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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Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
At PharmaCompass, we highlighted
the significance of India in the global active pharmaceutical ingredient (API)
supply chain last week with our list of generic drug facilities registered with
the US Food and Drug Administration (FDA).
Our compilation revealed that India had
182 generic drug facilities registered with the FDA and this number was nearly
as much as the corresponding numbers for China (100) and United States (84) put
together. These 182 facilities paid a fee of US$ 59,400 each to the FDA.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
This week, we review the API Drug Master
Files (DMFs) submitted to the FDA in 2019. Expectedly, India also led the DMF submission list.
In 2019, there were 616 active DMF submissions
to the FDA with Indian companies submitting more than half (331) of them.
Submissions from India were a little less than double the number of DMF
submissions made by Chinese (113) and the US (57) firms put together.
Drug master files (DMFs)
are submissions made to the FDA by manufacturers by providing the agency with
confidential, detailed information about facilities, processes, or articles
used in manufacturing, processing,
packaging, and storing of human drug products.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
MSN Labs
leads total count of DMF filings
The 616 active DMF filings to the FDA were quite diverse — they covered over 400 products, and over half (322) the filings were for unique products.
Among the products with multiple DMF
filings, Sugammadex Sodium topped the list as it had 18 DMF
filings. Sugammadex is the API used in Merck’s Bridion for the
reversal of neuromuscular blockade induced by rocuronium and vecuronium in
general anesthesia.
The other products with over five DMF
filings were for the APIs of Lundbeck and Otsuka’s antipsychotic drug Brexpiprazole, Novartis, Gilead and Intercept’s blockbuster products Sacubitril-Valsartan, Tenofovir Alafenamide Fumarate and Obeticholic Acid.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
The year 2019 also witnessed continued
DMF filings for Rivaroxaban, Sitagliptin Phosphate, Ticagrelor and Tipiracil Hydrochloride. These filings indicate that the
companies currently developing these products should brace themselves for
intense competition in the near future.
India’s MSN Labs continued to lead the count of total DMF
filings with 42, of which it had 17 filings where it was the only one
submitting a DMF for a specific product in 2019. The leading Chinese company
filing DMFs was Fuxin Long Rui Pharmaceutical with nine DMFs, followed by Brightgene Bio-Medical Technology Co with five.
The API DMF is part of
the final generic drug product submission to the FDA. Therefore, the owner of a
DMF incurs a one-time fee (US$ 55,013 for FY2019, US$ 57, 795 for FY2020) the
first time the generic drug submission references that DMF.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
DMF holders may also pay
the fee in advance in order to have their DMF subjected to an initial
completeness assessment by the FDA. This would allow their DMF to be included
on a publicly-available list of DMFs that have paid their fee and not
failed the initial completeness assessment.
Aurobindo, Sun, Lupin lead DMF assessments
While reviewing the DMF submissions made in 2019, we found that a third (209 out of 621) of the DMFs were listed on FDA’s publicly-available list of DMFs that have paid their fee and whose initial assessment had been completed. This indicates that either companies may have been unwilling to pay the fee or the FDA’s review process found shortcomings in their applications.
Major Indian generic drug companies like Aurobindo (16), Sun Pharmaceuticals (13), MSN Labs (12), Lupin (7) and Macleods (7) led the list of companies that had
the maximum DMF assessments completed for their 2019 submissions.
There are also DMF submissions for
products which can sometimes indicate future drug approvals.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
Sanyo Chemicals submitted a DMF for Ibudilast, an anti-inflammatory drug whose oral
capsules are used in Japan for the treatment of asthma and its ophthalmic
solution is used to treat allergic conjunctivitis. The product is currently not
approved in the United States.
New drug approvals in the future can also
be expected for Tertomotide, Omarigliptin, Estetrol Monohydrate, Abametapir, Pirenzepine, Cortexolone Proprionate, Lurbinectedin, Terlipressin, Ethyl Olivetolate, Remimazolam and Triapine. These products are currently under
clinical trials for a variety of indications.
Our view
After compiling the list of companies that have submitted DMFs to the FDA as well as the generic facilities that paid their user fees, it’s clear that the API industry is beginning to find a new equilibrium.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
Our compilations of the previous years
have shown that there is a steady decline in facility registrations and DMF
filings. Given the increasing costs involved, as well as scaled up regulatory
requirements, it seems that companies are becoming more selective in their
product development decisions and also their willingness to do business in the
United States.
While the number of Indian API facilities
registered with the FDA has remained relatively unchanged, the number of
Chinese sites that registered with the US has reduced by 35 percent over the
past five years.
Several factors are changing the landscape of the generic drug industry. For instance, environmental regulations in China are driving up the cost of raw materials. Quality issues — such as the valsartan impurities case — have increased regulatory scrutiny. Moreover, passing inspections continues to remain a challenge for many manufacturers. And generic drug product manufacturers are also facing margin pressures, which in turn is driving a lot of M&A activity. Given this scenario, the generic industry should brace itself for more challenges in 2020.
View FDA DMF Filings in 2019 (Power BI Dashboard, Free Excel Available)
Impressions: 8223
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-in-2019-india-maintains-bulk-drug-supply-supremacy-to-us
#PharmaFlow by PHARMACOMPASS
23 Jan 2020
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: 58406
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 the FY18 user fee schedule under GDUFA II, posted by the USFDA, with significantly higher fee for several applications. There is news on an old drug getting approved for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, and a new study revealed benefits of blood thinners — Xarelto and Brilinta. Meanwhile, Gilead acquired Kite Pharma to access a new kind
of cancer therapy. Read on.
USFDA announces generic user fees for FY18;
ANDAs, APIs, devices to pay higher fee
This week, the US Food and Drug Administration (FDA) posted
the FY18 user fee schedule for the
Generic Drug User Fee Amendments. Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) applications to market generic drugs, known as abbreviated new drug applications (ANDAs), will see fee increases of more than US$ 100,000 — from US$ 70,480 in 2017 to US$ 171,823 in 2018.
The fees were set based on
negotiations between the pharmaceutical industry and the USFDA as part of
a new five-year reauthorization
of the FDA user fee programs signed
into law earlier this month.
In the fee schedule, a US$ 15,000
foreign differential applies to all non-US facilities, for both finished dosage
form (FDF) and active pharmaceutical ingredients (API).
This is the first year when pure CMO
(contract manufacturing organization) facilities will pay a ‘reduced’ facility fee — one-third of the fee for a non-CMO.
