Category Archives: Drug Development

Prothena guts workforce by more than half, after trial failure

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Prothena Therapeutics has acted drastically by slashing staff numbers by more than half, after the failure of two pivotal trials for its lead candidate.

The company subsequently ditched NEOD001, when trials revealed that placebo treatment outperformed the drug candidate in the treatment of AL amyloidosis.

The reorganisation sees 63 positions cut away from the Dublin-based company, representing a shedding of 57% of the entire staff at the company.

As is usually the case, the process was necessitated to stymie cash losses during 2018 – it projected its estimated net cash burn for the year to be $40 million to $50 million, driven by a net loss of $170 million to $185 million.

Luckily for the biotech, it’s had some backers that were betting that its work would produce results and so estimates that it still have a relatively healthy $421 million in cash to end the year on.

One notable backer is renowned UK investor, Neil Woodford, who had to defend his investment in biotech in a blog post immediately after the trial failures were announced – pointing out strengths from within the Prothena’s pipeline and suggesting its partnership with Roche was one reason to keep faith with the biotech.

In the announcement regarding its restructuring, Prothena followed suit, with Gene Kinney, President and Chief Executive Officer of Prothena, saying: “As we move forward, we have the resources to support the advancement of our pipeline through meaningful milestones and we will focus on developing neuroscience programs that we believe have a potential to offer significant benefit to patients. This includes our two clinical-stage programs PRX002/RG7935, currently in Phase 2 development in the PASADENA study in patients with early Parkinson’s disease, and PRX004, which recently initiated a Phase 1 study in patients with ATTR amyloidosis.”

PRX002/RG7935 is both being developed in collaboration with Roche and there will be significant hopes placed on this candidate to pull the biotech out of a tricky spot; however, with the treatment being for patients with Parkinson’s disease, it’s a fairly risky bet given the dearth of disease-modifying treatments for the condition.

SOURCE: www.pharmafile.com/news/517476

Eczema drug effective against severe asthma

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Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies.

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients’ ability to breathe better than standard therapies. Dupilumab, an injectable anti-inflammatory drug, was approved in 2017 by the Food and Drug Administration as a treatment for eczema, a chronic skin disease.

The more than 2,000 patients enrolled in the studies suffered from moderate to severe asthma. All used standard asthma inhalers, and some also took oral steroids to control their severe asthma symptoms.

In one study, the rate of asthma exacerbations was almost cut in half for those taking dupilumab compared with those taking a placebo. On average, patients taking a placebo had close to one exacerbation per day during the year of the study. Exacerbations are periods of sudden worsening of asthma symptoms such as wheezing, coughing, shortness of breath and tightness in the chest.

Although the drug significantly reduced asthma symptoms for all patients, dupilumab worked particularly well in patients with high numbers of a specific type of white blood cell, called eosinophils, circulating in the bloodstream. For those patients, asthma exacerbations were cut by two-thirds.

“This drug not only reduced severe symptoms of asthma, it improved the ability to breathe,” said Dr Mario Castro, the Alan A. and Edith L. Wolff Distinguished Professor of Pulmonology and Critical Care Medicine. “That’s important because these patients have a chronic disabling disease that worsens over time with the loss of lung function. So far, we do not have a drug for asthma that changes the course of the disease. Current drugs for severe asthma help reduce trips to the emergency room, for example, but they don’t improve lung function.”

The first study included about 1,900 patients of at least 12 years of age and with moderate to severe asthma requiring they use at least three different inhalers to control their symptoms. One inhaler contained a corticosteroid that reduces inflammation, another contained a long-acting bronchodilator that relaxes airway muscles, and the third was a “rescue” inhaler filled with albuterol, a short-acting bronchodilator that quickly opens up the airway in the event of a more severe asthma attack.

Patients taking these inhaled medications then were randomly assigned to receive either dupilumab or a placebo for one year. Patients receiving dupilumab — an injectable antibody — also were randomly assigned to a higher or lower dose of the drug. Neither patients nor their doctors knew whether they were receiving the drug or the placebo.

In addition to reduced symptoms, the patients receiving dupilumab showed improved lung function in a test of “forced expiratory volume.” This test measures the amount of air a person can force from the lungs during a deep exhale. Patients receiving dupilumab, regardless of dose, improved their lung function by approximately 130-200 millilitres greater than those receiving the placebo. In general, there were no significant differences between the patients receiving high and low doses of dupilumab.

