Thrills, pills and paranoia... Pf looks behind the blood-streaked face of this year’s ‘must see’ pharma thriller and finds a ‘me-too’ product that hits easy targets while choking on its own off-patent formula.

Side Effects (2013)

You have to see this film. Not because it’s much good, but because it poses as a smart critique of the pharma industry and its place in modern culture. It’s saturated with references to prescribed drugs and the ways they are promoted. But in the end, it’s not about pharma. That’s just a MacGuffin: a plot device designed to distract the audience from what’s really going on. And what’s really going on in this self-important film is pure, FDA-approved bullshit.

Warning: this review will reveal what happens. If you want to be ‘surprised’ by the ending, don’t read any further. But if you want to know why this film merely pretends to be about pharma – why, in fact, it’s Frank Miller wearing a Ben Goldacre mask – and why its real message is misogynistic nonsense, then read on.

The film starts with bloodstains on an apartment door, then jumps back three months to the release from prison of a businessman, Martin, convicted of insider trading. His wife Emily (the enigmatic Rooney Mara) is suffering from periodic bouts of depression, one of which leads her to drive her car into a wall. While in hospital, she becomes a patient of psychiatrist Dr Banks (the not so enigmatic Jude Law).

Despite being prescribed SSRIs, Emily continues to suffer severe depressive spells. Unsure what else to prescribe, Dr Banks consults with Dr Siebert (Catherine Zeta- Jones, wearing an ‘I’ve got a dark secret’ T-shirt), who recommends a new drug called Ablixa. Emily thrives on Ablixa – but starts sleepwalking, which Dr Siebert says is a side effect. And then, one night, Emily picks up a knife in her sleep and stabs Martin to death.

Dr Banks convinces the court that Emily is innocent and the drug was to blame, but in the process his own career falls apart. Then he begins to suspect that Emily has been lying – and that she is in league with Dr Siebert. He persuades Emily to answer questions after taking the ‘truth drug’ sodium amytal. She says nothing new, but becomes woozy and passes out. This makes Dr Banks suspicious, because he had given her a placebo.

The plot thickens like cement. Dr Siebert sends fake photos to Dr Banks’ wife to make her think he has slept with Emily. She also tries to force Emily to undergo ECT, which gets Emily so scared she tells Dr Banks the truth: that she and Dr Siebert were lovers who gambled money on her husband’s death causing his company’s shares to lose value. She had been depressed after her husband was jailed, but everything later – including the sleepwalking – was faked.

Dr Banks gets Emily freed so she can set up Dr Siebert for arrest. Then he turns the tables on Emily, declaring her too dangerous to be free and condemning her to spend the rest of her life in a secure mental hospital, numbed by thorazine, while he returns to his family.

There’s an awful lot here about pharma marketing. After Martin’s death, his mother says: “I don’t understand. You see the ads on TV, people are getting better.” Dr Banks himself (and isn’t the name a giveaway?) is a store of pharma clichés: SSRIs “stop your brain telling you you’re sad”, Ablixa “helps you to be yourself”, sodium amytal “is a window into the psyche”. Ablixa carries the slogan “Take back tomorrow” – though Emily hilariously admits, “It didn’t do much for me.” Dr Banks is also being paid $50,000 to participate in a clinical trial of the drug.

However, it’s thorazine that gives the film its final and strongest moment: Emily in the mental institution, a shuffling zombie, with the camera panning back to show us the vast prison-like building. It’s a steal from Requiem for a Dream – and the ‘social relevance’ of Side Effects is borrowed from other films, while its only inherent message appears to be that lesbians are scheming psychos. For a film that’s supposed to be cutting-edge, that’s a dismayingly tawdry theme. 

Greek hospitals and pharmacies are running short of around 300 medicines because drug companies are refusing to supply them.

Hospitals failing to pay drug bills and parallel trading by wholesalers and pharmacists are the main reasons for supplies being withheld.

Major pharmaceutical companies that have admitted halting shipments of some products include Pfizer, Roche and Sanofi.

Medicines for arthritis, hepatitis C and hypertension, statins, antibiotics, anaesthetics, antipsychotics and antidepressants are all affected.

Dimitris Karageorgiou, Secretary General of the Panhellenic Pharmaceutical Association, said: “I would say supplies are down by 90%. The companies are ensuring that they come in dribs and drabs to avoid prosecution. Everyone is really frightened.

