Market Place
Over the last five years, a
lot has changed for Pfizer Inc, one of the world’s leading pharmaceutical companies based on pharma sales revenue. From entering into an agreement with German biotechnology company BioNTech SE in August 2018 for joint research
and development of mRNA-based influenza vaccines to merging its off-patent
branded and generic drug business, known as Upjohn, with Mylan to form Viatris and launching
Covid-19 vaccine Comirnaty and antiviral drug Paxlovid during the pandemic,
the New York-headquartered pharma giant has witnessed substantial
transformation in the recent past.The launch of Covid products was
undoubtedly the biggest event for the 174-year-old drugmaker, propelling it to the number 1 slot in 2021 with a turnover of US$ 81.3 billion, surpassing competitors such as AbbVie, Johnson & Johnson, Novartis, Roche, Bristol Myers Squibb, Merck, and several others. In 2022, Pfizer further consolidated its position, with revenues exceeding US$ 100 billion, largely due to the success of its Covid products. This success of Covid products filled Pfizer’s coffers, allowing it to expand through the acquisition of smaller companies. Pfizer’s new brand identity and logo,
unveiled in 2021, signaled the company's shift from "commerce to science".Pfizer commercially operates through two segments — Biopharma, or its innovative science-based biopharmaceutical business that posted revenues worth US$ 98.98 billion in 2022, and Pfizer CentreOne (PC1),
a global contract development and manufacturing organization as well as a
leading supplier of specialty active pharmaceutical ingredients (APIs) with US$ 1.3 billion in 2022 revenues.Pfizer’s core therapeutic areas are inflammation and immunology, internal medicine, oncology, rare diseases, vaccines and anti-infectives.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel)Pfizer in acquisition overdrive: Buys Seagen for US$ 43 bn, Biohaven for
US$ 11.6 bnPfizer has been utilizing its
war chest generated during the pandemic in acquiring companies that would help
grow the business when Covid is behind us and its other best-selling drugs
(such as Ibrance, Vyndaqel/Vyndamax, Xeljanz and Xtandi) face expiration of patents. In November 2021, Pfizer snapped
up Trillium Therapeutics for US$ 2.22 billion. Trillium is a
clinical stage immuno-oncology company developing innovative therapies for the
treatment of cancer. In March 2022, Pfizer acquired
Arena Pharmaceuticals for US$ 6.7 billion, a company that
develops novel therapies to treat immune-inflammatory ailments. Then, in Oct 2022 it completed the US$ 11.6 billion buyout of migraine specialist Biohaven. This brought Biohaven’s leading oral migraine drug in the US – Nurtec ODT (rimegepant) – into Pfizer’s fold. In June 2022, Pfizer completed the acquisition of ReViral Limited, gaining access to
its experimental drugs used to combat respiratory syncytial virus (RSV)
infections. In October, Pfizer paid US$ 5.4 billion for blood disorder
drugmaker Global Blood Therapeutics (GBT). Through this buyout, Pfizer has added GBT’s approved drug, Oxbryta, along with two other sickle cell medicines – GBT601 and inclacumab (both in mid- to late-stage testing) – to its portfolio.And this month, Pfizer
announced it will acquire Seattle-based cancer specialist Seagen for US$ 43 billion, its biggest acquisition in the recent past. “We are not buying the golden eggs,” Albert Bourla, CEO of Pfizer, said post the announcement. “We are acquiring the goose that is laying the golden eggs.”The Pfizer-Seagen deal is
also the largest biopharma acquisition since 2019, when BMS bought Celgene for US$ 74 billion. Seagen is a leader
in antibody-drug conjugate (ADC) technology. This deal will bring four
commercial medicines (Adcetris, Padcev, Tukysa and Tivdak) and a deep pipeline of ADC candidates to Pfizer’s fold.Seagen is likely to post US$
2.2 billion in revenues this year, which is expected to grow to over
US$ 10 billion (risk-adjusted) by 2030. Earlier this year, Bourla had said the company has planned to use its “extraordinary firepower” to buy products that will deliver US$ 25 billion in
incremental revenue by 2030. While Seagen will
bring in US$ 10 billion, another US$ 10.5 billion will come from Arena,
Biohaven, GBT and ReViral.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Diminishing demand for Covid products, expiring patents to drag turnover
downPfizer’s turnover has nearly doubled since 2018, when it was at US$ 53.6 billion. In July 2019,
Pfizer had announced the plan to combine
Upjohn with Mylan to form a new company — Viatris. With the separation of the Upjohn business and the formation of a consumer healthcare joint venture with GSK in 2019, Pfizer
transformed into a more focused player in innovative medicines and vaccines.
However, this restructuring measure also
led to a drop in its turnover to US$ 51.8 billion in 2019 and to US$ 41.9 billion in 2020. From the number three slot in 2018 (behind J&J and Roche), Pfizer’s ranking fell to eight in 2020.
