5 March 2021

Summary

  • Covid-19: Italy blocks shipment of Oxford/AstraZeneca vaccines to Australia – Financial Times 
  • Covid-19: Novartis signs 250 million-dose vaccine pact with CureVac – Bloomberg 
  • Amgen snaps up cancer drug player Five Prime, adding phase 3-ready FGFR2b drug in $2bn M&A play – Endpoints News 
  • Hutchison China MediTech reports 2020 full year results, provides business updates and evolves corporate identity
  • Covid-19: Largest vaccine maker warns of delays as US prioritizes Pfizer – Bloomberg 
  • Corvista advancing heart disease tech with $65m Series C – BioWorld MedTech 
  • BlackRock powers Exscientia to $100m Series C round to fund autonomous drug design – FierceBiotech 
  • Glasgow firm behind pioneering blood test to detect cancer secures seven-figure boost – The Scotsman
  • Kronos seals pact with regulators to hunt AML with previously off-limits biomarker endpoint – Endpoints News 
  • Biogen cements gene therapy ambitions with $200m factory in Research Triangle – FiercePharma 
  • Covid-19: Pfizer plant helping boost vaccines has repeat quality offenses – Bloomberg 
  • Pfizer’s Lorbrena breaks into front-line ALK lung cancer, jostling with Novartis, Roche and Takeda – FiercePharma 
  • Enzyre and Takeda partner to develop assays for bleeding disorders – Medical Device Network 
  • Johnson & Johnson loses pelvic mesh court appeal – ABC News 

N-Site workshops launched

N-Site has developed a series of online company specific participative workshops that are aimed to deliver deep and tailored insight ahead of critical events delivered by relevant specialists from the N-Site firms.  
 