This year an ANDA holder fee,
also known as program fee, was introduced. This fee has three tiers: entities that hold
20+ approved ANDAs, entities that hold six-19 approved ANDAs, and entities that
hold one to five approved ANDAs. ANDAs
pending approval are not added to this count, just as facilities that are only
referenced in pending ANDAs are not subject to a facility fee.
GDUFA II fee for FY 2018
in US dollar
One-time application fee
ANDA
171,823
DMF
47,829
Recurring fee for facilities
Domestic API facility
45,367
Foreign API facility
60,367
Domestic FDF facility
211,087
Foreign FDF facility
226,087
Domestic CMO facility
70,362
Foreign CMO facility
85,362
Recurring GDUFA program fee
(20+ANDAs) Large size operation generic drug applicant program
1,590,792
(6-19 ANDAs) Medium size operation drug applicant program
636,317
(1-5 ANDAs) Small business generic drug applicant program
159,079
The fee is applicable from
October 1, 2017, until September 30, 2018.
Decades old drug — amantadine — wins FDA approval to treat dyskinesia in Parkinson’s
Adamas Pharmaceutical got the nod from the USFDA last week to sell its therapy ADS-5102 — an extended-release version of the generic amantadine. The agency approved it for treatment of a side effect (dyskinesia) caused by a commonly prescribed Parkinson’s drug — levodopa.
Amantadine was able to beat a placebo in significantly reducing the side effects of levodopa. This
generic drug is already used off label for dyskinesia.
This is the first drug cleared by
the FDA to control levodopa-induced dyskinesia (LID). According to Adamas,
around 200,000 people in the US suffer from LID.
LID leads to involuntary movements, mostly non-rhythmic, purposeless and unpredictable, making life all the more difficult for a patient of Parkinson’s disease. The disease is progressive and debilitating, causing tremors, rigidity, extreme slowness of movement, impaired balance, and difficulties in swallowing and speaking.
After GSK, Novartis picks its chief digital officer from retail; Pfizer’s swanky new HQ
Last month, GlaxoSmithKline appointed former Walmart chief information officer — Karenann Terrell — as its chief digital and technology officer. And last week, Swiss drug major Novartis followed suit — it appointed Bertrand Bodson, who is currently the chief digital and marketing officer for Sainsbury’s
Argos retail chain,
as its new chief digital officer. Bodson will assume office on January 1, 2018.
These two appointments point to
the growing challenges drug companies face from the digital world. For
instance, mobile applications offer patients new ways to monitor their health. And clinicians increasingly communicate with their patients using the digital media. Bodson’s appointment is also an indication that Novartis intends to use
technology for nearly everything — from drug discovery to interactions between clinicians and patients around the world. Bodson’s job also entails automating business processes.
Bodson holds a degree from the Harvard Business School. He has also co-founded the social network site — bragster.com.
Pfizer’s new HQ in New York: Pharma giant Pfizer has chosen the skyscraper — The Spiral — for its new headquarters in New York. The Spiral is a 1,005-foot-tall office tower in the Hudson Yards district of Manhattan’s Midtown West.
According to New York Post,
Pfizer has taken up nearly 800,000 square feet of space in this
building. The 65-story, 2.85-million square-foot building is designed by Danish
architect Bjarke Ingels.
FDA approves first CAR-T therapy for cancer; Gilead bets big on it by acquiring Kite
California-headquartered
biopharma company Gilead Sciences is acquiring Kite Pharma for US$
11.9 billion. The
acquisition points to Gilead’s increased focus on a new kind of cancer therapy, known as chimeric antegen receptor (CAR) T-cell therapy (or CAR-T)
According to Gilead, Kite is an industry leader in cell therapy — a treatment that uses the patient’s own immune cells to fight cancer. Kite’s most advanced CAR-T therapy candidate, axicabtagene ciloleucel (axi-cel), is currently under priority review by the USFDA. The FDA has set a target action date of November 29, 2017 under the Prescription Drug User Fee Act (PDUFA).
For Gilead, Kite could bring in the much-needed growth. Gilead has been witnessing falling sales of its hepatitis C treatments. It generates most of its sales from anti-infective therapies. Therefore, the acquisition will diversify Gilead’s portfolio. It will also boost Gilead’s emerging oncology drug franchise.
For the biotech sector, this acquisition is a big endorsement of the immuno-oncology segment. CAR-T inhibitors allow doctors to create a “personalized” drug tailored to each cancer patient by harvesting their T-cells and modifying them in a laboratory to make them more efficient at combating and killing cancer cells.
Though critics say Gilead has overpaid for Kite, Gilead’s CEO, John Milligan, justified the purchase. “It is certainly our hope that as we are able to drive down manufacturing costs, and as or if these indications broaden to larger patient populations, that we would be able to drive down the prices over time through manufacturing efficiency,” he said.
“CAR-T has the potential to become one of the most powerful anti-cancer agents for hematologic cancers,” Arie
Belldegrun, president and CEO of Kite,
said.
Just days after Gilead’s announcement of its acquisition, the FDA approved Novartis’ Kymriah (tisagenlecleucel), the first CAR-T gene therapy, for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).
The list price of Kymriah is US$ 475,000 for a one-time
treatment.
Bayer-J&J, AZ post promising data on their blood thinners; AZ to
expand UK operations
At the annual meeting of the
European Society of Cardiology held in Barcelona
this week, studies brought to fore several benefits of blood thinners like Johnson
& Johnson and Bayer’s Xarelto, and AstraZeneca’s Brilinta.
A study published in the New
England Journal of Medicine revealed that the combination of a low dose of Xarelto and aspirin cut the risk of heart attacks by
14 percent, strokes by 42 percent, and death by 18 percent. Forty-one out of
every 1,000 people who took the Xarelto-and-aspirin combo would be expected to have a heart attack, stroke, or
heart-related death compared to 54 among those who got aspirin alone.
Next generation anticoagulants, such as Eliquis, had been giving Xarelto a run
for its money.
Similarly, a sub-analysis from
the Pegasus clinical trial, which first reported positive results in 2015, showed that AstraZeneca’s blood-thinner Brilinta cuts the risk of cardiovascular death by 29 percent in patients with a history of heart attacks who keep taking it beyond the standard 12-month initial period. The sub-analysis also showed a risk reduction of 20 percent in all causes of death.
The finding comes as a shot in
the arm for AstraZeneca, which had suffered several clinical failures last year.
AstraZeneca to invest in UK
facility: Meanwhile, AstraZeneca is making huge investments into its Macclesfield campus in England in order to ramp up production. This is Astra’s biggest manufacturing site. The investment — expected to run into tens of millions of pounds – is set to be announced soon.
