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
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This
week, Phispers brings you lots of regulatory news from the US, where the Trump
administration has instructed FDA to fund itself entirely through industry fees; and the agency’s chief has pledged to accelerate generic reviews through two new policies. This was yet another bad week for Teva, as it faced charges in Europe, lost a patent battle in the US to Takeda, and AstraZeneca’s CEO reportedly tossed away an offer to head it. Plus, there is news on AstraZeneca’s investment in China and Novartis’ CAR-T cell therapy for cancer.
Teva’s woes continue: Faces EC charges; loses patent battle; and Soriot drops offer
Teva’s troubles continued unabated. First, Pascal Soriot, the
chief executive of AstraZeneca, who was rumored to be the next head of
the Israeli drugmaker, decided not to leave AstraZeneca. He is reportedly forgoing an offer of a US$ 20 million bonus, and a chance to reorganize Teva, the world’s largest generic drug company.
Last week, the UK-based drug firm confirmed that Soriot would be presenting AstraZeneca’s second-quarter earnings, on July 27. Rumors of Soriot’s likely appointment were floated by an Israeli financial website. Teva is likely to announce the name of its new CEO within a month, Chaim Hurvitz, a member of Teva’s founding family, said.
Second, the European
Commission (EC) charged Teva of doing an illegal deal with Cephalon to delay selling a cheaper generic version of Cephalon’s sleep disorder drug. In the past, the EU regulator has charged scores of other companies as well, including Denmark’s Lundbeck, USA’s Johnson & Johnson and France’s Servier. According to the regulator, the pay-for-delay deals cost European consumers billions of euros.
Third, the Israeli
pharma biggie lost a patent battle in the US
appeals court to Takeda Pharmaceutical. The court said a patent on Takeda's cancer treatment — Velcade — is valid, pushing back the date when generic drug makers, including Teva and Mylan, will be allowed to launch lower-cost versions of the drug
in the US.
AZ invests US$ 79 million in Australia to cater to China’s demand for asthma drug
Air pollution is choking people in the big cities of China, raising demand for AstraZeneca’s asthma medicine — Pulmicort respules.
As a result, the British pharmaceutical giant
announced an investment of US$ 79.27 million (AUD $100 million) last week at its Sydney site which
manufactures the treatment.
The announcement was made in London on July 13, at a meeting between AstraZeneca CEO Pascal Soriot and Australia’s Prime Minister Malcolm Turnbull.
AstraZeneca will add three production lines
to the existing eight at its Sydney site, each with a capacity to produce over
70 million units of Pulmicort respules in a year. The company will bolster
exports from the site to over US$ 1.9 billion (AUD 2.4 billion) in the next
four years, with a further goal of doubling respules production to 1
billion by 2025.
“The demand for this asthma product, particularly for children in China, is immense and we see that trend continuing,” Mark Morgan, manufacturing director of AstraZeneca Australia, said.
Although labor costs are lower in China, the manufacturing technology “is difficult to replicate,” Morgan added. Over 50 percent of Pulmicort’s worldwide sales come from China. And its demand increased by 18 percent — from US$ 485 million in 2015 to US$ 570 million in 2016.
White
House tells FDA to fund itself via industry fees; FDA scouts for top talent
In the US last week, the House of Representatives passed the bill
that reauthorizes US Food and Drug Administration (FDA) to levy user fees. Soon
after that, the White House reiterated its earlier call to amend
the agreements so that the FDA is entirely funded by the medical products
industries.
In a statement, the White House said: “The Administration urges the Congress to provide for 100 percent user fee funding within the reauthorized programs… In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”
Last week’s statement said President Trump is “concerned with certain other provisions in the bill, such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition.”
Meanwhile,
the FDA
Commissioner Scott Gottlieb is
embarking on a talent hunt
to recruit new staffers for the
Prescription Drug User Fee Act (PDUFA)-related positions in the drugs and
biologics programs.
“To take on this new effort, we’re establishing a dedicated group of full-time staff with the responsibility to ensure that we reliably and predictably identify, recruit, and efficiently hire the scientific personnel the Agency needs,” Gottlieb said in his blog.
Novartis’ CAR-T cell therapy unanimously recommended for approval by FDA
The US FDA’s advisory committee has unanimously (10:0) recommended
Novartis’ CAR-T cell therapy — CTL019
(tisagenlecleucel) — for approval to treat pediatric and young adult patients with B-cell acute
lymphoblastic leukemia (ALL).
