PARIS, 29 Mar (APM) - Personalised cancer treatments are very expensive, with Novartis charging $475,000 in the U.S. for its CAR-T therapy Kymriah (tisagenlecleucel), reported Les Echos on Monday (p.21).
But does their efficacy justify their price tag? Numerous U.S. studies have tried to answer this question. Two in particular concentrated on Kymriah and concluded that although the drug’s 40% survival rate after five years was good, the drug’s price tag is only acceptable if the survival rate is seven to 12 years after treatment.
This is why the British authorities have limited its use to children and young adults with certain types of lymphoma.
The economic daily pointed out that a new wave of “allogenic” CAR-T therapy, so called because they use a donor to treat a wide range of patients instead of being personalised to the patient, are cheaper at around $100,000 to $200,000. However, there is the issue that they tend to be less effective on a long-term basis as they are progressively eliminated in the body.
So how should we treat these diseases? While awaiting the development of new bispecific antibodies, whose initial results seem very promising, the paper continued, pay-for-performance measures could be set up, when the drug is only paid for when the drug is proven to be effective.
Another suggestion, supported by U.S. senators, is paying for the drug over several years. However, the paper concluded, even at a price of $475,000 it is not certain that Novartis will make a profit on Kymriah, given the $1.5 billion it spent on developing the drug.
How pharma is using big data and artificial intelligence
Various pharma companies including Pfizer, GSK, Merck, Novartis and Sanofi have appointed chief digital officers and at the same time, each pharma company is starting to use digital technology and big data in its own way, reported Les Echos on Monday (p.21).
Novartis is running a pilot scheme in three of its factories testing production settings such as pH and temperature in real-time which are crucial for the production of biologics. The pharma is also using ‘digital twins’ to determine doctors’ prescribing habits and help its sales representatives. Sanofi, on the other hand, has created a ‘digital twin’ of one of its factories to optimise vaccine production.
Big data are also playing a role in R&D, with retrospective and real time analyses of data collected during clinical trials being used to reduce the times and costs of said trials, vital as it currently takes 12 years and $2 billion to get a drug to market.
In the short term, companies are using data to identify subgroups of patients likely to benefit from their drugs. Pfizer, for example, is investigating a patient subgroup with a particular type of heart failure, while Novartis is using data from the past 20 years to better analyse breast cancer and heart failure to find new biomarkers.
Roche wants to become champion of personalised medicine
Roche’s acquisitions of the U.S. company Foundation Medicine in June 2018 and the U.S. start-up Flatiron in 2016, should give the pharma the tools it needs to fulfil its ambition of becoming the champion of personalised cancer treatments, reported Les Echos on Monday (p.21).
Roche intends to give Foundation Medicine considerable autonomy and even the possibility of working with competitors, in its work identifying which cancer treatment should be used for which cancer patient based on a test sent in by the patient’s doctor.
Foundation Medicine can also help pharma companies to select patients for clinical trials and can test the pharma companies’ own samples. Hence why Roche was interested in the company.
This is where Flatiron comes in. Flatiron has a database of clinical trial data, which means the pharma can follow the results of treatments in real-life. With these two companies, Roche has come full circle and should be able to achieve its aim.
FDA approves first drug for post-natal depression
The U.S. Food and Drug Administration has approved the first treatment for post-natal depression: Sage Therapeutics’ Zulresso (brexanolone), reported Le Parisien on Wednesday (p.14).
It works in just two days, a lot faster than other antidepressants which can take months to have an impact. It will be available in the U.S. from the end of June. Post-natal depression affects around 7% of mothers in the three months after they have given birth the paper added and is a serious illness not to be confused with the ‘baby blues’.
Purdue Pharma to pay $270 million to end Oklahoma opioid case
The Sackler family, who own Purdue Pharma, have agreed to pay $270 million to end a court case in Oklahoma linked to the ongoing U.S. opioid crisis, reported Les Echos on Thursday (p.21).
Oklahoma’s attorney general Mike Hunter said it was a monumental victory, even though it was just a first step, in the battle against opioids.
The money will be used to finance the addiction research centre at Tulsa university in Oklahoma. Purdue’s settlement has not closed the ongoing case which also involves Johnson & Johnson and Teva, both of whom are due in court on 28 May. These pharma, along with Purdue, are accused of using aggressive marketing campaigns to promote over prescription of opioid drugs which has led to the current crisis.
French biotech Genfit floated on Nasdaq
French biotech Genfit went public on Nasdaq on Wednesday, reported Le Figaro on Thursday (p.26). It raised $135.1 million which it will potentially use to market its pipeline drug elafibranor for non-alcoholic steatohepatitis (NASH). The drug is currently undergoing Phase III trials whose results will be known at the beginning of 2020.
There is currently no treatment for NASH, which affects millions of people and whose potential market is currently valued to reach $20 billion by 2025. Genfit faces competition from Gilead and another biotech Intercept. Genfit is one of a very few French biotechs listed in the U.S. along with Cellectis, DBV and Erytech. Les Echos also reports on the subject on Friday (p.18).
Merck KGaA opens biologics test centre in east France
Merck KGaA has inaugurated a biologics test centre in Alsace in eastern France, reported Les Echos on Tuesday (p.20).
The pharma invested €10 million in the building, the latest in a global nine-centre network. Companies who produce biologics will be able to test the equipment they are thinking of buying in collaboration with Merck KGaA scientists and engineers at the centre, which acts as an industrial “shop window”.
Although Merck KGaA is primarily known as a pharmaceutical company, it also manufactures laboratory equipment, continued the economic daily. This subsidiary of the company, known as “life science” currently represents 70% of the group’s value.