GSK has been accused by the Office of Fair Trading of protecting its Seroxat revenues from 2001–2004 by illegally paying off three generic competitors.

The OFT claims that GSK abused its market position by making “substantial” payments to Alpharma, Generics (UK) and Norton Healthcare to delay their launch of generic paroxetine.

The deals meant that the NHS, which paid £100m for Seroxat in 2001, lost an opportunity for “significant” cost savings, the UK trading watchdog said.

Paroxetine, an SSRI that targets anxiety-based depression, has already caused GSK some anxiety.

In 2002, the company was fined $2bn by the US Government for illegally promoting the drug’s off-label use in children and young adults. CEO Sir Andrew Witty said GSK’s actions had been “unacceptable” and would “never” happen again.

The current OFT accusations relate to deals that applied from 2001 to 2004 – since which time, GSK’s paroxetine brands (Seroxat in the UK, Paxil in the US) have steadily lost ground to generic equivalents.

If found guilty of breaking competition law, GSK faces a UK fine of up to £2.6bn, 10% of its annual global revenue.

The OFT’s Ann Pope commented: “The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS.

“It is therefore particularly important that the OFT fully investigates concerns that independent generic entry may have been delayed in this case.”

In a public statement, GSK said: “We very strongly believe that we acted within the law, as the holder of valid patents for paroxetine, in entering the agreements under investigation.”

It also noted that the European Commission had reviewed these issues and declared that it would take no action against GSK.

The company has until August to respond to the OFT’s charges.

Sir Andrew Witty, Chief Executive of GlaxoSmithKline (GSK), has been asked by the Government to find ways of strengthening the partnerships between universities and the private sector.

The man recently described in the BMJ as “the acceptable face of big pharma” will conduct a review and suggest practical means of ensuring that more discoveries made by academic researchers bring commercial benefits.

Witty’s review seeks a new model for industry-academic partnerships (across a range of industries) as funding for the Technology Strategy Board (TSB) continues to be cut back.

The role of Local Enterprise Partnerships, which lack the funding and powers of the now-abolished Regional Development Agencies, is one aspect of local partnership that Witty will consider.

Another is the effectiveness of universities in training scientists and other skilled professionals to take up roles in industry.

According to the Government, Witty will “identify where we have world-leading capabilities in our research base that can underpin the sectors and technologies of the industrial strategy”.

“A strong relationship between businesses and universities can provide real growth opportunities in local areas,” said University and Science Minister David Willetts. “By forging links and sharing best practice, an efficient and practical partnership will help to boost the economy, benefiting both businesses and institutions.”

The relationship between industry and academia is already changing. The number of ‘spin-out’ companies formed by university researchers increased from 2,457 in 2010 to 3,118 in 2011; but cuts in the TSB’s budget have reduced the number of formal ‘knowledge transfer partnerships’ between universities and companies.

Sir Andrew Witty commented: “It is vitally important that the world-leading capabilities in our universities and research base are at the heart of both the industrial strategy and local growth strategies that recognise and build on areas of local strength.”

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.

GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.

In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.

The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.

Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.

According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.

The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.

Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.

GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.

In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.

Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.

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.

NICE has recommended the use of GSK’s Revolade (eltrombopag) in draft guidance for treating chronic immune (idiopathic) thrombocytopenic purpurai (ITP).

Original guidance, published in October 2010, was reviewed by NICE after GSK agreed a Patient Access Scheme with the DH to supply the treatment at a discounted rate.

The guidance now recommends Revolade in adults who have had their spleen removed and whose condition is refractory to other treatments and as a second-line treatment in patients who have not had their spleen removed due to surgery being contraindicated.

ITP is a bleeding disorder caused by abnormally low levels of platelets in the blood. It is estimated there are around 3,000-3,500 cases in the UK.

Revolade increases platelet production through activation of the thrombopoietin receptor. By stimulating production, the drug helps to reduce bleeding.

“People living with ITP are at daily risk of bleeding and subsequent bruising, and this can have a detrimental effect on quality of life,” said Dr Carole Longson, Health Technology Evaluation Centre Director at NICE. “NICE is, therefore, pleased to be able to recommend eltrombopag for this condition.”

Final guidance is now expected to be published in May 2013.

A new rotavirus vaccine from GlaxoSmithKline (GSK) has been chosen as the first routine NHS immunisation against the most common cause of diarrhoea in young children.

Rotarix, an oral suspension of the live attenuated virus, is expected to cut the incidence of rotavirus disease in babies and infants by half.

The vaccine will be added to the child immunisation programme for three years from September 2013, for all infants aged between 6 weeks and 6 months.

