New R&D leader at BMS

by IainBate 8. April 2013 15:30

Pharma Appointment Bristol-Myers Squibb has appointed a new Executive Vice President and Chief Scientific Officer after Dr Elliott Sigal announced his retirement from both positions at the end of June.

The experienced Dr Francis Cuss has been selected to fill both roles after serving in a number of senior appointments since he joined the company in 2003.

Lamberto Andreotti, BMS CEO, said Dr Cuss is a “strong and collaborative leader with broad experience” and now is a “natural time” for him to lead the company’s R&D team.

The new R&D leader said he was “honoured” to lead the “talented R&D team to fulfil our mission and find new ways to discover, develop and deliver innovative medicines for patients with unmet medical needs.”

He first joined the company a decade ago as Senior Vice President for Drug Discovery. He later went on to take responsibility for Discovery Medicine and Clinical Pharmacology and was appointed a member of the company’s senior management team three years ago.

The retiring Dr Sigal first joined BMS in 1997 as Vice President of the newly created department of Applied Genomics. He has been a member of the senior management team since 2001 and became Executive Vice President five years later. He was also elected to the board of directors in 2011.

“Elliott has been a key leader in the development and execution of our company’s strategy to become a BioPharma leader,” said Lamberto Andreotti. “He and his team have become one of the most productive and innovative R&D organisations in the industry. I am grateful for the many things that Elliott and I have been able to accomplish together.”

Patent Box gives boost to pharma innovation

by JoelLane 2. April 2013 13:29

happy child The new Patent Box tax break, active from 1 April, has been welcomed by the pharmaceutical and biotechnology industries as a boost to innovation.

By setting a corporation tax rate of 10% on profits earned from patents and supplementary protection certificates, the Patent Box is expected to strengthen life science R&D in the UK.

The tax break, which extends to royalty and milestone payments, comes together with the introduction of a special 10% rate of R&D tax credits.

The special 10% tax rate is a major cut from the current corporation tax rate of 23%, which falls to 21% in 2015. It will be phased in over four years, with 60% available this year.

The Patent Box was developed by the Office for Life Sciences under the previous government as a way to strengthen the UK’s ‘knowledge economy’.

HM Treasury estimates that it will save UK businesses £1bn in tax, differentially rewarding innovation and encouraging investment in the UK’s R&D base.

Leading UK pharma company GSK, which was involved in the Treasury working group that advised on the policy, has since invested in a new £350m manufacturing facility in Cumbria.

Paul Belsman, National Head of Tax at accountancy consultant RSM Tenon, commented: “Combined with the research and developments tax credits system, this should provide strong fiscal incentive for companies and arguably attract inbound investment into the UK.”

The BioIndustry Association, which represents the UK biotechnology industry, has welcomed the opportunities within the Patent Box.

Steve Bates, CEO of the BIA, said the Patent Box would combine with “the improvements to R&D tax credits and reduction in corporation tax, the Government’s Strategy for UK Life Sciences and programmes such as the Biomedical Catalyst” to establish the UK as “a globally competitive location for life science companies”.

AstraZeneca cuts 1,600 jobs in global R&D cull

by JoelLane 19. March 2013 16:37

pascal soriot, AZ (web) AstraZencca (AZ) is to cut 1,600 jobs in a global restructuring of its R&D operation, including 700 UK jobs and 650 in the US.

In the UK, AZ will shut down its R&D operations at Alderley Edge and relocate over 1,000 jobs to a new global HQ in Cambridge.

In the US, it will shift its Global Medicines Development Group from Delaware to Maryland.

The restructuring, which will take three years to complete, will concentrate the company’s R&D operations in three key global centres.

It follows a quarter in which global sales fell by 16% due to patent expiry – and while AZ continues to see R&D as a vital function it is keen to reduce costs.

AZ’s long-term growth has resulted in a structure that Mene Pangalos, Executive VP for Innovative Medicines, described as “too spread out and too diffuse”.

Research work at the Alderley Park site, which Zeneca took over in 1993 as a divestment from ICI, will cease. Some 700 non-R&D roles will remain at the site, while 1,600 R&D roles will be relocated and 550 will be cut.

This decision contrasts with the prospect in October 2012, when AZ secured a £5m grant from the Regional Growth Fund to develop a bioscience park at Alderley Park and Martin Mackay, AZ’s President of R&D, claimed: “Alderley Park is a site of critical importance to our global R&D organisation.”