Rates of emergency room (ER) visits and hospitalisations also were improved for patients receiving the drug. In the placebo group (with 638 patients), on average, 6.5 percent of the patients required an emergency room visit or hospitalisation due to asthma during the study. In the dupilumab group (with 1,264 patients), on average, 3.5 percent of patients needed emergency care or hospitalisation due to asthma.

Based on the second study, Dr Castro said another benefit of the drug could be the ability to wean severe asthma patients off of chronic oral steroids, which can cause debilitating long-term side effects, including stunted growth, diabetes, cataracts and osteoporosis. The second study included about 200 patients using the same inhaled asthma medications as patients in the larger trial, plus additional oral steroids — usually prednisone — to control their more severe symptoms. Half of the patients receiving dupilumab in this study were able to completely eliminate prednisone use. And 80 percent of dupilumab-treated patients were able to at least cut their doses in half. Patients on placebo also reduced prednisone use but to a lesser degree, likely because the protocols of participating in a clinical trial help asthma control generally.

Dr Castro said doctors would like to help patients rely less on steroids for asthma control because those with severe asthma can be forced to take these drugs for decades to enable them to breathe.

“I have patients who have had to stop working and go on disability because their asthma symptoms are so severe they can no longer function in the workplace,” Dr Castro said. “I’m excited about the potential of dupilumab because I have so many patients who have maxed out on available therapies and they still can’t breathe. It can become a very disabling disease.”

Patients receiving dupilumab did experience known side effects of the drug, including pain and swelling at the injection site and a short-term bump in the number of eosinophil cells in the blood. Five patients who received dupilumab and three patients who received placebo died during the study period. According to the investigators and descriptions of these patients’ medical histories, all suffered from multiple severe medical conditions, and none of the deaths was deemed related to the study protocol.

The studies will be published online in The New England Journal of Medicine.

SOURCE: www.europeanpharmaceuticalreview.com/news/75890

Sun Pharma drug combo scores FDA approval in advanced castration-resistant prostate cancer

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Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients.

Yonsa has been designed using Churchill Pharmaceuticals’ SoluMatrix Fine Particle Technology manufacturing process to offer a micronised formulation of abiraterone acetate tablets, allowing it to be more efficiently absorbed in the body. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).

As part of an existing deal between the pair, Churchill Pharmaceuticals will receive upfront, commercial milestone payments and royalties related to sales of the drug in the US, where Churchill will handle marketing duties.

“We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” commented Sun Pharma’s North American CEO Abhay Gandhi.

SOURCE: www.pharmafile.com/news/517442

Patient centricity: a winning formula

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Industry has taken a collective pause in an effort to re-evaluate and rethink longstanding approaches to drug development and commercialisation.

There has been considerable discussion about the concept of patient centricity in the pharmaceutical community, with attention being recalibrated on the ultimate goal — making it easier for the patient to reach improved health outcomes. This perspective is underpinned by the recognition that what is best for the patient will lead to beneficial outcomes for all stakeholders, including the drug company, the healthcare provider and the supporting community of associated service providers.

There is a famous quote from former United States Surgeon General, C. Everett Koop: “Drugs don’t work in people who don’t take them.” It is estimated that less than one third of all prescriptions written are actually filled at the pharmacy by patients. Wide-ranging studies have shown medication adherence rates for life-threatening diseases — including diabetes, heart disease and oncology — can be as low as 30–40%. With the benefit of interventional techniques and developing technologies, adherence rates have been shown to improve; however, these programmes are not broadly adopted within industry at scale and have neither significantly reduced the overall cost of healthcare nor benefitted large populations.

Patients may be non-adherent for a variety of reasons, some conscious and some unconscious. Certainly, we are all admittedly forgetful when it comes to taking our medicine on time or being diligent about timely refills of those prescriptions. Cost can also be a significant factor whereby patients will consciously stretch their medication supply or simply go off therapy. In either instance, doing so will hamper the health impact of their prescribed therapy or worse; taking a drug holiday while prescribed an anticoagulant could potentially put their life in jeopardy.