However, Covid turned its fortunes yet again and its turnover increased to US$
81.3 billion in 2021.When we split Pfizer’s 2022 revenues of US$ 100.3 billion, we notice that its
portfolio has 10 products with sales greater
than US$ 1 billion. These include the Covid-19 vaccine Comirnaty with US$ 37.8
billion in revenues, Paxlovid with US$ 18.9 billion, anticoagulant Eliquis with US$ 6.5
billion, and the Prevnar family of pneumococcal vaccines with US$ 6.3 billion
in revenues. Pfizer's partner BMS recorded sales of US$ 11.8 billion for Eliquis in 2022.With a drop in Covid cases,
demand for Comirnaty and Paxlovid has decreased significantly. In 2023,
Comirnaty’s revenue is likely to drop 64 percent to around US$ 13.5 billion, and Paxlovid’s revenue is likely to plummet by around 58 percent to around US$ 8 billion.Pfizer expects its 2023
revenues to be between US$ 67 billion and US$ 71 billion, reflecting an
operational decline of over 30 percent. However, when we exclude the revenues
of Covid products, we are likely to see a growth in revenues of around 7 to 9 percent, coming primarily from new product launches, recently acquired products and Pfizer’s in-line portfolio.“Pfizer expects 2024 sales of Covid products to stabilize, then starting in 2025 and continuing in
2026 and beyond, it expects to see an increase in Covid-19 vaccination rates, assuming the successful development and approval of a Covid-flu combination product,” said Bourla. Last December, Pfizer and BioNTech received fast track designation from the US Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and Covid-19, which aims to help prevent two respiratory diseases with a single injection.View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Stars in Pfizer’s pipeline — RSV, pneumococcal and meningococcal vaccinesIn 2022, Pfizer spent US$ 11.4 billion in research and development, up 12 percent from its R&D spend in 2021. It has a power-packed pipeline with 110 programs, including 72 new molecular entities. Out of the 110 programs, 33 are in oncology, 23 in inflammation and immunology, 19 in vaccines, 15 in internal medicines, 12 in rare diseases and eight in anti-infectives.However, the stars in Pfizer’s pipeline are its vaccine candidates. Pfizer’s RSV vaccine candidate RSVpreF is being developed for pregnant women (to help protect their babies from RSV after birth) and individuals 60 years of age or older for the prevention of lower respiratory tract disease caused by RSV. The vaccine recently received support from the FDA's advisory committee, and a decision on its use for older adults is expected by May 2023.The agency has also granted
priority review to the maternal RSV vaccine, with an action date of August
2023. If approved, it would be the first vaccine for pregnant women
to help protect against the complications of RSV disease in infants from birth
through six months.Recently, FDA also designated
Prevnar 20 for priority review in children aged six weeks through 17 years. Six months ago, Merck’s Vaxneuvance had received pediatric approval. The Merck vaccine defends against 15 serotypes, as compared to 13 strains covered by Pfizer’s Prevnar. However, Merck’s edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes. The US regulatory agency has also accepted the BLA (biologics license application) review of Pfizer’s pentavalent meningococcal vaccine candidate — MenABCWY — in adolescents with the PDUFA date of October 2023. Moreover, the
company has announced positive top-line results from a phase 3 study of
its hemophilia B gene therapy candidate, fidanacogene elaparvovec.Besides this vaccines and
therapies, FDA is going to decide on several other Pfizer drugs in 2023, such
as ritlecitinib for alopecia,
elranatamab for multiple myeloma, etrasimod for ulcerative
colitis, and Abrilada, a biosimilar of AbbVie’s blockbuster Humira (adalimumab).View our Dashboard to know more about Pfizer's Drugs in Development (Free Excel) Our viewAs of today, the sweet spot of US$ 100.3 billion in 2022 revenues posted by Pfizer surely looks like a one-off. Though the drug behemoth’s vaccine pipeline looks promising, its shopping list reflects a huge reliance on oncology for future growth.While only time can tell which of those bets will work and which won’t, it looks like Pfizer has capitalized on the lead the pandemic granted it to race ahead of competition.(All financial and drug pipeline-related information has been taken from the Pfizer website.)
Impressions: 2708
https://www.pharmacompass.com/radio-compass-blog/company-tracker-pfizer-turns-to-acquisitions-as-covid-products-sales-nosedive
#PharmaFlow by PHARMACOMPASS
23 Mar 2023
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In 2022, the world finally began to emerge out of Covid-related
restrictions. Though 2020 and 2021 saw several travel-related curbs, there was
no let up in the speed at which generic active pharmaceutical ingredient (API)
manufacturers were submitting Drug Master Files (DMFs) to the US Food and Drug
Administration (FDA). In the four years between 2018 and 2021, the number of
Type II DMF submissions (i.e. submissions for drug substance, drug substance
intermediate, and material used in their preparation, or drug product) remained
steady at over 630 per year.In 2022, the DMF submissions rose at an impressive pace of 12.1
percent. A total of 1,024 DMFs (Types II, III, IV and V) were submitted in
2022, as opposed to 913 in 2021.Last year, Type II DMF submissions increased by 7.2 percent — a total of 715 Type II DMFs were submitted in 2022 as opposed to 667 in 2021. However, of the 715 DMFs filed with the FDA, only 190 (26 percent) had their reviews completed.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) DMF submissions from India dip 10.6%, China’s filings increase 45%As always, DMFs filed from India and China were significantly higher than DMFs from other countries. However, the year saw DMF submissions from India drop by 10.6 percent. Overall DMF submission from India stood at 336, as opposed to 376 in 2021. In comparison, China’s DMF filings increased by 45 percent to 231 in 2022, as opposed to 159 in 2021. Interestingly, FDA had issued 31 Form 483s in 2022 out of which 15 were issued to Indian drugmakers. Out of 15, seven Form 483s were issued to manufacturing units belonging to four Indian API manufacturers — Lupin, Aurobindo Pharma, Torrent and Biocon Biologics.While DMFs are submissions to FDA that may be used to provide
