Tag Archives: Steven Bradshaw

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.

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.


Pharma Experts Call For Alternative UK Antibiotics Reimbursement Models

Steven Bradshaw has learned that pharmaceuticals experts have called for alternative antibiotics reimbursement models in the UK. Why?

Steven Bradshaw, International Policy Expert

Steven Bradshaw is an international healthcare policy expert, who acts as a consultant to some of the world’s top pharmaceuticals companies and think tanks.

In this capacity, Bradshaw weighs in on the issues currently being debated in the healthcare policy sector i.e. the Italian government’s recent decision to substitute AMD drugs, using his expertise to provide fresh insight into the issues at hand. Continue reading