Market Place
Endocrinology, a medicinal
branch that deals with endocrine and metabolic disorders, is witnessing
cutting-edge drug research to develop advanced drugs that can treat
diabetes, obesity, hypoparathyroidism and other
disorders.The endocrinology market is witnessing impressive growth — it is growing at a compound annual growth rate (CAGR) of 7.82 percent. Between 2023 and 2027, the market is poised to increase by US$ 36.5 billion. It includes treatments for various medical conditions, such as type 1 and type 2 diabetes, obesity, hypogonadism (a condition where the body’s sex glands produce little or no hormones), dwarfism, hypo or hyperparathyroidism, acromegaly (abnormal growth of the hands, feet, and face, caused by the overproduction of growth hormone by the pituitary gland) and congenital adrenal hyperplasia (a genetic disorder that affects the adrenal glands).The market is dominated by diabetes treatment drugs — valued at around US$ 48.7 billion in 2018, these are expected to generate US$ 78.3 billion by the end of 2026. The
market for obesity drugs is also expected to reach US$ 50 billion by 2030.The top companies in this
segment include Novo Nordisk, Eli Lilly, Merck, Sanofi, AstraZeneca and Boehringer Ingelheim. Several biotech companies
have joined the race to capture a share of the lucrative market for diabetes
and obesity drugs.Access the Endocrinology Newsmakers Dashboard (Free Excel)Lilly’s Mounjaro, Novo’s Wegovy gear up for larger share of obesity pieIn May 2022, Lilly’s potential blockbuster Mounjaro (tirzepatide) was approved by the US Food and Drug
Administration (FDA) as a once-weekly subcutaneous injection to treat adults with type 2 diabetes. Mounjaro is the first and only dual targeted glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist on the market, and has helped patients achieve a body weight loss of over 20 percent in clinical trials. Novo Nordisk’s Wegovy (semaglutide), the first and only once-weekly GLP-1 receptor agonist approved for weight management in people with obesity, has been found to help patients lose up to 15 percent of their body weight in over 68 weeks. In late 2022, the drug received FDA approval to treat obesity in pediatric patients aged 12 years and older.Last October, FDA granted fast track review designation to Mounjaro as a treatment for obesity. Lilly plans to go to the FDA soon and expects to get approval for the drug this year. Once approved, Mounjaro will give Wegovy a tough fight in the obesity market. Analysts predict Mounjaro to generate around US$ 8.1 billion in annual sales by 2028, while Wegovy is expected to bring in US$ 7 billion by 2030. Meanwhile, Amgen’s AMG 133 is also in early-stage trials for obesity. Access the Endocrinology Newsmakers Dashboard (Free Excel) ‘Skinny shot’ diabetes drugs face supply shortages; Lilly plans to double capacityFollowing its approval in the US in mid-2021, Wegovy quickly became the go-to “skinny shot” drug in Hollywood, thanks to its
impressive weight reduction data. But the drug hit a supply shortage in late 2021 due to manufacturing issues, which the manufacturer managed to fix in the second half of 2022. Novo’s blockbuster type 2 diabetes drug Ozempic is also in limited supply,
but the drugmaker expects the availability to return to normal around
mid-March.The supply constraints of Wegovy and Ozempic, coupled with the craze around using diabetes drugs for weight loss, sparked interest in Lilly’s Mounjaro. But Mounjaro, along with another Lilly drug Trulicity, began facing supply issues last December. While Lilly has fixed Mounjaro’s supply issues for the time being, it plans to double its manufacturing capacity by the year end to avoid any such shortages in the future.Meanwhile, the American Diabetes Association and Mutual Aid Diabetes have sounded an alarm, saying the off-label use of diabetes drugs for weight loss may cause shortages and affect diabetes patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)Provention launches treatment for type 1 diabetes; Novo retains market dominanceIn November, Provention Bio’s Tzield (teplizumab) bagged FDA approval as a preventive treatment for type 1 diabetes in individuals eight years or older who are in stage 2 of the disease. The injectable drug is the first treatment in the US to delay progression of the autoimmune disease.Novo remained the dominant player in the diabetes and obesity market, clocking sales of US$ 22.8 billion (DKK 156.4 billion) in 2022 in this segment. Ozempic’s sales increased by 77 percent to US$ 8.6 billion (DKK 59.8 billion). The Danish company consolidated its position further by
