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
Share
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
This week, Phispers brings you more bad news from India’s Biocon, as Health Canada’s caution notice cites data integrity violations highlighted by its regulatory partner. In the US, the generic industry failed to stall the passage of Maryland’s new price hike law. There is also an analysis of how Chinese firms are looking to buy out generic firms. Meanwhile, Takeda invested more in EU, and FDA launched its Adverse Event Reporting
System.
Health Canada’s caution notice highlights data integrity violations at Biocon
The news doesn’t seem to be getting any better for India’s Biocon. Last week, Health Canada sent out a caution notice. The notice highlighted that one of Health Canada’s regulatory partners had informed them about data integrity violations and other GMP failings at the same Biocon site in Bengaluru that had been inspected by French health agency ANSM and the US Food and Drug Administration (FDA).
In July this year, PharmaCompass was
the first to report on how
Biocon’s biosimilar program had
suffered a serious setback as an inspection
by ANSM in March 2017 of its Bengaluru site had uncovered 35 deficiencies, out
of which 11 had been deemed major.
However, there was no mention of
data-integrity concerns. The inspection was conducted by ANSM on behalf of the European Medicines Agency (EMA) as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine).
Post the non-compliance report issued by
the European regulators, Biocon said in a stock exchange filing that it had withdrawn the dossier for two of these products. Since the approval of its trastuzumab and pegfilgrastim applications would require re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon had said in the statement.
The board of Biocon also approved the transfer of the biosimilar business of the company to Biocon Biologics India, a step-down subsidiary of the
company, subject to the consent of its shareholders.
Biocon was also inspected by the FDA
this year where discrepancies
between the information submitted and the manufacturing process performed at
Biocon were uncovered. Biocon had responded by saying that a Form
483 is a standard outcome of any audit and it had responded to all FDA
observations.
Since then, things haven’t looked up for the Biocon/Mylan combine. After, they withdrew their applications for the trastuzumab and pegfilgrastim biosimilars from Europe, the FDA extended the target action date for their trastuzumab
biosimilar by three months.
Unlike other sites, the ANSM inspection report did not specifically raise concerns over data integrity at Biocon. And that’s why, PharmaCompass is of the
view that the USFDA might have shared these concerns with Health Canada.
Generic industry fails to stall passage of price hike law in Maryland
The generic drug industry in the US took a tough stance against Maryland's new pricing regulations and sought an injunction on passing of the law. However, the industry’s efforts failed to achieve the goal.
Generic companies said because they operate nationally, the law could disrupt their operations and impact commerce outside of Maryland. While the court ruled that some of the industry’s arguments have merit, it denied the industry’s request for a preliminary injunction. For now, Maryland’s price hike law has come into effect.
Unlike other approaches to regulate drug pricing throughout the country, Maryland’s law focuses specifically on the generic sector. With this new law, Maryland has become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers.
Takeda vests faith in post-Brexit EU,
expands capacity in Ireland
Japanese drugmaker Takeda is making another investment in its manufacturing facilities in the European Union. Takeda’s plans are being seen as a sign of faith in a post-Brexit EU. The company will invest up to US$ 118 million (€100 million) in a new manufacturing plant at its site in
Clondalkin near Dublin, Ireland. This investment could add another 100 jobs to
its operations in Ireland.
The outlay is for a 3,000 square-meter,
two-story manufacturing plant next to an existing facility at the Grange Castle
business park.
A few months back, Takeda had begun construction
of a US$ 42.8 million (€40 million) facility at
the Grange Castle site to manufacture its newly approved oral multiple myeloma
drug Ninlaro.
Other companies have been reluctant to
invest in Europe. Leif Johansson, chairman of AstraZeneca, recently said the company will have to pull some manufacturing and research operations out of the UK “if there is not a viable deal for its exit from the EU”.
“If something doesn’t happen to take away the current uncertainty it will become a big and important matter for us. Moving manufacturing takes several years,” Johansson said in an interview.
FDA launches Adverse Event Reporting System and new search
tool
This week, the US FDA launched its Adverse Event Reporting System (FAERS) — a database that contains adverse event (AE) reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the agency.
The FDA also launched a new dashboard to facilitate access to
reports of adverse drug reactions.
According to The Centre for Biosimilars,
FAERS
contains 14 million AE reports submitted by healthcare providers, consumers, manufacturers of drugs and biologics, and other stakeholders. “The database is designed to improve transparency and accessibility to AE data by allowing users to search it more easily,” it says.
