News in brief from around the world… The past week has seen China approve Takeda’s £46 billion acquisition of Shire, and Novartis sell off parts of its Sandoz portfolios to India’s Aurobindo. Meanwhile Gwyneth Paltrow’s Goop has settled a false advertising suit, the EMA and FDA have published the findings from a carcinogen study, and the British Medical Journal has criticised clinical trials compliance.

Companies

⇒ China’s State Administration for Market Regulation (SAMR) has approved Japanese pharma company Takeda’s £46 billion acquisition of Ireland’s Shire.

Linklaters and Slaughter & May advised the companies on the deal, which was announced in May and was waved through by the US Federal Trade Commission in July, followed by the Brazilian Administrative Council for Economic Defense at the end of August.

Takeda announced on 14 September that the deal had received “unconditional clearance” from the SAMR, which it said was “another key step in the transaction process.”

The deal still has to receive a number of other regulatory clearances, as well as the approval of shareholders of both companies.

⇒ A team from Arnold & Porter has helped Novartis to sell certain parts of its Sandoz US portfolios to Indian drug maker Aurobindo.

The specific portions of Sandoz being sold include its dermatology business and generic US oral solids portfolio, for US$900 million in cash and US$100 million in projected future earnings.

The deal will see Aurobindo buy around 300 products, as well as some development projects.

Richard Francis, CEO of Sandoz and Member of the Novartis Executive Committee, said in a press release that “through this transaction, we are refocusing our business but also striving to ensure continuity of supply of important long-used generic medicines for patients and customers in the US.”

Earlier this year Novartis bought out gene therapy company AveXis and sold a consumer health joint venture to GlaxoSmithKline to allow it to focus on its core pharmaceuticals business.

Courts and cases

⇒ US actress Gwyneth Paltrow’s lifestyle company Goop has been fined US$145,000 for making claims about the medicinal properties of one of its products that were “not supported by competent and reliable science.”

Goop faced claims that its Jade Egg, Rose Quartz Egg and Inner Judge Flower Essence Blend products had been falsely advertised as having the ability to balance hormones, regulate menstrual cycles, prevent uterine prolapse and increase bladder control.

As well as the payment of the agreed sum, the company has also been restrained from making any claims about how its products work without reliable, substantial, scientific evidence, and also from manufacturing or selling any falsely advertised medical devices.

“The health and money of Santa Clara County residents should never be put at risk by misleading advertising,” District Attorney Jeff Rosen said in a press release. “We will vigilantly protect consumers against companies that promise health benefits without the support of good science… or any science.”

Goop has also offered to refund any customer who purchased either egg or the Inner Judge Flower Essence Blend between 12 January 2017 and 31 August 2017; however, the products are still listed for sale on the company website.

“Used by women to increase sexual energy and pleasure, this nephrite jade stone helps connect the second chakra (the heart) and yoni for optimal self-love and well being” the product description reads.

⇒ For the past couple of years, Brazil’s Federal Prosecution Service (MPF) has been leading two fraud and corruption investigations into a suspected medical devices cartel that it alleges bribed public officials and artificially inflated the costs of medical equipment contracts between 1996 and 2016.

Eduardo El Hage, the MPF who is in charge of the probes, last week spoke to PLN’s sister publication Global Investigations Review about the progress of the investigation, which has already ensnared the likes of Philips Healthcare, Johnson & Johnson and Orthofix.

The full article can be accessed via the Global Investigations Review website.

Regulation

⇒ The European Medicines Agency and the US Food and Drug Administration last week published updates on their investigations into cancer risks associated with valsartan medicines containing N‑nitrosodimethylamine (NDMA), which led agencies around the world to recall the drug earlier in the year.

The EMA said that roughly 1 in every 5,000 adult patients taking a 320mg dose of affected valsartan medicine every day over six years would develop cancer as a result. Patients who have taken treatments with lower doses or for less time will be at a lower risk, the agency said.

The assessments follow the initial unexpected detection of NDMA, classified as an animal and probable human carcinogen, in valsartan medicines produced by Zhejiang Huahai, a Chinese pharmaceutical company.

The agencies say they are now investigating a related substance, N-nitrosodiethylamine (NDEA), after it was detected in batches of valsartan made by Zhejiang Huahai before it made manufacturing changes in 2012. NDEA is also classified as an animal and probable human carcinogen.

While the EMA’s review covers all valsartan medicines, it has focused primarily on Zhejiang Huahai and Zhejiang Tianyu, where “unacceptable” levels of NDMA were found.

⇒ The Russian Ministry of Industry and Trade has recently approved a new state strategy for the development of the country’s domestic pharmaceutical industry.

The measures were approved on 4 July 2018 and form a new “Strategy for the Development of the pharmaceutical industry of Russia until 2030” (Pharma-2030), which will focus on boosting pharmaceutical production and exporting to Asia-Pacific, Latin America and Eastern Europe.

Alimirzoev & Trofimov Lawyers (AT Lawyers) told PLN it is still unclear as to what Russian legislation will have to be amended or implemented to comply with the new strategy, but they suspect that patent and IP law will be tightened, and that Russia will see the introduction of legislation that governs state procurement and taxation in the pharmaceutical industry.

It will also likely see the advent of the harmonisation and unification of pharmaceutical law within the Eurasian Economic Union, in addition to drug price regulation in Russia.

Specifically, the strategy intends to change the balance of the industry towards manufacturers.

AT Lawyers say that the strategy’s authors believe that distribution chains currently dominate the Russian pharmaceutical industry, with profits allocated disproportionately in favour of distributors. The strategy will reportedly address this by enabling manufacturers to invest more in the development of new medicines, sectoral technologies and research laboratories and factories.

The strategy aims to limit the number of pharmacies in the country, as well as prohibit the sale of over-the-counter medicines in supermarkets, as the increase in drug prices has supposedly been caused by “competition between drugstores in pursuit of bonuses from manufacturers.”

The strategy authors also claim that Russian pharmacies are established “only in places with a high flow of potential customers”, which does not take the availability of medicines into account.

According to AT Lawyers, the most important aims of the strategy involve supporting local manufacturers, by reducing their dependence on imported products and providing state support for domestic producers.

⇒ Nearly half of the institutions running clinical trials in Europe have not reported their results, according to a study published by the British Medical Journal (BMJ).

Of 7,274 trials with overdue results, only 49.5% have reported results, the study says.

EU clinical trial legislation states that all trials put on the EU Clinical Trials Register (EUCTR) since 2004 must report their results within a year of the trial ending.

The research coincides with the launch of a new website (EU Trials Tracker) dedicated to reporting the performance of European drug companies, universities and hospitals conducting clinical trials. 

The BMJ study described the situation as “poor”, and also revealed that the EUCTR often held incomplete or contradictory data. For example, 29.4% of supposedly “completed” trials had no completion date registered, and other completed trials were mislabelled as “ongoing”.  

Despite receiving criticism in the study, the European Medicines Agency (EMA) has welcomed its findings.

Fergus Sweeney, Head of Inspections, Human Medicines Pharmacovigilance and Committees at EMA, said the study “helps to spread the word on how important it is to post trial results once a clinical trial is over.”