According to Financial Times, the US government is developing mrna-based bird flu vaccine. According to news, the government is having funding talks with Moderna and Pfizer and outcome is expected in June.
The H5N1 outbreak in the US agriculture is increasing the need to speed up the bird flu vaccine stockpile and its manufacturing processes. The current vaccines are seen effective but in case of a pandemic the vaccine manufacturing is too time consuming.
According to CDC, the bird flu cases in the US has been detected in poultry farms in 48 states and dairy cow in nine states. Three dairy workers were affected in recent months.
The German biotech company Biontech announced today that it has appointed Annemarie Hanekamp to lead the company’s first ongology product launch estimated in 2026 and lead the product candidates of 10 potential approvals by 2030.
Annemari Hanekamp will start as chief commercial officer in July 1 this year. She will come from Novartis with similar duties.
According to the company release, she will drive and execute the global commercialization strategy to leverage Biontech’s full potential as vertically integrated biopharmaceutical company.
The US biotech company Novavax said last week that it is aiming to launch its non-mRNA Covid-vaccine with influenza combination during 2026. The Phase 3 trial is estimated to start during the second half this year.
– 2023 was a transition year for Novavax and we have made tremendous progress towards strengthening the financial profile of the Company, delivering the only protein-based non-mRNA COVID-19 vaccine option to the U.S. and globally, and focusing our investment on the future expansion of our product portfolio,” said John Jacobs, Chief Executive Officer of Novavax.
The company reported total revenue full year 2023 984 million dollars and net loss of 567 million dollars. Year ago the net loss was 645 million dollars.
Novavax said it is expecting to have total revenue of 800-1000 million dollars this year and R&D expenses of 700-800 million dollars.
The company announced earlier the settlement of Gavi vaccine agreement for the next five years.
Novavax (NVAX) and Gavi, the Vaccine Alliance (Gavi) have reached a settlement related to the 2021 Advance Purchase Agreement (APA) for Novavax’s prototype COVID-19 vaccine. This agreement brings the pending arbitration related to the APA to a close. The stock of Novavax was up over 25% in New York Nasdaq today.
– Novavax is pleased to have reached this agreement with Gavi as it gives us the ability to continue to work together toward our shared mission of ensuring equitable access to safe and effective vaccines, said JohnJacobs, Chief Executive Officer of Novavax in the company release.
-We look forward to a long-term partnership with Gavi to provide continued access to our protein-based non-mRNA COVID-19 vaccine, he said.
-Gavi welcomes this agreement, which allows us to maintain focus on our core programmatic goals, including providing access to COVID-19 vaccines for vulnerable people in lower income countries. It is good for global immunisation, for countries and for healthy manufacturing markets,” said David Marlow, Chief Executive Officer (ad int) of Gavi, the Vaccine Alliance.
Under the terms, Novavax has made an initial payment of 75 million dollars to Gavi and has agreed to make deferred payments of 80 million dollars annually through December 31, 2028, which are due in quarterly installments and total up to 400 million dollars. Novavax’s annual cash obligation would be offset or reduced pursuant to an 80 million dollars annual vaccine credit, which may be used for qualifying sales of any of the Company’s vaccines funded by Gavi for supply to low-income and lower-middle income countries.
Use of the annual vaccine credit for qualifying sales would reduce Novavax’s annual cash obligation. In addition to the annual obligation, Novavax will provide an additional vaccine credit of up to $225 million, should there be additional demand, which can be applied towards qualifying dose purchases of any of the Company’s vaccines in such countries throughout the five-year term, the company
The US pharma company Moderna said on Thursday (14.12.2023) that it expects to launch its RSV vaccine next year globally. The company said it has sent applications to regulatos globally.
Moderna also published the latest Phase 3 study results evaluating its mRNA 1345 vaccine for RSV in the New England Journal of Medicine. According to company its RSV vaccine has the best in class profile and the only ready to use RSV vaccine available in single-dose.
Earlier the company had announced the top-line results from the study in January 2023. Moderna’s share closed up 7,76% for the week to 87,08 dollars.
