Category Archives: Collaborations

Six new startups win funding and expert support from Bayer

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Changing the experience of health: that’s the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year.

The young companies came out ahead of more than 1,800 competitors from 100 countries.

They now have 100 days in which to intensively drive the further development of their products and solutions with expertise and investment from Bayer. The company will provide them with offices in Berlin, pharmaceutical executives and industry experts as mentors and EUR 50,000 in funding for each project.

The startups that have applied are developing digital solutions that cover the entire value chain within healthcare. Also this year, a patient jury was asked to rank startups according to the impact that their solutions would have on patient experience.

This year’s winners are:
• Agamon (Israel, GB): A healthcare intelligence platform that can be used to compile and structure health-related data from various sources in order to derive new information. www.agamon.io
• Cyclica (Canada): A cloud platform that aims to use artificial intelligence and biophysics to accelerate drug development. www.cyclicarx.com
• KinAptic (USA): An accelerated learning system for VR stroke rehabilitation using electric stimulation that analyses and detects neural signals to stimulate nerves in stroke patients. www.kinaptic.com
• OME (GB): Personalised health coaching that uses extensive data analyses to compile individualized health programs (nutrition, sleep, physical activity) in order to prevent disease. www.ome.health
• S-There Technologies (Spain): A smart device that analyses health data through urine in the toilet and gives patients insights into their health. https://s-there.com/
• Zencorlabs (Germany): A smartphone software and device that uses artificial intelligence to warn patients of heart failure.

Six years ago, Bayer started cooperating with startups in the healthcare sector through the G4A program headed by Eugene Borukhovich, he said, “It’s incredible to see the tremendous impact that some of our startups have had in the industry. I’m impressed to see the maturity and significance of their innovative solutions. Through the Accelerator program, I’m convinced we will be able to make a significant contribution to truly change the experience of health as we know it. We will continue to put people at the centre of their health and care every single day.”

Dieter Weinand, Member of the Board of Management of Bayer AG and head of the Pharmaceuticals Division commented, “Digital solutions are essential to driving innovation in an evolving healthcare environment. Bayer is seeking to apply them across the pharmaceutical value chain in order to detect diseases at an earlier stage, to develop medicines faster, and to deliver individual treatments with a meaningful outcome for patients. In this endeavour, we benefit immensely from collaborations and the exchange of knowledge and skills with innovative startups.”

SOURCE: www.pharmafield.co.uk/pharma_news

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

Can pharma halt the world’s obesity crisis?

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Major research published in the Lancet this week comes as no surprise, but the findings are still sobering: across the world there are too many people who are not doing enough exercise, putting themselves at risk of diseases such as obesity and type 2 diabetes.

The research published in Lancet Global Health showed that more than a quarter (1.4 billion) adults are at risk from not doing enough physical activity – these diseases are hugely costly to society and to individuals affected.

The levels of insufficient physical activity varied widely across income groups – 16% in low-income countries, compared with 37% in high-income countries.

And in 55 (33%) of 168 countries, more than a third of the population was insufficiently active according to the figures collated in 2016.

In four countries more than half of adults were insufficiently active – Kuwait (67%), American Samoa (53%), Saudi Arabia (53%) and Iraq (52%).

But the regions with the highest increase in insufficient activity over time were high-income Western countries (from 31% in 2001 to 37% in 2016), and Latin America and the Caribbean (33% to 39%).

Countries from these regions driving this trend include Germany, New Zealand, the USA, Argentina, and Brazil.

Authors also identified several socioeconomic forces at work behind the problem – including urbanisation, sedentary occupations, and motorised transport in the richer countries where lack of exercise is most prevalent.

This research will be of interest to the pharma companies that are attempting to tackle diabetes and obesity related diseases, not just with medications but by working with governments to try and influence policy to reduce incidence of the disease.

Leaders in the field such as Novo Nordisk and AstraZeneca are actively campaigning to try and encourage governments to think about how they can encourage people to become more active, and reducing the levels of obesity in society.

With networks of experts in diabetes in countries across the world big pharma companies have realised that there is a huge opportunity to reach out to health systems using corporate social responsibility programmes that aim to tackle the issues outlined in the Lancet research.

For instance Novo has created an initiative entitled “Cities Changing Diabetes” that specifically aims to tackle the problem of “urban diabetes”.

The project involves collecting qualitative and quantitative evidence that could lead to better understanding of the problem and the contributing factors.

It has built up a network of partners across the world, including city leads, city administrations, academia, diabetes associations, health insurances, community centres and business corporations.

