This week in Phispers, we bring you news about a landmark court ruling
in the US that permitted Aceto to supply drugs to the US Department of Veterans
Affairs that contain APIs produced in foreign countries. Meanwhile, the FDA has been directed by the US government to explore ways in
which medicines can be imported from
other countries to check a dramatic price rise. This happened even as companies
like Pfizer, Novartis, Merck and
Roche stated their commitments towards holding the line on any drug
price hikes to the average inflation rate. Takeda CEO said he hopes China could be its second largest business in the long term. Novartis bought an atopic dermatitis drug from MorphoSys and Galapagos. It also sued over two dozen generic firms in the hope of blocking a generic to its blockbuster MS drug — Gilenya. And the first new treatment for malaria in 60 years — GSK’s tafenoquine — won the FDA nod, even as GSK reportedly planned to split itself to form a drug and vaccines company over the next two to three years.
Aceto gets a favorable ruling for using non-US made API in government contacts
In
a landmark ruling, a federal judge in the US ruled that Aceto Corporation, a
New York-based pharmaceutical company, can supply drugs to the US Department of Veterans Affairs (VA) that contain
active pharmaceutical ingredients (APIs) produced in foreign
countries.
The
court granted a declaratory judgment and the Judge Margaret Sweeney of the US Court of Federal
Claims ruled that under the Buy American Act, the VA is allowed to buy
drugs made in the US even if they contain some compounds produced outside the
country.
Earlier this year, the US Customs and Border Protection agency and the Department of Homeland Security had issued a notice that processing drugs in the US that contain APIs manufactured in other countries like India and China “does not result in a substantial transformation” and they considered those drugs as originating in foreign countries.
The ruling will most likely allow Aceto to regain some of the 11 VA contracts it lost earlier this year after the federal government said the company must either provide generics that didn’t contain ingredients made in India or lose the business. The government has 90 days to appeal the ruling.
China
and India are major producers of APIs bound for the US market.
The
VA contracts comprised about 15 percent of Aceto’s
revenues.
According to the US government (US Customs and Border
Protection, or CBP), the country of origin of the API in Rosuvastatin Calcium Tablets, Levofloxacin Tablets, Levetiracetam Tablets, Metoprolol Tartrate Tablets, Gabapentin Capsules, Carvedilol Tablets, Paroxetine Hydrochloride Tablets, Entecavir Tablets, Montelukast Sodium Tablets, Simvastatin Tablets, Donepezil Hydrochloride Tablets for US government procurement
purposes is India.
“CBP found that the API imported from two different countries was not substantially transformed when combined with stabilizers and excipients,” a government document had said.
FDA told to import drugs to
check price rise, despite commitments by pharma biggies
PharmaCompass has been covering FDA’s endeavors at exploring ways to reduce prices of drugs, as also to address drug shortages. In a latest move, the FDA has been directed by the US Health and Human Services (HSS) to explore ways in which medicines could be safely imported from other countries “in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.”
US HSS Secretary Alex Azar has directed the FDA to create a working group that aims at examining ways in which drugs could be safely imported from other countries. The directive comes as part of an ongoing effort to “address price hikes and supply disruptions that are harming American patients.”
The Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry’s most powerful trade lobby, has criticized the idea stating that the measures would “circumvent the robust safety requirements” in the US, thereby posing a “serious public health risk” and jeopardizing the country’s secure medicine system.
However
the initiative has received praise from various academics, analysts and observers.
This
happened even as pharma giants like Pfizer, Novartis and Merck stated their
commitments towards holding the line on any drug price hikes to the
average inflation rate. Merck is slashing the price of its hepatitis C combo Zepatier by 60 percent while also promising a
10 percent cut on other therapies. In all, Merck has lowered the price of six drugs.
Merck said it was lowering the prices in an effort to reduce out-of-pocket
costs for patients.
Both
Pfizer and Novartis had been subject to considerable scorn from the US
government over raising prices recently. However, in a tweet last week, Trump expressed his appreciation for these companies.
“Thank you to Novartis for not increasing your prices on prescription drugs. Likewise to Pfizer. We are making a big push to actually reduce the prices, maybe substantially, on prescription drugs,” Trump tweeted on July 19.
Meanwhile,
Roche has announced its intention to not
increase prices of its drugs, after two rounds of price hikes in January and
July. Roche told the HHS on July 11
that it will not take any more price increases this year.
Takeda
bets big on China; sees it as second largest market, on par with US, Europe
In
what maybe seen as a big shift in focus for the Japanese drugmaker, which is on
its way to acquire Irish drug company Shire for US$ 62 billion, the
Takeda CEO Christophe Weber recently said he hopes
China could be its second-largest business in the long term.