The UK Swedish pharma company AstraZeneca has today announced its offer to buy US biopharma company Icosavax. The transaction value is 800 million dollars and the offer is 15 dollars per share in cash and 5 dollars per share of non-tradable contingent value.
The US company Icosavax is a biopharma company with Phase 2 trials of RSV and hMPV vaccines. The company is focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.
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Author: M.Sc (Econ) Päivi Härkönen
1. Update the Coronavirus, Covid19
Date: 10.11.2023
There are over 771 million Covid-cases (771.820.937) and over 6,9 million deaths ( 6.978.175) globally (8.11.2023) according to WHO. In the US, the death toll is over 1,1 million people, in India over 530.000 and in Brazil over 704.000. In Russia the death toll is over 400.000.
During the weeks period the global Covid-cases have increased by 141.319 (129.900) and deaths by 1152 (2550 week before).
The latest updates of the virus variants show that the proportion of the new EG.5 variant of all Omicron variants is still the largest in the US. According to CDC data, the next variants to follow are FL 1.51 , XBB 1.16 and XBB1.16.6.
The European Commission said on Friday 1st September that it has authorised the updated Covid-vaccine from Pfizer/Biontech for the EU area. Earlier the EMA and its Committee for Medical Products for Human use had recommended the updated vaccine.
Moderna said on 14th September that the EMA committee recommends authorization of Moderna’s updated Covid-vaccine in the EU.
The dominant Covid- variants in the US in September 2023.
The US biotech company Moderna said (17.8.2023) its Covid-vaccine generates robust immune response against widely circulating variants. The updated vaccine targets effectively the new variants EG.5 and FL 1.5.1, the company said. Moderna and Pfizer/Biontech said they filed the regulatory approvals to the FDA and EMA in Europe in June.
The WHO said in 4th May that the Covid 19 pandemic emergency of international concern is over as the new cases and hospitalizations have declined remarkably because of the vaccinations.
– Covid-19 is now an established and ongoing health issue which no longer constitutes a public health emergency of international concern, the organization says.
In the US, the CDC announced that the Covid-19 public health emergency declaration ended on May 11, 2023. According to CDC, vaccines, treatments and tests remain available, but there will be changes in the raporting data. The frequency, source and availability may change in some data.
As a new data, CDC will follow percentage of Covid-associated deaths each week. And for example vaccines administered will be updated monthly, not weekly.
The latest Covid-updates from the CDC show that hospitalization increased 0,1% in recent weeks. The reporting period was October 22-28 2023. The numbers were 15.745 totalling 6.452.832. Covid- deaths from the period 22-28 October increased 2,5% to total 1.151.435. The deaths increased by 1316 (1428) in the US during the week.
Trend in emergency department visits decreased 5,3% in most recent weeks, but weekly increased 1,2%. This data was published 6th November.
The number of people tested positively Covid-19 was up 9,0% during the week’s period, October 22-28.
WHO said the US Covid updates will be published in the future in the Pan American Health Organization website (paho.org).
The new weekly Covid-cases in Europe during the year 2022. Source: EarthRate, Johns Hopkins University
The WHO Director General TedrosGhebreyesus said in September in the press conference in Geneva that as the northern hemisphere winter approaches, “we continue to see concerning trends for COVID-19”.
-Among the relatively few countries that report them, both hospitalizations and ICU admissions have increased in the past 28 days, particularly in the Americas and Europe.
-Meanwhile, vaccination levels among the most at-risk groups remain worryingly low.
-Two-thirds of the world’s population has received a complete primary series, but only one-third has received an additional, or “booster” dose.
-COVID-19 may no longer be the acute crisis it was two years ago, but that does not mean we can ignore it, he stated.