So far it has built relations with 16 cities across the world, representing 100 million citizens, including Beirut, Copenhagen, Leicester and Shanghai.

The project is driven by the recognition that the problem with diabetes is only going to get worse unless immediate action is taken.

According to modelling from Novo Nordisk, in order to hold the rise in prevalence at 10%, the world must set itself a target of reducing obesity by 25% by 2045.

Novo organised a Cities Changing Diabetes Summit last year, where it made the call for joint working across sectors and disciplines in order to unite them behind the cause.

Novo has launched an Urban Diabetes Toolbox that gives policy makers tools on how to tackle the problem, including diabetes vulnerability assessment tools, and tips about how to promote healthy living.

AstraZeneca has also been active in this regard, taking part in the multi-year Action in Diabetes initiative and participating in the Global Diabetes Policy Forum in Rome last October.

Now in its third year, the event brought together more than 100 leading global experts in type 2 diabetes care to discuss best practice in policy-making.

Inspired and funded by AstraZeneca, the initiative operates in partnership with the Internatioinal Diabetes Federation, the World Heart Federation, and Primary Care Diabetes Europe, among other organisations.

AstraZeneca’s work aims to demonstrate the interconnectivity between metabolic, cardiovascular, and renal diseases and foster policies that deal with these diseases in an holistic manner.

Eli Lilly is also known for its work in diabetes, and has launched its non-communicable disease partnership with a similar aim.

It has three aims  – piloting new approaches to strengthen diabetes care, advocating to governments for better disease management, and increasing appropriate use of and compliance with medicines to improve outcomes.

The scale of the problem is daunting, but pharma’s focus on raising awareness about the issue, and bringing different stakeholders together towards the common goal of reducing obesity is an example of how industry can help to tackle one of the major social problems of our times.

SOURCE: www.pharmaphorum.com/views-and-analysis

Ionis/Akcea’s ultra-rare disease drug rejected by FDA

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The FDA has opted to refuse approval to Akcea and Ionis’ Waylivra (volanesorsen) for the treatment of the ultra-rare hereditary condition familial chylomicronemia syndrome (FCS), despite the submission of Phase 3 data from the largest-ever study of the disease.

The US regulator alerted the manufacturers via a complete response letter (CRL), originating from its Division of Metabolism and Endocrinology Products, but the reason for the rejection was not given. Submitted data had shown that Waylivra reduced triglycerides by 94% in patients compared to placebo, which raised levels by 18%

FCS is characterised by extremely elevated triglyceride levels in the blood – levels which can’t be adequately metabolised due to a deficiency off lipoprotein lipase; it severely impacts daily life and can cause a range of damaging conditions including unpredictable and potentially fatal acute pancreatitis, chronic complications due to permanent organ damage.

“We are extremely disappointed with the FDA’s decision. FCS is an ultra-rare and debilitating disease. Our disappointment extends to the patient and physician community who currently do not have a treatment available to them,” commented Paula Soteropoulos, Chief Executive Officer of Akcea Therapeutics. “We continue to feel strongly that Waylivra demonstrates a favourable benefit/risk profile in people with FCS as was reflected in the positive outcome from our Advisory Committee hearing in May. We will continue to work with the FDA to confirm the path forward.”

Dr Brett P Monia, Chief Operating Officer of Ionis Pharmaceuticals, added: “We are fully supportive of WAYLIVRA and the many patients, physicians and researchers who are working to provide the first therapeutic option for FCS, a truly life-altering disease that deserves a treatment.”

SOURCE: www.pharmafile.com/news/518434

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

Collaborative working is key for the NHS and pharma

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Both the NHS and pharma recognise the need and the opportunity to collaborate in order to improve patient care and outcomes, and this was a key theme for discussions at the recent HSJ Life Sciences Forum, which united thought leaders across the healthcare spectrum. 

One way in which industry can work in mutually beneficial partnership with the NHS is by looking beyond the usual promotional plans and tactics, to how it can share valuable clinical evidence and information online by accessing NHS staff intranets. This can enable pharma to build its reputation and strengthen customer relationships whilst improving NHS staff knowledge and expertise.

There is a particular need to support NHS staff on the health economic benefits of complex speciality medicines, as indicated in McKinsey & Company’s recent Medical Affairs: Key Imperatives for Engaging and Educating Physicians in a Digital World report.

It states: “There is an increasing need for education and high-quality information, given the proliferation of specialty and more complex medicine.” The industry has to play an important role in collaborating with the NHS to keep staff abreast of the latest innovations and evidence to support the drive for outcomes-focused reimbursement models.

