Authors: Heather Jones, Future Science Group
Catch up on February’s industry headlines, including an MRSA breakthrough, a patent lawsuit, and the latest updates on the coronavirus outbreak and its impact on the biotechnology industry worldwide.
- Coronavirus threatens the pharmaceutical industry worldwide
- The worldwide scramble for a CoV cure
- FDA reproach Purell for claiming it can prevent Ebola
- Sanofi/GSK HIV regimen declared ineffective after large study
- Gilead loses patent challenges on best-selling HIV drug
- Grifols dishes out a final $3M for bankrupt antibiotics maker Aradigm
- FDA grants ‘breakthrough’ status to ContraFect’s MRSA antibiotic
- Shionogi’s FETROJA® now available in the USA for treatment of complicated UTIs
- Mologic and Institut Pasteur de Dakar launch accelerated program for Ebola diagnostics
- SoftBank invests $165M into Karius for infectious disease diagnoses
Coronavirus threatens the pharmaceutical industry worldwide
The coronavirus has dominated the headlines over the last few weeks, and as normal daily life has come to a standstill in large parts of China as a result of the outbreak, this is having a knock-on effect on the wider science industry.
The testing of experimental drugs in China has been severely disrupted, posing a threat to plans by global drug makers who have invested billions of dollars in the trials. Approximately 20% of global trials are conducted in China, with almost 500 studies located in the city of Wuhan. Efforts to control the spread of the virus have meant that several trials have been suspended and the launches of new studies have been delayed. Affected ongoing studies include trials testing a Novartis (Basel Switzerland) drug for a rare blood disorder, a cancer therapy from BieGene Ltd (Beijing, China) and a treatment for a type of spinal arthritis from Tasly Pharmaceutical Group (Beijing, China).
Meanwhile, AstraZeneca, whose sales from China account for nearly a fifth of total sales, has reported an impact on their fourth-quarter results as a result of the China-originated outbreak. Western reliance on China is also forcing many biotech firms to consider contingency plans as the virus disrupts operations in Chinese contract research organizations.
Many large pharmaceutical industries rely on China for a significant proportion of the active pharmaceutical ingredients needed for each drug. China is now home to 13% of the facilities that produce ingredients for medicines that are sold in the USA, according to the FDA, and approximately 80% of active ingredients used by commercial sources to produce pharmaceuticals come from China and India, according to Rosemarie Gibson (The Hastings Center, NY, USA) in a recent testimony before the United States–China Economic and Security Review Commission (Washington, DC).
Though no shortage has yet been identified, if the virus cannot be contained, it could be a serious problem. Axios recently reported that 150 prescription drugs are now at risk of shortage in the USA. Shortly after this report, Sanofi (Paris, France) announced plans to create the world’s second largest active pharmaceutical ingredients manufacturer by combining its six current sites into a single company. They expect £1 billion in sales by 2022.
As the novel coronavirus has swelled from a few early cases in the city of Wuhan to a ‘public health emergency of international concern,’ researchers, institutions and governments have been joining forces in the hunt for vaccines and therapies to fight the virus.
- The search for therapies
Early on in February, the EMA, FDA and WHO put special measures in place to support research into new coronavirus medicines, vaccines and in vitro diagnostics. This includes authorization for the use of diagnostic and regulatory tools.
“Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, or utilize a platform already approved by the US FDA,” a source from the US Department of Health and Human Services commented.
AbbVie (IL, USA) has been donating more than US$1 million worth of an HIV drug, termed Aluvia, in efforts to combat the virus. The pill contains lopinavir and ritonavir and has been suggested by China’s National Health Commission as a treatment for the symptoms of the coronavirus in the absence of effective antiviral medications.
Several other biotech companies are racing to add more potential weapons to the arsenal, with several trials underway. Regeneron (NY, USA) announced this month that it will be harnessing its antibody platform tech in the hunt for a therapy for the virus.
Gilead (CA, USA) shares soared after suggesting that one of its experimental antivirals, remdesivir, could be an effective treatment option. The company has since been working with Chinese authorities to test the drug, initially developed for Ebola, as a treatment for coronavirus. Researchers from the Wuhan Institute of Virology (China) and National Engineering Research Center for the Emergency Drug have found remdesivir, along with the malaria treatment chloroquine, to show potential against the coronavirus, so much so that they have applied for a patent on its use to combat the virus. While the first US clinical trial for remdesivir is scheduled to get underway in March, WHO assistant director-general Bruce Aylward commented that the drug has shown signs it could treat symptoms of the disease: “There is only one drug right now that we think may have real efficacy and that’s remdesivir.”
Gilead has since announced the initiation of two Phase III trials to evaluate the safety and efficiency of remdesivir. The studies are said to enrol approximately 1000 patients in countries across Asia, as well as others with high numbers of diagnosed cases.
Another drug, fapilavir, which is already commercially available in Japan, has already been approved in China for inclusion in the standard regimen.
Meanwhile, Harvard University (MA, USA) has collaborated with China Evergrande Group (Shenzhen, China) to play the long game in studying the virus in an effort to develop therapies against the virus, and to prevent new ones.
- Vaccine development
Early on in February, The Gates Foundation signed up to contribute up to US$100 million to help drive new research and development into vaccines, diagnostics and therapies, along with detection and containment work in the battle against the coronavirus.
A growing list of companies are searching for a vaccine. This includes Moderna (MA, USA), which, in partnership with the US National Institutes of Health, has shipped off the first batch of its mRNA-1273 vaccine against the virus to the National Institute of Allergy and Infectious diseases (MD, USA) in record time for a Phase I study.
