Market Place
Nearly every
year, drugmakers ring in the new year with drug price increases in the US. This
year too, prices of over 450 prescription
medicines increased by an average of around 5 percent at the start of January.
This, when high drug prices have been one of the biggest political issues in
the US over the last few years.
PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Rising healthcare, drug spends in US
Over the
last several years, we have repeatedly heard political leaders in the US
complain about high drug prices. Yet, drug prices and healthcare spends have
risen unabated.
America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8
trillion, accounting for 17.7 percent of the gross domestic product (GDP).
During the year, prescription drug spend increased by 5.7
percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7
percent to US$ 799.4 billion.
President
Joe Biden recently stressed on the need to cap the prices of essential drugs,
and said that the average American pays the highest prices for prescription
drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.
Pharma
companies, on the other hand, have vehemently argued against any price cuts in
the US, saying price cuts would hinder drug research and development for all
diseases.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Patented drugs account for 80.3 percent of total Part D spend
Medicare is the US federal government’s program that
provides health insurance to most people who are 65 years
or older. Medicare’s Part D plan provides outpatient drug coverage through private
insurance companies that have contracts with the federal government. Eligible
people have to choose and enroll in a private prescription drug plan for Part D
coverage. Medicare Part B, on the other hand, covers a wide variety of
medically necessary outpatient services and some preventative services.
Prescription
drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending
on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent
of the total spend for the year. Generic drugs made up for the remaining 19.7
percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8
billion were sold under Part D, accounting for 21 percent of the total spend
under the program.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Eliquis ranks highest on Medicare’s brand drug spend
Under Part
D, endocrinology and oncology were the two therapeutic areas that generated
maximum revenue for pharma companies, driving home sales of over US$ 31.8
billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of
around US$ 22.9 billion.
Among branded
drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018.
Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up
by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each
under the program.
Amongst
generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with
electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the
overall dosage units sold also jumped higher by 2.25 billion units to 111.35
billion.
The sales
ranking of Part D does bare some similarities with the global ranking of
highest selling drugs. In 2020, Humira had retained its position as the highest
selling drug in the world, generating sales of US$ 20.4 billion. Both
Eliquis and Revlimid had retained their ranking as the third and fourth most
selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global
sales in 2020.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Medicare’s inability to negotiate prices costs American taxpayers billions of dollars
Over the
years, drug companies have used Medicare’s
inability to negotiate prices under Part D to increase the prices of their
drugs significantly and rip off huge profits, a three-year-long US House
Oversight Committee investigation has revealed.
US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between
2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.
Elsewhere in
the world, the same drugmakers are bending over backwards to get into medical
insurance programs. For instance, China reported that several international
pharma firms, many of them headquartered in the US, slashed the prices of their
drugs by up to 94 percent to get into the country’s national medical insurance coverage.
In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022
if an expensive Alzheimer’s drug, Aduhelm, is included in the list.
In order to
ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Our view
President
Biden's Build Back Better legislation,
which the House passed last month, is up for vote in the Senate. The
legislation contains provisions that would allow Medicare to negotiate the
prices of some expensive drugs, penalize drugmakers who raise prices faster
than inflation and cap out-of-pocket costs for insulin at US$ 35 per month.
However, chances of the bill being passed in its present form are slim.
Even if the
Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025.
The number would increase over the years, reaching 100 in six years, and hence
forth grow by 20 drugs a year.
It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Impressions: 2622
https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data
#PharmaFlow by PHARMACOMPASS
06 Jan 2022
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In August, the biotech boom of 2018 continued unabated and the Wall
Street Journal reported that investment banks have lured top biotech
analysts with guaranteed pay packages of US$ 3 million or more.
At this time of the year, equity analysts who assess companies and
write reports that help investors gauge prospects and
interpret news will certainly have their hands full as investments into pharma
and biotech companies continue to grow at a rapid pace.
Leading the pack
in August was US-based Emergent BioSolutions which made two acquisitions to
stay on track of its growth plan to achieve US$ 1 billion in revenue by
2020.
While European
businesses have had a long-established practice of taking off during the months of July or August, last month two German startups — Affimed NV and Mologen AG — announced big ticket deals which could result in multi-billion dollar payouts. And
Hong Kong continued its efforts to lure overseas-listed firms to conduct
secondary share offerings in the financial hub.
Click here to view the major deals in August 2018 (FREE Excel version available)
Emergent
BioSolutions’ billion-dollar shopping spree
In a deal
valued up to US$
735 million, consisting of an upfront payment of US$ 635 million and up to US$ 100 million in cash for potential
sales-based milestones, Emergent Biosolutions acquired Adapt Pharma to access its flagship product Narcan (naloxone Hydrochlroride) Nasal Spray — the first and only US Food and Drug Administration (FDA) approved nasal form of naloxone for the
emergency treatment of a known or suspected opioid overdose.
The acquisition is designed to
help Emergent expand its presence within the public health threats market
to respond to the opioid crisis, which has been declared a public health
emergency by the US government.
Click here to view the major deals in August 2018 (FREE Excel version available)
Narcan is often carried by police officers and medical teams and was approved in 2015. Earlier
this year, the US Surgeon General released a public health advisory urging more
Americans to carry naloxone.
The
purchase of Adapt Pharma is expected to generate revenues of US$ 200
million to US$ 220 million and to be accretive to adjusted net income and
EBITDA in 2019.
Just weeks earlier, Emergent
announced an all-cash US$ 270 million acquisition of specialty vaccines company PaxVax. The
acquisition will add two revenue-generating FDA-licensed vaccines that
protect against cholera and typhoid fever to Emergent’s vaccine portfolio. These vaccines
are expected
to generate revenues of US$ 70 million to US$ 90 million in 2019.
Click here to view the major deals in August 2018 (FREE Excel version available)
Novo bags new diabetes technology by acquiring Bristol univ spinout — Ziylo
Novo Nordisk acquired full rights to Ziylo’s early-stage glucose binding molecules in a staged acquisition with a potential deal value that could exceed US$ 800 million. The acquisition will give Novo Nordisk full rights to Ziylo’s glucose binding molecule platform to develop glucose responsive insulin molecules.
Ziylo is a University of Bristol spin-out company based out of the Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology — synthetic glucose binding molecules — for therapeutic and diagnostic applications.
Click here to view the major deals in August 2018 (FREE Excel version available)
Ziylo’s glucose binding molecules are synthetic molecules that exhibit an unprecedented selectivity to glucose in complex environments such as blood.