The database is used as a surveillance tool to help the FDA look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer’s compliance with reporting regulations and responding to outside requests for information.
“The FDA is committed to fully informing patients and providers of adverse events reported with medical products, and this enhanced portal now provides patients, doctors, and others with easier access to the data they are interested in,” Scott Gottlieb, FDA Commissioner, said.
Chinese money chasing generic firms; Pfizer maybe interested in buying BMS
Chinese money is out to purchase one generic firm after
another. Weeks after Chinese pharmaceutical giant Fosun resurrected its deal to acquire India’s Gland Pharma for US$ 1 billion by scaling down the
stake it desires to purchase, it is now looking to acquire the manufacturing
facilities of another Indian pharma company.
It’s new target is Symbiotec Pharma, an active pharmaceutical ingredient (API)
maker specializing in steroid-hormone products. This mid-size drugmaker
complies with quality standards of the US FDA.
Private equity firm Actis holds a 70
percent stake in Symbiotec Pharma, which has been an acquisition target for other drug
makers too. Investment bank Rothschild has been mandated to initiate an auction
process.
But the Chinese money is looking beyond India. According to a Bloomberg
report, Shanghai Pharmaceuticals Holding is focusing on a sale of Alvogen’s US business. Alvogen is a generic pharma company, and owners of its US operations
(such as private equity owner CVC Capital Partners) are exploring various options. Alvogen’s US operations could be valued at US$ 4 billion.
Shanghai
Pharma is also bidding for a stake in Arbor Pharmaceuticals as well as Cardinal Health’s Chinese distribution business.
Pfizer and BMS: While rumors about Pfizer wanting to buy Bristol-Myers Squibb have been doing the rounds from some
months now, a FiercePharma report published this week quoted analysts as
saying they believe the American pharma biggie maybe interested in buying BMS. However, Pfizer may postpone pursuing such a big deal until it has “more clarity on corporate tax reform efforts.”
Pfizer may also be waiting for “further visibility” on BMS’ Opdivo-Yervoy trial in first-line lung cancer patients, the report says.
US health secy resigns over use of private planes; FDA’s Gottlieb travels commercial
In the US, the Health and Human Services
(HHS) Secretary Tom Price resigned last week in the
face of multiple investigations into his use of a private charter and military
jets to travel around the country.
This is being seen as a gross misuse of taxpayers’ money, amounting to nearly US$ 1 million. These trips were between cities where inexpensive commercial flights were also available.
Price apologized for his expensive habit, and vowed to cover the cost. In his resignation letter, Price said he regrets the “recent events have created a distraction,” from his work at HHS.
According to Endpoints, the FDA said
its commissioner Scott Gottlieb “has only traveled via commercial airlines for government travel.” The report adds: “Gottlieb, by the way, does enjoy the occasional treat while traveling”.
In fact, Price is not the only one. The US
Treasury Secretary Steven Mnuchin has made requests for special travel
arrangements using government craft.
Meanwhile, the White House has placed new requirements on officials’ air travel plans. Federal agencies were told “all travel on government-owned, rented, leased, or chartered aircraft, except space-available travel and travel to meet mission requirements ... shall require prior approval from the White House Chief of Staff."
Impressions: 4080
https://www.pharmacompass.com/radio-compass-blog/biocon-now-in-data-integrity-net-chinese-money-on-lookout-for-generic-firms
#PharmaFlow by PHARMACOMPASS
05 Oct 2017
This week, Phispers brings you the high-pitched drama from President Trump’s American Manufacturing Council, with Merck CEO Ken Frazier leading the pack of CEOs who abandoned it over the Charlottesville unrest, even as J&J’s CEO said he’ll stay on. But then, Trump disbanded the council.
We bring you
news on more generic companies in distress due to a drop in their business in
the US and compliance problems. Meanwhile, companies like Intas and Aurobindo
Pharma from India and Fosun from China are looking for growth via acquisitions.
And Softbank has invested US$ 1.1 billion in Roivant. Read on.
Merck CEO’s Trump council resignation over ‘intolerance’ has others follow; council disbanded
The US President Donald Trump’s American Manufacturing Council has been in the news for the last few days. First, Merck CEO Kenneth Frazier resigned from the council, after urging American leaders to reject expressions of ‘hatred, bigotry and group supremacy’ on Twitter.
In a statement, Trump had blamed “many sides” for the violence in Charlottesville, Virginia, over the last weekend. A white nationalist rally had turned violent in the city when a car rammed into many people who were protesting peacefully against the demonstration. White supremacists and other hate groups had assembled in the city to protest the removal of a statue of Confederate General Robert E. Lee.
