Market Place
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
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This week, PharmaCompass
reviews the recently released data on prescription drugs paid for under the
Medicare Part D Prescription Drug Program in the United States in calendar year
2016.
But first, let’s understand what is Medicare.
Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled.
Prescription drug coverage under this
program was started in 2006, and is known as Medicare Part D.
As part of this
coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance
companies and other private companies, known as plan sponsors, that offer
prescription drug plans to their beneficiaries with varying drug coverage and
cost-sharing requirements.
In
2017, the Congressional Budget Office (CBO) had estimated that spending on
Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare
expenditures for the year.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
According
to the CBO, Medicare Part D is the most significant expansion of the Medicare
program since it was created by Congress in 1965.
With
more than 1.48 billion claims from beneficiaries enrolled under the Part D
prescription drug benefit program under its umbrella, our analysis of Medicare
Part D provides valuable insights into how elderly Americans use prescription
drugs.
Top 10 drugs by
cost: The ones that bore the highest cost burden for Medicare
As in 2015, in 2016
too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion.
As Gilead continued
to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down
37 percent from US$ 7.03 billion in 2015.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for
cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion.
Generic Name
Number of Medicare Part D Claims
Number of Medicare Beneficiaries
Number of Prescribers
Aggregate Cost Paid for Part D
Claims (In USD)
LEDIPASVIR/ SOFOSBUVIR (HARVONI)
141,665
52,782
12,097
4,398,534,465
LENALIDOMIDE
239,049
35,368
10,382
2,661,106,127
LANTUS SOLOSTAR (INSULIN
GLARGINE, HUM.REC.ANLOG )
5,028,485
1,075,248
245,447
2,526,048,766
SITAGLIPTIN PHOSPHATE
4,742,505
864,442
206,223
2,440,013,513
ROSUVASTATIN CALCIUM
6,012,444
1,560,050
249,981
2,322,724,007
FLUTICASONE/SALMETEROL
5,194,391
1,196,007
275,442
2,319,808,482
PREGABALIN
4,940,115
852,497
267,532
2,098,953,250
RIVAROXABAN
4,403,332
807,820
252,141
1,954,748,890
APIXABAN
4,455,782
826,969
231,631
1,926,107,484
TIOTROPIUM BROMIDE
4,153,162
903,494
235,564
1,818,857,361
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Top 10 drugs by claims: The most commonly
used drugs of 2016
With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016.
The number of
Medicare Part D claims includes original prescriptions and refills.
Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that
were filed by almost 9.4 million beneficiaries.
Generic
Name
Number
of Prescribers
Number
of Medicare Part D Claims
Number
of Medicare Beneficiaries
LEVOTHYROXINE SODIUM
669,999
46,617,109
8,091,785
ATORVASTATIN CALCIUM
494,973
44,595,686
9,435,633
AMLODIPINE BESYLATE
497,017
39,913,468
7,802,905
LISINOPRIL
490,452
39,469,840
8,009,954
OMEPRAZOLE
492,951
32,909,236
7,001,160
METFORMIN HCL
611,700
31,007,932
6,394,014
SIMVASTATIN
380,560
29,687,947
6,201,911
HYDROCODONE/ACETAMINOPHEN
660,617
28,595,150
7,265,882
FUROSEMIDE
488,352
27,878,243
5,421,598
GABAPENTIN
555,997
27,627,466
5,363,382
Click here
to access the compilation of Medicare Part D Prescriber Summary Report
Top 10 drugs by prescribers: Medicines that were most popular with
doctors
Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had
over 900,000 unique providers (or
doctors) prescribing the drug.
Albuterol (salbutamol) is
used to provide quick relief from wheezing and shortness
of breath while Diltiazem is used to prevent chest
pain (angina).
Also
on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen.
With more doctors prescribing Hydrocodone-Acetaminophen (an
opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the
series of new FDA initiatives to combat the epidemic of opioid misuse and abuse
should change the position of opioids in the top 10 drugs by prescribers in the
coming years.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Generic
Name
Number of
Prescribers
Number of
Medicare Part D Claims
Number of
Medicare Beneficiaries
ALBUTEROL SULFATE
985,427
13,100,354
5,417,718
DILTIAZEM HCL
931,159
8,142,004
1,982,550
POTASSIUM CHLORIDE
879,491
18,945,969
4,278,000
PEN NEEDLE, DIABETIC
677,210
5,281,778
1,795,046
LEVOTHYROXINE SODIUM
669,999
46,617,109
8,091,785
HYDROCODONE/ACETAMINOPHEN
660,617
28,595,150
7,265,882
METFORMIN HCL
611,700
31,007,932
6,394,014
CEPHALEXIN
597,647
5,603,879
3,933,373
CIPROFLOXACIN HCL
594,129
7,000,081
4,851,657
AZITHROMYCIN
591,028
7,958,625
5,734,122
What does the
future hold?
Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations. Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries).
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Last
month, the Office of the Inspector General (OIG)
reviewed
the Part D claims data for the years 2011 to 2015 for brand-name drugs.
The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs.
With soaring drug prices being an issue for
regular debate in the Unites States and President Trump announcing that his
team will use strategies to strengthen the negotiating powers under
Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under
the Medicare Part D Prescription Drug Program will change in the coming years.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Impressions: 2500
https://www.pharmacompass.com/radio-compass-blog/analyzing-over-us-90-billion-of-medicare-prescription-drug-part-d-spending-in-2016
#PharmaFlow by PHARMACOMPASS
05 Jul 2018
The year 2017 was a landmark year for pharmaceutical
industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies.
The US Food
and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest
since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency
(EMA) approved 35 drugs with a new active substance, up from 27 in 2016.
Sales for most major pharmaceutical
companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has
generated investor hopes for accelerated dividend growth and share buyback
plans.
This week, PharmaCompass brings
you a compilation of the top drugs of 2017 by sales revenue.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second
There wasn’t any upheaval
at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant
Humira (adalimumab), which is approved to treat
psoriasis and rheumatoid arthritis, added
almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues.
Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The
company believes this drug will continue to be a significant cash contributor
until 2025 and the US $21 billion sales forecast
by 2020 is about US $3 billion higher than its expectation two years ago.
