PARIS, 22 Feb (APM) - R&D investments are becoming less and less profitable for ‘Big Pharma’, reported Le Figaro on Tuesday (p.20).
Over nine years, the cost of developing a drug has doubled to reach $2.2 billion, while average drug sales have halved to $407 million.
There are several reasons for this development, the paper continued, one being a longer development cycle. It now takes 6.61 years to develop a drug instead of the 6.15 years it took in 2015. Research is more complex and fewer patients are eligible for clinical trials.
Another issue is the demands made by national health authorities. Files submitted for approval have to include increasing amounts of data. Generic and biosimilar competition is also playing its part, as is the pressure to cut prices in western countries, Le Figaro said.
As a result, companies are realising that they cannot carry out all development in-house and are also starting to turn towards use of artificial intelligence to improve efficacy. Hence the recent recruitment of digital officers by GlaxoSmithKline, Novartis and Sanofi (APMHE 58196
, APMHE 61834
Biogen seeks to diversify by targeting Alzheimer’s disease
Biogen is seeking to diversify its portfolio by investing in potential Alzheimer treatments, reported Le Figaro on Tuesday (p.20). Biogen currently has six Alzheimer-dedicated programmes on the go, with two in Phase III.
Biogen spends $2 billion or 17% of sales on R&D, with projects ongoing in neuromuscular diseases in addition to Alzheimer’s as part of its plan to diversify its portfolio and pipeline.
This diversification is key, as currently 75% of the pharma’s income comes from five multiple sclerosis drugs which are now facing competition from generics. The potential market for Alzheimer’s treatments is huge, as it currently remains an incurable disease. By 2025, the market could be worth $6 billion in comparison to $3.5 billion in 2017.
French pharma lobby proposes action plan to combat shortages
French pharma body Leem presented an action plan to tackle shortages on Tuesday, reported Les Echos on Wednesday (p.23) (APMHE 61940
). Leem pointed out that the problem of shortages and stockouts is growing, with 44 supply tension alerts raised in 2008 compared to 404 in 2013 and 538 in 2017.
These shortages and stockouts can endanger patients’ lives in the short and long term, or reduce their chances of survival or recovery. There are several reasons for these shortages, reported Le Figaro on Wednesday (p.20). The main cause is that 60% to 80% of active ingredients are now manufactured outside of the European Union, compared to 30% 30 years ago. As a result, only two to three manufacturers of active ingredients are used to make numerous drugs. If there is an issue with one of those manufacturers, as was the case for valsartan last summer, this affects the whole supply chain.
Yet another issue is the completely legal practice of parallel trading, reported L’Opinion on Wednesday (p.4). Drug prices in France are lower than in neighbouring countries - in fact French prices are lower than in Germany, Italy, Spain and the UK in 93% of cases, it said.
In response, some wholesalers buy these drugs in France to resell them in other countries. To counter these issues, Leem suggests coordinating efforts on a European scale to counter shortages in a more effective manner, as well as sharing information on stocks at an earlier stage, continued Le Figaro (p.20) on Wednesday. It also suggests moving the manufacture of the most indispensable active ingredients back to Europe.
Another aspect of Leem’s action plan is to draw up a list of drugs “of therapeutic and strategic benefit”, reported Le Parisien in a brief on the same subject on Wednesday (p.9).
J&J cutting 30 posts in Actelion subsidiary in France
Johnson & Johnson is cutting 30 posts at its biotech subsidiary Actelion in France, reported Les Echos on Monday (p.20). J&J bought Actelion two years ago for $30 billion. (APMHE 61836
When J&J bought the biotech, it said its cardiovascular-orientated portfolio complemented its own. At the time, sales of Actelion’s key product Tracleer (bosentan) for pulmonary arterial hypertension (PAH, WHO Group 1) were over $1 billion. However, generic competition meant its sales fell by 60% in 2017.
The products intended to replace Tracleer, Opsumit (macitentan) and Uptravi (selexipag), have not filled the gap. In France, 20 out of the 30 posts are support-based, the paper said.
Warnings for Malay Tiger’s Clenox and Stanox-10
France’s drug regulator ANSM has published warnings for two products sold online which claim to burn fat, Malay Tiger’s Clenox (clenbuterol hydrochloride) and Stanox-10 (stanozolol), reported Le Parisien on Tuesday (p.13).
The tablets are used as steroids to increase muscle mass in athletes, but also for weight loss. ANSM warns that they are suspected of being dangerous for the heart.
Opioid meds consumption rising in France
The French are taking more and more opioid-based pain medication, according to a report published on Wednesday by France’s drug regulator ANSM, said Le Figaro (p.9) and Les Echos in a brief (p.19), both on Thursday.
ANSM’s report said that although France is not in a comparable situation to the U.S., where 115 people die from opioid overdoses every day, the number of overdoses, hospitalisations and deaths is on the rise. The number of hospitalisations has increased by 167% since 2000, and the number of deaths rocketed by 146% between 2000 and 2015.
Two drugs in particular are attracting attention as their prescription rates have exploded in the past 10 years: tramadol, a so-called weak opioid, marketed as Teva’s Contramal, and oxycodone, a so-called strong opioid, marketed as Purdue Pharma/Abbott Laboratories’ OxyContin and MundiPharma’s OxyNorm, reports Le Parisien on the same subject on Friday (p.10).
Nicolas Authier, president of the French observatory for pain medication (Ofma), is quoted in the paper as saying that opioids should not be condemned, but that their use should be monitored, and they should no longer be prescribed for migraine or fibromyalgia. He also says that pain-relieving alternatives to opioids need to be found.
France Biotech to organise first Health Tech Investor Day
France Biotech, a French association of Biotechnology and Life Sciences companies, is organising a Health Tech Investor Day in Paris on 25 June to put French health technology start-ups in contact with investors and pharma groups, reported Les Echos on Tuesday (p.19).
French biotech start-ups often face hurdles when trying to get listed on Nasdaq in the U.S., as start-ups in health tech require more significant and more long-term funding than those in other areas. Some French companies have several drugs in development but cannot obtain the €50 million to €150 million needed to carry out a Phase III trial.
France Biotech hopes that its Health Tech Investor Day will attract private investors from the U.S. to give these companies a boost, the paper said.