confidential, detailed information about facilities, processes, or articles
used in the manufacturing, processing, packaging, and storing of human drug
products, a Form 483 is a notification sent by the FDA to a
drugmaker regarding objectionable conditions at a facility. A Form 483 is
issued at the conclusion of an inspection, when an investigator finds
regulatory violations and/or non-compliance of good manufacturing practices. January 2023 saw a spate of Form
483s issued to Indian drugmakers, raising concerns within the pharma
industry.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) India’s Metrochem API tops DMF submissionsIndia’s Metrochem API led the list of companies with the highest number of DMF submissions at 19. MSN Labs stood second with 16 submissions.Other top Indian companies were Aurobindo Pharma (15), Biophore India (15), Hetero Group (11) and Cipla (10), followed by two Chinese companies — BrightGene Bio-Medical Technology and Changzhou Pharmaceutical Factory — with 9 submissions each.The maximum number of DMF filings were for elagolix sodium (11), empagliflozin (eight), tofacitinib citrate (six), revefenacin (six), apixaban (five), brivaracetam (five), cannabidiol (five), followed by mirabegron (five) and tafamidis (five).A total of 79 DMFs were filed for the
first time for 64 products, of which 28 had their GDUFA (Generic Drug User Fee Amendments) review
completed. These
include revefenacin (six), migalastat hydrochloride (three), cupric sulfate (three), ivosidenib (two), upadacitinib (one) and voxelotor (one). Revefenacin is losing
its marketing exclusivity this year.View FDA DMF Filings in 2022 (Power BI Dashboard, Free Excel Available) Our viewIn our last (H1 2022) review of DMF submissions, we had mentioned that less than half of the 350 Type II DMFs filed by the FDA had been reviewed, as the user fee program had not been reauthorized.FDA published the New GDUFA III fee structure at the eleventh hour — on September 30, 2022. GDUFA III includes several enhancements to the abbreviated new drug
application (ANDA) assessment process to maximize the efficiency and utility of
each assessment cycle. These enhancements aim to reduce the number of
assessment cycles and facilitate timely access to safe, effective, high-quality
and affordable generics.With the GDUFA III, the US government has made clear its intent to
lower generic drug prices. In future, more drugs are likely to go off-patent and we are likely to see the number of
DMF submissions rise even further.In
the second quarter of 2022, FDA resumed unannounced inspections in India. The regulator has also stepped up onsite inspections. FDA wants cheaper drugs, but not at the cost of quality. There are no short-cuts for generic and bulk drug manufacturers wanting to export to the US.(This article has been updated to accurately reflect the information on Metrochem API and MSN Labs.)
Impressions: 2214
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-rise-12-1-in-2022-india-sees-10-6-drop-in-type-ii-filings
#PharmaFlow by PHARMACOMPASS
02 Feb 2023
The year
2021 was eclipsed by the Covid-19 pandemic. In our update for the first half of 2020, we had mentioned that
Covid-19 has not slowed down the speed at which generic active pharmaceutical
ingredient (API) manufacturers were submitting Drug Master Files (DMFs) to the
US Food and Drug Administration (FDA). That trend continued in 2021, when the
speed of DMF submissions to the agency remained similar to that witnessed in
the previous years.
In fact,
Type II DMFs, or DMFs for active pharmaceutical ingredients (APIs), were higher
in 2021 as compared to previous years. In the first quarter, FDA received 164
Type II DMF submissions, which rose to 165, 166 and 172 submissions over the
next three quarters. In all, 667 Type II DMFs were filed in 2021, as opposed to
662 in 2020, 633 in 2019 and 644 in 2018.
DMFs are
submissions made to the FDA by manufacturers who provide the agency with
confidential, detailed information about facilities, processes or articles used
in manufacturing, processing, packaging and storing of human drug
products.
Overall,
2021 saw a total of 913 DMFs (Type II, III, IV and V) being submitted. In
comparison, FDA had received 931 DMF submissions in 2020, 894 in 2019 and 979
in 2018.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
India
continues to lead DMF filings, followed by China
Country-wise
data on DMF filings at
the FDA tells us the potential of a country in the field of pharmaceuticals. At the company-level, with each DMF filing, a firm commits itself to manufacturing drugs in a facility that is aligned to the FDA’s rules and regulations.
This year
too, DMFs filed from India and China were significantly higher than those from
other countries. Expectedly, India continued to lead with 376 DMF filings.
Submissions from India were over twice that of DMF filings from China (at 159).
This is not surprising since the two countries have the maximum number of API
manufacturing facilities registered with the FDA.
As compared
to this, the United States had 52 DMF filings, Italy had 10, Spain and Taiwan
had 9 each, and countries like Canada, Israel, Japan and UK had five DMF
filings each.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
India’s MSN Labs leads DMF count
As in the
past, India's MSN Laboratories continued to lead the DMF filings by a single company with 43 submissions. MSN was followed by five other Indian companies — Dr. Reddy’s Laboratories filed 15 submissions, Hetero Group and Aurobindo Pharma 14, Metrochem API 13 and Aurore Life Sciences filed 12 DMF submissions.
The only
Chinese company in the top 10 by DMF count was Brightgene Bio-Medical Technology Limited with nine DMF submissions.
The maximum
number of DMF filings were for semaglutide (eight), followed by favipiravir (seven), apalutamide (six), sitagliptin phosphate (six) and tofacitinib citrate (six). Others like acalabrutinib, elagolix sodium, lenalidomide, liraglutide and pantoprazole sodium had five DMF filings each.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
Slow
assessment review, higher GDUFA fee
Although
there were 667 Type II DMFs filed with the FDA, only 194 (or 29 percent) had
their review completed. The GDUFA (short for Generic Drug User Fee Amendments)
fee associated with a DMF assessment review for 2021 was considerably higher — at US$ 69,921 — as opposed to US$ 57,795 for 2020. For FY 2022, the GDUFA fee has been revised upward to US$ 74,952 (an increase of US$ 5,031).