In 2016, the US Food and Drug Administration
(FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo
(adalimumab-adbm) — received approval from the FDA and European authorities.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Enbrel (etanercept),
the longest-used biologic medicine for the treatment of rheumatism around the
world, was the second best-selling drug with US $8.262 billion in 2017 sales.
The sales of the drug were down from US $9.366 billion in
2016 owing to lower selling prices and increased
competition, which in turn hurt demand.
Since it was first approved in the United States in 1998,
Enbrel has been approved in over 100 countries and the drug is promoted by Amgen,
Pfizer
and Takeda
in different geographies.
Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August
2016 for the treatment of patients with
rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and
other diseases is still not on the market because of a patent-protection
challenge from Amgen.
Amgen is arguing in the US federal court
that its drug has patent protection until 2029.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Fast-growing drugs: Eylea and Revlimid bring
fortunes for Regeneron and Celgene
Regeneron’s
flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in
annual sales last year to record US $8.260 billion in total sales. Eylea net
sales grew 11 percent year-on-year in the US and 19 percent year-over-year
outside the US.
The company believes much of the recent
growth in the US was driven by demographic trends with an aging population as
well as an overall increase in the prevalence of diabetes.
These demographic trends are expected to
continue in the coming years, providing an opportunity for continued growth.
Eylea sales alone contribute 63 percent to Regeneron’s total sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Celgene’s
Revlimid
(lenalidomide)
— a thalidomide derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.
Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion.
Celgene received a setback this month as the
USFDA refused to consider Celgene’s
application for ozanimod, an experimental
treatment for relapsing multiple sclerosis. The treatment was being seen as a
key to the company’s fortunes as Celgene had
said ozanimod is worth US $4 billion to
US $6
billion a year in peak sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Gilead’s Hepatitis C franchise enters free fall
Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the
competitive heat as they registered US $9.137
billion in 2017 sales, down from US $14.834
billion the previous year.
While reporting 2017 results, Gilead provided guidance for
2018 and said its sales of Hepatitis C drugs could fall
further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated
US $19.1 billion in sales.
One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret
at a deep price discount to the competition. AbbVie
also claims to have the shortest treatment course at eight weeks, compared with
12 weeks or longer for other treatments.
AbbVie reported US $1.274 billion in Hepatitis C drug sales
in 2017, down from US $1.522 billion in 2016.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat
Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.
The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe)
and Vytorin (Ezetimibe
and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark
Pharmaceuticals entered into an agreement that allowed Glenmark to launch
a generic version of Zetia in late 2016. The drugs
that had combined sales of US $3.701
billion in 2016 felt the generic heat in 2017 and the sales were US
$1.606 billion lower at US $2.095
billion.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
GSK’s Advair, which was expected
to encounter generic competition in 2017, continued to breathe easy as the FDA
found deficiencies in the applications of Hikma, Mylan and Sandoz.
All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.
Top 15 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2017. This is based on information extracted from
annual reports and US Securities and Exchange Commission (SEC) filings of major
pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all the 2017 data (Excel
version available) for FREE!
S. No.
Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2017 Revenue in Millions (USD)
1
AbbVie Inc., Eisai
Humira®
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
18,946
2
Amgen, Pfizer Inc., Takeda
Enbrel®
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
8,262
3
Regeneron, Bayer
Eylea
Aflibercept
Ophthalmology
8,260
4
Celgene
Revlimid
Lenalidomide
Oncology
8,187
5
Roche
MabThera®/Rituxan®
Rituximab
Oncology
7,831
6
Johnson & Johnson, Merck, Mitsubishi Tanabe
Remicade®
Infliximab
Autoimmune Disorders
7,784
7
Roche
Herceptin®
Trastuzumab
Oncology
7,435
8
Bristol-Myers Squibb, Pfizer Inc.
Eliquis®
Apixaban
Cardiovascular Diseases
7,395
9
Roche
Avastin®
Bevacizumab
Oncology
7,089
10
Bayer, Johnson & Johnson
XareltoTM
Rivaroxaban
Cardiovascular Diseases
6,590
11
Bristol Myers Squibb, Ono Pharmaceutical
Opdivo
Nivolumab
Oncology
5,815
12
Sanofi
Lantus
Insulin Glargine
Diabetes
5,731
13
Pfizer Inc.
Prevnar 13/Prevenar 13
Pneumococcal 7-Valent Conjugate
Anti-bacterial
5,601
14
Pfizer Inc., Eisai
Lyrica
Pregabalin
Neurological/Mental Disorders
5,318
15
Amgen, Kyowa Hakko Kirin
Neulasta®
Pegfilgrastim
Blood Disorders
4,553
Sign up, stay ahead
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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 in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.
Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay
debt
Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade.
Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.
Teva had taken on
the debt in order to
dominate all facets of generic drugs, including a US$ 40.5 billion
acquisition of Allergan’s generics business last year. The
Allergan deal added more pressure on drug prices and margins.
Teva also slashed
its earnings goals
for the second time this year. It warned investors it may have to renegotiate
some debt agreements if cash flow worsens. Teva reduced its dividend by 75
percent.
The company also
mentioned that it is in the process of laying off 7,000 workers. Greater competition in the
generic drug business due to increased approvals (of generic drugs) by the US
Food and Drug Administration (USFDA) has led to poor results, the company said.
The continued deterioration of its business environment in Venezuela has made
matters worse.
The plight of Teva
has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months.
Activist
shareholder Benny
Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said.
Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges
Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his
crime and on his antics on the social media, say legal experts.
Back
in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime.
That
could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors.
While
Shkreli was convicted on three securities fraud and conspiracy counts, he was
acquitted of other charges, including the charge that he conspired to steal US$
11 million in assets from Retrophin.
What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”
Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.”
According
to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said.
Diabetes drug exenatide could stop the progress of Parkinson’s disease
In future,
clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying.
In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease.
In the trial, half
the patients were given
the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off.
Exenatide,
derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1)
agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which
triggers insulin secretion.
According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did
better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s.
