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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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
This week in Phispers, we bring you news about intepirdine, Axovant’s experimental drug for Alzheimer’s disease, on which both patients and investors had vested much faith. The drug failed primary endpoints. Meanwhile, Pfizer is emulating the Axovant strategy as it split four of its clinical-stage orphan drugs into a new company. There was more bad news for Biocon-Mylan, as Amgen filed a patent infringement case against Mylan in the US. Novartis’ new CEO says it will reduce the development cost of drugs by relying on data science. And, there is news on NASH drugs and on merger talks between Amneal and Impax Labs.
Axovant disappoints investors; its Alzheimer’s drug fails primary endpoints
After two years of brouhaha by investors, Axovant’s experimental drug intepirdine, as a treatment for mild to moderate Alzheimer’s disease, turned out to be a damp squib.
The
experimental drug did not meet its co-primary efficacy endpoints, a press
release issued by Axovant said. The medicine turned out to be no different from 99 percent of medicines tested against Alzheimer’s.
Investors
had poured millions of dollars into Axovant. According to an estimate compiled
by Bloomberg, intepirdine was expected to generate more than US$ 2 billion in sales for
Axovant by 2023.
But that was not to be. At 24 weeks, patients treated with 35 mg of intepirdine did not improve on either of two surveys — the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) — compared to patients treated with placebo.
Back in 2015, Axovant — a company founded by Vivek Ramaswamy — had bought intepirdine from GlaxoSmithKline for US$ 5 million and launched Axovant’s US$ 315 million IPO around the drug. That’s when PharmaCompass had raised the question — has 29 year-old Ramaswamy shown GlaxoSmithKline that it made a billion dollar mistake by
selling of its old Alzheimer drug to him?
In April this year, Ramaswamy stepped down as CEO of Axovant by
appointing former chief executive of Medivation, David Hung, in his place. Medivation got sold to Pfizer for US$
14.3 billion last year.
Last month, Ramaswamy’s Roivant (Axovant’s biggest shareholder) raised US$ 1.1 billion from big investors lead by Softbank’s Vision Fund. Roivant also raised millions of dollars from hedge funds like Viking Global Investors. These investments diluted the stakes of Ramaswamy and other initial investors in Roivant.
But
Ramaswamy is laughing all the way to the bank. Through divestments, he has
secured a war chest for Roivant, which has been spinning out new companies with names ending with ‘vant’ — such as Axovant (neurology), Myovant (women's health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology).
Pfizer emulates Axovant; Ibrance maybe a US$ 5 billion
drug next year
Even as Axovant’s intepirdine failed to meet primary endpoints, the American pharmaceutical behemoth Pfizer seems to have taken a leaf out of its strategy book.
Pfizer’s R&D strategy executive Lara Sullivan gained the company’s support to split four of its clinical-stage orphans into a new company called SpringWorks
Therapeutics.
And
much like Axovant, Pfizer too is starting out with a mega-round of US$ 103
million in venture capital funding. SpringWorks is getting considerable financial
support from Pfizer and funds like Bain Capital Life
Sciences, Bain Capital Double Impact, Orbimed and LifeArc.
Pfizer has spent US$ 24 billion over the past three years on R&D, the
third highest R&D spend amongst pharma companies. Along with drug-focused
acquisitions, Pfizer has spent US$ 43 billion in the same period.
Ibrance to brighten up Pfizer’s fortunes: Meanwhile, Pfizer’s breast cancer drug Ibrance now competes with Novartis’ Kisqali.
It will also compete with Lilly’s forthcoming drug
abemaciclib.
Though side effects are an issue for all the three drugs, Ibrance is expected to brighten up Pfizer’s fortunes. According to Morgan
Stanley, Ibrance could bring in sales of US$ 939 million in the third quarter
and US$ 1 billion in the fourth quarter, leading to US$ 3.5 billion in sales
for 2017. And in 2018, Ibrance could fetch US$ 4.85 billion in sales.
Novartis vows to slash drug development costs, while FDA terms system ‘broken’
The time and cost of taking a medicine from discovery to market has for long been seen as a drag on the pharmaceutical industry’s performance. The process has been estimated to take up to 14 years and cost at least US$ 2.5 billion.
Last week, Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the clinical trials system is “broken” and there needs to be
new ways to collect and utilize patient data. She was speaking at a workshop on
real world evidence (RWE) at the National Academies of Sciences, Engineering,
and Medicine.
This
week, the incoming chief executive of Novartis, Vas Narasimhan, has vowed to slash drug development costs, and save up to 25 per cent on multibillion-dollar clinical trials as part of a “productivity revolution” at the company.