In Europe (France, UK, Spain, Italy and Germany) confirmed new covid-cases during one week period (based on the data from EarthRate and WHO), decreased somewhat, but continued to grow. The new cases were 35.209 (34.844 week ago) in Europe in the period November 3-8
UK, new cases during the period 7835 (6920 week ago)
Spain, new cases, 0, (0 week ago)
France, new cases 0, (0 week ago),
Italy, new cases 27.371 (27.924 week ago),
Germany, new cases 0, (0 week ago),
November 25th 2022
November 18th 2022
November 11th 2022
November 4th 2022
October 28th 2022
October 21st 2022
October 14th 2022
October 7th 2022
September 30th 2022
September 23rd 2022
September 16th 2022
September 9th 2022
September 3rd 2022*
August 20th 2022
August 14th 2022
August 5th 2022
July 28th 2022
July 21st 2022
July 14th 2022
July 7th 2022
July 29th 2022
June 19th 2022
France
270.160
182.576
117.632
148.665
269.248
373.029
397.413
413.783
204.010
256.343
168.483
98.919
265.917
108.894
1.396.798
285.929
153.244
not updated
392.649
1.025.501
1.205.368
332.637
112.213
180.992
113.900
189.208
233.163
283.232
400.745
560.831
844.998
944.931
977.601
864.783
676.682
373.694
372.023
432.991
621.384
1.033.569
2.135.456
2.090.067
2.500.732
2.083.460
1.625.016
1.104.066
511.176
362.672
391.634
273.201
156.248
135.105
43.281
50.999
41.553
46.001
28.964
40.855
35.845
31.434
70.941
51.659
143.162
77.881
228.990
146.118
158.454
151.221
98.072
19.161
117.652
130.586
143.179
632.701
419.221
99.410
233.381
UK
387.326
23.972
24.815
32.154
43.940
57.408
64.614
114.229
1938
37.488
31.514
33.435
103.116
139
265.466
64.424
216.857
not updated
1629
190.776
323.787
92.553
78.554
30.068
40.514
61.542
69.086
78.146
107.666
189.345
200.781
336.635
530.632
604.973
570.593
416.512
318.289
228.171
318.238
521.758
1.423.016
555.458
645.726
824.112
1.247.539
1.215.600
615.334
510.561
353.078
314.176
308.121
323.114
187.583
246.519
285.707
413.752
242.052
280.364
241.257
172.523
262.579
191.672
312.840
174.137
252.889
228.145
184.886
194.805
255.410
385.155
190.488
14.509
13.512
17.554
30.851
1.068
28.327
Spain
22.182
21.896
17.875
23.753
25.422
20.652
10.843
18.835
8761
29.386
15.394
6703
45.718
12.162
48.143
42.768
229.613
not updated
83.613
155.964
255.044
84.405
75.749
76.981
147.030
52.112
173.641
120.024
96.564
109.406
75.913
0
99.898
127.039
100.663
123.546
120.904
168.302
205.022
404.484
420.586
803.672
882.422
928.130
870.161
576.738
262.480
165.337
87.232
71.946
50.349
33.507
21.517
14.491
13.416
13.346
11.367
12.491
14.527
17.055
22.085
29.706
45.946
61.356
76.913
105.408
141.088
166.615
180.207
33.842
208.523
43.331
55.460
61.334
70.646
35.672
45.641
Italy
208.346
181.181
110.988
55.836
220.554
264.432
297.289
297.630
132.830
148.029
109.811
97.199
325.496
82.386
285.972
374.326
1.313.971
not updated
366.088
718.297
785.502
225.785
147.402
132.232
168.724
174.870
262.374
304.573
383.991
419.374
421.707
447.332
990.627
503.932
472.000
332 956
257.543
304.907
374.443
510.537
858.845
902.757
1.231.741
1.268.153
1.014.358
644.508
257.579
158.547
112.233
99.181
78.910
72.024
35.910
36.082
300.780
28.703
14.444
22.280
39.647
17.585
39.553
25.118
54.006
32.821
49.605
51.221
40.268
35.984
23.203
9155
219.107
70.094
73.136
92.074
120.917
86.279
137.794
Germany
168.400
175.052
220.113
261.500
425.350
580.735
690.960
610.361
263.956
308.308
221.658
174.256
581.353
131.132
356.638
476.194
1.522.022
not updated
254.143
745.485
1.371.616
395.700
312.634
253.259
202.892
310.612
433.898
486.165
629.273
763.849
731.814
1.290.158
1.902.019
774.990
1.519.347
1.368.253
1.097.390
1.127.277
1.213.982
1.326.317
1.403.491
944.853
728.594
456.306
335.750
196.678
186.189
284.393
350.902
397.178
406.368
371.716
210.267
184.505
131.880
109.245
54.305
63.467
56.455
42.774
78.189
57.835
88.618
49.149
51.463
31.730
47.897
14.669
9038
5566
312.214
106.941
119.528
136.813
174.067
87.580
122.137
* two weeks period
Different Covid-vaccines in the EU and the US. Source: Our world of data, September 2023
The Nobel Committee announced on Monday 2nd October that researchers Katalin Kariko and Drew Weissman have won Nobel Prize for the work in mrna vaccine development. According to the committee their work laid the foundation of Pfizer-Biontech’s and Moderna’s mrna-vaccines and helped save millions of lives during the pandemic.