Though the UCL team is “excited”, it has urged caution as any
long-term benefit is uncertain and the drug needs more testing.
FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks
Last
week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is
also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the
discounts bring the net price down to US$ 30,000.
Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs
Sovaldi and Harvoni, that have been at the centre of a
controversy around their steep prices.
With
a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer.
J&J’s Invokana is CVS Caremark’s preferred diabetes drug
Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in,
and those that are out. Express
Scripts Holding is the largest PBM organization in the US.
In
the SGLT2 class of drugs to treat diabetes, CVS
removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s
Invokana as a preferred option. This, despite the fact that Invokana came with an
increased risk for amputations in a cardiovascular outcomes study finished
earlier this year.
A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added.
CVS removed 17
drugs in 10 classes, with Merck’s Zetia, Daiichi
Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76
percent of members will be able to keep using their current treatments.
US Senate overwhelmingly passes reauthorization of FDA’s user fees
In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval.
The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare.
The
funding reauthorizations are based on recommendations from industry groups.
This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years.
The
fee helps speed
up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires.
The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.
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#PharmaFlow by PHARMACOMPASS
10 Aug 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.
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In order to stay informed,
and receive industry updates along with our data compilations, do sign up for
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it becomes available along with a lot more industry analysis.
Click here to Access All the 2016 Data (Excel version available) for FREE!
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#PharmaFlow by PHARMACOMPASS
17 May 2017
The year 2016 finished with a whimper insofar as mergers and acquisitions (M&As) were concerned. The preceding year — 2015 — had gone down in history as a record year for M&As in the pharmaceutical and biotech space, when deals worth US $300 billion were announced.
While drug companies were not as active on
the M&A front, the product sales growth in 2016 continued to stay extremely
robust and the order of the top ranked drugs changed little from the previous
year.
This week, PharmaCompass brings you
a compilation of the top drugs of 2016 by sales revenue.
Click here to Access All the
2016 Data (Excel version available) for FREE!
The top-sellers
Abbvie’s Humira (adalimumab) continued to remain the best-selling drug in the
world and added another US $2 billion to its 2015 sales by generating record
sales of US $16.078 billion in 2016.
Last year also saw the US Food and Drug Administration (FDA) approve Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
Click here to Access All the
2016 Data (Excel version available) for FREE!
Gilead’s Harvoni (ledipasvir and sofosbuvir), with record sales of US $13.864 billion in 2015, had a slightly muted performance in 2016 as sales fell to US $9.081 billion (a drop of US $4.783 billion). Gilead failed to maintain its initial rate of new prescriptions, and competition from Merck and AbbVie forced it to offer major discounts to health insurers.
While Gilead executives still believe there is lots of growth left in the hepatitis C market, this year Gilead will continue to face headwinds as Merck's new combination pill — Zepatier — entered the market with a list price at US $54,600 for a 12-week regimen, well below the US $94,500 for Harvoni.
Biological drugs, Enbrel (etanercept),
Remicade (infliximab) and MabThera (rituximab), held onto their positions of 2015, although their combined sales increased a little over US $300
million.
This means that for yet another year, the
four best-selling drugs in the world are from biological origin.
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 the company's total sales of US $11.229 billion.
With almost identical sales of US $6.7
billion, Roche’s cancer treatments Herceptin and Avastin were also into
the top 10 best selling drugs in 2016, making Roche have the most number of
products, three of which made it to the list.
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2016 Data (Excel version available) for FREE!
Facing onslaught of generics, biosimilars
Against the backdrop of questions being raised about
insulin pricing and possible collusion in the United States, Sanofi saw its insulin treatment Lantus (insulin glargine) drop from number six on the 2015 list to number 9 in 2016 as sales fell by US $717 million to a little over US $6 billion. Sanofi’s competitors in the diabetes space — Novo Nordisk and Eli Lilly — also registered a drop in their insulin sales.
In addition to the pricing pressure, Sanofi will continue to contend with Lilly and Boehringer Ingelheim’s FDA approved biosimilar of insulin glargine — Basaglar — which was approved in December 2015.
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2016 Data (Excel version available) for FREE!
Basaglar is biologically similar to Sanofi’s Lantus and was announced at a price 15 percent lower than that of Lantus.
GSK’s Advair, which is preparing for generic competition in 2017, saw its sales drop 5 percent in British Pounds to £3,485. However, the dollar value was significantly lower in view of the fall in the Pound’s value after Brexit.
AstraZeneca’s Crestor (rosuvastatin calcium), Otsuka’s Abilify (aripiprazole) and Novartis’ Gleevec (imatinib) all saw their sales crash in 2016 as a result of generic onslaught. The three drugs together witnessed a combined sales drop of US $5.7 billion.
Top 20 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2016. 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 2016 data (Excel version available) for FREE!
S. No
Product
Active Ingredient
Main Therapeutic Indication
Company
2016 Revenue in Millions (USD)
2015 Revenue in Millions (USD)
Sales Difference in Millions (USD)
1
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
Abbvie
16,078
14,012
2,066
2
Harvoni
Ledipasvir and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
9,081
13,864
(4,783)
3
Enbrel
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
Amgen/Pfizer Inc.
8875
8697
178
4
Remicade
Infliximab
Immunology (Organ Transplant, Arthritis etc.)
Johnson & Johnson/Merck & Co
8,234
8,355
(121)
5
MabThera/Rituxan
Rituximab
Oncology
Roche
7227
6974.55
252
6
Revlimid
Lenalidomide
Oncology
Celgene
6,974
5,801
1,173
7
Avastin
Bevacizumab
Oncology
Roche
6,715
6,617
98
8
Herceptin
Trastuzumab
Oncology
Roche
6,714
6,473
242
9
Lantus
Insulin Glargine
Diabetes
Sanofi
6,057
6,773
(717)
10
Prevnar/Prevenar
13
Pneumococcal 13-Valent Conjugate
Anti-bacterial
Pfizer Inc.
5,718
6,246
(528)
11
Xarelto
Rivaroxaban
Cardiovascular Diseases
Bayer/Johnson & Johnson
5,392
4,255
1,137
12
Eylea
Aflibercept
Ophthalmology
Regeneron Pharmaceuticals, Inc./Bayer
5,046
3,978
1,068
13
Lyrica
Pregabalin
Neurological/Mental Disorders
Pfizer Inc.