The development of glucose
responsive insulin molecules is a key strategic area for Novo Nordisk, as it
wants to develop this safer and more effective (next generation of insulin)
therapy.
A glucose responsive insulin would
help eliminate the risk of hypoglycaemia (deficiency of glucose in the blood
stream), which is the main risk associated with insulin therapy and one of the
main barriers to achieving optimal glucose control. Such an insulin molecule
could also lead to better metabolic control.
Just before selling itself to
Novo, Ziylo spun out a new company
dubbed Carbometrics to develop the diagnostics and glucose monitoring
applications of its technology. Carbometrics is now the new home for all Ziylo
researchers. Through a research collaboration with Novo Nordisk, Carbometrics
will assist with ongoing optimization of glucose binding molecules for use in
glucose responsive insulin molecules.
Click here to view the major deals in August 2018 (FREE Excel version available)
Novo Nordisk has a strong presence in the diabetes care market with a global value market share of 27 percent. In the total insulin market, Novo’s global value market share is 46 percent; and in the modern and new-generation insulin market, it is 45 percent.
The European
discovery outfit at Evotec also announced a tie up with Novo Nordisk to build early-stage pipeline drugs
for diabetes, obesity drugs, and also diseases like NASH (non-alcoholic fatty
liver disease), cardiovascular diseases and diabetic kidney disease. The
scientists at Evotec will build a preclinical pipeline of small molecules
primarily concentrating on diabetes and obesity.
While the
financial details of the alliance are not known, it is clear that Evotec is
adding a major partnership on top of a string of deals with companies
like Celgene, Bayer and Sanofi, as well as a number of smaller
biotech firms.
Click here to view the major deals in August 2018 (FREE Excel version available)
German cancer
startups announce big ticket deals
Last month, Genentech, a member of the Roche group, announced it will pay German clinical stage biopharmaceutical company — Affimed — US$ 96 million upfront. It also committed to funding, thereby making Affimed eligible for up to an additional US$ 5.0 billion in revenues which includes milestone payments, and royalties on sales.
The German start up is focused on
discovering and developing highly targeted cancer immunotherapies that harness
the power of innate and adaptive immunity (NK and T cells).
Affimed will apply its proprietary Redirected Optimized Cell Killing (ROCK®) platform, which enables the generation of both NK cell and T cell-engaging antibodies, to discover and advance innate immune cell engager-based immunotherapeutics of interest to Genentech.
Click here to view the major deals in August 2018 (FREE Excel version available)
In June, at the European
Hematology Association, Affimed shared data of its lead candidate AFM13 in combination with
Keytruda (Pembrolizumab)
in patients with Relapsed/Refractory
Hodgkin Lymphoma. Assessment of 18 patients treated at the highest AFM13 dose
showed best overall response rate (ORR) of 89 percent (16/18 patients).
Another German company Mologen AG announced a deal with Oncologie which could generate
payouts of over US$ 1.16 billion (€1 billion) towards the development of its lead compound — lefitolimod.
In the near-term, Mologen would receive US$ 26.63 million (€23 million) to conduct the phase III Impala trial and build on the promising data from a phase II trial as a maintenance
therapy after first-line induction chemotherapy in patients with metastatic
colorectal cancer. Impala is a randomized phase III study in patients with
metastatic colorectal carcinoma.
In the field of
active immunotherapies, great hopes are riding on substances that bind to very
specific receptors, known as toll-like receptors (TLR). These receptors are
part of the innate defense system. Through activation of the immune system,
they are able to facilitate the recognition of tumor-associated antigens.
Click here to view the major deals in August 2018 (FREE Excel version available)
Many years of
research work have shown that toll-like receptor 9 (TLR9) plays a particularly
important role in the fight against cancer. Substances that activate TLR9 are
referred to as TLR9 agonists and form the main focus of global research and
development activities.
Lefitolimod
is regarded as the best-in-class TLR9 agonist.
Under new listing rules, Hong Kong stages second biotech IPO
Chinese cancer drug developer BeiGene, which debuted to a US$ 158 million public offering on the Nasdaq back in 2016, had its secondary IPO on the Hong Kong stock exchange last month.
As part of an effort to attract
secondary listings, Hong Kong is implementing new and more lenient rules for
drugmakers that are still in the earliest stages of the clinical trial process
without any products on the market.
BeiGene is only
the second to launch an IPO under the new regime and the US$ 903 million raised during the dual listing improves its exposure to
investors in Asia while being close to the mainland China market.
Click here to view the major deals in August 2018 (FREE Excel version available)
BeiGene intends to use net proceeds from the offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates — zanubrutinib, tislelizumab, and pamiparib.
Under the revised rules, Ascletis Pharma was the first early-stage biotechnology company to be listed on the Hong Kong Stock Exchange (HKEX) in July 2018. After the new rules were put in place
in Hong Kong, more than 10 biotech companies, mostly Chinese, announced plans
to list in Hong Kong. Some have also dropped plans to launch IPOs in the US in
favor of the Hong Kong exchange.
Click here to view the major deals in August 2018 (FREE Excel version available)
The overall IPO range sought by
BeiGene was reportedly between US$ 908 million and US$ 1.07 billion
and one of the reasons given for the biotech falling short of its target was the
vaccine scandal in China which has been making headlines and may have hurt
investor confidence.
Currently New York-based Nasdaq is
the biggest center for biotech listings, with US$ 2.4 billion worth of such
shares sold last year, according to the data provided by Thomson Reuters.
Click here to view the major deals in August 2018 (FREE Excel version available)
Our view
The first half of 2018 witnessed a spate of M&A activity in
the pharmaceutical and biotech space with the industry witnessing some of the
biggest deals from companies like Takeda, Celgene and Sanofi. In addition, healthcare startup funding
from venture capital firms reached US$ 15 billion, which is 70 percent higher
than the corresponding figure for last year.
Click here to view the major deals in August 2018 (FREE Excel version available)
While July and
August were comparatively slow months for activity, we expect a significant
ramp up of deal-making in the coming months.
Keep
track of all that is happening with PharmaCompass’ compilation of Top Pharma & Biotech Deals — PharmaFlow.
Click here to view the major deals in August 2018 (FREE Excel version available)
Impressions: 2526
https://www.pharmacompass.com/radio-compass-blog/top-pharma-biotech-deals-investments-m-as-in-august-2018
#PharmaFlow by PHARMACOMPASS
13 Sep 2018
The year 2017 was a landmark year for pharmaceutical
industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies.