“The government is panic-stricken and the multinationals only think about themselves and the issue of parallel trade because wholesalers can legally sell them to other European nations at a higher price.”

According to the Greek government, more than 50 companies are holding back products or planning to do so. The Ministry of Health is intending to fine eight major drug companies, which have not been named.

There are reports of widespread panic and anger among patients who are going from one pharmacy to another with prescriptions. “We have reached a tragic point,” commented Karageorgiou.

With austerity tightening in Greece, the debts owed to pharma companies by hospitals and social insurance funds has reached €1.9bn (£1.6bn).

Pfizer has admitted withdrawing four medicines “because alternatives were available and because of the parallel trade situation”: leukaemia drugs Zavedos and Aracytin, the analgesic Neurontin and the epilepsy treatment Epanutin.

Roche said it was withholding supplies to Greek public hospitals, apart from “critical medicines” such as HIV drugs, but was still supplying pharmacies.

Sanofi claimed it was still supplying public hospitals with life-saving and unique products (for which no generic version or recommended alternative exists).

GSK, AstraZeneca, Novartis and Boehringer Ingelheim denied they had stopped supply of any products to Greece.

The pharmaceutical industry has urged the Greek government to set its drug prices in accordance with a eurozone standard. Greek drug prices are 20% lower than the next lowest in the EU, giving rise to widespread parallel trading.

Greek regulator the National Organisation for Medicines has banned the export of 60 medicines and is considering another 300. It will fine wholesalers and pharmacists who have broken the export ban.

The Royal College of General Practitioners (RCGP) has queried the introduction of an innovation scorecard insisting it will not improve standards of patient care.

Chair Professor Clare Gerada (pictured) has revealed her scepticism towards the plans which would make it compulsory for NHS Trusts to have NICE recommended products on their formulary.

But Professor Gerada said that the scorecard focuses on individual diseases and not the complex patients that GPs see on a daily basis.

She said: “While it’s important that we follow best practice, we need to be allowed to do things if we know they’re in the best interests of patients.”

Dr Gerada added that the DH should allow doctors to express their professionalism instead of “monitoring everything that can be monitored.”

RCGP Deputy Chairman Dr Richard Vautrey said than an innovation scorecard would only work if resources were in place for the NHS to fund every drug recommended by NICE. “All it is going to indicate is which CCGs have the funding available,” he said.

“It is disingenuous of the NHS Commissioning Board to suggest that CCGs can provide every drug NICE recommends.”

The DH has told CCGs to start working with PCT pharmacies to remove any drugs which are recommended by NICE from local treatment ‘blacklists’ as part of measures to introduce the scorecard.

An earlier study by GPOnline found that one PCT in four was blacklisting drugs recommended by NICE.

After April 2013, who will commission which health services?

The new NHS structure is designed to promote integrated care by making the roles of a number of different commissioners interlock. The GP-led clinical commissioning groups (CCGs) are the core of the system, responsible for dealing with most areas of patient need in the local community. Around that, however, three other commissioning bodies are engaged with supporting patient health and wellbeing:

• the NHS Commissioning Board (NHSCB) is responsible for primary care and specialised services
• local authorities are responsible for improving public health
• Public Health England (PHE) is responsible for protecting and promoting health though intervention in health and social care services and public awareness.

A map of services

The Commissioning Board Authority’s Commissioning fact sheet for clinical commissioning groups maps the new health landscape by comparing the responsibilities of the four organisations. For each new commissioner, it lists the main functions and the similarities to other commissioners – thereby making the point that service integration is vital for effective care.

The fact sheet states that CCGs will need to work collaboratively with local authorities and the NHSCB – and that to do so, they may pool budgets or have joint commissioning arrangements. For example, it is suggested that responsibility for sexual health and for addiction-related services will need to be divided between the CCG and the local authority to avoid duplications or gaps in provision.

Clearly, the matrix of healthcare is a dynamic one that can be interpreted by local commissioners in a range of ways. The map is not a final one in any case: some details, including the specialised services covered by the NHSCB, are still to be confirmed by Parliament in the autumn.