4,966
4,839
127
14
Neulasta
Pegfilgrastim
Blood Disorders
Amgen
4,648
4,715
(67)
15
Seretide/Advair
Salmeterol
Respiratory Disorders
GlaxoSmithKline
4,252
4,491
(239)
16
Copaxone
Glatiramer
Neurological/Mental Disorders
Teva
4,223
4,023
200
17
Sovaldi
Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
4,001
5,276
(1,275)
18
Tecfidera
Dimethyl Fumarate
Neurological/Mental Disorders
Biogen
3,968
3,638
330
19
Januvia
Sitagliptin
Diabetes
Merck & Co
3,908
3,864
44
20
Opdivo
Nivolumab
Oncology
Bristol-Myers Squibb
3,774
942
2,832
Blockbusters in the making
With almost US $5 billion in sales, a 14 percent growth over the previous year, Pfizer’s Lyrica enjoyed its last year before generic competition enters the market as Generics (UK) Limited (Mylan) and Actavis Group PTC ehf won a patent challenge in the United Kingdom.
Lyrica generics are expected in the United
States in late 2018.
Click here to Access All the
2016 Data (Excel version available) for FREE!
As Abbvie’s Humira begins to face competition from Amgen, Abbvie’s US $21 billion buy of Pharmacyclics seems to be paying off. The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), which generated total 2016 sales of US $3.083 billion — an increase of US $1.64 billion over the previous year.
Anticoagulants, Xarelto (rivaroxaban), Eliquis (apixaban), Pradaxa (dabigatran) all registered significant positive growth with a combined increase of almost US $ 2.75 billion.
Gilead and GSK’s combination HIV treatments — Genvoya and Triumeq — also reported sales increase of over a billion dollars each.
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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.
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2016 Data (Excel version available) for FREE!
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#PharmaFlow by PHARMACOMPASS
19 Apr 2017
After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines.
This
week, PharmaCompass, shares its analysis of the new drug approvals by the FDA
in 2016.
Reasons behind the low approvals in 2016
Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications.
The 9
orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013.
The
reasons for the low 2016 approval count, have been attributed to the agency
approving five drugs in 2015 that actually had approval action dates in 2016
and an increase in the number of drugs that the agency rejected.
A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Gilead’s Epclusa, the first
all-oral, pan-genotypic, single tablet regimen for the treatment of adults with
chronic hepatitis C virus (HCV) infection, is expected to become the most
profitable approval of 2016 with expected sales of $ 8.4 billion by 2022.
2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States.
Approvals of three biosimilars which
target $ 33 billion in brand drug sales
In a
giant leap for the generic pharmaceutical industry, three biosimilar
applications were approved in 2016 that target brand drugs which generated more
than $ 33 billion in sales last year.
All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions.
Pfizer and Celltrion’s Inflectra, a
biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016.
After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $
9.1 billion).
On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Kim Kardashian’s pregnancy drug is now available in a new strength
Diclegis,
a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines
when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’
Duchesnay,
the company which produces Diclegis, got approval for Bonjesta which combines twice
the amount of doxylamine and pyridoxine when compared with Diclegis which contains
10mg of each ingredient.
Indian generic companies get approvals for
differentiated products
As the
generic industry in the U.S. continues to face severe pricing pressure, Indian
generic companies are attempting to overcome these challenges by trying to move
up the value chain by supplying differentiated generic products.
Consistent
with this strategy, the applications of Sun Pharmaceuticals
for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory
for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Pfizer launches an opioid treatment with
abuse-deterrent properties
The abuse
of opioids, including prescription painkillers and drugs like heroin, is
something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release
opioid painkillers such as oxycodone and fentanyl will have to
carry a "black box" warning
about the risk of abuse, addiction, overdose and death.
Pfizer
got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are
expected to reduce abuse when crushed and administered by the oral and
intranasal routes.
In it,
the oxycodone releases slowly over several hours. If the capsules are crushed,
the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric
effects.
Pfizer
also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
A dietary supplement gets approved along with new forms of commonly used drugs
In 2016, Endoceutics
got Intarosa, a once-daily vaginal insert, approved which is the first FDA
approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA).
Although
DHEA is included in some dietary supplements, the efficacy and safety of those
products have not been established for diagnosing, curing, mitigating, treating
or preventing any disease.
Lisinopril, the most commonly used drug
by U.S. Medicare patients, was approved as an Oral Solution for the first time.
Diabetes
treatments, one of the most commonly prescribed drug categories in the U.S., saw
the addition of Sanofi and Novo Nordisk’s fixed-dose,
long-acting insulin and glucagon-like peptide 1
(GLP-1) agonist combinations to the list of options available to treat adult
type-2 diabetes.
Our View
The approval
of new drugs ensures that the world has access to improved healthcare solutions
and breakthrough medical therapies.
With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug
approval scenario will be shaken up for time to come.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Impressions: 14454
https://www.pharmacompass.com/radio-compass-blog/fda-s-2016-approvals-of-new-drugs-formulations-strengths-more
#PharmaFlow by PHARMACOMPASS
09 Feb 2017
The New
Year began with the JP Morgan Healthcare Conference— the drug industry’s annual investor meet — where industry leaders were busy announcing deals, until Donald Trump accused the industry of “getting away with murder”. His comments sent shockwaves within the industry as pharma and biotech stocks tanked. In the first Phispers of 2017, we also bring you a compilation of the likely patent conflicts this year. And, there is news on Aurobindo Pharma’s acquisition, Teva's revised guidance for 2017, lowering of growth prospects for Mylan, fresh bribery charges against Novartis and more.
Trump promises aggressive
federal bidding process to slash drug prices
Donald Trump, America’s president-elect dropped a bombshell in his first news conference held Wednesday, accusing the pharmaceutical industry of “getting away with murder”. He said he would bring
down drug prices, as well as government spending on drugs by changing the way
the country bids for drugs.
During the event held at Trump Tower in New York, Trump said: “Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don’t bid properly.”