However, it is clear that pharma needs to modify its approach and consider different multi-channel methods, since the McKinsey report shows that although physicians’ use of digital content for discussion, research and collaboration continues to grow, “81% of physicians are dissatisfied with their interactions with biopharmaceutical companies, and more than 40% no longer perceive a ‘need’ for medical support from pharma”. Physicians’ dissatisfaction was said to be driven by a perceived lack of personalised, relevant content (28%) and appropriate communication channels (17%).

The highly regulated environment in which pharma operates is referenced in the McKinsey report as being partly to blame for industry’s failure to provide the kind of targeted, personalised digital communications for HCPs that are commonplace for customers in many other industries.

This isn’t helped by the rapid pace of structural change within the NHS, where new care models are emerging in different areas across England, key stakeholders often hold a number of roles and responsibilities, and collaborative decision-making is becoming increasingly important.

Despite these barriers, industry already has a wealth of approved and compliant information that can be shared through NHS staff intranets, as part of a more collaborative partnership approach both on and offline. This can enable NHS staff to gain easy access to vital information to help improve outcomes in key care pathways.

Content could range from clinical evidence papers, to trials results reported in conference highlights and clinical guidelines. Reports and outcomes from joint working initiatives that show, for example, how the re-design of a care pathway, combined with new treatments, is improving patient outcomes, could also provide valuable insight nationally and regionally.

By supporting continuing professional development (CPD), with knowledge-improving modules/quizzes, industry can add value to the cash-strapped NHS and help HCPs, who are finding it increasingly difficult to access traditional CPD courses, owing to funding cuts.

While historically the industry has prioritised promotional budgets and activity to drive sales performance, now is the time to explore equally measurable and focused routes to sharing the huge range of valuable clinical information at its disposal in order to work more closely with the NHS and help to optimise the performance of NHS staff. This, in turn, will build relationships, reputation and value for both the NHS and pharma.

As the resource constrained and cash strapped NHS looks for ways to collaborate with the life sciences industry to further improve and optimise patient outcomes, there is a substantial opportunity for the industry to align its own objectives by capitalising on its data, information and evidence.

SOURCE: www.pharmaphorum.com/views-and-analysis

 

Bristol diabetes spin-out company acquired by Novo Nordisk

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The global healthcare company has acquired all of the shares of the Bristol supramolecular chemistry company, of which total payments under the agreement could ultimately exceed $800 million.

Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at the Unit DX science incubator in Bristol, UK.

Ziylo has been pioneering the use of its platform technology – synthetic glucose binding molecules – for therapeutic and diagnostic applications.

The acquisition gives Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulins.

The development of glucose responsive insulins is a key strategic area for Novo Nordisk in its effort to develop this next generation of insulin, which would lead to a safer and more effective insulin therapy.

A glucose responsive insulin would help eliminate the risk of hypoglycaemia, which is the main risk associated with insulin therapy and one of the main barriers for achieving optimal glucose control. Thus, a glucose responsive insulin could also lead to better metabolic control and overall reduce the burden of diabetes for people living with the disease.

Prior to closing of the acquisition, certain research activities have been spun out of Ziylo to a new company, Carbometrics. Carbometrics has entered into a research collaboration with Novo Nordisk to assist with ongoing optimisation of glucose binding molecules for use in glucose responsive insulins.

Carbometrics has licenced rights to develop non-therapeutic applications of glucose binding molecules, with a focus on developing continuous glucose monitoring applications.

Ziylo’s glucose binding molecules are synthetic molecules that were designed by Professor Anthony Davis at the University of Bristol. These stable, synthetic molecules exhibit an unprecedented selectivity to glucose in complex environments such as blood.

The combination of this technology with engineered insulin pioneered by Novo Nordisk aspires to realise the world’s first glucose responsive insulin and transform the treatment of diabetes.

“We believe the glucose binding molecules discovered by the Ziylo team together with Novo Nordisk world-class insulin capabilities have the potential to lead to the development of glucose responsive insulins, which we hope can remove the risk of hypoglycaemia and ensure optimal glucose control for people with diabetes,” said Marcus Schindler, senior VP, Global Drug Discovery, Novo Nordisk.

“Novo Nordisk is the ideal company to maximise the potential of the Ziylo glucose binding molecules in glucose responsive insulins and diabetes applications, and it brings hope of a truly groundbreaking treatment to diabetes patients,” said Dr Harry Destecroix, CEO and cofounder of Ziylo.

