Industry news

US judge orders BMS and Sanofi to pay $834m for illegal marketing of Plavix

16 February | marketing

US Judge Dean Ochiai has ordered Bristol-Myers Squibb (BMS) and Sanofi to pay over $834m to the state of Hawaii for illegally marketing their blood-thinning drug Plavix.

Ochiai said that the companies failed to properly warn non-white patients of health risks from Plavix and marketed the drug disclosing that it could have a reduced or no effect on some individuals, particularly of East Asian and Pacific Island ancestry.

Plavix is indicated to prevent strokes and heart attacks and requires activation through the enzymes in the body, which could vary depending on the genetics of the person, Reuters reported.

The news agency quoted Ochiai as saying that from 1998 to 2010, the companies engaged in unfair and deceptive business practices by not changing the drug’s label to warn doctors and patients, despite knowing some of its risks.

Hawaii Attorney General Clare Connors, whose office took legal action against the companies in 2014, said that the latest order “puts the pharmaceutical industry on notice that it will be held accountable for conduct that deceives the public and places profit above safety”.

BMS and Sanofi, in a joint statement, vowed to appeal, saying the decision was “unsupported by the law and at odds with the evidence at trial.”

The companies collaborated to produce Plavix and called the drug safe and effective.

Ochiai, who presided over a non-jury trial for four weeks, conducted online owing to the Covid-19 situation. The judge ordered BMS and Sanofi to each pay $417m in penalties.

15 February | Covid-19

BHARAT BIOTECH’S COVAXIN MAY PROVIDE COVID-19 IMMUNITY FOR 12 MONTHS

The All India Institute of Medical Sciences (AIIMS) said that Bharat Biotech’s Covid-19 vaccine, Covaxin, may provide immunity against the disease for nine to 12 months, as per the mathematical calculations.

Covaxin’s approval in India faced criticism, especially when used for inoculating healthcare workers during Phase I of the vaccination drive, IANS reported.

The vaccine approval came even before the release of Phase III trial data.

IANS quoted AIIMS Bhopal and Jammu president YK Gupta as saying: “Covaxin was approved for emergency use and the data from Phase I and Phase II trials, and the ongoing Phase III trials, suggest that it is safe and effective, and by March-end tentatively, the data from Phase III trials will be available to establish its efficacy.”

“The vaccine is being given to lakhs of people, and there are hardly any serious side-effects. No death has been caused by Covaxin so far.”

15 february | vaccines

OXFORD UNIVERSITY LAUNCHES COVID-19 VACCINE STUDY IN CHILDREN

The University of Oxford has launched the first study of ChAdOx1 nCoV-19 Covid-19 vaccine in children and young adults.

The single-blind, randomised phase II trial, launched along with three partner sites in London, Southampton and Bristol, will analyse the vaccine’s safety and check whether it could elicit a good immune response in children and young adults aged six to 17 years.

It will enrol 300 subjects, with approximately 240 of them receiving the ChAdOx1 nCoV-19 vaccine. The remaining subjects will receive a control meningitis vaccine demonstrated to be safe in children.

Previous trials showed that the vaccine is safe, produces strong immune system responses and has high efficacy in all adults.

Funded by the National Institute for Health Research and AstraZeneca, the trial is likely to begin first vaccinations this month.

11 February | manufacturing

ASTRAZENECA AND IDT BIOLOGIKA TO BOOST COVID-19 VACCINE MANUFACTURING IN EUROPE

AstraZeneca and IDT Biologika have signed a letter of intent to increase Covid-19 vaccine manufacturing in Europe and secure long-term supply capacity.

On receiving the European Medicines Agency approval for the vaccine, AstraZeneca initiated shipping doses of the vaccines earlier this month as part of its initial commitment of 17 million doses. The company plans to supply more doses next month.

In a bid to support Europe’s immediate inoculation needs, the companies are exploring ways to boost output of finished Covid-19 Vaccine AstraZeneca in the second quarter of this year.

Furthermore, AstraZeneca and IDT Biologika plan to strengthen Europe’s vaccine manufacturing capability with a joint investment to set up a large additional drug substance capacity for the future.

AstraZeneca noted that the details of the agreement remain unfinalised.

The companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to set up about five 2,000-litre bioreactors, which can produce millions of doses of AstraZeneca’s Covid-19 vaccine per month.

AstraZeneca CEO Pascal Soriot said: “This agreement will greatly help Europe build an independent vaccine manufacturing capability that will allow it to meet the challenges of the current pandemic and create strategic supply capacity for the future.

“We are delighted to be investing with our partner IDT Biologika in the future health, security and wellbeing of millions of citizens across Europe.”

11 February | clinical trials

ALGERNON TO CONSIDER LUNG SCARRING AS ADDITIONAL ENDPOINT FOR COVID-19 TRIAL

Algernon Pharmaceuticals will be reviewing its protocol for its Phase IIb/III study to evaluate Ifenprodil for Covid-19.

The company is also considering lung scarring addition as another endpoint if adequate data is available.

In the original Phase IIb/III protocol drafted by the company last April, lung scarring and post-hospital release were not included as they remained unestablished as a crucial problem with recovering Covid-19 patients.

Each hospital part of the study managed their site-specific standard of care protocol for releasing a patient.