CAR-T is short for
chimeric antigen receptor T cell (CAR-T) therapy. In the US, ALL is the most
common childhood cancer.
This therapy is an immunotherapy approach to treat cancer, also considered the “fifth pillar” (after surgery, chemotherapy, radiation and targeted therapies like imatinib and trastuzumab) of cancer treatment. This approach,
called adoptive cell transfer (ACT), uses engineered immune cells to generate
remarkable responses in patients with advanced cancer.
In several early stage trials, when ACT was tested in patients with advanced ALL (with few treatment options left before these patients), many reported a complete disappearance of the cancer. And these patients remained cancer free for extended periods. Therefore, Novartis’ CTL019 assumes tremendous importance.
Meanwhile, the FDA
advisory committee also unanimously recommended Biocon/Mylan’s and Amgen’s biosimilars for approval. The two recommendations imply a
double whammy for Roche, with its drugs Avastin and Herceptin poised to get impacted by these
biosimilars.
The FDA’s Oncologic Drugs Advisory Committee (ODOC) voted 16-0 in favor of Milan’s proposed Herceptin biosimilar to treat HER2-positive breast
cancer, both for patients after surgery and for metastatic disease. The ODOC
also voted 17-0 to recommend FDA approval for Amgen’s ABP 215, an Avastin biosimilar, in each of the approved indications for the reference medication. The uses include metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.
Concord
Biotech faces GMP concerns; FDA warning letters to firms in
India, Italy
Ahmedabad-based Concord Biotech, a research and development-driven biotech firm that makes
fermentation-based APIs, was placed on Health Canada’s
Inspection Tracker due to “general GMP
observations” shared by a
regulatory partner. While no details of the observations were divulged, Health
Canada did not mention any data integrity concerns and is “continuing to review evidence submitted (i.e.
corrective actions, information from regulatory partner).”
The FDA also issued a warning letter to Tubilux Pharma SpA in Italy over concerns arising from an inspection
conducted in December 2016. The investigators raised concerns over turbulent
airflow on an aseptic processing line which “poses a significant contamination hazard” to the product. Limitations in Tubilux’s “current
equipment and process design” also
posed “a significant hazard” in the aseptic processing operation.
The warning letter also highlights that some of the products
manufactured at Tubilux were not tested for particulates prior to release.
During the inspection, FDA “observed repeated
instances of high particle count alarms during production”.
Tubilux specializes in manufacturing various types of products used in
ophthalmic applications.
A
September 2016, FDA inspection at Vista Pharmaceuticals in India highlighted concerns over the sale of
isoxsuprine hydrochloride USP, 20 mg tablets, by the firm. Although isoxsuprine
hydrochloride is sold in the US, the drug is not approved in the Orange Book.
The firm had also not validated the manufacturing process for isoxsuprine
hydrochloride USP, 20 mg tablets.
The warning letter also mentions that during the walk through of the
firm’s manufacturing
areas, FDA investigators observed that the equipment was in a state of
disrepair. “Specifically, our
investigators saw holes and corrosion in three pieces of equipment,” the letter noted.
FDA chief pledges to accelerate generic reviews through
two new policies
This week, the US FDA
Commissioner, Scott Gottlieb, made an announcement that by the end of 2017, the American
drug regulator will issue two new documents to improve the review process for
generic drugs.
These documents are
meant to streamline the submission and review of abbreviated new drug applications (ANDAs) under the FDA’s drug competition action plan.
The first document is a planned internal manual of policies and procedures (MAPP) — titled “Good ANDA Assessment Practices”. It will look to reduce “unnecessary” and “duplicative” procedures from FDA’s reviews to make them more efficient.
However, the document
will not alter any of the review goals the FDA agreed to as part of the
negotiations to reauthorize the GDUFA.
For applications that aren’t approved, MAPP will instruct reviewers to detail what needs to be fixed in the complete response letter (CRL), and provide follow up with sponsors over phone if the reasons in the letter are unclear, Gottlieb said.
The second document will be a guidance on “Good ANDA Submission Practices”. It will be added to the Center for Drug Evaluation and Research’s ‘to-do list’ for the year, which already includes 13 other new and revised draft guidances for generic drugs.
According to Gottlieb, this guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application.
Impressions: 3438
https://www.pharmacompass.com/radio-compass-blog/trump-tells-fda-to-fund-itself-fully-through-industry-fees-astra-s-ceo-dumps-teva-offer
#PharmaFlow by PHARMACOMPASS
20 Jul 2017
Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3086
https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production
#PharmaFlow by PHARMACOMPASS
03 Apr 2015
