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: 54754
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Share
This week, Phispers brings you news on how a federal judge in the US revoked ‘pharma bro’ Martin Shkreli’s bail due to his misconduct on Facebook. Roche, the world leader in oncology treatments, has to contend with more competition from biosimilars, as Amgen and Allergan’s Avastin copy bags USFDA approval. China’s Fosun Pharma tweaked its Gland Pharma buyout deal in order to avoid a review by the Indian government. And, Teva starts selling assets to reduce its debt burden.
Shkreli finally sees jail for putting a bounty on Hillary Clinton’s hair
Martin Shkreli, former CEO of Turing Pharmaceutical, an
entrepreneur and the founder of several hedge funds, was sent to jail last week, not
for the financial frauds or
for raising the sticker price of a life-saving drug (Daraprim) by 5,000 percent in 2015, but for offering US$ 5,000 for a strand of Hillary Clinton’s hair. The federal judge revoked his bail due to this misconduct on social media.
Shkreli has
been on a US$ 5 million bail, even as he is awaiting sentencing. He made two Facebook posts offering cash to anyone who could “grab a hair” from Clinton during her book tour. Shkreli has branded himself as one of social media’s ‘most notorious trolls’.
At the hearing in Brooklyn, the judge said Shkreli’s post could be perceived as a threat. And now, Shkreli (34), who called his post satire, is cooling his heels at the Metropolitan Detention Centre in Brooklyn.
Last month, Shkreli was convicted in three out of eight
charges, including securities fraud. He was scheduled to be sentenced on
January 16. Unless his lawyers prove he poses no threat to the community,
Shkreli is not likely to be released from jail.
China’s Fosun resurrects deal to buyout Gland by scaling down stake purchase
Shanghai Fosun Pharmaceutical Group has reduced the amount of stake it
wishes to buy into Indian drugmaker Gland Pharma from
86 percent to 74 percent, in order to avoid a review by the Indian government.
This way, Fosun is potentially resurrecting a
transaction that had been on hold for over a year.
Backed by Chinese billionaire Guo Guangchang, Fosun Pharma
will now buy 74 percent stake in Gland for US$ 1.09 billion, Fosun said in a
statement to the stock exchanges.
In June 2016, the Indian government had changed regulations
pertaining to foreign direct investment (FDI) in existing pharmaceutical firms
through the automatic route. Under the new rules, FDI involving more than 74 percent stake now requires an approval by the
Indian government.
The previous move, to buy 86 percent stake in Gland, would
have required an approval by the Cabinet Committee on Economic Affairs (CCEA).
The proposal was not taken up by the CCEA and was subsequently put in cold
storage during the Doklam tensions between India and China.
Hyderabad-based Gland specializes in injectable drugs such as antibiotics, oncology and cardiology treatments. Gland’s manufacturing facilities have been accepted by the US Food and Drug Administration (USFDA) and other regulatory agencies. The deal would give the Chinese firm access to Gland’s portfolio of generic injectable medicines and control of facilities to export to the US and other developed markets.
The original acquisition offer (for 86 percent stake) valued
Gland at about US$ 1.35 billion. The firm has also delayed the closing date for the
deal to October 3, from September 26.
Rise of biosimilars: Pfizer sues J&J;
Roche faces more heat from biosimilars
This
week, Pfizer filed a lawsuit against Johnson & Johnson (J&J), alleging
that J&J's contracts with health insurers for its blockbuster rheumatoid
arthritis drug, Remicade, were anticompetitive and blocked sales of Pfizer’s newly-approved biosimilar (known as Inflectra).
According
to Pfizer, J&J has signed exclusionary contracts with health insurers, hospitals and doctor groups which exclude Pfizer’s Inflectra from insurance coverage.
In the first quarter of 2017, J&J’s chief financial officer had mentioned that they saw “very little impact” from biosimilar competition to Remicade in the US.
Roche, the world’s biggest maker of oncology treatments, also has more biosimilars to contend with.
In the US, the FDA gave its nod to Mvasi (bevacizumab-awwb) as a biosimilar to
Avastin (bevacizumab) for
the treatment of multiple types of cancer. Mvasi is the first anti-cancer
biosimilar approved by the USFDA.
Amgen and Allergan’s
bevacizumab biosimilar is also undergoing review by the European Medicines
Agency (EMA). The companies are collaborating on the development and
commercialization of four oncology biosimilars.
Roche received another blow last week, when the EMA’s Committee for Medicinal Products for Human Use recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant. It is the first biosimilar copy of Herceptin to obtain such a backing in Europe.
In June this year, the European Commission had approved Rixathon — a biosimilar for Roche’s MabThera (or Rituximab, a
drug for blood cancer).
