This week in Phispers, we tell you how Amsterdam became EU’s choice for hosting the EMA. As Biocon receives an inspection closure from the FDA for its Bengaluru sterile injectables facility, we analyze how news reports on Biocon and Mylan moving a step closure to getting an FDA nod for its Herceptin biosimilar could be misplaced. We also bring you news on the positive trials from Roche and the Skype ban in China. Meanwhile, Concordia got into yet another drug price hike controversy. This time for its thyroid drug — liothyronine.
Lucky draw gets Brexit-struck EMA a new home in Amsterdam
The biggest news from the world of pharmaceuticals this week
was the decision to relocate the European Medicines Agency (EMA), with nearly 900
employees, to Amsterdam (the Netherlands).
The relocation of EMA from London is a consequence of the UK’s withdrawal from the European Union. The agency was not involved in the selection of the new location.
Amsterdam was one of the 19 offers to host the
EMA submitted by the EU member states at the end of July 2017. The EMA now has
just over 16 months to prepare for the move and take up its operations in
Amsterdam by March 30, 2019.
“Amsterdam ticks many of our boxes,” Guido
Rasi,
executive director, EMA said. “It offers excellent connectivity and a building that can be shaped according to our needs,” Rasi added.
The decision was made by closed ballot votes from each EU member state held in Brussels this week. An EMA survey of its staff found most of them might quit if posted to the bloc’s poor eastern regions. The employees had rated Amsterdam, Barcelona and Vienna as the top choices, while Warsaw, Poland, Bucharest, Romania, and Sofia, Bulgaria were rated the lowest.
Milan, Amsterdam and Barcelona campaigned hard. But there was
a push from eastern states, as Slovak capital Bratislava turned out to
be a strong contender.
In the first round, Milan (with 25 votes), Copenhagen and
Amsterdam (with 20 votes each) advanced out. Bratislava had 15 votes and
Barcelona had 12 votes.
Milan (with 12 votes) and Amsterdam (with 9 votes) then
proceeded into the third round of voting.
In the final round of voting, Milan and Amsterdam both tied
with 13 votes each. The decision was taken through a draw of lots, that
Amsterdam won.
Biocon gets EIR for sterile injectables facility; FDA nod for its biosimilar still in question
India’s Biocon has received
an EIR (establishment inspection closure) for its sterile injectables facility,
inspected by the US Food and Drug Administration (FDA) earlier this year.
However, contrary to what some recent news reports suggest, the company and its
partner Mylan are not a step
closer to getting an FDA nod for its biosimilar of Roche’s blockbuster cancer drug — Herceptin.
According to these reports, Biocon
and Mylan have resolved FDA concerns about its Bommasandra plant, setting it and Mylan up to potentially win FDA
approval for the first Herceptin biosimilar.
According to PharmaCompass’ analysis, there were two inspections at Biocon — the first one was for the biosimilars (during March 27 to April 7 this year); while the second one
was for their sterile injectables facility (during May 25 to June 3 this year).
Based on the dates shared in Biocon’s statement, the EIR is for the second inspection and there is no ‘exact’ news on the biosimilars inspection.
The location of both inspections is the same — Plot 2-4, Phase IV, in Bommasandra, Bengaluru. However,
there maybe different buildings within the campus that were inspected by the
FDA.
The same location in Bommasandra was also put on Health Canada’s Inspection Tracker list for data-integrity concerns found by a regulatory partner of Health Canada.
According to news reports, the FDA EIR to the sterile plant
comes less than two weeks before the December 3 date that the FDA has set for
considering approval of the Herceptin biosimilar. The original action date was
September 3, but the FDA delayed that for three months after seeking additional
information from Mylan and Biocon. However, in our view, the EIR and the
December 3 date have no correlation.
After
receiving the EIR, the FDA further indicated that Biocon needs to implement the CAPA (corrective
action and preventive action) plan and resubmit the updated details.
Meanwhile, Roche is using all its might to prevent its revenues from getting chewed away by cheaper biosimilars. This week,
Roche Holding sued Pfizer Inc to stop it
from selling a copy of Herceptin in the US.
Boehringer opens the door for crowdsourced research through opnMe.com
Germany’s Boehringer
Ingelheim has launched opnMe.com — a platform that offers free and open access to certain pre-clinical molecules and non-clinical investigation to scientists worldwide.
The opnMe.com
platform provides scientists with many best-in-class
molecules supported by comprehensive data packages on one centralized platform.
It also offers them direct access to molecules for independent research as well
as other molecules for partnering with Boehringer.