This investment is likely to take investors by surprise. A month back, Astra’s CEO Pascal Soriot had said he is putting all capital investment decisions on hold due to the uncertainty around Brexit.
The decision comes amid calls for the UK government to do more to support the sector ahead of Brexit. Recently, drugmakers, including AstraZeneca, published a paper calling on the public sector to invest up to US$ 181 million (£140 million) in three new drug manufacturing “centers of excellence” to stimulate the industry and help reverse a long-term decline in UK’s drug exports.
Impressions: 2484
https://www.pharmacompass.com/radio-compass-blog/fda-announces-generic-drug-user-fees-for-fy18-gilead-acquires-kite-for-us-12-billion
#PharmaFlow by PHARMACOMPASS
31 Aug 2017
A review of the Drug Master Files (DMFs) submitted to the United
States Food and Drug Administration (FDA) from October 2016 to March 2017 (the
fourth quarter of 2016 and the first quarter of 2017) indicates an extremely
robust pharmaceutical industry in India. However, the filing make one question
an article we had carried earlier this month on the end of India’s pharma honeymoon.
India filed more than half the DMFs submitted
Indian companies filed more than half (176) of the 345 DMFs
submitted with the FDA. China (60) came a distant second, followed by the
United States (40). While DMF submissions were made from 26 other countries,
the activity levels seen were a far cry from what was seen in India and
China.
In our past compilation for the second and third quarters of 2016,
Macleods Pharmaceuticals (14 DMFs) had pipped MSN Laboratories (13 DMFs) to become the leading filer from
India.
However, in the recent review period, MSN bounced back with 41 DMF
submissions, compared to six for Macleod. Leading Indian pharmaceutical majors
such as Aurobindo,
Sun Pharma, Amneal,
Mylan’s
India operations, Hetero,
Cipla
and Jubilant
had six or more filings each.
Ajinomoto’s
North American operations filed 11 DMFs for various amino acids and led the
submissions for products manufactured in the United States.
Tianjin Weijie Pharmaceutical led the pack from China, with eight DMF
submissions.
Over the review period, a total of 345 submissions were made to the
FDA, almost similar to the 379 DMFs filed during the second and third quarters
of 2016.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
The next FTF challenges
Since APIs form the building blocks of finished formulations, DMF
submissions give a sneak preview into the next possible first-to-file (FTF)
generic challenges to patented drugs.
In
December 2016, Indian drug major Sun Pharmaceutical Industries
announced it will acquire a branded oncology product, Odomzo,
from Novartis
for an upfront payment of US$ 175 million.
A little over three months after the announcement, MSN Labs filed the first DMF for Odomzo’s active pharmaceutical ingredient (API), sonidegib phosphate. Odomzo was approved by the FDA in July
2015 and is indicated for the treatment of adult patients with locally advanced
basal cell carcinoma.
While patents for Novartis’ drugs Tafinlar
and Mekinist
are not scheduled to expire until 2029, Novartis should prepare for a generic
competitor as DMFs were filed for the APIs used in both drugs by MSN Labs. The
drugs had combined sales in 2016 of US$ 672 million.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
In addition, MSN Labs also filed the first DMF for nintedanib esylate, the API used in Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment,
Ofev, and for cabozatinib (S)-malate, the API used by Exelixis for its kidney cancer treatment — Cabometyx.
While in most cases MSN’s DMF is the first one to get filed, in the case of Helsinn’s
Akynzeo,
which is used to prevent chemotherapy-induced nausea and vomiting, Apicore US also filed a DMF along with MSN.
Although sales forecasts for Bayer’s pulmonary arterial hypertension treatment — Adempas (riociguat) — were lowered as the drug did not get the expected sales start
and planned label expansions did not materialize, this did not stop MSN Labs
from filing the first DMF for this product as well.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Another drug which is struggling to meet analyst expectations is Novartis’ Entresto. Once considered “one of the most important products in the company's history” with an expectation to reach US$ 10 billion in peak sales, the drug generated sales of only US$ 170 million in 2016. Regardless, Mylan filed the first DMF for the API.
Another drug where MSN Labs did not file the first DMF was for AstraZeneca’s
ovarian cancer treatment, Lynparza (olaparib).
Alp Pharm Beijing submitted the DMF for the drug which
generated US$ 218 million in sales in 2016 and a figure Bernstein Research
analyst Timothy Anderson forecasts will grow to US$ 684 million by 2020.
The onslaught on Novartis’ portfolio is not limited to only patented products as Lamprene,
a product which has been on the market since 1986, and not had any generic
competitor, had Zhejiang Huahai file a DMF indicating a generic competitor maybe on the horizon
soon.
Mylan’s Sotradecol
has been the only injectable form of sodium tetradecyl sulfate
on the market since 2004. That monopoly may end soon as the FDA completed the
review of a DMF filed for the API early this year.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Most actively filed products — vortioxetine hydrobromide and dolutegravir sodium
The most actively filed DMFs, with seven filings each, were those
for Takeda’s
depression drug Trintellix (vortioxetine hydrobromide) and GSK’s HIV treatment dolutegravir sodium.
Johnson & Johnson’s diabetes treatment Invokana (canagliflozin), which recently demonstrated that it
decreased the risk of heart attacks and strokes, while increasing the risk of amputation,
particularly of toes, had six new DMFs filed.
There were also six new DMFs filed for apremilast,
five for darunavir
and four each for dapagliflozin
and rivaroxaban.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Filings for new drugs under development
Helsinn is moving ahead with the filing of anamorelin hydrochloride, as it filed DMFs for the API and the 100
mg tablets, a product which was welcomed enthusiastically by oncology experts as it raised hopes to
be a drug for cancer cachexia, the extreme wasting seen at the end stages of
the disease.
But those hopes were recently dashed, as a review of the clinical
data by the European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) found only "marginal" effects and recommended that
the product be refused marketing authorization in Europe.
Now it remains to be seen what the FDA’s verdict on this drug will be.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
AB Science’s Masitinib has been in the news recently as an EMA committee announced the drug, developed for a range of cancers, could not be approved due to “serious failings” in the way clinical studies were conducted.
However, this did not stop Excella GmbH from filing its second DMF for the API.
Multiple sclerosis treatment dimethyl fumarate (Biogen’s Tecfidera) generated
sales of US$ 3.97 billion in 2016 and is projected to achieve US$ 5.56 billion by 2020.
