Market Place
This week in Phispers, we look at the contrasting 2017 forecasts of Mylan and Teva, resulting from the FDA approval of Mylan’s generic Copaxone. Valeant decides to return the female libido pill business to Sprout Pharma. In India, two Lupin facilities receive FDA warning letters. And Torrent Pharma’s imminent acquisition of Unichem is set to make it the country’s fifth largest drug company. Meanwhile, Pfizer admits to have faltered on integrating Hospira and QuintilesIMS rebrands itself as IQVIA.
Teva’s credit rating nosedives, as Mylan raises 2017 forecast with approval of Copaxone
Here’s the tale of two drug makers — Teva Pharmaceutical Industries
and Mylan NV. Both have been facing tough times — Teva due to the declining prices of drugs and the high debt it incurred due to its US$ 40 billion acquisition of Allergan Plc’s generics business last
year; and Mylan due to its struggles with its blockbuster emergency allergy
shot EpiPen.
But
last week clearly favored Mylan. Teva saw its credit rating cut to junk by Fitch Ratings after the US Food and Drug Administration (FDA) approved two doses of Mylan’s generic version of Teva’s Copaxone. This multiple sclerosis drug happens to be Teva’s biggest product. As a result, Teva slashed its 2017 profit forecast for a third time.
Fitch
predicted that Teva will have to either sell assets or find external sources of
financing to meet its obligations. Mylan, on the other hand, raised its 2017 forecast as it expects to benefit from the ‘earlier-than-expected approval’ of its generic Copaxone.
Even
as Mylan hopes to benefit from its generic Copaxone, its challenges
continue unabated. Its third-quarter results highlighted the company's struggles with
declining sales of EpiPen. Sales of EpiPen fell by US$ 245.1 million on increased
competition and higher governmental rebates following a settlement with the US
Department of Justice.
EpiPens,
which contain the hormone epinephrine, are used to stave off allergic
reactions that can be fatal. However, since mid-September this year, seven
people have died as a result of failure of EpiPens to deploy correctly. In all, the FDA has
received 228 reports of EpiPen or EpiPen Jr failures since mid-September.
Teva’s JV with Guangzhou:
Meanwhile, Teva is exploring growth through the world’s second-largest market for drugs — China. It is setting
up a joint venture with Guangzhou Pharmaceutical Holdings
to manufacture and sell its drugs in the Chinese market. It is awaiting
approval from the local government.
Two years after buying ‘female-Viagra’, Valeant plans to sell it back to Sprout
After
buying the female libido pill business from Sprout Pharmaceuticals two years
back for US$ 1 billion, this week Valeant Pharmaceuticals International
said it plans to sell the business back to its original
owner.
The controversial pink pill — Addyi — made by Sprout was said to be a blockbuster drug, expected to command a US$ 2 billion market. However, Addyi proved to be a commercial disaster, with its sales being sluggish last year. What was worse, Valeant was sued on behalf of the former Sprout investors for
its alleged failure to market Addyi successfully. The complaint had said that
sales of the pill may have totaled less than US$ 10 million in 2016, far short
of the US$ 1 billion targeted by July, 2017.
Addyi, approved by the US FDA in August 2015 under intense pressure from patient advocacy groups, is meant to be taken daily. It is prescribed to activate sexual impulses, but carries a strong warning about its potential side effects — such as low blood pressure and fainting, especially when taken with alcohol. Many in the industry believe that the drug should never have been approved.
Valeant has agreed to sell its subsidiary and Addyi to a new company “associated” with Sprout’s founders, for a royalty stream of only 6 percent on global sales of Addyi. In addition, Valeant said it will provide a US$ 25 million loan to fund initial operating expenses to the new company to get things started. And in exchange, Sprout is dropping its lawsuit claiming Valeant mismanaged the launch by pricing the drug too high.
Valeant’s glaucoma drug:
Last week, the US FDA approved Valeant’s long-delayed glaucoma drug — latanoprostene bunod ophthalmic solution.
Christened Vyzulta, the solution was approved for the reduction of
intraocular pressure (IOP) in patients with open-angle glaucoma. Valeant hopes
to have the drug in the market before 2017-end, Joseph Papa, CEO of Valeant,
said in a statement.
Valeant
acquired the drug through its US$ 8.7 billion buyout of Bausch + Lomb in 2013. The drug was
licensed to Bausch + Lomb by France-based Nicox.
Torrent to emerge fifth-largest Indian drug player after
Unichem buyout
In
India, Ahmedabad-headquartered Torrent Pharmaceuticals plans to acquire Unichem Laboratories’ domestic business for US$ 558 million (Rs 36 billion) by the end of this week.
The
deal would make Torrent the fifth largest player in the Indian market with
a market share of 3.4 percent. According to a Reuters report, Torrent
would buy more than 120 brands from Unichem in India and Nepal,
along with its manufacturing plant in Sikkim.