The University of Pennsylvania researhers are also studying how the mrna technology can be used in other diseases like influenza and some cancers.
The Ukraine crisis:
The Ukraine Covid is showing 5.518.385 (5.518.385) cases and 109.904 (109.904 cumulative deaths). The data has not changed for weeks.
Earlier, before the war, it was as follows: cases 5.040.518 and deaths 112.459. Over 8 million people have left the country because of the invasion, but some are also returning back.
2. Updates in the vaccine and drug development
Global Covid–Vaccinations situation:
According to Our World in 13,53 billion doses have been given by November 13th 2023.
According to Our World in Data, 70,6% of the world population has now received at least one dose vaccination. (13.11.2023).
The virus situation varies in different countries. Only 32,8% of the people in low income countries have received their first dose of vaccination, according to Our World in Data.
Pfizer Chief Development Officer JamesRusnack said in the company release that Pfizer is committed to meet the critical need and helping address the global health threat of antimicrobial resistance. Pfizer is planning to file the regulatory filings in the EU, UK, China and the US in the second half of 2023. According to Pfizer, the US pharma company AbbVie holds the commerce rights in the US and Canada.
The Covid- vaccinations (initial protocoll) by different age groups in France. Source: Our world in dataThe US states, the share of at least one Covid-vaccine
The US pharma company Moderna said in October that it has got positive interim Phase1/2 results from combination of flu and Covid-19 vaccine.
-With today’s positive results from our combination vaccine against flu and Covid-19, we continue to expand our Phase 3 pipeline, the CEO Stephane Bancel said in the company release.
According to Moderna, the company is targeting potential regulatory approval for the combination vaccine in 2025.
Pfizer and Biontech also announced their applications to the US FDA and the European Medicines Agency on 23rd June 2023 . The composition of the application is the same, Omicron XBB 1.5 covid-vaccine. According to companies, the shipments could start immediately.
The vaccinations in Europe are mainly by Pfizer/Biontech and Moderna. The third vaccine is either from Oxford/AstraZeneca or from Johnson & Johnson.
In Hong Kong the vaccines are Pfizer/Biontech and Sinovac. In Switzerland the combination is vice versa compared to other European countries. Majority of Swiss vaccinations is made by Moderna.
In Germany the vaccines are from Pfizer/Biontech, Moderna, Oxford/AstraZeneca, Johnson & Johnson, Novavax and Valneva. In France the vaccinations list is Pfizer/Biontech, Moderna, Oxford/AstraZeneca, Johnson & Johnson, Novavax and SanofiGSK.
The US Pfizer said in March 2023 that the US FDA advisory board supports its Paxlovid Covid- drug for mild to moderate symptoms. According to company release, the drug helps to reduce the risk of hospitalizations and deaths. Now the company has received the authorisation of the Paxlovid oral treatment from the FDA (25.5.2023).
– We made significant progress in 2022 by advancing our pipeline and launching the world’s first Omicron BA.4/.5, the company CEO UgurSahin said in the release.