While there are now 28 DMFs filed for dimethyl fumarate, in March
this year Alkermes
announced the initiation of a new phase 3 study
of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in
development for the treatment of relapsing forms of multiple sclerosis.
It remains to be seen when Alkermes’ product will get approved. However, MSN Labs followed Honour Labs to file the second DMF for this product.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
A new submission for deslorelin acetate
(an injectable gonadotropin releasing hormone super-agonist) indicates there
maybe a new drug development underway for this age-old peptide as currently
there are no approved drugs in the US.
A similar situation seems to exist for taurolidine,
an antimicrobial that seeks to prevent infections in catheters.
Vasudha Pharma’s filing of cisapride monohydrate comes as a surprise. The product, which
was launched by Janssen for increased motility of the
gastrointestinal tract, was later withdrawn from the US market due to concerns of
fatalities linked to cardiac arrhythmias.
The product, however, continues to be exported from India to
countries like Switzerland, Thailand, Mexico, China and Canada.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Our view
The last quarter of 2016 and the first quarter of 2017 clearly
demonstrate an API industry in India and China, which is extremely active with
new product development, regardless of disappointing financial results posted
by major pharma companies and growing concerns over regulatory non-compliances.
Given the market headwinds and increased compliance expectations,
it remains to be seen how many of these DMFs filed actually result in drugs
reaching the market.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Impressions: 5931
https://www.pharmacompass.com/radio-compass-blog/india-leads-dmf-submissions-to-the-fda-during-q4-of-2016-and-q1-of-2017
#PharmaFlow by PHARMACOMPASS
22 Jun 2017
Global
pharmaceutical companies are increasingly focusing on the development of new
biologics. In fact, in 2016, nine out of the top
15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder
what the future holds for manufacturers specializing in drugs that originate
from chemical synthesis.
This
week, PharmaCompass continued its analysis of the top pharma drugs by
sales to evaluate the drugs that registered large sales growth in 2016.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Please
note that these are not the top-selling drugs, but are the top 10 drugs that
registered the maximum growth in global sales over 2015.
Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.
Here’s a list of drugs that witnessed the largest sales growth in 2016:
1. Opdivo (nivolumab) – Bristol-Myers Squibb
2016
sales: US$ 3,774 million
2015 sales:
US$ 942 million
Sales
growth: US$ 2,832 million
First
approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer.
With
a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth
of any single drug in 2016. However, Bristol-Myers Squibb received a nasty
surprise last year when Opdivo did not demonstrate the desired slowdown in the
progress of advanced lung cancer in a trial, as compared to conventional
chemotherapy.
While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million.
Click here to Access All the 2016 Data (Excel version available) for FREE!
2. Humira (adalimumab) – AbbVie
2016
sales: US$ 16,078 million
2015
sales: US$ 14,012 million
Sales
growth: US$ 2,066 million
Abbvie’s Humira (adalimumab)
juggernaut continued as it not only remained the best-selling drug in the
world, but also added another US$ 2 billion to its 2015 sales by generating
record sales of US $16.078 billion in 2016.
Last
year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
3. Epclusa (sofosbuvir and velpatasvir) – Gilead
2016
sales: US$ 1,752 million (new launch)
Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion.
Click here to Access All the 2016 Data (Excel version available) for FREE!
4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie
2016
sales: US$ 3,083 million
2015
sales: US$ 1,443 million
Sales
growth: US$ 1,640 million
Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off.
The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which
is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally.
5. Eliquis (apixaban) -
Bristol-Myers Squibb / Pfizer
2016
sales: US$ 3,342 million
2015
sales: US$ 1,860 million
Sales
growth: US$ 1,483 million
Although
apixaban was the third-to-market
novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its
class based on total prescriptions. Rivaroxaban's total 2016 sales were US$
5.392 billion.
While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban.
6. Genvoya (elvitegravir,
cobicistat, emtricitabine, tenofovir alafenamide) — Gilead
2016
sales: US$ 1,484 million
2015
sales: US$ 45 million
Sales
growth: US$ 1,439 million
Genvoya has been the most
successful HIV treatment launch since the introduction of Atripla (the first
single-tablet regimen launched a decade ago). Gilead is the dominant HIV
player in the US market and has the top three most-prescribed HIV regimens in
the US.
Genvoya
adds Tenofovir Alafenamide (TAF) to already known
treatments. TAF based drugs have demonstrated a better safety profile. They
would also allow Gilead to maintain its dominance in the HIV market.
Click here to Access All the 2016 Data (Excel version available) for FREE!
7. Ibrance (palbociclib) — Pfizer
2016
sales: US$ 2,135 million
2015
sales: US$ 723 million
Sales
growth: US$ 1,412 million
Discovered
in Pfizer laboratories and approved by the US
FDA in February 2015, Ibrance is used in combination
with Letrozole as a first-line
treatment of postmenopausal women with estrogen receptor-positive, human
epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast
cancer.
8. Triumeq (abacavir,
dolutegravir, lamivudine) – GlaxoSmithKline
2016
sales:US$ 2,151 million
2015
sales: US$ 905 million
Sales
growth: US$ 1,246 million
GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine.
9. Revlimid (lenalidomide) – Celgene
2016
sales: US$ 6,974 million
2015
sales: US$ 5,801 million
Sales
growth: US$ 1,173 million
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 US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion.
10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer
2016
sales: US$ 5,392 million
2015
sales: US$ 4,255 million
Sales
growth: US$ 1,137 million
Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other
novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the
class lead in indications.
Xarelto
recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the
blood thinner in preventing major adverse cardiac events (MACE).
The
trial was stopped a year early
on the advice of an independent Data Monitoring Committee, after the primary
endpoint of prevention of MACE (which includes cardiovascular death, myocardial
infarction and stroke) reached its pre-specified criteria for superiority over aspirin.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Our
view
In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that
over the coming five years the industry should continue to receive 40 to 45 new
drug approvals every year.
A quarter of all the drugs in late-stage development are now
focused on oncology. The rate of oncology drug development has hit such a
rapid pace that new drugs are superseding old ones in a matter of a few years.
It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore.
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 2016 Data (Excel version available) for FREE!
Impressions: 9289
https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016
#PharmaFlow by PHARMACOMPASS
17 May 2017
This
week, Phispers brings you a short analysis on how FDA might be promoting
European drugmakers over others. There is also news on how India plans to set
up a drug audit office in China to check quality of APIs coming from there.
Besides, there is news on lawsuits against J&J, a report on drug spends in
the US and updates on new drug trials and approvals.
Does
the FDA promote European manufacturers over others?
