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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The year 2017 was a landmark year for pharmaceutical
industries in the US and Europe, with a sharp increase in the number of new molecular entities (NMEs) being approved in both geographies.
The US Food
and Drug Administration (USFDA) approved 46 NMEs in 2017, the second highest
since 1996 when 53 NMEs were approved. In Europe, the European Medicines Agency
(EMA) approved 35 drugs with a new active substance, up from 27 in 2016.
Sales for most major pharmaceutical
companies continued to grow in 2017. Earnings forecasts for 2018 have been raised due to the recent US tax reform that has
generated investor hopes for accelerated dividend growth and share buyback
plans.
This week, PharmaCompass brings
you a compilation of the top drugs of 2017 by sales revenue.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Top-sellers: Humira races ahead, despite launch of biosimilars; Enbrel a distant second
There wasn’t any upheaval
at the top of the pharma drug sales charts. AbbVie’s anti-TNF (tumor necrosis factor) giant
Humira (adalimumab), which is approved to treat
psoriasis and rheumatoid arthritis, added
almost another US $3 billion to its 2016 sales and posted nearly US $19 billion in revenues.
Last year, AbbVie’s raised expectations for Humira’s earnings to reach US $21 billion in global sales by 2020. The
company believes this drug will continue to be a significant cash contributor
until 2025 and the US $21 billion sales forecast
by 2020 is about US $3 billion higher than its expectation two years ago.
In 2016, the US Food and Drug Administration
(FDA) approved Amgen’s Amjevita (adalimumab-atto) — a biosimilar of Humira. And in 2017, another Humira biosimilar — Boehringer Ingelheim’s Cyltezo
(adalimumab-adbm) — received approval from the FDA and European authorities.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Enbrel (etanercept),
the longest-used biologic medicine for the treatment of rheumatism around the
world, was the second best-selling drug with US $8.262 billion in 2017 sales.
The sales of the drug were down from US $9.366 billion in
2016 owing to lower selling prices and increased
competition, which in turn hurt demand.
Since it was first approved in the United States in 1998,
Enbrel has been approved in over 100 countries and the drug is promoted by Amgen,
Pfizer
and Takeda
in different geographies.
Novartis’ biosimilar copy of Enbrel, which got approved by the FDA in August
2016 for the treatment of patients with
rheumatoid arthritis (RA), plaque psoriasis, ankylosing spondylitis (AS) and
other diseases is still not on the market because of a patent-protection
challenge from Amgen.
Amgen is arguing in the US federal court
that its drug has patent protection until 2029.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Fast-growing drugs: Eylea and Revlimid bring
fortunes for Regeneron and Celgene
Regeneron’s
flagship eye treatment, Eylea (aflibercept) which is marketed by Bayer outside the United States, added another US $1 billion in
annual sales last year to record US $8.260 billion in total sales. Eylea net
sales grew 11 percent year-on-year in the US and 19 percent year-over-year
outside the US.
The company believes much of the recent
growth in the US was driven by demographic trends with an aging population as
well as an overall increase in the prevalence of diabetes.
These demographic trends are expected to
continue in the coming years, providing an opportunity for continued growth.
Eylea sales alone contribute 63 percent to Regeneron’s total sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
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 an additional US $1.2 billion in 2017 sales and had total revenues of US $8.187 billion.
Revlimid continues to contribute more than 60 percent to the company’s total sales of US $13 billion.
Celgene received a setback this month as the
USFDA refused to consider Celgene’s
application for ozanimod, an experimental
treatment for relapsing multiple sclerosis. The treatment was being seen as a
key to the company’s fortunes as Celgene had
said ozanimod is worth US $4 billion to
US $6
billion a year in peak sales.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Gilead’s Hepatitis C franchise enters free fall
Gilead Sciences’ blockbuster hepatitis C drugs franchise that includes Sovaldi and Harvoni continue to feel the
competitive heat as they registered US $9.137
billion in 2017 sales, down from US $14.834
billion the previous year.
While reporting 2017 results, Gilead provided guidance for
2018 and said its sales of Hepatitis C drugs could fall
further to US $3.5 billion - US $4 billion. At their peak in 2015, Gilead’s Sovaldi and Harvoni had together generated
US $19.1 billion in sales.
One of the major reasons for this drop is AbbVie’s launch of its new treatment Mavyret
at a deep price discount to the competition. AbbVie
also claims to have the shortest treatment course at eight weeks, compared with
12 weeks or longer for other treatments.
AbbVie reported US $1.274 billion in Hepatitis C drug sales
in 2017, down from US $1.522 billion in 2016.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
Novartis’ Gleevec, Merck’s cardiovascular drugs, GSK’s Advair face generic heat
Novartis’ Gleevec (imatinib), which had at one point become the best-selling drug for Novartis and had brought in US $3.323 billion for the company in 2016, started facing generic competition last year and the anti-cancer drug lost US $1.380 billion in sales to bring in ‘only’ US $1.943 billion last year.
The US patents of Merck’s cardiovascular drugs — Zetia (Ezetimibe)
and Vytorin (Ezetimibe
and Simvastatin) — expired in April 2017. In May 2010, Merck and Glenmark
Pharmaceuticals entered into an agreement that allowed Glenmark to launch
a generic version of Zetia in late 2016. The drugs
that had combined sales of US $3.701
billion in 2016 felt the generic heat in 2017 and the sales were US
$1.606 billion lower at US $2.095
billion.