The country’s federal law forbids the government from negotiating drug prices with drug companies in order to lower the price of drugs for seniors using Medicare. Trump, however, did not announce how he will address the
issue of high drug prices. In the past though, he has called for ending the
policy.
His comment came in the midst of the JP Morgan Healthcare Conference, a
major annual investor meeting taking place in San Francisco, and knocked down
the stocks of biotech and pharmaceutical companies by around 2 percent.
“If anybody is walking away from this conference thinking ‘business as usual,’ I think that’s a mistake,” Heather Bresch, chief executive of Mylan Pharmaceuticals said at the JP Morgan meet.
“The pricing model has got to change. It’s not incremental change; I don’t think that’s what this country needs. I think it’s truly rethinking the business model,” she added. Mylan was under scrutiny recently for repeated list price increases on its lifesaving allergy drug EpiPen.
RECOMMENDED READ:
Drug costs and prescription trends in the United States: Analyzing Medicare’s $121 billion spend
Teva lowers guidance, Mylan expected to lose
US $ 800 million in 2018
Israeli drugmaker Teva revised the predictions it made in July 2016, about its financial expectations for 2017.
And these are considerably below its previous expectations. For instance, it
laid out a revenue forecast of US $ 23.8 billion to US $ 24.5 billion for 2017,
well below the US $ 25.2 billion to US $ 26.2 billion guidance it had
previously estimated. Teva now expects its earnings per share (EPS) to be between US $ 4.90 and US $ 5.30 — another big drop from its July guidance of US $ 6.00 to US $ 6.50.
Several industry observers had expected this downward revision. “I think it’s pretty clear that management’s prior expectations for 2017 were very inflated,” Umer Raffat, an Evercore ISI analyst, said.
Meanwhile, Teva began the new year by forking out over US $ 520 million in order to resolve a bribery
lawsuit in the US filed by its shareholders. It pertained to its operations in
Russia, Ukraine and Mexico.
The year gone by was a turbulent one for Teva.
For instance, its US $ 2.3 billion acquisition of Rimsa (short for Representaciones e Investigaciones Médicas, SA de CV), a leading pharmaceutical manufacturing and distribution company in Mexico, went the Ranbaxy way, with the former owners filing a legal complaint against Teva. The complaint mentioned that Teva is suffering from “buyer’s remorse” and is trying to undo the transaction “by any desperate measure” after destroying the Rimsa companies with firings and manufacturing shutdowns.
It’s not just Teva which is set to see a downtrend. Mylan's EpiPen — which hogged the headlines last year for its price hikes — is projected to face substantial decline, until 2018, say analysts.
EpiPen is all set to face competition from Kaleo’s Auvi-Q (another
epinephrine injection), which is due for launch in the first half of 2017,
Ronny Gal of Bernstein Research said. EpiPen (excluding the generic version) will
bring in only US $ 300 million in 2018 for Mylan, down from its US $ 1.1
billion estimate for 2016, Bernstein Research said.
Aurobindo to acquire Portugal’s Generis Farmaceutica
The New Year began with a bang for India’s Aurobindo Pharma. The company said it has inked a pact to acquire Portugal’s Generis Farmaceutica SA from Magnum Capital Partners for a consideration of US $ 143 million (or €135 million).
In a statement, Aurobindo Pharma said the binding agreement has been inked through Aurobindo’s wholly-owned subsidiary — Agile Pharma BV Netherlands. Generis produces and sells pharmaceutical products in Portugal.
The combined entity will benefit from a robust pipeline covering all major molecules coming off patent in the next five years, V Muralidharan, Senior Vice President of European Operations at Aurobindo Pharma, said. “The acquisition of Generis, by leveraging its strong portfolio and unrivalled brand recognition will allow us to establish ourselves as the top generics player in the Portuguese market,” he added.
The deal, however, is conditional, and depends on obtaining necessary approvals from Portuguese authorities. The acquisition deal includes Generis’ manufacturing facility in Amadora (Portugal) with a capacity to produce 1.2 billion tablets/capsules/sachets annually.
Patent battles between the Big Pharma could dominate 2017
This year may well be the year of big patent
battles between pharmaceutical giants. It began with a ruling on a patent
infringement case involving partners Sanofi-Regeneron and Amgen. A US federal judge ordered French pharmaceutical giant Sanofi and partner Regeneron to stop selling their latest cholesterol treatment — Praluent — due to patent infringement. After the court order, the stocks of Regeneron and Sanofi got hammered.
Sanofi and Regeneron plan to immediately appeal
that decision. According to the ruling, Sanofi and Regeneron had infringed
biotech giant Amgen’s patents for a rival cholesterol fighting drug — Repatha. Both Praluent and Repatha are the only approved ‘PCSK9 inhibiting’ therapies known to considerably reduce bad cholesterol levels in patients during clinical trials. Both won FDA approval in 2015 and both are expensive — priced at US $ 14,000 per year.
Sanofi is also in a battle with Novo Nordisk. In the last week of December, there was news that Sanofi filed a lawsuit in the US accusing Novo Nordisk of making the false claim that Sanofi’s insulin drugs would no longer be available for many US patients. According to Sanofi, Novo made that claim in order to promote its own competing drug. The complaint seeks an order forcing Novo to pay damages and withdraw marketing materials for its drug Tresiba.
Both Sanofi and Novo have been tied in a regulatory
race for their basal insulin/GLP-1 combo diabetes products. But Sanofi is already ahead in the race, as last week it rolled out Soliqua, a combination of
(insulin) Lantus and GLP-1 drug Adlyxin, at a list price of US $ 127 for a 300-unit pen. Novo’s Xultophy—which received regulatory approval on November 21—won’t be in the market until early May.
And then there is the battle between Merck
and Gilead. The latter ended the year on a sour note after a federal jury in the US ordered Gilead to pay US $ 2.5 billion in royalties to Merck in an ongoing
dispute. The legal battle between Merck and Gilead centres around Gilead's flagship hepatitis C cures — Sovaldi and Harvoni. Both these drugs gained disrepute for their lofty prices. Yet they
dominated the hepatitis C drug market (before they ran into trouble with
insurers and benefits managers who demanded better deals).
