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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2017 was a landmark
year for the pharmaceutical industries in the US and Europe, with a sharp
increase in the number of new molecular entities (NMEs) being approved in both
the geographies.
The US Food and Drug Administration (USFDA) approved 46 NMEs
in 2017, a strong bounce back from only 22 NMEs approved in 2016.
The
46 approvals by the USFDA’s Center
for Drug Evaluation and Research (CDER) is the
second highest total 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. We also identified eight drugs that got approved
in Europe before winning the USFDA nod.
This
week PharmaCompass shares its compilation of the 46 novel drugs approved
in the US, of which 34 (or 74 percent) were small molecules and 12 (or
26 percent) were biologics, which were approved by the USFDA.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
We
have also evaluated these new
drug therapy approvals with regard to their estimated sales potential. While
the sales estimates of a new drug are far from certain, our effort is directed
at providing insights into the potential these drugs hold along with attempting
to identify emerging market trends.
An
overview of USFDA’s approvals
The USFDA’s CDER focusses extensively on the approval of novel drugs “which are often among the more innovative products in the marketplace, and/or help advance clinical care by providing therapies” that have never before been marketed in the United States.
In addition, CDER
also looks at new and expanded uses of USFDA-approved drugs. In 2017, the CDER
also worked on approving five new biosimilar drugs, which are highly similar to
the USFDA- approved
therapeutic biological products.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
New formulations or
new manufacturers of USFDA-approved products that can provide advantages over
original products, such as being able to take the drug on an empty stomach and
not with food, were also approved.
New dosage forms
entered the market that add value to already approved drugs, such as chewable
tablets for patients unable to swallow pills and Abilify MyCite (aripiprazole
tablets with a sensor).
Aripiprazole was
first approved by the USFDA in 2002 as a tablet to treat patients with
schizophrenia and was marketed under the brand name Abilify.
In 2017, Abilify MyCite
was approved as a tablet which contains an electronic sensor. Abilify MyCite
allows the patient to track whether he or she has taken the medication via a
smartphone or the cloud.
Patients can also
give their caregivers or physicians access to the information through a
web-based portal.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
In the list of 2017 approvals, CDER identified 15 of the 46 novel drugs approved in 2017 (33 percent) as first-in-class while 18 drugs (39 percent) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans.
Of the 46 novel drugs
approved in 2017, 36 (78 percent) were approved in the United States before
receiving approval in any other country.
The American stars of 2017, by sales revenue
Of all the drugs
approved by the USFDA, the highest expectations are from Regeneron and Sanofi’s first-in-class monoclonal antibody (mAb) — dupilumab. The (IL)-4 receptor subunit-α antagonist has shown benefits in various kinds of inflammatory and allergic diseases.
While the USFDA approved the drug for atopic dermatitis, it is also being developed for asthma, chronic obstructive pulmonary disease (COPD) and other indications.
Evaluate Pharma analysts estimate the sales of dupilumab
at US$ 4,938 million by 2022.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
Expectations are also
high from two other mAb products. Genentech and Roche’s anti-CD20 mAb ocrelizumab for relapsing and primary
progressive forms of multiple sclerosis is expected to bring in US$ 4,088
million by 2022 while Pfizer’s avelumab, an anti-PD L1 cancer drug
co-developed along with Merck KGaA, which was approved to treat metastatic
Merkel cell carcinoma, is expected to achieve peaks sales of US$ 4-6 billion
with an estimated US$ 3 billion in annual sales for Pfizer.
In late 2015, AstraZeneca partnered with Acerta Pharma to develop a potential best-in-class irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor — acalabrutinib.
AstraZeneca
acquired 55 percent equity in Acerta for an upfront payment of US$ 2.5 billion
and should have completed its payment of an additional US$ 1.5 billion now that
the USFDA has approved the cancer drug, which is estimated to have peak sales
of US$ 2,500 million.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
Also
expected to bring in US$ 2,500 million in sales is Novartis’ treatment for postmenopausal women with a type of advanced breast cancer — ribociclib. While the USFDA
approved the drug in March 2017, the EMA
approved it in August 2017.
The
European specials of 2017
While
many drugs were approved in the United States before being approved in Europe, PharmaCompass
has identified 8 active substances which have not been approved in the US but
got EMA approval in 2017.
AstraZeneca’s treatment for hyperkalaemia — Lokelma (sodium zirconium
cyclosilicate) — got approved by the EMA. However, the FDA did not approve it after the agency raised concerns over the manufacturing of the drug following an inspection of the facility.
Lutathera
— a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs — got approved by the EMA and its developer Advanced Accelerator Applications (AAA), who in turn got bought over by Novartis for US$ 3.9 billion.
The
application for Lutathera has been filed with the USFDA. Under the Prescription
Drug User Fee Act (PDUFA), the agency is scheduled to make a final approval
decision this week (on January 26, 2018).
