Category Archives: Biologics

Sartorius and Repligen collaborate on perfusion enabled bioreactors

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Designing the bioreactors to control cell growth, fluid management and cell retention to ultimately simplify the development and cGMP manufacture of biological drugs.

Sartorius Stedim Biotech (SSB) and Repligen Corporation have partnered to integrate Repligen’s XCell ATF cell retention control technology into SSB’s BIOSTAT STR large-scale single-use bioreactors to create novel perfusion-enabled bioreactors.

SSB is an international supplier for the biopharmaceutical industry and Repligen Corporation is a global life sciences company focused on bioprocessing technologies.

Christine Gebski, VP of Product Management at Repligen, said: “We are excited to partner with SSB, a global innovator in bioreactor technology. The integration of our market-leading XCell ATF control technology with SSB’s high-performance bioreactors offers a simplified perfusion-enabled bioreactor solution for end users to develop cell culture processes more quickly and implement perfusion more efficiently.”

As a result of this collaboration, end users will stand to benefit from a single control system for 50–2000 litre bioreactors used in perfusion cell culture applications. This single interface is designed to control cell growth, fluid management and cell retention in continuous and intensified bioprocessing and ultimately, simplify the development and cGMP manufacture of biological drugs.

Through the partnership, SSB and Repligen will further collaborate to equip SSB’s recently launched ambr 250ht perfusion single-use mini bioreactor system with Repligen’s KrosFlo hollow fibre filter technology.

The bioreactor system will be sold by SSB as a complete single-use assembly. This optimal design conserves the hollow fibre filter technology across scales, enabling customers to fast track development and scale up their cell culture perfusion processes.

“Sartorius Stedim Biotech has continuously expanded its integrated upstream portfolio for the past years with a focus on robust and scalable, automated single-use solutions, optimized for high-cell-density applications. The collaboration with Repligen will result in easy-to-implement, high-performance and perfusion-ready bioreactors ranging from process development to commercial manufacturing scale,” commented Stefan Schlack, Head of Marketing at SSB.

SOURCE: www.manufacturingchemist.com/news

LEO Pharma to develop and commercialise JW Pharmaceutical’s JW1601

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Denmark-based LEO Pharma has entered into a global licensing agreement to develop and commercialise South Korean JW Pharmaceutical’s JW1601 drug candidate in a deal worth approximately $402m.

Under the terms of the deal, LEO Pharma will get exclusive global rights to JW1601. However, JW Pharmaceutical will retain its exclusivity in South Korea.

JW Pharmaceutical’s JW1601 is a new drug candidate for the treatment of atopic dermatitis. It was developed by one of the company’s affiliates C&C Research Laboratories.

Last year, JW Pharmaceutical acquired the exclusive rights to develop and commercialise the drug candidate globally. An investigational new drug application for a Phase I clinical trial is expected to be submitted over the coming months.

JW1601 is designed to prevent the activation and migration of immune cells that cause atopic dermatitis. The therapeutic selectively targets the histamine H4 receptor and inhibits histamine signalling responsible for itching.

The anti-pruritic and anti-inflammatory effects are expected to deliver better efficacy, while the selectivity towards H4 receptor is expected to show a good safety profile.

LEO Pharma Global R&D executive vice-president Kim Kjoeller said: “At LEO Pharma, we continuously seek to expand our pipeline with new innovative solutions with the ultimate aim of bringing real life-changing medicines to the many patients we serve.

This compound is a perfect fit with our existing biologics currently in phase III (Tralokinumab) and phase I (LP0145) and our topical Delgocitinib currently in phase II.”

As part of the agreement, JW Pharmaceutical will receive an upfront fee of $17m, followed by up to $385m in stepwise development and sales milestones.

In addition to the milestone payments, LEO Pharma will pay royalties on net sales of the drug candidate.

SOURCE: www.pharmaceutical-technology.com/news

Celebrating 15 years of life-saving technology

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The experts in temperature controlled packaging Peli BioThermal, are celebrating 15 years of the Original Golden Hour container, developed to provide blood to critically wounded soldiers.