The US Food
and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest
since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency
(EMA) approved 35 drugs with a new active substance, up from 27 in 2016.
Sales for most major pharmaceutical
companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has
generated investor hopes for accelerated dividend growth and share buyback
plans.
This week, PharmaCompass brings
you a compilation of the top drugs of 2017 by sales revenue.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second
There wasn’t any upheaval
at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant
Humira (adalimumab), which is approved to treat
psoriasis and rheumatoid arthritis, added
almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues.
Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The
company believes this drug will continue to be a significant cash contributor
until 2025 and the US $21 billion sales forecast
by 2020 is about US $3 billion higher than its expectation two years ago.
In 2016, the US Food and Drug Administration
(FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo
(adalimumab-adbm) — received approval from the FDA and European authorities.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Enbrel (etanercept),
the longest-used biologic medicine for the treatment of rheumatism around the
world, was the second best-selling drug with US $8.262 billion in 2017 sales.
The sales of the drug were down from US $9.366 billion in
2016 owing to lower selling prices and increased
competition, which in turn hurt demand.
Since it was first approved in the United States in 1998,
Enbrel has been approved in over 100 countries and the drug is promoted by Amgen,
Pfizer
and Takeda
in different geographies.
Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August
2016 for the treatment of patients with
rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and
other diseases is still not on the market because of a patent-protection
challenge from Amgen.
Amgen is arguing in the US federal court
that its drug has patent protection until 2029.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Fast-growing drugs: Eylea and Revlimid bring
fortunes for Regeneron and Celgene
Regeneron’s
flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in
annual sales last year to record US $8.260 billion in total sales. Eylea net
sales grew 11 percent year-on-year in the US and 19 percent year-over-year
outside the US.
The company believes much of the recent
growth in the US was driven by demographic trends with an aging population as
well as an overall increase in the prevalence of diabetes.
These demographic trends are expected to
continue in the coming years, providing an opportunity for continued growth.
Eylea sales alone contribute 63 percent to Regeneron’s total sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Celgene’s
Revlimid
(lenalidomide)
— a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.
Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion.
Celgene received a setback this month as the
USFDA refused to consider Celgene’s
application for ozanimod, an experimental
treatment for relapsing multiple sclerosis. The treatment was being seen as a
key to the company’s fortunes as Celgene had
said ozanimod is worth US $4 billion to
US $6
billion a year in peak sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Gilead’s Hepatitis C franchise enters free fall
Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the
competitive heat as they registered US $9.137
billion in 2017 sales, down from US $14.834
billion the previous year.
While reporting 2017 results, Gilead provided guidance for
2018 and said its sales of Hepatitis C drugs could fall
further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated
US $19.1 billion in sales.
One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret
at a deep price discount to the competition. AbbVie
also claims to have the shortest treatment course at eight weeks, compared with
12 weeks or longer for other treatments.
AbbVie reported US $1.274 billion in Hepatitis C drug sales
in 2017, down from US $1.522 billion in 2016.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat
Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.
The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe)
and Vytorin (Ezetimibe
and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark
Pharmaceuticals entered into an agreement that allowed Glenmark to launch
a generic version of Zetia in late 2016. The drugs
that had combined sales of US $3.701
billion in 2016 felt the generic heat in 2017 and the sales were US
$1.606 billion lower at US $2.095
billion.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
GSK’s Advair, which was expected
to encounter generic competition in 2017, continued to breathe easy as the FDA
found deficiencies in the applications of Hikma, Mylan and Sandoz.
All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.
Top 15 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2017. This is based on information extracted from
annual reports and US Securities and Exchange Commission (SEC) filings of major
pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all the 2017 data (Excel
version available) for FREE!
S. No.
Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2017 Revenue in Millions (USD)
1
AbbVie Inc., Eisai
Humira®
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
18,946
2
Amgen, Pfizer Inc., Takeda
Enbrel®
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
8,262
3
Regeneron, Bayer
Eylea
Aflibercept
Ophthalmology
8,260
4
Celgene
Revlimid
Lenalidomide
Oncology
8,187
5
Roche
MabThera®/Rituxan®
Rituximab
Oncology
7,831
6
Johnson & Johnson, Merck, Mitsubishi Tanabe
Remicade®
Infliximab
Autoimmune Disorders
7,784
7
Roche
Herceptin®
Trastuzumab
Oncology
7,435
8
Bristol-Myers Squibb, Pfizer Inc.
Eliquis®
Apixaban
Cardiovascular Diseases
7,395
9
Roche
Avastin®
Bevacizumab
Oncology
7,089
10
Bayer, Johnson & Johnson
XareltoTM
Rivaroxaban
Cardiovascular Diseases
6,590
11
Bristol Myers Squibb, Ono Pharmaceutical
Opdivo
Nivolumab
Oncology
5,815
12
Sanofi
Lantus
Insulin Glargine
Diabetes
5,731
13
Pfizer Inc.
Prevnar 13/Prevenar 13
Pneumococcal 7-Valent Conjugate
Anti-bacterial
5,601
14
Pfizer Inc., Eisai
Lyrica
Pregabalin
Neurological/Mental Disorders
5,318
15
Amgen, Kyowa Hakko Kirin
Neulasta®
Pegfilgrastim
Blood Disorders
4,553
Sign up, stay ahead
In order to stay informed, and receive
industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and
you will receive updated information as it becomes available along with a lot
more industry analysis.
Click here to Access All
the 2017 Data (Excel version available) for FREE!
Impressions: 58413
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
29 Mar 2018
This
week, Phispers brings you news about Teva, which finally found a CEO in Kare
Schultz. Allergan transferred the patent of its best-selling eye drug Restasis
to the Mohawk tribe in order to protect it from patent dispute. There was more
news on EpiPen, as Pfizer received an FDA warning
letter for Mylan’s flagship product. And, a leaked audio revealed how Insys lied to a patient who didn’t have cancer to sell a prescription opioid.
Teva nabs Lundbeck’s CEO to revive its fortunes; to pay over US$ 44 million
After
months of bad news, this week there was finally some good news from the
much-troubled Teva. The Israeli generic
drug giant finally managed to get a new chief executive officer for itself, after Erez Vigodman’s resignation in February this year.
Teva
poached Lundbeck’s Kare Schultz as its new CEO. Schultz, 56, will move to Israel and be based at Teva’s headquarters in Petach Tikva. In an SEC filing, Teva said Schultz is starting with a base pay of US$ 2 million. Along
with several bonuses (including a signing bonus of US$ 20 million), his initial
package adds up to over US $44 million. Schultz has 30 years of
experience in global pharma business.