There are 42
products for which a DMF was filed for the first time. Among the patented
products which should expect generic competition are avatrombopag, encorafenib, esketamine hydrochloride, siponimod fumaric acid, tedizolid phosphate and vorapaxar sulfate.
In fact,
DMFs were also filed for products that are yet to receive an FDA approval. Some of these products are imeglimin, aviptadil, gimeracil, linzagolix choline, meglumine antimoniate, roluperidone hydrochloride and teneligliptin.
View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
Our view
The Covid-19
pandemic revealed how the global supply chain for pharmaceuticals is excessively dependent on India and China. As a
result, many countries across the world are making investments into expanding
their API production capacities. This should translate into more Type II DMF
filings from countries other than India and China.
Moreover, as the pandemic begins to wane and the FDA increases its inspections — both domestic and international — compliance issues are bound to increase. The US is planning to run a pilot program
soon that will test a system of unannounced inspections in India and China.
Companies in both India and China will need to increase their focus on
compliance if they wish to continue to be major contributors to the global
supply chain for pharmaceuticals. We can certainly expect more regulatory news
in 2022.View FDA DMF Filings in 2021 (Power BI Dashboard, Free Excel Available)
Impressions: 5380
https://www.pharmacompass.com/radio-compass-blog/dmf-submissions-in-2021-india-china-continue-to-top-filings
#PharmaFlow by PHARMACOMPASS
17 Feb 2022
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
After 2 years of sky-high approval numbers, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research approved 22 novel drugs in 2016, down from the 19-year high of 45 in 2015. The FDA also approved many new dose forms, formulations, combination products and vaccines.
This
week, PharmaCompass, shares its analysis of the new drug approvals by the FDA
in 2016.
Reasons behind the low approvals in 2016
Of the 22 novel drugs approved by the FDA, the FDA approved 9 products with orphan designation, in line with the industry’s recent focus on rare diseases. However, as the industry shifts its focus towards biotechnology, only 7 of the novel products approved were biologic applications.
The 9
orphan designees approved (41% of all new drug approvals) were significantly lower than the 21 (47%) orphan designees approved in 2015 and 17 (41%) in 2014. FDA’s approval of 4 (18%) oncology drugs in 2016, was also down from the 14 (31%) approvals in 2015, 9 (22%) in 2014 and 9 (33%) in 2013.
The
reasons for the low 2016 approval count, have been attributed to the agency
approving five drugs in 2015 that actually had approval action dates in 2016
and an increase in the number of drugs that the agency rejected.
A key reason for the rejections was the sponsors’ failure to comply with good manufacturing practice regulations.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Gilead’s Epclusa, the first
all-oral, pan-genotypic, single tablet regimen for the treatment of adults with
chronic hepatitis C virus (HCV) infection, is expected to become the most
profitable approval of 2016 with expected sales of $ 8.4 billion by 2022.
2016 also saw the FDA’s contentious approval of Exondys 51™ (eteplirsen) under its accelerated approval process. Exondys 51™ treats Duchenne muscular dystrophy (DMD), a rare genetic disease which causes progressive muscle wasting that affects around 20,000 boys and young men in the United States.
Approvals of three biosimilars which
target $ 33 billion in brand drug sales
In a
giant leap for the generic pharmaceutical industry, three biosimilar
applications were approved in 2016 that target brand drugs which generated more
than $ 33 billion in sales last year.
All the three biosimilars approved were tumor-necrosis factor alpha (TNF α) inhibitors used to manage inflammatory conditions.
Pfizer and Celltrion’s Inflectra, a
biosimilar to Janssen’s Remicade® (2016 sales - $ 8.8 billion), was the first to get approval for all Remicade-approved indications, except pediatric ulcerative colitis. Inflectra was launched at risk in November 2016.
After Inflectra’s approval, the FDA approved Sandoz’s Erelzi, a biosimilar to Enbrel® (etanercept – Amgen, 2016 sales - $
9.1 billion).
On Sept. 23, 2016, Amgen’s Amjevita™ (adalimumab – atto), a biosimilar of the world’s best-selling drug by revenue, AbbVie’s Humira®(2016 sales - $ 16.4 billion), was also approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Kim Kardashian’s pregnancy drug is now available in a new strength
Diclegis,
a combination of an antihistamine (doxylamine succinate) and a form of vitamin B6 (pyridoxine HCl), made headlines
when the FDA issued a warning letter for the social media promotion of the drug by Kim Kardashain, star of the reality show ‘Keeping Up With The Kardashians’
Duchesnay,
the company which produces Diclegis, got approval for Bonjesta which combines twice
the amount of doxylamine and pyridoxine when compared with Diclegis which contains
10mg of each ingredient.
Indian generic companies get approvals for
differentiated products
As the
generic industry in the U.S. continues to face severe pricing pressure, Indian
generic companies are attempting to overcome these challenges by trying to move
up the value chain by supplying differentiated generic products.
Consistent
with this strategy, the applications of Sun Pharmaceuticals
for a new ophthalmic version of Bromfenac (Bromsite) and Dr. Reddy’s Laboratory
for an injectable version of Sumatriptan (Zembrace™ SymTouch) to treat migraines were also approved.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Pfizer launches an opioid treatment with
abuse-deterrent properties
The abuse
of opioids, including prescription painkillers and drugs like heroin, is
something the United States has struggled with since before the 1900s. Last year, the FDA announced that immediate-release
opioid painkillers such as oxycodone and fentanyl will have to
carry a "black box" warning
about the risk of abuse, addiction, overdose and death.