Tivozanib
(Fotivda, an oral, once-daily, vascular endothelial growth factor or VEGF) tyrosine kinase inhibitor (TKI)
discovered by Kyowa Hakko Kirin and approved for
the treatment of adult patients with advanced renal cell carcinoma was also
approved in Europe before getting the nod in the US.
Our view
While the USFDA’s CDER approved the highest number of drugs in two decades, the approvals of the year were done by USFDA’s Center for Biologics Evaluation and Research (CBER) which approved two cell-based gene therapies.
Novartis’ Kymriah (tisagenlecleucel), the first-ever gene therapy — known as CAR-T (short for chimeric antigen receptor T-cell) — was approved for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).
In its press statement, the USFDA described this as a “historic action”.
CAR-T is a type of cancer immunotherapy
that harnesses the body’s immune system to fight cancer cells. In this case, the therapy removes a person’s cells, reengineers them and then puts them back in their body to attack cancer cells.
In CAR-T therapy, every single dose of the
treatment is unique and completely personalized to the patient. The Novartis drug came with a list price of US$ 475,000 for a one-time treatment.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
Gilead also
bet big on the technology and acquired Kite Pharma for US$ 11.9 billion in
August. The USFDA also approved Kite’s most advanced CAR-T therapy candidate — axicabtagene ciloleucel (axe-cel).
Gilead announced a price significantly lower than the launch price at which Novartis
is selling its CAR-T treatment (Kymriah).
With Novartis and
AstraZeneca getting three therapies approved, Pfizer, Roche, Valeant and the
team of Sanofi and
Regeneron bagging two each
and almost half the drugs approved by the USFDA’s CDER in 2017 expected to generate more than US$ 1 billion in sales, things look promising for innovation in pharmaceuticals and also provide interesting
opportunities for generic drug manufacturers.
Click here for our list of FDA’s Novel Drug Approvals in 2017 (Excel version available) for FREE!
Impressions: 14347
https://www.pharmacompass.com/radio-compass-blog/sales-forecast-of-fda-s-new-drug-approvals-of-2017
#PharmaFlow by PHARMACOMPASS
25 Jan 2018
This week in Phispers, we look at the measures US FDA announced last week to increase competition in generics, which in turn would reduce the increases in their prices. Pfizer exited its JV with Hisun in China, while Albert Bourla became its new COO. We also look at a digital pill for mental illnesses from Japanese drugmaker Otsuka that obtained the FDA’s nod this week. Meanwhile, the EU plans to change patent rules for APIs to give an impetus to its manufacturing sector.
After
Brazil, Pfizer exits
Chinese venture plagued with data-integrity concerns
In July this year,
Pfizer had bowed out of Brazil with the
sale of its stake in Laboratório Teuto Brasileiro. The reason — the historic recession in Brazil, because of which the joint venture never really took off.
Last week, Pfizer sold its 49 percent equity stake in the joint venture — Hisun-Pfizer Pharmaceutical to Sapphire I (HK) Holdings Limited. Though the company did not give a reason in its statement, we suspect data integrity concerns to be the key reason behind this exit.
The joint venture
between Pfizer Inc and Zhejiang Hisun Pharmaceuticals Company Ltd had been formed in
2012 to develop, manufacture and commercialize branded generic pharmaceutical
products in China and in the global markets.
In September 2015,
PharmaCompass had covered
how the United States Food and Drug Administration (FDA) had placed Zhejiang Hisun Pharma on its import alert list
after a March 2015 inspection uncovered “systemic data manipulation across your facility”
The transfer of Pfizer’s equity stake will allow both Hisun and Pfizer to focus on their core strengths, a Pfizer statement said. “After Pfizer’s equity share transfer, the joint venture will change its name but will retain its current rights to manufacture, sell and distribute all of Hisun-Pfizer Pharmaceutical’s currently marketed and pipeline products in China,” it added.
Pfizer
has been facing problems with its acquisitions. Last week, PharmaCompass
reported on Pfizer facing supply shortages for products from the legacy Hospira portfolio. Pfizer had
acquired Hospira in 2015 for US$ 15 billion.
Meanwhile, Pfizer
has promoted Albert Bourla to the newly created post of chief operating officer. This way, America’s largest drug maker hopes to free up its CEO Ian Read to focus more on long-term strategy and in engaging with the government and industry leaders. Bourla, who had joined Pfizer in 1993, will
assume the COO post next year.
FDA okays Otsuka’s Abilify MyCite, a digital ingestible pill for mental illness
Back in September
2015, PharmaCompass had covered ingestible sensors in a story on Abilify (aripiprazole), a combination product embedded with a
Proteus ingestible sensor.
Japanese drugmaker
Otsuka Pharmaceutical Company’s Abilify is a drug used to treat a variety of mental illnesses. It uses Proteus Digital’s
ingestible sensor that can
be incorporated into a tablet, placed inside a hard gelatin capsule, or
attached to the surface of a tablet/capsule using an edible adhesive layer.
This week, the US FDA approved Otsuka’s Abilify MyCite. This is the first drug with a digital ingestion tracking system to be approved in the United States.
