Market Place
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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This week, Phispers brings you news about Teva — which received a warning letter from the FDA for its China facility and a setback from the Mexican regulator in its ongoing legal battle with Rimsa. Also, there is news on how Aspen employees allegedly destroyed stocks of life-saving drugs, along with news on Eli Lilly, Korea’s Hanmi and Pfizer-BMS. Read on.
FDA issues warning letter to Teva’s China facility; Mexico regulator supports Rimsa
In a difficult
week for Teva, the world’s largest manufacturer of generic drugs reported that its facility in China got a warning letter
from the US Food and Drug Administration (FDA).The warning letter
came in on April 10, based on a regulatory inspection carried out in September
last year. Teva said they are in the process of addressing the concerns raised
by the FDA and will respond to the regulator by May 1.
The FDA referenced several deficiencies at Teva’s active pharmaceutical (API) plant pertaining to production controls and sampling techniques and processes.
To make matters
worse for the Israeli drugmaker, Mexico’s pharmaceutical regulator — Federal Commission for the Protection against Sanitary Risk (COFEPRIS) — issued a memorandum that appears to undermine the claims of Teva against drugmaker
Representaciones e Investigaciones Medicas SA, known as Rimsa, which it acquired for US $2.3 billion in 2015.
In the memorandum,
COFEPRIS says it found no “unexpected adverse effects” in 147
drugs produced by Rimsa. It said the drugs were safe. Teva is engaged in a
legal battle against Rimsa for allegedly selling defective products and duping
regulators.
In September 2016, the former owners of Rimsa had filed a legal suit in a New York State court against Teva’s subsidiary Lemery SA, saying Teva was suffering from “a classic case of buyers’ remorse” and was therefore alleging that the
former owners fraudulently induced it to purchase the Rimsa companies.
Teva has had issues with the FDA since last year. And these have affected
its operations. The company
has received two warning letters in just six months, say news reports.
Aspen’s staff plotted to destroy stocks of life-saving drugs
Employees at Africa’s leading drug company — Aspen Pharmacare — reportedly plotted to destroy stocks of life-saving medicines during a price dispute with the Spanish health service in 2014. In fact, leaked internal emails suggest that employees at Aspen called for a “celebration” over price hikes of cancer drugs, an investigation has revealed.
In October last
year, Italian antitrust authorities fined Aspen nearly US $ 5.5 million
for halting supplies of several cancer drugs. The authorities viewed this as a
negotiating tactic to hike the prices of these cancer drugs by as much as 1,500
percent. The price-gouging episode began after Aspen purchased five different
cancer drugs from GlaxoSmithKline. It then began negotiations with the
Italian Medicines Agency over pricing for the cancer medicines.
This news from
Aspen comes at a time when Baxter’s possible price fixing of intravenous
(IV) saline has led to an employee being subpoenaed. Baxter said the subpoena, obtained by federal investigators, is “pursuant to a criminal investigation”. It calls for the employee to produce documents and
testimony related to pricing, shortages of Baxter's IV solutions “and communications with competitors regarding the same,” the company said.
BMS, Pfizer
hope to slow generic competition to Eliquis through patent suits
Pfizer and Bristol-Myers Squibb have filed 16 patent infringement suits
against generic drug makers over the last fortnight. And these include legal
suits against companies like Mylan, Dr. Reddy’s Laboratories and Accord Healthcare.
With these patent
infringement lawsuits, the two companies hope to slow the advance of generic versions of
their shared blockbuster Eliquis.
Eliquis is a stroke and blood clot preventer that brought in about
US $3.3 billion for BMS last year, up nearly 60 percent from the US $1.9
billion earned the year before. Pfizer, on the other hand, earned US $1.6
billion from this drug.
The two companies have gone to great lengths to protect and promote this drug — which is a top-selling product for both companies. Pfizer spent US $174 million on direct-to-consumer advertising for Eliquis last year.
Modi says India
may bring legal framework for doctors to prescribe generics
India is keen on encouraging cheaper generics over branded drugs. India’s Prime Minister Narendra Modi on Monday indicated that his government may bring in a legal framework under
which doctors will have to prescribe generic medicines to their patients, which
are cheaper than the corresponding branded drugs.
The government has
brought in a health policy after 15 years and capped the prices of medicines
and stents, which has angered some pharmaceutical companies, Modi said.
“Doctors write prescriptions in such a way that poor people do not understand the handwriting, and he has to buy that medicine from private stores at high prices,” Modi said.
“It is the government’s responsibility that everybody should get health services at minimal price,” he added.
FDA tells
Lilly to do more work on its new rheumatoid arthritis drug
Eli Lilly was not able to pacify FDA’s concerns over the safety risks of its much anticipated rheumatoid arthritis drug — baricitinib.
The
Indianapolis-based drug company and its partner Incyte were expecting an
approval for baricitinib. Instead, they received a complete response (CRL)
letter from the FDA, which said they need to do more work on the drug.
FDA wants to see
additional clinical data to get the doses right and to better characterize
safety concerns for the once-daily oral medication for moderate-to-severe
rheumatoid arthritis (RA), Eli Lilly said.
More trials will increase the time and money
that Eli Lilly and Incyte spend on baricitinib before its approval. Incyte and Lilly both said they are committed to working with the
agency to get approval.
“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the US,” Shaw added.
Controversy around Korea’s Hanmi and the death of a patient
Korean drug maker Hanmi is involved in a controversy pertaining to its cancer drug — olmutinib. A Korean patient taking this drug died from a rare case of Stevens-Johnson syndrome. And the death was reported after 14 months to the country’s health authorities. As a result, Hanmi’s partner — Boehringer Ingelheim — abruptly withdrew from their US $730 million partnership for olmutinib.
The death of the
patient occurred in July 2015, when the patient was taking olmutinib and two
other drugs. The physicians involved in the case said it was triggered by the
other drugs and reported the case to a monitoring agency. But it was not
reported as an unexpected serious adverse event. Hanmi and the agency finally
reported the death to health officials in September, 2016.
According to
Korean officials, Hanmi broke two medical laws related to monitoring and
reporting clinical trials. The opposition party in Korea said the influential
Hanmi had intentionally delayed reporting the death so it could get the drug
approved in Korea. But investigators say they found no evidence of that.
Impressions: 2986
https://www.pharmacompass.com/radio-compass-blog/more-bad-news-engulfs-teva-india-to-bring-laws-so-that-doctors-prescribe-generics
#PharmaFlow by PHARMACOMPASS
20 Apr 2017
