26 May 2020

Summary

  • Sanofi to slash $12bn stake in US biotech Regeneron – Financial Times
  • Chi-Med and BeiGene enter into clinical collaboration to evaluate combinations of surufatinib and fruquintinib with tislelizumab
  • Birth control gel approved as first no-hormone option in decades – Bloomberg
  • Coronavirus: Coronavirus study in China shows CanSino’s vaccine spurs immune responses – BioPharma Dive
  • Coronavirus: Gilead’s remdesivir mainly helped healthier COVID-19 patients – Bloomberg
  • Coronavirus: WHO’s Hydroxychloroquine trial suspended pending safety data – Bloomberg
  • Coronavirus: Oxford University vaccine trials run into hurdle – Bloomberg
  • Coronavirus: Fujifilm research into COVID-19 drug spills into June, dashing hope of May approval – Reuters
  • Coronavirus: Novavax starts phase 1 clinical trial of coronavirus vaccine candidate – Reuters
  • Coronavirus: Two executives at drug firm Moderna quietly sold nearly $30m of stock when they unveiled coronavirus vaccine and value rose – before share price went down again – MailOnline

Innovation loans and SME R&D tax credits

Richard Turner, Senior Managing Director in FTI Consulting’s Tax and Life Science group advises:
 
“We wanted to make sure that companies were aware of the potential implications of taking loans from government during this period and going forward.  Although the implications of grant funding are generally well understood, we are concerned that the same may not apply to loan finance. Many loans given by governmental bodies are likely to be a notified state aid because of the discounted interest rate and lack of fees. Even though the loan will be repaid, if it is specifically linked/granted in respect of R&D activities, then the entire project designated under the terms of the loan would no longer be eligible for the SME R&D incentive.  As a consequence, it could result in being a very expensive means of finance.”
Please contact Richard Turner  if you would like an further information >>
 

MedCity SME Survey support

“It’s been almost two months since we first reached out to ask you to share your immediate challenges in this unprecedented environment. The results of that first survey were shared with key stakeholders in our ecosystem including BEIS, the BIA, OLS and UKRI to help shape support packages, as well as leading to two successful in-depth advice webinars with FTI consulting and Taylor Wessing.

We now need more insight into areas of constraint and opportunity as we move forward to focus on the recovery and continued growth of one of the UK’s leading sectors. Produced in partnership with One Nucleus and SEHTA, and with input from UKRI Innovate UK and the Medical Research Council, this second survey will also influence the work we do as we move forward.

Your input will directly support recovery in innovation, investment and growth for companies like yours. Please take less than ten minutes of your time to complete the survey here.

Please contact Sarah Bruce at MedCity for further information sarahbrucewhite@medcityhq.com

Leila Abboud at the Financial Times writes that Sanofi plans to sell down most of its 20.6% stake in US biotech Regeneron as part of chief executive Paul Hudson’s promised overhaul of the French pharmaceutical maker. The two companies have had a research and marketing partnership since 2003, which led Sanofi to build up an equity stake worth $12.1bn as of the market’s close on Friday. Mr Hudson said the cash from the Regeneron exit would go towards boosting Sanofi’s research and development of new drugs and could include acquisitions.
The Financial Times >>

Chi-Med and Beigene announced that they have entered into a clinical collaboration agreement to evaluate the safety, tolerability and efficacy of combining two of Chi-Med’s drug candidates, surufatinib and fruquintinib, with BeiGene’s anti-PD-1 antibody tislelizumab, for the treatment of various solid tumor cancers, in the US, Europe, China and Australia. Under the terms of the agreement, both plan to explore development of the combination of surufatinib with tislelizumab or fruquintinib with tislelizumab in different indications and regions.
Chi-Med >>
 
Bailey Lipschultz at Bloomberg writes that a new birth control gel is the first non-hormonal contraceptive to win US Food and Drug Administration (FDA) approval in decades, bringing another option to the $5.4bn market. The gel, marketed as Phexxi by Evofem Biosciences, works by making pH levels in the vagina inhospitable to sperm when applied up to an hour before sex. The approval marks a rare new option in the contraceptive market, which has been dominated by pills for the past 60 years. The last wholly new type of birth control without hormones was the female condom, approved in 1993.
Bloomberg >>
 
Ned Pagliarulo at BioPharma Dive writes that an experimental coronavirus vaccine developed by China’s CanSino Biologics triggered immune system responses in healthy adults enrolled into a clinical trial conducted in Wuhan, China, the initial epicenter of the COVID-19 pandemic. Study results, published in The Lancet, suggest the vaccine could be helping train the body to recognize and resist infection by the new coronavirus, and show inoculation at lower doses appeared generally safe. BioPharma Dive
BioPharma Dive >>
 
Michelle Fay Cortez at Bloomberg writes that Gilead’s remdesivir, the first medicine cleared for the treatment of COVID-19, mainly benefited healthier patients who weren’t dependent on ventilators or heart-lung bypass machines, according to a study in the New England Journal of Medicine used to get the medicine on the market. The drug helped patients infected with the novel coronavirus heal faster, allowing them to return home after about 11 days, compared to 15 days for those who were treated with a placebo. 
Bloomberg >>
 
Corinne Gretler at Bloomberg writes that the World Health Organization temporarily halted tests on hydroxychloroquine in its COVID-19 drug trials pending more data because of safety concerns. The steering committee decided to suspend enrolment to that arm of the so-called Solidarity trials, WHO officials said. That’s after the Lancet published a study that said the drug, touted by US President Donald Trump as a treatment, was linked to an increased risk of death and heart ailments. 
Bloomberg >>
 
Anchalee Worrachate at Bloomberg writes that  the Oxford University team in charge of developing a coronavirus vaccine said a decline in the infection rate will make it increasingly difficult to prove whether it’s been successful. “It’s a race against the virus disappearing, and against time,” Professor Adrian Hill, director of the university’s Jenner Institute. Hill said he expects fewer than 50 of the 10,000 people who have volunteered to test the vaccine trial in coming week to catch the virus. If fewer than 20 test positive, the results may be useless.
Bloomberg >>
 
Chang-Ran Kim, Makiko Yamazaki and Rocky Swift at Reuters write that research into Fujifilm’s Avigan will continue into June, Japan’s government said, effectively dashing hopes by Prime Minister Shinzo Abe that the drug would be approved as a COVID-19 treatment this month. Abe had said he hoped the drug would be approved in May if its efficacy and safety could be confirmed. 
Reuters >>
 
Kanishka Singh at Reuters writes that Novavax has said it has started the phase 1 clinical trial of a novel coronavirus vaccine candidate and has enrolled the trial’s first participants, with preliminary results slated for July. The company in April said it identified the candidate, NVX-CoV2373, with which it planned to use its Matrix-M adjuvant to enhance immune responses. Novavax said it expects preliminary immunogenicity and safety results from the trial in July.
Reuters >>

Rachel Sharp at MailOnline writes that two executives at drug firm Moderna quietly sold nearly $30m of stock when they unveiled a coronavirus vaccine and value surged, before the share price quickly fell again amid. Moderna’s CFO Lorence Kim and CMO Tal Zaks dumped the staggering value of stocks following the company’s announcement of what it described as ‘positive’ results from its vaccine trial. The two executives pocketed almost $25m in profits in a day’s work before experts cast doubt on the vaccine’s success and sent shares tumbling. 
MailOnline >>

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