Lastly, there is a significant patent battle brewing in experimental biopharma technology in the form of a spat between the University of California and the University of Vienna on one side and the Broad Institute of MIT and Harvard University on the other. The battle centers around CRISPR-Cas9 — an early-stage gene-editing platform that significantly simplifies the process of slicing and dicing problematic genetic material. It is being tested as a treatment option for cancer, sickle cell, and a host of other diseases.
The dispute is around who owns the patent
right to CRISPR. While University of California at Berkeley professor Jennifer Doudna and the University of Vienna’s Emannuelle Charpentier were first to announce their discoveries, MIT's Feng Zhang actually won the patent after going through an expedited process.
After Korea, US and China, Novartis faces
bribery charges in Greece
In the last one year, Swiss drugmaker Novartis has faced three sets
of bribery charges. The fourth one came in the New Year, with Greek officials
announcing they are investigating Novartis for bribery in the wake of local media reports raising questions about the
company.
Greek corruption prosecutors raided the Athens offices of Novartis last week, as part of the probe over bribery
allegations. Greek authorities have reportedly interviewed scores of sources.
In March 2016, Novartis paid US $ 25 million to settle a US Securities and Exchange
Commission (SEC) case that claimed the Swiss drug maker paid bribes to health
professionals in China to increase sales during 2009 and 2013.
While the US case got settled, Novartis has
been accused by a whistleblower in Turkey of paying bribes through a consulting
firm to secure business advantages.
In August 2016, PharmaCompass had
reported that six former and current Novartis executives at its unit in South Korea allegedly paid more than US $ 2 million to doctors in return for prescribing its medicines. Among those indicted was the former CEO of Novartis’ Korea unit.
Twitter
bans Martin Shkreli for making unwanted advances at journalist
In September 2015, Martin Shkreli, the former
CEO of Turing Pharmaceuticals, had received widespread flak for raising the
price of anti-parasitic drug Daraprim by a factor of
56. Since the Daraprim episode, Shkreli has also been indicted on unrelated
fraud charges.
Well, Shkreli is back in news. And once again for
all the wrong reasons. A few days back, he was temporarily kicked off Twitter and its live-streaming platform — Periscope — for making unwanted advances toward Lauren Duca, the weekend editor of Teen Vogue.
In a tweet to Twitter’s CEO Jack Dorsey, Duca said: “How is this allowed?” She included two screenshots of Shkreli's Twitter profile page.
Apparently, Shkreli manipulated a photograph of Duca with her husband, wherein he had put his face in place of Duca’s husband. Duca also posted another screenshot wherein Shkreli had put up a montage of Duca’s photos as his Twitter background image, with the text: “For better or worse, till death do us part, I love you with every single beat of my heart.” Moreover, Shkreli’s Twitter bio said that he had a “small crush” on Duca. “Hope she doesn't find out,” it said.
According to the Twitter spokesperson, Twitter’s rules prohibit “targeted harassment”.
Oncology deals: Takeda acquires Ariad; Daiichi ties up
with Kite; Ipsen with Merrimack
The JP Morgan conference saw some major deals being announced in the field of oncology. Japan’s Takeda Pharmaceutical Company and Massachusetts-headquartered Ariad Pharmaceuticals recently entered into a definitive agreement under which Takeda will acquire all outstanding shares in Ariad for
US $24 per share in cash, in a deal valued at US $ 5.2 billion.
Ariad
Pharmaceuticals is a cancer-focused drugmaker. The agreement has been
unanimously approved by the boards of directors of both companies. It is likely
to close by the end of February this year, subject to required regulatory
approvals and other conditions.
Kite Pharma — a California-based, clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products — has entered into a deal with Daiichi Sankyo of
Japan. Kite Pharma will enter the Japanese
market, along with Daiichi, which has lined up US $ 250 million deal.
Kite Pharma’s new drug application for the pioneering CAR-T drug —KTE-C19 — is in the final weeks of being completed and shipped to regulators in search of an accelerated approval. CAR-T (short for chimeric antigen receptors-T cell) is a therapy for cancer, using a technique called adoptive cell transfer. The T cells, which can recognize and kill cancer cells, are reintroduced into the patient.
Under the deal, Kite will be taking US $ 50 million
upfront and US $ 200 million in milestones for the deal, while Daiichi Sankyo
is reserving another US $ 200 million in additional milestones for each new
drug candidate that Kite takes to the FDA over the next three years.
Meanwhile, French pharmaceutical company Ipsen
has entered into a US $ 1 billion deal to acquire oncology assets from Massachusetts-headquartered Merrimack
Pharmaceuticals, including the pancreatic cancer drug Onivyde.
The deal is broken down into two steps, involving
an upfront fee of US $ 575 million, to be followed by a potential US $450 million that
would depend on approvals for Onivyde in the US.
With this deal, Merrimack is likely to pay off
US $ 195 million in debts, return US $ 200 million to stockholders and make a
further payment of US $ 450 million to shareholders. Merrimack would also
plough US $ 125 million into the development of three experimental cancer
drugs.
Impressions: 5614
https://www.pharmacompass.com/radio-compass-blog/trump-s-comments-on-drug-prices-sink-pharma-stocks-teva-lowers-guidance-by-1-billion
#PharmaFlow by PHARMACOMPASS
12 Jan 2017
In less than three weeks, Donald Trump will assume office as the
President of the United States. He has mentioned that he wants Medicare (a
national social insurance program) to directly negotiate the price it pays for prescription drugs.
Medicare provides health insurance to Americans aged 65 or more, who
have worked and paid into the system through the payroll tax. It also provides
health insurance to younger people with some disabilities or end-stage renal
disease and amyotrophic lateral sclerosis.
In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people.
As we flag off the New Year, PharmaCompass
provides insights into drug prices and prescription patterns in the US in order
to help professionals make informed decisions. We believe that the cost of
medicines in the US, which have been a subject of much public outcry and
discussions in the recent years, will continue to be scrutinized during 2017.
Medicare data for 2014
Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers
who collectively prescribed approximately US $121 billion worth of prescription
drugs paid for under this program.