Quoting analysts, Narasimhan said between 10 and 25 per cent of trial costs could be reduced if digital technology were used to carry them out more efficiently. The Swiss drug major has 200 drug development projects under way and is running 500 trials. Therefore, digital technology “will have a big effect if we can do it at scale,” he added.
Narasimhan plans to partner with, or acquire, artificial intelligence and data analytics companies, to supplement Novartis’s strong but “scattered” data
science capability.
After
Pfizer, Takeda may soon exit Brazil; seeks suitors for Multilab
Not
long ago, Brazil was one of the hottest emerging markets for
drugs, and big pharma were lining up to cash in on this opportunity.
Today, Brazil is in the midst of a historic recession that has
dampened drug demand.
In July this year, Pfizer relinquished its 40 percent stake in the Brazilian generic drug firm — Laboratório Teuto Brasileiro — for a paltry 1 Brazilian Real (or US$ 0.30) to the heirs of the company. Pfizer had acquired the stake for US$ 240 million back in 2010.
And this month, it looks like Japan's largest
pharmaceutical company Takeda is
following Pfizer’s footsteps and is going to dispose off its 2012 acquisition of Multilab laboratory (which it had acquired for Brazilian Real 500 million or US$ 158 million). According to news reports, Takeda may recover only a fifth of its original investment (of Brazilian Real 100 million or US$ 31.57 million).
Takeda is expected to receive proposals for
Multilab from mutual funds and domestic companies with similar business
interests.
FDA issues warning on Ocaliva (obeticholic acid) use; Allergan’s NASH drug also stumbles
The US FDA issued a warning as 19 patients died after taking Intercept’s liver disease drug Ocaliva. The company responded by saying the dosing administered was
incorrect.
In
most cases, the exact cause of death wasn’t known. But seven of the patients who died were taking Ocaliva more frequently than
recommended, the FDA said.
Earlier this month, Intercept had warned doctors that Ocaliva can cause injuries, organ failure, or death if it’s not used exactly as intended in patients with primary biliary cholangitis, a relatively rare liver condition for which the drug was approved last year.
The company says it is working with the FDA on
revised labeling aimed at more clearly indicating the recommended dosing
regimen for all patients.
Intercept is in the final stages of testing Ocaliva for nonalcoholic
steatohepatitis, or NASH, a silent disease in which the liver gets inflamed and
damaged due to a buildup of fat. Dozens
of pharma companies including Gilead Sciences, Allergan and Intercept Pharmaceuticals are trying to
develop a treatment for the disease. Over the last two years, at least six
deals valued at US$ 3.52 billion or more
have taken place involving drugs that target various aspects of NASH.
Meanwhile, Allergan’s Cenicriviroc (CVC) showed mixed results in a Phase 2b clinical
trial. CVC is facing trials for the treatment of liver fibrosis in adult NASH
patients. The trial involved a two-year study. According to Seeking Pharma,
20 percent of patients in the placebo arm during year one who crossed over to
receive CVC during year two achieved the combined endpoint of reduction in
fibrosis by at least one stage and no worsening of NASH compared to 13 percent
for those who continued on placebo.
However, “there was no difference between CVC and placebo in patients who remained on treatment for two years as determined by the composite endpoint,” it added.
Another
setback for Biocon/Mylan, as
Amgen files patent infringement case in US
News doesn’t seem to be getting better for the Biocon/Mylan
combine. First, they withdrew their applications for
the trastuzumab and pegfilgrastim biosimilars from Europe. And then, the FDA extended the target action date for their trastuzumab biosimilar.
Now,
the duo will be facing Amgen in court to defend themselves in a patent infringement case.
Last week, Amgen filed a complaint for patent infringement
under the Biologics Price Competition Innovation Act (BPCIA) against Mylan, which is developing a biosimilar of its drug Neulasta (pegfilgrastim).
Approval delays, spiraling compliance costs and now litigation expenses won’t help the profitability of Mylan-Biocon’s endeavors.
In
Europe, competition is already moving ahead as the EMA’s Committee for Medicinal Products for Human Use recommended the approval of Samsung’s Herceptin-referencing biosimilar Ontruzant.
This is the fourth patent litigation under the BPCIA
regarding a proposed biosimilar of Neulasta, none of which are yet
FDA-approved.
Amneal in merger talks with Impax
Laboratories
Analysts
have been predicting a consolidation in the world of generics. According to
reports, Impax is in merger talks with generics competitor Amneal Pharmaceuticals. The deal would value Impax at US$ 2 billion
or more. According to FiercePharma, the talks could result in a
deal next month.
Impax is headed by Paul Bisaro (who quit Allergan to join Impax in March this year). He has considerable experience in M&As. Last year, Bisaro sold off part of Allergan’s business to Teva Pharmaceuticals in a US$ 40.5 billion
deal.