After
the acquisition of Allergan’s generic business — Actavis — last year, Teva has been saddled with huge debts. And the key question before the new CEO is whether he will maintain Teva as both a generics and specialty drugmaker, or split it in two or get out of the highly competitive generics business.
During
the last quarter (April to June), Teva posted revenues of US$ 5.7 billion, out
of which US$ 3.1 billion came from generics and US$ 2.1 billion from its own
branded drugs. About half the sales of its own medicines come from a
blockbuster multiple sclerosis drug which is now facing competition from generics.
Pfizer
gets FDA warning letter for supplying faulty EpiPens to Mylan
The
US Food and Drug Administration (FDA) has told Meridian
Medical Technologies,
a division of Pfizer
that makes the EpiPen injector device (sold
by Mylan NV), that serious component and product failures have been associated with patient deaths.
In
a warning letter issued on September 5, the FDA said the Pfizer unit failed to
adequately investigate problems at its manufacturing facility in Brentwood,
Missouri. It also did not take appropriate corrective actions before an FDA
inspection earlier this year.
Throughout last year,
Meridian received hundreds of complaints that the EpiPen device, which is used
to combat serious allergic reactions, failed to operate during life-threatening
emergencies.
In
March this year, tens of thousands of EpiPens were recalled worldwide after two
reports of the shot failing to work in emergencies.
In
a note to Stat News, Pfizer said: “Between 2015 and now, we have shipped more than 30 million EpiPen Auto-Injectors globally. It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.”
“We currently have no information to indicate that there was any causal connection between these product complaints and any patient deaths,” it added.
In
a statement, Mylan said it is confident of the safety
and efficacy of EpiPen products being produced at the Brentwood site.
According to the FDA warning letter, in April 2016, a customer complained that an EpiPen failed to activate. Though Meridian confirmed the problem, in June 2016 it decided the defect was infrequent. Moreover, between 2014 and 2017, Meridian received 171 devices from patients who complained their devices failed to activate even when they followed the instructions. But Meridian only examined some of the devices and told the FDA inspectors they could not examine the rest without “approval by management”.
The warning letter highlights that Meridian “failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA's inspection.”
Allergan tries to protect eye drug by selling its patent
rights to Mohawk tribe
Allergan
played an unusual gambit last week to protect its best-selling eye drug — Restasis — from a patent dispute. It did that by transferring the patent of the drug to the Saint Regis Mohawk Tribe, a Mohawk Indian reservation in Franklin County, New York, United States.
Under
the deal, Allergan will pay the tribe US$ 13.75 million. In exchange, the tribe
will claim sovereign immunity as grounds to dismiss a patent challenge through
a unit of the United States Patent and Trademark Office. The tribe will lease
the patents back to Allergan, and will receive US$ 15 million in annual royalties
as long as the patents remain valid.
For
the Mohawk tribe, the deal could generate a new revenue stream. Bob Bailey, Allergan’s chief legal officer told FiercePharma: “I have spent time with the chiefs and their primary motivation for doing this… is to diversify the stream of incomes that this tribe enjoys away from casinos and cigarettes, into longer term, more viable streams…”
If
successful, the move will represent a new way for drug companies to circumvent
the inter partes review, a procedure for challenging the validity of a
United States patent before the United States Patent and Trademark Office.
The
move sent ripples across the pharmaceutical industry. Surely, if this strategy
pays off, there will be other drug companies following suit. Many observers
ridiculed the company on social media by calling the deal unscrupulous and sure
to bring more criticism to the industry. The tribe has reportedly also
taken ownership of patents owned by a technology company.
Interestingly,
last year, Allergan CEO Brent Saunders had won accolades for
condemning predatory drug pricing by the likes of Martin Shkreli and emphasized the company’s commitment to research and development.
This week, in a Federal District Court in
Marshall, Texas, Mylan challenged Allergan’s move. Netherland headquartered Mylan, in its court filing stated that Ireland headquartered Allergan is “attempting to misuse Native American sovereignty to shield invalid patents from cancellation.”
Biocon’s Malaysia facility gets EU nod; Dr Reddy’s gets six major observations
Biocon, India’s leading biopharmaceutical company, had some good news to share, after its recent setbacks related to its biosimilar program. Its insulin facility in Malaysia — Biocon Sdn Bhd — received an EU GMP compliance certificate
from the
HPRA (Ireland), the representative European inspection authority.
Biocon Malaysia is “one of Asia’s largest state-of-the-art integrated insulins manufacturing facilities, set up with an investment of about US$ 275 million, at the BioXcell Biotech Park in Johor, Malaysia,” Biocon said in a statement.
Dr Reddy’s Vizag plant:
Indian pharma major Dr Reddy’s said its plant in
Vishakapatnam (India) has been issued
six major observations related to good manufacturing practices (GMP) by the regulatory authority of Germany — Regierung von Oberbayern.
In a statement issued to the Bombay Stock Exchange last week, the company said: “This is to inform you that on 7th September, 2017, the Regulatory Authority of Germany, concluded an audit for our formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations.” Products manufactured at this facility are not currently exported to the EU.
The
company will be submitting a Corrective and Preventive Action plan (CAPA) to
the authorities, the company added. The Duvvada facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of its
EU-GMP certification, the
statement added.
Meanwhile,
Cadila Healthcare received zero observations from the USFDA for its Moraiya plant, situated in Gujarat
(India). The FDA has issued zero observations for the unit after its
re-inspection this year.
Opioid crisis: Leaked audio reveals how Insys lied to a patient who didn’t have cancer
In
the United States, an explosive audio revealed how opioids were being given by a drug company to a patient who didn’t have cancer. The audio was released by Senator Claire McCaskill’s office last week. It explains how many in America had been victims of the opioid crisis.
According
to Business Insider, the audio is a phone call between an employee from Insys, the Arizona-based maker of Subsys (an opioid pain medication given to cancer patients), and a pharmacy benefit manager (PBM).
In
the US, PBMs are supposed to ensure that everyone who gets Subsys has cancer.
But the patient in question, Sarah Fuller, didn't have cancer.
An
Insys employee tried to convince Fuller she had cancer, and succeeded. Fuller
eventually died of a Subsys overdose on March 25, 2016.
The audio accompanies a report from McCaskill’s office on the marketing and business practices of Insys. Since December 2016, several Insys executives, including a former CEO, have been arrested over the opioid issue.