The product has
been approved for treatment of schizophrenia, acute treatment of manic and
mixed episodes associated with bipolar I disorder and for use as an add-on
treatment for depression in adults, the FDA said. It uses digital tracking to record if the
medication was taken.
The system sends a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application, so that patients can track the ingestion of the medication on devices such as a smart phone.
However, Abilify
MyCite is not approved to treat patients with dementia-related psychosis.
AstraZeneca continues
to struggle; GSK gets new R&D chief at sky-high salary
Last week, it was AstraZeneca’s turn to announce third quarter results.
The company saw its drug sales drop yet again,
due to generic competition to its erstwhile blockbuster pills, such as
cholesterol pill Crestor. The good news was that the pace of decline had slowed
down, as the company turned towards new cancer treatments to revive its
fortunes.
Astra’s product sales were down 3 percent compared to an 11 percent fall during the first half of the year. Growth came from emerging markets, such as China.
According to CEO Pascal Soriot, Astra has reached a turning-point — its pipeline of new medicines should start delivering soon, and the impact of patent losses should also recede. Forecasts also point to a recovery in sales and profits from next year.
Astra’s total revenues rose 9 percent to US$ 6.23 billion in the quarter, helped by a US$ 997 million payment from Merck, which struck a cancer drug partnership deal with Astra in July.
GSK’s new R&D chief:
Meanwhile, GSK has replaced the outgoing chief science officer
Patrick Vallance with the president of research and development at Calico, Hal
Barron. And if the grapevine is to be believed, Barron’s pay package could be higher than that of GSK CEO, Emma Walmsley.
Vallance is to leave GlaxoSmithKline next year to take the job of chief scientific adviser to the UK government. Barron will take up his new job on January 1, and will be based in San Francisco and Stevenage in the UK. The hiring is Walmsley’s third key appointment, the previous two being hiring of Luke Miels from AstraZeneca as head of pharmaceuticals and hiring Karenann Terrell (from Wal-Mart) as chief digital and technology officer.
FDA mulls
more steps to increase generic drug competition and fight price hikes
The US is trying
to bring more low-cost competition
in the generic market in order to bring down the prices of drugs.
The US FDA
Commissioner Scott Gottlieb said at a Federal Trade
Commission (FTC)-sponsored
conference that the agency intends to smoothen generic drug development, so
that generic drugs get to market faster.
According to a report released by the FTC and
the FDA at the conference, titled Understanding Competition in Prescription
Drug Markets: Entry and Supply Chain Dynamics, “generic competition consistently and substantially lowers prescription drug prices.”
Looking
out for unfair practices: Gottlieb said the FDA is on the lookout for brand drugmakers that
deliberately slow collaboration on risk strategies to delay generics from
coming to market. Drug companies have used the terms of Risk Evaluation and
Mitigation Strategies (REMS) to restrict generic competition by delaying
generic manufacturers from purchasing drug products needed to run
bioequivalence or bioavailability studies that are required for FDA approval.
Acting FTC
Chairman Maureen Ohlhausen said her agency will vigorously watch for unfair
practices among drugmakers.
Expanding ANDAs
that seek priority review:
Gottlieb also indicated
that the agency will expand which abbreviated new drug applications
(ANDA) will see priority reviews.
“Earlier this year we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug,” Gottlieb said in a statement. “Today we’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine.”
The shift could
accelerate generic competitors to market more quickly and help bring down
costs.
Trump’s HHS Secy candidate for lowering drug prices: The US President
Donald Trump is nominating former pharmaceutical executive and industry lobbyist Alex Azar to serve as US Health and Human Services secretary. According to Trump, Azar would push to lower the price of medicines. If confirmed, Azar would also take the lead in implementing Trump’s campaign promise to dismantle Obamacare (the Affordable Care Act).
Incentivizing pediatric research: The US FDA is taking various steps to
increase the number of therapies for children, approved by the agency. Some 60
percent of drugs that are used in children are not approved for pediatric use, as these drugs have not been successfully
tested in pediatric clinical trials. In fact, in the case of neonates, the
FDA-approved options is even smaller with 90 percent of drugs used in this
population unapproved for neonatal use.
According to a blog written by Susan McCune, FDA’s Director, Office of Pediatric Therapeutics, the FDA is issuing awards to the Institute for Advanced Clinical Trials for Children (IACT for Children) and Duke University in order to facilitate pediatric clinical trials and pediatric trial-related research. “Each awardee will receive US$ 1 million for this year under the Global Pediatric Clinical Trials Network Cooperative Agreement,” she said in the blog.
Europe seeks
to change patent rules for APIs to bolster manufacturing sector
The European Union
is working towards bolstering the competitiveness of its manufacturing sector.
One of the means it is looking at is to waive supplementary protection certificates or SPCs — an intellectual property right that serves as an extension to a patent right.
As a first step in
that direction, the European Commission has issued a public consultation to
obtain feedback on a proposal that allows for such a waiver for SPCs.
