FDA panel backs Victoza for obesity

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An FDA panel has voted 14-1 to allow Novo Nordisk’s type 2 diabetes treatment Victoza to help obese patients lose weight.

If it gains final FDA approval (and the regulator usually follows the advice of its specialist panels) Novo says the new treatment will be called Saxenda. According to analysts it could generate an extra $1 billion in revenue for the company.

The panel’s recommendation comes from one main study where half of obese patients given a daily 3mg injection of the drug lost at least 5% of body weight, while 22% lost more than 10 per cent.

The treatment is proposed for use in patients who also have at least one other weight-related condition, such as high blood pressure. Novo’s drug is already sold under the brand name Victoza (liraglutide) for certain type 2 diabetes patients who are not able to control their blood sugar levels.

It is usually taken as an add-on to metformin or sulphonylurea when these drugs are no longer helping patients to keep their blood sugar levels down, and is the step before needing to use insulin.

It made just over $2 billion in sales last year, a growth of 27% on 2012 sales, but has faced safety concerns from regulators, predominately over its potential to increase the risk of side effects on the pancreas.

Growing market

This comes in the same week that in the US the FDA approved the fourth such obesity pill in the form of Orexigen’s Contrave, and follows the 2012 approvals of Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).

These were the first new obesity treatments approved in the US since Roche’s Xenical (orlistat) in 1999.

But all of these medicines have suffered a difficult path on the road to approval, with a number of FDA rejections and concerns from doctors over safety, notably the effect of these medicines on the heart.

This has led to poor sales trajectories, despite the high rate of obesity in the US. Arena reported Belviq sales of just $5.7 million in 2013, with $5.3 million of that going to its partner Eisai.

Qsymia’s sales were higher at $23.7 million in the same period, but still weak given the market potential.

This means Saxenda, should it gain approval, would be fifth such medicine to market, but analysts still expect the drug to do well given that it has been used for four years by doctors for diabetes, and has not faced the same cardiovascular safety concerns as many of its rivals.

According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese.

Furthermore, the prevalence of obesity in the US more than doubled among adults from 1980 to 2010, meaning any new – and safe – obesity drugs could be highly lucrative, although no company has yet managed to bring their drug into the blockbuster range.

By Ben Adams – Pharmafile online

AbbVie and Infinity sign cancer deal

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AbbVie has partnered with US company Infinity Pharmaceuticals to develop and commercialise the latter firm’s blood cancer treatment duvelisib (IPI-145).

Infinity will receive an upfront payment of $275 million and could receive an additional $530 million for reaching certain milestones under the terms of the deal. This includes up to $405 million for successful development and regulatory approval.

The two companies will jointly commercialise and share profits of duvelisib in the US, while AbbVie alone will commercialise the drug in other markets – although Infinity will be eligible to receive double-digit royalties on net product sales outside the US.

Duvelisib, Infinity’s only clinical-stage asset, is an oral inhibitor of the PI3K-delta and PI3K-gamma enzymes. It has shown promising clinical activity across a range of blood cancers, including indolent non-Hodgkin lymphoma (iNHL) and chronic lymphocytic leukaemia (CLL).

AbbVie’s own lead blood cancer drug candidate, ABT-199, has been troubled by safety concerns, and this partnership offers a new avenue through which the firm can continue its drive towards an expanded cancer portfolio, despite duvelisib also having faced questions about its safety in the past.

The drug is currently undergoing three trials – the Phase II DYNAMO trial for iNHL, the Phase III DUO trial for CLL, and an additional Phase I trial for advanced blood cancers – to further evaluate its safety and efficacy. A Phase III study testing duvelisib in combination with rituximab for the treatment of patients with follicular lymphoma will begin later this year.

Michael Severino, AbbVie’s executive vice president and chief scientific officer, says: “We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers.

“The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients.”

This ‘emerging oncology pipeline’ also includes the US firm’s recently-announced $1.5 billion collaboration with Google’s Calico to develop new treatments for age-related cancers (among other conditions), its in-development breast cancer treatment veliparib, and its prostate cancer drug Lupron – although Lupron has been performing poorly since coming on the market.