purchasing Dicerna Pharma for US$ 3.3 billion in 2021 for its RNA interference (RNAi) technology.Novo is planning to file for approval of its once-weekly insulin icodec for type 2 diabetes in the US, the EU and China in the first half of 2023. It is also running a phase 1 trial of Ozempic as a once-weekly oral treatment.In 2022, sales of Lilly’s blockbuster drug Trulicity (dulaglutide) touched US$ 7.4 billion. Two other drugs, Humalog and Jardiance, generated US$ 2.1 billion each in sales. In addition, Lilly’s partner Boehringer Ingelheim also reported US$ 2.55 billion (€ 2.5 billion) sales of Jardiance in the first half of 2022.Biosimilar drugmaker Biocon Biologics acquired Viatris’ biosimilars business for a total of US$ 3.34 billion, strengthening its presence in the diabetes, tumors and autoimmune diseases market. Viatris’ portfolio is expected to generate sales of over US$ 1 billion for Biocon in 2023.Access the Endocrinology Newsmakers Dashboard (Free Excel)Drugmakers work on triple agonist therapies to
treat diabetes, obesitySeveral drugmakers are working on triple agonist therapies that target multiple receptors, such as GLP-1, GIP and glucagon (GCG). These drugs, such as Novo and partner Marcadia’s MAR423, Hanmi’s HM1521, Sanofi’s SAR441255, and Eli Lilly’s retatrutide, are currently in early- to mid-stage trials. Studies have shown that these triple agonists are more effective in reducing body
weight and improving glucose control compared to mono- or
dual-incretin receptor agonists.In addition, a few triple drug combinations containing metformin, DPP4 inhibitors and SGLT2 inhibitors have recently been approved. Treatments such as Astra’s Qternmet XR and Lilly-BI’s Trijardy XR have shown
significant improvement in glycemic control and are generally well tolerated by
patients.Access the Endocrinology Newsmakers Dashboard (Free Excel)TheracosBio’s oral med for diabetes approved; gene therapies gather interest Recently, TheracosBio’s Brenzavvy was approved by the agency as an oral
medication for type 2 diabetes. And Marinus Pharmaceuticals’ oral testosterone replacement therapy Kyzatrex received FDA’s nod last year for a range of diseases in men that arise from deficiency or absence of endogenous testosterone. New York-based Oramed is currently conducting a phase 1 trial of its oral GLP-1 drug – ORMD-0901 – as a treatment for type 2 diabetes.Meanwhile, Vertex and Arbor Biotechnologies are working on a gene therapy
(VX-880) for type 1 diabetes. BridgeBio Pharma’s BBP-631 adeno-associated virus (AAV) gene therapy for congenital adrenal
hyperplasia is in phase 1/2 trials. And
Swedish biotech Diamyd is carrying out phase 3 trials of its type 1 diabetes vaccine.In other medical conditions, Ascendis Pharma’s TransCon PTH, a long-acting prodrug of parathyroid hormone, has a PDUFA date in April
2023. If approved, it would become the first hormone replacement therapy to
address the underlying cause of hypoparathyroidism. Crinetics Pharmaceuticals’ Paltusotine, a non-peptide
somatostatin type 2 (SST2) receptor agonist, is currently in phase 3 trials for
acromegaly, representing a new class of oral once-daily medication.Access the Endocrinology Newsmakers Dashboard (Free Excel)Our viewDiabetes and obesity have
reached epidemic proportions in the recent decades, while other endocrine
disorders such as hypoparathyroidism are also growing rapidly the world over.According to the World Health Organization, around 422 million people worldwide have diabetes, and 1.5 million deaths are directly attributed to diabetes each year.While factors
such as long working hours, sedentary lifestyles, and unhealthy eating and
drinking habits are contributing to the rise of these diseases, drugmakers are
doing some cutting edge research for these conditions. Given this scenario,
endocrinology should see a lot of pathbreaking drugs in the coming years.
Impressions: 2095
https://www.pharmacompass.com/radio-compass-blog/endocrinology-newsmakers-drugmakers-work-on-triple-agonist-treatments-oral-insulin-to-fight-diabetes
#PharmaFlow by PHARMACOMPASS
02 Mar 2023
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Nearly every
year, drugmakers ring in the new year with drug price increases in the US. This
year too, prices of over 450 prescription
medicines increased by an average of around 5 percent at the start of January.
This, when high drug prices have been one of the biggest political issues in
the US over the last few years.
PharmaCompass decided to usher in 2022 with a review of the US Medicare Part D Prescription Drug data recently released by the Centers for Medicare and Medicaid Services (CMS) for calendar year 2019. Using the available data, we have developed our own dashboard to show recent trends in consumption of prescription drugs. With this analysis, we hope our readers will get a better understanding of the world’s largest market for pharmaceuticals, as also a fix on where it may be headed.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Rising healthcare, drug spends in US
Over the
last several years, we have repeatedly heard political leaders in the US
complain about high drug prices. Yet, drug prices and healthcare spends have
risen unabated.