Does
the US regulator have more faith on European manufacturers over those based in
India and China? Recent news reports seem to suggest it does.
Thomas Cosgrove, the Director of the Office of Manufacturing Quality (OMQ) within US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) spoke at the Food and Drug Law Institute's annual conference last week. Cosgrove directs CDER’s compliance activities with respect to current good manufacturing practice (cGMP) and product quality.
In
the coverage provided by RAPS, Cosgrove detailed some of the biggest challenges drugmakers face when contracting with foreign manufacturers. “If any firm in the supply chain falls down, the supply chain itself can fall down. This is a very real risk," Cosgrove said, noting that the agency can reject applications for drugs over good manufacturing practice (GMP) issues.
He further said: “You're pretty confident that those European companies you're dealing with have a strong culture of quality and can perform pretty consistently," But, like in other parts of the world, these companies might not have a deep experience with how the US regulations work or even how to deal with the FDA, and may not have been inspected by the agency before, he added.
Cosgrove’s comments come at a time when a compilation by Barbara Unger on FDAZilla.com highlighted that the warning letters issued
due to data-integrity concerns to firms in US and Europe (13 total) were more
than those issued to firms in India (9) and almost equivalent to firms in China
(14).
There
have also been other examples where inspection data highlights a difference in
inspection outcomes for the same facilities. PharmaCompass had recently covered the US and EU’s efforts to utilize each other’s GMP inspections, and how such a dependence maybe problematic.
While
FDA has stepped up its inspections of foreign drug manufacturers in recent
years, there are more than 1,000 foreign drug facilities the agency has never
inspected.
India
to restart inspection of Chinese API manufacturers
India
is cracking the whip on quality and will restart inspecting drug manufacturing facilities in China soon, in order to ensure only quality
active pharmaceutical ingredients (API) are imported from countries like China.
“In the light of the fact that India has faced repeated scrutiny of its manufacturing facilities in the name of quality medicines, the commerce ministry along with other concerned ministries are serious to set up a permanent audit office in China to conduct inspections on a regular basis in China,” G N Singh, Drug Controller General of India, said.
The
plan to set up a drug audit office in China for inspecting manufacturing units
there is not new. It has been in the pipeline for the past three years, as the
project is awaiting approval from several ministries in both India and China.
India’s health ministry is also in the final stages to release a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products.
The ice-bucket challenge
winner! First new treatment approved by the FDA for ALS in 22 years
Last
week, the US FDA approved Radicava (edaravone)
— a drug to treat patients with the rare amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig’s disease.
ALS is a progressive disease that attacks and kills the nerve cells that control voluntary muscles. Eventually, the brain’s ability to start and control voluntary movement is lost, and the patient succumbs to the disease — usually after three to five years from the onset of the symptoms.
Around
12,000-15,000 Americans are said to have ALS. Most people with ALS die from
respiratory failure. British physicist Stephen Hawking is suffering from ALS.
An “ice bucket challenge” conducted in 2014 drew global attention back to ALS. The challenge involved people pouring ice-cold water over each other’s heads, and posting a video on social media, seeking funds for research on the condition.
Edaravone
is an intravenous drug. The drug is being sold in Japan and South Korea by Mitsubishi Tanabe Pharma Corp.
The company is selling the drug at US$ 145,000 per year.
In
the US, the last drug approved to treat this disease was Riluzole in 1995. However, the drug isn’t a cure for ALS, it only delayed the need for a breathing tube. Six months of treatment with edaravone reportedly reduced the rate of functional decline in patients by about a third.
Another
bad week for Teva — its new MS drug fails to meet primary endpoint
Teva’s bad days don’t seem to relent. Last week, it’s late-stage
trial for laquinimod — considered a successor to the aging flagship multiple sclerosis therapy Copaxone — failed the test on the relapsing-remitting form of the disease.
The
drug did not meet the primary endpoint, trying to significantly improve the
time to disability progression compared to placebo after three months.
Teva’s laquinimod was heralded as its brightest pipeline prospect. Investigators are still testing this drug for primary progressive MS and Huntington’s disease. But due to this failure, it’s unlikely that analysts will ascribe much potential value to the drug.
Early last year, Teva (which had partnered with Active
Biotech) was forced to suspend use of
the highest dose of laquinimod due to cardio side effects. Despite this
setback, Teva was hopeful of a win with the lower doses and was preparing for a
launch after completing studies this year.
Trump
administration gets FDA to switch TVs from CNN to Fox News
The
Trump administration is ensuring researchers at FDA view the media of its
choice. This week, CBS News confirmed an email was sent to researchers at the
FDA's Center for Biologics Evaluation and Research to change the channel on
internal television screens from CNN to Fox News.
CNN and Donald Trump have been feuding for several months now. On May 2, CNN had refused to air an advertisement issued on 100 days of Trump administration, that called mainstream media “fake news” — a term frequently used by the president.
The email from “[White Oak] Digital Display” sent on Wednesday, May 3, was sent to inform the researchers of the “reason for the change from CNN to Fox". White Oak is the name of the FDA’s campus.
The email informs employees that the decision came from the Trump administration. “The reason for the change is that a decision from the current administration, administrative officials has requested that all monitors, under our control, on the White Oak Campus, display FOX news,” the email reads.
People
are paying less for drugs, says IMS
Quintiles report
While there
is widespread outrage in the US over soaring drug prices, a new study by
QuintilesIMS Institute shows people are, on an average, actually paying less for their medications than they did a
few years ago.
QuintilesIMS Institute is a research organization that specializes in
healthcare analysis. The report is independent, and did not receive
industry funding.
While drug prices are on the rise with net prices rising 3.5 percent last year, patients’ out-of-pocket costs for medicines have declined — from US$ 32 per name-brand prescription in 2013 to US$ 28 today, the study said.
“The outlook for medicine spending through 2020 is for mid-single digit growth driven by further clusters of innovative treatments, offset by a rising impact from brands facing generic or biosimilar competition,” says a QuintilesIMS report titled ‘Medicines Use and Spending in the U.S. – A Review of 2015 and Outlook to 2020’.
However, this isn’t the only report that shows this counterintuitive pattern of declining out-of-pocket costs. A Peterson-Kaiser Health System Tracker report last year found a slight decline in patients' personal spending on prescriptions, even as the overall costs increased.
Mixed
week for J&J, as it loses talc verdict and wins Xarelto case
Last week was a mixed week for Johnson & Johnson (J&J). On the one hand, the St. Louis jury
ordered Johnson & Johnson to pay US$ 110 million to Lois Slemp, a lady who claimed several decades of using talc products caused her ovarian cancer that later spread to her liver. On
the other hand, J&J won a bellwether case last week over the alleged risks
of its blockbuster drug, Xarelto.