Pfizer
got approval last year for Troxyca ER a combination containing oxycodone and naltrexone. Troxyca ER has properties that are
expected to reduce abuse when crushed and administered by the oral and
intranasal routes.
In it,
the oxycodone releases slowly over several hours. If the capsules are crushed,
the encased naltrexone mixes with oxycodone, essentially cancelling any euphoric
effects.
Pfizer
also received approval for an extended release form of Tofacitinib (Xeljanz® XR) to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
A dietary supplement gets approved along with new forms of commonly used drugs
In 2016, Endoceutics
got Intarosa, a once-daily vaginal insert, approved which is the first FDA
approved product to contain prasterone, also known as dehydroepiandrosterone (DHEA).
Although
DHEA is included in some dietary supplements, the efficacy and safety of those
products have not been established for diagnosing, curing, mitigating, treating
or preventing any disease.
Lisinopril, the most commonly used drug
by U.S. Medicare patients, was approved as an Oral Solution for the first time.
Diabetes
treatments, one of the most commonly prescribed drug categories in the U.S., saw
the addition of Sanofi and Novo Nordisk’s fixed-dose,
long-acting insulin and glucagon-like peptide 1
(GLP-1) agonist combinations to the list of options available to treat adult
type-2 diabetes.
Our View
The approval
of new drugs ensures that the world has access to improved healthcare solutions
and breakthrough medical therapies.
With Donald Trump “focused on accelerating the FDA” and an on-going argument that drugs should not have to be proven effective before getting approved, this year looks like the one where the new drug
approval scenario will be shaken up for time to come.
Click here to access our list of all New Drug Approvals (Excel version available) for FREE!
Impressions: 14456
https://www.pharmacompass.com/radio-compass-blog/fda-s-2016-approvals-of-new-drugs-formulations-strengths-more
#PharmaFlow by PHARMACOMPASS
09 Feb 2017
This week, PharmaCompass brings you a compilation of the Drug Master Files (DMFs) updates at the US Food and Drug Administration (FDA) over the past two quarters. These applications provide an overview of the products active pharmaceutical ingredient (API) manufacturers are investing in. And, they also give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.
Here are some key findings from our compilation of the FDA’s DMF updates over the second and third quarter of 2016, details of which were provided in July and October:
India leads
the pack, as the number of filings remain the same
Over the period, there were a total of 379 updates of DMFs at the FDA. This number
indicates a pace in filings that is nearly the same as the previous quarters.
We had seen 180 DMFs updates in the last quarter (Q4) of 2015 and 190 in the first quarter (Q1) of 2016.
During the last
two quarters, the DMF updates were led by Indian companies, such as Macleods Pharmaceuticals (14 DMFs), MSN Labs (13 DMFs), Hetero
(12 DMFs), Lupin (9 DMFs), Cipla and Biophore. The other prominent companies were Mylan and Teva.
Companies
with compliance issues stay away
Unlike previous
quarters, where
companies with compliance problems continued to submit DMFs, the last two
quarters were slightly different, since companies like Zhejiang Hisun and Ipca
Laboratories did not submit DMFs.
However,
Emcure Pharmaceuticals — whose Pune facility was inspected by
the FDA last year and a warning letter was issued to the company for violations of current good manufacturing practices (cGMPs) in March this year — submitted one DMF (for Phytonadione)
While
China shut down antibiotic manufacturing in the Shijiazhuang
city, raising concerns about the global supply chain’s dependence on China, Sinopharm Weiqida Datong
Pharmaceutical, located about 300 kilometers away from Shijiazhuang, filed DMFs for the key building blocks of antibiotic manufacturing — 6-APA and 7-ACA.
Once
again, this filing reinforces the dependence of global
antibiotic manufacturing on China.
Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!
Imminent FTF challenges
The
FTF challenges to Alvimopan Dihydrate (Merck’s Entereg), Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulib), Daclatasvir
Dihydrochloride (Bristol-Myer
Squibb’s Daklinza), Elvitegravir (an ingredient in Gilead’s Vitekta,
Stribild, Genvoya), Ibrutinib (AbbVie’s
Imbruvica), Ospemifene (Shionogi’s Osphena), Perampanel (Eisai’s Fycompa), Pomalidomide (Celgene’s Pomalyst), Regorafenib (Bayer’s Stivarga), Tofacitinib (Pfizer’s Xeljanz) and
Vortioxetine
Hydrobromide (Takeda’s Trintellix) seem to be imminent in
view of the recent filings of DMFs.
Roche’s 2014 acquisition of
InterMune for US $ 8.3 billion to gain rights to Esbriet (pirfenidone)
is likely to come under attack as three more DMFs were submitted during the
period under review.
The ink wasn’t dry on the deal papers of Pfizer’s US $1 4 billion acquisition of Medivation in August this year, when two more companies — Watson Pharma (now Allergan) and Scinopharm — submitted filings for Enzalutamide, the product for
which Pfizer paid all that money. This takes the total number of US submissions
for this product to seven.
Apixaban and Canagliflozin are most actively filed products
The most actively updated DMFs in the past six months were for the APIs of Bristol-Myer Squibb’s new-age anticoagulant Eliquis (Apixaban)
and Johnson & Johnson’s diabetes treatment Invokana (Canagliflozin). Sixteen DMFs were submitted for Apixaban along with nine for
Canagliflozin.
Products
like Dimethyl Fumarate and Teriflunomide — which were the
most frequently filed DMFs in our previous reports — continued to see vigorous filing activity.