The public consultation is open until January 4, 2018. Through this SPC
manufacturing waiver, the EU hopes to fix unintended side effects of the SPC by
allowing developers of generic and biosimilar medicines to produce during the
SPC period in order to supply unprotected markets, soon after the protections
expire.
SPCs provide an
incentive in the EU that extends the protection of patented medicines by up to
five years to compensate the time lost in obtaining regulatory approval of the
drug. During this period, European manufacturers of generic and biosimilar
medicines cannot produce their medicines in the EU.
Groups, such as
Medicines for Europe, the industry association representing generic-drug
manufacturers in Europe, have advocated for a SPC manufacturing waiver to
promote a strong manufacturing base in Europe.
SPCs is an issue
for European API manufacturers, as they limit the time in which they can begin
development of generics. With this consultation, the European
Commission is seeking public input to evaluate the current legislation and
assess the impact of any modification to the SPC and patent-exemption framework
in the EU.
Impressions: 3334
https://www.pharmacompass.com/radio-compass-blog/pfizer-exits-china-venture-with-hisun-fda-mulls-more-steps-to-increase-generic-drug-competition
#PharmaFlow by PHARMACOMPASS
16 Nov 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
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along with a lot more industry analysis.
Click here to Access All the
2016 Data (Excel version available) for FREE!
Impressions: 58545
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2016-who-sold-the-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
19 Apr 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 delves into Pfizer’s acquisition of Medivation and its impact on Sanofi. There is also news on antipsychotic drug Abilify, besides snippets on a lawsuit against Valeant, Mylan’s price hikes and more quality snags that were unveiled at Pfizer’s plant near Chennai. Read on.
Rough week for Sanofi as FDA
delays its diabetes drugs, while Pfizer walks away with Medivation
Pfizer
agreed to pay US $14 billion in cash for Medivation in a deal that adds the
prostate cancer drug Xtandi
to its product portfolio.
Medivation was one of the few independent companies with a cancer treatment
that is selling well. Xtandi currently generates about US $ 2 billion a year in
annual sales.
The acquisition has come as a setback
for French drug maker Sanofi that spent five months pursuing Medivation. At one point, Sanofi even attempted to replace Medivation’s board and force a deal.
There
was another setback for Sanofi,
as it saw the launch of its diabetes combination medicine get delayed until
November this year. Sanofi spent US $ 245 million on a priority
review voucher to beat Danish drug maker Novo
Nordisk to market with a diabetes drug that pairs its best-selling
medicine Lantus
(a basal insulin) with lixisenatide. However, the FDA’s fast-track review pushed out the launch of the combination till at least November.
The FDA asked Sanofi for more data on the dual-drug delivery pen – a device that triggered debate during an FDA advisory panel review in May this year.
The FDA decision on Novo’s product is due next month. With this unexpected delay, Novo could get more than a two months’ head start over Sanofi.
FDA warns against the
use of antipsychotic drug Abilify
In the US, patients taking the antipsychotic drug Abilify have
reported uncontrollable urges to gamble, binge eat, shop, and have sex, according
to the FDA. The regulator issued a warning this week
on the drug, which is one of the top-selling prescription medications in the
United States.
Other serious side effects of the drug include a higher chance
of developing diabetes and hyperglycemia, and increased risk of suicide among
patients under the age of 24.
Also known as aripiprazole,
the drug is used to
treat schizophrenia, and can be used in combination with other drugs to
treat depression. In the US, 1.6 million patients received Abilify
prescriptions last year.
The warning comes amid pending class-action lawsuits against
the manufacturer of Abilify – Otsuka America Pharmaceutical. The class-action suits allege the company didn’t properly warn patients about the possibility of impulse-control issues.
However, these problems are rare. In the 13 years since the
drug was approved, there have been only 167 reports of patients experiencing
significant impulse-control problems, according to the FDA.
Counterfeit pills may
have killed the late singer Prince
A little over a year ago, the Drug Supply Chain Security
Act (or Drug Quality and Security Act) became effective in the United States. The law was introduced to secure the supply chain of medicines and restrict counterfeit drugs – an industry estimated to be bigger than Pfizer and GSK put
together.
It seems that regulatory agencies still have a lot of work to do in this
area. A mis-labelled bottle of
pills found in the home of the late singer Prince contained the powerful
painkiller fentanyl, a synthetic opioid 50 times more powerful than heroin. Prince died on April 21 this year.
According
to sources close to the investigation, the pills were found in a bottle
of Aleve, an over-the-counter medication sold in the US that contains
the painkiller naproxen. Two dozen pills, found in one bottle, were falsely labelled as ‘Watson 385’ – an identifier for a mix of acetaminophen
(paracetamol)
and hydrocodone.
Valeant mired in trouble
with a lawsuit and faltering sales of female sexual dysfunction drug
According to a lawsuit
filed last week, Valeant
Pharmaceuticals refilled
patient prescriptions without their permission and directed them to buy expensive drugs in
order to boost sales. The lawsuit provides insight into how a mail-order pharmacy – Philidor Rx Services – assisted Valeant in directing prescriptions to its brand-name medicines over cheaper generic versions.