The award-winning Original Golden Hour container – the company’s flagship product – was recognised in 2003 as part of the US Army’s Greatest Inventions programme, has gone on to shape future product development, influencing the full range of Peli BioThermal reusable and single-use products.

“We developed the Original Golden Hour to address a critical need facing our military personnel — how to make blood available to treat the critically wounded within the crucial first hour after injury,” explained Kevin Lawler, Peli BioThermal VP of sales, “Today, the technology behind this product allows us to provide reliable temperature control not only for blood on the battlefield, but also for life-saving civilian applications, including the transport of biologics and temperature sensitive pharmaceuticals for clinical trials and commercial distribution.”

The technology is incorporated in a range of Peli BioThermal products, which are utilised by emergency first responders globally.

In 2003, the US Army needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The answer, The Original Golden Hour container was the answer to a proposal from the US Army in 2003, when they needed a way to store blood and platelets to aid emergency medics saving lives on the battlefield. The container was subsequently included as part of the 2003 US Army’s Greatest Inventions program by the US Army Research, Development and Engineering Command (RDECOM) Public Affairs office.

“If you can make sure that someone doesn’t bleed out by giving a resupply of blood right there, you’ve exponentially impacted the ability to save that soldier’s life,” said sixteenth chairman of the joint chiefs of staff, retired US Marine general, Peter Pace, who also serves as chairman of the board for Pelican Products.

It truly makes a difference on the battlefield. And that’s as true today as it was 15 years ago.”

Patented Golden Hour Technology provides superior thermal protection for high value temperature-sensitive payloads between 2 and 1686 liters, from -50ºC to 25°C for up to seven days (168 hours). Today, Golden Hour Technology is integral to all of the company’s products, including reusable products like the Credo Cube shipper and the Credo ProMed series, as well as the Chronos range of single-use shippers.

SOURCE: www.manufacturingchemist.com/news

Risankizumab approval could strengthen AbbVie’s market position

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According to GlobalData, if approved, risankizumab would further strengthen AbbVie’s position in the psoriasis market.

If European approval is granted for AbbVie’s risankizumab for moderate-to-severe plaque psoriasis, the company could further strengthen its position in the psoriasis market, according to GlobalData, a leading data and analytics company.

In 2017, AbbVie reported that Humira (adalimumab), an anti-tumour necrosis factor (TNF) biologic indicated for multiple immunological disorders including psoriasis, generated global sales of $18.42 billion, accounting for 65% of AbbVie’s total net revenue.

Risankizumab is an investigational compound that has been designed by AbbVie to selectively inhibit IL-23 by binding to its subunit p19. AbbVie has submitted a marketing authorisation application (MAA) for risankizumab to the European Medicines Agency (EMA).

Vikesh Devlia, Pharma Analyst at GlobalData, said: “With the anticipated launch of Humira biosimilars in the EU starting from October 2018, AbbVie’s position is threatened in the psoriasis market by both biosimilar erosion and other major pharma companies gaining approval for their IL-17 and IL-23 biologics.”

“This may not affect AbbVie immediately, since physicians will likely continue to prescribe Humira as one of their first-line biologic therapies for moderate-to-severe psoriatic patients. However, the less frequent dosing of IL-17 and IL-23 biologics could shift physicians to opt for these therapeutics eventually.”

“Despite these challenges, AbbVie intends to remain a player within the changing field of psoriasis treatment. With the submission of an MAA for risankizumab, the company could be closer to retaining a strong position in the psoriasis space.”

The currently approved IL-23 inhibitors for psoriasis include Johnson and Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Both Tremfya and Ilumya have been shown to have high efficacy in moderate-to-severe psoriasis.

Devlia added: “Although there are not yet any head-to-head trials comparing the efficacy of these drugs to one another, it is clear from Phase III trials that risankizumab and Tremfya will compete for best-in-class status, as both IL-23 drugs deliver high efficacy for moderate-to-severe psoriasis patients.”

SOURCE: www.manufacturingchemist.com/news

Daiichi Sankyo to restructure vaccines subsidiary

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Daiichi Sankyo is set to restructure its wholly owned Kitasato Daiichi Sankyo Vaccine subsidiary into a specialised manufacturing division to enhance stable production and quality.

