26 September 2018

Gilead to launch generic versions of hepatitis C drugs 

Gilead Sciences has revealed plans to introduce generic versions of its Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni (ledipasvir 90mg/sofosbuvir 400mg) in the US for the treatment of chronic hepatitis C virus (HCV) infection.

Set to be launched through the company’s new subsidiary Asegua Therapeutics, the generics will be available from January 2019 at a list price of $24,000 for the most common course of therapy.

Harvoni was commercially launched in 2014 at a list price of $94,500, while Epclusa came in 2016 with a price of $74,760, as reported by Bloomberg.

Gilead noted that the lower price for generics is intended to more closely reflect the current discounts received by health insurers and government payers.

The generics are estimated to potentially save up to $2,500 in out-of-pocket costs per course for patients, in the Medicare Part D setting.

Furthermore, the company plans to work with all its healthcare partners to enable list price reductions of its HCV drugs and for solutions to minimise patients’ out-of-pocket costs.

Gilead Sciences president and CEO John Milligan said: “Launching these authorised generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business.

“This launch also will hopefully help increase transparency by more closely aligning our medications’ list prices with their cost. Our ultimate goal is to lower the list price of Epclusa – a medication we believe is of great importance given its clinical profile across genotypes – and Harvoni.

“We are committed to working with all of our partners in the healthcare system to help enable list price reductions of our HCV medications and find better solutions to reduce patients’ out-of-pocket costs.”

Gilead will also continue to explore new alliances and long-term financing models to bolster access to medications, as well as eliminate HCV.

26 September 2018

Researchers devise new approach to target Alzheimer’s 

An international research team has developed a new method that addresses the cause of Alzheimer’s disease by targeting toxic particles responsible for the death of healthy brain cells.

The team, which comprises researchers from the University of Cambridge in the UK and Sweden’s Lund University, expects the new approach to help in the development of new dementia medications.

During the research, the team identified abnormal deposits called protein oligomers as the most likely reason for the development of dementia.

The proteins normally participate in cell processes. However, in Alzheimer’s patients, they were found to become faulty, cause the formation of clumps and destroy healthy nerve cells.

University of Cambridge chemistry department professor Michele Vendruscolo said: “This is the first time that a systematic method to go after the pathogens – the cause of Alzheimer’s disease – has been proposed.

“As the pathogens have now been identified as small clumps of proteins known as oligomers, we have been able to develop a strategy to aim drugs at these toxic particles.”

The researchers believe that the new approach will facilitate systematic development of compounds to target these toxic protein oligomers.

Vendruscolo added: “Our research is based on the major conceptual step of identifying protein oligomers as the pathogens and reports a method to systematically develop compounds to target them. This approach enables a new drug discovery strategy.”

The team estimates that the first drug candidates based on their new approach will enter clinical trials in about two years.

Furthermore, the researchers have co-founded a biotechnology company called Wren Therapeutics, which will focus on advancing the ideas developed at Cambridge into new techniques to diagnose and treat misfolding disorders, including Alzheimer’s.

26 September 2018

BioElectron reports positive Phase IIa results from ALS drug trial

BioElectron Technology has reported positive results from a Phase lla clinical trial evaluating the safety, tolerability, and pharmacology of EPI-589 in patients with amyotrophic lateral sclerosis (ALS).

The open-label, single-group assignment trial enrolled 21 ALS patients who were on medication for the disease.

It included a 30-day run-in period to establish baseline biomarker and clinical status.

During the trial, the enrolled patients received EPI-589 for a period of 90 days and were followed for an additional three months after withdrawal of therapy.

BioElectron conducted the trial at three ALS sites in the US, namely California Pacific Medical Center (CPMC) in San Francisco; Cedars-Sinai Medical Center in Los Angeles; and Providence Portland Medical Center in Portland.

The trial met its primary safety and tolerability objective with no drug-related serious adverse events or dose-limiting toxicities.

A statistically significant improvement in cerebrospinal fluid (CSF) and plasma-based biomarkers related to neuroinflammation and ALS disease progression were also observed.

Results of a series of clinical evaluation further showed that EPI-589 was able to slow down disease progression as measured by ALS Functional Rating Scale, as well as improved grip strength and swallowing.

BioElectron CEO Dr Matthew Klein said: “This data demonstrating drug safety, tolerability, and disease biomarker effect provides a strong rationale for the continued development of EPI-589 for ALS.

“Furthermore, the biochemical evidence of EPI-589’s effect on biomarkers of neuroinflammation and disease progression support the development of EPI-589 for other neurological disorders characterised by neuroinflammation.”

EPI-589 is a new, orally administered small molecule currently under development for adult neurodegenerative diseases.

25 September 2018

Noxopharm finds new approach to address chronic inflammation

Australia-based Noxopharm and its subsidiary Nyrada have found a new compound that inhibits interleukin-1 receptor-associated kinase 4 (IRAK4) protein to potentially help treat various chronic inflammatory and autoimmune diseases.