Other considerations may be unwanted side-effects or a lack of understanding about how to optimally take the medication, such as taking with food or alternatively avoiding food for some period of time, resulting in reduced effectiveness. Fear or general lack of understanding can also inhibit the path to improved health by affecting the patient’s perception of the medication and their willingness to be compliant.

Likewise, the patient may not physically experience the benefit of the drug and, in some instances, may have a negative perception owing to the unwanted side-effects. Hypertension is the classic example; the patient may have high blood pressure but generally not feel the effects of their disease. However, they may experience considerably unpleasant side-effects as a result of their course of treatment.

Likewise, a similar scenario plays out in popular cholesterol lowering medications. By scale, these two examples are noteworthy; in the US, with a population of more than 300 million people, of which 75% are adults, it is estimated that one in every three adults has hypertension, whereas 10–20% of adults have high cholesterol. A large-scale patient-centric approach to benefit medication adherence would have significant positive health and economic impacts.

Focusing patient centricity in clinical trials

In addition to challenges with patient adherence to medication in clinical trials, sponsors and study organisers are also constantly faced with hurdles such as patient recruitment and patient retention. As the industry is tasked with further expediting drug development and decreasing clinical study duration, FDA is increasingly requiring additional studies and further data to prove long-term safety and comparative effectiveness, including post-marketing studies once the drug is commercially available in the market.

This trend is coupled with an increasing percentage of drugs being brought to market for very specialised disease states and narrow therapeutic indications. This wave of specialised medicines and the ongoing need for treatment-naïve candidates, paired with cost pressures in the R&D sector, has increased the use of multinational studies. These complex studies in turn create the requirement for multilingual labelling. This can result in the creation of investigational medicinal product (IMP) study materials that may contain upwards of 16–20 languages on a single label.

Clinical trial professionals are left to balance all of these demands and creatively identify initiatives to keep the focus on the patient. At a surface level, these competing priorities may seem to be in direct conflict. However, when one looks at the situation from a broader perspective, the focus on patient centricity clearly generates tangible value and outweighs the short-term inefficiencies created by opting for a solution solely based on speed or cost.

Patient centricity in package design

A practical example of patient centricity in action can be found in package selection for investigational studies. When looking to initiate a clinical study, a sponsor company may be evaluating whether to choose a bottle or a unit dose blister in a calendarised format for their clinical study material.

Looking simply at the short-term criteria of expediting material for study initiation, when a difference of weeks or days can be considerable, the path of selecting a bottle would be a logical solution. It is a cost-effective packaging option, it is relatively “off the shelf” in its availability, it can be hand filled by a clinical packager with minimal start-up costs, has an acceptable stability profile for barrier properties and is child resistant.

Conversely, when evaluating the development of a unit dose adherence package, the company might find that it may involve a longer lead time for development and be more costly to produce. Looking from a short-term perspective and the immediate pressures of cost and expediting, the choice leaves little room for debate. However, if the sponsor company is taking a holistic approach with a focus on patient centricity, the broader economics absolutely point to the use of a patient-centric package.

Using a calendarised unit dose blister format or compliance/adherence packaging enables sponsor companies to both address the needs of the patient as well as positively impact the desire for better data, more efficient studies and lower total delivered cost. The use of this style of package allows patients to take medication exactly as prescribed and track their usage, rather than a bulk approach in a bottle format. Physicians can capture vital information on the package, including the specific date to start the therapy and any other pertinent notes for the patient. With the returned package, the patient can physically demonstrate to clinical providers that they have taken the product as prescribed. Furthermore, technologies are available that can provide real-time tracking of patient dosing, allowing for clinical interventions to ensure proper adherence while the study is in progress.

These technologies and principles extend to other delivery forms such as injectables. The ability to prompt, monitor and even track real-time information is a powerful tool. Likewise, with the advent of Bluetooth and nearfield communication technologies, packages with integrated technology can capture real-time information about side-effects or other vital information as patients take the medication during the course of treatment. Better adherence leads to healthier patients and more valuable study data.

Poor adherence can be rectified and corrected as it happens. Better information gathering can lead to improved patient retention, a significant cost in clinical trial administration and a persistent challenge in study duration. It is estimated that, in the industry, clinical studies on average have a 30% drop out rate. With more adherent investigational study patients, health outcomes are improved and better retention is realised, translating into reduced total delivered cost, more valuable data generated and studies executed more efficiently.

