Author Archives: DrStevenB

Antidepressants to Reduce Impact of Genericisation on Unipolar Market

New research suggesting that despite generics, good opportunities are arising for new antidepressants, is research that Steven Bradshaw believes could prove pivotal going forward.

Dr Steven Bradshaw, International Healthcare Policy Expert

Dr Steven Bradshaw is an expert on international healthcare policy. In this capacity, Bradshaw uses his industry experience to act in an advisory capacity to some of the world’s most prominent pharmaceuticals chains and government think tanks.

As such, Bradshaw often comments on the healthcare issues of the day. Often Bradshaw’s observations over the deeper issues facing the international healthcare sector i.e. his recent commentary on the blurred lines of ethical publishing, provides the pharmaceuticals industry with fresh insight into its most complex issues. That is why Bradshaw felt he must comment this week on this new research.

Impact of Genericisation on Unipolar Market Reduced by Novel Antidepressants?

According to Pharmatimes, new research has been released suggesting that the impact of genericisation on the unipolar depression market could be reduced by the ongoing uptake of novel antipsychotics and antidepressants.

Specifically, the research from Decision Resources, suggests that the growing use of two therapies that have recently been approved – Actavis/Pierre Fabre’s Fetzima (levomilnacipran ER) and Lundbeck/Takeda Pharmaceutical’s Brintellix (vortioxetine), along with soon to be launched Otsuka Pharmaceutical/Lundbeck’s brexpiprazole, will act to negate a steep near-term decline in sales spurred by the expiring patents for two essential treatments attributed to unipolar depression. These are Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify (aripiprazole) and Eli Lilly/Shionogi’s Cymbalta/Xeristar (duloxetine).

What Will Happen When Current Treatments Aren’t Enough?

The research further found that it believes emerging antidepressant therapies will be ascribed to patients as third and fourth line treatments. The research elaborated by saying that it believes this will be the case for patients whose depressive symptoms are not effectively met by generic selective serotonin and norephinephrine reuptake inhibitors (SNRIs) as well as serotonin reuptake inhibitors (SSRIs), along with patients known to hold low tolerance thresholds for the therapies currently available.

Furthermore, the study suggested that in the absence of more effacious options, it sees evidence to suggest that the use of atypical antipsychotics as adjunctive treatment in patients known for their minimal responses to antidepressants, will continue to grow. Particularly, the launch of generic aripiprazole during the period of examination will by 2023, see greater use of the treatment in this manner.

Brintellix Will Witness a Modest Uptake

Meanwhile, the research went on to find that Brintellix will witness a modest uptake in the role of a later-line option in the treatment of non-responders during the forecasted period.

Detailed trial data has provided evidence to suggest that the drug has a significant advantage over other antidepressants, because it may foster improvements in cognition. Furthermore, it boasts a low risk of sexual dysfunction and weight gain. DR went on to conclude that the relatively high price of Brintellix will spur its peak-year sales in key markets, to a forecasted $2.4 billion by the year 2022, even as a later-line treatment.

Decision Resources Clarifies Their Findings

DR went on to say that despite increasingly restrictive reimbursement cultures in most major international sectors, and the extensive generic availability of antidepressants used for early-line treatment, there are still opportunities to be had for novel antidepressants. This is because of the fact that a large share of the drug-treated populace reacts suboptimally to available monoaminergic-targeted drugs.

It further forecasted that the use of generics Abilify and Cymbalta/Xeristar will not only lead to a dramatic drop in sales in the near-term – because of the quick uptake and extensive use of generics – but will also foster market access pressure for emerging agents planning to launch in these classes – Brexpiprazole and Fetzima respectively.

Decision Resources Group Analyst Alana Simorellis Speaks Out

Group Analyst Alana Simorellis at Decision Resources spoke out on the study. Simorellis suggested that treatment-resistant depression has and should continue to be the area of largest unmet need as far as treatment of the condition goes throughout the next decade.

steven bradshaw antidepressant

Simorellis went on to say that “an agent proven to be more effective than current agents in treatment-resistant patients would be welcomed by physicians and would likely be used as part of combination therapy.”