Trump has since faced widespread criticism for not specifically denouncing the white supremacists. Following Frazier’s resignation, many CEOs — including Intel
Corp’s Brian Krzanich, Under
Armour Inc’s Kevin
Plank and AFL-CIO chief Richard Trumka — quit Trump’s council over his ‘response to the Charlottesville
violence’.
Though Frazier
said he was taking a stand “against intolerance and extremism”, Trump mocked at him on Twitter, and said he will now “have more time to LOWER RIPOFF DRUG PRICES!” Later, Trump did condemn the hate groups, but it seemed too little to late.
Only three
weeks back, Trump had called Frazier a “business genius” and a “great, great business leader” and had thanked Merck for investing in American jobs. Frazier is one of the few African-Americans to head a Fortune 500 company.
Meanwhile, on
Tuesday, Johnson & Johnson’s CEO Alex Gorsky said he isn’t abandoning Trump’s council. In a statement, Gorsky said he’ll stick with the council as a way to express “the values of Our Credo as crucial public policy is discussed and developed.” He said J&J is “an important voice on healthcare.”
However, as the CEO resignations
continued to mount, Trump tweeted, “Rather than putting pressure on the business people of the Manufacturing Council & Strategy & Policy Forum, I am ending both. Thank you all!”
Trump made
the announcement on Twitter, less than an hour after one of the groups was planning to inform
the White House that it would disband, a CNBC report said.
Dr. Reddy’s fails EU GMP inspection; can’t export to EU until it clears next inspection
Less than two
months after providing positive inspection updates with regard to the status of its
manufacturing compliance, Dr. Reddy’s Laboratories (DRL)
failed a European cGMP manufacturing inspection last week. The inspection, by the German regulatory authority, at DRL’s FTO 2 finished formulation plant (situated in Hyderabad) uncovered critical deficiencies.
The inspectors concluded that the ‘essential elements of the Pharmaceutical Quality System’ were not effective. Due to this, the plant will not be able to make any further dispatches to the European Union until the next inspection, “to be initiated by an invitation from betapharm,” DRL said in a filing.
Betapharm Arzneimittel GmbH is DRL’s wholly-owned subsidiary in Germany and the Hyderabad plant produces tablets and capsules.
Previously, PharmaCompass
had observed that the inspection focus of regulators has moved beyond audit trails. In the case of DRL, the inspectors found that out of specification (OOS) results were “systematically invalidated in hundreds of cases”.
The integrity of the batch manufacturing/packaging record at the Hyderabad facility was also questioned. The absence of recording “negative events” on the “clean” batch manufacturing records prevented successful investigation into market-complaints.
In addition to
the integrity of the cleaning being questioned, the design, condition and maintenance of rooms and
equipment were also major concerns at DRL. The inspectors found dirty rooms and
equipment, along with unsuitable doors and dispensing equipment for
manufacturing.
Generics in distress: Sun reports its first loss in 12 years; Mylan cuts
forecast
Generic
drugmakers have seen their US businesses plummet as the US Food and Drug
Administration (USFDA) has stepped up product approvals, ushering in more
competition and prompting a steady erosion in prices.
As a result,
generic drug stocks have been under pressure. Last week, Phispers
reported on how Teva Pharmaceutical had reduced its earnings goal. Well, companies like Mylan NV and Sun Pharmaceutical Industries have
joined the pack by reporting lackluster quarterly results and cutting
guidance.
After a gap of 12 years or more, Sun Pharma reported its first quarterly loss last week, after it
settled an antitrust case in the US. Sun Pharma paid US$ 148 million (INR 9.5
billion) to plaintiffs including Canadian rival Apotex in July to settle an antitrust
lawsuit in the US over sleep-disorder drug modafinil.
Sun, which is India’s biggest drugmaker, posted a total loss of US$ 66.3 million (INR 4.25 billion) in the three months ended June 30, 2017.
Last week, Mylan also said it is likely to see a decline in its profitability due to delays in the launch of key new drugs and erosion in the prices for generics in the US.
Though the FDA is speeding up generics approvals, it’s just not speeding up the ones that Mylan badly needs.
Mylan said it plans to remove copies of big drugs like Copaxone from Teva and Advair from GlaxoSmithKline—from its 2017 guidance, pushing them into 2018. It now expects revenues to hit between US$ 11.5 billion and US$ 12.5 billion for the year, down from a previous range of US$ 12.25 billion to US$ 13.75 billion.