Community healthcare

The fact sheet compares the responsibilities of CCGs and the NHSCB for commissioning patient care. It notes that local authorities will provide “public health advice” to CCGs, but will not commission at that level. The role of local authorities in commissioning social care is not covered, but is a further dynamic that CCGs will need to be aware of.

The core elements of CCG commissioning relate to: emergency care; out-of-hours primary medical care (where not covered by the GP contract); elective hospital care; community health (such as physiotherapy and continence services, but not health visiting or family nursing); rehabilitation; maternity and newborn care (except where intensive); paediatric care; mental health and learning disability care; and infertility treatment.

The core elements of NHSCB commissioning relate to: primary care through the GP contract; community pharmacy; primary ophthalmic care; all dental care; health services for people in prisons and other custodial institutions; health services for members of the armed forces; and specialised services.

The fact sheet draws out some detailed differences between the two lists in order to avoid confusion – for example, noting that health services for offenders in the community are covered by CCGs. Sometimes, as where the GP contract varies, certain services may be commissioned by the CCG in some localities and by the NHSCB in others. None the less, overall there is a clear division of responsibilities.

Public health services

With the commissioning of public health services, the picture is significantly more complex. Responsibility is divided between the NHSCB, the local authority and Public Health England. In some cases – notably immunisation programmes – these services can relate to provision of medication. In other cases – notably epidemic preparedness – they can relate significantly to medicines management and other aspects of primary and secondary NHS care.

Public health services to be commissioned by the NHSCB include services for children from pregnancy to age 5. This responsibility will transfer to local authorities in 2015. It covers health visiting, family nurse partnership and responsibility for child health data. The NHSCB will also be responsible for immunisation and national screening programmes – both being areas of increasing NHS spend, as evidenced by recent investment in cervical cancer and prostate cancer screening and in vaccines against HPV and influenza. With hepatitis C vaccines on the market and HIV vaccines a real prospect, this area of medication will become increasingly crucial for the NHS.

Local authorities will be responsible for providing or commissioning a wide range of public health services that relate mostly to preventative measures and raising awareness, including: children’s public health for ages 5 to 19; sexual health; public mental health; obesity management; drugs, alcohol and smoking services; dental public health; and seasonal mortality. Active medical intervention, including medication, features strongly in the sexual health and drug, alcohol and smoking services to be provided; the transfer of sexual health services from NHS to local authority control is a major change in the provision of UK healthcare. Notably, however, HIV treatment will be commissioned by the NHSCB.

PHE is taking over the functions of the Health Protection Agency and will impact significantly on the health protection activities of CCGs, the NHSCB and local authorities. Sometimes all relevant health stakeholders will work together – for example, PHE has a strategic role in influenza and other epidemic preparedness, to which local authorities, CCGs and the NHSCB will contribute. PHE’s role also covers behaviour change campaigns around early diagnosis and other issues; public oversight of infection prevention and control; and general intelligence on health protection and improvement, including the current functions of the Cancer Registries. These initiatives will also impact on GP services.

Joined-up care

CCGs will be the glue in the new healthcare commissioning system: the first port of call when gaps or inequalities in service provision arise. While they cannot commission GP care, their close professional connection to it should ensure that what impacts on CCGs will be taken to heart by GPs. But given that austerity measures will dominate the NHS for the “foreseeable future” (in David Nicholson’s words), it is inevitable that funding and staffing shortages will create holes in the patchwork of the new health system. The pharmaceutical industry will thus need to be alert to partnership opportunities opening up at local and national levels.

Sir Michael Rawlins wants campaigners to take legal action against trusts that deny patients access to NICE-recommended drugs. Maxine Vaccine asks whether this is a powerful strike against bureaucracy or a pointless fit of sulking.

It’s not easy being NICE. When you decide a drug is not cost-effective, the manufacturer contacts a bunch of patient groups on Facebook and passes on soundbites to the press that make you out to be the most heartless despot since King Herod. When you decide a drug is cost-effective, the NHS quietly ignores you.

The Government says it will force trusts to make NICE-approved treatments available to patients – but at the same time, the recession comes back for whatever it forgot to wreck the first time, and the NHS is told it has to make deep spending cuts for the foreseeable future. Andrew Lansley first praises the NHS for hacking nearly £6 billion from its budget, then says rationing of NHS treatments is “unacceptable”. Simon Burns tells Radio Five Live that Monitor will sack CCG leaders who ration services, then the DH shamefacedly explains that he meant to say the Commissioning Board would do that.