But AbbVie and Infinity will be facing stiff competition as they enter the blood cancer market, as several other CLL drugs have recently gained various levels of approval in the US and Europe – including Roche’s Gazyvaro (obinutuzumab), Janssen’s Imbruvica (ibrutinib) and Gilead’s Zydelig (idelalisib).

By George Underwood – PHARMAFILE, online

Novartis drug could be breakthrough in heart failure

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A new treatment, LCZ696, has produced exceptionally impressive results in cutting risk of death in heart failure patients, and has been heralded as a major breakthrough in the condition.

The potential of the drug, developed by Novartis, became clear in March when its phase III trial was stopped early, but full data unveiled at the European Society of Cardiology meeting in Barcelona at the weekend showed it could potentially revolutionise treatment.

The drug showed exceptional results in heart failure patients with reduced ejection fraction (HF-REF): reducing the risk of death from cardiovascular causes by 20 per cent; reducing heart failure hospitalisations by 21 per cent; and reduced the risk of all-cause mortality by 16 per cent.

Overall, LCZ696 produced a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalisation.

These results have been acclaimed as a major step forward in treating the disease, and means that Novartis has a blockbuster drug on its hands. There is no consensus yet among analyst on how much the drug could generate in peak sales, but Bernstein’s Tim Anderson forecasts that LCZ696 could reach as high as $8 billion.

“By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis’ new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade,” said David Epstein, division head, Novartis Pharmaceuticals.

“We want to thank leading cardiologists from around the world for their collaboration with us and their determination in advancing this important new life saving therapy for heart failure patients.”

LCZ696 is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart. It acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).

Currently available medicines for HF-REF work only to block the detrimental effects. Despite existing therapies, the mortality rate remains very high with up to 50% of patients dying within five years of a diagnosis of heart failure. Approximately half of patients with heart failure have HF-REF.

Novartis plans to file the drug with the FDA by the end of 2014 and in the EU in early 2015. A further advantage for Novartis is that the drug has no immediate rivals, giving it a clear run at developing the market.

Novartis has another heart failure drug in its late-stage pipeline, serelaxin (RLX030), which had looked like the more promising of the two candidates, but was rejected by an FDA committee in March because of doubts about its clinical evidence base.

By Andrew McConaghie – Pharmaphorum online

Janssen: why transparency is essential to the health of our industry

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By Jane Griffiths, company group chairman for Janssen EMEA and chairwoman of the EFPIA, via Pharmafile.com

The pharmaceutical industry is moving forward, working together to ensure patients have access to new and innovative medicines.

However, more must be done to meet society’s huge unmet medical need and to enhance society’s perception of the value we bring. We need to live up to the high standards we have set ourselves.

Despite the great value that pharmaceutical companies bring to public health and individual patients, as well as the contribution they make to the European economy, the reputation and perception of the industry as a whole has long been an issue.

Just as we strive to harness the best science for the benefit of patients, we also endeavour to enhance our efforts in the area of clinical trial data transparency – especially because demands for disclosure have never been higher.

As a company, we believe that greater clinical trial data sharing for the advancement of science and medicine is the right thing to do, and I think there will be a coalescing of the industry to move that topic forward.

In fact, we are seeing movement in this direction with some recent clinical trial data sharing announcements. Whilst we believe this is the right thing to do, it involves a number of complex issues and so, contrary to what some may think, it is not straightforward to achieve. For example, we have to be constantly vigilant about maintaining patient confidentiality.

We also need to ensure that we do not compromise existing partnership agreements. Perceived lack of transparency can be a barrier to open dialogue and being a trusted industry. If people believe things are being withheld or hidden, then the sooner that transparency can be established the better.

I believe that it will break down barriers if the industry is seen to be more transparent, and I’m quite sure that by the end of this year and into next year, you will see more transparency commitments from companies.