Click here to Access All the 2017 Data (Excel
version available) for FREE!
GSK’s Advair, which was expected
to encounter generic competition in 2017, continued to breathe easy as the FDA
found deficiencies in the applications of Hikma, Mylan and Sandoz.
All three failed to get the FDA nod for their generic versions of Advair, a drug used in the management of asthma and chronic obstructive pulmonary disease that generated sales worth US $4.431 billion (£3.130 billion) in 2017.
Top 15 drugs by sales
Here is PharmaCompass’ compilation
of the best-selling drugs of 2017. This is based on information extracted from
annual reports and US Securities and Exchange Commission (SEC) filings of major
pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all the 2017 data (Excel
version available) for FREE!
S. No.
Company / Companies
Product Name
Active Ingredient
Main Therapeutic Indication
2017 Revenue in Millions (USD)
1
AbbVie Inc., Eisai
Humira®
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
18,946
2
Amgen, Pfizer Inc., Takeda
Enbrel®
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
8,262
3
Regeneron, Bayer
Eylea
Aflibercept
Ophthalmology
8,260
4
Celgene
Revlimid
Lenalidomide
Oncology
8,187
5
Roche
MabThera®/Rituxan®
Rituximab
Oncology
7,831
6
Johnson & Johnson, Merck, Mitsubishi Tanabe
Remicade®
Infliximab
Autoimmune Disorders
7,784
7
Roche
Herceptin®
Trastuzumab
Oncology
7,435
8
Bristol-Myers Squibb, Pfizer Inc.
Eliquis®
Apixaban
Cardiovascular Diseases
7,395
9
Roche
Avastin®
Bevacizumab
Oncology
7,089
10
Bayer, Johnson & Johnson
XareltoTM
Rivaroxaban
Cardiovascular Diseases
6,590
11
Bristol Myers Squibb, Ono Pharmaceutical
Opdivo
Nivolumab
Oncology
5,815
12
Sanofi
Lantus
Insulin Glargine
Diabetes
5,731
13
Pfizer Inc.
Prevnar 13/Prevenar 13
Pneumococcal 7-Valent Conjugate
Anti-bacterial
5,601
14
Pfizer Inc., Eisai
Lyrica
Pregabalin
Neurological/Mental Disorders
5,318
15
Amgen, Kyowa Hakko Kirin
Neulasta®
Pegfilgrastim
Blood Disorders
4,553
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industry updates along with our data compilations, do sign up for the PharmaCompass Newsletter and
you will receive updated information as it becomes available along with a lot
more industry analysis.
Click here to Access All
the 2017 Data (Excel version available) for FREE!
Impressions: 58413
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-in-2017-who-sold-the-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
29 Mar 2018
This week, Phispers brings you more bad news from India’s Biocon, as Health Canada’s caution notice cites data integrity violations highlighted by its regulatory partner. In the US, the generic industry failed to stall the passage of Maryland’s new price hike law. There is also an analysis of how Chinese firms are looking to buy out generic firms. Meanwhile, Takeda invested more in EU, and FDA launched its Adverse Event Reporting
System.
Health Canada’s caution notice highlights data integrity violations at Biocon
The news doesn’t seem to be getting any better for India’s Biocon. Last week, Health Canada sent out a caution notice. The notice highlighted that one of Health Canada’s regulatory partners had informed them about data integrity violations and other GMP failings at the same Biocon site in Bengaluru that had been inspected by French health agency ANSM and the US Food and Drug Administration (FDA).
In July this year, PharmaCompass was
the first to report on how
Biocon’s biosimilar program had
suffered a serious setback as an inspection
by ANSM in March 2017 of its Bengaluru site had uncovered 35 deficiencies, out
of which 11 had been deemed major.
However, there was no mention of
data-integrity concerns. The inspection was conducted by ANSM on behalf of the European Medicines Agency (EMA) as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine).
Post the non-compliance report issued by
the European regulators, Biocon said in a stock exchange filing that it had withdrawn the dossier for two of these products. Since the approval of its trastuzumab and pegfilgrastim applications would require re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon had said in the statement.
The board of Biocon also approved the transfer of the biosimilar business of the company to Biocon Biologics India, a step-down subsidiary of the
company, subject to the consent of its shareholders.
Biocon was also inspected by the FDA
this year where discrepancies
between the information submitted and the manufacturing process performed at
Biocon were uncovered. Biocon had responded by saying that a Form
483 is a standard outcome of any audit and it had responded to all FDA
observations.
Since then, things haven’t looked up for the Biocon/Mylan combine. After, they withdrew their applications for the trastuzumab and pegfilgrastim biosimilars from Europe, the FDA extended the target action date for their trastuzumab
biosimilar by three months.
Unlike other sites, the ANSM inspection report did not specifically raise concerns over data integrity at Biocon. And that’s why, PharmaCompass is of the
view that the USFDA might have shared these concerns with Health Canada.
Generic industry fails to stall passage of price hike law in Maryland
The generic drug industry in the US took a tough stance against Maryland's new pricing regulations and sought an injunction on passing of the law. However, the industry’s efforts failed to achieve the goal.
Generic companies said because they operate nationally, the law could disrupt their operations and impact commerce outside of Maryland. While the court ruled that some of the industry’s arguments have merit, it denied the industry’s request for a preliminary injunction. For now, Maryland’s price hike law has come into effect.
Unlike other approaches to regulate drug pricing throughout the country, Maryland’s law focuses specifically on the generic sector. With this new law, Maryland has become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers.
