1 Dec 2020

Summary

  • Deepmind finds biology’s ‘holy grail’ with answer to protein problem – The Times
  • Covid-19: Moderna to submit its Covid-19 vaccine for US and EU regulatory approval – Financial Times
  • Covid-19: Covid R&D Alliance launches trial of Amgen, UCB, Takeda drugs – Reuters
  • New data from Cell and Gene Therapy Catapult report shows move towards commercialisation and 48% increase in GMP manufacturing space despite Covid-19 pandemic
  • AstraZeneca’s Crestor to be sold to Grünenthal in Europe – Bloomberg
  • Covid-19: UK set to be first to clear Pfizer-BioNTech Covid-19 vaccine – Bloomberg
  • Indivior ‘will fight’ claim by Reckitt – The Times
  • Ipsen expects to generate over $3 billion by 2024 for drug pipeline expansion – Reuters
  • Covid-19: Novavax gains after UK vaccine study fully enrolled – Bloomberg
  • Covid-19: US reports over 10,000 coronavirus deaths last week – Reuters
  • Amarin files patent infringement suit against Hikma – Bloomberg Law
  • Genmab axes development of AXL-targeting cancer drug enapotamab vedotin – PharmaPhorum
  • Bayer raises $1.6bn by selling most of stake in Elanco – Bloomberg
  • Galapagos reports positive topline results with GLPG1205 in IPF patients in PINTA proof-of-concept trial 
  • Covid-19: China gave Covid-19 vaccine candidate to North Korea’s Kim – Reuters
  • Amgen, Teva ordered to face generic delay claims over Sensipar – Bloomberg
Tom Whipple of The Times reports that one of the greatest challenges in modern biology has been “largely solved” by British researchers who have developed a method to visualise the proteins that power the biological processes in our bodies. The “stunning” announcement by scientists at Deepmind that they can calculate the structure of proteins using only a computer has profound implications for drug discovery and defeating disease, and was hailed by other scientists as an “enormous advance” that many had not expected to see in their lifetime.The Times >>
Hannah Kutcher from the Financial Times writes that Moderna plans to submit its Covid-19 shot for regulatory approval in the US and the EU, making it the second western vaccine maker on track to start distribution in December. The Boston-based biotech’s new trial data showed its vaccine’s efficacy rate was 94.1% and there were no serious safety concerns. Stéphane Bancel, Moderna chief executive, said the company was “most excited” about the vaccine’s ability to prevent severe disease. In the trial of 30,000, none of the participants who were vaccinated developed severe Covid-19.Financial Times >>
Deena Beasley from Reuters reports that AmgenUCB and Takeda Pharmaceuticals have launched a global trial to identify whether any of three different drugs can reduce the severity of Covid-19 in hospitalised patients by moderating the immune system’s response to the disease. The drugmakers are part of the Covid-19 Research and Development Alliance, a group of more than 20 pharmaceutical and biotechnology companies cooperating to speed development of therapies for the disease that has killed more than 1.4m people worldwide. Reuters >>
The CGT Catapult today released new data in their 2020 Cell and gene therapy Good Manufacturing Practice (GMP) manufacturing in the UK: capability and capacity analysis report, which shows progress of the industry towards commercialisation of therapies with further growth across a number of indicators including facilities, manufacturing space, and personnel. Matthew Durdy, CEO said: “We can see a clear progress of gene and cell therapies towards commercialisation and the consequent growth in GMP manufacturing space to support this.” CGT Catapult >>
Bloomberg’s Sarah Jacob writes that AstraZeneca has agreed to sell the rights to Crestor and associated medicines in over 30 countries in Europe, except the UK and Spain, to Grünenthal. Grünenthal is to make an upfront, non-contingent payment to AstraZeneca of $320m and may also make future milestone payments of up to $30m.Bloomberg >>
Bloomberg’s Deirdre Hipwell, Naomi Kresge and Tim Ross write that the UK is poised to become the first country to approve Pfizer and BioNTech’s Covid-19 vaccine, ahead of a long line of countries waiting for protection from the Covid-19. Clearance is possible as early as this week, according to a person familiar with the situation, who asked not to be identified because the process is confidential. The UK had long signalled it would move fast on any promising vaccine candidate, and British doctors have been put on standby for a possible rollout before Christmas. Bloomberg >>
Alex Ralph of The Times writes that a pledge to “vigorously defend” itself against a £1.1bn legal claim from Reckitt Benckiser helped to arrest a sell-off in Indivior’s shares yesterday. The drugs company that was spun-off by Reckitt said that it “strongly believes that the claim is without merit and that it has strong grounds for defending should it be served”.  The claim is understood to relate to the $1.4bn settlement that Reckitt reached last year with authorities in America to resolve an investigation into the marketing of Suboxone Film, an anti-opioid drug made by Indivior. The Times >>