German Merck hires JP Morgan to divest its consumer health
business
Germany’s Merck KGaA has hired JP Morgan to sell its consumer health business, which includes brands such as Seven Seas vitamins, the company said last week. The annual sales of Merck’s over-the-counter medicines and vitamin supplements are around US$ 1 billion.
The
divestment would help fund research into higher-margin prescription drugs,
Merck said. The business could be worth around US$ 4.5 billion.
According to news reports, Merck has already sounded out prospective buyers including Swiss food giant Nestle. Merck had held preliminary talks with Nestle in summer this year. Nestle reportedly favored a joint venture deal and no agreement could be reached.
According
to Euromonitor International, the global market for consumer health products is
worth around US$ 233 billion. Merck ranks 32nd in this sector, with a 0.4
percent share.
J&J
dumps hepatitis C drug development; Roche suffers R&D setback
Janssen Sciences Ireland UC, a unit of Johnson & Johnson, said it would discontinue further development of its hepatitis C
research, citing increased availability of a number of effective hepatitis C
therapies.
Its investigational hepatitis C treatment regimen — JNJ-4178 — is a combination of three direct acting antivirals. “The ongoing phase II studies with JNJ-4178 will be completed as planned, with no additional development thereafter,” Janssen said in a statement.
Roche
drug fails endpoints:
Roche said its drug for geographic atrophy — lampalizumab — failed in first of two late-stage studies.
Lampalizumab was once considered a potential mega-blockbuster that could bring
in US$ 6 billion a year.
Lampalizumab did not reduce mean change in geographic atrophy lesion area compared to a placebo at one year (48 weeks). Given the lack of efficacy, “further dosing in patients will be interrupted until the results from the second Phase III study are evaluated,” Roche said.
Impressions: 3145
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#PharmaFlow by PHARMACOMPASS
14 Sep 2017
After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines.
This
week, PharmaCompass, shares its analysis of the new drug approvals by the FDA
in 2016.
Reasons behind the low approvals in 2016
Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications.
The 9
orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013.
The
reasons for the low 2016 approval count, have been attributed to the agency
approving five drugs in 2015 that actually had approval action dates in 2016
and an increase in the number of drugs that the agency rejected.
A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Gilead’s Epclusa, the first
all-oral, pan-genotypic, single tablet regimen for the treatment of adults with
chronic hepatitis C virus (HCV) infection, is expected to become the most
profitable approval of 2016 with expected sales of $ 8.4 billion by 2022.
2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States.
Approvals of three biosimilars which
target $ 33 billion in brand drug sales
In a
giant leap for the generic pharmaceutical industry, three biosimilar
applications were approved in 2016 that target brand drugs which generated more
than $ 33 billion in sales last year.
All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions.
Pfizer and Celltrion’s Inflectra, a
biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016.
After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $
9.1 billion).
On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Kim Kardashian’s pregnancy drug is now available in a new strength
Diclegis,
a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines
when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’
Duchesnay,
the company which produces Diclegis, got approval for Bonjesta which combines twice
the amount of doxylamine and pyridoxine when compared with Diclegis which contains
10mg of each ingredient.
Indian generic companies get approvals for
differentiated products
As the
generic industry in the U.S. continues to face severe pricing pressure, Indian
generic companies are attempting to overcome these challenges by trying to move
up the value chain by supplying differentiated generic products.
Consistent
with this strategy, the applications of Sun Pharmaceuticals
for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory
for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Pfizer launches an opioid treatment with
abuse-deterrent properties
The abuse
of opioids, including prescription painkillers and drugs like heroin, is
something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release
opioid painkillers such as oxycodone and fentanyl will have to
carry a "black box" warning
about the risk of abuse, addiction, overdose and death.
Pfizer
got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are
expected to reduce abuse when crushed and administered by the oral and
intranasal routes.
In it,
the oxycodone releases slowly over several hours. If the capsules are crushed,
the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric
effects.
Pfizer
also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
A dietary supplement gets approved along with new forms of commonly used drugs
In 2016, Endoceutics
got Intarosa, a once-daily vaginal insert, approved which is the first FDA
approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA).
Although
DHEA is included in some dietary supplements, the efficacy and safety of those
products have not been established for diagnosing, curing, mitigating, treating
or preventing any disease.
Lisinopril, the most commonly used drug
by U.S. Medicare patients, was approved as an Oral Solution for the first time.
Diabetes
treatments, one of the most commonly prescribed drug categories in the U.S., saw
the addition of Sanofi and Novo Nordisk’s fixed-dose,
long-acting insulin and glucagon-like peptide 1
(GLP-1) agonist combinations to the list of options available to treat adult
type-2 diabetes.
Our View
The approval
of new drugs ensures that the world has access to improved healthcare solutions
and breakthrough medical therapies.
With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug
approval scenario will be shaken up for time to come.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Impressions: 14460
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#PharmaFlow by PHARMACOMPASS
09 Feb 2017
FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution
This week, Phispers brings you news about Wockhardt and how its
turnaround plans are going awry. There is also news about Novo Nordisk ending
development of an oral form of insulin, data manipulation at Beijing Taiyang,
the latest on treatment of high cholesterol and lots more.
Novo ends
development of oral insulin, slashes long term growth forecast
Novo Nordisk – the world’s biggest maker of insulin – slashed its long-term profit-growth forecast by half due to pressure on prices in its largest market – the US. The company is also ending development of an oral form of insulin, which has long been an unattainable dream for the global
pharmaceutical industry.
The Danish pharma company will be relying
more on in-licensing early stage projects and working with external academic
collaborators. Moreover, the company will focus more on diabetes and obesity
adjacent conditions such as nonalcoholic steatohepatitis (NASH), cardiovascular
disease and chronic kidney disease.
In the US, Novo is experiencing payer
difficulties that have resulted in disappointing performance of its modern
insulins. The profit-growth estimate was trimmed to 5 percent from the 10 percent projected in
February this year, as it lost key contracts. The company also saw some
products being excluded from insurance-coverage plans as it promised large
rebates in the US on 2017 prices.
While Novo controls almost half the
global market for insulins, the intermediaries who negotiate prices for insured
patients in the US are opting for cheaper alternatives.
Lower prices and escalating competition
from biosimilars have dimmed prospects for Novo, Sanofi and Eli Lilly & Co.
These pharma companies have been forced to deepen rebates and discounts.
Systemic data
manipulation uncovered at Chinese API manufacturer
The
FDA has issued a warning
letter to Beijing Taiyang Pharmaceutical Industry, a manufacturer of active pharmaceutical ingredients such as diphenyhydramine hydrochloride, a commonly used ingredient in cold preparations.