Takeda
is betting big on China for global growth, and sees the country ‘on a par’ with the US and Europe
“There’s no reason in the long term China shouldn’t be our second-biggest business in the world,” Weber said in a recent interview,
China’s drug market is the world’s second-largest after the US, and is slated to reach US$ 167 billion by 2020, according to a 2016 report by the US Department of Commerce. But most global pharma companies are yet to realize China’s potential.
Takeda is likely to take a long time to boost its China sales. In fact, Takeda’s revenue from China has dropped in recent years — from 66 billion Japanese yen (US$ 594 million) in 2015 fiscal year (April 2015 to March 2016) to ¥57.6 billion (US$ 518.2 million) in 2016 and then to ¥49.6 billion (US$ 446.2 million) in 2017. In comparison, it posted nearly ¥600 billion (US$ 5.4 billion) and ¥510 billion (US$ 4.6 billion) from sales in the US and Japan, respectively.
This means Japan, currently second on Takeda’s sales list, is worth ten times that of China insofar as the drugmaker’s global sales revenue is concerned.
Shire
sells only three drugs in China right now, its hemophilia drug Advate, albumin injection Flexbumin and
renal product Fosrenol. Moreover, Takeda’s China management team has recently been through big changes. However, Takeda plans to launch seven new products in China over the next five years.
Novartis
makes a billion dollar buy; files lawsuits against two dozen generic firms
Novartis
has bought a MorphoSys/Galapagos
drug — MOR106, an IL-17C monoclonal antibody — in a US$ 1.1 billion deal.
In
exchange, MorphoSys and Galapagos will give up all development
and marketing rights. The duo will also split the US$ 111 million (€95
million) upfront payment, and potential milestone payments totaling US$ 1
billion (€850 million).
The drug will be the second atopic dermatitis drug in Novartis’ pipeline, the first one being ZPL389, the Phase II eczema treatment it acquired
from Ziarco in 2016.
Novartis
will pay for all future R&D, manufacturing and commercialization costs.
MorphoSys and Galapagos will remain involved in both the ongoing early-stage
trials and any future trials to support development of MOR106 in this
indication.
Meanwhile,
Novartis is suing over two dozen generic drugmakers in the hope of blocking a Gilenya generic entrance until
2027.
Last
week, Novartis got a reprieve when the US Patent and Trademark Office (PTO)
upheld a patent on its multiple sclerosis blockbuster Gilenya. The Swiss
drugmaker now wants to use that win in court against generics makers in the
hope to block Gilenya copycats from entering the US market until 2027.
Post
the PTO ruling, Novartis filed four lawsuits that name multiple generic makers,
including Apotex, Mylan, Torrent Pharma, Teva, Sun Pharma and Accord Healthcare, all of which are
seeking to make copies of Gilenya.
Currently
approved for relapsing multiple sclerosis, Gilenya generatedmore than US$ 3 billion
in revenue in 2017, with a little more than half of that coming from sales in
the United States.
GSK
may split drugs and vaccines into new firm; its malaria drug bags FDA nod
GlaxoSmithKline’s chairman Philip Hampton is considering splitting the company. According to a Financial Times report,
Hampton has discussed creating a new company from its pharma and vaccines
divisions.
This news came after several of GSK’s top 10 investors asked the board to consider spinning off its consumer division. GSK currently divides its
business into pharmaceuticals, vaccines and consumer branches. According to the
report, a split up could happen within two or three years.
A GSK spokesman said the group’s priority is to improve the performance of its pharmaceutical business, especially research and development. The company is set to outline its new approach for the division next week.
In
June, GSK completed its purchase of Novartis AG’s 36.5 percent stake in
their consumer healthcare joint venture for US$ 13 billion.
Meanwhile,
a new drug to treat malaria — tafenoquine — manufactured by GSK, has received the USFDA’s nod. This is the first new treatment approved in 60 years for
malaria, an endemic in Asia and Latin America.
Tafenoquine has been in existence since the 1970s. By working with (non-profit organisation) Medicines for Malaria, GSK has repurposed the drug so that it can be used to get rid of malaria parasites in the liver.
The
medicine is meant for the recurring form of malaria caused by the parasite
plasmodium vivax that makes 8.5 million people ill each year. Treating this
type of malaria is a challenge as it can remain dormant in the liver for years
before reawakening.
Scientists have described tafenoquine as a “phenomenal achievement”. Regulators around the world will now look at the drug to see if they can recommend it for their populations.
There is already a medication that can be used to get rid of malaria hiding in the liver called primaquine. But unlike tafenoquine (which requires only single dose), primaquine often needs to be taken for 14 days. Some experts are concerned that many people feel better after just a few days and stop taking the pills, allowing the parasite to awaken at a later date.
In 2016, there were roughly 216 million malaria cases worldwide (an increase of 5 million on 2015), and an estimated 445,000 malaria deaths.
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