BERLIN, 19 June (APM) - German biotech CureVac is planning to launch its mRNA Covid-19 vaccine in the middle of next year if all clinical trials are successful, Frankfurter Allgemeine Zeitung (FAZ) (p18), Handelsblatt (p16-17) and Süddeutsche Zeitung (SZ) (p2) reported on Thursday.
CureVac announced two major milestone this week: a €300 million investment by the German state which talks a 23% stake in the company (APMHE 67759
) on Monday, covered in Handelsblatt (p1, 4-5), FAZ (p15), SZ (p15) and Die Welt (p1); the regulatory approval from German and Belgian authorities to initiate a Phase I trial in 168 participants in three dosages on Wednesday.
First Phase I data are expected in September or October and a larger Phase II study will follow, acting chief executive Franz-Werner Haas said.
CureVac is up to three months behind its immediate competitors U.S. Moderna and Germany's BioNTech in the race for a mRNA Covid-19 vaccine but is confident to keep up with them thanks to a more efficient technology, wrote Handelsblatt.
Moderna and BioNTech have already started their clinical trials in March and April and Moderna says it has already completed planning for a large Phase III study, which is expected to start shortly.
However, Curevac says its RNA technology is able to generate high quantities of protein in the cells and a strong T-cell stimulation, which is considered important for the longer-term efficacy of such a vaccine.
Questions on German's biotech investment policy
Concerns emerged on the consistency in German state's investment policy after the CureVac operation, reported FAZ on Wednesday (p19), calling it the "CureVac mystery".
First, it is not clear whether CureVac is preparing an initial public offering (IPO) on the U.S. Nasdaq in July as stated in as a letter from the Ministry of Finance to a parliamentary commission. However, Curevac did not confirm.
Second, economists questioned why CureVac was selected while several other biotech companies in Germany are working on Covid-19 related treatments or vaccines without state participation.
The state entry represents "a potential danger to free competition", said the chairman of the Monopolies Commission, Achim Wambach.
However others, like Dietmar Harhoff, director at the Max Planck Institute for innovation and competition, saw it as "a wise decision". People in the Ministry of Economics "have finally woken up" and the Ministry is now talking of setting up a "future fund".
Many vaccine developers needed to supply Covid-19 vaccines globally - BioNTech
Many vaccine developers are needed to supply Covid-19 vaccines globally and developing a Covid-19 vaccine is not about "winning a race", BioNTech's chief executive Ugur Sahin has told SZ in an interview published on Monday (p16).
A success of mRNA vaccine developing biotechs CureVac or Moderna would mean a success for this new technology. Therefore, BioNTech - who is conducting clinical studies in four mRNA vaccine candidates - would be happy for any of its competitors, Sahin said.
Sahin did not take a long time to look for a partner for the vaccine candidate but just called the head of Pfizer's vaccine unit, who agreed quickly. In Germany, BioNTech is building up manufacturing capacity and Pfizer in other EU countries and the U.S., Sahin told SZ.
The companies expect first clinical data on the vaccine within two months, Sahin said. Also, BioNTech expects to start pivotal studies in its focus area of mRNA cancer vaccines this year.
BioNTech investor hopes for next win against big pharma
BioNTech investor Thomas Strüngmann hopes for his next win against big pharma companies, after building up generic drug company Hexal in the 80s and first successes from his biotech investments, he told Wirtschaftswoche in an interview published on Friday (p50-51).
Strüngmann hopes that one of BioNTech’s Covid-19 vaccine candidates could be successful before his next birthday, or one of the German biotech’s cancer vaccines within the next five years, alternatively.
Strüngmann and his twin brother hold about 50% of BioNTech’s shares, acquired through an investment of €130 million.
This would be Strüngmann's third win after selling Hexal to Novartis for €5.5 billion in 2017 and after Merck & Co bought global commercial rights to cytomegaly virus drug Prevymis (letermovir) in 2012, developed by AiCuris, one of Strüngmann's investments.
U.S. Moderna and Johnson & Johnson accelerate Covid-19 vaccine development
U.S. companies Moderna and Johnson & Johnson are intensifying the development of their Covid-19 vaccines, Handelsblatt reported on Monday (p19). (APMHE 67724
J&J said it will start the Phase I/IIa study on Ad26.COV2-S vector vaccine in the second half of July instead of September while Moderna said it will take its messenger RNA-based candidate, mRNA-1273, to Phase III in July in a trial involving 30,000 people.
In addition to the University of Oxford and its partner Astra-Zeneca, which started a Phase II/III at the end of May, Moderna is probably the second Western company with a large pivotal clinical trial for a Covid-19 vaccine.
Siemens and Exyte collaborate to build pharma manufacturing plants within six months
Siemens and Exyte collaborate to build pharma manufacturing plants within six months, to produce Covid-19 vaccines, biologic drugs or cell and gene therapies, FAZ reported on Saturday (p20).