America’s National Health Expenditure Accounts (NHEA) includes annual expenditures on healthcare goods and services, public health activities, the net cost of health insurance, and investment related to healthcare. In 2019, America’s national health expenditure (NHE) grew by 4.6 percent to US$ 3.8
trillion, accounting for 17.7 percent of the gross domestic product (GDP).
During the year, prescription drug spend increased by 5.7
percent to US$ 369.7 billion. In comparison, Medicare spend grew 6.7
percent to US$ 799.4 billion.
President
Joe Biden recently stressed on the need to cap the prices of essential drugs,
and said that the average American pays the highest prices for prescription
drugs anywhere in the world. Americans pay 10 times as much as other countries for life-saving insulin — the top selling prescription drug covered by the Part D program.
Pharma
companies, on the other hand, have vehemently argued against any price cuts in
the US, saying price cuts would hinder drug research and development for all
diseases.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Patented drugs account for 80.3 percent of total Part D spend
Medicare is the US federal government’s program that
provides health insurance to most people who are 65 years
or older. Medicare’s Part D plan provides outpatient drug coverage through private
insurance companies that have contracts with the federal government. Eligible
people have to choose and enroll in a private prescription drug plan for Part D
coverage. Medicare Part B, on the other hand, covers a wide variety of
medically necessary outpatient services and some preventative services.
Prescription
drug coverage under Part D reached US$ 183 billion in 2019 — a growth of around 9 percent over 2018, when spending was US$ 168 billion. Spending
on patented drugs in 2019 accounted for around US$ 147 billion or 80.3 percent
of the total spend for the year. Generic drugs made up for the remaining 19.7
percent (approximately US$ 36 billion). In 2018, generic drugs worth US$ 35.8
billion were sold under Part D, accounting for 21 percent of the total spend
under the program.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Eliquis ranks highest on Medicare’s brand drug spend
Under Part
D, endocrinology and oncology were the two therapeutic areas that generated
maximum revenue for pharma companies, driving home sales of over US$ 31.8
billion and US$ 23.5 billion, respectively. Neurology drugs generated sales of
around US$ 22.9 billion.
Among branded
drugs, Bristol Myers Squibb’s anticoagulant Eliquis (apixaban) was the most selling drug in 2019 under Part D, notching up about US$ 7.3 billion in sales — a rise of US$ 2.3 billion or 46 percent over 2018.
Celgene’s cancer drug Revlimid (lenalidomide) roped in US$ 4.7 billion (up
by 14.6 percent), while another anticoagulant drug Xarelto (rivaroxaban) by Janssen Pharma — a unit of Johnson & Johnson — fetched US$ 4.1 billion (up 20.6 percent) in sales through Part D. AbbVie’s anti-rheumatic drug Humira and Sanofi’s diabetes drug Lantus saw sales of around US$ 3.7 billion each
under the program.
Amongst
generics, the largest selling drug under Part D (by dosage units) was metformin (diabetes), followed by gabapentin (seizure), PEG3350 with
electrolyte (gastroenterology), metoprolol (hypertension) and atorvastatin (cholesterol). In 2019, the
overall dosage units sold also jumped higher by 2.25 billion units to 111.35
billion.
The sales
ranking of Part D does bare some similarities with the global ranking of
highest selling drugs. In 2020, Humira had retained its position as the highest
selling drug in the world, generating sales of US$ 20.4 billion. Both
Eliquis and Revlimid had retained their ranking as the third and fourth most
selling drugs, bringing home US$ 14.1 billion and US$ 12.1 billion in global
sales in 2020.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Medicare’s inability to negotiate prices costs American taxpayers billions of dollars
Over the
years, drug companies have used Medicare’s
inability to negotiate prices under Part D to increase the prices of their
drugs significantly and rip off huge profits, a three-year-long US House
Oversight Committee investigation has revealed.
US taxpayers could have saved over US$ 25 billion in five years if the prices of just seven drugs — Humira, Imbruvica, Sensipar, Enbrel, Lantus, NovoLog and Lyrica — were negotiated by Medicare. Another US$ 16.7 billion could have been saved between
2011 and 2017 on insulin products manufactured by Eli Lilly, Novo Nordisk and Sanofi, which control 90 percent of the insulin market in the US, the committee’s report revealed.
