This week, Phispers brings you contrasting news on two immunotherapy drugs -- Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda. In other news, Bangladesh begins exporting drugs to the US, while Myanmar struggles to curb a crystal meth boom. And Sanofi’s acquisition of Boehringer Ingelheim’s consumer health business gets a conditional approval from the European Commission.
Bristol-Myers Squibb reanalyzes cancer
drug, as Merck races ahead with Keytruda
in 2014, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo – also known as checkpoint inhibitors – have been forecast to be among the top 20 best-selling
drugs in the world by 2020. They represent the hot new field of immunotherapy
and are known to have given 90-year old Jimmy Carter (former President of the
United States) hope in his fight against cancer.
However, the field
of immunotherapy received a nasty surprise when Bristol-Myers Squibb said its
treatment Opdivo had not slowed the progress of advanced lung cancer in a trial
which compared it with conventional chemotherapy.
While Bristol-Myers’ stock price plunged, Merck announced that not only did Keytruda succeed in a clinical trial as an initial
treatment for advanced non-small cell lung cancer, but patients actually lived
longer. In addition, the FDA approved Keytruda for head-and-neck cancer.
Bristol-Myers Squibb is re-analyzing the (patient groups’) data in a trial called CHECKMATE-026 to see whether it can salvage the study.
China’s FDA proposes new drug registration rules
China Food and
Drug Administration (CFDA) has issued new proposals to revamp China's Drug Registration Rules (DRR).
The proposals offer the prospect of eliminating a backlog of drug reviews, updating
China's drug classification system and reforming clinical trial rules to allow
parallel drug development in and outside of China.
rules would also eliminate statutory timelines for CFDA to review applications
and prohibit sponsors from marketing APIs without an approved drug product
the new regulations could weaken intellectual property protection in China and
effectively force API manufacturers to seek marketing approval of drugs. In the
long term, the new regulations may even reduce the number of API manufacturers
in the country.
Indian drug regulator eases norms for
Controller General of India (DCGI), in a recent notification, eased norms related to pharmaceutical research in
India, paving the way for an increase in the number of clinical trials being
run in the country.
Under the new
ruling, an investigator or researcher can now undertake as many trials as
approved by the ethics committee, as opposed to the present cap of three
trials. The regulator has also relaxed norms for hospitals or clinical sites
undertaking such trials. Through a separate notification, the DCGI has revised
the rule that prohibited any hospital with less than 50 beds to take up a
This announcement comes at a time when foreign drug regulators such as the US Food and Drug Administration (FDA) and EU's European Medicines Agency (EMA) have increased their inspections of Indian clinical research organizations (CROs). Incidentally, India’s share in global clinical trials today is only 1.46
India’s pharma sector behind Myanmar’s crystal meth boom
contain pseudoephedrine, the main ingredient of meth, which is a highly addictive drug whose ever-soaring popularity is rattling governments across Asia. Meth is sold in pill form, known as ‘ya ba’ (Thai for ‘crazy medicine’), or in a more potent, crystalized form, known as ‘crystal meth’, ‘ice’ or ‘shabu’.
Myanmar's current boom in meth production would not have been
possible without a recent surge in smuggling of pseudoephedrine from across
India's huge and ill-regulated pharmaceuticals sector.
In a raid held in Myanmar in mid-June
, the police intercepted a car carrying more than 60 kg (130 lbs) of Indian pseudoephedrine – enough to make more than a million ‘ya ba’ pills.
According to the US State Department 2015 report, global demand for methamphetamine has created “new precursor chemical entrepreneurs in India”.
say China is also a major supplier of pseudoephedrine. But with tighter
controls there, and with greater demand for the chemical as meth use booms,
drug producers have increasingly turned to India.
Bangladesh’s Beximco is the first company to export drugs to the US
The first pharmaceutical product made in Bangladesh has hit the American market, opening a new window for increasing the country’s export earnings. The company is Beximco Pharmaceuticals, and the product it will export is Carvedilol – a hypertensive drug.
The United States is the largest and most lucrative pharmaceutical market in the world. It is also one of the most regulated markets in the world. While congratulating Beximco, Bangladesh’s health minister Mohammed Nasim said “receiving the FDA nod is a rigorous process”.
European Commission clears Sanofi-Boehringer Ingelheim deal
The European Commission approved the (proposed) acquisition
of the consumer health business of Boehringer
Ingelheim by Sanofi, subject to conditions.
Under the approval, France’s Sanofi and Germany’s Boehringer
Ingelheim have to divest a number of businesses in the Czech Republic,
Estonia, France, Hungary, Greece, Ireland, Latvia, Poland and Slovakia.
The Commission had concerns that the transaction would have
reduced competition in some pharmaceutical products in these markets where both
the companies have very strong products, with a lack of alternatives. This,
according to the Commission, could have led to higher prices and less choice
The commitments offered by Sanofi address these concerns. Sanofi
offered to divest either its own or Boehringer Ingelheim's local businesses in
the markets concerned, including the relevant marketing authorizations,
customer information and brands, and personnel.
This news comes at the time when Mylan has
wrapped up its US
$ 7.2 billion acquisition of Meda,
which will now operate as a controlled subsidiary of Mylan.
Six executives of Novartis’ Korea unit indicted in doctor bribery case
The Korean unit of Novartis has come under fire for bribing doctors for prescribing the company’s medicines. Six former and current Novartis executives at its Korean unit allegedly paid more than US $ 2 million to doctors in return for prescribing its medicines. Among those indicted was the former chief executive of Novartis’ Korea unit.
publishers of medical publications and 15 doctors who work at general hospitals
were also indicted. Novartis funded academic events that were supposedly
organized by these publications. According to Korea Herald, these publications distributed money to doctors, disguised
as attendance fees and as fee for articles that the doctors contributed to the
These activities occurred between 2011 and 2016. Six months ago, the Seoul Western District Prosecutors’ Office raided Novartis’ offices in search of evidence that the drug maker had paid bribes.