The
board of Torrent is meeting on November 10 to approve the second quarter
results. A formal announcement on the acquisition of Unichem is likely to come on
that day.
Unichem has not been able to leverage its slow-growing, mature brands. The deal includes the purchase of the brands like Unienzyme, Losar, Ampoxin and Telsar.
The
acquisition is likely to deliver synergies in both cost and revenues for Torrent’s branded drugs business in India. Torrent is expected to turnaround Unichem’s mature brand, just the way it had turned around Elder Pharma’s branded formulations,
which it had acquired in 2014 for US$ 308 million (Rs 20 billion).
Analysts expect Unichem to use the proceeds from the deal to ramp up its unprofitable international business. The transaction will strengthen Torrent’s position in cardiology, diabetology, gastro-intestinals and central nervous systems therapies, Torrent chairman Samir Mehta said.
Despite record profits, Pfizer’s CEO says troubles with Hospira persist
American pharmaceutical giant Pfizer reported third-quarter profits
last week, which more than doubled as its new drugs to treat cancer and other
illnesses made up for the hit the company took due to patent expirations.
Pfizer’s net income from the
quarter stood at US$ 2.8 billion, compared with just under US$ 1.4 billion in
the year-ago period.
However, Pfizer’s Essential Health unit remained an area of concern, into which Hospira was folded. The third quarter
revenue of this unit was down 11 percent, at US$ 5.06 billion. Pfizer had
acquired Hospira in 2015 for US$ 15
billion.
While praising other parts of the Essential Health unit (such as biosimilars and emerging markets), Pfizer CEO Ian Read pointed his finger at Hospira. “Within our Essential Health portfolio, we have been experiencing supply shortages with some products. The shortages are primarily for products from the legacy Hospira portfolio and are largely driven by capacity constraints and technical issues,” Read said.
Pfizer
has attributed a 12 percent operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from the former Hospira facilities.
At
the time of acquisition, the sterile injectables player Hospira was facing
regulatory challenges. The executives of Pfizer had assured
investors and regulators that they would quickly resolve issues at
the plants. However, two years on, the problems still persist.
Pfizer has sold or closed some of the troubled operations of Hospira. But one that has continued to bother the company is a facility in McPherson, Kansas. Earlier this year, Pfizer’s fill/finish manufacturing facility in McPherson received a warning letter from the US FDA. The manufacturing problems at the McPherson plant also derailed the launch of a generic version of Teva’s Copaxone, that was being developed by Sandoz and Momenta. The drug
was being finished at the McPherson plant, which was slapped the FDA warning
letter.
Goodbye
QuintilesIMS, Hello IQVIA
QuintilesIMS has rebranded itself and changed its name to IQVIA. Last year, Quintiles and IMS Health had merged. The merged entity — QuintilesIMS — had emerged as the world's largest pharma services provider, with a market value of almost US$ 18 billion and around 50,000 employees.
The name change (to IQVIA) is effective from November 6, 2017; and beginning November 15, 2017, equity shares of the company will trade on the New York Stock Exchange (NYSE) under the new name and new ticker symbol ‘IQV’.
“IQVIA may be grounded in the intelligence and capabilities of I and Q, but it is ‘via’ the path forward that we hope to inspire and ignite real change for healthcare stakeholders,” a spokesperson told Endpoints News.
Two Lupin facilities receive FDA warning letters
In another setback to Indian generic manufacturers trying to
overcome concerns of non-compliance with good manufacturing practices (GMPs),
Lupin informed the bourses that it had received a warning
letter for its formulation manufacturing facilities in Goa
and Indore (Pithampur Unit II).
In April 2017, Lupin had received three Form 483 observations for its Goa facility, and a month later six Form 483 observations for Pithampur.
In June last year, a PharmaCompass article had asked the question — “Lupin’s FDA inspections, how serious are the concerns?”. In our review of FDA observations of previous inspections at Lupin, we had highlighted concerns over “instances where batches that generated ‘out of specification (OOS)’ results and failed in-process specifications, had the finished product released by the quality control unit (QCU) and distributed” without invalidating the OOS results.
The recent warning letters indicate continued
concerns at Lupin.
The observations of the recent inspections specifically highlight Lupin’s continued “failure to thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all OOS results obtained at Pithampur and over 75 percent of them in Goa.
While Lupin does not expect any disruption
in supplies, the company does anticipate a delay of new product approvals.
Impressions: 3807
https://www.pharmacompass.com/radio-compass-blog/teva-s-rating-cut-to-junk-two-lupin-facilities-receive-fda-warning-letters
#PharmaFlow by PHARMACOMPASS
09 Nov 2017
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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.
Impressions: 5522
https://www.pharmacompass.com/radio-compass-blog/sanofi-s-rough-week-quality-snags-at-pfizer-fda-warns-against-commonly-used-drug
#PharmaFlow by PHARMACOMPASS
25 Aug 2016