These approvals are expected to herald in a gradual erosion
in sales of patented cancer drugs. Rituximab, Herceptin and Avastin together
had 2016 revenue of US$ 21.8 billion. But their combined sales are expected to
fall more than 40 percent by 2022, says a forecast compiled by Thomson Reuters.
Roche needs to offset this ‘anticipated’ drop in sales by making a success of its new cancer drugs, such as Perjeta, Gazyva and Tecentriq.
Biosimilars
(medicines that are highly similar to the original drug) offer a route to more
affordable cancer care at a time when the price of modern therapies to fight
tumors is going through the roof.
Generics under pressure: Teva sells assets to reduce debt;
new M&A head at Lupin
Last week, there was finally some good news from Teva Pharmaceutical Industries, when it announced the name of Kare Schultz as its new CEO. Soon
after that, the Israeli drugmaker announced it has sold its Paragard intrauterine copper contraceptive to CooperSurgical for
US$ 1.1 billion in cash in order to bring down its debt load.
Teva will also sell the remaining assets in its specialty women’s health business for US$ 1.38 billion in two separate transactions. CVC Capital Partners Fund VI will pay US$ 703 million in cash for a portfolio in Teva’s global women’s health business including contraception, fertility, menopause and osteoporosis products.
Teva also agreed to sell its Plan B One-Step and its brands
of emergency contraception to Foundation Consumer Healthcare for US$ 675
million in cash. Combined annual net sales of these products were US$ 140 million
last year.
However, even after these sales, Teva will continue to
remain highly indebted. Last year, Teva had purchased Allergan’s generic unit for US$ 40.5 billion, taking its debt load to US$ 35 billion. Teva is actively pursuing divestitures and expects to garner at least $2 billion in total asset sales for the year.
Meanwhile, Mumbai-headquartered Lupin has
hired Jim Loerop to drive its global M&A strategy. He will also lead Lupin’s overall corporate development efforts, besides being responsible for its M&A and business development functions. Loerop joins
Lupin from Alexion Pharmaceuticals.
FDA wants
more compounding pharmacies to register under law
The USFDA Commissioner Scott Gottlieb said the agency is working on a new policy that would encourage more compounding
pharmacies to register under a law enacted in the wake of a deadly 2012
meningitis outbreak linked to one such company.
The traditional role of compounding pharmacies is to make drugs prescribed by doctors for specific patients with needs that can’t be met by commercially available drugs. Back in 2012, a compounding pharmacy known as the New England Compounding Center (NECC) had triggered a meningitis outbreak by using contaminated steroids. NECC is now defunct. But prosecutors are preparing for the second criminal trial over
contaminated steroids manufactured by NECC. Glenn Chin, a former supervisory
pharmacist at NECC, is facing trial this week for
second-degree murder and fraud. He has pleaded not guilty.
The 2012 meningitis outbreak had affected 778 patients
across the US, out of which 76 had died after receiving contaminated steroids.
After the outbreak, the US had passed the Drug Quality and
Security Act in 2013, which aimed to bring more compounding pharmacies under
the FDA (rather than under the state pharmacy boards).
The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients. Today, around 70 firms have registered as outsourcing facilities.
According to the American Pharmacists Association, there are
about 7,500 pharmacies that specialize in compounding services. Gottlieb said
in order to encourage more compounders to register, the FDA would release draft
guidance in the next two months.
FDA nod for GSK’s triple drug inhaler for COPD puts it ahead of rivals
The USFDA has approved British pharma giant GlaxoSmithKline’s three-in-one inhaler — Trelegy Ellipta — for chronic obstructive pulmonary disease (COPD). This is a key new product for GSK as it
strives to keep its lead in respiratory medicine,
despite falling sales of Advair (an
asthma and COPD treatment).
Trelegy Ellipta is the first once-daily triple medicine for
COPD. The inhaler puts GSK ahead of rivals such as AstraZeneca and Novartis. GSK
developed this inhaler along with Innoviva, an
American drug company.
Last week, the inhaler, also won a recommendation for
approval from the EMA.
GSK’s CEO Emma Walmsley sees Trelegy Ellipta as one of three “critical” launches that would fill in the revenue gap left by the sagging sales of Advair, which is expected to face generic competition in the US sometime next year. Walmsley’s other two key new products are Shingrix, a shingles vaccine that was unanimously recommended for approval by a USFDA advisory panel last week, and a novel dual-drug regimen for HIV.
Impressions: 2799
https://www.pharmacompass.com/radio-compass-blog/pfizer-sues-j-j-generics-under-pressure-china-s-fosun-resurrects-deal-to-buyout-india-s-gland
#PharmaFlow by PHARMACOMPASS
21 Sep 2017