Takeda vests faith in post-Brexit EU,
expands capacity in Ireland
Japanese drugmaker Takeda is making another investment in its manufacturing facilities in the European Union. Takeda’s plans are being seen as a sign of faith in a post-Brexit EU. The company will invest up to US$ 118 million (€100 million) in a new manufacturing plant at its site in
Clondalkin near Dublin, Ireland. This investment could add another 100 jobs to
its operations in Ireland.
The outlay is for a 3,000 square-meter,
two-story manufacturing plant next to an existing facility at the Grange Castle
business park.
A few months back, Takeda had begun construction
of a US$ 42.8 million (€40 million) facility at
the Grange Castle site to manufacture its newly approved oral multiple myeloma
drug Ninlaro.
Other companies have been reluctant to
invest in Europe. Leif Johansson, chairman of AstraZeneca, recently said the company will have to pull some manufacturing and research operations out of the UK “if there is not a viable deal for its exit from the EU”.
“If something doesn’t happen to take away the current uncertainty it will become a big and important matter for us. Moving manufacturing takes several years,” Johansson said in an interview.
FDA launches Adverse Event Reporting System and new search
tool
This week, the US FDA launched its Adverse Event Reporting System (FAERS) — a database that contains adverse event (AE) reports, medication error reports and product quality complaints resulting in adverse events that are submitted to the agency.
The FDA also launched a new dashboard to facilitate access to
reports of adverse drug reactions.
According to The Centre for Biosimilars,
FAERS
contains 14 million AE reports submitted by healthcare providers, consumers, manufacturers of drugs and biologics, and other stakeholders. “The database is designed to improve transparency and accessibility to AE data by allowing users to search it more easily,” it says.
The database is used as a surveillance tool to help the FDA look for new safety concerns that might be related to a marketed product. It is also used to evaluate a manufacturer’s compliance with reporting regulations and responding to outside requests for information.
“The FDA is committed to fully informing patients and providers of adverse events reported with medical products, and this enhanced portal now provides patients, doctors, and others with easier access to the data they are interested in,” Scott Gottlieb, FDA Commissioner, said.
Chinese money chasing generic firms; Pfizer maybe interested in buying BMS
Chinese money is out to purchase one generic firm after
another. Weeks after Chinese pharmaceutical giant Fosun resurrected its deal to acquire India’s Gland Pharma for US$ 1 billion by scaling down the
stake it desires to purchase, it is now looking to acquire the manufacturing
facilities of another Indian pharma company.
It’s new target is Symbiotec Pharma, an active pharmaceutical ingredient (API)
maker specializing in steroid-hormone products. This mid-size drugmaker
complies with quality standards of the US FDA.
Private equity firm Actis holds a 70
percent stake in Symbiotec Pharma, which has been an acquisition target for other drug
makers too. Investment bank Rothschild has been mandated to initiate an auction
process.
But the Chinese money is looking beyond India. According to a Bloomberg
report, Shanghai Pharmaceuticals Holding is focusing on a sale of Alvogen’s US business. Alvogen is a generic pharma company, and owners of its US operations
(such as private equity owner CVC Capital Partners) are exploring various options. Alvogen’s US operations could be valued at US$ 4 billion.
Shanghai
Pharma is also bidding for a stake in Arbor Pharmaceuticals as well as Cardinal Health’s Chinese distribution business.
Pfizer and BMS: While rumors about Pfizer wanting to buy Bristol-Myers Squibb have been doing the rounds from some
months now, a FiercePharma report published this week quoted analysts as
saying they believe the American pharma biggie maybe interested in buying BMS. However, Pfizer may postpone pursuing such a big deal until it has “more clarity on corporate tax reform efforts.”
Pfizer may also be waiting for “further visibility” on BMS’ Opdivo-Yervoy trial in first-line lung cancer patients, the report says.
US health secy resigns over use of private planes; FDA’s Gottlieb travels commercial
In the US, the Health and Human Services
(HHS) Secretary Tom Price resigned last week in the
face of multiple investigations into his use of a private charter and military
jets to travel around the country.
This is being seen as a gross misuse of taxpayers’ money, amounting to nearly US$ 1 million. These trips were between cities where inexpensive commercial flights were also available.
Price apologized for his expensive habit, and vowed to cover the cost. In his resignation letter, Price said he regrets the “recent events have created a distraction,” from his work at HHS.
According to Endpoints, the FDA said
its commissioner Scott Gottlieb “has only traveled via commercial airlines for government travel.” The report adds: “Gottlieb, by the way, does enjoy the occasional treat while traveling”.
In fact, Price is not the only one. The US
Treasury Secretary Steven Mnuchin has made requests for special travel
arrangements using government craft.
Meanwhile, the White House has placed new requirements on officials’ air travel plans. Federal agencies were told “all travel on government-owned, rented, leased, or chartered aircraft, except space-available travel and travel to meet mission requirements ... shall require prior approval from the White House Chief of Staff."
