A programme to test cancer patients for 97 genes that increase cancer risk will be piloted at a London hospital and funded by the Wellcome Trust.

The tests, which will start with women who have breast or ovarian cancer in 2014, aim to make genetic risk testing a standard feature of NHS cancer treatment.

The results will be used to select targeted drugs, and could influence other treatment decisions such as the extent of surgery.

Knowledge of genetic risks could also affect the health decisions of relatives of cancer patients.

The testing programme, which will be run by the Institute of Cancer Research and the Royal Marsden Hospital, London, is the first attempt to use mass genetic risk testing as a core aspect of cancer treatment.

Genetic mutations are responsible for 15% of ovarian cancers and around 2% of all cancers. The BRAC gene mutation in women increases the risk of breast cancer to as high as 80%.

The genetic tests were developed by biotechnology company Illumina.

According to Prof. Nazneen Rahman, lead investigator of the programme, knowledge of genetic risk factors “allows more personalised treatment, so for example such people are often at risk of getting another cancer and may choose to have more comprehensive surgery, or may need different medicines, or extra monitoring.”

Prof. Peter Johnson, chief clinician at Cancer Research UK, said: “This exciting new initiative will help embed genetic testing into routine NHS cancer care, and hopefully allow more cancer patients to benefit from genetic testing – and more personalised care – in the future.”

Roche has abandoned its attempt to take over US biotech company Illumina after a year of increasingly bitter argument.

The pharmaceuticals and diagnostics giant has seen an increased cash offer and an attempt to take over the gene sequencing company’s board of directors fail.

Roche’s Chairman, Franz Humer (pictured), has indicated that Roche is interested in discussions with other biotech companies that have similar platforms.

Roche’s pursuit of Illumina has been likened by industry observers to Gollum’s doomed quest for his “precious” ring.

It began at the start of 2012, with Roche offering $5.7bn to acquire the US company – an offer described by Illumina as “grossly inadequate”.

Roche extended its deadline by two months and then increased the offer to $6.8bn, citing a positive “market reaction”.

The pharma giant urged Illumina’s shareholders to support the deal by electing Roche representatives to the biotech company’s board of directors.

“As a standalone company, Illumina’s future is far from certain,” commented Roche’s CEO, Severin Schwan, at that time.

However, the Illumina board’s annual meeting did not elect a majority of Roche supporters, and Illumina CEO Jay Flatley called the bid “opportunistic”.

Despite the predictions of industry experts that a deal would be struck, Humer has announced that Roche is no longer pursuing the biotech firm.

The Illumina takeover was a “nice to have”, not a “must have”, he claimed, and Roche was considering other specialists – such as Life Technologies and Oxford Nanopore Technologies – to provide its diagnostics division with a less costly gene sequencing platform.

Meanwhile, Illumina reports 20% revenue growth in the last quarter. It plans to expand into the increasingly profitable field of cancer diagnostics and targeted drugs.

Researchers in the UK and the US have developed a method of designing drugs that can act on multiple gene targets, enabling them to treat complex diseases.

The new drug development process could revolutionise the treatment of major diseases including diabetes, cancer and bipolar disorder.

Whereas current genetic therapies target individual genes, leading to a highly specialised or ‘personalised’ drug regime for the patient, the new drugs could be effective across a wide patient spectrum.

Susceptibility to complex diseases such as cancer is known to depend on a considerable number of genetic and non-genetic factors – so the impact of a drug that can treat all known genetic factors could be massive.

Ironically, this research breakthrough could reverse the trend of pharmaceutical innovation towards ‘personalised’ medicine over the last decade, renewing the role of broad-spectrum drugs in treating major diseases.

The research collaboration by scientists at the Universities of Dundee (UK) and North Carolina (US) has developed a method of computerised drug design, based on large databases of drug-target interactions.

The scientists tested 800 predicted drug-target interactions using new drugs designed by this method: 75% were confirmed by in vitro tests.

In addition, the concept of using one new drug to treat a complex disease across a range of genetic factors has been proven in mouse models.

A drug designed to treat ADHD was shown to be effective in preventing typical hyperactive behaviours in two mouse groups with different genetic defects: a missing dopamine receptor and a missing brain neuropeptide.

Study co-leader Brian L. Roth, Professor of Pharmacology at the UNC School of Medicine, commented that for a complex disease, “we know there are likely hundreds of different genes that can influence the risk for disease and, because of that, there’s likely no single gene and no one drug target that will be useful for treating it.

“And so the realisation has been that perhaps one way forward is to make drugs that hit collections of drug targets simultaneously. Here we show how to efficiently and effectively make designer drugs that can do that.”

The NHS will build a database of 100,000 human genomes to assist the development of new therapies for cancer and rare genetic diseases.

Prime Minister David Cameron announced the UK Genome Project, which will strengthen the capacity of the NHS to provide targeted drugs, as part of the Strategy for Life Sciences.

The UK will be the first country to use DNA sequences within its mainstream health service.