Global vaccine and drug development
The US pharma company Pfizer (PFE) said last week that its Q3 revenue were 13,2 billion dollars and reaffirmed its full year quidance after the Covid-product profit warning in October
Pfizer expects its full year revenue to be between 58-61 billion dollars and EPS between 1,45-1,65 dollars. The company also announced a cost savings plan of 3,5 billion dollars in October after the Covid-products decline. The sales of Paxlovid and Comirnaty decreased by 9,3 billion dollars.
– We are encouraged by the strong performance of Pfizer’s non-Covid products in the third quarter of 2023 including significant contributions from new launches and robust year over year growth of several key in-line brands, the company CEO Albert Bourla said in the release.
Pfizer said on Friday (October 13th) that it has reduced the Covid product sales estimates for this year and reduced the full year quidance. The new full year revenue is now 58-61 billion dollars when it was earlier 67-70 billion dollars. The EPS estimate is now 1,45-1,65 dollars when it was earlier 3,25-3,45 dollars.
According to Pfizer, it has reduced the Comirnaty revenue quidance by approximately 2 billion dollars and for Paxlovid about 7 billion dollars. The decline is about 9 billion dollars in the Covid-products. The company informed cost cutting program of about 3,5 billion dollars.
Pfizer said also that it has reached an agreement with the US government to provide Paxlovid free of charge for federally insured patients through 2024 as the government returns about 7,9 million Paxlovid treatment courses by the year endPfizer said also that it has reached an agreement with the US government to provide Paxlovid free of charge for federally insured patients through 2024 as the government returns about 7,9 million Paxlovid treatment courses by the year end
Pfizer will also provide the US goverment with one million treatment for a strategic national stockpile and the company continues to commersialise the product further.
The WHO released on 19th October a new document related to artificial intelligence and heathcare. The publication emphasizes the importance of establishing AI systems’ safety and effectiveness at the same time fostering dialoque with stakeholders.
The AI can help strengthening clinical trials, improving medical diagnosis, treatments, self-care and person- centered care, knowledge sharing, skills and competence. The systems should emphasize privacy, security and integrity.The developers should include transparency, documentation, risk management, dataprivacy and protection validation, data quality and collaboration.
Pfizer said in early 2023 that it has made Phase 3 studies related to novel antibiotic combination ATM-AVI (aztreonum-avibactan) and that it could be important treatment option for patients with life-threathening bacterial infections that are resistant to almost all currently available antibiotics.
Pfizer said in April 4th that the FDA has accepted their supplemental new drug for lung cancer. According to company the US FDA has accepted for review the supplemental new drug application for Braftovi and Mektovi for patients with metastatic non-small cell lung cancer with Braf v600E mutation, as detected by an FDA- approved test.
In October 2023 the company announced that the FDA has approved Braftovi and Mektovi for adults as a new personalised treatment option for this disease.
– For more than a decade, Pfizer oncology has been at the forefont of bringing biomarker- driven treatment options to patients with cancer. Since their initial regulatory approvals, Braftovi and Mektovi have helped improve outcomes on their respective indication of Braf- mutated metastatic melanoma and cancer, said chief development officer ChrisBosheff in the release. According to Pfizer, lung cancer is the second most common type of cancer and the number one cause of cancer-related death around the world.
The Danish pharma company Novo Nordisk (NVO) reported last week its 9 months 2023 figures. According to company info, net sales increased by 29% to 166,4 billion DKK and net profit increased by 31% to 61,7 billion DKK during the first nine months this year compared to year ago. reported
– We are very satisfied with the sales growth in the first nine months of 2023 which is reflecting that more people than ever are benefiting from our innovative diabetes and obesity treatment, the company CEO Lars Fruergaard Jorgensen said in the release.
Moderna said 11.4.2023 that it has five influenza vaccine candidates in clinical development. The company has also vaccine development ongoing related to norovirus and lyme disease. The lyme disease vaccine candidate is the first bacterial vaccinre for Moderna, the company CEO StephaneBancel said in the release.