Through opnMe.com, molecules for some of the most relevant
targets in biomedical research would be shared. This, in turn, would create
possibilities for further independent and collaborative discovery as well as
the identification of novel treatment approaches for patients.
“Working together with scientists across the world, we can accelerate research in a wide range of biomedical research areas,” Clive R. Wood, PhD, senior corporate vice president, Discovery Research at Boehringer Ingelheim, said.
This launch is part of the German research-based pharma company’s ongoing mission to further scientific research and medical progress through collaboration and innovation.
Roche’s shares surge after two trial wins of its potential blockbuster drugs
Roche, which has been plagued by shrinking revenues from its
older medicines, got a shot in the arm this week with two trial wins for its cancer (Tecentriq) and hemophilia (Hemlibra) drugs. The two
drugs are potential blockbusters.
Expectedly, Roche shares surged by 6.5 percent on Monday. This added more than US$ 12 billion to the company’s market capitalization.
With Tecentriq, in combination with Avastin
and chemotherapy, Roche has posted significant gains for progression-free survival
and risk of death for a segment of lung cancer patients. Hemophilia agent Hemlibra, on the other
hand, had reduced bleeds in a new group of patients.
Tecentriq and Hemlibra, along with Roche’s multiple sclerosis medicine Ocrevus, are pillars of CEO Severin Schwan’s strategy that would offset the patent expiry of its top-selling drugs — Rituxan,
Avastin and Herceptin. Together, these three drugs account for US$ 20 billion
in annual sales.
Since lung cancer is the largest oncology market, Roche’s trial of Tecentriq, in combination with Avastin and chemo, has been closely observed. With this drug, Roche seeks to compete with rivals in cancer immunotherapy.
The mixture “provided a statistically significant and clinically meaningful reduction” in the risk of the disease worsening or death compared to Avastin plus chemotherapy in first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC), Roche said.
Concordia’s thyroid drug caught in price hike controversy in the UK
Last month, PharmaCompass had reported on a popular thyroid drug levothyroxine receiving several complaints of severe side effects from patients in France. The drug works as a stand-in for the hormone thyroxine in patients suffering from hypothyroidism, a condition that affects the body’s metabolism.
And this week, Concordia Healthcare’s thyroid drug — liothyronine — got caught in a drug price
hike controversy. An antitrust probe in the UK into Concordia’s pricing for liothyronine has found that the drug is now 57 times more expensive than it was in 2006.
Both the thyroid drugs are different compounds — while liothyronine is the synthetic form of T3-triiodothyronine,
levothyroxine is the manufactured form of T4-thyroxin. Physicians
use liothyronine instead of or in addition to levothyroxine for
patients undergoing thyroid hormone withdrawal.
Concordia Healthcare has caught the ire of watchdogs even
earlier for hikes in their drug prices. This matter only adds to the ongoing
investigations.
The UK Competition and Markets Authority (CMA) recently
levied its biggest fine ever against Pfizer and Flynn Pharma, for driving
up the price of an epilepsy drug. The fine is currently under appeal.
“Pharmaceutical companies which abuse their position and overcharge for drugs are forcing the NHS—and the UK taxpayer—to pay over the odds for important medical treatments,” CMA chief Andrea Coscelli said in a statement. “We allege that Concordia used its market dominance in the supply of liothyronine tablets to do exactly that.”
According to a statement provided to the Financial Times, Concordia said the pricing of liothyronine has been “conducted openly and transparently with the Department of Health in the UK over a period of 10 years.”
Drug industry in China hit by local law that pulls Skype out from app stores
Like several other industries, the pharmaceutical industry
relies heavily on Microsoft’s
Skype to communicate with its business partners. But this
telecommunications application can no longer be downloaded
in China, as Skype has been removed from both the Apple and Android app stores
there.
Apple said it is one of the several voice over internet
protocol (VoIP) apps which was found not to comply with the local law by the
Chinese government. Microsoft told the BBC that the app had been “temporarily removed” and the company was “working to reinstate the app as soon as possible”.
China has increased scrutiny of internet applications this year, ordering firms to remove hundreds of apps that allow users to communicate confidentially or get around China’s so-called ‘great firewall system of censorship’ to use overseas social media. According to Reuters, over the last two months, authorities have also periodically interrupted services of Facebook Inc’s encrypted messenger app WhatsApp.
Alphabet’s Google, Facebook and Twitter are unavailable to Chinese users.
According to news reports, downloaded Skype apps continue to operate. However, users will not be able to update them.
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