Chip Davis, CEO of the Association of Accessible Medicines — a trade group for generic and biosimilar drugs — said some of the (demand-supply) imbalances in the generic marketplace haven’t happened overnight. But the “reality is that the sustainable, robust competitive market is at risk now.” He expects generic drugmakers to continue to feel the pressure, amid declining prices and flat revenues.
From June 2016
to June 2017, the number of generic prescriptions is nearly flat, with an
increase of only around 1 percent; while revenue is down 12 percent, Davis
said.
However, one
generic company that bucked the trend was Perrigo. It reported US$ 1.24 billion in sales and adjusted
earnings of US$ 1.22 per share, topping the consensus for US$ 1.18 billion and
92 cents, respectively.
However, this performance too did not come on the back of generics — Perrigo’s generic business declined 13 percent
year-on-year. The company performed well due to its consumer business.
India’s Intas and Aurobindo, PE player SK Capital and China’s Fosun in acquisition mode
Even during
these bad times for generics, some pharma companies are on the prowl. For
instance, Ahmedabad-based Intas Pharmaceuticals is on the look out for buying into a larger piece of Israeli-drugmaker Teva’s existing operations in Europe. Last year, it had bought out Teva’s UK and Ireland assets.
Intas — with Temasek and Chrys Capital as its investors — is bidding for Teva’s women's health, oncology and pain management divisions in Europe for US$ 1.5 billion. The company has reportedly reached out to several Indian and global banks, such as ICICI, Axis, Citi, Bank of Tokyo Mitsubishi UFJ, HSBC among others, to finalize the financing before putting in a bid by the month-end. If successful, this will be the largest cross-border M&A involving an Indian pharma company.
PharmaCompass has been routinely covering the troubles at Teva, the world’s largest maker of generic drugs. Teva plans to sell off its assets, in order to reduce its US$ 36 billion debt.
There is another company that Intas has set its eyes on — Mallinckrodt's US generic business. According to a news report, India’s Aurobindo Pharma and Intas are in the race to buy
UK-based Mallinckrodt’s generic drugs business in the US
valued at US$ 2 billion.
Once complete, this will be the biggest-ever overseas acquisition made by an
Indian drug company.
The generic
business of Mallinckrodt generates sales of around US$ 1 billion. The companies have submitted an initial bid for Mallinckrodt’s generic business, which has been up for sale for the last couple of months.
Meanwhile, US specialty drugmaker — Arbor Pharmaceuticals — too is up for grabs. And amongst the bidders for a stake in Arbor are companies like Fosun International Limited’s healthcare business and Shanghai Pharmaceuticals Holding. The two companies are competing to buy a stake of at least 20 to 30 percent, sources said. The holding in the Atlanta-based Arbor could fetch around US$ 600 to US$ 700 million.
In the US, SK
Capital, a private investment firm focused on specialty materials, chemicals
and pharmaceuticals, said it has signed a definitive agreement to acquire Perrigo API, the active pharmaceutical ingredients (API) business
of Perrigo Company Plc.
The two
parties have agreed to enter into a long-term supply agreement for Perrigo API
to supply multiple existing commercial and pipeline APIs to Perrigo. The
transaction is expected to close during the last quarter of this year.
Softbank invests US$ 1.1 billion in Vivek Ramaswamy’s abandoned drug venture —Roivant
Last week, Roivant
Sciences announced that Japanese conglomerate — SoftBank Group — is leading a US$ 1.1 billion investment to fund its expansion. SoftBank is the largest
private financier in healthcare.
Roivant was
founded by Vivek Ramaswamy, a 32-year old American entrepreneur who began his
career as an investor in the biotechnology sector. Roivant is a holding company
with companies like Axovant Sciences and Myovant Sciences under its umbrella,
along with private-subsidiaries like Dermavant, Urovant and Enzyyant.
According to Endpoints
News, SoftBank’s US$ 1.1 billion mega-investment in Roivant won’t likely be its last in biotech. Quoting reports, it says SoftBank group’s global US$ 100 billion equity fund has begun a recruitment campaign for scientists with an eye to backing more companies that use new data technology to identify drugs with solid development potential.
Ramaswamy’s business model has relied on therapies that have been taken off the shelves of some big players. Back in December 2014, Ramaswamy had bought an old Alzheimer’s drug that GSK had dropped for US$ 5 million. Six months after purchasing the compound from GSK, and without doing any clinical development, the drug resulted in the biggest biotech IPO ever for Axovant, which got valued at US$ 2 billion. Since then, Ramaswamy has been setting up more companies.