Moderna and Merck announced in December that they have done statistically and clinically remarkable results in cancer treatment with mrna vaccine. The companies published on 17th April results from Phase 2 study related to skin cancer. According to the results, mrna vaccine reduced the risk of recurrence or death by 44 % compared to Keytruda alone in stage III/ V melanoma patients. Moderna said it will continue the Phase 3 studies soon and enlarge testing to lung cancer and beyond. Moderna stated in its earnings report 3.8.2023 that they have started the Phase3 studies in high- risk melanoma.
Moderna published its collaboration with IBM in quantum computing and generative AI on April 20th 2023. The company is building its quantum workforce.
Moderna said on July 5th 2023 that it has submitted marketing authorisation for its RSV vaccine for older adults in Europe, Switzerland and Australia. In the US the company has applied for BLA. The efficacy of this mrna vaccine 1345 is 83,7%.
Moderna said in April 3rd that the company will establish its mrna manufacturing facility in the Republic of Kenya. It will produce 500 million doses of vaccines each year.
Moderna reported the Q3 2023 earnings which showed revenue of 1,8 billion dollars and the whole year estimate is 6 billion dollars.
According to Moderna, Spikevax US market share increased to 45% from 36% in 2022. The company is expecting a revenue of 4 billion dollars next year and to return to growth in 2025.
Moderna said it is expeting to launch its RSV vaccine in 2024 with a potential best in class profile. In Q2 report the company stated that it expects the Covid- product sales to reach 6-8 billion dollars this year.
The UK regulator MRHA said that it has authorised Moderna’s Covid-vaccine for use in infants and children 6 months to 5 years. According to agency, the vaccine has met the required safety, quality and effectiveness standards to be authorised for use in this age group.
Merck said its sales were 16 billion dollars in Q3, up 7% from year ago. Keytruda sales were up 17% to 6,3 billion dollars. The company raised also its full year sales to be 59,7 – 60,2 billion dollars and EPas to 1,33-1,38 dollars.
Merck also announcedca collaboration with Daiichi Sankyo.
On April 17th the company said that it is buying Biosciences for 10,8 billion dollars to increase the resources in immunology products and services.
The UK government announced the new UK Biobank, supported by private and public funding. The aim of the Biobank is to ensure that it continues to support the lifechanging breakthroughs and combining new technology like AI in the development.
During this week there will be also a Covid inquiry into the government’s handling of the pandemic. It focuses the political and administrative governance and decision-making during the pandemic.
NHSEngland has published a one-year cancer survival index, which compares the situation from 2020 to 2005. The index show the one- year survival rate has risen 9% to 74,6. (13.4.2023)
According to Health minister HelenWhately the figures are encouraging and represent evidence of the great work being made.
– We are also taking a vaccine task force style approach to cancer research to develop new immune- based cancer therapies, including cancer vaccines, as well as producing a major conditions strategy, she said in the release 13.4.2023.
According to her the aim of the UK is to diagnose 75% of cancer at an early stage by 2028 which will help save tens of thousands of lives for longer.
AstraZeneca, the UK/Swedish pharma company AstraZeneca said last week that it is entering the obesity markets as well. AstraZeneca will be then competing with the US Eli Lilly and the Danish Novo Nordisk.
-I am excited about the acceleration of our cardiometabolic and obesity pipeline with today’s licensing agreement for ECC5004, a potential best-in-class, oral GLP-1RA. This molecule could offer an important advance, as both a monotherapy and in combinations, for the estimated one billion people living with cardiometabolic diseases such as type-2 diabetes and obesity, AstraZeneca Pascal Soriot said in the release.
According to release, AstraZeneca and Chinese pharma company Eccogene have entered into an exclusive licence agreement for ECC5004, an investigational oral, once- daily medicine for the treatment of obesity, type 2 diabetes and other cardiometabolic conditions.
The UK/Swedish pharma company AstraZeneca reported also its Q3 figures. According to release, the total revenue increased 5% to 11,49 billion dollars compared to year earlier
The US Centers for the Disease Control and Prevention, CDC updated its Covid-vaccine recommendations. According to the new recommendations, older adults are now allowed to get second dose of updated vaccine.