The Slemp trial lasted several weeks and had Slemp’s attorneys call upon scientists to testify studies documenting a link between ovarian cancer and talc use.
Slemp’s attorneys also presented documents showing that J&J knew about the risks. J&J, however, said it will appeal against the verdict.
A company spokesperson said a previous victory (for J&J) in St. Louis and two in New Jersey “highlight the lack of credible scientific evidence behind plaintiffs’ allegations."
In the other case, a US court (the federal jury
in New Orleans) cleared Bayer AG and J&J of liability in the first trial emanating from thousands of lawsuits that blamed
injuries on the blood thinner Xarelto.
“The jury's verdict affirms both the safety and efficacy of Xarelto, and that its FDA-approved label contains accurate, science-based information on the benefits and risks of this life-saving medicine,” Bayer said in a statement.
Rivaroxaban's total 2016 sales were $ 5.392 billion.
Impressions: 3208
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#PharmaFlow by PHARMACOMPASS
11 May 2017
This week, Phispers highlights more bad news for Israeli drugmaker Teva, along with news on the ‘overwhelming efficacy’ of blood thinner Rivaroxaban over Aspirin, Sanofi’s plans to resubmit its application for Sarilumab, Denmark’s entry into the tug of war for hosting the EMA headquarters and are routine round up of global non-compliance concerns.
Teva CEO steps down, as
another bribery probe emerges and discussions of a split start
The chief executive of Teva Pharmaceutical Industries, Erez Vigodman, stepped down after serving for
three years. He has been replaced by Chairman Yitzhak Peterburg for the interim period. Teva is the world's biggest maker of generic
drugs.
In the last five years, he is the third CEO to vacate the position. A sudden change in the company’s leadership came just two months after the resignation of Sigurdur Olafsson, the former head of Teva’s main business unit — generic medicines. Both the executives played an important role in Teva’s US $ 40.5 billion purchase of Actavis Generics last year, touting it as a move that would provide growth.
Instead, the acquisition led to more bad news.
In a short statement after leaving, Vigodman stated: “I believe that now is the right time for me to step down. It has been a privilege to lead Teva, and I am proud of all we have accomplished. I am confident that the company’s future is bright.”
A lot of bad news has already piled up for Teva’s investors since the New Year. This includes the following negative events:
The market is criticizing Teva’s acquisition of Actavis (Allergan’s generics division) for US $ 40 billion in cash and shares.
Teva’s acquisition of Mexican company Rimsa proved to be a catastrophe. Rimsa's plants are now shut down.
Apart from the bad decisions over acquisitions,
Teva is also involved in two legal wrangles. One was a case of bribery in
developing countries, in which Teva agreed to pay US $ 519 million to US
authorities after paying bribes to officials in Mexico, Ukraine and Russia to
boost sales. Another legal issue
involves the investigation of Teva over bribe allegations by Israeli
authorities which came up a day after Vigodman stepped down.
A US district court ruling invalidated four patents out of five on its top seller — the multiple sclerosis drug Copaxone. The ruling, issued in late January, may open the door to generic
competition (Novartis and Mylan) for thr drug that generates a fifth of Teva’s US $ 20 billion in annual sales.
In the company’s own words: “New products stemming from that asset (Copaxone) would be unexpectedly delayed, while prices of its copycat medicines are likely to remain under pressure in the US, prompting a cut to its 2017 profit forecast.”
Following the resignation, at the company's earnings call
earlier this week, analysts started asking if Teva would consider a split-up?
FDA issues Warning Letters to
Indian, Japanese & Chinese firms
Sato
Pharmaceutical, a company established in 1939 in Japan, received a warning letter from the FDA as it failed to establish an adequate system for monitoring the conditions of its cleanroom environments. Following the inspection, the firm revised its standard operating procedure related to the “Aseptic Production Area”, however,
the FDA found the response to be deficient.
FDA inspectors also uncovered that the company had not
performed the necessary smoke studies to evaluate air flow characteristics of
its open Restricted Access Barrier System (RABS). The company released sterile
products manufactured on the aseptic processing line, without studies to
demonstrate unidirectional airflow over the exposed sterile product during
processing.
Although, Sato renovated its RABS to use a closed design and
conducted validation studies, the response was found deficient as it does not
address the quality of the products which had already been released
to the U.S. market using the original open RABS design.
An active
pharmaceutical ingredient (API) manufacturer in India, Resonance Laboratories Private Limited also
received a warning letter from the FDA as the inspectors
raised concerns over the facilities water systems and cleaning validation
methods.
The FDA found that the firm’s response to the inspection observations had failed to perform a retrospective review of CGMP deficiencies on the quality of the products which had already been distributed within the United States.
PharmaCompass
had shared the news about the compliance troubles at
Resonance in November, 2016.
The FDA also issued warning letters this week to two Chinese firms who
had been placed on its Import Alert list last year. The warning letters sent to
Ausmetics Daily
Chemicals (Guangzhou) Co., Ltd. and Zhejiang Bangli Medical Products Co., Ltd.
showed that the companies failed to sufficiently test the batches of the final
product they produced and did not adequately confirm the quality of the
incoming active raw materials.
Bayer’s Rivaroxaban shows 'overwhelming efficacy' over aspirin
Back in 1897, a young scientist at a Bayer laboratory in Wuppertal, Germany — Dr. Felix Hoffmann — synthesized a chemically pure and stable form of acetylsalicylic acid (ASA), which
became the active ingredient in Aspirin™.
Since then, Aspirin has been an important medicine due to its
remarkable pain relief, as well as cardiovascular (CV) event prevention
properties. The medicine has truly stood the test of time.
Last week, Bayer AG and its development partner Janssen Research & Development announced the successful outcome of a
large-scale Phase 3 study -- COMPASS, involving 27,402 patients, that assessed the
effect of blood thinner Xarelto (rivaroxaban)
in preventing major adverse cardiac events (MACE).
The trial was scheduled to finish next year but
was stopped early on the advice of an independent Data Monitoring Committee, after the primary endpoint of prevention of MACE — which includes cardiovascular death, myocardial infarction and stroke —reached its pre-specified criteria for superiority over aspirin.
The drug could potentially be used on 30 million
patients with coronary artery disease (CAD) and peripheral artery disease (PAD), in addition to the roughly 25 million patients
it sees in the atrial fibrillation market, says Bayer.