The current decision to focus R&D in Cambridge reflects the growing importance of biotech clusters for global pharma.

Pascal Soriot (pictured), CEO of AZ, commented: “Cambridge, which boasts strong links with London-based research institutions, is a world-renowned bioscience hotspot that rivals the likes of San Francisco and Boston.

“I believe the investment greatly increases the chances that the next generation of innovative medicines will be invented and manufactured in Britain.”

Government lifts patent restrictions on UK drug trials

by JoelLane 27. February 2013 16:43

lord-younger (web) Patent restrictions on drug trials in the UK will be lifted, making it easier for new drugs to be compared with the standard treatment.

The new exceptions enable companies to trial a new drug or a generic version against an established brand without violating its patent.

The changes to the Patents Act could both strengthen the UK as a base for pharmaceutical R&D and improve the medical value of clinical trial findings.

Life science industry trade associations have welcomed the new regulations for the boost they offer to innovative drug development, despite potential losses to established brands.

An Intellectual Property Office consultation showed overwhelming industry support for both changes to the patent law: the ‘research exception’ for trials of new drugs and the ‘Bolar exception’ for trials of generic drugs.

Not only does the rule that head-to-head clinical trials infringe patent make it harder to establish new drugs, it has also led to widespread criticism of clinical trials that compare a new drug with placebo – which no doctor prescribes.

Most EU countries exempt clinical trials from patent infringement, and the UK law has been a barrier to clinical trial work in the UK.

“The Government is keen to create a supportive environment for pharmaceutical research and development in the UK,” said Lord Younger (pictured), Minister for Intellectual Property.

“Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”

Stephen Whitehead, CEO of the ABPI, commented: “This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here.”

Janssen team partners with NHS to find dementia solutions

by JoelLane 18. February 2013 14:47

Marco Mohwinkel Janssen web An entrepreneurial team within Janssen’s R&D operation is working with the NHS to promote innovative dementia care.

Janssen Healthcare Innovation and the NHS have partnered to launch the Innovation Challenge Prize for Dementia.

The biopharma company, a subsidiary of Johnson & Johnson, will award up to £150,000 for solutions that make a lasting difference to the lives of people suffering from dementia.

As a first step, people involved with dementia care as healthcare providers, carers, patients and patient groups are being encouraged to identify the key issues in diagnosis, treatment and management of the condition.

Once the challenges have been agreed, relevant stakeholders will be able to submit innovative solutions to be assessed by a panel of experts from the NHS, industry and academia.

The ageing population is driving up the incidence of dementia in the UK: the terminal condition is estimated to affect 800,000 people, with the cost of NHS care predicted to rise from £23bn to £28bn by 2018.

“We are delighted to be the first industry partner to support the NHS in these important innovation challenges,” said Marco Mohwinckel of Janssen Healthcare Innovation (pictured).

“We hope this initiative will help identify forward-thinking solutions to help transform care for people with dementia and better support their caregivers.”

The deadline for ideas to help define the key challenges is 20 March 2013.

GSK to cut sales jobs in Europe

by JoelLane 8. February 2013 12:06

Andrew Witty GlaxoSmithKline (GSK) plans redundancies in its European sales and administration force to help it cut £1bn from its annual European, R&D and manufacturing costs by 2016.

The London-based pharma giant said it will achieve most of the cost reductions through technical improvements in its R&D and manufacturing processes.

According to CEO Andrew Witty, the cost savings plan has been driven by drug pricing pressures across Europe as the recession continues to worsen.

He also noted that job cuts would primarily affect sales and administration staff across Europe, but did not indicate the likely numbers.

Witty emphasised that GSK has six new drugs (including treatments for HIV, type 2 diabetes, melanoma and asthma) under review by regulatory bodies, with late-stage clinical trial data expected for another nine products within two years.

The company aims to launch up to 15 products within three years, he told business analysts. But given the economic uncertainties affecting Europe, 2013 would be a year of “twists and turns” and “not everything is going to go smoothly”.

According to a company spokeswoman, the technical and staffing changes (including redundancy payments) will have a combined one-off cost of £1.5bn, and will primarily be focused on Europe.

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).