In my role as chairwoman of the European Federation of Pharmaceutical Industries and Associations (EFPIA) executive committee, I have first-hand experience of the EFPIA Transfer of Value Code. This was adopted by the EFPIA Statutory General Assembly in June last year, and establishes a code on the disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations.

The Code is the current major pan-European transparency initiative for the industry, in addition to similar transparency initiatives in countries across Europe.

Data disclosure

There is currently ongoing discussion over the transparency of clinical trial data. At Janssen, in January we announced a novel agreement with Yale School of Medicine’s Open Data Access Project (YODA) to share data from our clinical trials to enhance public health and advance science and medicine.

Under this agreement, YODA will serve as an independent body to review requests from investigators and clinicians seeking access to clinical trial data from Janssen, and will make decisions on sharing data.

This is the first time any company has collaborated with a completely independent third party to review and make final decisions regarding every request for clinical data, and we believe it sets a new industry standard in ensuring all requests for clinical data are reviewed in a systematic and objective way that protects patient privacy and confidentiality.

In order not to compromise competitiveness, we believe it is important that data relating to new medicines, in the early stages of development pre-license, are granted an exception: so data will only be available on medicines that have been granted a licence by the US Food & Drugs Administration and/or the European Medicines Agency.

But, for all licensed medicines and medicines that are already protected by patents, there is more we can do to disclose data. It has long been acknowledged that the success of the industry in delivering life-saving medicines is due in part to healthy competition.

Furthermore, we are fully engaged with experts and stakeholders to integrate their views on the development of measures to collate commercially confidential information and to ensure patient confidentiality is not compromised.

Clinical trials are conducted according to the same scientific and ethical standards, irrespective of the country. At Janssen, we ensure the highest ethical standards are applied to everything we do – and we apply these standards globally. We conduct our trials across the globe, in multi-centre studies, not only because this is required by regulators but also because it is medically appropriate in respect to future users of our medicines.

Most regulatory authorities will only approve medicines if a percentage of the trial population is from their native country or region. Every trial protocol that is set up is posted on a website, clinicaltrials.gov.

Furthermore, every clinical research programme ultimately will be in the public domain after the approval of a medicine.

Our collaborations

At Janssen we can see the value of collaborations in helping us achieve better outcomes for patients, and we have increased the number of collaborations we have with universities and small biotech companies.

In EMEA we have set up Janssen Healthcare Innovation, an entrepreneurial group within Janssen R&D, with the aim of developing cutting-edge health solutions designed to modernise healthcare delivery as well as improve patient outcomes.

Additionally, there are the Johnson & Johnson Innovation Centres in California, Boston and London, each focussing on developing research partnerships in their region. These centres are aimed at fostering collaboration between small biotechs, university research establishments, funders and ourselves. Collaboration between pharmaceutical companies is on the increase and is likely to stay that way.

For example, there is a lot of sharing of science, particularly in areas such as Alzheimer’s, which has proved to be a challenging disease to tackle. Moreover, through Transcelerate Biopharma, Janssen is working with 15 other pharmaceutical companies to simplify and accelerate the drug development process, so that we can get innovative medicines to patients as soon as possible.

We have also created the Janssen Health Policy Centre, a new initiative to encourage healthcare debates that will address ways in which the healthcare expectations of patients and broader society can be better met in the future.

It will establish multi-stakeholder forums for open discussions with key groups – public health specialists, healthcare providers, caregivers, policy makers, health economists and patient advocacy groups.

The debates will be based on data and health policy related reports. The insights gained by the Janssen Health Policy Centre will offer a holistic healthcare perspective and provide pragmatic recommendations to benefit society at large.

Mutual trust

Society itself is increasingly being driven by transparency and a more open dialogue on all topics. We have made progress but there is much more we can do as a company and as an industry. Our stakeholders have asked us to become more transparent and accessible. They want an even stronger commitment to demonstrate ethical behaviour in everything we do.

We want results for patients and for public health. It is only by developing medicines with high medical value, and in an ethical manner, that we will change perceptions and be recognised for the value we create for society. In order to achieve this, we need mutual trust.