For each prescriber and drug, the dataset
includes the total number of prescriptions that were dispensed (including
original prescriptions and any refills), and the total drug cost.
The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).
The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not
include information in cases where 10 or fewer prescriptions were dispensed.
Top
Ten Drugs by Cost, 2014 [Most expensive for Medicare]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Sofosbuvir
109,543
33,028
7,323
$3,106,589,192
Esomeprazole Magnesium
7,537,736
1,405,570
286,927
$2,660,052,054
Rosuvastatin Calcium
9,072,799
1,752,423
266,499
$2,543,475,142
Aripiprazole
2,963,457
405,048
130,933
$2,526,731,476
Fluticasone/Salmeterol
6,093,354
1,420,515
281,775
$2,276,060,161
Tiotropium Bromide
5,852,258
1,211,919
253,277
$2,158,219,163
Lantus
Solostar
(Insulin Glargine)
4,441,782
972,882
224,710
$2,016,728,436
Sitagliptin Phosphate
4,495,964
789,828
190,741
$1,775,094,282
Lantus
(Insulin Glargine)
4,284,173
787,077
223,502
$1,725,391,907
Lenalidomide
178,373
27,142
9,337
$1,671,610,362
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Average Cost Per Claim
Adagen
13
$1,224,835
$94,218
Elaprase
100
$6,560,225
$65,602
Cinryze
1,820
194
196
$96,155,785
$52,833
Carbaglu
60
$2,901,115
$48,352
Naglazyme
129
$6,189,045
$47,977
Berinert
538
73
68
$25,685,311
$47,742
Firazyr
1,568
269
232
$70,948,143
$45,248
H.P. Acthar
9,611
2,932
1,621
$391,189,653
$40,702
Procysbi
314
41
47
$12,542,911
$39,946
Folotyn
15
$598,210
$39,881
Top
Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Lisinopril
38,278,860
7,454,940
464,747
$281,614,340
Levothyroxine Sodium
37,711,869
6,245,507
416,518
$631,855,415
Amlodipine Besylate
36,344,166
6,750,062
451,350
$303,779,661
Simvastatin
34,092,548
6,768,159
387,651
$346,677,118
Hydrocodone-Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Omeprazole
33,032,770
6,707,964
475,122
$529,050,385
Atorvastatin Calcium
32,603,055
6,740,061
419,327
$747,635,818
Furosemide
27,133,430
5,176,582
456,047
$135,710,772
Metformin HCl
23,475,787
4,509,978
364,273
$203,948,989
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Hydrocodone/Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Ciprofloxacin HCl
7,253,018
4,926,835
568,201
$46,728,353
Amoxicillin
6,298,980
4,384,899
557,614
$31,193,739
Cephalexin
5,040,219
3,529,303
557,048
$36,987,401
Azithromycin
7,339,954
5,274,010
544,625
$70,699,119
Prednisone
11,032,986
4,505,821
536,108
$86,537,932
Tramadol HCl
14,250,227
4,272,724
515,816
$125,343,514
Sulfamethoxazole /Trimethoprim
4,833,758
3,090,944
500,790
$29,231,511
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
Amoxicillin/Potassium Clav
3,551,452
2,710,244
478,361
$61,713,432
The findings from CMS
data
The CY 2014 data represented a 17 percent
increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.
Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail
drugs and US $ 128 billion (28.1 percent) was for non-retail drugs.
The drug pricing process in the US is complex and
reflects the influence of numerous factors, including manufacturer list prices,
confidential negotiated discounts and rebates, insurance plan benefit designs,
and patient choices.
An IMS study found that across 12 therapy classes widely used in Medicare Part D,
medicine costs to plans and patients in Medicare Part D are 35 percent below
list prices.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
While the CMS does not
currently have an established formulary, Part D drug coverage excludes drugs
not approved by the US Food and Drug Administration, those prescribed for off-label
use, drugs not available by prescription for
purchase in the US, and drugs for which payments would be available under Parts
A or B of Medicare.
Part D coverage
excludes drugs or classes of drugs excluded from Medicaid coverage,
such as:
Drugs used for anorexia, weight loss, or weight gain
Drugs used to promote fertility
Drugs used for erectile dysfunction
Drugs used for cosmetic purposes (hair growth, etc.)
Drugs used for the symptomatic relief of cough and colds
Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations
Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee
Our view
The Medicare program is designed such that the
federal government is not permitted to negotiate prices of drugs with the drug
companies, as federal agencies do under other programs.
For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D.