Synbias Pharma made a submission
for Nelarabine, the only
submission for a Novartis product that was approved in 2005
and for which the only listed patent is expiring in June 2017. Similarly DSM’s submission of Dexpanthenol is the only DMF
listed for a product used in a variety of injectable and intravenous solution
products.
Established
pharmaceutical companies like Quimica Sintetica and Piramal Healthcare made submissions for products — Benznidazole and Norprostol — which are currently not approved in the United States, indicating the possibility of development projects being underway.
Our view
With drug filings ranging from multiple FTFs to cannabis derivatives,
updates over the two quarters have shown that regardless of the compliance
news, activity in the API industry is extremely robust.
You can view the PharmaCompass compilation of
the new DMF filings by clicking here or simply by sending us an email to get
your own Excel version of the new submissions.
Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!
Impressions: 4465
https://www.pharmacompass.com/radio-compass-blog/us-dmf-filings-indicate-a-robust-api-industry-with-multiple-first-to-file-challenges
#PharmaFlow by PHARMACOMPASS
08 Dec 2016
PharmaCompass has assessed the second quarter US Drug Master
File (DMFs) filings. In our view, with five potential first-to-file (FTF)
applications along with another five DMFs challenging markets that have been
monopolized for decades, the pharmaceutical industry in the United States
should brace itself for some serious shakeups. Unlike the first
quarter of 2015 where 241 new DMF filings were listed on the USFDA site,
this quarter saw a reduction of almost 35 percent in the DMFs filed. As DMFs
form a critical part of the regulatory submissions made by generics to
challenge innovator companies, a reduction in filings, in the recent quarter,
seems to bear no correlation with the disruption the market will potentially
witness in times to come. The ‘first-to-file’ disruptors Profits in the generic pharmaceutical business are highly dependent on how quickly a drug is introduced in the market. The ‘first-to-file’ generic is a coveted position, since the company is legally granted
a 180-day period of market exclusivity, where no other generic can be in the
market. This six month exclusivity invariably leads to windfall gains for the
company.This quarter DMFs were received by the FDA, which could potentially drive the first-to-file challenges against J&J’s blockbuster Inovkana (canagliflozin), Eisai’s Belviq (lorcaserin
hydrochloride), Incyte’s Jakavi (ruxolitinib
phosphate), Celgene’s Pomalyst (pomalidomide) and Akorn’s Zioptan (tafluprost).However, given the complexities involved in bringing a
generic product to market, the first DMF filing does not always result in the
first generic challenge to the brand drug. The second DMFs filed for a product
are also strong contenders which must not be ignored. For example, Glenmark
recently filed their DMF for tofacitinib,
almost 18 months after serial-DMF filing by MSN
Pharmaceuticals. But Glenmark
has moved ahead by already getting their DMF reviewed by the FDA. Similarly, while Alp Pharma Beijing’s dapagliflozin, Perrigo’s ferric citrate and Amino Chemicals’ miglustat
are the second DMFs to be received by the FDA, the innovator should start
counting the days before they are plagued by generic challengers. Exclusively
not-patentedFor several years, Indian companies have been leading many
first-to-file generic challenges in the United States. However, as they have
scaled up in size, the same companies have also obtained rights to some
exclusive markets in the United States; either through acquisitions or
alliances. Sun Pharmaceutical’s US
$ 230 million acquisition of dermatology specialist Dusa was triggered by the successful sales of Dusa’s photo-chemotherapy treatment, Levulan. German Midas Pharma GmbH’s filing will not only subject Sun’s market domination to generic competition, the fact that there are six other DMFs filed for this product (of which none of the filings have come from Indian or Chinese companies) indicates a change in the way the industry is beginning to operate. Like Sun Pharmaceutical’s monopoly of Levulan, Dr. Reddy’s has enjoyed no competition for their topical treatment, Cloderm (clocortolone
pivalate) since 2011 when they purchased the rights for the product by
making an
upfront payment of US $ 36 million to Canadian, Valeant Pharmaceuticals. Dr. Reddy’s needs to start monitoring the progress of Italian Trifarma’s filing since this is the fifth time a DMF for this product has been received by the FDA.Indian companies aside, Aspen’s Leukeran, Bausch & Lomb’s Zirgan, Mission Pharmaceuticals’ Thiola and GSK’s topical treatment Abreva have
all marketed their products without any competition. The DMF filings of this
quarter indicate that generics have narrowed in on the profits being made and
the market dynamics for these products will change in the future. Down, but not outIntriguingly, companies like Apotex
Pharmachem, Emcure
Pharmaceuticals and Global Calcium
are currently on the FDA Import Alert list and banned from exporting products
to the United States since they did not operate in
conformity with the current good manufacturing practices (GMP's). However, these companies are definitely optimistic about
their future since they have all filed new DMFs this quarter. It remains to be
seen if the bans will get lifted in the near future.This quarter also saw Dr. Reddy’s get creative in their challenge to Japanese Astellas Pharma’s leaky bladder treatment, Myrbetriq (mirabegron).
After having filed a DMF last year, they re-filed again recently, with a
different polymorphic form, to potentially circumvent the patents around this
product. Our supportGeneric pharmaceutical companies are continuously looking
for opportunities where they can get the maximum possible market share in the
fastest way possible. While the number of manufacturers of active pharmaceutical
ingredients (APIs) keep increasing, we are also witnessing an increase in the cost
of regulatory support required to sustain the production of these APIs. The industry is becoming more challenging – identifying target markets is becoming a science which requires high-level management focus. In order to help you, PharmaCompass will share its compilation of this quarter’s DMF filing list. Just send
us an email by clicking here and we’re happy to support you in every possible way.Last week, the FDA also announced the fee dues (as on
October 1, 2015), as per the Generic Drug User Fee Act (GDUFA). We are sharing
the amounts due, in case you have not been able to access this information.