I want to emphasise the importance of experts and expertise. We have to trust the people in charge, the academics in the various committees of our national and regional public health authorities. We rely on them to put things in perspective, to weigh the benefits and risks.

At Janssen, our dedication to finding solutions for unmet medical needs is extremely high.

For example, our portfolio of medicines to treat life-threatening conditions – including HIV, cancer and hepatitis C – as well as many other acute and chronic conditions, mean we dramatically improve and enhance the lives of thousands of patients every day.


Government rips up blank cheque on cancer drugs

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Pharma has priced itself out of the Cancer Drugs Fund as the rising costs of its new oncology treatments sees Whitehall getting tougher with the industry.

In response, the British government has announced today that it will be extending the annual spend on the Cancer Drugs Fund (CDF) from £200 million a year to £280 million a year to accommodate the inexorable rise of cancer drug costs.

But where once the CDF would pay for any drug at any price, each medicine will now be scrutinised for its cost-effectiveness, and it will not pay out for medicines deemed too costly.

The extra £160 million over the next two years is simply to pay for the rising costs of the new medicines, and the 55,000 patients using them, but the governent will still need to tighten its belt depsite the increase in investment for new patients using the Fund from now until 2016.

The money from the CDF pays for new oncology drugs not recommended by the cost-effectiveness body NICE, or are under appraisal from the watchdog. The Fund will have paid more than $1 billion from its start date in October 2010 to its current end date of March 2016.

NHS England, which effectively runs the health service, will now negotiate with the pharma industry on cost to “ensure best value for the NHS” to help keep the Fund sustainable.

But this will turn the entire process into a Heath Robinson system, whereby NICE rejects a new cancer drug, it is then referred to the CDF, but then it is also deemed not cost-effective here either, and will not be available to patients unless pharma backs down on price – exactly the process that NICE currently employs.

In a statement the Department of Health says NHS England are now working with NICE, researchers and patient charities to “examine the wider process by which the way the NHS makes commissioning decisions on new cancer drugs”.

It also says that it will remove the ‘least clinically effective’ medicines from the CDF list.

The CDF is meant to be axed in two years, but the DH says that longer term it will ‘consider carefully’ with NHS England the ‘best course of action’ for the Fund in the future.

But this uncertainty is irking some, including Chris Askew, chief executive of Breakthrough Breast Cancer, who says: “This is good news for patients because the Cancer Drugs Fund remains the only way that they can access expensive but effective cancer treatments that NICE cannot approve.

“However, we remain concerned that this is not a long-term solution to the problem of access to drugs that currently exists in the UK.”

Currently cancer drug specialist Roche makes the most from the Fund, taking around a quarter (£50 million) of all spending each year since 2010, predominately for its older multi-cancer drug Avastin (bevacizumab), which has been continually knocked back by NICE.

In fact the Swiss firm landed in hot water earlier this month after refusing to drop the price on its new breast cancer drug Kadcyla (trastuzumab emtansine) any lower, meaning NICE rejected the treatment given its £90,000 price tag.

Kadcyla can be used via the CDF, but it is uncertain whether it will now also come under greater scrutiny before being given to new patients.

The government also announced in April that it would shell out nearly £19 million for a new silo fund for Gilead’s hepatitis C pill Sovaldi (sofosbuvir), in combination with the firm’s other antiviral ledipasvir.

NICE is now recommending the treatment for NHS funding in draft guidance issued in August, meaning this silo fund will soon be stopped.

Standing up to pharma

Speaking on the BBC’s Newsnight programme before the announcement, the prominent pharmacologist David Colquhoun says the CDF has been brought about by ‘political pressure’. He goes on: “It’s enormous this pressure and it’s brought by pharma and by patient organisations, which are often just fronts for a pharma company.”

Oncologist Dr Karol Sikora says today’s announcement is the government “standing up to pharma on pricing”.

He adds that the situation is a strange one, as: “You have NICE, which is an assessor on cost who turns a new drug down, but then the government gives pharma a back door to get into the NHS.