Patient centricity in clinical supply chain logistics

Another focus point for realising patient centricity in clinical trials is in the area of study design and administration. Considerable interest is being focused on Direct-to-Patient models, in which patients may minimise or in some instances avoid the need to come to a hospital or clinic to receive the study drug, as well as provide critical health feedback. In this scenario, patients are engaged by clinical trial or healthcare professionals in a home setting and the study drug is physically delivered to their home by a trained specialist. Clearly, this model is not applicable for all studies and disease states, but for certain programmes there can be considerable benefit to the patient and the study.

In certain geographies, patients in a traditional clinical study may have to travel significant distances to participate, which can considerably hamper patient recruitment and retention. In a Direct-to-Patient model, the study effectively comes to them. This model may increase the cost of study administration for the sponsor company; however, by executing the study in a more patient-focused approach, the sponsor company can realise significant benefit through patient recruitment and retention, again translating into better data, more efficient studies and a faster path to completion.

Patient centricity in a global world

One of the increasing challenges in taking a patient-centric approach to clinical study execution is the growth in multinational study execution. Often, supplies are designed to pool, so that multiple languages are provided and materials can be directed to individual countries as needed.

This scenario forces sponsor companies to either manage a multitude of language-specific supplies or focus on common supplies — whereby they condense information owing to the shear amount of text being added, often squeezed into a multi-page booklet.

Careful consideration must be paid to graphics that are common to all languages and cultures to ensure patients can clearly comprehend considerably distilled opening instructions, dosing regimens and other key information. Rather than a traditional pooled supply approach, some companies have developed newer strategies for just-in-time (JIT) labelling or late stage customisation logistics, whereby they label study materials according to country specific requirements at the time of drug dispatch.

This can reduce the complexity of a scenario in which they would be trying to accommodate 16 different languages on the same label in a multi-page booklet approach. This JIT strategy might decentralise supplies but may bring other benefits, such as meeting the language and cultural needs of patients in their geography, as well as those of the study administration.

Patient focus yields powerful results

The industry is only in the infancy of its journey towards patient centricity; but, it is clear that with a focus on the patient, many tangible benefits can be realised by drug companies in the development and commercialisation of life-saving medicines.

With so many significant breakthroughs during the past decade, it is exciting to see where this patient focused journey will lead as new patient breakthroughs are happening every day.

SOURCE: www.manufacturingchemist.com/news

ABPI expert urges to find new ‘blockbuster treatments’ for brain tumors

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With the Government set to invest an additional £20 million into the research, diagnosis and development of treatments for brain tumours, we need to talk more about how we are going to find the next blockbuster treatments for these devastating diseases.

Nearly 11,500 people are diagnosed with a brain tumour every year in the UK with fewer than 15% surviving beyond 10 years. This week’s announcement from the from the Department of Health and Social Care – following the death of Dame Tessa Jowell – that they would be doubling investment for brain cancer research to £40 million is a welcome commitment to helping achieve a goal our industry shares: finding innovative new treatments and cures for these diseases.

The science is advancing in laboratories here in the UK and around the world, funded and supported by charities, universities and the pharmaceutical industry, collectively we are working to fight back against this terrible disease.

Among the 7,000 medicines currently being developed by the global pharmaceutical industry, there are 58 medicines in the pipeline for brain tumours, including gliomas. Companies are actively working to find better ways to speed up medicines development to get treatments to patients sooner.

In her speech to the House of Lords in January, Dame Tessa Jowell talked candidly about her glioblastoma diagnosis and called for greater collaboration in the fight against cancer. She also talked about the speeding up of drug trials by testing more than one at a time, saying: “I am not afraid, but I am fearful that this new and important approach may be put into the ‘too difficult’ box.”

The type of clinical trials Tessa Jowell talked about have many different names: adaptive randomisation, drop-the-loser, adaptive dose-finding, adaptive seamless and the list goes on.

The one thing they all have in common is flexibility. In trials like this – that we call adaptive design clinical trials – researchers can see how patients are responding to treatments and then change or stop parts of the trial in real time.

When used appropriately, trials like this may improve efficiency, reduce cost, maximize information gained and minimize risk to the patients and sponsors. Ultimately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients. The UK is seen as a pioneer of innovative clinical trials and this involves collaboration between academia, the NHS, industry and medical research charities –  we must ensure we keep it that way in the future.