In August this year, Daiichi Sankyo will establish Daiichi Sankyo Biotech as a wholly owned subsidiary.

The change will be effective from 1 April next year, and all of the subsidiary’s functions, except manufacturing and production technologies and marketing approvals, will be shifted to Daiichi Sankyo.

The subsidary will be involved in contract manufacturing of vaccines, biologics and investigational drugs.

“All of the subsidiary’s functions, except manufacturing and production technologies and marketing approvals, will be shifted to Daiichi Sankyo.”

Kitasato Daiichi Sankyo Vaccine was founded in 2011 as a joint venture (JV) between Daiichi Sankyo and the Kitasato Institute.

The JV’s operations include research and development (R&D), production and the sale of vaccines to prevent and treat verioud infectious diseases in humans.

Kitasato Vaccine was created as a wholly owned subsidary in November last year during a review of its vaccine business structure.

After the integration, the division focussed on the quality and stable supply of vaccines, along with the R&D and commercialisation of new products.

Daiichi Sankyo is a research-based pharmaceutical company involved in making generic pharmaceuticals, vaccines and over-the-counter medicines.

With operations across the US, Japan and Europe, the company has various other subsidiaries, including Luitpold Pharmaceuticals, Plexxikon, Daiichi Sankyo Ilac Ticaret, Daiichi Sankyo UK and Daiichi Sankyo RD Novare.

SOURCE: www.pharmaceutical-technology.com/news

More than 400 jobs to be created by Dundalk’s “Factory of the Future”

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The move will see the creation of a further 700 construction jobs.

400 new, high-skilled jobs will be created over the next five years in Dundalk, Co. Louth after it was confirmed that a Chinese bio-manufacturing company will be investing €325 million into the creation of a new drug substances manufacturing facility in Mullagharlin.

WuXi Biologics is a Shanghai-based and Hong Kong-listed biologics technology firm, which provides pharmaceutical and biotechnology companies services to develop and manufacture biologics.

The facility is situated on the Industrial Development Authority’s greenfield site in Mullagharlin, Dundalk and will be the company’s first site outside China.

Launched on Monday, 30 April in Dundalk, Taoiseach Leo Varadkar said: “This is the start of something special.”

“We will see the Factory of the Future, right here in Dundalk. It’s the first sizable Greenfield project from China in the pharma sector and I am delighted to see it located here in Dundalk. It’s also the latest in a number of investments in this town which has become a hub for a range of sectors, mainly in the new knowledge based and pharmaceutical sectors.”

Minister for Business, Enterprise & Innovation, Heather Humphreys TD said: “This investment will result in the creation of over 400 highly skilled jobs over 5 years as well as approximately 700 construction jobs.

“This development is a further example of the success of our commitment under the Regional Action Plans for Jobs to provide quality jobs in regional locations.”

Dr. Chris Chen, CEO of WuXi Biologics later added: “We are all excited to initiate our first global site to enable local companies and expedite biologics development in Europe.

“In addition, this is the start and a critical part of our global biomanufacturing network to ensure that biologics are manufactured to the highest quality and with a robust supply chain to benefit patients worldwide. We are committed to Ireland and will work with all local partners to build this state-of-art next generation biomanufacturing facility as a showcase to the global biotech community.”

SOURCE: www.joe.ie/news/400-dundalk-chinese-biotechnology-624392

Celgene bucks trend to strengthen neuroscience pipeline

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Celgene has gone against industry movement to back out of the neuroscience area by putting down a potential $2.2 billion to gain options on three drug candidates held by Prothena.

The deal sees Celgene pay $100 million up front, alongside buying $50 million in shares of Prothena, with milestone payments on the three drugs potentially racking up to a total payment of $2.2 billion.

Whether Prothena will see anything of this money depends on how well each clinical candidate performs in Phase 1 trials.

The neuroscience area has not been blessed with a huge amount of good news of late, with Pfizer pulling out of the space and a raft of Alzheimer’s drugs flopping. Celgene backing the area as a long-term investment is welcome news, particularly in regards to Alzheimer’s research, with fears it could begin to flag after so many failures.

One of the candidates is a protein that targets tau. The build-up of tau protein in the brain is one hypothesis about how best to treat the degeneration linked with Alzheimer’s disease.