“But that back door is only there to stop politicians losing face, especially as we are in the run up to the General Election [in May 2015].”

Colquhoun adds: “Axing the Fund is the only way to go – you have to stand up to these companies and I believe they will probably back down in the end, but it won’t be easy.”

Ben Adams – Pharmafile

Pfizer/BMS blood thinner gains new licence

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Pfizer and Bristol-Myers Squibb have been handed a much-needed lift after its new blood thinner Eliquis gained a licence extension in the US today.

The drug has been approved by the FDA for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) – i.e., clots in the legs and lungs. It now also can be used for the reduction in the risk of recurrent DVT and PE following initial therapy.

The drug is already licenced to help reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), a type of heart flutter that can increase the risk of death, but these new licences should help Pfizer and BMS pick up more sales.

Eliquis (apixaban) is one of three new oral anticoagulants to the market that includes Boehringer’s Pradaxa (dabigatran) and Janssen/Bayer’s Xarelto (rivaroxaban).

Pradaxa increased by nearly 9% in euro sales last year to hit €1.2 billion, whilst Xarelto generated sales of €949 million ($1.3 billion) in the same period. Eliquis has fared far worse, making just $171 million in sales for the second quarter which is far behind the trajectory needed to be a blockbuster medicine.

Pradaxa and Xarelto were approved before Eliquis, and for a number of years have had the DVT and PE licences – as well as the AF indication. This means doctors have become more use to the older medicines, and are less willing to use newer anticoagulants such as Eliquis.

But despite its high sales Pradaxa has come under pressure for safety issues, predominately in the US, for increased bleeding rates and is currently looking to settle around 2,000 legal cases in the country.

Meanwhile Janssen, which markets Xarelto in the US, is said to be fighting a number of legal cases in North America relating to its medicine. Pfizer and BMS have so far steered clear of any similar major legal action.

All three are designed as an alternative to warfarin, an older oral drug that can cause serious bleeding episodes and comes with strict dietary restrictions and the need for frequent blood checks.

Ben Adams – Pharmafile

FDA approves Sanofi’s new rare disease drug

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Sanofi’s biologics unit Genzyme has been granted approval for a new drug to treat the rare genetic disorder Gaucher’s disease.

Cerdelga (eliglustat) is now available for the long-term treatment of patients with the Type 1 form of Gaucher’s disease, which affects around 10,000 people worldwide and 6,000 in the US.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase, and is a rare genetic condition.

The enzyme deficiency causes fatty materials to collect in the spleen, liver and bone marrow. The major signs of Gaucher’s disease include liver and spleen enlargement, low red blood cell counts (anaemia), low blood platelet counts and bone problems.

Despite being for such a small copulation, Sanofi already markets Cerezyme (imiglucerase) for the disease, which it acquired via its 2011 purchase of Genzyme.

But both medicines will face competition from Pfizer’s new treatment Elelyso (taliglucerase alfa), which was approved for the same licence as Sanofi’s drugs in May this year.

Elelyso is slightly different from these drugs as it is the established FDA-approved plant cell-based ERT for Gaucher disease – as the other two use animal-based ERT.

And there is a fourth treatment on the market in the shape of Shire’s Vpriv (velaglucerase alfa), a drug which brought in $256 million last year for the firm.

Shire has been buoyed by Genzyme’s manufacturing issues that have been ongoing since 2009, something which has slowed production of its drug. It still managed to produce $914 million in sales for 2013 however, and holds the majority market share for Gaucher’s disease.

Cerdelga is a hard gelatin capsule containing eliglustat that is taken as a pill. In patients with Gaucher disease Type 1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them.

Cerezyme must be infused into patients, whereas Cerdelga comes in a pill form which is usually taken twice a day and therefore more manageable for patients than infusion.

It is unclear how many Gaucher patients on intravenous drugs will make the switch to Cerdelga, Genzyme’s chief executive Dr David Meeker told journalists before the approval. He added the company plans to price its new drug on a par with Cerezyme.