Two weeks prior, Codagenix (NY, USA) announced plans to use a software platform to try and build a vaccine in collaboration with the Serum Institute of India (Pune, India). Among others joining the race is China’s Clover Biopharmaceuticals (Chengdu, China), which is reported to be adding an adjuvant from GlaxoSmithKline (London, UK) to its preclinical, protein-based vaccine candidate, COVID-19 S-Trimer, against the virus.
FDA reproach Purell for claiming it can prevent Ebola
The makers of Purell had a slap on the wrist in the form of a warning letter from the US FDA at the end of January for unproven claims that the hand sanitizer can prevent diseases such as Ebola, norovirus and MRSA.
This comes as the United States prepares itself for one of its worst flu seasons in decades and worldwide concerns about the growing coronavirus epidemic.
Sanofi/GSK HIV regimen declared ineffective after large study
An experimental HIV vaccine regimen developed by Sanofi and GlaxoSmithKline stopped being administered in the Phase IIb/III HVTN 702 trial after an interim review concluded that it didn’t prevent HIV. This raises the stakes for a mosaic vaccine being tested by a Johnson & Johnson-led coalition.
“An HIV vaccine is essential to end the global pandemic, and we hoped this vaccine candidate would work. Regrettably, it does not,” commented NIAID director Anthony Fauci. “Research continues on other approaches to a safe and effective HIV vaccine, which I still believe can be achieved.”
Gilead loses patent challenges on best-selling HIV drug
Another one for the HIV epidemic. Gilead (CA, USA) have sustained two more losses in court following an activist-backed patent lawsuit from the Department of Health and Human Services (HHS), making a claim on the patents and seeking to divert a portion of Gilead’s revenue to clinics and prevention programs.
The drug, Truvada, also known as PrEP, is more than 90% effective, and Gilead has raised its price by more than US $10,000 since it was introduced in 2004.
Gilead responded by arguing that HHS’s patents were invalid and has noted that its assistance programs control costs for many patients.
Grifols dishes out a final $3M for bankrupt antibiotics maker Aradigm
Grifols (Barcelona, Spain) already owns a US $26 million stake in Aradigm’s (CA, USA) inhaled antibiotics, but the Spanish drug maker is now buying it all and obtaining assets and IP to Apulmiq, Lipoquin and free ciprofloxacin.
This comes after scepticism towards Aradigm’s data, as the FDA and EMA threatened refusals for Apulmiq’s use in non-cystic fibrosis bronchiectasis and requests were made for a new Phase III trial back in 2017.
Though no comment has been made yet, Grifols are likely to conduct the 2-year trial that the FDA asked for but Aradigm didn’t have the money to fund.
FDA grants ‘breakthrough’ status to ContraFect’s MRSA antibiotic
In a first for the MRSA field, an experimental drug developed by ContraFect (NY, USA) has achieved the FDA’s ‘breakthrough’ status after a Phase II trial testing it against the MRSA superbug. The trial data demonstrated exebacase’s potential to prove superior to vancomycin, an antibiotic approved in 1958, with analysis revealing a clinical responder rate 42.8% higher than that among those treated with standard care.
The company is now conducting a pivotal Phase III study to examine the drug’s efficacy in all infections caused by Staphylococcus aureus.
“Based on our interactions with the FDA regarding streamlined development of exebacase, this single Phase III study, in addition to the full package of data generated to date, may serve as the basis of a Biologics License Application for FDA review and potential approval of exebacase,” commented CMO Cara Cassino.
Shionogi’s FETROJA® now available in the USA for treatment of complicated UTIs
Shionogi (Osaka, Japan) have announced that their drug FETROJA® (cefiderocol) is now available in the USA for patients aged 18 years or older who have limited or no treatment options for the treatment of complicated urinary tract infections (cUTIs).
The drug was approved by the US FDA in November 2019 and is the first approved antibiotic that functions as a siderophore with the ability to overcome many of the resistance mechanisms employed by gram-negative bacteria.
“We are proud to make FETROJA available for patients and their infectious disease care teams. Currently, FETROJA is the only available antibiotic which provides in vitro coverage against all Gram-negative pathogens considered top priority by the WHO,” commented Nate McCutcheon, Chief Commercial Officer (Shionogi).
Mologic and Institut Pasteur de Dakar launch accelerated program for Ebola diagnostics
Mologic (Bedford, UK) and Institut Pasteur de Dakar (Senegal) have announced the launch of an accelerated program with the Institut Pasteur de Dakar to develop a rapid diagnostic test for Ebola, in efforts advance epidemic preparedness.
The project is supported by the Wellcome Trust and the UK Government’s Department for International Development.
Amadou Sall, Director of Institut Pasteur de Dakar, commented: “This project will provide a breakthrough in the ecosystem of rapid diagnostic discovery, development and delivery, not only for Ebola but for epidemic diseases in general. In an era of regular emergencies caused by pathogens, our partnership will strengthen the capability of local communities who are first detectors and responders to any outbreak.”
SoftBank invests $165M into Karius for infectious disease diagnoses
The Japanese bank has invested US $165 million into Karius (CA, USA), a company that uses blood samples to diagnose infectious diseases. The bank’s Vision Fund 2 has invested $100 billion into technology companies including several biotechs.
Now used in over 100 hospitals and health systems across the USA, the infection genomics test can rapidly diagnose tests as opposed to the standard guess-and-check system, and has shown promising results so far, though it doesn’t come cheap: $2000 per test.