FISCAL YEAR AND FEE TYPE
2014 (Rate)
2015 (Rate)
$ & %
Difference from previous year
Abbreviated New Drug Application
$63,860
$58,730
-$5,130 (-8.0%)
Prior Approval Supplement
$31,930
$29,370
-$2,560 (-8.0%)
Drug Master File
$31,460
$26,720
-$4,740 (-15.1%)
Finished Dosage Form Facility
$220,152 (Domestic)
$247,717 (Domestic)
$27,565 (12.5%)
$235,152 (Foreign)
$262,717 (Foreign)
Active Pharmaceutical Ingredient
Facility
$34,515 (Domestic)
$41,926 (Domestic)
$7,411 (21.5%)
$49,515 (Foreign)
$56,926 (Foreign)
Impressions: 5140
https://www.pharmacompass.com/radio-compass-blog/generic-challenges-the-next-first-to-files-gdufa-dues-fy-2016-and-more
#PharmaFlow by PHARMACOMPASS
13 Aug 2015
We always knew math was fuzzy, but never imagined addition could get so
complicated.
A recent publication on 2014 Global Prescription Medication Statistics listed the top pharmaceutical corporations by revenues, the best
selling products along with the top therapy areas.
The list, based on data published by IMS Health,
caught us by surprise since a previous publication by FiercePharma had a completely different order when ranking the top 15 pharmaceutical
companies.
As the difference in revenues of the top-10 companies was in excess of $60 billion and IMS Health’s data is an industry standard for decision making, we dug deeper to analyze the correlation between the information in the annual reports and IMS Health’s statistics.
Which pharmaceutical company is the largest?
Simply put, the answer is, ‘it depends’ on how you define a pharmaceutical company.
Should divisions like diagnostics, animal health, vaccines, consumer
health be counted when determining the size of a pharmaceutical company?
FiercePharma, in their analysis, used the total
revenue of all divisions of the organizations to determine the largest
organization; in their case it is Johnson & Johnson.
IMS determines their numbers by measuring “prescription sales and dispensing” and hence, excludes divisions like diagnostics, consumer health and animal health, making Novartis the largest
company.
As currency exchange rate fluctuations have their own, big role, in
determining the size of organizations, we believed it would be best to share
the revenues, as presented, so that you can draw your own conclusions.
Table 1/ Sales comparison for top pharmaceutical companies in 2014 from different sources (IMS, Fierce Pharma and Annual Reports)
Big Pharma
IMS Rank
IMS Sales
(US $Mn)
Fierce Pharma Rank
Fierce Pharma Sales (US $Mn)
Group Sales based on the Annual Report
(Currency as reported, Mn)
Novartis
1
51,307
2
57,996
USD
57,996
Pfizer
2
44,929
4
49,605
USD
49,605
Sanofi
3
40,037
5
43,070
Euro
33,770
Roche
4
37,607
3
49,866
CHF 49,866
Merck & Co
5
36,550
6
42,237
USD
42,237
Johnson &
Johnson
6
36,422
1
74,331
USD
74,331
AstraZeneca
7
33,313
8
26,095
USD
26,095
Glaxo SmithKline
8
31,470
7
37,960
GBP
23,006
Teva
9
26,001
11
20,272
USD
20,272
Gilead Sciences
10
23,673
10
24,474
USD
24,890
Amgen
11
20,473
12
20,063
USD
20,063
Lilly
12
19,909
14
19,615
USD 19,615
AbbVie
13
19,049
13
19,960
USD
19,960
Bayer
14
18,347
9
25,470
Euro
42,239
Bristol-Myers
Squibb
Not
in Top 20
15
15,879
USD
15,879
NB: Mn is million
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Since each group has multiple divisions, we further split the sales for
you to brainstorm:
Table 2/ Sales comparison of the different divisions of top
pharmaceutical companies in 2014 (Annual Reports in Mn)
Big Pharma
Pharma Division
Vaccine Division
Generics
Consumer Health
Other Divisions
Medical Devices/ Diagnostics Division
Animal Health Division
Divestures/ Other adjustments
Novartis
USD 31,791
Sandoz USD 9,562
Alcon USD 10,827
USD 5,816
Pfizer
USD 45,708
USD 3,446
USD 451
Sanofi
Euro 22,578
Euro 3,974
Euro 1,805
Euro 3,337
Euro 2,076
Roche
CHF 38,969
CHF 10,897
Merck & Co
USD 30,740
USD 5,302
USD 6,195
Johnson &
Johnson
USD 32,313
USD 14,496
USD 27,522
AstraZeneca
USD 26,095
Glaxo SmithKline
GBP 18,670
GBP 4,336
Teva
USD 10,458
USD 9,814
Gilead Sciences
USD 24,474
USD 416
Amgen
USD
19,327
USD 736
Lilly
USD 16,481
USD 788
USD 2,346
AbbVie
USD 19,960
Bayer
Euro 12,052
Euro 7,923
Euro 22,264
Bristol-Myers
Squibb
USD 15,879
Click here to access and download all
the 2014 data (Excel version available) for FREE!
Not sure that it adds any extra clarity on what should define a global pharmaceutical company…
Since the various divisions make
companies complicated to assess, what about product sales?
The good news is that we have a winner!
Humira®, AbbVie’s monoclonal antibody Adalimumab, used to treat rheumatoid and other types of arthritis, is the highest selling product globally. IMS reported Humira’s annual sales for 2014 at $11,844 million, while AbbVie mentions their sales of Humira at $12,543 million, the difference: a mere $700 million! However, with IMS gathering data across various points of the supply chain, and the recent volatility of the currency markets, we believe that a difference of 5.5% of total sales is within range of reason.