The issue is that these clinical trial types are not easy to design, plan or execute. An adaptive design will not rescue a poorly planned trial or ineffective treatment.

We need to make sure the regulatory authorities in the UK are not seen as a barrier to innovation; the MHRA and HRA are open to discussion and we need to encourage researchers and pharmaceutical companies to start conversations with them early in the process of planning an innovative clinical trial.

We think that adaptive design clinical trials could be the solution to speeding up the research and development of not only brain tumor treatments, but for all sorts of diseases. Research into small or rare patient populations could really benefit from these trials since they help us quickly rule out the drugs or drug combinations that aren’t working and give more patients the option to contribute to research and clinical trials.

We’re not alone. In February, the Department of Health and Social Care published their brain tumor research report which stated that, because brain tumors are one of the areas that have small patient populations, we need to think differently about how we conduct clinical trials and incorporate innovative trial designs.

The report provided practical recommendations for how we can work collaboratively to make quicker progress in this area. The next steps are to build on the UK’s existing strengths, ensure we have access to researchers with the right skills, and make sure that the right infrastructure is in place for us to make really make progress in this area.

Alongside their funding announcement, we welcome the Government’s commitment this week to accelerate the use of adaptive design trials. When used appropriately, drug development can be accelerated so that the right treatments can be delivered rapidly to the right patients – and that’s where the real benefit lies.

As we look to the future of cutting-edge research and development for blockbuster treatments, we know we need to make the case for innovative clinical trial design, talk more about the amazing science our researchers, companies and NHS are pioneering and encourage them to have open conversations with the UK regulators to ensure that innovative clinical research is safe and effective.

Together, we won’t rest until devastating brain tumours are a thing of the past.

SOURCE: www.news-medical.net/news

Boehringer partners with Bactevo on drug discovery

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Boehringer Ingelheim is bolstering its drug discovery efforts with a new collaboration with UK tech-enabled research firm Bactevo.

Enabled by advance machine learning, Bactevo claims that its Totally Integrated Medicines Engine platform (TIME) will be able to bring about a paradigm shift in the speed, efficiency and quality of drug discovery, as well as dramatically enhanced safety profiling.

Aiming to identify novel small molecule lead compounds, the deal will see Bactevo use its TIME and synthetic chemistry technology to further enhance speed, efficiency and quality when detecting novel in vivo enabled leads.

In addition to working with partners to develop novel first-in-class medicines, Bactevo is also developing breakthrough medicines for the treatment of diseases that involve defects in mitochondrial function, such as MELAS and LHON. It is also targeting diseases of the central nervous system, such as Parkinson’s, Alzheimer’s and Amyotrophic Lateral Sclerosis (ALS).

Bactevo will receive upfront payments and research funding, although that specific amount was not disclosed at the time of writing.

The tech group could also be eligible to receive payments for certain research, development and commercialisation milestones.

David Williams, chief executive officer of Bactevo, said: “We are pleased to be commencing this highly complementary collaboration with Boehringer Ingelheim.

“It combines our cutting-edge TIME drug discovery platform with the powerful therapeutic drug development and commercialisation experience at Boehringer Ingelheim to create much needed new medicines in areas outside of our current therapeutic focus.”

SOURCE: www.pmlive.com/pharma_news

New indication for evolocumab in established atherosclerotic cardiovascular disease

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Amgen has announced announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

With the expanded label now in place, Amgen is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

“With its proven ability to prevent heart attacks and strokes, Repatha offers hope for one of the greatest health challenges we face today. However, the majority of patients in Europe who could benefit from treatment with a PCSK9 inhibitor remain unserved and at risk of a cardiovascular event,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen. “To help ensure eligible patients around the world can access and benefit from Repatha, Amgen is willing to work in partnership with payers to help manage affordability concerns from increased patient access. Furthermore, we are committed to excellence in LDL-C management and collaborating with healthcare providers to deliver comprehensive solutions for patients.”

Of all the modifiable risk factors for heart attack and stroke, lowering high LDL-C is one of the most important and impactful.1,2 Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Repatha is a groundbreaking medicine proven to significantly lower “bad cholesterol” or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.

“We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year,”3-5 said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “With far too many patients at risk of recurrent cardiovascular events, we are pleased that the European Commission has approved Repatha to prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease. The science clearly indicates that ‘lower LDL-C is better’ and this approval underscores the role for Repatha among high-risk patients for whom statins alone are not enough.”