Algernon Pharmaceuticals CEO Christopher Moreau said: “If we determine that X-rays were taken on release of a meaningful number of our treated patients, and Ifenprodil is showing a reduction in the amount of scarring post-infection, this would be an extremely important discovery for us.

“If this is confirmed in the planned Phase III portion of the study, it would mean that Ifenprodil could be used to treat patients who have survived Covid-19 but are suffering from lung damage.”

Furthermore, the latest Oxford University study showed that 60% of patients had scarring or inflammation in their lungs at two-three months from disease-onset.

10 February | Approvals

NEW ZEALAND APPROVES USE OF PFIZER-BIONTECH’S COVID-19 VACCINE

The New Zealand Government has granted formal approval for use of Pfizer and BioNTech’s Covid-19 vaccine as a critical step to ensure the vaccine is safe and effective.

The previous week, the New Zealand Medicines and Medical Devices Safety Authority, Medsafe, granted provisional approval for the vaccine.

Covid-19 Response Minister Chris Hipkins said: “The government is continuing to go by the book and has carefully considered the ‘decision to use’ the Pfizer/BioNTech vaccine as part of our nationwide programme.

“As part of our portfolio, we have secured up to 750,000 courses of the Pfizer Covid-19 vaccine through an Advance Purchase Agreement, and we are seeking a further small allocation through the COVAX Facility.

“We will start vaccinating our border workers within days of arrival and then the people they live with.”

Last October, Pfizer and BioNTech entered an agreement with the New Zealand government to supply 1.5 million doses of their Covid-19 vaccine.

Initially, the country plans to inoculate cleaners, nurses who undertake health checks in MIQ, security staff, customs and border officials, airline staff and hotel workers.

In brief

Vaxart’s oral vaccine triggers immune response in Covid-19 trial

Vaxart has reported preliminary data from its Phase I study that showed its oral Covid-19 tablet vaccine candidate, VXA-CoV2-1, triggered multiple immune responses against SARS-CoV-2 antigens. It proved generally well-tolerated and immunogenic as measured by multiple markers of an immune response to the antigens.

China approves AstraZeneca’s Forxiga for heart failure

China’s National Medical Products Administration has approved AstraZeneca’s Forxiga (dapagliflozin) for heart failure with reduced ejection fraction in adults with and without type-2 diabetes.

The first-in-class, oral, once-daily SGLT2 inhibitor can be used for the reduction of the risk of cardiovascular death and hospitalisation for heart failure in adults.

Regulatory agencies start rolling review of Novavax’s Covid-19 vaccine

Novavax has announced that multiple regulatory authorities started the rolling review process for authorisation of its Covid-19 vaccine, NVX-CoV2373. A protein-based vaccine candidate, NVX-CoV2373 derives from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19. To boost the immune response and stimulate high levels of neutralising antibodies, it is adjuvanted with the company’s patented saponin-based Matrix-M.

GSK and CureVac enter Covid-19 vaccine development collaboration

GlaxoSmithKline and CureVac have entered a €150m ($180m) collaboration to jointly develop mRNA vaccines for Covid-19. The companies aim to develop a multivalent approach for addressing emergent virus variants with one vaccine.

Aeterna Zentaris signs agreement to evaluate oral Covid-19 vaccine

Aeterna Zentaris has signed an exclusive option agreement with the Julius-Maximilians-University Wuerzburg, Germany, to analyse the latter’s preclinical potential Covid-19 vaccine.

08 February | clinical trials

FDA CASTS DOUBT ON CLINICAL MEANINGFULNESS OF MERCK’S KEYTRUDA TRIAL DATA

The US Food and Drug Administration (FDA) has cast doubt on the results from Merck’s KEYNOTE-522 trial of Keytruda (pembrolizumab) submitted to support its expanded label in treating triple-negative breast cancer (TNBC).

Keytruda is an anti-PD-1 therapy.

Merck is seeking approval for the use of Keytruda in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment after surgery, for TNBC treatment.

The randomised, double-blind, placebo-controlled trial analysed Keytruda versus placebo in combination with chemotherapy in the neoadjuvant setting and as monotherapy in the adjuvant setting in 1174 subjects with high-risk, early-stage TNBC.

The co-primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS) and overall survival (OS) is a key secondary endpoint.

According to the briefing documents posted by the FDA on its website, the latest interim analysis trial data showed the pCR rate difference between the two treatment arms was 7.5% based on all randomised patients.

Furthermore, EFS endpoint failed to meet the pre-specified threshold for statistical significance and remained immature with 53% of targeted EFS events having occurred.

As such, the OS endpoint could not be formally tested and is immature with 32% of the targeted OS events having occurred.

08 february | supply

MERCK AND BIONTECH TO BOOST LIPID SUPPLY FOR COVID-19 VACCINE PRODUCTION

Merck and BioNTech have announced a further expansion of their strategic partnership to accelerate the supply of urgently needed lipids and boost the amount of their delivery by the year-end.

The lipids will be used for producing the Pfizer and BioNTech Covid-19 vaccine (BNT162b2).

Lipids are vital to the drug delivery system of mRNA therapies to the body for a vaccine to be effective.

At present, only some companies across the globe are able to produce custom lipids in significant quantities and according to the greatest quality requirements required for vaccine production.