This week, Phispers delves into Pfizer’s acquisition of Medivation and its impact on Sanofi. There is also news on antipsychotic drug Abilify, besides snippets on a lawsuit against Valeant, Mylan’s price hikes and more quality snags that were unveiled at Pfizer’s plant near Chennai. Read on.
Rough week for Sanofi as FDA
delays its diabetes drugs, while Pfizer walks away with Medivation
Pfizer
agreed to pay US $14 billion in cash for Medivation in a deal that adds the
prostate cancer drug Xtandi
to its product portfolio.
Medivation was one of the few independent companies with a cancer treatment
that is selling well. Xtandi currently generates about US $ 2 billion a year in
annual sales.
The acquisition has come as a setback
for French drug maker Sanofi that spent five months pursuing Medivation. At one point, Sanofi even attempted to replace Medivation’s board and force a deal.
There
was another setback for Sanofi,
as it saw the launch of its diabetes combination medicine get delayed until
November this year. Sanofi spent US $ 245 million on a priority
review voucher to beat Danish drug maker Novo
Nordisk to market with a diabetes drug that pairs its best-selling
medicine Lantus
(a basal insulin) with lixisenatide. However, the FDA’s fast-track review pushed out the launch of the combination till at least November.
The FDA asked Sanofi for more data on the dual-drug delivery pen – a device that triggered debate during an FDA advisory panel review in May this year.
The FDA decision on Novo’s product is due next month. With this unexpected delay, Novo could get more than a two months’ head start over Sanofi.
FDA warns against the
use of antipsychotic drug Abilify
In the US, patients taking the antipsychotic drug Abilify have
reported uncontrollable urges to gamble, binge eat, shop, and have sex, according
to the FDA. The regulator issued a warning this week
on the drug, which is one of the top-selling prescription medications in the
United States.
Other serious side effects of the drug include a higher chance
of developing diabetes and hyperglycemia, and increased risk of suicide among
patients under the age of 24.
Also known as aripiprazole,
the drug is used to
treat schizophrenia, and can be used in combination with other drugs to
treat depression. In the US, 1.6 million patients received Abilify
prescriptions last year.
The warning comes amid pending class-action lawsuits against
the manufacturer of Abilify – Otsuka America Pharmaceutical. The class-action suits allege the company didn’t properly warn patients about the possibility of impulse-control issues.
However, these problems are rare. In the 13 years since the
drug was approved, there have been only 167 reports of patients experiencing
significant impulse-control problems, according to the FDA.
Counterfeit pills may
have killed the late singer Prince
A little over a year ago, the Drug Supply Chain Security
Act (or Drug Quality and Security Act) became effective in the United States. The law was introduced to secure the supply chain of medicines and restrict counterfeit drugs – an industry estimated to be bigger than Pfizer and GSK put
together.
It seems that regulatory agencies still have a lot of work to do in this
area. A mis-labelled bottle of
pills found in the home of the late singer Prince contained the powerful
painkiller fentanyl, a synthetic opioid 50 times more powerful than heroin. Prince died on April 21 this year.
According
to sources close to the investigation, the pills were found in a bottle
of Aleve, an over-the-counter medication sold in the US that contains
the painkiller naproxen. Two dozen pills, found in one bottle, were falsely labelled as ‘Watson 385’ – an identifier for a mix of acetaminophen
(paracetamol)
and hydrocodone.
Valeant mired in trouble
with a lawsuit and faltering sales of female sexual dysfunction drug
According to a lawsuit
filed last week, Valeant
Pharmaceuticals refilled
patient prescriptions without their permission and directed them to buy expensive drugs in
order to boost sales. The lawsuit provides insight into how a mail-order pharmacy – Philidor Rx Services – assisted Valeant in directing prescriptions to its brand-name medicines over cheaper generic versions.
Meanwhile,
Valeant hired Paul Herendeen as its new chief financial officer, luring the
executive away from Zoetis,
the animal health products maker.
While
Valeant is busy battling
challenges on various fronts, its US $
1 billion acquisition of Sprout Pharmaceuticals of Addyi – the first medicine to combat female sexual dysfunction – is turning
out of be a bust, as it has reported meagre sales.