Meanwhile,
Valeant hired Paul Herendeen as its new chief financial officer, luring the
executive away from Zoetis,
the animal health products maker.
While
Valeant is busy battling
challenges on various fronts, its US $
1 billion acquisition of Sprout Pharmaceuticals of Addyi – the first medicine to combat female sexual dysfunction – is turning
out of be a bust, as it has reported meagre sales.
Pfizer’s plant in Chennai faces more compliance issues
Earlier this month, Pfizer had to halt production at a plant near Chennai in India, after a Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
joint inspection highlighted quality concerns. The other regulators in the
PIC/S inspection were the Medicines and Healthcare products Regulatory Agency
of the UK (MHRA), the United States Food and Drug Administration (USFDA),
Therapeutic Goods Administration of Australia (TGA) and Health Canada.
Three
years ago, the plant was first cited with an FDA warning letter. Last year, when
Pfizer acquired the plant from Hospira, it was well aware of the quality issues.
But Pfizer was probably not aware of the extent of troubles that awaited it. Last
week, a GMP non-compliance report posted by European Medicines Agency (EMA) listed
that an inspection by the MHRA uncovered
a variety of critical issues, raising doubts on whether
the injectable products coming out of the facility are sterile or not.
MHRA inspectors found that employees were using aseptic processes that could allow for microbial contamination. Pfizer’s investigations into issues were not getting to root causes of problems, they said. All of the plant’s shortcomings were linked to employees who lacked the “scientific knowledge” to know what to do.
The MHRA withdrew the plant’s GMP certificate and has halted imports to the European Union of six injected antibiotics until the problems get addressed.
Mylan’s outrageous drug price hikes for EpiPen come under scrutiny
The EpiPen auto-injector, which reverses life-threatening
allergic reactions, is under scrutiny. In 2015, the drug had generated US $ 1.2
billion in sales for Mylan.
The EpiPen has been around since 1977, but Mylan acquired
the auto-injector in 2007. The EpiPen precisely calibrates the dosage of epinephrine.
The patient now pays
about 400 percent more for this advantage to receive a dollar’s worth of the life-saving drug. EpiPens were sold for about US $ 57 when Mylan acquired it. Today, it is being
sold at US $ 500 or more in the US.
Meanwhile, Senator Amy Klobuchar (District Minnesota) has
asked the US Federal Trade Commission and the Senate Judiciary Committee to investigate
price hikes undertaken by Mylan. Klobuchar is the ranking member of Senate
Judiciary Antitrust Subcommittee. And Senator Richard Blumenthal (District Connecticut)
wrote to the company for data about assistance programs for
patients and first responders. He also
demanded that Mylan lower its price.
Last year, Mylan raised the price on EpiPen — its biggest-selling product — twice by 15 percent (each time). Due to lack of competition, the
price hikes were easy.
Korea’s Celltrion ships first batch of biosimilar Remicade to US
Last week, a day after winning a lawsuit in the US, Korean pharmaceutical firm Celltrion shipped
the first batch of its biosimilar medicine -- Remsima – to the country. The lawsuit was on the sale of Remsima – an autoimmune disorder drug – in the US, the world’s largest pharmaceutical market.
Celltrion said that the move will accelerate the US launch of Remsima, a
biosimilar version of Janssen's
Remicade. Remsima has been on sale in Europe since 2013.
Pfizer will take charge of sales of Remsima in the US. The drug will soon be
available to patients in the US suffering from rheumatoid arthritis and
ulcerative colitis under the brand name of Inflectra.
Remicaid’s sales were in excess of US $
8 billion in 2015. Celltrion
CEO Kim Hyoung-ki has projected that the company will earn more than US $ 1.7 billion in the US market next year, assuming a
double-digit market share.
Four healthcare CEOs on the world’s top 20 severance packages list
Even though the Pfizer-Allergan US $ 160 billion merger did not go through, Allergan CEO’s Brent Saunders has little
to complain. In a recent Bloomberg
compilation, his severance package of US $ 140 million ranks in the top
20 of all S&P 500 CEOs.
Joining him in the top 20 are other CEOs of healthcare
companies such as McKesson (with a severance package of US $ 198 million),
Aetna (US $ 91 million) and Regeneron (US $ 90 million).
McKesson Corporation is an American company distributing
pharmaceuticals at a retail sale level and providing health information
technology, medical supplies, and care management tools.
Aetna is an American managed health care company, which sells
traditional and consumer directed health care
insurance plans and related services, such as medical, pharmaceutical, dental,
behavioral health, long-term care, and disability plans.
Regeneron is a US-based biotechnology company with four FDA approved products and over US $ 4 billion in revenues in 2015.
