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A small dose — a capsule view of some key developments in the industry, June 2018

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A brief round-up of some of the developments in the industry including a step in the right direction for oral insulin and an overview of Alantra Pharma’s Fast 50 index…

Down the hatch? Oral insulin could be closer than you thought…

The first oral form of insulin has taken a big step towards approval by the US Food and Drug Administration (FDA) recently.

Why is this a big deal?

Daily administration of insulin can be burdensome and difficult for many patients, with the injections taking time and for some being an unpleasant interruption of the day. However, other administration routes have been hampered due to the importance of getting the therapy to the bloodstream intact.

Oral delivery systems in particular have found themselves wanting in this arena as the digestive system can be too effective leaving the amount of insulin that can reach the bloodstream at insufficient levels.

What is the breakthrough this time?

New York based Oramed Pharmaceuticals has just launched its largest and most advanced clinical trial under the direction of the FDA, evaluating its oral insulin (an orally ingestible insulin capsule — ORMD-0801) in 240 patients with type 2 diabetes.

In an earlier trial, the company’s oral option for administration of insulin proved promising as a safe delivery method with no serious adverse events in a group of 180 patients over a course of 28 days.

“This is our most important study to date,” said Oramed CEO Nadav Kidron. “A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection.”

Data from this clinical trial is expected to be available early next year and is hoped to set the stage for final FDA studies needed prior to approval.

Eye on drug delivery

A new project from the Chemelot Institute for Science and Technology (InSciTe, The Netherlands) is set to enter clinical testing.

The Ocular Coil Drug Delivery Comfort Trial (OCDC) project will assess an innovative eye implant — a small flexible coil — that can be positioned under the eyelid and deliver a drug via a drug delivery matrix made of a unique biomaterial over a set period of time — weeks or months.

“This method will give patients more freedom in treatment, accurate drug administration and there are no caregivers needed,” explained Professor Rudy Nuijts from the Maastricht University Medical Center+ (MUMC+), head of the OCDC-project.

Common drug delivery systems are not always effective in the treatment of diseases like glaucoma and ocular inflammation and so an alternative method could improve treatment efficacy as well as patient adherence while also lowering unwanted side effects.

The study will initially assess the comfort of the implant with placebo-filled coils in healthy subjects and there are plans to perform safety and efficacy tests with drug-loaded coils in the second half of this year.

Brexit comment — impact on AMR

The latest report from the Business, Energy and Industrial Strategy Committee has been released — which in fact is its final one in a series of reports on specific sectors — highlighting a positive view on the approach so far by the government to the pharmaceutical sector in light of Brexit.

However, what will the impact of Brexit potentially mean for the country’s continuing battle against antimicrobial resistance. Dr Peter Jackson, executive director of the AMR Centre, gives us his view on the report:

“The fight against antimicrobial resistance (AMR) requires coordinated international effort. Leaving the European Union (EU) with no deal for the pharmaceutical sector could significantly impact this effort and remove millions of pounds of potential funding from the UK AMR sector.

“The AMR community in the UK is particularly concerned that vital EU AMR funding initiatives, such as the Innovative Medicines Initiative’s ENABLE and COMBACTE programs, will no longer accept UK applicants after Brexit.

“Similarly, the European Investment Bank’s ‘Innovfin’ AMR debt instrument may no longer be available to support UK clinical trials.

“We would urge the UK government to ensure that significant levels of R&D support remain available to UK companies to progress innovative treatments for drug-resistant infections.

“Alongside this, there must be the right support to translate the scientific advances made in AMR at UK universities into the creation of new biotech companies so we can continue to do what the UK does best: develop new drugs to treat global healthcare problems.

“The AMR Centre is leading the UK’s response to AMR and working on a number of projects with partner organisations in Europe. This work much must be able to progress unhindered post-Brexit.

“Whether the UK is in or out of the EU, the most important thing is that companies, in particular SMEs, can work together across borders to gain access to funding, expertise and capacity to develop their new antibiotics, vaccines and diagnostics.”

The future’s bright…

New research from global investment banking and asset management firm, Alantra (which last year combined with Catalyst Corporate Finance) has revealed that the future is bright for UK pharmaceutical companies.

The Alantra Pharma Fast 50 Index— an annual ranking of non-listed UK pharmaceutical companies — has highlighted strong growth in the privately-owned sector with the top 10 businesses seeing sales growth on average by at least 43%.

“The UK is rightly regarded as a world leader in the pharmaceutical and life sciences industry and beneath the well-known names of big pharma, it is home to a thriving community of privately-owned businesses that consistently deliver long-term value,” said Tom Cowap, a director in Alantra’s UK advisory business (formerly Catalyst Corporate Finance) who specialises in the Pharmaceutical sector. “Despite the fact that the industry is facing difficult challenges including the spectre of Brexit, tough pressure on margins, demanding regulatory scrutiny and issues such as the patent cliff, the companies in the Alantra Pharma Fast 50 have repeatedly managed to grow their sales at an impressive rate.”

According to the index, the fastest growing privately-owned pharma business in the UK is Qualasept Pharmaxo, which grew its sales by an average of 69% over the past two years. This makes it the second year running for the company to top the list.

Additionally, businesses are grouped into four distinct sub-sectors — pharma outsourcing, pharmacy chains, development, wholesale and supply (DWS), and consulting. The companies ranking top in these include:

A bitter pill to swallow?

Comedian Roseanne Barr has perhaps been left with a bitter taste in the mouth after receiving a swift response to her tweet that partially blamed the sleeping pill, Ambien, for her social media discrepancies.

Barr, who had been fired and her sitcom cancelled after making a series of racist tweets, had written that she had been ‘Ambien tweeting’ at two in the morning, implying the drug was partially to blame for her actions.

In response, Sanofi US released a written statement and tweet stating: “While all pharmaceutical treatments have side effects, racism is not a known side effect of any Sanofi medication.”

So, although some of Ambien’s listed side effects include the possibility of driving, walking or even having sex while sleeping when taking the sedative, Twitter outbursts of a racist nature are not listed among them…

Making haste in the detection of designer drugs

Italian scientists have developed a method that allows them to accurately detect and identify designer drugs in record time.

Designer drugs are those that are structurally or functionally similar to a controlled substance but differ sufficiently enough that they can avoid classification as illicit. As the numbers of such drugs are on the rise, they are not only causing law enforcement and regulatory agencies’ problems they are also posing a threat to public health.

Current analytical detection methods that are used to test for drugs work by recognising and interacting with a specified drug molecule. However, with new designer drugs the molecules are not yet known and so identification has be done from scratch, which is a lengthy process.

To tackle the issues of identification and detection of these new psychoactive substances, researchers from the University of Padova (led by Fabrizio Mancin) have used nanoparticles with a coating that binds to most psychoactive substances.

How does it work?

Adding the coated-nanoparticles to water containing psychoactive substances will see the formation of a new compound. It is this new compound — which is part nanoparticle, part drug — that can be analysed in a nuclear magnetic resonance (NMR) spectrometer. It is possible to perform this analysis as the nanoparticle molecular structure is known and so can be eliminated from the resulting data from the NMR machine, which will enable the analysts to discern what other structures are present.

This method will allow for ‘cocktails’ of drugs to be identified simultaneously and even with low concentrations of drugs due to the sensitivity afforded by NMR. “In principle,” Mancin wrote in his paper published in Chemical Science, “by using this protocol it should be possible to propose a tentative chemical structure of a new ‘designer’ drug a few hours after the seizure of a single tablet.”

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