Prothena commented in the press release that it has “identified antibodies targeting novel epitopes on the tau protein with the ability to block misfolded tau from binding to cells and to inhibit cell-to-cell transmission, preventing downstream functional toxic effects.”

This could be of huge interest, after a number of the other major alterantive hypothesis, amyloid-targeting Alzheimer’s treatments, failed to show efficacy in trials.

The other named target was the protein, TDP-43, which is associated with amytrophic lateral sclerosis and dementia. There is one other protein that Prothena has chosen not to name as being a target, though this is still within the neuroscience space.

“Prothena has a legacy of innovation in neuroscience and a team with a deep understanding of biological approaches that target protein misfolding disorders. Our collaboration leverages each company’s core expertise in protein homeostasis and protein clearance to target proteins that are the underlying cause of many neurodegenerative and orphan diseases. The programs we have chosen to collaborate on have the potential to provide foundational assets from which we can build new therapeutic approaches to these currently untreatable neurological disorders” said Richard Hargreaves, PhD, Corporate Vice President Neuroscience and Imaging for Celgene.

Should Celgene choose to take any of these candidates further than Phase 1, it will be responsible for all global clinical development and commercialisation. Prothena will, in return, receive $80 million per candidate picked up.

SOURCE: www.pharmafile.com/news/516844

Launch of first breast cancer biosimilar in the UK

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MSD has announced the launch of Ontruzant®, (trastuzumab), a biosimilar referencing Herceptin® (trastuzumab/TRZ), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

This was the first trastuzumab biosimilar to receive regulatory approval in Europe and is the first to launch in the UK.

Biosimilar trastuzumab represents the first product approved in the UK under a global biosimilars development and commercialisation agreement between MSD and Samsung Bioepis Co Ltd.

The European Medicines Agency (EMA) requires biosimilars to show they are highly similar to the reference medicine in terms of structure, biological activity and efficacy, safety and immunogenicity profile. Ontruzant (trastuzumab biosimilar (SB3)) is a monoclonal antibody and has been shown to have similar safety and efficacy as its reference product Herceptin (TRZ) in early breast cancer, with breast pathologic complete response rates (bpCR) being 51.7% and 42.0% with SB3 and TRZ respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within and the upper limit outside the equivalence margin. The overall response rates were 96.3% and 91.2% with SB3 and TRZ.

Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the deputy lead clinician for breast cancer in the North of England Cancer Network said, “This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS. The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving.”

Denise Blake, Senior Lead Clinical Pharmacist at Newcastle Hospitals, explains, “The introduction of biosimilar trastuzumab provides an opportunity for the NHS to realise substantial financial savings without compromising patient care. Close collaboration between oncologists, pharmacists and nursing staff is required to ensure a seamless introduction into routine clinical practice.”

“As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis,”explains Louise Houson, UK Managing Director, MSD.

Regulatory approval was based on a Phase III study that compared SB3 with reference TRZ in patients with human epidermal growth factor receptor HER-2 positive early breast cancer in the neoadjuvant setting.

The study showed the total pathologic complete response rates were 45.8% and 35.8% and the overall response rates were 96.3% and 91.2% with SB3 and TRZ, respectively. Eight hundred patients were included in the per-protocol set (SB3, n = 402; TRZ, n = 398). The bpCR rates were 51.7% and 42.0% with SB3 and TRZ, respectively. The adjusted ratio of bpCR was 1.259 (95%CI, 1.085 to 1.460), which was within the predefined equivalence margins. The adjusted difference was 10.70% (95% CI, 4.13% to 17.26%), with the lower limit contained within pre-specified equivalence margins and the upper limit of the confidence interval slightly exceeding the pre-specified equivalence margins (-13%, 13%).

Overall, 96.6% and 95.2% of patients experienced one or more adverse event, 10.5% and 10.7% had a serious adverse event, and 0.7% and 0.0% had antidrug antibodies (up to cycle 9) with SB3 and TRZ, respectively.