Unfortunately, things stopped making sense the moment we reached the
number-two product on the IMS list. Lantus®,
Sanofi’s insulin glargine, recorded sales of Euro 6,344 million (based on Sanofi’s 2014 annual report), while IMS mentions Lantus sales were $10,331 million last year. In addition, Sanofi has an 11% growth rate reported while IMS indicates a growth of 30%.
So unless the Euro/Dollar exchange rate moves back towards the 1.5
range, there seems to be a serious difference in the way the product sales are
calculated by companies and by IMS.
Using information available in the annual reports and other company declarations, we attempted to compare IMS’ Top 20 Global Products 2014 with available public information, to only find more complications!
Table 3/ Sales comparison of the top pharmaceutical products in 2014 (IMS vs Annual Reports)
Products
IMS Rank
IMS Sales (US $Mn)
Annual Reports Sales (US $Mn)
Pharma
Compass Rank
Big Pharma
Currency
Annual Reports Sales in Mn
Marketing Partner
Marketing Partner Annual Report Sales
(US $Mn)
Humira®
1
11,844
12,543
1
Abbvie
USD
12,543
Lantus®
2
10,331
7,676
5
Sanofi
Euro
6,344
Sovaldi®
3
9,375
10,283
2
Gilead Sciences
USD
10,283
Abilify®
4
9,285
7,556
6
Bristol
Myers-Squibb
USD
2,020
Otsuka
5,536
Enbrel®
5
8,707
8,538
4
Amgen
USD
4,688
Pfizer
3,850
Seretide®
6
8,652
6,589
8
GSK
GBP
4,229
Crestor®
7
8,473
5,512
11
AstraZeneca
USD
5,512
Remicade®
8
8,097
9,880
3
Johnson &
Johnson
USD
6,868
Merck & Co.
2,372
Mitsubishi
Tanabe
640
Nexium®
9
7,681
3,655
19
AstraZeneca
USD
3,655
Mabthera®
10
6,552
6,936
7
Roche
CHF
5,603
Roche
1,305
Avastin®
11
6,070
6,449
9
Roche
CHF
6,417
Lyrica®
12
6,002
5,168
12
Pfizer
USD
5,168
Herceptin®
13
5,564
6,306
10
Roche
CHF
6,275
Spiriva®
14
5,483
3,917
17
Boehringer
Euro
3,237
Januvia®
15
4,991
3,931
16
Merck & Co.
USD
3,931
Copaxone®
16
4,788
4,237
14
Teva
USD
4,237
Novorapid®
17
4,718
2,835
20
Novo Nordisk
DKK
17,449
Neulasta®
18
4,627
4,596
13
Amgen
USD
4,596
Symbicort®
19
4,535
3,801
18
AstraZeneca
USD
3,801
Lucentis®
20
4,437
4,152
15
Novartis
USD
2,441
Roche
1,711
Click here to access and download all
the 2014 data (Excel version available) for FREE!
It’s clear that the methods used to determine product sales are considerably different between IMS and the pharmaceutical companies, however there is a range of consistency as well. How accurate is each information really depends on the analyst’s point of view.
Our take:
With over $350 billion in total sales, we have provided our raw data for your review since we are certain that there are opportunities worth capitalizing
upon and others, which may not be worthwhile to pursue.
While the assessment of pharmaceutical sales is far more complicated
than what we had originally imaged, the focus of Big Pharma on small molecules
is on Hepatitis C drugs (Sofosbuvir, Olysio, AbbVie Hep C), blood thinners, Eliquis® (Apixaban), Xarelto®(Rivaroxaban) and of course ‘tinib’ cancer treatments.
Table 4/ Growth of ‘tinib’ cancer treatments in 2014 (Annual Reports)
Products
Big Pharma
Sales (US $Mn) 2013
Sales (US $Mn) 2014
Growth (%)
Ibrutinib
Pharmacyclics,
Inc
(now
AbbVie)
14
492
3414%
Dasatinib
Bristol-Myers
Squibb
1280
1493
17%
Trametinib
GSK
10
68
580%
Nilotinib
Novartis
1266
1529
21%
Ruxolitinib
Novartis
163
279
71%
Ceritinib
Novartis
Not
launched
31
Sunitinib
Maleate
Pfizer
1204
1174
-2%
Crizotinib
Pfizer
282
438
55%
Axitinib
Pfizer
319
410
29%
Tofacitinib
Citrate
Pfizer
114
308
170%
Click here to access and download all
the 2014 data (Excel version available) for FREE!
However, Big Pharma is now all about biologics.
IMS’s data indicates that the top 10 products have only 5 biologics, while our calculations have 8 out of the top 10 products as biologics. The future strategy is best summed up by the statement in Bristol-Myers Squibb’s annual report “Just 5 years ago, we had about 40% of our development projects in biologics. If we look forward 3-5 years, we believe that number could potentially grow to about 75%”.
The barriers of entry for generic competition and potential windfalls have made rivals come together to co-market Synagis® (AbbVie & AstraZeneca), Remicade® (Johnson & Johnson, Merck and Tanabe), Xolair® and Lucentis® (Roche & Novartis).
Our pharmaceutical whisper (phisper): join the bio-age or bio-degrade!
Impressions: 12778
https://www.pharmacompass.com/radio-compass-blog/who-has-the-biggest-one-sales-of-the-top-pharma-products-by-revenue
#PharmaFlow by PHARMACOMPASS
23 Apr 2015