IRAK4 is found in the cells of the body’s immune system and said to be the ‘master switch’ in the development of chronic inflammation.

Any faulty behaviour of this protein in the immune cells is known to be responsible for most of the chronic inflammation forms. Based on this, IRAK4 inhibitors are considered as the next generation of anti-inflammatory medicines.

Noxopharm noted the discovery of a new ‘potent’ IRAK4 inhibitor. The company believes that the candidate can be used to treat common inflammatory diseases, along with those of the central nervous system and peripheral nerves.

The therapy of central nervous system conditions is expected to be possible as the new compound can cross the barriers to enter the brain and peripheral nerves.

Nyrada R&D vice president James Bonnar said: “A lot of attention currently is being given to developing IRAK4 inhibitors for diseases such as rheumatoid arthritis and gouty arthritis and lupus, but we see our discovery as a breakthrough in providing the tools needed to address inflammatory and autoimmune diseases of the nervous system.”

Noxopharm added that capability to cross barriers may allow development of drugs for inflammation related to Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, amyotrophic lateral sclerosis and peripheral neuropathies, among others.

Noxopharm CEO Graham Kelly said: “Having a drug that blocks IRAK4 and all its downstream pro-inflammatory cytokine effects, combined with its ability to reach the brain in sufficient levels, is an exciting breakthrough that has resulted from a lot of hard work by a team of Australian chemists and scientists.”

The company is currently conducting pre-clinical programmes to determine the most appropriate therapeutic indications for the new compound. It anticipates entering human clinical trials in 2020.

24 September 2018

Mylan and Fujifilm secure EC clearance for Humira biosimilar

Mylan and Fujifilm Kyowa Kirin Biologics have received authorisation from the European Commission (EC) to market Hulio, a biosimilar to AbbVie’s Humira (adalimumab).

Adalimumab is a selective inhibitor of tumour necrosis factor (TNF), which is known to cause inflammation in autoimmune disorders. The Humira biosimilar binds to TNF, blocks its activity and therefore reduces inflammation and other symptoms.

The EC clearance of Hulio covers all Humira indications. These include rheumatoid arthritis, ankylosing spondylitis, psoriasis, Crohn’s disease, ulcerative colitis, uveitis and hidradenitis suppurativa in adults, as well as paediatric indications, such as polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, hidradenitis suppurativa and uveitis.

Fujifilm Kyowa Kirin Biologics president and CEO Dr Yoshifumi Torii said: “The EC’s approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries.”

AbbVie granted a non-exclusive royalty bearing licence to Fujifilm Kyowa Kirin Biologics for the use and sale of Hulio in European countries.

In July this year, Mylan signed similar patent licence agreements with AbbVie over rights for Humira biosimilar in the US and other relevant international markets, with the exception of Europe.

Fujifilm Kyowa Kirin Biologics and Mylan initially partnered earlier this year. Mylan plans to launch Hulio across multiple European markets from mid-October.

Mylan Europe president Jacek Glinkasaid: “Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care in the face of ageing populations and increasingly stretched resources.”

The clearance comes at a time when AbbVie is facing insurance-fraud charges in the US for allegedly offering illegal kickbacks to healthcare providers in order to maintain Humira sales.

21 September 2018

Innovate UK funds AI drug discovery platform

Innovate UK has been awarded a grant to support the development of an artificial intelligence (AI) drug discovery project by Optibrium, Intellegens and Medicines Discovery Catapult.

Optibrium focuses on development of software to enhance drug discovery, Intellegens is a spin out of the University of Cambridge working on deep learning and Medicines Discovery Catapult is the UK's national centre of applied research and development (R&D) expertise.

Under the £1m project, the companies will utilise the Innovate UK grant to co-develop a next generation AI drug discovery platform using new deep learning techniques.

These new AI techniques will be based on Optibrium’s StarDrop software and Intellegens’ Alchemite deep learning toolkit.

The platform will be designed to learn from complex data and predict the absorption, distribution, metabolism, excretion and toxicity (ADMET) of potential new medicines.

Such predictions are expected to provide guidance for scientists when designing and testing new drug candidates.

Optibrium, Intellegens and Medicines Discovery Catapult aim to offer better insights into the interaction of a drug with the body in order to enhance the efficiency and productivity of drug discovery.

Optibrium CEO Matthew Segall said: “We will apply cutting edge deep learning methods and new data to address important challenges in drug optimisation.

“The funding from Innovate UK is important validation of our project team’s expertise and the impact it will have on the industry’s efficiency and productivity.”

Medicines Discovery Catapult chief informatics officer Professor John Overington said: “At Medicines Discovery Catapult we apply innovation, working alongside UK SMEs to drive the development and adoption of new approaches for the discovery and early development of new medicines.

“This collaborative R&D activity will allow us to do just that and the grant from Innovate UK represents an important milestone for the advancement of informatics and data science.”