SOURCE: www.hospitalhealthcare.com

The FDA commissioner just laid out how ‘everybody wins’ in the US healthcare system except the patients

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  • FDA Commissioner Dr. Scott Gottlieb put the pressure on health insurance companies and pharma middlemen about the high drug prices patients are facing at a health insurance conference on Wednesday. 
  • “Sick people aren’t supposed to be subsidizing the healthy,” Gottlieb said. “That’s exactly the opposite of what most people thought they were buying when they bought into the notion of having insurance.”
  • Gottlieb’s interested in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far. 

FDA Commissioner Dr. Scott Gottlieb has health insurers in his crosshairs.

Speaking at a policy conference hosted by America’s Health Insurance Plans, the lobby that represents health insurers, Gottlieb called out the practices insurers and pharmaceutical middlemen use that keep prices high for patients.

The Food and Drug Administration, which Gottlieb oversees, is responsible for regulating food and drugs, as well as medical devices, blood donations, veterinary products, cosmetics, and tobacco. While he has oversight into whether or not a drug is approved, the agency does not play a role in determining how much the medication costs once it’s on the market.

Even so, he did not mince words when it came to pointing out the shortcomings of the way those prescriptions get paid for.

“The top three PBMs control more than two-thirds of the market; the top three wholesalers more than 80%; and the top five pharmacies more than 50%,” he said, referring to pharmacy benefits managers, which negotiate lower prices for brand-name medications. “Market concentration may prevent optimal competition. And so the saving may not always be passed along to employers or consumers.”

That’s putting pressure on patients when they show up at the pharmacy counter.

“We continue to see a backlash against these Kabuki drug-pricing constructs — constructs that obscure profit taking across the supply chain that drives up costs; that expose consumers to high out of pocket spending; and that actively discourage competition.”

That can lead to those with chronic conditions paying more for their medication, often close to the list price if they have a high deductible health plan that leaves them on the hook for paying a certain amount before insurance kicks in. And because the rebates drug companies pay to insurers and middlemen are still getting paid, that cost gets absorbed into lowering premiums for everyone who’s insured, healthy and sick alike.

“Sick people aren’t supposed to be subsidizing the healthy,” he said. “That’s exactly the opposite of what most people thought they were buying when the bought into the notion of having insurance.”

The insurers and the pharmaceutical middlemen need to own their role in the pressure it’s putting on patients, Gottlieb said.

“Now I understand that there’s a perverse incentive to use that rebated money to lower premium costs, since most health plans compete on the sticker cost of their premiums,” he said. “But we’re living in a world where financial toxicity is a real concern for patients. And every member of the drug supply chain needs to take responsibility for addressing it.”

Gottlieb’s bringing this responsibility up due to his interest in making the market for biosimilars — essentially generic versions of biologic drugs that could save the US billions — more competitive, something that has proven challenging so far.

Because of how rebates get paid out, there’s not a lot of incentive to use a cheaper version of the biologic drug, which keeps costs high.

“Everybody wins. The health plans get the big rebates. The PBMs get paid on these spreads. And branded sponsors hold onto market share,” he said. “Everyone that is, but the patients, who in the long run, don’t benefit from the full value of increased competition Congress intended.”

On Tuesday, the biggest health insurer in the US, UnitedHealthcare, said that starting in 2019, some of its members on high deductible plans would be eligible to get rebates for their medications. So, for example, if a patient went to the pharmacy for a medication that under their high deductible cost $600, that might get lowered to $300 after factoring in the rebate the insurer receives. Gottlieb called the move a “potentially disruptive step.”

“This could make the difference between patients affording their medicines and remaining adherent, or stopping effective therapy to save on out of pocket costs,” he said.

“Payors are going to have to decide what they want: The short-term profit goose that comes with the rebates, or in the long run, a system that functions better for patients, providers, and those who pay for care.”

SOURCE: www.http://uk.businessinsider.com

How can pharma navigate the complex marketing landscape?

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The first chapter of pharma’s commercial evolution takes us from the insatiable sales-drive of the 1980s to the present, highly complex marketing landscape.

It is easy to forget that our competitive industry still has 80-90% gross margins and, as a consequence, its traditional commercial model is driven by sales growth, rather than worrying about costs.

Under most circumstances, incremental sales drive incremental profit. Within the affiliates this is obvious, and country managers have often resisted attempts by corporate counterparts to take a centralised approach to sales and marketing, claiming their country’s commercial ecosystem is unique and not amenable to meddling.