Xarelto is currently the only non-vitamin K
antagonist oral anticoagulant (NOAC) currently under assessment in this
high-risk patient population. The drug is already on the market for reducing the risk of stroke and blood clots.
Sanofi fixes problems
in French plant, to resubmit application for Sarilumab
In 2014 and 2015, while reviewing new drug
applications, the US Food and Drug Administration (FDA) had raised manufacturing questions in only one Complete Response Letter (CRL) sent to the applicant. However, by mid-December, 2016 “an astonishing 40 percent were specifically tied to questions the agency raised about the manufacturing capabilities of a drugmaker or its contractor.”
Manufacturing issues derailed sales forecasts through new drug
approvals of Sanofi, AstraZeneca, Valeant, Bristol-Myers Squibb, Pfizer and many others.
In October 2016, Sanofi received the FDA’s Form 483 for it’s Le Trait facility in France since manufacturing deficiencies were
discovered during a routine good manufacturing practice (cGMP) inspection where
Sarilumab and Dupilumab are manufactured.
This plant is involved in one of the last steps in the manufacturing process of Sarilumab — an investigational interleukin-6 receptor (IL-6R) antibody for the treatment of adult patients with moderate to severely active rheumatoid arthritis (RA) which is a combined program of Sanofi and Regeneron. Due to the manufacturing issues, FDA issued a CRL regarding
the Biologics License Applications (BLA) for Sarilumab.
Sarilumab is said to become a blockbuster after beating the world’s best-selling drug AbbVie's Humira (adalimumab) in a head-to-head trial. Analysts have previously
predicted the drug could bring in more than US $ 1 billion by 2020.
In response to the letter received from the FDA, the French company has filed a comprehensive corrective action plan with the FDA and is “working towards a timely resolution that addresses these concerns.” Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market.
In January 2017, Sanofi and its drug development partner Regeneron Pharmaceuticals said they have resolved manufacturing defects at Le Trait facility, which caused the delay for the approval of Sarilumab drug. Sanofi’s CEO Olivier Brandicourt said: “We worked closely with the US FDA to implement a corrective plan and got positive feedback".
Assuming the formal inspection will also play out
positively, the companies have decided to resubmit their application for
Sarilumab by the end of March.
Denmark
officially bids for relocation of EMA head office
The future location of the European Medicines Agency (EMA) — one of the regulatory jewels of the EU — has been a consistent topic of conversation since the outcome of the Brexit vote.
The intervention of the Japanese government in
early September 2016 brought the EMA issue further into the open when a 15-page letter came up where Japanese officials told their counterparts in the UK that if “the EMA were to transfer to other EU Member States, the appeal of London as an environment for the development of pharmaceuticals would be lost, which could possibly lead to a shift in the flow of R&D funds and personnel to Continental Europe.”
And now, Denmark is also in the list of countries that are bidding for EMA headquarters’ relocation. Copenhagen’s candidacy launch on February 8 comes in the wake of similar launches by
Amsterdam, Milan, Stockholm, Barcelona and Dublin. Only the Czech Republic and
Estonia have ruled themselves out, according to the Financial Times.
Therefore, we may see a 20-way tug of war amongst cities that want to host the EMA.
The Danish Medicines Agency is excited about the Danish government’s decision. Thomas Senderovitz, Director General of the Danish Medicines Agency, said: “The EMA is the most important European coordination forum in the pharmaceutical field, and Copenhagen offers a visionary and innovative life science cluster. Major international pharmaceutical companies have a presence in Copenhagen, and we offer a strong administration and unique culture for collaboration between the health sector and universities in Denmark and southern Sweden”. As the news came out, healthcare giant Novo Nordisk backed and supported the decision of the Danish Government.
India’s Strides plans to spin off API unit
Just two months after Perrigo agreed to sell its entire shareholding in Perrigo API India to Strides for INR 1000 million (US $14.8
million), Strides announced an organizational restructuring plan. As per the
plan, Strides has decided to move away from its business-to-business (B2B) model to a business-to-consumer (B2C) model, which
includes de-merging and listing its APIs business, exiting
probiotics and capping its investment in the biotech business which was also
approved by SeQuent Scientific, which bought into Shasun several years ago.
SeQuent also has a veterinary drug business. Strides Shasun plans to rename itself as Strides Pharma. Post restructuring, the new
Strides Pharma will comprise its retained formulations business having four US
FDA-approved plants in India, Europe and Singapore, and three research and
development (R&D) centers. This business will have a front-end presence in
the regulated markets of Australia, US and the UK and emerging markets of
Africa and India.
Last year, Strides Shasun had mentioned they plan to hive off its commodity focused API manufacturing unit as a separate business. Strides — with two API manufacturing facilities, one in India and one in the UK — is a global supplier of painkiller (Ibuprofen), anti-epileptic medication (Gabapentin) and anti-acidity medication (Ranitidine). Strides had said that it would retain API capacities required for
captive use while setting up a separate company for manufacturing low-margin APIs such as Ibuprofen, Gabapentin and Ranitidine.
