “I was struck by MedImmune’s history of innovation. And I looked at who they had on their board of directors and their executives. There were more women than you would see at other companies.”

The fortune paid by AZ to acquire MedImmune surprised many in the industry. The acquisition was followed by investment in its R&D capability, including the development of a new site in Cambridge, England, and the merger of the UK group with Cambridge Antibody Technology.

According to MedImmune spokesman Mike O’Brien, the biotech company’s commercial operation now formally belongs to AZ’s North American business, while its manufacturing operation is part of AZ’s global operations.

“The driver for these changes is not cost but even faster decision-making in key areas of the business and a need to reduce complexity,” he said.

Through MedImmune, AZ plans to deliver an average of one new biologic drug per year from 2013.

MedImmune’s past successes include two innovative vaccines: the first monoclonal antibody approved by the FDA for use against an infectious disease (Synagis, used to prevent the childhood lung disease RSV); and the first intranasal vaccine against influenza (FluMist).

Coffee break with... Kate Evans

by IainBate 17. December 2012 10:10

This month John Pinching is in the big smoke with Crucell’s high-flying city slicker Kate Evans. She has an almost Dickensian ‘rags to riches’ tale to tell – forced to wash pots in order to make ends meet, Kate had a ‘road to Damascus’ moment, and now she’s one of the industry’s shining stars. What better way to kick off the festive season?

CB web A frosty winter’s morn, Oxford Circus (exit 8, to be precise), I meet Kate Evans (right) – resplendent in an aquamarine cardigan – and we alight to a nearby hot beverage purveyor. This ain’t called ‘Coffee Break’ for nothing, dear reader. Realism is essential – we do actually go ‘for coffee’. Having said that, Kate orders a tea, shattering the illusion. I, true to my word, request a latte. The checkout girl seems a bit stroppy, but we proceed with the interview, we are professionals after all...

What do you think of the new mag? It was very eye-catching when it came through the post, which is a good thing, because usually it gets shoved on a pile. It looked different, therefore I read it. It was fun, more relaxed and sharp.

Thanks, the cheque’s in the post. So, Kate, what’s your story?  I was born and brought up in Middlesbrough and went to university in Durham. I got a 2:2 and was mortified; I cried for an entire day. I thought I’d never get a job, but I’ve realised that it’s actually your personality and drive that get you through, not what’s on your degree certificate.

Where are you based now? I arrived in London two years ago when I joined Crucell. My mum still thinks it’s another country, but I had to go and see what it was all about. I go into the office a couple of days a week in High Wycombe and the rest of the time I’m out meeting people. I prefer to be on the road, speaking to the NHS payers at the coal face: finding out about how the reforms are affecting them and how we can work together. I’m nationally based, so I go wherever people want to talk and engage in interesting projects!

How did you get into pharma? After uni I got a position as a peptide chemist, which after doing a Biomedical Science degree seemed the job of choice. It was based in the north east and we were making synthetic proteins for pharmaceutical research and development. After about a year of doing that I was ready to leave the North East and I got a job at Nottingham City hospital as a tumour immunologist researching how to create a blood kit which could detect breast cancer earlier than a mammogram.

What happened to make you change career direction? I used to chat with the reps who came in to sell pipettes and lab equipment to us. Talking to them was the highlight of my day and I used to think, ‘What am I doing every day, just staring down a microscope?’ What they were doing seemed much more ‘me’. You got to chat to people..  At the time I had to work in a pub during the evenings in order to pay my rent. That was when I became obsessed with becoming a pharmaceutical rep.

How did you get your big break? I started trying to find a rep job, but a couple of companies said you’ve got no sales experience, ‘go and work in a call centre.’ There was no way I was going to do that. Eventually I got into the industry through Innovex and worked with them for two and a half years selling MSD products. From there I went on to various positions at Sanofi Pasteur, MSD, and then on to Crucell in 2010.

How is the relationship between NHS and pharma changing? There is still a lot of mistrust stemming back to the era when everything was about a hard sell. Now you have to be able to sell a value proposition, focusing on the new NHS targets. It’s much more about ‘how we can help you with your care pathway, reduce health inequalities and improve patient outcomes’.

What is the best way to ensure relations continue to improve in the future? The key for pharma is deciding who you actually send to the Chief Executive of a CCG, because a Key Account Manager in one company may be very different to another, and some have only ever covered primary care. It is important to understand the whole local health economy and its needs. You need to have at least read the CCG strategy plan, and understood how your product can link to helping them meet their QIPP and QOF targets. I was very passionate about this at the recent Pf Local Insight Forum: many of the people in that room didn’t know what a Joint Strategic Needs Assessment (JSNA) was. In any other business you wouldn’t go and face a client if you knew nothing about what they do. Other feedback I get from customers is that they want someone who can make a quick decision, not someone who has to go back to head office and get agreement.

Have you established some good partnerships with public sector organisations? My own personal experience of working with PCTs has been very rewarding. The uptake of flu vaccines can be low due to various health inequalities, such as transient population, reduced access to clinics, and language barriers. Using local hospital data, you can start to build a business case about how a project may improve vaccination uptake and therefore potentially reduce hospitalisations. It is important to tailor any project to the needs of the local health economy as each has different requirements. I have worked with NHS, pharmacy and other private providers in these ventures. As well as improving patient care, the projects aim to improve uptake and therefore increase the overall market in the process. It shows you can be commercial and still be part of the NHS’s agenda.