The genomes of over 100,000 patients with cancer or rare genetic diseases will be mapped within five years, with the potential to reduce the number of premature deaths from these conditions.

“By unlocking the power of DNA data, the NHS will lead the global race for better tests, better drugs and above all better care,” Cameron said.

The NHS will dedicate £100m over 2013–18 to fund DNA sequencing, build the database and provide training for doctors to use the information.

Harpal Kumar, Chief Executive of Cancer Research UK, pointed to Gleevec – Novartis’ drug for chronic myeloid leukaemia – as a successful example of a targeted cancer drug.

The human genome database would enable doctors and scientists to develop new ways to prevent, diagnose and treat cancers, he said.

The project was welcomed by life science industry representatives. Stephen Whitehead, Chief Executive of the ABPI, said: “The cancer genome initiative will harness the latest science and technology to take the next transformative step towards personalised medicine.

“With our strong science base, our biopharmaceutical industry and the potential of the NHS as an engine for research, the UK is in a prime position to lead on the development and delivery of personalised medicines.”

Roche’s Zelboraf (vemurafenib) can extend the lives of patients with advanced melanoma by more than a year, data from a phase III trial has shown.

Patients given Zelboraf showed a median overall survival of 13.2 months, compared to 9.6 months with chemotherapy.

An abstract of the trial report stated that the increased survival meant a 38% reduction in the risk of death from melanoma.

A previous controlled trial, which formed the basis for the drug’s FDA approval in 2011, was halted early so that patients in the chemotherapy arm could be given Zelboraf for their clinical benefit.

Zelboraf has been hailed as a leading example of ‘personalised’ medicine as it targets the BRAF gene mutation, carried by about half of all melanoma patients.

Jennifer Low, Group Medical Director in Product Development for Genentech, Roche’s US subsidiary, commented: “The life expectancy for these patients isn’t very long, so they have an opportunity to have therapy that on average improves survival by a really significant amount.”

Roche is also testing Zelboraf as a treatment for other types of cancer, alone or in combination with other drugs.

Three leading pharmaceutical companies are working with the US National Institutes of Health (NIH) to find new indications for failed drugs.

Pfizer, AstraZeneca and Eli Lilly have joined a research programme that aims to speed innovative drug development by using existing compounds.

The programme will seek to match these compounds to newly discovered genetic disease pathways to identify accidentally pre-targeted drugs.

NIH Director Dr Francis Collins pointed to a familiar example: the first effective HIV treatment, AZT, was an unsuccessful cancer drug.

Such discoveries, he said, have been “sort of serendipitous” – but the goal of the new research programme is to replace serendipity with systematic analysis.

Recent research has identified the genetic causes of 4,500 diseases, but so far targeted treatments have only been developed for 250 of these.

The three drug companies have agreed to each make available at least 24 ‘failed’ drugs (withdrawn or never launched) that passed safety tests, making their testing in new indications relatively easy.

Scientists will apply for NIH grants to study specific drugs.

To simplify the legal framework, the programme allows the companies to retain ownership of their drugs while the researchers can patent their own discoveries.

The NIH will invest about $20m in the programme in its first year, and hopes for support from more pharmaceutical companies in the future.

US company Array BioPharma Inc. has appointed Ron Squarer as CEO.

Ron Squarer’s 20-year career in the pharmaceutical industry has included a range of commercial, development and leadership roles

The appointment reflects Array’s ambitions as a developer of targeted drugs for cancer and inflammatory disorders.

Squarer, 45, joins Array from Hospira, where he was Chief Commercial Officer after being Senior VP, Global Marketing and Corporate Development. He was previously Senior VP, Global Corporate and Business Development, at oncology specialist Mayne Pharma, acquired by Hospira in 2007.

Earlier, he held senior management positions at Pfizer and SmithKline Beecham (now GSK).

“I am delighted to join Array, a recognised leader in small molecule drug development,” commented Ron Squarer. “Array is an exceptional company with 10 Array-invented drugs in phase 2, as well as outstanding people, a strong cash position and uniquely productive discovery and development capabilities.”

Kyle Lefkoff, Executive Chairman of Array, said: “Ron’s appointment is the culmination of the Board’s comprehensive selection process to identify the best executive to lead Array to the registration and commercialisation of our oncology and inflammation portfolio.”

Breast cancer tumours have been reclassified into 10 distinct types linked to genetic features, following the largest ever study of breast cancer tissue.

The study findings have implications for patient selection in clinical trials and the development of drugs targeted at specific patient populations.

Tests to identify which group a woman belongs to, enabling more specific treatment recommendations and survival predictions, are expected to be available in the NHS in three to five years.

Researchers in the UK and Canada analysed DNA and RNA samples from breast cancer tumours in 2000 women. Through genetic profiling, they found 10 subtypes of tumour with genetic features that correlate with survival.

Carlos Caldas of Cancer Research UK’s Cambridge Research Institute said the study meant that breast cancer was an “umbrella term”.