Impressions: 5513
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#PharmaFlow by PHARMACOMPASS
16 Feb 2017
This week, the US Senate cleared the 21st Century Cures bill, touted as the most significant reform in medical treatments. Phispers also brings you news on a court order that reverses a ban on 344 fixed-dose combination drugs in India, a shouting match between head honchos of pharma companies at a healthcare summit, a court order on J&J’s hip implant, and a warning letter to Interquim. US Senate clears Cures Act — the biggest reform on medical treatments On Wednesday, the US Senate passed the landmark 21st
Century Cures Act. The bill had passed the House on November 30 and had advanced through the Senate earlier this week. After the vote, President Barack Obama said he would sign the measure “as soon as it reaches my desk.”The 21st Century Cures Act is a labyrinthine bill
that would bring about significant changes in the way medical treatments are tested and brought to market over the coming decades. The legislation calls for the use of ‘data summaries’ to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.It includes
ambitious goals to advance biomedical science, and will inject US $ 4.8 billion
into a long-stagnating National Institute of Health budget.Critics call this deregulation, and a wolf in sheep’s clothing. They worry that both science and patients are going to suffer. They have argued the legislation is too friendly to Big Pharma, won’t curb high drug prices and may lead to unsafe treatments being put on the market. Tucked away in the 99-page bill are provisions that are likely to weaken the authority of the FDA as the bill includes language to put forward “real-world evidence” to support the approval of a new indication (or use) for an existing drug.Indian
court quashes ban on fixed dose combination drugs
As the 21st Century Cures Act will take us to an era of ‘inject and see’, the Indian government may want to see if the debate on banning fixed-dose combination (FDC) drugs can be resolved using ‘real-world evidence’. A government order banning 344 FDC drugs was overturned last week when the court was hearing a
plea filed by pharmaceutical companies challenging the March 10, 2016 order
which banned 344 FDC drugs. The ban included several common cough syrups, analgesics (pain killers) and
anti-diabetes combinations.Pharmaceutical companies’ argued that the government’s action had been ad hoc in nature and is not aligned with the procedures mentioned under Section 26A of the Drugs and Cosmetics Act, 1940. They argued that the decision was taken without considering clinical data. And that it was based on an ‘absurd’ claim that there are safer alternatives available in the market today.Pfizer fined US $ 106.5 million in UK for hiking price of epilepsy drug
The Competition and Markets Authority in the UK fined Pfizer a record US $ 106.5 million (GBP
84.2 million) for its role in increasing the cost of an epilepsy drug by a
whopping 2,600 percent. The CMA also fined Flynn Pharma US $ 6.58 million (GBP
5.2 million) for overcharging for phenytoin
sodium capsules.The ruling comes at a time when there is a growing debate both in the US and
Europe about the ethics of price hikes for old off-patent medicines that have
little competition.Pfizer
used to market the (epilepsy) medicine under the brand name Epanutin, but sold the rights to Flynn, a privately owned British company, in September 2012. It was then debranded — i.e. it was no longer subject to price regulation — and the price soared.“The companies deliberately exploited the opportunity offered by debranding to hike up the price for a drug which is relied upon by many thousands of patients,” Philip Marsden, chairman of the CMA’s case decision group, said.“This is the highest fine the CMA has imposed and it sends out a clear message to the sector that we are determined to crack down on such behaviour,” Marsden addedPfizer, Regeneron CEOs get into a shouting match at
healthcare summit
At the Forbes Healthcare Summit held last week, a panel featuring
Gilead CEO
John Milligan, Pfizer CEO Ian Read, incoming Eli Lilly CEO
David Ricks, Astellas Americas President Jim Robinson, and Regeneron CEO
Leonard Schleifer were asked to contemplate on why the pharma industry isn't liked.While the panel discussed middlemen and adding value, Schleifer offered his
own take.“I think you've just seen why our industry isn't liked. You've asked a question why we're not liked, we are a room full of people who are biased to like us, and nobody answered the question why we're not liked,” Schleifer said.“We dispelled of some of it last year, because we blamed it on the extremists, the people who come in, dial up a product that's off patent, raising price ten-fold and they're evil-doers, that's why we're not liked,” he continued. “But the real reason we're not liked, in my opinion, is because we as an industry have used price increases to cover up the gaps in innovation. That's just a fact.”Pfizer’s Read countered this with an often cited statistic that drug costs as a percentage of healthcare expenses haven’t changed in two decades, regardless of price increases.Schleifer’s response: “You’re not entitled to a fraction of the GDP.” What followed was a shouting match, until a member of the panel interjected.
The pharma industry surely needs a unified message to send out to the world.
Spain’s Interquim gets FDA warning letter for using dirty equipmentThe latest
company to receive a warning letter from the FDA is Interquim SA of Spain. FDA investigators found the presence of residue in the interior surfaces of non-dedicated drug manufacturing equipment at Interquim that were labeled “clean.” Inadequate
removal of residues from manufacturing equipment during cleaning can lead to
cross-contamination of API subsequently manufactured, using the same equipment.Investigators
also questioned the impact on API quality of the product produced from
equipment whose interior surfaces were discolored even after an equipment
maintenance contractor had previously noted the damage and repaired it.Interquim
is a part of Ferrer, an international group of more than 50 companies with
activities in the pharmaceutical, hospital, diagnostics, fine chemicals, feed
and food sectors. Headquartered in Spain, its products are sold in more than 70
countries. It is a leading manufacturer of APIs like Celecoxib, Imiquimod, Paliperidone Palmitate, Rivaroxaban, Rivastigmine, etc.
Explosion
at excipient manufacturer in India claims two livesAn explosion at a manufacturer of pharmaceutical excipients — Nitika Pharmaceutical Specialities — in India claimed two lives and injured 19 others. While initial news reports claimed a boiler explosion, a
report submitted by the inspector of boilers stated: “The explosion at M/s Nitika Pharmaceuticals Pvt Ltd is not a case of boiler explosion. There is no registered or exempted or unauthorized boiler in the unit. The heat requirement of the factory was being catered to by two thermic fluid heaters installed in the factory.”The local police arrested the company’s senior manager (operations), the senior manager (maintenance) and its managing director, who were later granted bail by the court.
Cannabis cultivation to get boost due to upcoming
approvalsGW Pharmaceuticals, a UK-based company focused on developing medicines from marijuana, plans to expand manufacturing in the UK and boost
cultivation of the cannabis plants it uses to make a treatment for severe epilepsy.The British biotech firm is gearing up to submit Epidiolex — an experimental drug that has shown to be hugely effective in
treating rare and life-threatening forms of childhood epilepsy —with US regulators in the first-half of 2017. Approval could come by early 2018.It was just
last week that PharmaCompass covered the news of the medical cannabis sector managing to comply with pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical
to market medical cannabis in Israel for pain management.
Will
Apple launch FDA regulated cardiac monitoring products soon?A
collection of emails obtained by MobiHealthNews, through a Freedom of Information Act request to the FDA,
indicates that since July 2016, Apple has been in discussions with the FDA
about two FDA-regulated products in the cardiac monitoring space.In an
interview with the Telegraph last year, Apple CEO Tim Cook had also
hinted at a regulated medical device from Apple.“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook had said.
J&J to pay over US $1 billion in Pinnacle
hip implants caseLast week, a
federal jury in Dallas ordered Johnson
& Johnson and its unit DePuy Orthopaedics to pay more than US $ 1
billion to six plaintiffs who said they were injured by the Pinnacle hip implants.According to the jurors, the metal-on-metal Pinnacle hip implants were
defectively designed. And both companies failed to warn consumers about the
risks. J&J and DePuy have been hit with nearly 8,400 lawsuits over the
devices.However, verdicts of such size are often lowered by courts. In July, the
judge presiding over this case reduced a US $ 500 million verdict in an earlier
Pinnacle implant case to US $ 151 million by citing a Texas state law that
limits punitive damages awards.
Impressions: 2065
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#PharmaFlow by PHARMACOMPASS
08 Dec 2016