Sarah Morland of Reuters reports that French healthcare company Ipsen expects to generate about €3bn ($3.59bn) by 2024, excluding asset sales, to power the expansion of its drug pipeline. The group, which develops and commercialises medicines for use in oncology, neuroscience and rare diseases, is prioritising building a sustainable pipeline to drive long-term growth. Ipsen said it would strengthen its external innovation efforts by targeting differentiated medicines in the three core therapeutic areas.Reuters >>
Christine Flanagan from Bloomberg notes that Novavax’s stock reversed a premarket drop to climb as much as 6.6% following other companies developing Covid-19 vaccines higher after the company said a study in the UK reached full enrolment and would have results soon. A first look at results from that 15,000-person trial are expected in the first quarter. Meanwhile a large-scale study in the US and Mexico was delayed for the second time.Bloomberg >>
Reuters reports that the United States recorded 10,000 Covid-19 deaths and over 1.1m new cases last week, although state and health officials have said the Thanksgiving holiday likely caused numbers to be under-reported. New cases fell 3.8% in the week ended 29 November, while deaths fell 3.9%, according to a Reuters analysis of state and county reports. Reuters >>
Hari Govind of Bloomberg Law reports that Amarin said it filed a patent infringement lawsuit against Hikma Pharmaceuticals and Hikma’s US affiliate in the United States District Court in Delaware. The complaint alleges that Hikma has induced the infringement of three patents by making, selling, offering to sell and importing generic icosapent ethyl capsules in or into the United States.Bloomberg Law >>
PharmaPhorum’s Richard Staines reports that Genmab has axed development of its pipeline cancer drug enapotamab vedotin after it failed to show enough activity in a proof-of-concept trial. The drug is an antibody-drug conjugate where a monoclonal antibody is linked to monomethyl auristatin, a cancer-killing “payload”. It is targeted against AXL, a signalling molecule that is overexpressed in several haematologic and solid malignancies. Developing enapotamab vedotin formed a major part in the rationale behind the company’s $506m Nasdaq IPO last year.PharmaPhorum >>
Thomas Nulier from Bloomberg reports that Bayer raised $1.6bn by selling most of its stake in Elanco Animal Health, shoring up cash as the German drugmaker faces legal bills over the weedkiller Roundup. Bayer said it sold 54.5m Elanco shares at $30.25 each in a placement. Bayer has given the underwriters a 30-day option to purchase as many as 8.175m more shares at the same conditions.Bloomberg >>
Galapagos announces positive topline results with its investigational GPR84 antagonist GLPG1205 in proof-of-concept phase 2 trial in idiopathic pulmonary fibrosis patients. The primary objective of the trial was to assess the change from baseline in FVC (in mL) over 26 weeks compared to placebo. Based on the results of this trial, Galapagos plans to progress GLPG1205 in a dose finding phase 2b trial.Galapagos NV >>
Reuters’s Hyonhee Shin writes China has provided North Korean leader Kim Jong Un and his family with an experimental coronavirus vaccine, a US analyst said, citing two unidentified Japanese intelligence sources. Harry Kazianis, a North Korea expert at the Center for the National Interest think tank in Washington, said the Kims and several senior North Korean officials had been vaccinated. It was unclear which company had supplied its drug candidate to the Kims and whether it had proven to be safe, he added.Reuters >>
Mike Leonard of Bloomberg reports that Amgen and Teva Pharmaceuticals must face a lawsuit claiming Amgen offered Teva a “reverse payment” when it settled patent litigation over its calcium reducer Sensipar in exchange for Teva’s pledge to pull its generic version and pay suspiciously low damages, a Delaware federal judge ruled. Teva’s $40m payment “cannot be divorced from what Teva did not pay,” Judge Leonard P. Stark wrote. Bloomberg >>
Leke Oso Alabi of the Financial Times reports the prospect of three viable Covid-19 vaccines has caused a reshuffle this month in Wall Street’s blue-chip S&P 500 stock index, as investors moved out of tech stocks into sectors that they expect to benefit most from a quicker end to the health and economic crisis. Equity investors took the positive trial results from Pfizer and BioNTech, followed by Moderna and others as a sign that a return to normal economic activity could be coming. Financial Times >>
Elisabeth Mahase of the BMJ reports that the UK government has asked the Medicines and Healthcare Products Regulatory Agency to evaluate if the University of Oxford and AstraZeneca vaccine can be authorised for temporary supply as soon as the data on safety, quality, and efficacy are submitted. If approved, the UK could receive 4m doses by the end of the year and 40m by the end of March 2021. But the request comes as questions have been raised over the researchers’ data. The BMJ >>