Impressions: 5520
https://www.pharmacompass.com/radio-compass-blog/sanofi-s-rough-week-quality-snags-at-pfizer-fda-warns-against-commonly-used-drug
#PharmaFlow by PHARMACOMPASS
25 Aug 2016
Each year,
the US Food and Drug Administration (FDA) approve hundreds
of new medications. A small subset of approvals, classified as novel drugs, are considered to
be truly innovative products that often help advance clinical care.
In 2015, the
FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).
This week, PharmaCompass focuses on the new dosage
forms of existing drugs that got approved last year.
Modified blockbusters
Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:
Jadenu (deferasirox): With
almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a
tablet for use in a suspension. Novartis, the innovator,
got approval in March 2015
for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation
of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has
simplified daily treatment administration for patients with chronic iron
overload.
Nexium
24HR (esomeprazole magnesium): Also
known as the Purple Pill, Nexium – Astra
Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as
Nexium 24HR. Last year, the FDA granted approval to the tablet form of the
drug.
Iressa
(gefitinib): AstraZeneca re-introduced Iressa in
the US market in 2015. The
FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved
as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets
from the market, as post-marketing studies had failed
to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted.
Onivyde (irinotecan): Liposomal formulation of anti-cancer
drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the
treatment of patients with metastatic pancreatic cancer, sold under the brand
name Onivyde.
Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines
because of its high price (more than US $ 300,000 a year). Price concerns
aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.
Extended release versions
Many of
the approvals granted by the FDA last year were to extended release
formulations (a pill formulated so that the drug is released slowly) of
existing drugs.
Kremers Urban’s
extended release version of Methylphenidate
capsules made headlines last year because of a reclassification of the drug by
the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may
not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc.
In
addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus
and Morphine Sulphate also received green signals for a market launch.
First generic opportunities
Last year, PharmaCompass
shared the names of some drugs which had no generic competition and were also
not protected by patents. (Read: “Litigation Free, first generic opportunities list”).
Deferiprone (a drug that chelates iron and is
used to treat iron overload in thalassemia major) met the criteria. But it still
has no generic competitor and is now available as a new dosage form.
Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades
without generic competition in the US. Albendazole is a medication used for the
treatment of a variety of parasitic worm infestations. In 2015, patients were
provided access to chewable tablets of Albendazole.
New combinations at work
The FDA also approved
multiple combination drugs where the individual active ingredients had been brought
to market previously.
Most of the combination drugs
approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc.
Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and
Tradjenta (linagliptin) approved in 2011, were
combined and the combination drug product Glyxambi was approved in 2015. Another
combination of empagliflozin, with metformin – Synjardy – was also approved in August last
year.
Lesser known companies also
got combination drugs approved. UK-based
development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine
polistirex.
Similarly, US-based biopharmaceutical startup, Spriaso LLC, also
working in the cold and cough therapeutic area, got an extended release tablet
containing codeine phosphate and chlorpheniramine maleate approved.
Symplmed, a company which is
developing various forms of Perindopril, got approval for Prestalia (a
combination of perindopril arginine and amlodipine besylate) for the
treatment of hypertension.
Our view
Each year, the FDA approves several
pharmaceutical drugs in order to improve patient care; and often versions of
these drugs are marketed and distributed across the globe.
PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy.
Accelerate your drug development
PharmaCompass has also launched
the Drug Development Assistance tool on its platform.
Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate
the various drug products approved in the United States.
Impressions: 5419
https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs
#PharmaFlow by PHARMACOMPASS
14 Jan 2016
Wouldn’t it be great if your medicine could send a signal from your stomach to the clinic that it’s been ingested? Such a message would end your worries about whether you took your pill or not. Besides, it will also inform your doctor that you have been a good patient.Such a pill isn’t something we’ve lifted from the latest sci-fi novel. Welcome to the new world of ingestible sensors.Last week, the FDA determined that the New
Drug Application (NDA) for the combination product of ABILIFY® (aripiprazole) embedded with a
Proteus® ingestible sensor in a single tablet is sufficiently complete for submission.Abilify has been Japanese drug maker Otsuka’s crown jewel. The drug – used to treat a variety of mental illnesses – brought in sales of US $ 9.2 billion in 2014 before generics got approved earlier
this year. Otsuka has tried almost everything in the playbook to keep their Abilify franchise alive. However,
the use of ingestible sensors may just be their first real chance to realize
their dream. The new paradigm of ingestible sensorsStudies have estimated that 30 to 50
percent of prescription medicines are never taken, which create significant
complications, resulting in deterioration of health of patients. Such neglect
costs the healthcare system in the United States an estimated US $ 100 to 300
billion annually. Digital medicine represents a new and rapidly evolving paradigm which allows for continuous measurements of physiological metrics – such as heart rate, activity and respiratory patterns – along with rapid sharing of data between patients and caregivers.Proteus Digital, backed by Oracle and Novartis along with other investors, is a
well-funded privately held start up. Their ingestible sensor can be incorporated into a tablet during tablet compression, placed inside a hard gelatin capsule during capsule filling, or attached to the surface of a tablet or capsule using an edible adhesive layer From the stomach to the mobile phoneUpon ingestion, when the sensor makes contact with the fluids in the patient’s stomach, a tiny electric charge is generated. Each sensor communicates a unique and private digital code to a sensing patch placed on the patient’s skin. The patch records the time and date that the pill is digested and a mobile-phone-based user interface provides real-time, continuous measurement of medication adherence. If the patient is willing, the information from the mobile phone
can be transmitted over the internet for caregivers to review and analyze.The design of the sensor consists of an insoluble portion, the
integrated circuit, which is equivalent in size to a food particle and is
handled by the gut like a food particle or incidentally ingested grain of sand.