Impressions: 4081
https://www.pharmacompass.com/radio-compass-blog/biocon-now-in-data-integrity-net-chinese-money-on-lookout-for-generic-firms
#PharmaFlow by PHARMACOMPASS
05 Oct 2017
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
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#PharmaFlow by PHARMACOMPASS
28 Sep 2017
This week, Phispers brings you the latest from the world of biosimilars, with Samsung Bioepis tying up with Japan’s Takeda, Biocon transferring its biosimilar business to a subsidiary, and South Korea’s Celltrion denying reports that its proposed biosimilar of Herceptin could face delays in Europe. Teva faced yet another bad week, with two Congressmen in the US attacking it over price increases of its multiple sclerosis drug. Meanwhile, Mylan and J&J will have to pay millions of dollars for cases against them. In vaccines, GSK faces flak for shortage of its Hepatitis B vaccine in the UK. And Pfizer won a pneumonia vaccine patent battle in India.
Biocon transfers biosimilar business to subsidiary; Samsung
Bioepis ties up with Takeda
A lot has been going on in the world of biosimilars. Last week, in
a stock exchange filing, Biocon said it has withdrawn the dossier for the biosimilar products — Fulphila® (pegfilgrastim) and Ogivri® (trastuzumab). Since the
approval of its trastuzumab and pegfilgrastim applications would require re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon said in the statement.
The announcement came a fortnight before
the FDA was supposed to take a decision on the trastuzumab application.
This week, the board of Biocon approved
the transfer of the biosimilar business of the company to Biocon Biologics India, a step-down subsidiary of the company, subject to the consent of its shareholders. The transfer of the biosimilar business has been done by way of a ‘slump sale’ as a going concern — wherein a sale is done for a lump sum consideration without values being assigned to the individual assets and liabilities.
Concerns also emerged over Biocon’s Herceptin
biosimilar competitor — Celltrion — as it denied a news report that its proposed biosimilar of Herceptin (a breast cancer drug) could face delayed European approval due to late submission of data. With global sales of around US$ 7 billion a year, Herceptin is one of Roche’s best-selling drugs.
According to the Celltrion, the European Medicines Agency
(EMA) found no lapses during a pre-approval inspection of its product site and drug substance Herzuma — its copy version of Roche’s Herceptin. The South Korea-headquartered biopharmaceutical firm also managed to hand in the documents that it was required to provide after inspection.
“We don’t expect any major changes in approval procedures although the inspection date had been pushed back a little because of differing schedules,” a Celltrion official said. There was news that the EMA could postpone approval of Herzuma to 2018 as the company failed to submit documents on time. However, it seems like Celltrion’s Herzuma may get EMA’s nod this autumn.
Any delays in approval procedures for Herceptin biosimilar candidates could have an impact on other drug makers eyeing the US$ 2 billion EU market for the original drug including another South Korean biosimilar firm — Samsung Bioepis — which filed for EU approval in September 2016.
The biosimilar industry is keeping a close
watch on which of the two South Korean firms is the first to get the nod for
its Herceptin biosimilar, after Biocon withdrew its application last week.
Meanwhile, Samsung Bioepis unveiled a new alliance this week — with Japan’s Takeda. Together with Takeda, Samsung Bioepis hopes to accelerate the development of effective therapies. The Japanese firm
has been open to devising new alliances that will share the risk in order to
broaden its overall drug development work.
More bad news for Teva as US
Congressmen attack pricing of its flagship therapy
Two US Congressmen accused Teva of hiking the price of its flagship multiple sclerosis (MS) drug — Copaxone (glatiramer acetate) — by more than 1,000 percent since 1996. Copaxone generated US$ 4.22 billion in sales last year.
The Congressmen — Elijah Cummings and Peter Welch — want to fully investigate Teva’s pricing practices, while also calling out firms such as Novartis, Bayer and Biogen.
According to the Congressmen, a year’s worth of 20 mg Copaxone was priced at US$ 8,292 in 1996. This increased to US$ 51,315 in 2012 and US$ 91,401 in 2017. Lack of generic competition permitted Teva to increase the price of the drug to such high levels.
Cummings and Welch said they were launching an investigation into
why prices for MS treatments have nearly quintupled since 2004. According to
the National Multiple Sclerosis Society, the average annual cost of MS therapy
rose to US$ 78,000 in 2016 from US$ 16,000 in 2004.
Meanwhile, Teva is planning to tie up with other drugmakers to fund some
of its development pipeline as it struggles with debts and expiring patents.
Teva needs funds to develop new drugs, and striking alliances with big pharma
players is one way of doing that.
Earlier this month, Teva reported a steep
drop in second-quarter earnings. Teva is saddled with debts of around US$ 35
billion, which it took on when it acquired Actavis (Allergan’s generic business) for US$ 40.5 billion last year.
Sanofi
gains millions via Mylan’s EpiPen settlement; J&J to pay US$ 417 million in baby powder case
Last week, Mylan NV and the US Justice Department finalized a US$ 465 million
settlement to resolve claims that Mylan had defrauded taxpayers and overcharged
the government by misclassifying its EpiPen emergency allergy treatment as a generic drug.
EpiPen had become the center of a drug
price-hikes controversy last year.
The probe into the price of EpiPen followed
a whistleblower lawsuit filed under the False Claims Act that rival drugmaker Sanofi SA filed in 2016. As a result of the settlement, Sanofi will
receive US$ 38.7 million as a reward, authorities said.
Meanwhile, lawmakers in the US say the settlement wasn’t tough enough. According to Democratic Senator Richard Blumenthal of Connecticut, the agreement was a “feeble fraction” of the US$ 1.27 billion that a government report found taxpayers may have overpaid for EpiPen over the last decade.
Mylan had acquired EpiPen in
2007. It is a handheld device that treats life-threatening allergic reactions
by automatically injecting a dose of epinephrine. Mylan had raised the price of a pair of EpiPens to US$ 600,
from US$ 100 in 2008.