The question for pharma companies of when to invest in plants is always an issue when planning manufacturing capacities. Drug candidates may fail in Phase III or the company may not be ready for mass manufacturing at the time of approval.
To resolve this, Exyte designs plants composed of standardised modules and Siemens equips the cleanrooms. First customers are located in China and Europe, while Exyte's chief executive Wolfgang Büchele expects that more pharma manufacturing will be built up in Europe, he told FAZ.
French president Macron reconciles with Sanofi
French president Emmanuel Macron has reconciled with Sanofi's chief executive Paul Hudson after the controversy on Covid-19 vaccine supply in May, Handelsblatt said on Wednesday (p47).
Macron's visit to Sanofi's vaccine plant near Lyon on Tuesday (APMHE 67787
) was a clear sign that the relationship has eased again, the paper said. (APMHE 67787
Macron said he expects Sanofi to participate in the "inclusive vaccine alliance" formed by France, Germany, Italy and the Netherlands to supply covid-19 vaccines to Europe (APMHE 67789
Hudson also announced a €610 million investment to create a new production site and a research centre for vaccines in France, FAZ (p19) and SZ (p18) reported on Wednesday.
Sanofi had to prove that it is rooted in France, FAZ said. Hudson said Sanofi's "heart" is in France, which has appeased Macron, SZ said.
Dexamethasone prevents Covid-19 deaths
Low doses of corticosteroid dexamethasone could prevent up to a third of deaths in ventilated Covid-19 patients, according to Oxford University data from the UK RECOVERY trial, FAZ (p8) and SZ (p15) reported on Wednesday, SZ (p2) on Thursday (APMHE 67785
Physicians are optimistic that the drug, which is inexpensive and widely available, may be a "game-changer", as it could reduce over-active immune reactions. However, adverse events and the final proof are not known or available, as the original data have not yet been revealed, SZ said.
Novartis to launch gene therapy Zolgensma in Germany on 1 July
Novartis' AveXis will launch gene therapy Zolgensma (onasemnogene abeparvovec) in Germany on 1 July priced at €1.945 million to treat toddlers with rare disease spinal muscular atrophy (SMA), FAZ reported on Thursday (p22) (APMHE 67808
About 500 patients have already received the one-time therapy in the U.S. and Japan, where Zolgensma has already been on the market, under the global compassionate use programme, or in clinical studies. In five-year data, Zolgensma has shown long-lasting efficacy, according to AveXis.
AveXis Germany told FAZ that it plans to manufacture Zolgensma at two additional sites from the beginning of next year, adding to the existing U.S. site.
AZN to supply up to 400 million doses for EU at end of year
AstraZeneca has signed a deal with Germany, France, Italy and the Netherlands to supply up to 400 million doses for the EU at the end of the year under a vaccine alliance that will be combined with the European Commission's initiative, FAZ reported on Sunday (p1) and Monday (p15).
Health Minister Jens Spahn said that this deal could be annulled if another pharma company would have its vaccine candidate approved earlier than AZN, FAZ said.
Drug manufacturing to be fostered as 'strategic industry' in EU
Germany is planning measures to foster drug manufacturing as one of several "strategic industries" during Germany's EU Council presidency, according to an inofficial draft of the presidency programme, SZ reported on Tuesday (p6).
The EU's sovereignty in supply of drugs, protective equipment and medical devices - products for which a strong dependency is seen of Chinese and Indian suppliers. In general, relations between the EU and China should become more "balanced".
Cancer drug sales slump 18% in June
Sales of cytostatic drugs and immunomodulators fell 18% in the first week of June compared to that week in 2019, as patients do not frequent doctor's offices out of fear of Covid-19 infections, FAZ reports on Friday (p24).
According to data from consultancy firm IQVIA, the package number of prescription drugs fell 0.5% and of OTC drugs 3% this year up to the first week of June, as sales increased in March, shortly before the lockdown, and slumped during the restricted period.
Stada sold even 30% fewer packages of cancer drugs in May than in 2019, while the number of packages of dietary supplements increased by a double-digit percentage, FAZ said.
Covid-19 vaccines and drug R&D not to threaten oncology R&D - EY
Pharma companies will not drop their oncology research and development (R&D) projects to jump on the recent trend of vaccine and drug R&D for Covid-19, consultancy firm EY said in its pharma report, FAZ reported on Tuesday (p22).
In 2019, sales of the biggest 21 pharma companies increased 12% to €500 billion, €331 billion of which belong to the 10 biggest companies. A third of sales, comes from oncology drugs, totalling €174 billion, representing a 20% increase.
Some 97% of the 161 vaccine candidates under development to prevent Covid-19 might not be approved in the end. Also, 242 drug candidates are under development to treat Covid-19 - but only three to four are likely to be used in clinical practice in the end, according to EY.