This week, Phispers brings you news on FDA meeting its generic drug approval goal, M&A deals in the world of pharma, Obama’s article in JAMA, Abbott’s new bio-degradable stent for heart patients, Amgen’s predicament in the field of biosimilars and more.
FDA meets generic
drug approval goal a year ahead of schedule
The Center for Drug Evaluation and Research (CDER) at the US
Food and Drug Administration (FDA) has acted on more than 90 percent of the
Generic Drug User Fee Amendments (GDUFA)
backlog.
The GDUFA required the FDA to meet this goal by September 30,
2017, which is the end of the five-year funding period authorized under the GDUFA.
This way, the FDA has achieved its backlog commitment more than one year ahead
of schedule. This information was provided by Janet Woodcock, director of the
CDER.
Amgen’s double-standards on biosimilars; China to lead the biotech boom
Amgen
is playing
on the offense as well as on defense insofar as biosimilars are concerned. Last week, the FDA approved Amgen’s biosimilar of AbbVie’s Humira. And, if FDA insiders are to be believed, Novartis’
generics division Sandoz
may soon get the nod for its biosimilar of the US $ 9 billion drug Enbrel.
Amgen sells Enbrel in the US.
Amgen’s Humira biosimilar threatens AbbVie’s US $ 14 billion franchise. While Amgen is fighting to get its biosimilar on the market, it’s also fighting Novartis tooth and nail to guard its drug Enbrel. It has waged a legal war against Novartis’ development strategy, which studied the drug only for psoriasis but is now looking for an approval on a full slate of indications.
Meanwhile, a survey of international companies found that 85
percent of the respondents believe that China is set to have the fastest
growing biologics sector over the next decade, while 65 percent predict
patented new chemical entities (NCEs) will be discovered and developed within
China in as little as five years. The driving force behind these findings is
the growing biotechnology and R&D industry, which is heavily supported by
the Chinese government.
2016 shows lively
M&A activity, but deal sizes are smaller
Merger and acquisitions in the world of pharma picked up in
the April-June quarter of 2016.
According to market intelligence firm EvaluatePharma, pharma and biotech
companies announced transactions worth US $ 22.1 billion. However, the size of the
M&A
deals were a lot smaller, with AbbVie’s US $ 9.8 billion acquisition of Stemcentrx being the largest deal in the April-June quarter.
The pickup in M&A activity is an encouraging sign for
the industry that has been concerned about fears of a slowdown. This week also
saw Japanese drug maker Nichi-iko
acquire Sagent Pharmaceuticals in an all-cash deal of US $ 736 million. Yet,
2016 might not match the last two years in terms of deal value.
Theresa May says Britain will defend its pharma sector
from takeovers
While Britain mulls a second Brexit
referendum, Theresa May, the new prime minister of the UK, indicated in a press
conference that she
would help shield the nation’s pharmaceutical industry from takeovers, considering it an important sector for Britain.
This announcement comes after US giant Pfizer failed
in its bid to acquire AstraZeneca
and GlaxoSmithKline
has been rumored to be a takeover target.
British drug companies Shire,
AstraZeneca and GSK have been picked as potential takeover targets by
Pfizer, which had earlier tied up with Ireland's Allergan
before the deal got cancelled. Analysts say Pfizer needs to find a partner in
its quest to relocate its headquarters and lower its tax burden. And the three
British drug companies fit the bill.
A new industrial strategy is needed to enable the government to “defend a sector that is as important as pharmaceuticals is to Britain,” May said in a press conference in London this week.
Abbott’s dissolving stent offers long-term benefits to heart patients
Cardiologists and heart patients in the US now have a new
option for treating blockages in coronary arteries. Last week, cardiologists
began implanting
Absorb – Abbott Laboratories’ new biodegradable stent – in patients after it got FDA’s approval on July 5.
Unlike the permanent metal devices that have been used to
prop open clogged vessels for more than 20 years, Absorb is designed to fully
dissolve within two to three years of its deployment.
Proponents of the new device say it holds the potential for
long-term benefits over metal stents, including widely used drug-coated stents
that have dominated the market since 2003.
Drug makers
financially supported lawmakers who opposed Medicare Part B overhaul
Four months ago, the Obama administration had unveiled a
proposal to overhaul Medicare Part B, a medical insurance that covers necessary
services and supplies for American citizens. A large number of lawmakers had opposed
the effort.
This week, a new analysis has revealed that drug makers, who were worried that the Obama administration’s proposal to overhaul Medicare Part B will cut into their revenues, gave
lawmakers who opposed the overhaul considerably more
financial support than lawmakers who have not raised objections.
According to an analysis by a consumer advocacy group, 310
lawmakers who opposed the overhaul or were critical of it received a total of
more than US $7.2 million from drug and health product firms for their 2016
campaigns. The amount given to each representative averaged more than US $ 23,300.
Obama tells drug
makers to renew their commitment to improving public health
US President Barack Obama has written a game plan on
healthcare for the next president, including a crackdown on prices of
prescription drugs. In a first for a sitting president, Obama wrote
a scholarly article in the Journal of the American Medical Association (JAMA) that examines the passage of the Affordable Care Act – his landmark health law.
He also proposes future improvements to the US healthcare
system. Obama reprimanded drug makers for their stance
on pharmaceutical pricing and challenged companies to renew their
commitment to improving public health. He also castigated the Congress for
refusing to work with him to provide health coverage more quickly.
Cadila, Lupin,
Alembic close issues with the FDA
After weeks of news pertaining to non-compliance by India’s drug companies, the country’s pharmaceutical industry heaved a sigh of relief as Cadila,
Lupin and Alembic
reported
closure of some issues with the FDA.
“This receipt of EIR (Establishment Inspection Report) only indicates closure
of the inspection points (483s) raised, based on the inspection carried out between August 28, 2014 and September 05, 2014. What is ‘closed’ is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said in a regulatory filing.
Gilead wins lawsuit
against AIDS activist group; gets approval for hepatitis C drug
It’s been a good fortnight for Gilead
Sciences. Last week, a
lawsuit against the drug maker by an AIDS activist group was dismissed by a
US federal court judge. The lawsuit accused Gilead Sciences of manipulating the
patent system in order to thwart competition for its HIV medicines.
In its lawsuit, the AIDS Healthcare Foundation had charged
that Gilead not only violated antitrust laws, but also prevented countless HIV
patients from access to a newer and safer treatment.
Gilead Sciences also recently won FDA approval for another groundbreaking hepatitis C drug. This first of its kind oral, once-a-day drug – known as Epclusa – can treat all six major subtypes of hepatitis without patients taking any other drug, including the debilitating ribavirin.
But the cost
of Epclusa is prohibitive. The company said Epclusa would be priced at US $
74,760 for a 12-week course of treatment, which works out to US $ 900 per
tablet.
In 2013, Gilead was criticized for initially pricing its first hepatitis C drug – Sovaldi – at US $ 1,000 a pill. Its second-generation drug Harvoni was
also launched at around the same price.
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