The approval by the EC recognises the positive findings from the Repatha cardiovascular outcomes study (FOURIER), expanding the label to include data on the additional reduction and prevention of heart attacks, strokes and coronary revascularisations on top of maximally tolerated statin therapy. FOURIER showed reductions in the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularisation procedures by 22% in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.6

References

  1. National Heart, Lung, and Blood Institute. How To Prevent and Control Coronary Heart Disease Risk Factors. Accessed April 10, 2018
  2. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14
  3. Mohan KM, et al. Stroke. 2011;42:1489-94
  4. Bhatt DL, et al. JAMA.  2010;304:1350-7.
  5. Jernberg, T., et al. Eur Heart J. 2015. 36(19), 1163-117
  6. Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Pfizer eyes AI-powered drug discovery and development software

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Pfizer has partnered with a ‘computation-driven’ pharmaceutical technology company to develop a drug discovery platform powered by artificial intelligence (AI).

Its collaboration with Cambridge, Massachusetts-based XtalPi will see the firms work on molecular modelling software that can be applied to drug-like small molecules.

Charlotte Allerton, Pfizer’s head of medicine design, said: “The XtalPi collaboration is an opportunity to enhance our computational modelling capabilities.

“We are looking forward to potentially utilising new tools to increase our effectiveness in small molecule drug discovery and development.”

In addition to supporting its own efforts, Pfizer plans to make available to the wider academic community some of the molecular mechanics parameters it will generate with public-domain compounds.

The new software platform will combine quantum mechanics, machine learning algorithms and cloud computing architecture to help Pfizer predict pharmaceutical properties that would be relevant for drug discovery and development.

Shuhao Wen, XtalPi’s co-founder and chairman of the board, said: “The collaboration allows us to apply our expertise in molecular modelling, AI, and cloud computing towards improving existing computational methods while exploring new algorithms to address a wide range of drug design challenges.

“We look forward to helping expedite research into novel therapeutics as our intelligent digital drug discovery and development platform continues to expand and succeed.”

The deal builds on XtalPi’s existing work with Pfizer on crystal structure prediction (CSP), with that project aiming to advance the partners’ capabilities in computation-based rational drug design and solid-form selection.

Founded in 2014 by a group of quantum physicists from MIT, XtalPi’s team combines expertise in physics, chemistry, pharmaceutical R&D, and algorithm design.

The company, which counts Google and Chinese internet conglomerate Tencent among its investors, is one of a swathe of AI players looking to innovate drug discovery and development processes.

These include BenevolentAI, Hitachi and Scotland’s Exscientia, with the latter working with the likes of GlaxoSmithKline, Sanofi and Evotec.

At stake is a share in market for healthcare AI applications that’s predicted to be worth more than $10 billion by 2024, driven by the rise in precision medicine and the need to reduce healthcare costs.

SOURCE: www.pharmaphorum.com/news

Emergex wins Innovate UK grant to advance universal flu vaccine

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A UK biotech developing a pioneering a new approach to developing vaccines for infectious diseases has been awarded a grant of £979,318 by Innovate UK.

Emergex Vaccines says the funds will help fuel progress of its universal flu vaccine programme through preclinical development.

The vaccine is designed to target components of the influenza virus that are common to all strains, and will therefore also be suitable to target the outbreak of a new flu pandemic caused by the emergence of a novel form of the virus at the time it moves from an animal species into humans, according to the firm.

The vaccine is 100 percent synthetic and delivers “highly conserved immunogenic peptide fragments from the flu virus to antigen presenting cells in the skin, eliciting a strong and long-lasting T-cell immune response,” it said.

The grant should cover 70 percent of the cost of developing the flu vaccine programme over a period of two years, and will be used to complete preclinical toxicology and validation studies and the manufacturing of the vaccine, so that clinical batches are ready for Phase I clinical testing in the first half of 2020.

“This Innovate UK grant provides endorsement of our flu vaccine programme and reinforces our belief that an innovative approach, using the very latest technologies, could help protect the public from this inevitable epidemic or pandemic health threat,” noted Professor Thomas Rademacher, co-founder, chief executive and chief scientific officer at Emergex.

SOURCE: www.pharmatimes.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