If Trump administration kick starts direct
negotiations on Medicare drug prices with drug companies, 2017 will surely turn
out to be a year for the pharmaceutical industry to remember.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Impressions: 7923
https://www.pharmacompass.com/radio-compass-blog/drug-costs-and-prescription-trends-in-the-united-states-analyzing-medicare-s-121-billion-spend
#PharmaFlow by PHARMACOMPASS
05 Jan 2017
This week, Phispers has two news items that demonstrate Indian government’s keenness to improve drug quality and reduce bribing of doctors by drug companies. There is more news on Mylan’s EpiPen and Novo Nordisk’s combination drug for diabetes. Read on. Indian government
takes steps to improve drug quality standardsThe Indian government is firm on improving the quality standards in the
pharmaceutical industry. As a first step, it is working on enhancing the skills
of the workforce employed in the industry. Through a notice issued last week by the Central Drugs Standards Control Organization (CDSCO) under the Ministry of Health and Family Welfare, the government has made it “imperative that all personnel employed in pharmaceutical manufacturing units undergo
certification programs developed by the Life Science Skill Sector Development Council”. With effect from January 1, 2018, no person shall be employed in any pharmaceutical
manufacturing unit unless the person has obtained a formal diploma or degree in
the relevant area, the notice said.Meanwhile, the CDSCO is planning to recruit
500 drug inspectors in the coming year in order to double its manpower
by the end of 2017. The organization has already recruited 147 drug inspectors,
who will enhance inspections of manufacturing units in line with current Good
Manufacturing Practices (cGMP) In EpiPen
aftermath, Allergan CEO promises to limit price hikesIn the wake of Mylan’s EpiPen fiasco, Allergan’s CEO Brent Saunders has committed to rebuilding its “social contract” with patients by promising to avoid price gouging
and limiting
price hikes on brand-name medicines.In a blog posted
on the company website this week, Saunders said Allergan would not raise
prices more than once a year. And that any price hike will be limited to
single-digit percentage increases.Saunders also said the company will avoid “major” price hikes without any corresponding increases in costs as products near patent-expiration. Condemning price gouging, Saunders said: “Recently, the actions of these outliers have shifted attention away from the increasingly vibrant medical innovation ecosystem focused on finding new medicines, improving outcomes for patients and, by doing so, lowering the overall cost of disease.” Mylan now under
antitrust investigation over marketing of EpiPens to schools It seems more trouble awaits Mylan
Pharmaceuticals over the EpiPen price increase. Mylan is now being investigated
by the New York attorney general for potential antitrust violations involving
the marketing of these allergy auto-injectors to schools. The attorney general’s office began looking into this matter last week and has issued subpoenas to Mylan for information about its policy of offering discounted EpiPens to schools on the condition that these schools would not purchase competitive products.Since 2004, the price of EpiPens has been increased by 450 percent, after
adjusting for inflation. A two-pack now sells for more than US $ 600. Mylan has
announced several steps to reduce the cost of EpiPen, including introducing a
generic version. But it continues to face political flak.According to an analyst at Sanford C. Bernstein & Co, Mylan’s financial incentive plans are to be blamed for its EpiPen price hike. In 2014, Mylan announced it would reward some 100 employees and executives for not only hitting, but exceeding aggressive profit targets. The company’s top five executives could earn as much as US $ 82 million through the price increases.According to another news report, Mylan has increased its branded ad
spending on the EpiPen by 357 percent over five years. During the same
time, it hiked the price of EpiPen by 179 percent. FDA puts off decision on Novo’s combination diabetes drug The competition between Sanofi and Novo Nordisk over FDA approval for their combination diabetes drugs is getting interesting. Two weeks after the FDA put off approval of Sanofi’s insulin-plus-GLP-1 combo, the FDA has put off a decision on Novo Nordisk’s combination drug too. The FDA will now review Novo’s drug in December. The drug – which is a marriage of Tresiba and Victoza – has already been approved in the EU as Xultophy. Sanofi’s LixiLan is a combination of Lixisenatide and Lantus.Both Xultophy and LixiLan have prospects of becoming blockbuster drugs, with a US $ 6 billion market potential between them. Both companies are counting on these drugs to increase sales, since their diabetes products are being subject to increased competition and pricing pressure. However, a decision on Sanofi’s combination drug is expected to be taken before Novo’s Xultophy. This news has come at nearly
the same time as news about its long-time CEO, Rebien Sorensen, stepping down. From January, Sorensen will be succeeded by
Lars Fruergaard Jorgensen, currently executive vice president and head of
corporate development. India plans penal provisions
to deter drug companies from bribing doctors The Indian government
plans to deter pharmaceutical companies from bribing doctors with freebies by replacing the voluntary code, brought into
place in January 2015, with a strong mandatory code that has penal provisions.The voluntary code was to expire in June 2015. But it has been given four extensions, even though it wasn’t deterring drug companies from giving freebies to doctors. According to a report
published in The Economic Times, the
chemicals and fertilizers ministry is reworking on the toothless voluntary code
to come out with a mandatory one, with penal provisions. The ministry has
sought legal opinion on the new code, which will be applicable to both pharmaceutical
and medical devices companies. Gilead urged to drop legal action against
generic Sovaldi in UkraineIn June, Gilead Sciences had filed a claim against a Ukrainian drug wholesaler, the Ukrainian Drug Regulation Authority, and the Ministry of Health, alleging several of its patents prevent generic drug makers from marketing a version of its Hepatitis C drug – Sovaldi – for the next few years.This week, International humanitarian-aid non-governmental organization – Doctors Without Borders – has urged Gilead Sciences to drop the
case that prevents Pharco Pharmaceuticals – a generic drug maker – from selling a copycat version of Gilead’s Sovaldi in Ukraine.If Gilead wins the
case, generic versions of Sovaldi will not be available in Ukraine. According
to the World Health Organization, more than 1.3 million people are believed to
be infected with Hepatitis C in Ukraine.In a letter, dated September 5, the organization has urged Gilead to “reconsider its business strategy in high-burden, middle-income countries, especially Ukraine,” since its strategies “threaten sustainable access to Hepatitis C treatment in a number of countries” where the advocacy group treats patients. A hearing in this case is scheduled for September 12.In March 2015, a US $ 10 version of Sovaldi was made available in Bangladesh by Incepta
Pharmaceuticals. Sovaldi sells for US $1 ,000 a pill in the US. FDA’s letters to Pan Drugs and Zhejiang Hisoar explain reasons behind import alerts India’s Pan Drugs had two of its facilities placed on FDA’s import alert list last year. Recently, the FDA posted the warning letter issued to Pan Drugs on its website. The letter explains why the
finished formulations unit failed an inspection.For instance, Pan Drugs’ quality unit allowed the use of adulterated API ‘dated May 25–31, 2015’ which was manufactured at Pan Drugs’ Nandesari facility. The Nandesari facility was placed on FDA import alert on May 5, 2015, for egregious cGMP deviations. “Your firm used this API for the manufacture of drugs which were then shipped to the US market from October 7 to November 23, 2015,” the warning letter said.Additionally, the quality unit of Pan Drugs approved certificates of analysis for several API as well as finished products, prior to conducting all quality control and release testing. The production manager “falsified the documents,” the warning letter said.In the case of Hisoar, whose facility was also placed on import alert, FDA investigators discovered that the facility lacked basic laboratory controls to prevent changes to its electronically-stored data and paper records. “When you encountered suspect and out-of-specification (OOS) results, you retested samples until you obtained desirable results,” the warning letter said.
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https://www.pharmacompass.com/radio-compass-blog/india-steps-up-efforts-to-improve-drug-quality-allergan-vows-to-limit-price-hikes
#PharmaFlow by PHARMACOMPASS
08 Sep 2016