Biocon,
Mylan suffer another setback as European biosimilar applications are withdrawn
Last month, PharmaCompass broke the story about Biocon’s biosimilar
program suffering a serious setback as a current Good Manufacturing Practices (cGMP) inspection by the French health agency — ANSM — in March 2017 of its drug product site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major.
The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine).
This week, in
a stock exchange filing, Biocon said it has withdrawn the dossier for two of these products. Since the approval of its trastuzumab and pegfilgrastim applications would require a re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon said in the statement.
The
announcement comes two weeks before the FDA is supposed to take a decision on
the trastuzumab application.
Although Roche’s European patents
on Herceptin (trastuzumab) expired in 2014, it is still the third-biggest drug,
with 2016 sales of US$ 6.7 billion (CHF 6.8 billion) for the Swiss Group.
Until the news of the
ANSM inspection surfaced, Mylan and Biocon were expected to be the first to bring a Herceptin biosimilar to market.
Impressions: 4444
https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-fails-eu-inspection-trump-disbands-business-councils-after-merck-ceo-and-others-quit-it-over-intolerance
#PharmaFlow by PHARMACOMPASS
17 Aug 2017
Last week, PharmaCompass
broke the story about Biocon’s biosimilar program suffering a serious setback as a current Good Manufacturing Practices (cGMP) inspection by the French health agency — ANSM — in March 2017 of its site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major.
The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine).
Following our story,
Biocon issued a statement which mentioned that it had received “GMP approval
for biologics drug substance facilities” from the French regulator; and that the drug product facility is “to be re-inspected”.
This week, PharmaCompass delves deeper into the findings of the French health agency and looks at potentially what this could mean for the future of Biocon’s biosimilar program.
Concerns raised by
ANSM in March 2017 inspection
In 2006, Biocon established India’s largest integrated biotechnology hub, comprising of an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in a Special Economic Zone (SEZ) near Bengaluru.
In March 2017, the
French health agency conducted inspections of three Biocon facilities, two of
which were located within the Special Economic Zone in Bommasandra
in Bengaluru, and the other in Electronics City, Bengaluru.
Biocon received Good
Manufacturing Practices (GMP) compliance
certificates for one facility located in the SEZ and the other in Electronic
City. The inspection certificate reports that the approved SEZ plant performed
manufacturing activities for trastuzumab. It also performed activities for
pegfilgrastim, restricted to quality control (physico-chemical and
microbiological).
The Electronics City
facility manufactures the active substance used in the pegfilgrastim and
insulin glargine biosimilars.
In ANSM’s non-compliance report issued to the drug product manufacturing facility (situated in the SEZ in Bommasandra), its concerns relate to the following operations of the biosimilar products: Fulphila® (pegfilgrastim), pre-filled syringe presentation: drug product manufacture and quality control operations; Ogivri® (trastuzumab), vial presentation (freeze-dried product): drug product manufacture and quality control operations; Semglee® (Insulin glargine), cartridge presentation: secondary packaging and drug product quality control.
cGMP manufacturing – a stumbling block for biologic drugs
There is no doubt that ANSM’s issuance of GMP compliance certificates to Biocon’s two drug substance facilities for biosimilars is a tremendous achievement.
However, concerns over
fill/finish drug product operations have recently delayed US approvals for Pfizer’s biosimilar
of Amgen’s drug Epogen (epoetin alfa) as well as Sanofi’s Humira competitor, sarilumab. While
Sanofi was able to address the regulator’s concerns in just a few months, Pfizer is facing
an uphill battle in its effort to resolve compliance issues at its McPherson,
Kansas facility, which it acquired as part of the US$ 17 billion acquisition of Hospira.
Unlike other products for which biosimilars have been approved by the US and European regulators, Amgen’s Neulasta (pegfilgrastim), which brought in US$ 4.6 billion in sales last year, has not been an easy product to get approved.
Sandoz — Biocon’s competitor for a Neulasta biosimilar — withdrew its European application earlier this year after clinical equivalency concerns coupled with concerns over the lack of a certificate of GMP for the medicine’s manufacturing site emerged.
Sandoz’s European withdrawal follows a rejection by the US Food and Drug Administration (FDA) of Sandoz’s application for its proposed Neulasta biosimilar in July 2016, after accepting it for review in November 2015.
A little over a month
ago, Coherus BioSciences Inc announced that the FDA denied the approval of its Neulasta
biosimilar. The FDA requested Coherus for a re-analysis of certain data and
asked the drug developer for more manufacturing information, the company said.