J&J baby powder case: A US court directed Johnson & Johnson to pay US$ 417 million to a woman who alleged that the company’s baby powder causes ovarian cancer.
In her lawsuit, 63-year-old Eva Echeverria
had claimed that she used the talcum powder from the 1950s till 2016, and
developed ovarian cancer in 2007. Echeverria alleged that J&J failed to warn consumers about the risks involved in using
their talcum powder. The court awarded the woman US$ 68 million as compensatory
damages, and US$ 340 million as punitive damages.
Hikma raises price of diarrhea drug by 400
percent; Trump signs user fee law
Last
week, the US saw another price-gouging incident. The US subsidiary of Hikma Pharmaceuticals Plc raised the price of a common diarrhea drug by more than 400 percent. Known as West-Ward Pharmaceuticals, the US division of Hikma is also charging more
for five other medicines.
According
to a Financial Times report, the average
wholesale price of a 60 ml bottle of liquid atropine-diphenoxylate,
a common diarrhea drug also known as Lomotil, went from about US$ 16 a bottle
to US$ 84.
FDA Reauthorization Act: Last week, President
Donald Trump signed the FDA Reauthorization Act of 2017 into law. With this, the FDA saw the end of a
two-year long process that was threatening to disrupt its operations.
The law comes at a time when the FDA, under
the new commissioner Scott Gottlieb, is approving generics at a record pace.
Though the legislation had been passed by both the houses of the Congress, it faced a number of threats, including Trump’s intent to fund the FDA entirely with user fees from companies. Between 2018 and 2022, the FDA is expected to collect US$ 9 billion in fees — US$ 8 billion for prescription drugs and US$ 1 billion for devices — based on the fee level set in the Senate bill.
GSK
faces flak for Hep B vaccine shortage in
UK;
Pfizer wins vaccine patent in India
In
the UK, drug giant GlaxoSmithKline faced flak and an increasing number of questions over shortages of its vaccine for the deadly liver disease hepatitis B. The shortage of this vaccine in the UK has led to rationing.
Earlier this month, Public Health England (PHE) took the rare step of advising doctors to limit prescription of the vaccine, citing a “global shortage”.
This comes at a time when GSK’s supplies of the vaccine to the US appear to be unaffected. The disparity has led to suggestions from liver disease campaigners that GSK may be “prioritizing” the massive American market.
Hepatitis B is considered a “silent killer” leading to 900,000 global deaths a year. However, the disease is more prevalent in the developing world and is rare in the UK. Meanwhile, the World Health Organisation (WHO), has said there is no global shortage of the vaccine. The WHO is responsible for monitoring stocks of vaccines worldwide.
In
India, Pfizer Inc was granted a patent for its powerful pneumonia vaccine —Prevenar 13.
The
decision bars other companies from making cheaper copies of the vaccine and
allows Pfizer to exclusively sell it
in India until 2026.
The
patent came as a blow to some health groups that said this would put the
treatment out of reach of thousands in poorer nations. The move comes at a time
when India is facing increased pressure from the US to tighten its patent laws.
In a report published in June this year, the United States Trade Representative
expressed concerns over India’s intellectual property laws.
India has the largest number of pneumonia cases, and for Pfizer, this is a big gain. The decision also has international implications, as several poorer nations rely on India’s robust pharmaceutical industry to supply cheaper copies of medicines and vaccines.
FDA to start
sharing full inspection reports with European regulators
This week, the European Commission (EC), the US Food and Drug Administration (FDA)
and the European Medicines Agency (EMA) signed a new confidentiality commitment that allows the FDA to
share non-public and commercially confidential
information, including trade secret information relating to
inspections with European regulators.
In
March 2017, the United States and the European Union (EU) finally announced that they will be able to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.
The
deal is expected to enable the US Food and Drug Administration (FDA) and the EU
to avoid duplication of drug inspections, lower inspection costs and enable
regulators to devote more resources to other parts of the world where there may
be greater risk.
This confidentiality commitment is a step in the ongoing
implementation of the mutual recognition of inspections
program.
Impressions: 4148
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#PharmaFlow by PHARMACOMPASS
24 Aug 2017
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
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#PharmaFlow by PHARMACOMPASS
20 Jul 2017
Last week, PharmaCompass
broke the story about Biocon’s biosimilar program suffering a serious setback as a current Good Manufacturing Practices (cGMP) inspection by the French health agency — ANSM — in March 2017 of its site located in Bengaluru, India, uncovered 35 deficiencies, of which 11 were deemed major.
The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (pegfilgrastim), Ogivri® (trastuzumab) and Semglee® (insulin glargine).
Following our story,
Biocon issued a statement which mentioned that it had received “GMP approval
for biologics drug substance facilities” from the French regulator; and that the drug product facility is “to be re-inspected”.
This week, PharmaCompass delves deeper into the findings of the French health agency and looks at potentially what this could mean for the future of Biocon’s biosimilar program.
Concerns raised by
ANSM in March 2017 inspection
In 2006, Biocon established India’s largest integrated biotechnology hub, comprising of an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in a Special Economic Zone (SEZ) near Bengaluru.
In March 2017, the
French health agency conducted inspections of three Biocon facilities, two of
which were located within the Special Economic Zone in Bommasandra
in Bengaluru, and the other in Electronics City, Bengaluru.