CDC also recommends that everyone ages 6 years and older recieve an updated (bivalent) mrna Covid-vaccine regardless of whether they previously completed their primary series.
The agency said it has launched BridgeAccess Programm to provide fee Covid vaccines for uninsured and underinsured adults. The agency said “protecting people from Covid remains a top priority for CDC”. The agency is working with selected national pharmacy chains in the deliveries . This temporarily programm is schedule to end in December 2024.
JohnsonandJohnson reported second quarter sales growth of 6,3% to 25,5 billion dollars. Sales in the US were 13,4 billion dollars, in Europe 5,9 billion dollars and in Asia/Africa 4,1 billion dollars. EPS increased to 1,96 dollars from 1,80 dollars year ago.
Johnson & Johnson made the IPO of Kenvue on May 8 to the Nyse, in New York. The long- term target is to reduce the shareholding in Kenvue as Johnson & Johnson is still the majority owner in the company.
The US pharma Company Eli Lilly reported its Q3 figures last week. According to info, group’s revenue increased by 37% to 9,5 billion dollars thanks to Mounjaro, Verzenio and Jardiance products. The sales of diabetes and weight loss drug Mounjaro was 1,4 billion dollars.
The company net loss was 57,4 million dollars in the quarter compared to 1,4 million profit year ago.
Biontech, the German biotech company, reported today its Q3 figures. According to info, sales were 895 million euros and EPS 0,67 euros compared to 6,98 euros year ago. Biontech said its 9 months sales were 2,3 billion euros and net profit 472 million euros. The sales of Covid-vaccines is expected to be 4 billion euros, down from 5 billion euros earlier.
Biontech said it is preparing its oncology pipeline into late-stage development and the CEO Ugur Sahin said the company is preparing for additional trials with registrational potential in the coming months.
– Simultaneously we are enhancing our infectious diseases pipeline to address global health needs and are developing an Omicron XBB 1.5 adopted monovalent Covid-19 vaccine to become available for the upcoming fall-winter season, subject to regulatory approvals, he said in the release.
Biontech said also it is planning to set up new laboratories in Cambridge with an expected capacity of 70 highly skilked scientists.
The company reveiled in Q1 that it has started the first in human clinical trial for the first mrna-based Tuberculosis vaccine candidate.
Biontech and the US biotech company OncoC4 said their Phase 1/2 trials gave encouraging signs of clinical anti-tumor activity and a manageable safety profile in lung patients. The company says it is providing optimal therapeutic strategy for each cancer patient.
Biontech and Pfizer said on Friday 26th May that they have reached an updated agreement with the EU Commission related to Covid19 vaccines. The new agreement includes Covid- doses delivered annually through 2026 in the EU area.
Roche said in the Investor Event for example that they will target sustainable electricity by 2025 and reduce envionnmental impact on buildings.
Calendar&Events:
Pfizer, Q4 29. January 2024
AstraZeneca ,Q4 27. February 2024
Merck, Q4 1st February 2024
NovoNordisk , Q4 31. January 2024
Moderna, Investor Day December, Q4 21.February 2024
Otherreleases, publicationsandarticles:
“Wegovy could receive expanded FDA approval within six months”, Novo Nordisk says. (2.11.2023 CNBC)
UK regulator approves Pfizer’s hair loss drug (Reuters 1.11.2023)
US shifting Covid antivirals to commercial market on Nov 1, (1.11.2023 The Economic Times)
Novo Nordisk obesity drug cuts the risk of deaths by 18%, trial data shows. (Financial Times, 11.11.2023).
3. Stocks and economies
Last week stocks closed mixed. Dow Jones closed up 0,65% to 34.283,10 points and S&P 500 index closed up 1,29% to 4415,24 points. Nasdaq closed up 2,32% to 13.798,11 points.
In Europe Dax index closed up 0,30% to 15.234,39 points. In Paris the CAC40 down 0,03% to 7045,04 points for the week. The luxury sector was down due to US Capri Holdings earnings which showed weakening consumer demand in the Americas.