“It is not going to change the management of women treated in the NHS tomorrow, but it is surely going to change the way in which we do clinical trials,” he commented. “We will be doing clinical trials that are much more targeted at each of these 10 subtypes.

“And finally, because we have discovered new breast cancer genes, this will give us new avenues to develop targeted treatments.”

The study identified genes for enzymes active in tumour growth – which make good targets for drug therapy because their receptor sites can be targeted.

Breast cancer is currently classified into four types according to whether the tumour is positive for receptors for oestrogen (Er+), human epidermal growth factor receptor 2 (Her2+), or progesterone (Pr+).

Targeted drugs exist for Er+ and Her2+ tumours. Tumours that are negative for all three receptors have a very poor prognosis.

The study allowed the largest group (70%) of women with breast cancer (Er+ and Her2−) to be divided into seven subtypes. Whereas their overall 10-year survival rate is 75%, the new subtypes allow 15-year survival predictions from under 40% to over 80%.

Another new subtype definitely identifies Her2+ tumours, while another includes most of the ‘triple negative’ tumours.

The final subtype identifies tumours where inflammatory cells and lymphocytes are infiltrated. According to Caldas, this subset “is a very important one for us to have recognised” because it shows the role of the immune system in fighting cancer.

Novartis has entered into a strategic collaboration with biotech company Enanta Pharmaceuticals to develop, manufacture and commercialise a new targeted drug for hepatitis C.

The agreement gives US-based specialist Enanta the backing of Novartis for EDP-239, the lead drug candidate from its hepatitis C virus (HCV) inhibitor program targeting the NS5A genotype.

Enanta will receive an upfront payment of $34m, and stands to receive a further $406m in clinical, regulatory and commercial milestone payments.

The US company will also receive tiered double-digit royalties on global sales and retain co-detail rights in the US.

Novartis will be responsible for all costs of developing, manufacturing and commercialising EDP-239, and will fund Enanta’s further drug discovery work targeting the same genotype.

NS5A is a non-structural viral protein that is essential to viral replication. Drugs targeting it have been shown to have major antiviral effects.

EDP-239 was recently included in Windhover’s top 10 ‘Most interesting infectious disease projects to watch’ list.

“Novartis is a recognised leader in the field of HCV, and access to its global expertise combined with our shared vision for commercialising HCV therapies will support the successful development and commercialisation of products targeting NS5A,” commented Jay R. Luly, Enanta’s CEO.

“We believe EDP-239 has great potential as a potent ingredient in combination drug therapy, and our preclinical studies have demonstrated high potency against multiple genotypes of the virus, excellent safety profile and a preclinical pharmacokinetic profile amenable to once-a-day dosing in humans.”

Hepatitis C is a chronic and life-threatening disease that affects over 170 million people worldwide. Drugs to inhibit the virus are increasingly a major goal for the pharma industry.

Based in Massachusetts, Enanta Pharmaceuticals is a research and development company specialising in targeted drugs to combat HCV.

Now more or less recovered from the festive break, Maxine Vaccine looks forward to the creative and rewarding possibilities of partnership (strictly in the business sense).

January is the worst month of the year. Back at work, no money, not much daylight, freezing rain and the memory of a festive break that was one long hangover. More breakups happen in January than in the rest of the year put together. It’s enough to drive you to drugs – not the ones you sell, of course, because you already know how rubbish they are.

But never mind! The pharma industry is glowing with thoughts of partnership and fruitful collaboration. Valentine’s Day has come a month early. That nice Mr Cameron said that for the UK to become the world’s leading hub for life science research and development, industry and the NHS need to work ‘hand-in-glove’ to find new solutions to the world’s pressing health problems.

If you listen carefully, you can just hear a faint harmonica playing in the cold January wind, and that supernatural twelve-string guitar weaving its spell. Hand in glove... It’s like being a teenager again. But is it true? Does the sun shine out of our pipeline? Does it really all depend on how near you stand to me? (Having shared hotel lifts with too many hungover male pharma reps in the past, I devoutly hope not.)

This week, Merck CEO Kenneth Frazier (I would) declared: “The future of the industry is going to be more partnerships.” He noted that the use of combination therapies for viral and other conditions made partnership between pharma companies necessary. The company intends to augment its pipeline through acquisitions, he said. “Typically, for Merck, the sweet spot has been earlier rather than later.” I was always a first-date girl myself.

Also this week, Roche CEO Severin Schwan (I also would) said the company was looking to acquire innovative products in the rapidly growing field of stratified medicine, where targeted drugs are developed alongside diagnostics that can select patients with the right genetic profile. Roche’s 2008 $3.4 billion purchase of diagnostic company Ventana “would certainly be a size, if the right opportunity came up, that we would look at,” he said. Just remember to send a photo to my phone.

The good life is out there somewhere, so stay on my arm you little pharma... but we know how that song ends. And if the Queen is dead, you can’t expect much in the way of royalties. Still, keep in touch. And have a good year.

Note: the views of Maxine Vaccine are not necessarily those of Pharmaceutical Field.