Biocon received Good
Manufacturing Practices (GMP) compliance
certificates for one facility located in the SEZ and the other in Electronic
City. The inspection certificate reports that the approved SEZ plant performed
manufacturing activities for trastuzumab. It also performed activities for
pegfilgrastim, restricted to quality control (physico-chemical and
microbiological).
The Electronics City
facility manufactures the active substance used in the pegfilgrastim and
insulin glargine biosimilars.
In ANSM’s non-compliance report issued to the drug product manufacturing facility (situated in the SEZ in Bommasandra), its concerns relate to the following operations of the biosimilar products: Fulphila® (pegfilgrastim), pre-filled syringe presentation: drug product manufacture and quality control operations; Ogivri® (trastuzumab), vial presentation (freeze-dried product): drug product manufacture and quality control operations; Semglee® (Insulin glargine), cartridge presentation: secondary packaging and drug product quality control.
cGMP manufacturing – a stumbling block for biologic drugs
There is no doubt that ANSM’s issuance of GMP compliance certificates to Biocon’s two drug substance facilities for biosimilars is a tremendous achievement.
However, concerns over
fill/finish drug product operations have recently delayed US approvals for Pfizer’s biosimilar
of Amgen’s drug Epogen (epoetin alfa) as well as Sanofi’s Humira competitor, sarilumab. While
Sanofi was able to address the regulator’s concerns in just a few months, Pfizer is facing
an uphill battle in its effort to resolve compliance issues at its McPherson,
Kansas facility, which it acquired as part of the US$ 17 billion acquisition of Hospira.
Unlike other products for which biosimilars have been approved by the US and European regulators, Amgen’s Neulasta (pegfilgrastim), which brought in US$ 4.6 billion in sales last year, has not been an easy product to get approved.
Sandoz — Biocon’s competitor for a Neulasta biosimilar — withdrew its European application earlier this year after clinical equivalency concerns coupled with concerns over the lack of a certificate of GMP for the medicine’s manufacturing site emerged.
Sandoz’s European withdrawal follows a rejection by the US Food and Drug Administration (FDA) of Sandoz’s application for its proposed Neulasta biosimilar in July 2016, after accepting it for review in November 2015.
A little over a month
ago, Coherus BioSciences Inc announced that the FDA denied the approval of its Neulasta
biosimilar. The FDA requested Coherus for a re-analysis of certain data and
asked the drug developer for more manufacturing information, the company said.
Other biosimilar makers have encountered problems as well. Hungary’s Gedeon Richter, withdrew its application for a biosimilar of Neulasta after the EMA “was concerned that study results had not shown that (the proposed biosimilar) was handled by the body in the same way as the reference medicine Neulasta.”
In 2014, Apotex was the first to file a proposed
biosimilar application for pegfilgrastim in the United States. After that,
there has been no news from Apotex, though in a recent May 2017 citizen
petition Apotex has asked the FDA to require pegfilgrastim
biosimilar applicants to conduct appropriate clinical studies for this
complex biologic.
In its petition, Apotex highlighted that Coherus had apparently not conducted the necessary studies and a month later, the FDA denied Coherus’ approval.
In 2013, Biocon entered
into an exclusive strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin
analogs. And, in February 2017, the FDA accepted Mylan/Biocon’s proposed pegfilgrastim biosimilar (MYL-1401H) for review. Based on the User Fee Act, the
FDA should take a decision on this application by October 9, 2017.
Losing the pole
position on trastuzumab
Although Roche’s European patents on Herceptin (trastuzumab) expired in 2014, it is
still the third-biggest drug, with 2016 sales of US$ 6.7 billion (CHF 6.8 billion) for the Swiss Group.
Until the news of the
ANSM inspection surfaced, Mylan and Biocon were expected to be the first to
bring a Herceptin biosimilar to market.
A recent QuintilesIMS report, commissioned by the
European Commission, shows that in therapy classes where more than one
biosimilar has been launched, the first to market biosimilar usually takes the
highest biosimilar market share. The report shared examples where the first
biosimilar entry captured over 70 percent of the biosimilar market share
compared with just 30 to 40 percent for the second entry. A third entrant captured
only 5 to 22 percent of the market.
While Biocon submitted its application to the European agency in August 2016,
Samsung followed with its submission in October 2016, Celltrion in November 2016 and Amgen in March 2017.
Any approval delay could
lead to a revenue loss of hundreds of millions of dollars.
Biocon stock gains on back of meet to discuss Mylan’s trastuzumab filing
Despite everything, there hasn’t been much adverse impact on the Biocon stock due to the news on the French health agency’s inspection. The Biocon stock gained over 13 percent intraday on July 12 as investors turned bullish ahead of the FDA’s Advisory Committee (Adcom) meeting (to be held on July 13) to discuss the trastuzumab filing done by Mylan.
According to news reports,
investors could monitor the outcome of the Adcom. If the product is approved by
the FDA, it will be the first Herceptin biosimilar in the US market.
Moreover, the brokerages remained mixed on Biocon’s prospects. According to Moneycontrol, “Biocon could be a beneficiary of the unfolding global biosimilar opportunity.”
Our view
Prior to the ANSM
inspection, Biocon was inspected by the FDA where discrepancies between the
information submitted and the manufacturing process performed at Biocon were
uncovered.
The company responded in a similar manner by saying that a
Form 483 is a standard outcome of any audit and it had responded to all FDA
observations.
Now, it remains to be
seen how quickly the regulators are convinced with the responses so that Biocon
and its exclusive strategic partner Mylan can make a landmark entry into the
field of biosimilars.
