With festivities and holidays galore during the latter part of December we thought it would be a good idea to briefly run through some of the pharma news that came out in the run up to Christmas.
Newspapers round up
GlobalData asks if a ‘softer’ Brexit may be on the cards, helping UK pharma
After the government suffered a narrow defeat on amendment seven of the European Union withdrawal bill, debate as to whether the UK could now have a softer Brexit and the impact this may have on industries has been fuelled.
To address some of the issues surrounding Brexit GlobalData hosted a webinar, looking at the reputational, economic and R&D implications of Brexit for the UK pharma sector. The outcomes of this webinar were as follows:
From a reputational point of view, the UK’s status as a first-tier drugs market could come to an end and its regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), may no longer serve as a model to other agencies.
Economically the UK will remain an important market but depending on the outcome of negotiations, specifically regarding drug regulation, the UK may experience delays in its ability to launch new products. The MHRA, or a new agency that may form post-Brexit, may have to take on marketing authorisation, orphan drug approvals and small and medium enterprise (SME) designations. Sharing pharmacovigilance data is a key concern for UK pharma R&D in the post-Brexit environment.
Despite Merck opening a $1.3 billion research hub in London recently, much of the country’s life sciences R&D work could be driven to the continent, as exiting the single market and potential immigration restrictions will make the UK a less attractive place for drug firms. Any perception that the UK has become less hospitable to migrant workers and overseas researchers due to Brexit, will make it more difficult to recruit and retain R&D talent, impacting pharma operations.
2018 set to usher in major changes to bio supply, according to bioLIVE forecast
Industry experts from the biomanufacturing and bioprocessing event that will take place alongside this year’s CPhI in Madrid, bioLIVE, have predicted increased integration and collaboration across the large and small molecule supply chain, continued rise in the European bioprocessing and biomanufacturing sectors as well as a resurgence in European biotechs.
“One of the consistent problems in bio for the last year has been getting the right level of skilled workers, as well as building a global and stable partners base. This is an area that small and large molecule will likely collide in 2018 — particularly as more CDMOs, and pharma companies begin to diversify their capabilities,” commented Rutger Oudejans, brand director Pharma at UBM. “In the past few years we have seen the supply chains of bio and small molecule coming together, particularly as you have seen more and more CDMOs transferring their skills into bio. There is a growing issue of availability of resource, and undoubtedly there are learnings and contacts that can be shared, since there is a global shortage of skills and manufacturing. For bioLIVE, this is a significant opportunity.”
Research shows a third of diabetic patients do not adhere to treatment regimens
Research from the University of Surrey, published in the journal Diabetes, Obesity and Metabolism, revealed that patients with Type 2 diabetes and prescribed the drug metformin, were the least likely to take the required dosages in comparison to other diabetes drugs.
The researchers, who examined combined data from clinical trials and observational studies of on the adherence rates of 1.6 million patients with Type 2 diabetes, found that 30% of prescribed doses of metformin were not taken compared to 23% of sulfonylureas (such as gliclazide) and 20% for pioglitazone. One of the newer medication classes, DPP4 inhibitors (gliptins), had the highest rates of adherence.
On comparing the injectables, the team found that patients were twice as likely to stop taking GLP1 receptor agonists (such as exenatide) compared with insulin.
This variance in adherence rates was attributed to, in part at least, side effects — metformin commonly causes gastrointestinal symptoms whereas DPP4 inhibitors are generally better tolerated. Additionally, the requirement to take multiple doses a day was highlighted as a potential cause for reduced adherence.
“The importance of diabetes patients taking their prescribed medication cannot be underestimated. A failure to do so can lead to complications in their condition including eye disease and kidney damage,” said Dr Andy McGovern, clinical researcher at the University of Surrey. “I urge anyone who is struggling to take their medication as prescribed, whether this is because of side effects or because the schedule is too complicated, to discuss this openly with their doctor or nurse.”