Innovate UK has also awarded co-funding to Storm ID, NHS Greater Glasgow & Clyde and KenSci for the development of a new care pathway to help chronic obstructive pulmonary disease (COPD) patients.

This project is set to use remote monitoring and AI-based preventative approaches to minimise emergency hospital admissions among COPD patients who are at the highest risk.

The machine learning algorithms will remotely monitor patients’ symptoms, physiology and treatment at home, to provide clinical decision support for patients at high risk of an exacerbation.

21 September 2018

NHS wins landmark ruling against pharma companies over AMD drug 

The UK High Court has ruled in favour of the NHS regarding the use of a cheaper, unlicensed drug for common eye condition wet age-related macular degeneration (AMD) over the much more expensive treatments from Novartis and Bayer.

The court also ordered the pharmaceutical companies to pay the NHS’s legal costs for the case.

Novartis and Bayer initiated a legal challenge against 12 NHS Clinical Commission Groups (CCGs) in the North East and North Cumbria CCG Forum for instituting a policy in November 2017. The policy told doctors that off-label Avastin was the preferred choice for wet AMD, but patients still had the option to choose Novartis’ Lucentis or Bayer's Eylea.

Novartis and Bayer claimed that the CCGs were acting illegally because patients were denied their right to an approved drug. In addition, the companies argued that using an unlicensed medication rather than an approved option undermined the UK’s pharmaceutical regulatory framework. They also suggested that elderly patients may not have the mental capacity to make informed choices between the three drugs.

In January, the UK’s pricing regulator the National Institute of Health and Clinical Excellence (NICE) concluded that although Avastin is not approved in the UK for wet AMD, the treatment was considered as safe and effective as Novartis' and Bayer’s drugs.

However, NICE’s guidance noted that Avastin should only be prescribed if no other licensed products met the treatment need of the patient and it cannot be used only because it is cheaper than the alternatives.

Avastin cost £28 per injection vial, compared to £561 for Lucentis and £800 for Eylea for similar doses. The NHS estimates that using Avastin saves the 12 CCGs £13.5m a year. Furthermore, if the drug was used throughout the NHS, then it could save the organisation a projected £500m annually.

High Court judge Philipa Whipple said in her ruling: “The CCGs have adopted this policy because of the significant difference in price between Avastin and the other two medicines. I have dismissed the claimant’s application on all grounds advanced. I find the defendants’ policy to be lawful.”

In response to the outcome, NHS South Tyneside CCG chief executive officer David Hambledon said: “We’ve always said we think that it’s important that patients should have the choice of a very effective treatment for wet AMD, and it’s actually a fraction of the cost of the other alternatives.

“So I think what we do now is offer patients that choice. We believe that they will support very strongly having a cost-effective, safe treatment and saving the NHS generally a lot of money. It is a victory for common sense over commercial interests.”

In a statement, Novartis said: “Novartis is deeply disappointed in this decision and remains of the opinion that the policy undermines the well-established legal and regulatory framework that is there to protect both patients’ safety and to ensure health care professionals can prescribe with confidence.”

It is not yet clear if Novartis and Bayer are going to appeal against the ruling.

18 September 2018

FDA lifts partial clinical hold on Mersana’s Phase i study of XMT-1522

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on a Phase l study initiated by Mersana Therapeutics to investigate XMT-1522 for the treatment of solid tumours.

The hold was lifted after Mersana and the FDA reached an agreement on changes to be made to the trial protocol, including increased monitoring and exclusion of patients with advanced hepatic impairment from the trial.

Mersana has decided to make these amendments to the trial investigating its Dolaflexin ADC targeting sodium-dependent phosphate transport protein 2B (NaPi2b), XMT-1536, though the solution was not subject to a clinical hold.

In both trials of XMT-1522 and XMT-1536, Mersana plans to examine alternative dosing regimens.

The XMT-1522 trial is expected to start with a once-every-four-week dose regimen, which has already been used in the XMT-1536 trial to enable a comparison of relevant doses and their impact on the safety, efficacy and PK profile of the investigational drug.

Mersana Therapeutics could evaluate additional regimens and is expected to release data from the XMT-1536 trial in the first half of next year.

The company’s Phase l trial of XMT-1522 intends to enrol 120 subjects.

The first in-human, single-group assignment, open-label, and dose-escalation and expansion trial aims to evaluate XMT-1522 in patients with advanced breast cancer and other advanced tumours expressing HER2.

During the trial, XMT-1522 will be administered in groups of patients who will receive doses that increase over time.

After the maximum-tolerated dose or recommended Phase ll dose is achieved, the trial will include new groups of patients to provide XMT-1522 at this fixed dose.

The trial’s primary goal is maximum-tolerated dose or recommended Phase ll dose.

Its secondary goals comprise time of maximum observed concentration of XMT-1522, maximum concentration of XMT-1522, anti-drug antibody and others.

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