Given all the hurdles in the way to get a biosimilar approved, it remains to be seen whether the Biocon-Mylan combine will create history, or become yet another ‘has been’ in the race for biosimilars.
Impressions: 4052
https://www.pharmacompass.com/radio-compass-blog/can-biocon-mylan-combine-overcome-its-biosimilar-program-s-european-inspection-failure
#PharmaFlow by PHARMACOMPASS
13 Jul 2017
India’s pharma stocks have been taking
a beating of late due to compliance-related issues and the pressures on the US market, putting a big question mark on the growth of the country’s pharmaceutical industry in the future. So
far, Biocon had been able to weather
this storm
due to its successful compliance record, and an exclusive
strategic partnership with Mylan for a broad portfolio of biosimilars and generic insulin analogs, which in turn were expected to bring in a windfall for the company.However,
Biocon’s biosimilar program suffered a serious
setback as an inspection by the French health agency, ANSM, in March 2017 of its
site located in Bengaluru, India, uncovered 35
deficiencies, of which 11 were deemed major. The inspection was conducted on behalf of the European Medicines Agency (EMA) by the ANSM as a pre-approval inspection for the drug product manufacturing activities of the following (three) biosimilar products — Fulphila® (Pegfilgrastim), Ogivri® (Trastuzumab) and Semglee® (Insulin glargine).Need
for a follow-up GMP inspection The
ANSM found major deficiencies in the following areas: Environmental
monitoring-training, OOS results management, cleaning validation, process
validation, vendors qualification, media fill test, cross-contamination risks, batch manufacturing record, differential pressure alarms’ management in classified areas and access management in SAP for batch certification.The
agencies concluded that the European Marketing Authorization Applications of
the three biosimilar products currently under assessment should not be approved
while the non-compliance report is in effect.The
report also mentions that a follow-up GMP inspection is required in order to
ensure that all the corrective and preventive action (CAPA) plans have been
implemented and finalized by the site and that a robust quality system is in
place.Biocon
and Mylan have made two
submissions to the FDA for their biosimilars of Amgen’s Neulasta (pegfilgrastim) and Roche’s Herceptin (trastuzamab). Now,
it remains to be seen if the verdict of the FDA will be any different from that
of the European agencies.
Impressions: 12435
https://www.pharmacompass.com/radio-compass-blog/biocon-s-biosimilars-program-fails-european-cgmp-inspection
#PharmaFlow by PHARMACOMPASS
08 Jul 2017
The year 2015 has gone down
in history as a record year for mergers and acquisitions in the pharmaceutical
and biotech space with deals worth US $ 300 billion being announced. The highlight
of the year was the Pfizer-Allergan mega-merger – the biggest-ever pharma transaction worth more than US $ 160 billion.
Pharma Letter tracked transactions
through the year and found the number of deals exceeding US $1 billion at 30 in
2015, as compared to 26 in 2014 and 20 in 2013. In all, a total of 166 M&A
deals were announced in 2015 (out of which some are yet to be completed),
compared to 137 in 2014.
This week, PharmaCompass
brings you a compilation of the top drugs of 2015 by sales revenue and growth.
Sofosbuvir – the outright winner of 2015
2015 was the year of Sofosbuvir – the revolutionary active ingredient used for the treatment of hepatitis. Together, through the sale of drugs Harvoni and
Sovaldi, Sofosbuvir brought in sales of almost US $ 19 billion.
The PharmaCompass prediction
that Harvoni (a combination of Ledipasvir and Sofosbuvir; and used for the treatment
of infectious diseases like hepatitis and HIV) would become the best-selling
drug ever in 2015 fell slightly short of expectations as its sales of US $ 13.864
billion were marginally less than AbbVie’s rheumatoid arthritis treatment – Humira.
Humira retained its place as the best-selling drug with US $
14.012 billion in sales in 2015. However, with sales growth of US $ 11.737
billion in a single year, Harvoni is poised to become the best-selling drug by
the end of 2016.
Top 20 Drugs by Sales
Here is PharmaCompass’ compilation of the best-selling drugs of 2015. This is based on information
extracted from annual reports and US Securities and Exchange Commission (SEC) filings
of major pharmaceutical companies.
If you would like your own copy of all the information we’ve collected, email us at support@pharmacompass.com and we’ll send you an Excel version.
Click here to access all
the 2015 data (Excel version available) for FREE!
Product
Active Ingredient
Main Therapeutic Indication
Company
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
AbbVie
12,543
14,012
1,469
2
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
2,127
13,864
11,737
3
Enbrel
Etanercept
Immunology (Organ Transplant, Arthritis etc.)
Amgen / Pfizer
4,688
8,697
4009
4
Remicade
Infliximab
Immunology (Organ Transplant, Arthritis etc.)
Johnson
& Johnson / Merck
6,868
8,355
1487
5
MabThera/Rituxan
Rituximab
Oncology
Roche
5,659
7,115
1,456
6
Lantus
Insulin Glargine
Diabetes
Sanofi
6,978
7,029
51
7
Avastin
Bevacizumab
Oncology
Roche
6,481
6,751
270
8
Herceptin
Trastuzumab
Oncology
Roche
6,338
6,603
265
9
Revlimid
Lenalidomide
Blood Related Disorders
Celgene
Corpoartion
4,980
5,801
821
10
Sovaldi
Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
Gilead
Sciences
10,283
5,276
(5,007)
11
Seretide / Advair
Salmeterol
Respiratory Disorders
GlaxoSmithKline
6,005
5,227
(778)
12
Crestor
Rosuvastatin
Calcium
Cardiovascular
AstraZeneca
5,512
5,017
(495)
13
Lyrica
Pregabalin
Neuroscience and Mental Health
Pfizer
Inc.