And just to make matters worse, if you’re Sir Michael Rawlins, people confuse you with Sir Andrew Dillon and vice versa. Is it your fault that you both look exactly like 1970s newsreaders? Having good taste in neckwear wasn’t part of your job description. And you both have something of the knight about you. It’s time you stood up for yourself.

At least, that’s my rationalisation of why Rawlins went on the HSJ website and revealed that he encouraged the RNIB to take legal action against the NHS. I could be wrong, however. He may have had a touch of the sun, or a bout of lansley that his GP wasn’t allowed to prescribe for.

Whatever the reasons, his blog was in the awesome NICE tradition of standing on the moral high ground and waxing ironic over those below. He recommended that patient groups should use legal measures to “blow the whistle” on trusts that use “delaying tactics” to save money – thereby forcing them to put in place “appropriate financial arrangements” for the drugs in question to be provided. Then came his parting shot: “That would be a much better use of the time of formulary committees than trying to pretend they have the knowledge and skills of a NICE appraisal committee.”

Strangely enough, that didn’t go down too well with the NHS. David Stout, Chief Executive of the NHS Confederation, responded with an air of wounded dignity: “We must remember the reality is that every NHS organisation has a finite amount of money available. Every new treatment covered and funded under a NICE technology appraisal means fewer resources for other treatments.

“The issue raised by Sir Michael Rawlins leads us on to the wider debate that we need to have about the fact that the NHS is facing an unprecedented financial challenge,” he continued. “We need to be open and honest with the public about what the consequences of this financial challenge are, and the fact that trade-offs will be required if we are to improve standards of care while keeping the NHS affordable.”

That is rather good – and it cuts through the DH’s excuses like a scalpel through the contents of an inflamed colorectal tract. We need a public debate about NHS rationing – its economics, its democratic basis, its medical and social impact – not confused denials that such activity was ever dreamt of. If it was Rawlins’ intention to force that debate into the public space, he did well.

Bring it on.

Maxine’s views are not necessarily those of Pharmaceutical Field.

Maxine Vaccine, blogger with attitude, takes a look at some key issues affecting the pharma industry – this week, the potential impact of minor side-effects on a drug’s sales.

Let’s consider a hypothetical case. A male patient has chronic disease A, which requires careful monitoring and treatment with drug Z. Because of the risks of developing co-morbidities, he is also put on statin Y and anti-hypertensive X. So far so good.

But Z has digestive side-effect B, which is socially embarrassing, while Y causes dysfunction C, which affects his private life. His GP prescribes famous drug W (or rather, its generic equivalent) for the latter condition. The patient’s girlfriend notes the improvement, but W also causes the patient to suffer headaches, insomnia and loss of peripheral sensation, which detracts from the point of the drug (for him at least).

This conflict of interests, combined with the untreated side-effect B, results in the girlfriend packing her bags. As a result, the patient develops affective disorder D, for which he is prescribed famous drug V (or rather, its generic equivalent).

By now, the patient is beginning to feel his life is an exercise in product placement. And in generic equivalents – but let’s not dwell on that. Before he develops carpal tunnel syndrome and the two ends of the alphabet converge, let’s ask why this is happening.

Some of you may recall the classic Flanders and Swann song ‘The Gasman Cometh’, in which a gasman carrying out a domestic repair creates a new problem that requires a plumber, who in turn creates the need for an electrician, and so on. Do pharma reps invariably create business for other pharma reps, regardless of company?

Of course not, you’ll reply. All side-effects are duly listed in the product literature, and they only affect a minority of patients anyway. That’s true – but only major side-effects are reliably reported. Many persistent symptoms may not be reported due to denial or embarrassment – or, once reported, they may not be recognised as side-effects. After all, when you’ve got lots of things wrong with you, who knows the precise cause of a symptom? Does it even matter?

Yes, it does. We’re moving rapidly towards a model of community-based prevention and treatment of chronic diseases through long-term medication. Patients need to recognise, understand and deal with the side-effects of these drugs. The same patients are increasingly aware of, and able to choose from, the range of treatment options available. They are sharing their experiences via the Internet (as are GPs). And when they give a drug a bad name, you can bet that it always sticks.