Clinical trial participants say non-publication is a ‘betrayal’

by JoelLane 23. January 2013 17:23

Three_wise_monkeys_figure An open letter to the European Medical Association (EMA) calling for all clinical trial results to be published has been signed by 53 trial participants.

The fact that half of clinical trials are withheld from publication by their industry sponsors is a “betrayal of our trust”, the letter said.

However, the ABPI argued that clinical trial results contain “commercially confidential information” whose publication could harm investment.

The letter is part of the growing campaign for an end to industry control of medical trial data, fuelled by the ‘Tamiflugate’ scandal.

A petition with 8,000 signatories, including the Cochrane Collaboration and the Medical Research Council, calls for the inclusion of all clinical trial data in a public register to be mandatory.

According to a 2010 study by the National Institute of Health Research, half of all clinical trials are never published, and those with results supporting the use of a drug are twice as likely to be published as those with negative findings.

The Commons Health Select Committee has backed the call for a legal obligation on pharmaceutical companies to share all trial data.

The letter from 53 clinical trial participants, some of whom are seriously ill, said that the right of companies and researchers to withhold results is “dangerous and expensive” and “holds backs good medicine”.

“It is a betrayal of our trust in clinical trial regulation and the trust of the families of those patients who volunteer for trials having had a terminal diagnosis,” the letter added.

The ABPI insisted, however, that trial protocols and results are “commercially confidential information” whose publication “could undermine investment in research and development of future medicines.”

Vaccine R&D ‘investment’ scam busted

by JoelLane 22. January 2013 10:59

burglar_art-555px A scheme that used bogus figures for investment in vaccine research to exploit a tax loophole has been exposed by HM Revenue and Customs (HMRC).

Matrix Securities sold a scheme to investors whereby they could gain tax relief at nearly twice their level of investment, using a tax break designed to encourage medical research.

However, HMRC exposed their investment figures as fraudulent and refused most of their tax relief claim, forcing the Matrix Group into administration.

The company raised £28m from 83 investors and borrowed another £86m from banks to fund research into vaccines against HIV, influenza and hepatitis B.

It claimed a first year trading loss of £193m and £77m tax relief, of which £50m would be paid to the investors.

However, HMRC established in a tribunal that only £14m had been spent on R&D and was therefore subject to tax relief.

Matrix Securities and other members of the Matrix Group have gone into administration – though another member, Matrix Asset Management, claims to have invested £107m in the development of a universal flu vaccine.

Clients who invested in the fraudulent scheme are claiming it was misrepresented to them.

David Gauke, Exchequer Secretary to the Treasury, commented that HMRC “will take decisive action to close down schemes with the sole purpose of avoiding paying tax.”

Sanofi Pasteur MSD executive to lead Vaccines Europe

by JoelLane 14. January 2013 13:54

Andrea Rappagliosi Sanofi Pasteur MSD (resized) Andrea Rappagliosi, Sanofi Pasteur MSD’s Vice President of Market Access, Health Policy & Medical Affairs, has been appointed President of Vaccines Europe.

Rappagliosi, who has held senior roles in EuropaBio and Vaccines Europe, is one of the new management team appointed by Jean Paul Kress when he became President of Sanofi Pasteur MSD in 2011.

The appointment reflects the importance of Sanofi Pasteur MSD as a major partnership between firms, and the only company in Europe to develop and manufacture only vaccines.

Vaccines Europe represents vaccine manufacturers within the European Federation of Pharmaceutical Industries and Associations (EFPIA), including Sanofi Pasteur MSD, AstraZeneca, Novartis, GSK, Crucell, Pfizer, Abbott and Baxter.

Rappagliosi joined Sanofi Pasteur MSD from GlaxoSmithKline in 2012, where he was Vice President of European Government Affairs.

He has 20 years’ experience in the pharmaceutical industry, and has served as Vice President of Vaccines Europe and Chairman of biotechnology trade association EuropaBio.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said: “Andrea's expertise will boost Vaccines Europe’s advocacy focus whilst highlighting Sanofi Pasteur MSD’s profile as a clear leader in vaccines in Europe.”

Sanofi Pasteur MSD is an alliance between Sanofi Pasteur, the vaccines division of Sanofi, and MSD (Merck Sharp & Dohme), combining the R&D capability of both companies to focus exclusively on vaccines.

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