The warning letter states that FDA investigators “observed systemic data manipulation across the facility.” The investigators documented “unexplained deletions of laboratory test results, discovered that analysts repeated tests until they obtained acceptable results and that the company failed to investigate results that were out-of-specification.”
The
FDA investigators
observed, through a window, a warehouse containing numerous drums bearing the company’s label. “When the investigators
requested access to this warehouse, Beijing Taiyang’s staff barred them from
entering the warehouse to examine the containers,” the letter adds.
The following
day, when FDA investigators were given access to the warehouse, they observed
that a significant number of drums had been removed and were not available for
inspection. The firm also relied on falsified and manipulated test results to
support batch release and stability data.
The FDA had
placed Beijing Taiyang on its import alert list in April of this year.
Wockhardt’s compliance foibles haunt biotech startup Cempra
Wockhardt’s
ambitious turnaround plans received a serious setback last week when Cempra, a
clinical-stage pharmaceutical company focused on developing antibiotics, learnt
that the US Food and Drug Administration (FDA) may not allow it to use an active
pharmaceutical ingredient (API) produced by Wockhardt for approval and in the
commercial use of its product Solithromycin.
Two of Cempra’s products are in advanced clinical development. One of them – Solithromycin – has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP). Its applications for approval have been accepted by the FDA and the EMA.
The setback to Cempra was the result of an
in-person meeting held with the FDA in late October. The reason for the FDA
decision was an import alert placed on a Wockhardt manufacturing facility in August 2016, several months after Cempra’s New Drug Applications (NDA) with Wockhardt had been submitted and accepted for review by the FDA. Cempra began an active dialog with the FDA to determine if the API produced at Wockhardt prior to the import alert was adequate for the NDA.
While Cempra plans to provide the FDA with data from API sourced from another supplier, the news is a serious setback for Wockhardt’s ambitious turnaround plans to fix its compliance issues and become an antibiotic research powerhouse.
Sanofi-Regeneron’s potential blockbuster runs into manufacturing problems
Last week, Sanofi and Regeneron Pharmaceuticals’ Sarilumab – a product in development for the treatment of moderately to severely active rheumatoid arthritis (RA)—received a setback. The two companies announced that the
US FDA has issued a Complete Response Letter (CRL) regarding the Biologics
License Applications (BLA) for Sarilumab.
The CRL refers to certain deficiencies identified during a routine
good manufacturing practice (GMP) inspection of the Sanofi facility in Le Trait
(France) where Sarilumab is filled and finished. Satisfactory resolution
of these deficiencies is required before the BLA can be approved.
However, Sarilumab performed extremely well in a head-to-head
clinical study against AbbVie’s world best-selling drug, Humira.
The manufacturing glitch was also the only negative in Sanofi’s better than expected earnings report which was released last week in which Sanofi announced that it would exit its European generics business in the next 12 to 24 months.
Cholesterol woes: Raising HDL can’t save you, and new drugs don’t work.
Last year, two new drugs – Rephata and Praluent – that lower cholesterol, came on the market. Back then, analysts had estimated sales of more than US $ 3 billion a year. Working by blocking a protein called PCSK9, the drugs would clear out LDL, or bad cholesterol.
While Sanofi and Regeneron launched Praluent, which is said to succeed where the traditional treatment – an inexpensive class of drugs called statins – fails, Amgen launched Rephata with a similar mechanism of action.
A year on, doctors are reluctant to write prescriptions until they
are sure of the benefits. Similarly, insurers are unwilling to pay for these
drugs.
“These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” Geoffrey Porges, a biotech analyst at Leerink, an investment bank specialising in healthcare told STAT News.
There was more bad news for patients suffering from high
cholesterol. A study
published this week has found little evidence that raising HDL, widely known as
good cholesterol, protects against heart attacks and strokes.
The study was published in the Journal
of the American College of Cardiology. The drug industry has repeatedly failed to design a pill that might improve patients’ lives by increasing HDL.
A decade ago, Pfizer spent more than US $ 800 million to get the
HDL-boosting medication torcetrapib into
late-stage trials, only to find that more patients died on the drug than on
placebo. Roche was next to fail when its drug, dalcetrapib, came up
short in a 16,000-patient trial in 2012. And last year, Eli Lilly shut down a
study testing its evacetrapib on 12,000 patients after discovering that the
drug had no effect on heart attack and stroke.
Pfizer fined for violating environmental laws in the US
For the second time in recent years, Pfizer has been fined by the American authorities for violating the
Clean Air Act at a manufacturing plant in Barceloneta, Puerto Rico.
Pfizer
was fined US $ 190,000 for failing to disclose information about hazardous
chemicals that were used at the concerned plant.
In early 2014, the Environmental Protection Agency (EPA) had found that Pfizer stored certain substances — in this case, ammonia and methylamine — that exceeded permitted amounts. This triggered a requirement to file a plan, which Pfizer failed to do and had to be fined. The substances were also used without properly being disclosed to the EPA.
Pharmexcil refutes report on drug-resistant
bacteria
Growing
antimicrobial resistance (AMR) is one of the gravest threats to human health.
Global deaths because of drug-resistant infections are projected to reach 10
million per year by 2050, with cumulative economic losses of US $100 trillion.
A new report by campaigning organisation – Changing Markets – titled ‘Superbugs in the Supply Chain - How pollution from antibiotics factories in India and China is fueling the global rise of drug-resistant infections’ has revealed
the presence of drug-resistant bacteria at pharmaceutical manufacturing sites
in India.
On-the-ground research and analysis of water samples found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai. Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics, the report says. At four of the sites, resistance to three major classes of antibiotics was detected, including antibiotics of ‘last resort’, those used to treat infections that fail to respond to all other medicines.
The report says antibiotics manufactured at or near these sites are being exported to United Kingdom’s National Health Service (NHS), French hospitals, and pharma majors including US distribution giant McKesson and French company Sanofi’s generics arm Zentiva.
The report cites
Hyderabad-based Aurobindo Pharma as one of the worst offenders. However, Pharmaceuticals Export Promotion Council of India (Pharmexcil), which is part of India’s ministry of commerce, has termed the report as “fabricated” and “backed by vested interests” to malign the Indian pharma industry—the world’s largest producer of antibiotics.
Aurobindo Pharma’s wholetime director M Madan Mohan Reddy is the chairman of Pharmexcil.