N-Site is  currently offering workshops across eight areas: fundraising, starting-up, partnering and collaboration, IPO, i nternational expansion, investing in the UK, product launch and Brexit.
The workshops will typically be half a day and will be specific to the registering company and not open to others. 
Further details from N-Site >>
Sam Fleming, Jim Brunsden and Miles Johnson of the Financial Times reports that Italy has blocked a shipment of the Oxford/AstraZeneca Covid-19 vaccine that was destined for Australia, in the first intervention since the EU introduced rules over the shipment of vaccines outside the bloc. Rome stopped the export of 250,000 doses of the vaccine, officials said. Italy notified Brussels of its move at the end of last week under the EU’s vaccine export transparency regime. Financial Times >>
Naomi Kresge of Bloomberg report that Novartis has agreed to produce CureVac’s Covid-19 vaccine candidate in a deal that will boost the potential supply of the shot by as much as 250 million doses over the course of this year and next. The Swiss pharmaceutical giant could make as many as 50 million doses this year and 200 million doses in 2022. Once the final agreement is signed, Novartis plans to start production in the second quarter and ship the first deliveries to CureVac this summer. Bloomberg >>
John Carroll of Endpoints News reports that Amgen is making a long-awaited move on the M&A side, buying Five Prime for close to $2bn and adding a slate of new cancer drugs to the pipeline. Amgen is paying $38 a share, putting the deal value at $1.9bn. The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, phase 3-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer.Endpoints News >>
Hutchison China MediTech reported its full year results, alongside a business update and a proposed name change to Hutchmed. 2020 was a year of significant clinical and regulatory progress, with Hutchmed also expanding its commercial capabilities to support sales of its first two oncology drugs, Elunate and Sulanda. Chairman, Simon To, said, “Over the next three years, we will continue to grow our R&D and commercial organisations globally to support the anticipated launch of our oncology drugs in China, the US and Europe.”Hutchmed >>
Chris Kay of Bloomberg reports that the head of the world’s biggest vaccine maker and the World Health Organization chief scientist said manufacturers of coronavirus shots face a global shortage of the raw materials needed to churn out the inoculations. Adar Poonawalla, CEO of the Serum Institute of India told a World Bank panel that a US law blocking the export of certain key items, including bags and filters, will likely cause serious bottlenecks. Bloomberg >>
Meg Bryant of BioWorld MedTech reports that Corvista Health has raised $65m in a Series C equity financing led by Ambix Life Science Fund. The new funds are earmarked for ongoing research, product development and commercialization of the company’s noninvasive, point-of-care solution for rapid detection of heart disease. Joining Ambix in the round were Medventure Partners and several new and existing investors. With this latest infusion, Corvista has raised a total of nearly $100m. BioWorld MedTech >>
Nick Paul Taylor of FierceBiotech reports that Exscientia has raised $100m to further develop its artificial intelligence drug discovery platform while advancing its proprietary pipeline into clinical trials. The Series C saw Exscientia add BlackRock to an investor syndicate already dotted with big names. Exscientia has established itself as a notable player in the AI drug discovery space through a series of deals with biopharma companies. Having raised $60m in series C funding last year, Exscientia has now closed the round at $100m. FierceBiotech >>
Emma Newlands of The Scotsman reports that ClinSpec Diagnostics is behind a blood test using pioneering “drop, dry, detect” technology based on the research of Dr Matthew Baker. The firm, a spinout from the University of Strathclyde, says its offering not only helps enable earlier diagnosis of cancer, but also has the potential to indicate the type and severity of the tumour. It has secured the new £1.1m investment from Norcliffe Capital, the University of Strathclyde, Eos Advisory, and the firm’s founders to reach its goal of £3.5m.The Scotsman >>
Max Gelman of Endpoints News reports that Kronos has reached an agreement with the US Food and Drug Administration to conduct a phase 3 trial with a unique primary endpoint, one that it hopes will accelerate entospletinib’s path forward in a certain type of acute myeloid leukemia. The endpoint is measurable residual disease negativity, which Kronos says can paint a clearer picture when it comes to the study’s complete response rate. It’s the first time this endpoint has been used for a potential approval in a phase 3 study for AML.Endpoints News >>
Fraiser Kansteiner of FiercePharma reports that as Biogen awaits a US Food and Drug Administration decision on its controversial Alzheimer’s disease hopeful aducanumab, the company is setting the stage for an entry into the hot gene therapy field. Biogen has drawn up plans for a new gene therapy manufacturing facility at its Research Triangle Park campus in North Carolina. The company will invest some $200m in the new 175,000-square-foot facility designed to scale up the manufacturing of the products that are in Biogen’s growing gene therapy pipeline. FiercePharma >>
Anna Edney of Bloomberg reports that the factory Pfizer plans to use to boost production of its Covid-19 vaccine for the massive US inoculation effort was cited by federal inspectors last year for repeated quality-control violations. US Food and Drug Administration inspectors visited the McPherson, Kansas, plant at the end of 2019 into January 2020, according to an inspection report. They found the drug giant released medications for sale after failing to thoroughly review quality issues that arose in routine testing, the report shows.Bloomberg >>
Angus Liu of FiercePharma reports that Pfizer’s Lorbrena has finally broken into front-line non-small cell lung cancer, where NovartisRoche and Takeda are already jockeying for a niche market. The US Food and Drug Administration expanded Lorbrena’s use into newly diagnosed patients with ALK-positive NSCLC. With that front-line nod, the agency converted Lorbrena’s conditional green light for previously treated cases into a full approval. FiercePharma >>
Chloe Kent of Medical Device Network reports that Enzyre and Takeda Pharmaceutical have entered into a strategic collaboration to develop assays for the diagnosis and monitoring of congenital bleeding disorders. In December 2019, Enzyre entered a research collaboration with Takeda Pharmaceutical to develop a device for haemophilia patients to quickly determine their coagulation status at home. The latest deal builds on the existing agreement while Takeda confirmed the partnership by investing in Enzyre and joining its supervisory board.Medical Device Network >>
Jamelle Wells of ABC News reports that the Australian Federal Court has dismissed an appeal against a landmark judgment awarding $2.6m to Australian women with faulty vaginal mesh implants. In March 2020, Johnson & Johnson were ordered to pay damages to three women with faulty mesh implants. During a seven-month trial, a court heard of a “tidal wave” of aggressive marketing to surgeons and patients that suggested implanting the mesh was a “quick and easy operation”. ABC News >>

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