The two drugs also work differently as Cerezyme is an enzyme replacement therapy and accounts for about 70% of the Gaucher market. The new drug works by reducing the amount of fatty lipids produced by the body.

Cerdelga may generate $749 million in sales in 2020, according to analysts’ estimates produced by Bloomberg.

Price wars

Pfizer said that its drug will cost 25% less than Cerezyme, a move the company hopes will help it seize market share from its rivals. Vpriv is currently priced at around 15% less than Cerezyme, which has an average annual cost of about $300,000 (£180,500).

Ben Adams – Pharmafile

FDA approves Biogen’s long-acting MS drug

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Biogen Idec has racked up another approval over the weekend after its latest multiple sclerosis treatment Plegridy gained FDA backing.

The US regulator says that Plegridy (peginterferon beta-1a) can be used with relapsing forms of multiple sclerosis (RMS).

Biogen’s new treatment is faster-acting than other MS treatments for the same indication, as it designed to be injected every two weeks compared with weekly injections for its older MS drug Avonex (interferon beta-1a).

This dosing is also less frequent than rival Pfizer’s established injectable medicine Rebif, which is in fact dosed more often than Avonex, and even Teva’s $4 billion a year MS treatment Copaxone (glatiramer acetate), which was recently approved in a new less-frequent dosing regimen (three times a week).

George Scangos, chief executive of Biogen Idec, says: “Plegridy represents the most significant innovation in the interferon class in over a decade, and is the result of our deep commitment to improving the lives of people with MS and those who care for them.”

Avonex has been on the market for many years but has still brought in more than $1.5 billion in the first six months of 2014, and also enjoys US patent protection until 2026.

The drug is expected to come under more pressure from newer medicines however, and Biogen is hoping its growing MS portfolio will sustain its future as a leading firm in this disease area.

This is the US company’s second MS drug approval this year, and follows European backing for its other MS treatment Tecfidera (dimethyl fumarate), which unlike Plegridy comes in a pill form.

It was first approved in the US in March 2013 and quickly became the country’s number one prescribed oral therapy for relapsing forms of multiple sclerosis, despite being the third oral MS drug to reach the market behind Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide).

The firm says that it expects Plegridy to ‘diminish’ Avonex sales and take market share from other rivals even as overall sales from the class decline with the increasing popularity of oral treatments, such as Tecfidera.

Analysts on average forecast annual worldwide sales of Tecfidera to reach $6 billion by 2019, whilst Plegridy is expected to bring in around $2 billion in peak annual sales.

By Ben Adams – Pharmafile

GlaxoSmithKline Faces Fresh Bribery Allegations in Syria

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British drugmaker GlaxoSmithKline is facing fresh bribery allegations in Syria in a further blow to its reputation after China launched an investigation into the company on similar grounds.

Reuters, citing an anonymous email sent to the company’s top managers, reported that GSK allegedly bribed Syrian doctors and officials to boost sales of its medicines. It comes after accusations that the company engaged in malpractices in its non-prescription business in the country.

The email dated 6 August claimed that GSK paid bribes to doctors and officials in the country in the form of cash, trips and free medical samples.

“GSK has been engaging in multiple corrupt and illegal practices in conducting its pharmaceutical business in Syria,” according to the lengthy email addressed to Chief Executive Andrew Witty and Judy Lewent, chair of GSK’s audit committee.

Following the allegations, GSK said it will launch a probe into the matter. The company has also suspended relations with its Syrian distributors pending results of the probe.

“All the claims in this email will be thoroughly investigated using internal and external resources as part of our ongoing investigation into operations in Syria,” a spokesman for the drugmaker told Reuters.

“We are committed to taking any disciplinary actions resulting from the findings. We have suspended our relationship with our distributors in the country pending the outcome of our investigation.”

The allegations of corruption in Syria involve relatively small sums of money, compared to the hundreds of millions of dollars the company allegedly paid to Chinese doctors and officials. GSK generates sales of less than £6m ($10m, €7.5m) per year in Syria, compared to its total sales of £26.5bn in 2013.

By Jerin Mathew – International Business Times