Other biosimilar makers have encountered problems as well. Hungary’s Gedeon Richter, withdrew its application for a biosimilar of Neulasta after the EMA “was concerned that study results had not shown that (the proposed biosimilar) was handled by the body in the same way as the reference medicine Neulasta.”
In 2014, Apotex was the first to file a proposed
biosimilar application for pegfilgrastim in the United States. After that,
there has been no news from Apotex, though in a recent May 2017 citizen
petition Apotex has asked the FDA to require pegfilgrastim
biosimilar applicants to conduct appropriate clinical studies for this
complex biologic.
In its petition, Apotex highlighted that Coherus had apparently not conducted the necessary studies and a month later, the FDA denied Coherus’ approval.
In 2013, Biocon entered
into an exclusive strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin
analogs. And, in February 2017, the FDA accepted Mylan/Biocon’s proposed pegfilgrastim biosimilar (MYL-1401H) for review. Based on the User Fee Act, the
FDA should take a decision on this application by October 9, 2017.
Losing the pole
position on trastuzumab
Although Roche’s European patents on Herceptin (trastuzumab) expired in 2014, it is
still the third-biggest drug, with 2016 sales of US$ 6.7 billion (CHF 6.8 billion) for the Swiss Group.
Until the news of the
ANSM inspection surfaced, Mylan and Biocon were expected to be the first to
bring a Herceptin biosimilar to market.
A recent QuintilesIMS report, commissioned by the
European Commission, shows that in therapy classes where more than one
biosimilar has been launched, the first to market biosimilar usually takes the
highest biosimilar market share. The report shared examples where the first
biosimilar entry captured over 70 percent of the biosimilar market share
compared with just 30 to 40 percent for the second entry. A third entrant captured
only 5 to 22 percent of the market.
While Biocon submitted its application to the European agency in August 2016,
Samsung followed with its submission in October 2016, Celltrion in November 2016 and Amgen in March 2017.
Any approval delay could
lead to a revenue loss of hundreds of millions of dollars.
Biocon stock gains on back of meet to discuss Mylan’s trastuzumab filing
Despite everything, there hasn’t been much adverse impact on the Biocon stock due to the news on the French health agency’s inspection. The Biocon stock gained over 13 percent intraday on July 12 as investors turned bullish ahead of the FDA’s Advisory Committee (Adcom) meeting (to be held on July 13) to discuss the trastuzumab filing done by Mylan.
According to news reports,
investors could monitor the outcome of the Adcom. If the product is approved by
the FDA, it will be the first Herceptin biosimilar in the US market.
Moreover, the brokerages remained mixed on Biocon’s prospects. According to Moneycontrol, “Biocon could be a beneficiary of the unfolding global biosimilar opportunity.”
Our view
Prior to the ANSM
inspection, Biocon was inspected by the FDA where discrepancies between the
information submitted and the manufacturing process performed at Biocon were
uncovered.
The company responded in a similar manner by saying that a
Form 483 is a standard outcome of any audit and it had responded to all FDA
observations.
Now, it remains to be
seen how quickly the regulators are convinced with the responses so that Biocon
and its exclusive strategic partner Mylan can make a landmark entry into the
field of biosimilars.
Given all the hurdles in the way to get a biosimilar approved, it remains to be seen whether the Biocon-Mylan combine will create history, or become yet another ‘has been’ in the race for biosimilars.
Impressions: 4052
https://www.pharmacompass.com/radio-compass-blog/can-biocon-mylan-combine-overcome-its-biosimilar-program-s-european-inspection-failure
#PharmaFlow by PHARMACOMPASS
13 Jul 2017
India’s pharma stocks have been taking
a beating of late due to compliance-related issues and the pressures on the US market, putting a big question mark on the growth of the country’s pharmaceutical industry in the future. So
far, Biocon had been able to weather
this storm
due to its successful compliance record, and an exclusive
strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin analogs, which in turn were expected to bring in a windfall for the company.However,
Biocon’s biosimilar program suffered a serious
setback as an inspection by the French health agency, ANSM, in March 2017 of its
site located in Bengaluru, India, uncovered 35
deficiencies, of which 11 were deemed major. The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (Pegfilgrastim), Ogivri® (Trastuzumab) and Semglee® (Insulin glargine).Need
for a follow-up GMP inspection The
ANSM found major deficiencies in the following areas: Environmental
monitoring-training, OOS results management, cleaning validation, process
validation, vendors qualification, media fill test, cross-contamination risks, batch manufacturing record, differential pressure alarms’ management in classified areas and access management in SAP for batch certification.The
agencies concluded that the European Marketing Authorization Applications of
the three biosimilar products currently under assessment should not be approved
while the non-compliance report is in effect.The
report also mentions that a follow-up GMP inspection is required in order to
ensure that all the corrective and preventive action (CAPA) plans have been
implemented and finalized by the site and that a robust quality system is in
place.Biocon
and Mylan have made two
submissions to the FDA for their biosimilars of Amgen’s Neulasta (pegfilgrastim) and Roche’s Herceptin (trastuzamab). Now,
it remains to be seen if the verdict of the FDA will be any different from that
of the European agencies.