Many patients and their GPs are surprised and confused by the side-effects of medication. By raising their awareness of these side-effects and the best ways of dealing with them, you’re providing a patient-focused solution rather than just a product. You’re also helping to improve patient compliance. In the era of personalised medicine, that’s the best route to customer loyalty.

If you ignore the yellow card, the red card may follow.

Maxine Vaccine is keen to receive your feedback on these and other pharma industry issues. Be nice (but don’t be NICE)!

Pharmaceutical companies Lundbeck and Otsuka have formed a global alliance to deliver up to five new psychiatric and neuroscience drugs.

The Danish and Japanese pharma companies, both of which have a strong record in CNS products, have signed a sales and cost share agreement.

The alliance covers two near-term projects from Otsuka and an earlier-stage portfolio of psychiatric disorder treatments, encompassing psychotic, mood and behavioural disorders at all levels of severity, from Lundbeck.

The two companies have identified psychiatric disorders as a major area of unmet need.

Lundbeck is granted co-development and co-commercialisation rights to two Otsuka drugs: aripiprazole depot formulation (which improves compliance in users of the drug) and OPC-34712 (for schizophrenia and major depressive disorder).

Otsuka will have an option to co-develop and co-commercialise up to three early-stage compounds in Lundbeck’s R&D pipeline.

“With the addition of aripiprazole depot formulation and OPC-34712, Lundbeck has significantly broadened its growing psychiatry portfolio with exciting and unique treatments in an area of high unmet needs,” said Ulf Wiinberg, Lundbeck’s President and CEO.

“This collaboration further strengthens our US platform and allows us to be introduced with the US psychiatry community already in 2013."

Dr. Taro Iwamoto, President and Representative Director, Otsuka, commented: “We are very excited that Otsuka and Lundbeck have entered into a co-development and co-commercialisation agreement for aripiprazole depot formulation and OPC-34712, both potential key drivers of future growth for Otsuka’s CNS business.

“Lundbeck’s expertise in developing depression and anxiety treatments and Otsuka’s expertise in developing anti-psychotics will maximise the medical and commercial value of Otsuka’s portfolio in CNS. In addition, our partnership with Lundbeck will enable us to establish a strong platform to deliver these compounds to patients who need them.”

Through the sales and cost share agreement, Otsuka will receive up to US$1.8 billion from Lundbeck – which will see its psychiatry portfolio and US market penetration increase.

The combination of Otsuka’s strong presence in North America and Asia with Lundbeck’s strong presence in Europe, Canada and Latin America mean that the alliance will reach most of the global psychiatric market.

In Part III of his diary, Omar Ali discusses the significance of process mapping and the wide reaching influence of health technology assessments and regulatory bodies.

1.10pm: GP CONSORTIA/CCG – RESPIRATORY ASTHMA PROCESS MAPPING & FORMULARY

I’m trying to step into the main meeting room but one of the CCG/GPs pulls me aside. It’s a mixture of a low-key signal and a discreet ‘thumbing’ to pull away from the group. He wants a quiet word and it’s clear that there are some key issues, agendas and directions that are on the table for this asthma meeting.

The process mapping event takes some four hours – evaluating everything and anything that ‘leads to an asthma admission’, followed by everything and anything that occurs after the admission and leads to discharge – which is then followed by QIPP ‘bottlenecks’, where re-admissions and inefficiencies occur.

It’s always a challenge having so many viewpoints – nurses, physicians, pharmacists, budget holders, and of course patients and carers who often change the whole paradigm when we hear about their experience, expectations and concerns around ‘choice’.

Thoughts for pharma

Respiratory is big. Whether on prescribing budgets, healthcare priorities, implementation of national guidance or QIPP streamlines. Companies haven’t yet got their act together on process mapping of care pathways, but it’s the only way to invest in prescribing up-front drugs for potential ‘return to the QIPP baseline’ over the next three to five years. Needless to say, whilst the NHS talks QIPP, pharma is getting used to it and patients are still puzzled by it.

Asthma

With so much behind National Guidance/BTS, QoF and commissioning cycles, some companies are indeed getting into the mix with Clinical Commissioning Groups and supporting process mapping. That support is vital, as not only does it bring pharma in as key stakeholders, but more importantly there is a level playing field here in the same room bringing the cause back on track.