You seem passionate about your work. Vaccines, whether they’re paediatric, flu or HPV, have saved millions of lives worldwide and that’s why I’m so passionate about this area. The highlight for me was being chosen by Crucell Global to visit Bangladesh in June this year to see their vaccination campaigns and how money is being put back into developing countries that don’t have a recognised health service. Since merging with Janssen this year it has been very interesting to widen my horizons and apply my skills to other disease areas. I also contribute to the NHS intranet blog for the company, keeping everyone up to date with the reforms.

What other changes excite you? It’ll be really interesting next year to see the emergence of companies like Circle Health, who have already started to fulfil contracts on behalf of the NHS, easing in the whole ‘competition element’ of reform. NHS hospitals are advertising for marketing and business development managers, perhaps because they won’t necessarily get all the referrals from primary care, given that there are some really impressive ‘Any Qualified Providers’ out there.

You’re clearly a bit of a mover and shaker, what does the future hold for Kate Evans? Everyone always wonders where they will be in five years, but I just take opportunities as they come along. As the NHS changes, so will the jobs within pharma. Companies will soon need specific people to handle joint working, for example, and I am sure more even more niched jobs will start to appear as the new NHS goes ‘live’ in April 2013.

Do you have a good work/life balance? In the days when I was winning Rep of the Year in consecutive years, the ratio was more work/work! I don’t stay on the computer until midnight any more; however, sometimes when deadlines are due, work can still start to eat into personal life. I have learnt over the years how to manage my time more effectively; it’s just part of the job. You’ve got to have relaxation time in order to function properly.

All UK children to be offered flu vaccine

by JoelLane 25. July 2012 17:19

happy child Annual influenza vaccinations will be offered to all children aged two to 17 in the UK from 2014.

A nasal spray of the Fluenz vaccine will be used rather than an injectable form, except with children in high-risk groups.

The vaccination programme – the first of its kind in the world – is predicted to save 2,000 lives per year given only moderate uptake (30%).

As well as saving many children’s lives it could protect non-vaccinated people, especially elderly family members, through the ‘herd immunity’ effect.

The Joint Committee on Vaccination and Immunisation (JCVI) said the vaccine would be offered to nine million children in the UK, more than doubling the number of vaccinations available.

According to the Chief Medical Officer for England, Professor Dame Sally Davies, if only 30% of these children receive the vaccine there will be 11,000 fewer hospital admissions and 2,000 fewer deaths.

The vaccination will be optional and will depend primarily on GP surgeries, as there are too few school nurses to deliver the programme.

AstraZeneca’s Fluenz is a live attenuated vaccine sold in the US as FluMist. The UK contract could be worth £100m a year to the company.

Vaccinating children could also protect vulnerable family members, including babies and the elderly – an effect known as ‘herd immunity’.

Novartis pulls flu vaccine application

by IainBate 17. February 2012 11:42

Pharma Product News Novartis Vaccines and Diagnostics S.r.l. has formally notified the EMA of its intention to withdraw the paediatric-use marketing authorisation (PUMA) for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted with MF59C.1).

The EMA was informed in an official letter that Novartis were unable to address the questions raised by the Committee for Medicinal Products for Human Use (CHMP) within the required timelines.

The European healthcare regulator said the withdrawal does not prejudice the possibility of Novartis making a new application at a later stage.

Fluad Paediatric was intended to be used for the active immunisation against influenza in infants and young children. Its initial application was submitted to the EMA in December 2010. At the time of the withdrawal, it was under evaluation by the CHMP.

Flu ‘superjab’ offers lifetime protection

by emma 7. November 2011 11:51

Pharma Product News

A single ‘superjab’ offering lifetime immunisation against flu has been developed by scientists.

According to developers, SEEK, once-in-a-lifetime Flu-v fights could start to be used on patients in three to five years, against all strains of the virus, including the deadly avian, swine and seasonal variants.

Gregory Stoloff, SEEK, said: “Our aim is for the flu vaccine to become more like the mumps and measles vaccine – where you need it once and you get protection for a long time.”

The NHS spends £100 million on vaccinations every year, but the changing virus means that vaccines have to be updated, so the new jab could cut this cost down considerably.

But upon vaccination with Flu-v, the immune system is said to detect and fight a part of the virus that is present in all strains.

Results of clinical trials have found that healthy volunteers who were vaccinated with Flu-v had less of the virus in their blood.

Professor John Oxford, of trial constructors Retroscreen Virology, said: “It clearly has a biological effect worthy of further investigation, particularly with respect to the broadness of the response.”

Last winter, 600 people in Britain were killed by flu.

The DH has said that it is too early to comment on Flu-v.

Baxter recalls 300k flu jabs

by emma 4. November 2011 16:20

Pharma Industry News

Baxter International has recalled 300,000 doses of its flu vaccine Preflucel after a considerably high number of side effects were reported.

Most of the vaccines were distributed in Ireland and Scotland, where reports of side effects included tiredness, muscle pain and headache, which are typically associated with flu jabs.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement on its website saying: “The vaccine should no longer be used and any remaining stock should be returned to the original supplier for credit. No further Preflucel of any batch should be administered at this time.”

Baxter commented that the recall was precautionary and that those who have received the jab do not need to be re-vaccinated.

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