Of course, the modern pharma company will also have to conduct market access, medical education and phase IV studies within its affiliates, but the reality is that most affiliate activity is focused on sales. For large pharma companies the sales and marketing budget usually beats R&D budgets by 1.7 times, and this is becoming increasingly difficult to justify.

Rise of primary care dominance

Throughout the 1980s and 90s the focus on sales-driven growth led to the evolution of some very different ways of working within primary care, from co-promotion and co-marketing with embedded local players, to the ‘petal’ system of multiple salesforces detailing overlapping product ranges.

The purpose of these techniques, together with employment of contract sales teams, was a sort of ‘shock and awe’ strategy which swamped the physician with frequent visits about particular products. The competitive response was usually swift and commensurate, resulting in a commercial arms race between players within a hotly contested therapeutic area.

This was known as the ‘share of voice’ model, and when applied to large primary care categories, it drove top line growth so successfully that governments and institutional payers were forced to find a response to escalating drug bills around the world.

Backlash from health technology

This response varied from country to country, but has taken two main forms; the Health Technology Assessment response and the consolidated payer response. Throughout the 1990s and 2000s, in the UK (NICE), much of Europe, Australia and parts of Asia, there has been systematic developing of a process that assesses whether a product represents value for society.

Much of the health economics work is shared among countries, and pricing comparisons made between the same product in different countries are routine. The benchmarks for the monetary value of a healthy human being are the subject of debate, but are necessary to make budgetary choices in a system without unlimited resources.

The consolidated payer model, operating in the US through pharmacy benefit managers such as Express Scripts, relies on large payers exerting pressure on manufacturers for rebates, with some undifferentiated product portfolios having to rebate as much as 50% of their gross price.

The impact of health technology assessments can be seen today, manifesting itself in pricing pressure, therapeutic substitution, a diminution of decision-making by physicians and a conscious shift towards products with a confirmed medical need. A decline in R&D productivity, however, has not made this process easy.

Dead end: Primary care hits a wall

Many commentators blame the decline in R&D productivity for the steep fall in product approvals through the 2000s but, in reality, there have been several forces at work.

The rise in genomics, together with high-speed screening techniques, led to a belief that chemical libraries could be screened against unprecedented targets and that optimised drug candidates would flood through the discovery phase into phase I trials.

The sharp product rise in the early clinical phases then came to a shuddering halt during phase II ‘proof of concept’ studies, when large numbers of clinical failures unveiled the reality – there is no short cut to understanding disease biology.

As research cul de sacs were explored, a squeeze on primary care products began in the form of price pressure from above and greater safety demands from below. As a consequence, and aided by the rise in technology, a rapid increase in the proportion of newly-approved, biological in origin drugs commenced.

Monoclonal antibodies, vaccines, enzyme replacement therapy and other therapeutic peptides, aided by insatiable demand for insulin, developed strong sales and completely changed the nature of commercial interfacing with physicians.

Biologicals change the commercial dynamic

The pressure on primary care products, together with the impact of the patent cliff in 2012/13, have combined to drive sales of primary care products into stagnation. Much of industry downsizing, particularly within commercial operations, has been in response to this.

Perhaps most merger and acquisition activity within pharma also has its origins in this relentless pressure on primary care sales and the need to reload the pipeline quickly with biologicals and specialties.

The success of biologicals and other specialties, such as oral cancer drugs, in terms of both approval and sales, has required the industry to change its commercial emphasis. The huge traditional focus on primary care or family doctors has changed to specialists, and their support workers within a secondary care or hospital environment.

The increased complexity of the specialty sell, sometimes involving multiple decision-makers, formulary approval, health economic arguments, companion diagnostics and performance-related reimbursement, has required a much smaller, but more skilled group of people to interface with the healthcare network.

Many companies have yet to find the necessary mix of skills within their workforce and are still working under the old assumptions that spending on promotional activities can remain as high as it used to be under traditional models. They do so at their peril. Check out Part 2in the next issue, as promotional resources and modern data come under intense scrutiny.

SOURCE: www.pharmafield.co.uk/features