Novo Nordisk has acquired all shares in Ziylo for an upfront payment and earn-outs with contingent milestone payments. Total payments under the agreement could ultimately exceed $800 million upon the achievement of certain development, regulatory and sales milestones by Novo Nordisk.

SOURCE: www.manufacturingchemist.com/news

Seven million euros for research into chronic inflammatory bowel conditions

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A new collaborative research centre/Transregio 241 ‘Immune-epithelial communication in inflammatory bowel diseases’ is due to commence its research at Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) in July 2018.

In conjunction with the Charité hospital in Berlin, doctors and biotechnologists at FAU will be conducting research in order to better understand the interaction between cells in mucous membranes and immune cells in the bowel and to develop more effective therapy methods for chronic inflammation. The German Research Foundation (DFG) is providing funding worth 11.5 million euros for the first funding period until 2022, and FAU has been allocated nearly 7 million euros of this amount.

Number of patients with IBD is increasing

Severe diarrhoea, stomach pain, cramps – these are the most common symptoms of inflammatory bowel disease (IBD) such as Morbus Crohn or Colitis ulcerosa. Around 40,000 people in Germany suffer from IBD and this number continues to rise. Patients of IBD often suffer from flare-ups of their condition, which severely affects their quality of life and physical capabilities. ‘Despite the use of strong medication, chronic inflammatory bowel conditions remain difficult to treat’, says Prof. Dr. Christoph Becker, lead researcher at the Department of Medicine 1 at FAU’s Universitätsklinikum Erlangen and spokesperson of the collaborative research centre. ‘Acute flare-ups are often treated with corticosteroids that ease symptoms only in some cases. Many patients have to take several immunosuppressive substances.’ In addition, their symptoms are often accompanied by other conditions such as arthritis, acute inflammation of fatty tissue and chronic inflammation of the biliary tract in the liver.

Little research to date on molecular and cellular mechanisms

IBD is difficult to treat because the interactions between various cell populations in the bowel are not yet fully understood. ‘Newer findings show that the intestinal mucosa cannot be regarded as merely a physical barrier. In fact, it is highly-dynamic tissue that reacts to a large number of environmental stimuli including intestinal flora and local or systemic signals,’ explains Christoph Becker. ‘The immune system in the intestine regulates the barrier function of the intestinal wall and the composition of intestinal flora and vice versa as the intestinal barrier influences the immune system.’ However, there is a lack of knowledge of how the interactions between the epithelium and immune cells influence the long-term cellular reactions that contribute to controlling chronic inflammation processes.

New concept for new therapies

This is the starting point for the researchers from Erlangen and Berlin. During the next few years, they aim to integrate findings about the regulation and function of the immune system in the bowel and current data about anti-microbial defence on the mucous membrane barrier into a new concept. The individual projects will focus in particular on the role of misdirected communication between epithelium and immune cells during the pathogenesis of IBD. The researchers’ long-term aim is to develop medication that targets the causes of bowel inflammation while retaining the ability of the immune system to fight infections and cancer cells. In addition, they hope to find diagnostic methods that predict patients’ response to therapies – a goal that not only serves to relieve symptoms quickly, but should also contribute to lowering treatment costs.

Researchers from Erlangen involved in 14 projects

The scientific programme of CRC/TRR 241 is divided into three research areas: Area A ‘Immune regulation of intestinal barrier functions’, comprises projects focusing on the effects of acute and chronic inflammation on epithelial cells, in particular on their cell homeostasis and barrier-forming functions. Area B ‘The epithelium as a regulator of immunity and inflammation in the bowel’ examines the effects of disruptions to the barrier function and antigen translocation on the mucosal immune system. The objective of research area C ‘Diagnosis and therapeutic intervention of IBD’ is to develop innovative therapeutic and diagnostic approaches and evaluate them in a clinical setting. CRC/TRR 241 comprises a total of 22 projects, 14 of which are either based in Erlangen or involve researchers from Erlangen. The Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology, Department of Medicine 3 – Rheumatology and Immunology, the Department of Surgery and the Department of Dermatology and the Institute for Medical Biotechnology are all involved. 23 jobs and 9 scholarships are being funded during the next four years with the nearly 7 million euros allocated to the FAU.

SOURCE: www.eurekalert.org/pub_releases

Roche SMA drug shines in study as costly new therapies advance

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A drug being co-developed by Roche to treat spinal muscular atrophy (SMA) helped improve development scores in babies with the genetic disease, a study released on Monday showed, as the race heats up for therapies destined to be among the drug industry’s most expensive.