Rotavirus affects up to 18,000 UK children up to the age of five, causing severe gastroenteritis and costing the NHS an estimated £14.2m per year. It requires hospitalisation in about 10% of cases.

GSK’s product was chosen following a DH tender, after the UK’s Joint Committee of Vaccination and Immunisation (JCVI) recommended using a rotavirus vaccine to reduce the incidence of gastroenteritis.

Rotarix has been used successfully for infant vaccination in the USA, Australia and some EU countries.

Erik van Snippenberg, General Manager of GSK UK, said: “Adding Rotarix to the UK vaccination schedule will help protect children in the UK from rotavirus and alleviate the unnecessary distress it can cause.

“The vaccination programme represents a significant opportunity to protect infants and to save vital NHS resources.”

According to Professor David Salisbury, Director of Immunisation at the DH, the safety and effectiveness of Rotarix have been proven by “huge trials”. He commented: “I’d encourage all parents of young children to accept this vaccine when the programme begins next year.”

The vaccination programme will be applied to 840,000 infants per year, costing £25m – but it is expected to save the NHS £20m annually, and to reduce pressure on crowded hospital facilities in the winter months.

Human Genome Sciences (HGS) has told its shareholders not to accept GSK’s hostile $13 per share tender offer.

Its Board of Directors insist the $2.6bn offer is inadequate, undervalues the company and is not in the best interests of HGS or its shareholders.

H. Thomas Watkins, HGS President and CEO, said its Board “has concluded unanimously” that the offer “does not reflect the value inherent in Human Genome Sciences”.

HSG rejected GSK’s initial takeover approach towards the end of April, forcing the pharma company to go back and target the company’s shareholders.

In the meantime, HGS instructed Wall Street advisors to search for potential suitors as part of a strategic review process – something GSK refused to participate in.

On reaching its recommendations to shareholders, HGS’s Board considered numerous factors.

Its Directors decided that its main product Benlysta – which it is in partnership with GSK – has “substantial growth opportunities” and pointed towards HGS’s “substantial financial assets”.

GSK were also accused of “opportunistically” capitalising on recent share price dislocation and capturing for itself the “significant upside opportunity for upcoming value-driving products”.

“The HGS Board of Directors has determined that the GSK offer is not in the best interests of our stockholders and recommends that they not tender shares to GSK,” said Mr Watkins.

GSK will table a hostile $2.6bn takeover bid for Human Genome Sciences after refusing to participate in its strategic review process.

Instead, Glaxo intends to press ahead with its $13 per share offer to HGS’ shareholders, despite the company’s board having previously rejected the same offer.

The bid offers a premium of 81% of HGS’s share price in mid-April, GSK says, and the pharma giant now hopes to evolve its relationship with the Maryland-based firm.

The two are in partnership for the diabetes drug Benlysta. GSK says it “values the long relationship” it has with HSG and would prefer to conduct takeover “on a friendly basis in a timely fashion”.

HSG rejected Glaxo’s initial $13 per share offer on the grounds it undervalued its potential and instructed Wall Street advisors to search for potential suitors, sources claim.

But GSK say their decision not to participate in the review process and to target HGS’s shareholders is unnecessary as there is “clear and strategic logic” to the combination of the companies.

It added that a month has passed since its original offer and that “provides a reasonable amount of time” for HGS to complete its review process.

GSK says it continues to believe that it has made a “full and fair offer” which provides “immediate liquidity” to shareholders in HSG.

GSK has appointed Lynn Elsenhans and Jing Ulrich as Non-Executive Directors to its Board.

The two will join the company from 1 July 2012 after being recommended by GSK’s Nominations Committee.

Sir Christopher Gent, GSK Chairman, said the appointments will help take “GSK’s global business forward”.

The former Chair, President and CEO of Sunoco Inc, a leading transportation fuel provider in the US, from 2009 to 2012, Lynn Elsenhans previously served at Royal Dutch Shell for nearly 30 years.

Ms Jing Ulrich, currently the Managing Director and Chairman of Global Markets, China at J.P. Morgan, serves as an advisor to global organisations across various industries and asset classes. She also advises Chinese institutions making investments overseas. 

“I am delighted to welcome Lynn and Jing to the Board of GSK,” said Sir Christopher.

He added the appointments reflect GSK’s “priority of appointing candidates who have deep knowledge of Emerging Markets or experience of running global companies.”

GSK has also made two additions to its Remuneration Committee and two to its Nominations Committee. Sir Deryck Maughan will join the Remuneration Committee from 1 July 2012 and be joined by Judy Lewent from 1 January 2013. Tom de Swaan and Professor Roy Anderson will join the Nominations Committee from next year onwards.