Impressions: 12435
https://www.pharmacompass.com/radio-compass-blog/biocon-s-biosimilars-program-fails-european-cgmp-inspection
#PharmaFlow by PHARMACOMPASS
08 Jul 2017
This week in Phispers, we bring you news on J&J’s Invokana, a drug that reduces heart risk while increasing the risk of amputation of toes. There is news from Google, which is tying up with India’s Aravind Eye Care System for its artificial intelligence eye doctor initiative. And WHO takes a step towards reducing antibiotic resistance by grouping antibiotics into ‘Access’, ‘Watch’ and ‘Reserve’.
Manufacturing errors trigger drug recalls by Lupin and Dr. Reddy’s in the US
Earlier this month,
we carried an article on the end of India’s pharma honeymoon.
News this week from Lupin and Cipla added another dimension to the problem as manufacturing
errors triggered drug recalls in the United States.
Lupin voluntarily recalled a lot of its birth control pills — Mibelas 24 Fe — in the US. A market complaint indicated a packaging error, making the lot number and expiration
date no longer visible. This product is an oral contraceptive for women.
As a result of the
packaging error, the FDA says the first four days of the birth control packet have four
non-hormonal placebo tablets as opposed to the active tablets. This may place
the user at risk for contraceptive failure and unintended pregnancy.
Similarly, Dr. Reddy’s had to recall hundreds of thousands of cartons of a popular acne medicine — Zenatane — manufactured by Cipla’s plant in Pune.
According to FDA enforcement reports, Dr. Reddy’s is recalling 190 lots, consisting of 778,279 cartons of its Zenatane brand isotretinoin capsules, in four dose sizes. The voluntary Class II recall was initiated in late May after the products failed dissolution testing.
During this period of
turmoil, the Indian company which is generating a lot of positive press is Cadila Healthcare.
Cadila’s US
division Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has received final FDA approval to
market Nystatin Topical Powder, an anti-fungal
antibiotic used to treat skin infections caused by yeast.
There is more good
news from Zydus Cadila. After years of patent battles, the FDA has approved Zydus Cadila’s generic version
of Shire’s ulcerative colitis drug Lialda.
This came as a rude
shock to Shire investors who had believed the US$ 800 million drug was safe for
a few more years. However, there is a chance that instead of a flood of
generics, the Zydus' generic may be the only competition for Lialda for sometime.
Zydus Cadilla has indicated that its version will have a six-month exclusivity.
J&J’s diabetes
drug saves heart at the cost of toes; Sanofi’s insulin slashes hypoglycemia risks for seniors
Would you like to
sacrifice your toes to save yourself from a heart attack? Well, a diabetes drug
made by Johnson & Johnson (J&J), does just that. The drug — Invokana — decreases the risk of heart attacks and strokes, while increasing the risk of amputation,
particularly of toes.
According to the
results of the 10,142-patient study, funded by J&J, for every three heart
attacks, strokes, or cardiovascular deaths prevented by Invokana, there were
two amputations, 71 percent of them of toes or the lower foot.
While this is a setback to J&J, its rivals — Eli Lilly and Boehringer Ingelheim — who make a similar drug called Jardiance, may be cheering the findings of this
study, performed on sodium-glucose co-transporter 2 (SGLT2) inhibitors. These
drugs prevent the kidney from absorbing sugar from the blood.
But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” Harlan Krumholz of Yale University said.
Another study
examining an at-risk population of seniors who
had switched to basal insulin found Sanofi’s Toujeo to outdo its peers at cutting the risk of
hypoglycemia in older patients.
During a six-month follow-up, the study found that amongst the ‘at-risk’ seniors, those taking Toujeo were 57 percent less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s predecessor, Lantus.
Google ties up
with Indian hospital chain for artificial intelligence eye doctor initiative
Google will soon begin
work on a grand experiment that would use machines to widen access of
healthcare. If successful, this initiative will protect millions of diabetes patients
from an eye disease that leads to blindness.