So often in the NHS we have silo budgets chasing after silo savings. Process mapping brings us out of our silos into the bigger picture and into the ‘process map’. Seeing it happen is a wonderful thing.

COPD

Given we make such a fuss around the cost of drugs, in truth we know two things: the most expensive drug is the one that is not being taken, and the tariff for an admission for COPD at £3,400 is more expensive than the annual price of the most expensive inhaler!

So where’s the issue? It goes like this. Pharmaceutical companies come to us quoting the costs of admissions in COPD then tell us how amazing it would be to reduce these hospitalisations.

They then tell us how amazing their COPD product is and tell us that we would be crazy to not buy their inhaler, which is a fraction of the cost of COPD burden/admissions. The GPs, nurses and patients love it and want it and state they ‘need it’. Medicines Management then look like the bad guys for not funding the said branded inhaler.

4.15pm: DRIVING BACK TO NHS BASE CAMP – CHECKING VOICEMAILS

One of the big five companies has asked me to come and present to their European heads-of-country on ‘payer issues’ in the UK and the influence of HTAs.

It’s a bit short notice and I gather the VP for Europe, Middle-East and Asia will be there. Times are tough and I see this as an example of how the EU can join forces on some of the key payer issues beginning to filter through.

I have one question back to these pharma companies. What is your data on reducing these expensive hospitalisations in COPD? Because in truth, with the data, I buy the story.

In most cases pharma will then spin another story around how compliance is great, or a patient support programme is excellent. But given all the spin that has come on how much COPD costs me in hospitalisations, it’s a shame many of the companies don’t have the evidence to help me.

They have marketing but not the evidence. Show me the money. And the formulary will be yours.

Thoughts for pharma

There is no doubt that the UK is ‘different’, but I don’t imagine global HQ for any of the pharmaceutical companies readily accepting that – especially when the targets are high and sales may not be so. It sometimes takes global agencies to hear about payer issues ‘from the horse’s mouth’.

This was the quote stated to me regarding this piece of work/event. From my work abroad – at NICE I informally interact with a number of contacts in other countries who belong to their residing equivalents – I can’t stress enough the importance of NICE, the SMC and similar bodies.

The last SMC decision on pain management was quoted verbatim within two weeks by three different countries within the EU. I’m also aware from my US/value-based pricing work that when NICE rules on a drug the impact on the US healthcare system is far reaching.

Insurance companies download the information – they can’t believe NICE do all this work transparently and then leave it freely available for anyone to download – and the US agencies then use this information on deciding what percentage they will ask patients to pay.

So, if NICE say no and SMC say no, somewhere a butterfly flaps its wings and then a patient in the US, who has paid extra funds into a private insurance policy, will be told that this particular brand is not covered and that the patient will have to make an additional payment if they want the drug.

To be continued...

Omar Ali is the Formulary Development Pharmacist for Surrey & Sussex Healthcare NHS Trust and sits on the External Reference Group for Cost Impact Modelling for NICE. He may be reached on omar.ali@sash.nhs.uk.

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

Bristol-Myers Squibb (BMS) has entered into a broad framework agreement with Dako on the development of pharmacodiagnostic tests.

The agreement, which builds on a collaboration begun in 2008, aims to develop diagnostics to identify patients more likely to benefit from treatment with BMS investigational drug candidates.

Pharmacodiagnostics (or companion diagnostics) are an important feature of the growing personalised medicine approach, which can improve outcomes and reduce healthcare costs by identifying individuals who are more likely to benefit from specific therapies.

Dako, a global leader in tissue-based diagnostics, has a history of developing clinical diagnostics in collaboration with pharmaceutical companies that are used in conjunction with drugs.

“It is a great pleasure for me to announce Dako’s new collaboration with Bristol-Myers Squibb,” said Lars Holmkvist, CEO of Dako. “This alliance heralds the intentions of both companies to work closely together to develop new diagnostic tests linked to drugs for the higher purpose of identifying the patients most likely to respond to treatment.”

“It is part of Dako’s long-term strategy to collaborate with pharma companies on the development of companion diagnostic tests.”

Based in Denmark, Dako produces reagents, instruments and software used by hospitals and clinics in more than 80 countries worldwide in the diagnosis of cancer and the planning of its treatment.