5,168
4,839
(329)
14
Neulasta
Pegfilgrastim
Blood Related Disorders
Amgen
4,596
4,715
119
15
Gleevec / Glivec
Imatinib
Oncology
Novartis
4,746
4,658
(88)
16
Xarelto
Rivaroxaban
Anticoagulants
Bayer / Johnson
& Johnson
3,369
4,345
976
17
Copaxone
Glatiramer
Neuroscience and Mental Health
Teva
4,237
4,023
(214)
18
Januvia
Sitagliptin
Diabetes
Merck
& Co
3,931
3,863
(68)
19
Abilify
Aripiprazole
Neuroscience and Mental Health
Bristol-Myers
Squibb/ Otsuka
Holdings
6,485
3,804
(2681)
20
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
Biogen
2,909
3,638
729
Click here to access all
the 2015 data (Excel version available) for FREE!
A year of record FDA approvals
2015 was also the
year when the US Food and Drug Administration (FDA) approved 45 novel drugs, another
all-time record high. In January this year, PharmaCompass had compiled a list of novel drugs approved by the FDA in 2015. We also extensively covered the new dosage forms of existing drugs approved in 2015. Do go through the article published on January 14, 2016, for more information.
PharmaCompass’ compilation of sales forecasts of novel drugs indicated a significant
variation in estimates. However, in our view, drugs that
saw highest sales growth in 2015 are likely to do well this year as well.
Top 20 drugs by sales growth (in USD, millions)
Product
Active Ingredient
Main Therapeutic Indication
2014 Revenue in Millions
(USD)
2015 Revenue in Millions
(USD)
2015 Sales Difference
Millions (USD)
1
Harvoni
Ledipasvir
and Sofosbuvir
Infectious Diseases (HIV, Hepatitis etc.)
2,127
13,864
11,737
2
Viekira Pak
Ombitasvir/Paritaprevir/Ritonavir
Infectious Diseases (HIV, Hepatitis etc.)
48
1,639
1,591
3
Humira
Adalimumab
Immunology (Organ Transplant, Arthritis etc.)
12,543
14,012
1,469
4
Hepatits C Franchise
Daclatasvir and Asunaprevir
Infectious Diseases (HIV, Hepatitis etc.)
256
1,603
1,347
5
Imbruvica
Ibrutinib
Chronic lymphocytic leukemia
200
1,443
1,243
6
Cubicin
Daptomycin
Anti-bacterial
25
1,127
1,102
7
Eliquis
Apixaban
Anticoagulants
774
1,860
1,086
8
Triumeq
Abacavir, Dolutegravir and Lamivudine
Infectious Diseases (HIV, Hepatitis etc.)
-
1,037
1,037
9
Xarelto
Rivaroxaban
Anticoagulants
3,369
4,345
976
10
Opdivo
Nivolumab
Oncology
6
942
936
11
Revlimid
Lenalidomide
Blood Related Disorders
4,980
5,801
821
12
Tecfidera
Dimethyl
Fumarate
Neuroscience and Mental Health
2,909
3,638
729
13
Xtandi
Enzalutamide
Oncology
480
1,207
727
14
Ibrance
Palbociclib
Oncology
-
723
723
15
Invokana / Invokamet
Canagliflozin
Type 2 diabetes
586
1,308
722
16
Victoza
Liraglutide
Diabetes
2,014
2,704
690
17
Stribild
Cobicistat, Elvitegravir, Emtricitabine and Tenofovir
Disoproxil Fumarate
Infectious Diseases (HIV, Hepatitis etc.)
1,197
1,825
628
18
Levemir
Insulin
Diabetes
2,133
2,745
612
19
Votrient
Pazopanib
Oncology
565
565
20
Perjeta
Pertuzumab
Oncology
927
1459
532
Hepatitis C products, which had three
of the four highest sales growths in 2015, clearly show the impact these
revolutionary treatments will have on the global healthcare landscape in time
to come. Cancer immunotherapy treatments, a new generation of blood thinners
and novel diabetes treatments were some of the others which demonstrated stellar
growth in 2015.
Vaccines from Pfizer and Sanofi also displayed tremendous sales growth although they
have not been included in the compilation of drugs.
Click here to access all
the 2015 data (Excel version available) for FREE!
Sign Up, Stay Ahead
While some companies like Boehringer and Valeant are yet to release their annual reports. In order to
stay informed, do sign up for the PharmaCompass
Newsletter and you will receive updated information as it becomes available
along with a lot more industry analysis.
Click here to access all
the 2015 data (Excel version available) for FREE!
CORRECTION, April 12, 2016: An earlier version of this compilation
did not account for cases where the same drug is sold by multiple companies
(e.g. Enbrel, Remicade, Xarelto etc.). As an outcome, a re-ranking of the Top
20 Drugs by Sales and Sales Growth has been done.
Impressions: 56517
https://www.pharmacompass.com/radio-compass-blog/top-drugs-by-sales-revenue-in-2015-who-sold-the-biggest-blockbuster-drugs
#PharmaFlow by PHARMACOMPASS
10 Mar 2016