Suzi Ring and James Paton of Bloomberg report AstraZeneca Covid-19 vaccine looks like it’s headed for an additional global trial as the drugmaker tries to clear up uncertainty and confusion surrounding favourable results in its current study. The company wants the new test to confirm the 90% efficacy rate that the shot showed in a portion of an existing trial, CEO Pascal Soriot said. It’s favouring that option rather than adding an arm to a separate study that’s already underway in the US.  Bloomberg >>
Tony Allen-Mills, Andrew Gregory and Sabah Meddings of The Sunday Times report Britain is getting ready to give jabs to millions. But will the cheaper Oxford formula provide effective protection, or will it be down to imports at nearly four times the price? Britain may be only weeks away from launching one of the great medical missions in modern history, but many questions lie in the gap in our understanding of what any of these vaccines may achieve. The Times >>
The Financial Times reports UK scientists are worried that cancer research advances would be delayed by nearly a year and a half due to the coronavirus pandemic, a survey shows. The figure was calculated from the broader effects on charity funding, disruption of collaboration and personal interaction between scientists, and diversion of research efforts to Covid-19. The researchers said their advances would be pushed back by an average of six months by the initial lockdown and subsequent restrictions.The Financial Times >>
Mrinalika Roy of Reuters reports Biogen will take a $650m stake in Sage Therapeutics and make an upfront payment of $875m to jointly develop and sell treatments for depression and other neurological disorders. The deal will give Biogen access to zuranolone, an oral therapy being developed for major depressive disorder and postpartum depression as well as SAGE-324, which is being developed for essential tremor and other neurological disorders. Reuters >>
Sudip Kar-Gupta of Reuters reports that Sanofi and Regeneron said that their Dupixent product has won approval from the European Commission to treat children aged 6-11 suffering from severe atopic dermatitis, often known as eczema. The European Commission had extended the marketing approval for Dupixent in the European Union, citing a trial that showed the product resulted in an average improvement of about 80% in the condition of nearly three in four children who was suffering from severe atopic dermatitis.  Reuters >>
Judith Evans of the Financial Times reports consumer goods group Reckitt Benckiser has filed a £1bn legal claim against Indivior related to an opioid addiction treatment sold by its former subsidiary, causing the drugmaker’s shares to lose a fifth of their value. The claim relates to a $1.4bn settlement Reckitt reached last year with the US Department of Justice over Indivior’s past marketing of Suboxone. Shares in the group, which also sells treatments for schizophrenia, dropped as much as 44% to 69.7p after the announcement. Financial Times >>
Samuel Lovett of the Independent reports that North Korean hackers are said to have targeted the coronavirus vaccine project led by Oxford University and AstraZeneca in recent weeks. The hackers, who posed as recruiters on LinkedIn and WhatsApp, approached AstraZeneca staff with fake job offers, according to Reuters. They then sent documents purporting to be job descriptions that were encrypted with malicious code designed to gain access to a victim’s computer.   Independent >>
Rachel Wearmouth of HuffPost reports No.10′s newly-formed “Union unit”, tasked with fighting calls for Scottish independence and other campaigns to break up the UK, is said to have asked for the vaccine injection kits to branding with the union jack flag. No.10 said there were no plans for the Union Jack to be on doses, but did not deny that the request – said by insiders to have strong backing from health secretary Matt Hancock and business secretary Alok Sharma – had been made.HuffPost >>
BBC News reports that a blood test designed to detect more than 50 types of cancer at an early stage will be trialled by the NHS. More than 165,000 people in England will be offered the tests from next year and if successful, the NHS hopes to expand it to 1m people from 2024. This test, developed by the Californian firm Grail, is designed to detect molecular changes in the blood caused by cancer in people with no obvious symptoms.BBC News >>
Alex Ralph and Rhys Blakley of The Times report that Astrazeneca will carry out additional trials of the Covid vaccine it has developed with Oxford University to shore up confidence over its effectiveness. The Oxford team, whose own trials have suggested that the vaccine could be 90% effective, said that the extra testing was not expected to slow an application for regulatory approval in Britain. However, Pascal Soriat, Astrazeneca’s CEO, suggested that data submitted to the UK regulator from trials in the UK and Brazil was unlikely to be sufficient for clearance in the US.The Times >>