Pfizer’s plant in Chennai faces more compliance issues
Earlier this month, Pfizer had to halt production at a plant near Chennai in India, after a Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
joint inspection highlighted quality concerns. The other regulators in the
PIC/S inspection were the Medicines and Healthcare products Regulatory Agency
of the UK (MHRA), the United States Food and Drug Administration (USFDA),
Therapeutic Goods Administration of Australia (TGA) and Health Canada.
Three
years ago, the plant was first cited with an FDA warning letter. Last year, when
Pfizer acquired the plant from Hospira, it was well aware of the quality issues.
But Pfizer was probably not aware of the extent of troubles that awaited it. Last
week, a GMP non-compliance report posted by European Medicines Agency (EMA) listed
that an inspection by the MHRA uncovered
a variety of critical issues, raising doubts on whether
the injectable products coming out of the facility are sterile or not.
MHRA inspectors found that employees were using aseptic processes that could allow for microbial contamination. Pfizer’s investigations into issues were not getting to root causes of problems, they said. All of the plant’s shortcomings were linked to employees who lacked the “scientific knowledge” to know what to do.
The MHRA withdrew the plant’s GMP certificate and has halted imports to the European Union of six injected antibiotics until the problems get addressed.
Mylan’s outrageous drug price hikes for EpiPen come under scrutiny
The EpiPen auto-injector, which reverses life-threatening
allergic reactions, is under scrutiny. In 2015, the drug had generated US $ 1.2
billion in sales for Mylan.
The EpiPen has been around since 1977, but Mylan acquired
the auto-injector in 2007. The EpiPen precisely calibrates the dosage of epinephrine.
The patient now pays
about 400 percent more for this advantage to receive a dollar’s worth of the life-saving drug. EpiPens were sold for about US $ 57 when Mylan acquired it. Today, it is being
sold at US $ 500 or more in the US.
Meanwhile, Senator Amy Klobuchar (District Minnesota) has
asked the US Federal Trade Commission and the Senate Judiciary Committee to investigate
price hikes undertaken by Mylan. Klobuchar is the ranking member of Senate
Judiciary Antitrust Subcommittee. And Senator Richard Blumenthal (District Connecticut)
wrote to the company for data about assistance programs for
patients and first responders. He also
demanded that Mylan lower its price.
Last year, Mylan raised the price on EpiPen — its biggest-selling product — twice by 15 percent (each time). Due to lack of competition, the
price hikes were easy.
Korea’s Celltrion ships first batch of biosimilar Remicade to US
Last week, a day after winning a lawsuit in the US, Korean pharmaceutical firm Celltrion shipped
the first batch of its biosimilar medicine -- Remsima – to the country. The lawsuit was on the sale of Remsima – an autoimmune disorder drug – in the US, the world’s largest pharmaceutical market.
Celltrion said that the move will accelerate the US launch of Remsima, a
biosimilar version of Janssen's
Remicade. Remsima has been on sale in Europe since 2013.
Pfizer will take charge of sales of Remsima in the US. The drug will soon be
available to patients in the US suffering from rheumatoid arthritis and
ulcerative colitis under the brand name of Inflectra.
Remicaid’s sales were in excess of US $
8 billion in 2015. Celltrion
CEO Kim Hyoung-ki has projected that the company will earn more than US $ 1.7 billion in the US market next year, assuming a
double-digit market share.
Four healthcare CEOs on the world’s top 20 severance packages list
Even though the Pfizer-Allergan US $ 160 billion merger did not go through, Allergan CEO’s Brent Saunders has little
to complain. In a recent Bloomberg
compilation, his severance package of US $ 140 million ranks in the top
20 of all S&P 500 CEOs.
Joining him in the top 20 are other CEOs of healthcare
companies such as McKesson (with a severance package of US $ 198 million),
Aetna (US $ 91 million) and Regeneron (US $ 90 million).
McKesson Corporation is an American company distributing
pharmaceuticals at a retail sale level and providing health information
technology, medical supplies, and care management tools.
Aetna is an American managed health care company, which sells
traditional and consumer directed health care
insurance plans and related services, such as medical, pharmaceutical, dental,
behavioral health, long-term care, and disability plans.
Regeneron is a US-based biotechnology company with four FDA approved products and over US $ 4 billion in revenues in 2015.
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