PTC Therapeutics, which struck a licensing deal with Roche in 2011 for its SMA program, said more than 90 percent of babies with severe Type 1 SMA given the RG7916 drug achieved a greater than four-point increase in a test to measure their neuromuscular progress six months after treatment began.

PTC shares, which are listed on the Nasdaq, rose as much as 30 percent.

The companies hope their medicine, also known as risdiplam, will be approved to take on rival drug Spinraza from Biogen, which sells for $750,000 for the first year of therapy and about $375,000 annually after that.

Novartis is also quickly advancing in the SMA field with its $8.7 billion acquisition this year of U.S.-based Avexis that is working on a gene therapy for the disorder.

Analysts from Barclays project Novartis’s one-time treatment could run to $1.25 million per patient.

“We are delighted that up to 6.5-fold increase of protein production has translated into clinical impact for these babies,” PTC Chief Executive Stuart Peltz said in a statement about the RG7916 study, adding no babies required a tracheostomy or permanent ventilation since the study began, and no baby lost his or her ability to swallow.

SMA is an often-deadly genetic neuromuscular disorder caused by a missing or defective gene that normally produces a protein needed for development of motor neurons in the spinal cord. This leads to muscle wasting. Many babies with the severest form of the disorder die, while others never stand or walk.

Barclays analyst Emmanuel Papadakis expects that if Roche and PTC’s data holds up on RG7916 with regulators, it could become a fierce competitor to Spinraza, now the only licensed SMA therapy.

Cowen analysts also said on Monday they view PTC’s update as very encouraging for approval — and for competitiveness versus Spinraza, which is administered into the spine about four times a year. Roche’s and PTC’s drug is taken orally.

Novartis Chief Executive Vas Narasimhan also has high hopes for his own newly acquired SMA treatment, saying in April after the Swiss company bought Avexis that its gene therapy has “multi-billion dollar peak sales potential”.

SOURCE: www.pmlive.com/pharma_news

AbbVie trial backs chemo-free Imbruvica combo regimen

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The pairing of of AbbVie’s Imbruvica and Roche’s Gazyva has hit the mark in a chronic lymphocytic leukaemia trial – raising the prospect of a new chemotherapy-free combination regimen for previously untreated CLL patients.

The iLLUMINATE trial showed that oral BTK inhibitor Imbruvica (ibrutinib) plus anti-CD20 injection Gazyva (obinutuzumab) was more effective than Gazyva plus chemo (chlorambucil) in treatment-naïve, older patents (aged 65 or more) with either CLL or small lymphocytic leukaemia (SLL) – a different form of the same disease.

The top-line data isn’t being made available just yet, but in a statement AbbVie said the duo extended progression-free survival (PFS) compared to the active control arm, adding that it will be sharing the data with regulators, in the hope of bringing “the first chemotherapy-free CD20 combination in first-line CLL treatment” to market.

The trial ties in with AbbVie’s strategy of expanding use of Imbruvica as a first-line CLL treatment and, while Gazyva has been something of a slow burner for Roche since its launch in that setting in 2014, it has started to gain momentum with sales rising 41% to CHF 278m last year.

The combination of Gazyva and chlorambucil is now recommended as a first-line therapy for CLL by the US National Comprehensive Cancer Network, which deems it a category 1 treatment, ie one with a high level of evidence backing its use, so outperforming it is a big win for the combination.

“This chemotherapy-free combination represents a potential new treatment option for patients with CLL,” said John Gribben of Barts Cancer Institute in the UK, the lead investigator for the iLLUMINATE study.

“It’s exciting to see the blood cancer treatment paradigm continue to evolve – each advance moves us one step closer to a better standard of care for these patients,” he added.

Imbruvica is already approved for all lines of therapy in CLL, and beating out chlorambucil is not a big surprise as AbbVie’s drug comprehensively outperformed the chemotherapy as a monotherapy in the head-to-head RESONATE-2 trial.

The trial was the basis of Imbruvica’s approval in 2016 as a chemo alternative in treatment-naïve CLL, and the disease accounts for the lion’s share of the drug’s sales, which grew almost 39% to $762m in the first quarter of this year, topping estimates. AbbVie is predicting sales of $3.3bn this year, well on course for its peak sales target of $6bn-$7bn.

AbbVie’s head of R&D Michael Severino said on the company’s first-quarter results call that the strategy is to build a “body of evidence” for Imbruvica – both as a monotherapy and in combination – across different CLL segments “including young and fit patients and the watch-and-wait population”.

SOURCE: www.pmlive.com/pharma_news