Darvadstrocel receives positive CHMP opinion
Takeda Pharmaceutical Company and TiGenix announced that the investigational compound Cx601, darvadstrocel, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), for marketing authorisation.
The compound is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.
The opinion will now be referred to the European Commission with a decision anticipated in the coming months. An MA will allow Cx601 to be marketed in all 28 member states of the EU, plus Norway, Iceland and Lichtenstein.
Lonza announces serialisation capabilities now operational at its Edinburgh facility
Lonza revealed that its integrated development and manufacturing site for biopharmaceutical liquid-filled hard capsules in Edinburgh has new anti-counterfeiting security capabilities in place and is in full compliance with EU and US regulatory requirements for serialisation.
“It’s important for our customers to know that our Lonza Edinburgh facility is ahead of the curve and already fully compliant with the new regulatory requirements in the US and EU to combat anti-counterfeiting,” said Jane Fraser, PhD, site head at Lonza’s Edinburgh facility. “Our new serialisation line and quality system — fully commissioned and qualified this year — are now being used to serialise our customers’ sales packs, well in advance of the serialisation deadlines."
FDA lifts clinical hold on fitusiran
The US Food and Drug Administration (FDA) lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III programme.
“We are pleased with the FDA's decision to lift the clinical hold, as fitusiran holds the potential to help improve the lives of people living with hemophilia,” said Akin Akinc, PhD, vice president and general manager, Fitusiran at Alnylam. “With the additional risk mitigation measures in place, we look forward to the continued late-stage development of fitusiran and expect to resume dosing around year-end.”
Sanofi has an alliance with Alnylam Pharmaceuticals to co-develop and co-commercialise fitusiran in the US, Canada and Western Europe. In addition, Sanofi has the exclusive right to commercialise fitusiran in the rest of the world.
Horizon and Roche enter into agreement for development of IHC assays
Horizon Discovery revealed that it has entered into an agreement with Roche Diagnostics to support the development of immunohistochemistry (IHC) assays for oncology.
Under the terms of the agreement, Horizon will develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase (NTRK) fusion biomarkers.
“Horizon continues to establish itself as a leading supporter of the development and validation of molecular diagnostics by providing reliable and high quality reference standards to assay developers,” commented Dr Darrin M Disley, chief executive officer, Horizon Discovery Group. “We are very pleased to announce this agreement, further strengthening our ongoing partnership with Roche, and we look forward to continuing to work alongside them as they develop additional important diagnostic assays in areas of significant need.”
Safic-Alcan acquires Biochimex
French independent distributor of speciality chemicals, Safic-Alcan, acquired Biochimex — a distributor of active pharmaceutical ingredients (APIs) to the pharma industries overseas and in Europe and the Maghreb.
“The acquisition of Biochimex is in line with Safic-Alcan’s growth strategy. This acquisition will enable us to accelerate our international development, particularly in the Maghreb, to expand our product portfolio and to consolidate our relationships with our suppliers,” stated Philippe Combette, CEO of Safic-Alcan.
Agreement formed to develop drug delivery technology product for oncology
DelSiTech, a Finnish drug delivery technology and development company, has signed a partnership and collaboration agreement with Korean biopharmaceutical company, C-Tri, to develop long-acting controlled release formulations with commercial potential.
The first C-Tri product being developed in this partnership is NHM-CT-007, a peptide drug for oncology.
“We are very pleased that C-Tri has selected DelSiTech’s drug delivery technology for its new projects,” said Dr Lasse Leino, CEO of DelSiTech. “It illustrates the great potential of biodegradable silica material in developing novel product opportunities.”
“We are very excited to have secured DelSiTech’s innovative drug delivery technology. We are confident in taking a step towards entering the global oncology market based on progressing NHM-CT-007 clinical trials in Europe and plan to continue the manufacturing process in Europe as well,” said Dr Wan-joo Kim, founder, CEO and president of C-Tri. “We also plan to apply this drug delivery technology to other peptide drugs, specifically novel drugs, as part of our efforts to expand our pipeline.”