Unacom Pharma News

Monday 11th February 2019

Industry fear about Brexit withdrawal legislation

The Patents Regulation 2018 Statutory Instrument covers the UKs exit from the EU patent regime but according to the bio-pharma industry it could weaken the UKs IP infrastructure and thus affect our reputation as a leader in the life sciences.

The primary concern was with how the Statutory Instrument would affect the SPC (Supplementary Patent Certificates), which provide up to an extra five years of additional patent life to make up for the years taken for regulatory approval. Concerns are raised because of how the UK government will calculate the SPC with it likely to be based on only a UK market authorization, rather than the first approval granted by a European Economic Area (EEA) country. This would lead to industry launching new products later in the UK compared to the EU and also the SPC period could be shorter for UK compared to the EU, thus reducing the attractiveness of the UK as bio-sciences hub.

Tuesday 12th February 2019

Cancer drugs and China help AstraZeneca’s climb to growth

AZ continues its recovery to growth after suffering patent losses with its promising cancer drugs leading the way. Sales rose 5% to $5.77bn in the fourth quarter, following an upward trend that started in the third quarter and put AZ in positive territory for the full-year for the first time in almost a decade. The return to annual growth, resulted in a 4.7% rise in AZ’s shares, as a 50% increase in sales for the company’s cancer franchise was released. With new launches of Lynparza and Tagrisso both doubling in the year – and a 28% increase in Chinese revenues. The star in its portfolio was Tagrisso, which grew 95% to $1.86bn last year.

This reflects strongly on AZ reorganization of its R&D department, to focus on growing cancer drugs, by splitting the oncology and bio pharma divisions.

Wednesday 13th February

Novartis is the first to benefit from NICE spin off for advice on patient preference

NICE’s Scientific Advice team has produced its first guidance on how pharma companies can improve clinical trial design, to meet the needs of patients.
The Scientific advice team is a spin off the cost agency NICE and provides a fee-based service to bio-pharma, medical devices and diagnostic companies. It has announced today that it has provided its first piece advice to Novartis on the design of a ‘patient preference’ study - these aim to capture patient insights which can then be incorporated into the clinical development programmes for new treatments.
In its last financial year, this branch generated a £1.8m income, which is a nice contribution to sustaining the agency, which has seen its workload increase and funding cut by the Government.

Nigel Cook, Head of Decision Support and Insights, Global Patient Access at Novartis said: “ The scientific advice provided by NICE, together with the patient representative and other external experts, has been very valuable to Novartis; both in endorsing the approach to gathering early patient preference data to inform evidence generation plans, and in regard to valuable input received to improve the design of the COPD patient preference study.

There have been concerns that NICE’s fee-based approach for technology appraisals could compromise integrity and their decision making. NICE has since clarified that paying for scientific advice has no bearing on tech appraisals and will not make a positive recommendation more likely.

Thursday 14th February.

Europe's first medicine tracking system goes live. 

The new worlds first digital tracking system covering the medicine supply chain across the EU has gone live, promising greater security against counterfeit medicines. The new European Medicines Verification System (EMVS) is a world first and uses a 2D data matrix (barcode) to track every pack of medicines as they make their way from the manufacturer into the supply chain and on to the patient. The medicines also now have anti-tamper device (ATD) to ensure they are not interfered with before the patient receives them. This system aims to prevent the occurrence of fake drugs entering the supply chain, which has quickly become a multi-million pound industry. 

The EMVS will connect around 2,000 pharmaceutical companies, around 6,000 wholesale distribution authorization holders, 140,000 pharmacies, 5,000 hospital pharmacies and around 2,000 dispensing doctors in 28 EEA countries. 

The UK pharma industry and NICE welcomed the new system, praising it as the ‘world’s best’ medicines safety system and that it would be a travesty if the UK had to leave the system because of a no deal Brexit.

Friday 15th February

The potential in AI predicting survival of Ovarian Cancer Patients.

Researchers from Imperial College London have created an AI software that can predict the survival rates and responses to treatments of patients with ovarian cancer. Researchers say that this new tech could help clinicians administer the best/most effective treatment to patients faster and pave the way for more personalized medicines. AI has the huge potential to revolutionize the healthcare industry by offering more accurate and earlier diagnoses, transforming the lives of the patients.