And
last month, Shanghai Fosun Pharmaceutical picked up a 5.2 percent
stake in Impax. Amneal, on the other hand, is owned by Chintu and Chirag Patel.
Impressions: 3227
https://www.pharmacompass.com/radio-compass-blog/axovant-s-hyped-alzheimer-s-drug-fails-trial-as-pfizer-emulates-axovant-amneal-and-impax-in-merger-talks
#PharmaFlow by PHARMACOMPASS
28 Sep 2017
Global
pharmaceutical companies are increasingly focusing on the development of new
biologics. In fact, in 2016, nine out of the top
15 pharmaceutical drugs by sales were of biologic origin. This makes us wonder
what the future holds for manufacturers specializing in drugs that originate
from chemical synthesis.
This
week, PharmaCompass continued its analysis of the top pharma drugs by
sales to evaluate the drugs that registered large sales growth in 2016.
Click here to Access All the 2016 Data (Excel version available) for FREE!
Please
note that these are not the top-selling drugs, but are the top 10 drugs that
registered the maximum growth in global sales over 2015.
Interestingly, things didn’t appear that bad for drugs originating from chemical synthesis — while the top two drugs on the list were biologics, the remaining originated from chemical synthesis.
Here’s a list of drugs that witnessed the largest sales growth in 2016:
1. Opdivo (nivolumab) – Bristol-Myers Squibb
2016
sales: US$ 3,774 million
2015 sales:
US$ 942 million
Sales
growth: US$ 2,832 million
First
approved in 2014, Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda — also known as checkpoint inhibitors — continued to stay on track to be among the top 20 best-selling drugs in the world by 2020. They represent the hot new field of immunotherapy and are known to have given 90-year old Jimmy Carter (former President of the United States) hope in his fight against cancer.
With
a sales growth of US$ 2.832 billion, Opdivo registered the highest sales growth
of any single drug in 2016. However, Bristol-Myers Squibb received a nasty
surprise last year when Opdivo did not demonstrate the desired slowdown in the
progress of advanced lung cancer in a trial, as compared to conventional
chemotherapy.
While Bristol-Myers’ stock price plunged on this news, Merck announced that not only did Keytruda succeed in a clinical trial as an initial treatment for advanced non-small cell lung cancer, but patients actually lived longer. Although Keytruda did not make it to our list of top 10 drugs by sales growth in 2016, it did register a sales increase of US$ 836 million, as its sales grew from US$ 566 million to US$ 1,402 million.
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2. Humira (adalimumab) – AbbVie
2016
sales: US$ 16,078 million
2015
sales: US$ 14,012 million
Sales
growth: US$ 2,066 million
Abbvie’s Humira (adalimumab)
juggernaut continued as it not only remained the best-selling drug in the
world, but also added another US$ 2 billion to its 2015 sales by generating
record sales of US $16.078 billion in 2016.
Last
year, the US Food and Drug Administration (FDA) approved Amgen’s Amjevita™ (adalimumab – atto) — a biosimilar of Humira®. Therefore, it remains to be seen if Humira will be able to sustain the momentum. Amjevita was approved for treating adults with a variety of medical conditions ranging from rheumatoid arthritis, plaque psoriasis, to ulcerative colitis.
3. Epclusa (sofosbuvir and velpatasvir) – Gilead
2016
sales: US$ 1,752 million (new launch)
Gilead’s third sofosbuvir-based regimen — Epclusa (sofosbuvir and velpatasvir) was approved by the US FDA in June 2016. It is the first and only all-oral, pan-genotypic single tablet regimen for chronic Hepatitis C virus infection. While Epclusa registered an impressive start, Gilead's other two sofosbuvir-based treatments — Sovaldi (sofosbuvir) and Harvoni (sofosbuvir and lepidasvir) — saw their combined sales decline by almost US$ 6 billion.
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4. Imbruvica (ibrutinib) — Johnson & Johnson / AbbVie
2016
sales: US$ 3,083 million
2015
sales: US$ 1,443 million
Sales
growth: US$ 1,640 million
Abbvie’s 2015 US$ 21 billion buy of Pharmacyclics seems to be paying off.
The Pharmacyclics buy was a way to get access to Imbruvica (ibrutinib), a cancer drug which
is co-marketed with Johnson & Johnson. It generated sales of US$ 3.083 billion in 2016. Imbruvica works by blocking a specific protein called Bruton’s tyrosine kinase (BTK). In December 2011, Johnson & Johnson said it would pay Pharmacyclics as much as US$ 975 million to fund getting the drug to market in exchange for half the profits generated globally.