Dr Steven Bradshaw Comments

In Steven Bradshaw’s opinion, Simorellis makes a prudent point. An agent that has been proven to be more effective would be welcomed by the entire healthcare industry. However, clinical trials in depression are challenging. There are known difficulties in assessing severity and limitations of clinical rating scales and the placebo effect. Changes to clinical trial design and developing multidimensional endpoints, or allowing for introduction of composite measures in which objective markers of disease could be used as endpoints could help to solve these issues. Whether the ongoing uptake of novel antidepressants does replace genericisation in the treatment of the condition, as the study suggests, only time will tell and it is important to remember that from the perspective of those who hold the purse strings, generics are all so much cheaper.

NICE Updates Recommendations for Second Line Treatment NSCLC

In light of NICE’S latest policy change, Steven Bradshaw comments on how this decision will effect second line treatment of non-small cell lung cancer.

Dr Steven Bradshaw, Medical Expert

As a regularly-published medical expert with a significant degree of experience in HTA submissions and market access of pharmaceuticals, Dr Steven Bradshaw act as a consultant to some of the top pharmaceuticals companies, healthcare research organizations and government think tanks in the world. Continue reading

Government Announces £300 Million for UK 100,000 Genomes Project

The UK government has announced that it will provide £300,000,000 for the UK 100,000 genomes project, which Steven Bradshaw believes could make the UK a global leader in genetic research for cancers and other rare diseases.

Steven Bradshaw, a Prolifically-Published Medical Expert

A prolifically-published medical expert experienced in clinical trial research, Steven Bradshaw acts as a consultant to some of the world’s premier pharmaceuticals companies and think tanks. Most recently, Bradshaw’s 15+ years of industry experience lead to his appointment as European director for MKTXS.

As such, Bradshaw’s experience with issues such as research funding, sees him regularly comment on the funding issues shaping the modern healthcare research landscape. This is why Bradshaw felt he must comment on the latest research funding move by the UK.

UK to Become Global Leader in Genetic Research?

According to news sources such as Pharmatimes, Prime Minister David Cameron’s government has announced a new £300 million investment package for the 100,000 genomes project. It is hoped that this project will act to ensure that the UK becomes a global leader in genetic research in cancer and other rare conditions.

The project is certainly ambitious. By 2017, it hopes to map 100,000 human genomes. It is hoped that this achievement will aid in unlocking the power of human DNA; which can then be used to foster new targeted, personalised, diagnostics and medicines. Eventually, the project hopes that this will herald an end to traditional treatments i.e. chemotherapy.

How Did the Project Receive £300 Million in Funding?

It was earlier this week that David Cameron made the announcement. Specifically, the Prime Minister detailed the release of £300 million in funding via a stream of investment from major parties for the gene mapping research.

In a deal worth £78 million, Illumina’s services were secured for the project. This will also see the injection of roughly £162 million in capital into the research over a span of four years. Meanwhile, the Welcome Trust are set to provide £27 million. This will be spent on a sequencing hub at its Genome Campus close to Cambridge. This will house Genomics England’s operations, as well as those of the Sanger Institute.

Furthermore, £24 million will be provided by the Medical Research Council. These funds will help provide the necessary computing power that will make sure the data can be properly analysed, interpreted and secured. Finally, NHS England has agreed to underwrite £20 million in NHS contributions to the project. NHS England has already initiated work on selecting the first NHS Genomics Medicine Centres.

The Project Will Benefit 40,000

The government went on to say that this project could eventually benefit up to 40,000 people. This is essential, because it will eventually make way for genomics-based treatments to become a part of everyday care throughout the health service.

David Cameron commented on the matter, saying that: “I believe we will be able to transform how devastating diseases are diagnosed and treated in the NHS and across the world, while supporting our best scientists and life science businesses to discover the next wonder drug or breakthrough technology.”