Unacom Pharma News

Mon 4th February- Fri 8th February

Monday 4th February 2019

European decision on biosimilar change causes dismay for the Industry

The European parliament voted in favour for allowing manufacturers to produce and stockpile generic and biosimilar medicine, two years before the original brands exclusivity ends. The proposed change could come in as soon as 2021 and it involves adding a new ‘manufacturing waiver’ to the SPC (Supplementary Protection Certificate), a current law which extends market exclusivity for branded medicines in the EU. The waiver is being introduced because generic and biosimilar companies in Europe are restricted by strict rules which prevent them from manufacturing their copies before the SPC expires. Competitors in China, Canada and India face no such restriction and can be ready to release their versions on ‘Day 1’ of the exclusivity ending. The new waiver will create a more level playing Field for European Biosimilar firms.
The usual patent for a pharma product in the EU is 20 years, but an SPC can extend this up to 5 years, considering the time taken to put in through development and regulatory approval. Currently biosimilar manufacturers cannot manufacture their copycat products during the SPC period. The proposed changes mean that these companies will be able to produce generics for export outside the EU, during this period and stockpile products so they can launch in the EU market, as soon as exclusivity ends.
European generic manufacturers have long argued that international companies face an unfair advantage as they are not restricted by these rules. The EC also believe that these changes will boost the EU competitiveness, as a hub for R&D.

Tuesday 5th February 2019
Global pharma market heading for future downturn says IQVIA
The global pharma market is set to be headed for a downturn between now and 2023, as growth rates dip below the 6% average seen in the last five years. Growth will range from 3% to 6% in the next coming years, due to sluggish growth in Europe and static/shrinking sales in Japan. China’s wider economic slowdown will also affect pharma, as pharmerging markets will see lower growth in the five years compared to the five years past, as the economic growth and healthcare access expansions of the past contribute less to growth.
IQVIA, is predicting ‘explosive’ growth in biosimilars, which will result in $160bn in lower spending over the next five years, with 18 of the top 20 drugs facing biosimilar competition by 2023. There is also an expected increase in the output of novel products from industry pipelines, with the average yearly number of new novel products released expected to rise from 45 to 54 by 2023. With the increasing number of launches, shifting towards specialty products such as oncology products.

Wednesday 6th February
GSK signs $4.2bn immunotherapy deal with Merck
Merck and GSK have unveiled a global alliance to jointly develop and commercialize M7824, a novel immunotherapy with potential to treat a wide range of cancers This drug is just one of eight immune-oncology studies ongoing or expected to begin in 2019, with GSK hoping to make up for lost time and enter the hotly anticipated Immuno-oncology field.
The deal with GSK, sees Merck receive an upfront payment of 300million Euros with potential development milestones payments of up to 500 million euros, triggered by data from the M7824 lung programme. With this added to future approval and commercial milestones of up to 2.9bn euros. The total potential deal value comes to $4.2bn
GSK is likely to have outbid other interested parties, with Pfizer being the most likely candidate, due to its existing alliance with Merck in Immuno Oncology.
GSK and Merck will jointly conduct development and commercialization with all profits and costs from the collaboration being equally shared on a global basis.

Thursday 7th February 2019
UK unveils new antibiotic buying plan, to combat rising antimicrobial resistance
Health secretary Matt Hancock has revealed the UKs five year plan to handle rising antibiotic resistance. Key elements of the plan include incentives for pharmaceutical industries to carry out R&D in new antimicrobial drugs, such as the £50 million in funding made available via the UKs GlobalAMR Innovation Fund, reducing the inappropriate usage of antibiotics by 15% in five years. The plan also set out specific targets, including halving healthcare associated Gram-negative blood stream infections, reducing the overall number of specific drug resistant infections by 10% within five years and reducing antibiotic use in food producing animals by 25% between 2016 and 2020.  

                                           Unacom Energy news

                                                                        Mon 28th Jan- Fri 1st Feb

Monday 28th January

Shale drilling in the US expands for the first time this year, as Oil recuperates

Oil explorers expanded drilling in U.S fields for the first time thus year as rising crude oil prices lifted optimism. The number of rigs targeting oil in the country rose by 10 this week to 862. Crude has been climbing since Christmas Eve, restoring confidence to manufacturers and investors.

Tuesday 29th January

Total makes Gas discovery at North Sea Glengorm Prospect

Total and Chinese partners, CNNOC, have made a significant discovery of the coast of Britain at the North Sea Glengorm Prospect, with recoverable resources amounted to around 250 million barrels of oil equivalent.
Kevin McLachlan, Totals Senior Vice-President for Exploration, said in a statement: “Glengorm is another great success for Total in the North Sea, with results at the top end of expectations and a high condensate yield in addition to the gas.”
Kevin Swann, a senior analyst at Wood Mackenzie, said that at 250 million boe, Glengorm was the largest gas discovery in the UK since Culzean in 2008.

Wednesday 30th January

Saudi Arabia pledges even deeper Oil cuts in February under OPEC deal

Saudi Arabia will pump oil for six months at levels ‘well below’ the voluntary production limit it accepted under OPEC’s oil-cuts accord. Saudi Arabia, the worlds biggest exporter, started off in January at a production level of 10.2MMbpd and is aiming to reduce this to 10.1 million in February. Saudi Arabia’s voluntary limits under the December cuts were 10.33MMbpd.