The remaining components present materials which are ingested as part of a
typical diet. Are these sensors safe? Proteus Digital’s ingestible sensor has been under development for many years now and undergone extensive safety and efficacy evaluations. Clinical studies have been performed on over 20,000 device ingestions. While the sensor patch received FDA clearance in 2010, the
ingestible sensor was approved in 2012. However, the application filed last
week with Abilify is a first where the sensor has been embedded with a drug and
given to the FDA for review. Proteus claims the sensor recorded
ingestion events with 99.1 percent accuracy, and 100 percent correct
identification of the type and dose of the drug taken. No serious adverse
events (SAEs) or unanticipated adverse device effects (UADEs) were recorded. Our viewEarlier this month, we covered drug-device combinations
heralding a new era in the way the
pharmaceutical industry will operate in the future. So whether it is the pill with a camera – designed to take high-speed photos of the intestinal tract and avoid invasive colonoscopy – or nano-sensors that travel the bloodstream and send messages to a smartphone, alerting the user of signs of infection, an impending heart attack or other cardiovascular issues; medicine will be very different in the coming future.As the technology revolution has made smartphones ubiquitous, digital drugs could usher an era where we will witness ‘digital smart drugs’ with superior capabilities and connectivity to the ‘not-smart drugs’ as we know them today.
Impressions: 2285
https://www.pharmacompass.com/radio-compass-blog/next-gen-aripiprazole-pill-that-sends-messages-from-the-patient-s-stomach
#PharmaFlow by PHARMACOMPASS
17 Sep 2015
Over
700 commonly used generic medicines were
recommended for suspension by the European Medicines Agency (EMA) based on data
integrity concerns, over clinical studies conducted at GVK Biosciences in
Hyderabad, India.What
will be the global fallout of the European decision? The European decision has
impacted products from companies such as:Abbott Laboratories, Accord Healthcare (Intas), Actavis, Alembic, Apotex, Betapharm (Dr. Reddy’s), Brown & Burk UK, Fair Med Healthcare AG, Glenmark, Lupin, Micro Labs, Mylan, Orion Corporation, Ranbaxy, Ratiopharm, Sandoz, Sanofi-Aventis, Stada, Teva, Torrent, Wockhardt, Zydus… and many, many more.The
original recommendation of suspending
some of the medicines
made in January 2015, was an outcome of an inspection of GVK Biosciences’ site in Hyderabad (GVK BIO is a Clinical Research Organization-
CRO) by the
French medicines agency (ANSM) through the EMA. The EMA stated in their official release: “The
inspection revealed data manipulations of electrocardiograms (ECGs) during the
conduct of some studies of generic medicines, which appeared to have taken
place over a period of at least five years. Their systematic nature, the
extended period of time during which they took place and the number of members
of staff involved cast doubt on the integrity of the conduct of trials at the
site.” 1000 drugs reviewed// 700
rejectedWhile
over 1,000 pharmaceutical forms and strengths were reviewed at the GVK site,
over 300 of them had sufficient supporting data available from other sources.