EMA probes Wanbury Pharma; French agency ANSM warns about fake GMP certificates
Mumbai-based
drug manufacturer Wanbury Pharma, which is one of the largest exporters
of diabetes drug metformin, had been served a show-cause notice by the Maharashtra Food and Drug Administration
last week for allegedly re-labelling its drugs that were being exported to
Brazil, Mexico, Bangladesh and Pakistan.
Wanbury has now
come under the lens of the European Medicines Agency (EMA). The EMA is learnt
to be investigating the allegations made by the Maharashtra FDA.
Meanwhile, the
ANSM (French agency for the safety of health products) has been informed of the
use of several falsified GMP certificates under its letterhead for import and export activities of active substances. “Because of a recent increase in observed cases, the ANSM reminds stakeholders that the authenticity of GMP certificates should be checked on EudraGMDP Community database,” the ANSM website says.
Teva
takes a shot at delaying generic Copaxone by writing to FDA
Teva Pharmaceutical has submitted a document to the US FDA explaining
the differences between its original multiple sclerosis drug Copaxone and the generic
product being marketed by Momenta and Sandoz.
In order to enter the
market, the generic version of Copaxone requires both FDA approval and legal
confirmation that it does not violate Teva's patent.
According to analysts,
the document is designed to delay the entry of a 40-mg generic version of
Copaxone into the market (20mg generic Copaxone is already on the market). The
document is also likely to undermine the confidence of FDA officials, leading
to considerable delay in approval of the Momenta's generic drug for 40 mg
Copaxone.
Teva is currently in a
court case concerning the patents that protect Copaxone against generic
competition (for the 40mg version). However, most analysts believe Teva will
lose the case, and that the generic product will be allowed to enter the market
in 2017.
Former Valeant CEO and CFO being probed for accounting fraud
In the US, an ongoing criminal probe into Valeant Pharmaceuticals is focusing on the extent to which the former chief executive officer – Michael Pearson – and former chief financial officer – Howard Schiller – allegedly hid a relationship with a specialty pharmacy – Philidor Rx Services – from insurers.
Pearson was the key
driver behind Valeant’s growth, which relied
on price-gouging as a growth strategy. Pearson bought older medicines and hiked
their prices manifolds to push up profits.
Federal prosecutors are reportedly exploring potential charges of accounting fraud in connection with Valeant’s ties with Philidor Rx Services, a Bloomberg news report said. Valeant used its ties with Philidor to steer
prescriptions and boost reimbursements for its medicines.
For now, the probe is
examining actions taken by Pearson and Schiller, though sources say others,
such as Philidor executives, may also be charged.
Impressions: 4715
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#PharmaFlow by PHARMACOMPASS
03 Nov 2016
Each year,
the US Food and Drug Administration (FDA) approve hundreds
of new medications. A small subset of approvals, classified as novel drugs, are considered to
be truly innovative products that often help advance clinical care.
In 2015, the
FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).
This week, PharmaCompass focuses on the new dosage
forms of existing drugs that got approved last year.
Modified blockbusters
Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:
Jadenu (deferasirox): With
almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a
tablet for use in a suspension. Novartis, the innovator,
got approval in March 2015
for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation
of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has
simplified daily treatment administration for patients with chronic iron
overload.
Nexium
24HR (esomeprazole magnesium): Also
known as the Purple Pill, Nexium – Astra
Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as
Nexium 24HR. Last year, the FDA granted approval to the tablet form of the
drug.
Iressa
(gefitinib): AstraZeneca re-introduced Iressa in
the US market in 2015. The
FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved
as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets
from the market, as post-marketing studies had failed
to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted.
Onivyde (irinotecan): Liposomal formulation of anti-cancer
drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the
treatment of patients with metastatic pancreatic cancer, sold under the brand
name Onivyde.
Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines
because of its high price (more than US $ 300,000 a year). Price concerns
aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.
Extended release versions
Many of
the approvals granted by the FDA last year were to extended release
formulations (a pill formulated so that the drug is released slowly) of
existing drugs.
Kremers Urban’s
extended release version of Methylphenidate
capsules made headlines last year because of a reclassification of the drug by
the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may
not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc.
In
addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus
and Morphine Sulphate also received green signals for a market launch.
First generic opportunities
Last year, PharmaCompass
shared the names of some drugs which had no generic competition and were also
not protected by patents. (Read: “Litigation Free, first generic opportunities list”).
Deferiprone (a drug that chelates iron and is
used to treat iron overload in thalassemia major) met the criteria. But it still
has no generic competitor and is now available as a new dosage form.
Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades
without generic competition in the US. Albendazole is a medication used for the
treatment of a variety of parasitic worm infestations. In 2015, patients were
provided access to chewable tablets of Albendazole.
New combinations at work
The FDA also approved
multiple combination drugs where the individual active ingredients had been brought
to market previously.
Most of the combination drugs
approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc.
Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and
Tradjenta (linagliptin) approved in 2011, were
combined and the combination drug product Glyxambi was approved in 2015. Another
combination of empagliflozin, with metformin – Synjardy – was also approved in August last
year.
Lesser known companies also
got combination drugs approved. UK-based
development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine
polistirex.
Similarly, US-based biopharmaceutical startup, Spriaso LLC, also
working in the cold and cough therapeutic area, got an extended release tablet
containing codeine phosphate and chlorpheniramine maleate approved.
Symplmed, a company which is
developing various forms of Perindopril, got approval for Prestalia (a
combination of perindopril arginine and amlodipine besylate) for the
treatment of hypertension.
Our view
Each year, the FDA approves several
pharmaceutical drugs in order to improve patient care; and often versions of
these drugs are marketed and distributed across the globe.
PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy.
Accelerate your drug development
PharmaCompass has also launched
the Drug Development Assistance tool on its platform.
Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate
the various drug products approved in the United States.
Impressions: 5419
https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs
#PharmaFlow by PHARMACOMPASS
14 Jan 2016
We always knew math was fuzzy, but never imagined addition could get so
complicated.
A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best
selling products along with the top therapy areas.
The list, based on data published by IMS Health,
caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical
companies.
As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics.
Which pharmaceutical company is the largest?
Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.
Should divisions like diagnostics, animal health, vaccines, consumer
health be counted when determining the size of a pharmaceutical company?
FiercePharma, in their analysis, used the total
revenue of all divisions of the organizations to determine the largest
organization; in their case it is Johnson & Johnson.
IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest
company.
As currency exchange rate fluctuations have their own, big role, in
determining the size of organizations, we believed it would be best to share
the revenues, as presented, so that you can draw your own conclusions.
Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)
Big Pharma
IMS Rank
IMS Sales
(US $Mn)
Fierce Pharma Rank
Fierce Pharma Sales (US $Mn)
Group Sales based on the Annual Report
(Currency as reported, Mn)
Novartis
1
51,307
2
57,996
USD
57,996
Pfizer
2
44,929
4
49,605
USD
49,605
Sanofi
3
40,037
5
43,070
Euro
33,770
Roche
4
37,607
3
49,866
CHF 49,866
Merck & Co
5
36,550
6
42,237
USD
42,237
Johnson &
Johnson
6
36,422
1
74,331
USD
74,331
AstraZeneca
7
33,313
8
26,095
USD
26,095
Glaxo SmithKline
8
31,470
7
37,960
GBP
23,006
Teva
9
26,001
11
20,272
USD
20,272
Gilead Sciences
10
23,673
10
24,474
USD
24,890
Amgen
11
20,473
12
20,063
USD
20,063
Lilly
12
19,909
14
19,615
USD 19,615
AbbVie
13
19,049
13
19,960
USD
19,960
Bayer
14
18,347
9
25,470
Euro
42,239
Bristol-Myers
Squibb
Not
in Top 20
15
15,879
USD
15,879
NB: Mn is million
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Since each group has multiple divisions, we further split the sales for
you to brainstorm:
Table 2/ Sales comparison of the different divisions of top
pharmaceutical companies in 2014 (Annual Reports in Mn)
Big Pharma
Pharma Division
Vaccine Division
Generics
Consumer Health
Other Divisions
Medical Devices/ Diagnostics Division
Animal Health Division
Divestures/ Other adjustments
Novartis
USD 31,791
Sandoz USD 9,562
Alcon USD 10,827
USD 5,816
Pfizer
USD 45,708
USD 3,446
USD 451
Sanofi
Euro 22,578
Euro 3,974
Euro 1,805
Euro 3,337
Euro 2,076
Roche
CHF 38,969
CHF 10,897
Merck & Co
USD 30,740
USD 5,302
USD 6,195
Johnson &
Johnson
USD 32,313
USD 14,496
USD 27,522
AstraZeneca
USD 26,095
Glaxo SmithKline
GBP 18,670
GBP 4,336
Teva
USD 10,458
USD 9,814
Gilead Sciences
USD 24,474
USD 416
Amgen
USD
19,327
USD 736
Lilly
USD 16,481
USD 788
USD 2,346
AbbVie
USD 19,960
Bayer
Euro 12,052
Euro 7,923
Euro 22,264
Bristol-Myers
Squibb
USD 15,879
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Not sure that it adds any extra clarity on what should define a global pharmaceutical company…
Since the various divisions make
companies complicated to assess, what about product sales?
The good news is that we have a winner!
Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason.
Unfortunately, things stopped making sense the moment we reached the
number-two product on the IMS list. Lantus®,
Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.
So unless the Euro/Dollar exchange rate moves back towards the 1.5
range, there seems to be a serious difference in the way the product sales are
calculated by companies and by IMS.
Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications!
Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports)
Products
IMS Rank
IMS Sales (US $Mn)
Annual Reports Sales (US $Mn)
Pharma
Compass Rank
Big Pharma
Currency
Annual Reports Sales in Mn
Marketing Partner
Marketing Partner Annual Report Sales
(US $Mn)
Humira®
1
11,844
12,543
1
Abbvie
USD
12,543
Lantus®
2
10,331
7,676
5
Sanofi
Euro
6,344
Sovaldi®
3
9,375
10,283
2
Gilead Sciences
USD
10,283
Abilify®
4
9,285
7,556
6
Bristol
Myers-Squibb
USD
2,020
Otsuka
5,536
Enbrel®
5
8,707
8,538
4
Amgen
USD
4,688
Pfizer
3,850
Seretide®
6
8,652
6,589
8
GSK
GBP
4,229
Crestor®
7
8,473
5,512
11
AstraZeneca
USD
5,512
Remicade®
8
8,097
9,880
3
Johnson &
Johnson
USD
6,868
Merck & Co.
2,372
Mitsubishi
Tanabe
640
Nexium®
9
7,681
3,655
19
AstraZeneca
USD
3,655
Mabthera®
10
6,552
6,936
7
Roche
CHF
5,603
Roche
1,305
Avastin®
11
6,070
6,449
9
Roche
CHF
6,417
Lyrica®
12
6,002
5,168
12
Pfizer
USD
5,168
Herceptin®
13
5,564
6,306
10
Roche
CHF
6,275
Spiriva®
14
5,483
3,917
17
Boehringer
Euro
3,237
Januvia®
15
4,991
3,931
16
Merck & Co.
USD
3,931
Copaxone®
16
4,788
4,237
14
Teva
USD
4,237
Novorapid®
17
4,718
2,835
20
Novo Nordisk
DKK
17,449
Neulasta®
18
4,627
4,596
13
Amgen
USD
4,596
Symbicort®
19
4,535
3,801
18
AstraZeneca
USD
3,801
Lucentis®
20
4,437
4,152
15
Novartis
USD
2,441
Roche
1,711
Click here to access and download all
the 2014 data (Excel version available) for FREE!
It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view.
Our take:
With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing
upon and others, which may not be worthwhile to pursue.
While the assessment of pharmaceutical sales is far more complicated
than what we had originally imaged, the focus of Big Pharma on small molecules
is on Hepatitis C drugs (Sofosbuvir, Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments.
Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports)
Products
Big Pharma
Sales (US $Mn) 2013
Sales (US $Mn) 2014
Growth (%)
Ibrutinib
Pharmacyclics,
Inc
(now
AbbVie)
14
492
3414%
Dasatinib
Bristol-Myers
Squibb
1280
1493
17%
Trametinib
GSK
10
68
580%
Nilotinib
Novartis
1266
1529
21%
Ruxolitinib
Novartis
163
279
71%
Ceritinib
Novartis
Not
launched
31
Sunitinib
Maleate
Pfizer
1204
1174
-2%
Crizotinib
Pfizer
282
438
55%
Axitinib
Pfizer
319
410
29%
Tofacitinib
Citrate
Pfizer
114
308
170%
Click here to access and download all
the 2014 data (Excel version available) for FREE!
However, Big Pharma is now all about biologics.
IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.
The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis).
Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!
Impressions: 12778
https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue
#PharmaFlow by PHARMACOMPASS
23 Apr 2015