Last year, researchers at Google had said they had trained image recognition algorithms to detect signs of diabetic retinopathy roughly as accurately as human experts. Left untreated, diabetic retinopathy causes blindness. The software examines photos of a patient’s retina to spot tiny aneurisms that would help detect early stages of the disease.
Google is working
with the Aravind Eye Care System in India, a network of eye hospitals, in order
to integrate this technology.
“This kind of blindness is completely preventable, but because people can’t get screened, half suffer vision loss before they’re detected,” Lily Peng, a product manager with the Google Brain AI research group, said. “One of the promises of this technology is being able to make healthcare more accessible.” There are more than 400 million people worldwide with diabetes, including 70 million in India.
FDA tells Endo to
pull out its opioid pain medication, as Gottlieb attacks addiction
Last week, the US FDA
asked drugmaker Endo Pharmaceuticals to remove its powerful opioid pain medication — Opana ER — from the market, due to “the public health consequences of abuse”.
“We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” he added.
Opioid overdoses killed 33,000
Americans in 2015, with half of those involving a prescription opioid.
Opana ER, which is oxymorphone hydrochloride, is used to manage severe pain. The FDA
approved it for this use in 2006. The drug is about twice as powerful as OxyContin, another often abused opioid.
In 2012, Endo
reformulated the drug to make it more resistant to physical and chemical
tampering. While the drug met the standards for approval, FDA says Endo never
showed that the reformulation would reduce abuse.
Amgen loses bid to delay Novartis’ biosimilar; FDA rejects Coherus’ biosimilar for Neulasta
Amgen lost a case in the Supreme Court of the United States that
sought to delay biosimilars of its rivals. Amgen had argued that its biosimilar rivals
should be forced to delay their 180-day marketing notices until the FDA had
made up its mind on the marketing application.
However, on Monday, the Supreme Court took a decision by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.”
This has proven to be
a clear win for Sandoz — the generic unit of Novartis that is fielding an array of copycat biologics. The group is launching a copy of Amgen’s Neupogen. And in the process, Sandoz has
unleashed a fresh wave of biosimilars hitting the US market.
However, Amgen won somewhere else — the FDA rejected Coherus Biosciences’ application for a biosimilar of Amgen’s blockbuster Neulasta (a drug that fights infections in cancer
patients). This action effectively delays any rival until 2018, at the
earliest.
The FDA's response
comes as Amgen gears up for biosimilar competition for Neulasta, which
generated about US$ 4.6 billion in sales last year. The FDA requested Coherus
for a re-analysis of certain data and asked the drug developer for more
manufacturing information.
WHO updates list
of essential medicines; groups antibiotics into three categories
Last week, the World
Health Organization (WHO) released its Essential Medicines List (EML), with a
new advice on which antibiotics to use for common infections and which to
preserve for serious circumstances. Amongst the additions to the WHO Model list of essential medicines
for 2017 are medicines for HIV, hepatitis C, tuberculosis and leukaemia.
The EML is used by
many countries to increase access to medicines. The updated list has added 30
drugs for adults and 25 for children, and specifies new uses for 9
already-listed products. In all, it contains 433 drugs deemed essential to
address the most important public health needs.
This time, WHO has grouped antibiotics into three categories – ACCESS, WATCH and RESERVE – with recommendations on when each category should be used.
Initially, the new
categories apply only to antibiotics used to treat 21 of the most common
general infections. If found useful, it could be broadened in future versions
of the EML to apply to drugs to treat other infections.
Antibiotics in the
ACCESS group must be available at all times as treatments for a wide range of
common infections. It includes drugs like amoxicillin, an antibiotic used to treat infections such as
pneumonia.
The WATCH group
includes antibiotics that are recommended as first- or second-choice treatments
for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of
urinary tract infection) and upper respiratory tract infections (such as
bacterial sinusitis and bacterial bronchitis), should be dramatically reduced
to avoid further development of resistance.
The third group, RESERVE, includes antibiotics that should be considered as last resorts, such as colistin and some cephalosporins. These must be used
only in the most severe circumstances when all other alternatives have failed.
Impressions: 3373
https://www.pharmacompass.com/radio-compass-blog/j-j-s-diabetes-drug-reduces-heart-risk-at-the-cost-of-toes-google-s-ai-eye-doctor-initiative
#PharmaFlow by PHARMACOMPASS
15 Jun 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.
Click here to Access All the
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.
Click here to Access All the
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.
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: 58546
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2016-who-sold-the-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
19 Apr 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