As a result, these medicines were allowed to remain on the market in the EU.However, for the over 700 other medicines, the EMA after its second review, maintained its previous recommendation of January 2015, to suspend medicines, where no additional supporting data from other studies was available. Only one exception after that second review was spared from suspension, as the company was able to address the EMA’s concerns: it was Bivolet Nebivolol (5 mg tablets/ marketing authorisation holder: Neo Balkanika EOOD).While the agency noted that “there is no evidence of harm or
lack of effectiveness linked to the conduct of studies by GVK Biosciences at
Hyderabad. Some of these medicines may remain on the market” if they are of critical importance for patients. However, the recommendation
will now be sent to the European Commission for a legally binding decision,
which will apply to Member States regardless of the decision taken in the
interim period.The updated list of medicines for which, the CHMP (Committee
for Medicinal Products for Human Use) recommends suspension, is available on the EMA website. Companies
are given 12 months to submit additional data. The potential global impact of the European
suspensions?The GVK Biosciences
scandal is almost as severe in magnitude and impact, as the data falsification
concerns, which were discovered at Ranbaxy (Katherine Eban’s stunning investigation in Fortune, “Dirty Medicine” covers this extensively). One of the main promoters of GVK Biosciences is Mr. D.S. Brar who was CEO & Managing Director of Ranbaxy from 1999-2004. The impact of GVK
Biosciences’ misdeeds is already being felt on new product launches. Mylan recently withdrew its European application for generic
Abilify (aripiprazole) (2014 sales US$6.2x billion) citing “identification of major GCP issues (Good
Clinical Practices).” What about the impact on the US market?In 2010, FDA discovered data integrity
violations, which bankrupted
clinical research organization, Cetero Research/PRACS. Based on the Cetero findings
in the United States, the EMA suspended seven drugs. Now it remains to
be seen, how the FDA will handle the data integrity concerns found in Europe
since products like repaglinide & candesartan cilexitil (Mylan), levetiracetam (Dr. Reddy’s), clonazepam (Sandoz), metformin hydrochloride (Actavis), tacrolimus (Panacea Biotech) all have U.S. FDA approvals. Leading GVK Biosciences’ defense is the Indian government, who warned last month that if the European Union does not reconsider their decision, it may go to the World Trade Organization. The Indian government’s position is based on an appeal by GVK Biosciences, which made the “Indian government set up a panel of experts last year to investigate
the matter and found no manipulation”, GVK Biosciences CEO Manni Kantipudi told Reuters.However, globally reputed GMP expert, Lachman Consultants, believes that the GVK Bioscience episode “could potentially impact data integrity, similar to the Cetero/PRACS
case”.It’s clear for us that this is not the end of the story…
Impressions: 4077
https://www.pharmacompass.com/radio-compass-blog/will-data-integrity-concerns-on-clinical-trials-done-at-gvk-biosciences-go-beyond-europe
#PharmaFlow by PHARMACOMPASS
28 May 2015
Two blockbusters,
Otsuka’s
Abilify® (aripiprazole)
and Teva’s
Copaxone® (glatiramer
acetate), with combined sales of more than $10 billion in 2014 are going to
face severe generic competition this
year. Interestingly, both companies have turned to a new technology
platform, which uses deuterium chemistry analogs of old, off-patent drugs to secure their future profits.
A simple
swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine),
resulted in an improved version of the drug, called deutetrabenzaine or SD-809.
This improved version breaks down more slowly in the body,
allowing physicians to give it less often and at lower doses.
The worth was established, when Teva paid $3.5
billion for the company Auspex, which developed SD-809.
SD-809 is
expected to be approved in 2016 for the potential treatment of chorea (abnormal
involuntary writhing movements), associated with central nervous system disorders like Huntington’s disease, tardive dyskinesia, and Tourette syndrome.
Now, while this may have sounded like complex chemistry, you’ll be surprised by the simplicity of the concept.
What is this deuterium
that replaced the hydrogen?
Deuterium is a non-radioactive,
stable and naturally occurring hydrogen isotope. The atomic mass of hydrogen is
approximately 1.0 atomic mass unit (AMU), while that of deuterium is
approximately 2.0 AMU. We all have 1-2g of deuterium in our bodies.
Why does a deuterium
swap make a difference?
Replacing some hydrogen atoms
with deuterium does not change the shape or electronic structure of the
molecule, but it can make a big difference in how it behaves.
The reason: chemical
bonds formed with deuterium are generally stronger
and longer-lasting than those with hydrogen. Stronger bonds allow for small
molecule drugs to resist to metabolic enzymes in the body that break down
weaker hydrogen bonds.
The result: the
drug is broken down slower in the body, stays longer and hence is not required
in high doses or as often. In addition, the deuterated drug is more
stable in the presence of other drugs,
resulting in reduced drug-drug interactions.
What did Teva &
Otsuka buy?
Teva: In addition
to Auspex’s lead compound, SD-809, Teva also procured other pipeline candidates, which include deuterated versions of levodopa for Parkinson’s disease and pirfenidone for idiopathic pulmonary fibrosis.
As Roche purchased InterMune® $8.3 billion last year needs to get changed to “As Roche purchase Intermune for $8.3 billion last year”
Otsuka’s $3.5 billion acquisition of Avanir Pharmaceuticals involved
a pipeline of products, which are combinations of common, cough syrup ingredient, dextromethorphan with an old-heart drug, quinidine.
The promise of deuterated dextromethorphan for Alzheimer’s disease (Avanir compound AVR-786) was a key driver for Otsuka to purchase Avanir.
The challenges and
opportunities
It can be difficult and not always clear to figure
out where exactly to swap the deuterium for maximum effect.
Legally, a deuterated compound is only considered a new drug if there is sufficient difference in the “active moiety” structure because initially the FDA had considered tetrabenzaine and
deutetrabenzaine (SD-809) to be the same drug!
However, deuterium chemistry, while simple, requires specialization, which serves as an opportunity for chemical companies to consider developing.
With almost $7 billion in acquisitions in under 6
months, deuterium chemistry does deserve attention.
Impressions: 4752
https://www.pharmacompass.com/radio-compass-blog/teva-and-otsuka-s-multi-billion-dollar-plan-when-blockbusters-turn-generic-deuterium-chemistry
#PharmaFlow by PHARMACOMPASS
21 May 2015