5. Eliquis (apixaban) -
Bristol-Myers Squibb / Pfizer
2016
sales: US$ 3,342 million
2015
sales: US$ 1,860 million
Sales
growth: US$ 1,483 million
Although
apixaban was the third-to-market
novel oral anticoagulant (NOAC), which is co-promoted by Pfizer and Bristol-Myers Squibb as Eliquis, it continues to unseat Johnson & Johnson’s Xarelto (rivaroxaban) as the leader in its
class based on total prescriptions. Rivaroxaban's total 2016 sales were US$
5.392 billion.
While Pfizer’s reports its sales as part of Alliance revenues, and exact sales are not known, Bristol-Myers Squibb results alone put Eliquis in the top 10 list. Generics are hot on their tail as, last month, Pfizer and Bristol-Myers’ filed suits against 16 generic makers to uphold their patents for apixaban.
6. Genvoya (elvitegravir,
cobicistat, emtricitabine, tenofovir alafenamide) — Gilead
2016
sales: US$ 1,484 million
2015
sales: US$ 45 million
Sales
growth: US$ 1,439 million
Genvoya has been the most
successful HIV treatment launch since the introduction of Atripla (the first
single-tablet regimen launched a decade ago). Gilead is the dominant HIV
player in the US market and has the top three most-prescribed HIV regimens in
the US.
Genvoya
adds Tenofovir Alafenamide (TAF) to already known
treatments. TAF based drugs have demonstrated a better safety profile. They
would also allow Gilead to maintain its dominance in the HIV market.
Click here to Access All the 2016 Data (Excel version available) for FREE!
7. Ibrance (palbociclib) — Pfizer
2016
sales: US$ 2,135 million
2015
sales: US$ 723 million
Sales
growth: US$ 1,412 million
Discovered
in Pfizer laboratories and approved by the US
FDA in February 2015, Ibrance is used in combination
with Letrozole as a first-line
treatment of postmenopausal women with estrogen receptor-positive, human
epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast
cancer.
8. Triumeq (abacavir,
dolutegravir, lamivudine) – GlaxoSmithKline
2016
sales:US$ 2,151 million
2015
sales: US$ 905 million
Sales
growth: US$ 1,246 million
GlaxoSmithKline's HIV drugs business — ViiV Healthcare — has been enjoying sales growth with the introduction of Triumeq ® in its portfolio. While GSK is the major shareholder in ViiV Healthcare, Pfizer and Shionogi also have a stake. Triumeq® is the company’s first fixed-dose combination tablet for a once-daily single pill regimen that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors — abacavir and lamivudine.
9. Revlimid (lenalidomide) – Celgene
2016
sales: US$ 6,974 million
2015
sales: US$ 5,801 million
Sales
growth: US$ 1,173 million
Celgene’s Revlimid (lenalidomide) — a thalidomide-derivative introduced in 2004 as an immunomodulatory agent for the treatment of various cancers such as multiple myeloma — brought in US$ 5.8 billion in 2015, and grew another 20 percent this year, to US $6.974 billion. Revlimid now contributes more than 60 percent to Celgene's total sales of US$ 11.229 billion.
10. Xarelto (rivaroxaban) – Johnson & Johnson (US) and Bayer
2016
sales: US$ 5,392 million
2015
sales: US$ 4,255 million
Sales
growth: US$ 1,137 million
Bayer’s Xarelto, which is promoted by Johnson & Johnson in the United States, provided patients with an alternative to the old-guard therapy — warfarin. While rivaroxaban is competing with other
novel oral anticoagulants (NOAC) like Eliquis (apixaban) and Pradaxa (dabigatran), rivaroxaban has the
class lead in indications.
Xarelto
recently posted positive results in a large-scale Phase 3 study —COMPASS, involving 27,402 patients, that assessed the effect of the
blood thinner in preventing major adverse cardiac events (MACE).
The
trial was stopped a year early
on the advice of an independent Data Monitoring Committee, after the primary
endpoint of prevention of MACE (which includes cardiovascular death, myocardial
infarction and stroke) reached its pre-specified criteria for superiority over aspirin.
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Our
view
In QuintilesIMS Institute’s new annual drug spending report, analysts have forecasted that
over the coming five years the industry should continue to receive 40 to 45 new
drug approvals every year.
A quarter of all the drugs in late-stage development are now
focused on oncology. The rate of oncology drug development has hit such a
rapid pace that new drugs are superseding old ones in a matter of a few years.
It’s clear that this compilation will see radical changes next year. However, with eight out of the 10 fastest-selling drugs coming from chemical synthesis, traditional generic manufacturers still have a lot of opportunities to explore.
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Impressions: 9289
https://www.pharmacompass.com/radio-compass-blog/chemical-entities-shine-in-the-top-10-fastest-growing-drugs-of-2016
#PharmaFlow by PHARMACOMPASS
17 May 2017