In London, the FTSE 100 index lost 0,78% gsduring the week and closed to 7360,55 points.
In Asia Topix closed up 0,61% to 2336,72 points and Hang Seng in Hong Kong closed down 2,68% to 17.203,26 points.
Pharma companies closed mixed for the week in the US and Europe. The Danish Novo Nordisk (NOVO-B) which had stock split in September closed on Friday at 691,60 Danish kronor, up 1,13 % for the week.
Novartis (NOVN) shareholders agreed the spinn-off of Sandoz, the generics and biosimilar business and the trading started in early October. The stock closed down 1,18% to 24,56 Swiss francs. The Swiss have been discussing the increasd health insurance costs and this is estimated to increase the use of the biosimilar medicines in the country, Bloomberg reports. Sandoz (SAN)reported 9 months figures late October showing sales were 7,1 billion dollars. The company confirmed the full year outlook.
Sanofi stock decreased by 0,25% for the week. The company announced in October Q3 earnings that were under estimates. The company announced also to spinoff its consumer health business. Sanofi closed down to 85,14 Swiss francs.
Abbot (ABT) closed down 2,06% to 93,97 dollars for the week.
Eli Lilly (LLE) closed up 5,0% to 597,71 dollars. The FDA approved the company drug Mounjaro as a weight loss drug as well during last week.
Pfizer (PFE) closed at 29,48 on Friday in New York, down 6,04% for the week.
Johnson & Johnson (JNJ) closed at 147,25 dollars, down 2,78 % for the week.
AbbVie (ABBV) closed down 2,06 % to 138,59 99,80 dollars for the week.
Merck (MRK) closed down 1,96% to 101,39 dollars for the week.
AstraZeneca (AZN) closed down 3,79 % to 10.106 for the week in London.
GSK (GSK) closed up 0,59% to 1399,80 pounds for the week in London.
Novartis (NOVN) closed down 0,62 % to 83,86 swiss francs for the week.
Novavax (NVAX)closed down 13,14 % to 6,24 dollars for the week. The company revenue were 187 million dollars compared to 835 million dollars year ago. EPS was -1,26 dollars, the company said last week and announced a cost refuction program of 300 milion dollars next year.
Sanofi (SAN) closed down 0,25% to 85,14 euros. Roche (ROG) closed down 0,21% to 236,75 Swiss francs.
Kenvue ( KVUE) closed at 19,15 dollars, down 1,15%.
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The US biotech company Moderna (MRNA) reported its Q3 results on Thursday. According to the info, revenue was 1 8 billion dollars and net loss 3,6 billion dollars.
Moderna said it is expecting this year’s vaccination rate to be similar to the last fall, the CEO Stephane Bancel stated.
– In the third quarter we significantly resized our manufacturing infrastructure to make our Covid-19 franchise profitable for 2024, he continued.
Moderna said it is expecting 2024 revenue to be 4 billion dollars and the company to return to growth in 2025 and break even in 2026.
R&D increased 41% to 1,2 billion dollars in the quarter, mainly because of clinical trials expenses. In 2024 the R&D costs are estimated to be 4,5 billion dollars.
Moderna continues to expect to launch its RSV vaccine next year with a potential Best in class profile. The company has published positive Phase 3 data related to its Covid, RSV and influenza vaccine.
The market share of the company’s Covid-vaccine Spikevax increased to 45% from 36% last year, the company said.
The US pharma company Pfizer reported on Friday that the CDC Advisory committee has recommended the company’s RSV vaccine for infants. Earlier Pfizer got the marketing approval for RSV vaccine for older adults.
The company says the Abrysvo recommendation for pregnant persons 32 through 36 weeks gestation would help to protect the baby from RSV from birth through the first six months of life.
Pfizer says it is the only company with an RSV vaccine to help older adults as well as infants. This recommendation will be official once it is reviewed and adopted by the CDC.
This is also the first time when people can have access to the RSV vaccine, Covid-19 vaccine and flu vaccine.
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