Thursday 31st January

Equinor gains approval from to extend life of Asgard A 

Equinor will now start consider new drilling targets and wells linked to Asgard A in the Norwegian Sea, as well as measures to improve the recovery from existing sites to extend the technical lifetime of the facility until 2027, 12 years longer than originally planned.

Friday 1st February

Total operating on a drilling spree

Total has plans in 2019 to drill 23 wells, three times more than it drilled in 2016/2017. The focus of the drilling for Total will be in Africa and Brazil.
The strategy is a marked departure from Total’s traditional prioritizing of high-risk but also high-return frontier areas and a turn to already producing regions where the chances of striking commercial quantities of oil and gas are higher.

                                                           Unacom Pharma News

                                                             Mon 28th January – Fri 1st February 

Monday 28th January

Novartis has urged the government to minimize Brexit disruptions as much as possible

Novartis has released a statement expressing its concern over the state of medicine supply to the UK adding that it has begun to increase its inventory across its portfolios of medicines in the UK. The arrival of the statement stems from the events of Theresa Mays Brexit deal rejection and the heightened chance of a no deal being reached. The statement also brought attention and an appeal for the Government to make minimizing the disruption as the highest priority. With calls for a comprehensive continuity plan that includes the Department of Health, Social Care and the NHS, to ensure medicine can still reach the patients. It is also essential for NHS trusts and pharmacists to adhere to the governments advice to not stockpile medicine, so supply can be managed centrally, minimizing the risk of medicine shortages across the UK.
Novartis currently imports 120 million packs of medicine to the UK from Europe.

Tuesday 29th January

GSK and Sanofi join FinnGen, joining the ranks of Pfizer, AstraZeneca and MSD

GSK and Sanofi have joined Finland’s largest scale genomics project, based on the data from 500,000 biobank volunteers. FinnGen will be one of the largest studies of its kind, representing 10% of the Finnish population and being five times larger than England’s comparable project of 100,000 volunteers. FinnGen can cover a greater number of individuals because it uses a less comprehensive genomic mapping approach, which identifies a single nucleotide polymorphism while the UK project is involved in the whole genome, which takes longer and costs more, but could lead to a deeper understanding of the influence of genes on disease. This project aims to contribute towards genetic research by identifying new therapeutic targets and diagnostics for treating numerous diseases.
Matt Nelson, Head of Human Genetics at GSK stated that: “FinnGen offers an exciting collaborative opportunity to study genetic impacts on human conditions over time in a world class research environment.”
FinnGen is expected to continue for 10 years, with a current budget of 59m

Wednesday 30th January

The UK Biotech Industry boomed in 2018, despite Brexit fluctuations

According to a BioIndustry Association (BIA) Report, UK biotech attracted a record breaking £2.2bn in investment last year, with UK firms claiming 40% of the venture capital funding that went to the sector across Europe. This is £1bn more than the amount raised in 2017. BIA chief executive stated that this report clearly shows investors, see the value and want to be apart of the UKs fast- growing biotech opportunity.
A clear trend shown in the 2018 report is that biotech's are staying private for longer, with only just five IPOs in the year coming from Orchard Therapeutics, Autolus, Sensyne Health, Acacia Pharma and Renalytix Al. Other trends include the diversification of the industry with new business models in areas such as Artificial Intelligence as well as receiving investment from Chinese and US investment groups. And despite a weak pound, UK companies where just as much the acquirer and the acquired with 8 acquisitions by UK domiciled companies in the year, compared to seven involving overseas firms.

Thursday 31st January

GSKs Advair Diskus faces first American biosimilar

GSKs hugely successful respiratory blockbuster Advair finally faces its first biosimilar from Mylan after a series of delays. The FDA approval of this drug puts a risk of decline in Advairs $1bn sales. Mylans drug termed Wixela Inhub has made it to the market head of rivals such as Novartis and Himka/Vectura with all of these generics slowed down by not showing sufficient equivalence with Advairs dry powder inhaler.
Analysts are predicting that Mylans generic could make around $250 million in sales this year, with a drop-in opportunity because GSK have been heavily discounting its brand to maintain market share. The delays in competition for Advair, gave it hundreds of million of dollars in revenue as well as time while new CEO Emma Walmsley, aimed at reinvigorating the company.

Friday 1st February

European Medical Agency departs London ahead of Brexit

The EMA lowered the 28 flags of the member states as it follows its move from London to Amsterdam. EMA executive director Guido Rasi, expressed his thanks to the UK for its contribution towards the agency. Although the move from Canary Wharf is without some drama, as the EMA is battling the owners of the Canary Wharf over its right to break the 2011 lease. With the EMA arguing that Brexit amounts to ‘an event of frustration’, that means it has the right to break early and the Canary Wharf group arguing that Brexit was predictable as it had been in the Conservative manifesto.
The outcome of this suit could be proven to be very important for other business that have leased facilities trying to relocate away from the UK as a result of Brexit.

Coranavirus and its relationship with IP exclusivity

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