Alex Morales of Bloomberg reports that Health Secretary Matt Hancock asked the UK medical regulator to potentially bypass its European Union counterpart and approve the supply of AstraZeneca’s (AZ) Covid vaccine to speed its deployment. Until the end of the year, when the UK exits a post-Brexit transition period, vaccines must be authorised by the European Medicines Agency. But on Friday, Hancock said he invoked a special rule allowing Britain’s Medicines and Healthcare products Regulatory Agency to authorise a temporary supply of the vaccine AZ is developing with Oxford University if the data is robust enough.Bloomberg >>
Marie-Louise Connolly of the BBC News reports that plans are under way to allow Northern Ireland’s Covid-19 vaccination programme to begin next month. It will be carried out on a phased basis and is expected to run until well into 2021. Rollout would start with care home residents and staff, health and social care workers and those aged over 80, however, without regulatory approval, any plans at this stage are provisional.BBC News >>
Selina McKee of PharmaTimes reports that patients with a difficult to treat form of multiple myeloma will now gain access to a new treatment on the NHS, after cost regulators issued final guidance on the use of Sanofi‘s Sarclisa. Sarclisa, administered as an intravenous infusion, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund as an option for treating relapsed and refractory multiple myeloma in adults. PharmaTimes >>
Andrew McConaghie of Scrip reports that BioNTech has developed its Covid-19 vaccine in record-breaking time, but artificial intelligence (AI) could help accelerate drug discovery over the longer term. The company has announced a new alliance with London-based AI specialist InstaDeep aimed at applying the latest advances in AI and machine learning technology to develop its pipeline.  Scrip >>
Sangmi Cha and Hyunjoo Jin of Reuters report that South Korean drug company SK Bioscience aims to seek a domestic stock market listing in the first half of next year. The company said the share sale will enable it to respond to the rapidly changing environment, such as the spread of Covid-19. SK Bioscience this week received regulatory approval to begin human clinical trials of its Covid-19 experimental vaccine, having agreed in July to manufacture AstraZeneca’s experimental vaccine to help the British company build global supplies.Reuters >>
The Pharma Letter reports that Takeda is building a €74m plant at its production facility in Germany. The Company is already spending €130m on vaccine production at the site, where an extra 100 employees will be added to the 1,000 already based at the facility. Takeda’s plant is dedicated to producing the drug substance for its dengue vaccine candidate, TAK-003, and this new building means that everything from the manufacturing of the active drug substance to the production of the vaccine, to the filling and final packaging, to worldwide shipping, will take place in one location. It is hoped that this will all be up-and-running by 2025.The Pharma Letter >>
John Davis of Scrip reports that Genmab has dropped the AXL targeted antibody-drug conjugate, enapotamab vedotin from early clinical development, and is focusing its resources on other therapeutic programmes. The company said that enapotamab vedotin’s initial promise has not been backed up by early clinical studies. The compound, “has shown some evidence of clinical activity,” but “this was not optimized by different dose schedules and/or predictive biomarkers.”   Scrip >>
Tina Tan of FirstWord MedTech reports that SomaLogic is accelerating commercialisation of its SomaSignal proteomic tests and the underlying SomaScan protein analysis platform, after raising $121m in the initial tranche of a series A round. The SomaScan assay is able to measure thousands of proteins at one time. Having identified specific signals given off by the proteins, SomaLogic can then package the biomarkers into its menu of SomaSignal tests, covering areas such as metabolic, cardiovascular and respiratory, among other things.FirstWord MedTech >>
Ilya Arkhipov of Bloomberg reports that Russia will begin vaccinating the general population this year. This will be carried out in stages, but the task is to have a minimum number of stages as possible and have as many people vaccinated as who want it, said Dmitry Peskov, a Kremlin spokesperson. Bloomberg >>
Jack Sidders of Bloomberg reports that Axa is to buy Kadans Science Partner, one of Europe’s largest owners of science parks and office labs, betting on a surge in demand for such properties across the region. The recent success of Covid-19 vaccine trials has added to the potential of this industry. “There’s a lot of investment going into research and development, life sciences, bio-tech, and ultimately the real estate component needs to follow,” Axa head of European transactions John O’Driscoll said.
Bloomberg >>

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