Steven Bradshaw Believes This Project Could Have Numerous Benefits

In Steven Bradshaw’s opinion, this ambitious project could go on to provide innumerable benefits to patients with genetic conditions and it will hopefully provide essential information, through which the medical industry can learn to more effectively target and treat conditions such as cancer and other rare diseases. Should the initiative lead to developing new therapies, given their anticipated high costs, how they will be eventually funded within the NHS will need to be carefully thought through because their development costs alone will likely be very high. It is almost certain that, at least initially, such therapies would only be available in specialised centres and provided to select groups of patients. However, the journey from bench to bedside takes time; the long-term benefits of this project will take time to be known, but this is a great start and further goes to show why we need to invest in clinical research.


Investment in Antibiotics Measures Just 0.7% of UK Research Funding

Over the past five years, only 0.7% of UK research funding has been invested in antibiotics; a problem Dr Steven Bradshaw believes pharma and governments need to work together to address.

Dr Steven Bradshaw, Clinical Trial Research Expert

As a regularly published medical expert with experience in clinical trial research, Dr Steven Bradshaw primarily acts in an advisory capacity to some of the world’s premier pharmaceuticals firms, along with various government think tanks.

Bradshaw’s experience often leads him to comment in the media on the research news of the day, e.g. his recent commentary on the debate raised by the latest incident of stem cell research fraud.

How Much Did the UK Devote to Antibiotics Research in the Past Five Years?

Just 0.7% of UK research funding was invested in antibiotics work in the past five years, according to work published in The Lancet Infectious Diseases by researchers from the University of Birmingham. Considering the current industry fears over antibiotics resistance, Steven Bradshaw considers this finding is more relevant than ever to the work of pharmaceuticals companies going forward.

Specifically, the research revealed that out of a total of £13.85 billion in research funds which were available from between 2008 and last year, only £95 million was devoted to research on antibiotics. Furthermore, European Union funding to the tune of £181.4 million was released to antibiotics research consortia. This included UK-based research teams, encapsulating two EU Innovative Medicines Initiatives awards, which collectively equalled £85.2 million.

What can we learn from the Study’s Findings?

What can we glean from these findings? Essentially, these findings suggest an inadequate level of government funds is currently being devoted to antibiotics research in the UK. Furthermore, it suggests that this will certainly require an urgent increase, to ensure that the UK has the capability to tackle on the on-coming antibiotics resistance crisis effectively, according to the authors of the study.

dr steven bradshaw antibiotics resistance

The authors went on to suggest that “publicly available, subject-specific, funding databases will allow investment in priority areas to be tracked in future.”

The issue of antimicrobial resistance is quickly growing to become a significant global crisis. It is furthermore becoming increasingly clear that the UK, as a leader in biomedical research, has an important role to play in addressing the issue, as the crisis becomes more apparent on an international scale.

However the University of Birmingham’s Laura Piddock, according to Pharmatimes, went on to say that “our study clearly shows that the proportion of public and charitable funding for research into new antibiotics, understanding resistance mechanisms and ways of tackling resistance are inadequate for the size of the task.”

Steven Bradshaw Believes the UK Must Devote More Capital to Antibiotics Research

In Steven Bradshaw’s opinion, the results of this study are clear. The UK is not devoting enough research funds to tackle the challenge of the oncoming antimicrobial crisis. “Most antibiotics are now off-patent (generic) and are cheap; however, the economic burden of endemic antibiotic resistance would be an extremely serious and costly problem for patients and for society. Health services could be totally overwhelmed if this becomes endemic. The sensible approach would be to take precautionary action and invest in new treatments to remain a step ahead”. The pharmaceuticals sector must focus on this issue to ensure that we have the treatments we need to tackle this emerging global medical crisis, but they need the support from policy makers for them to be able to devote the resources to this problem.


Pharma gets Together to Attract Investment

Steven Bradshaw is a global healthcare policy expert, who works as a consultant to some of the world’s top pharmaceuticals companies and think tanks. In this blog post Steven looks at news about the pharma industry banding together in a bid to make investment in pharmaceuticals a more attractive proposition. Continue reading