Elsewhere in
the world, the same drugmakers are bending over backwards to get into medical
insurance programs. For instance, China reported that several international
pharma firms, many of them headquartered in the US, slashed the prices of their
drugs by up to 94 percent to get into the country’s national medical insurance coverage.
In the US — which accounted for around 46 percent of the global share of drugs in 2020 — senior citizens may have to pay more for medicines as the government announced a large hike in Medicare premiums for 2022
if an expensive Alzheimer’s drug, Aduhelm, is included in the list.
In order to
ensure inclusion in Medicare, Biogen slashed the price of Aduhelm by half — from US$ 56,000 to US$ 28,200 — just weeks before a crucial meeting called by the CMS. Clearly, this has set a precedent in an industry which is known for rampant price hikes and rarely for any price cuts. This could also be put forth as an example of what Medicare could achieve if it receives negotiation rights.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Our view
President
Biden's Build Back Better legislation,
which the House passed last month, is up for vote in the Senate. The
legislation contains provisions that would allow Medicare to negotiate the
prices of some expensive drugs, penalize drugmakers who raise prices faster
than inflation and cap out-of-pocket costs for insulin at US$ 35 per month.
However, chances of the bill being passed in its present form are slim.
Even if the
Senate passes the bill, Medicare would be able to negotiate the prices of only 10 prescription drugs and insulin products in 2025.
The number would increase over the years, reaching 100 in six years, and hence
forth grow by 20 drugs a year.
It seems like 2022 won’t be the last year when January 1 will be braced with price hikes in the US by drugmakers. Looks like they will continue to make hay while the sun shines.
View US Medicare Part D 2019 Drug Spending (Free Excel Available)
Impressions: 2622
https://www.pharmacompass.com/radio-compass-blog/america-s-drug-price-hike-conundrum-in-backdrop-of-2019-medicare-part-d-data
#PharmaFlow by PHARMACOMPASS
06 Jan 2022
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
Now that it has been
established that the novel coronavirus is going to globally impact the drug
supply chain, it becomes imperative to analyze the extent of the impact.
Since the outbreak of
the novel coronavirus — COVID-19 — in December, PharmaCompass has been constantly reaching out to
manufacturers around the world to assess the current state of the drug supply
chain. This week, we share our preliminary analysis based on the feedback we
have received from drug manufacturers around the world.
Drug shortages are
for real
Last week, the US
Food and Drug Administration (FDA) announced the first human drug shortage
as a result of the coronavirus outbreak. In addition, the FDA announced it was
tracking 20 drugs that could face shortages. Some generic drugmakers are predicting shortages
as early as in June or July, due to the novel coronavirus.
The FDA did not disclose the name of the drug in shortage or the 20 drugs it is tracking, as this is considered ‘confidential commercial information’.
In India, a committee constituted by the country’s Department of Pharmaceuticals started monitoring the availability of 58 active pharmaceutical ingredients (APIs) to take preventive measures
against illegal hoarding and black-marketing in the country.
According to a report published in The Economic Times, after
reviewing the list of drugs, 34 were found to have no alternatives which
include critical and essential drugs like potassium clavulanate, ceftriaxone sodium sterile, piperacillin tazobactam, meropenem, vancomycin, gentamycin and ciprofloxacin.
This was immediately
followed by the Indian government restricting the exports of 13
APIs along with some of their finished formulations. The list includes paracetamol, tinidazole, metronidazole, acyclovir, vitamin B1, vitamin B6, vitamin B12, progesterone, chloramphenicol and neomycin. For most
of the products on this list, India is a net importer, as there is little
domestic manufacturing of these APIs.
COVID-19 is also
likely to impact bottomlines. Leading generic drugmaker Mylan said it expects the coronavirus outbreak to impact its financial results
while some of the largest drugmakers — including AstraZeneca, Merck and Pfizer — have said that the coronavirus outbreak could affect their supplies or sales.
Paracetamol
affected; prices double in less regulated markets
The decline in industrial activity in China is certainly taking its toll, as drugs which are on the World Health Organization’s Model list of Essential Medicines are beginning to face significant price increases in the wake of disruption of key starting raw materials for bulk drugs.
The export
restriction out of India on commonly used analgesic, Paracetamol — sold under the brand names such as Tylenol (in the US), Panadol (in the UK), Dafalgan (France) and Crocin
(India) — is not surprising as the API has witnessed almost doubling of prices in less regulated markets because exports of its key building block para-amino phenol (PAP) have dramatically reduced from China.
While there are only
a few manufacturers who produce paracetamol without being dependent on Chinese
PAP, a few major manufacturers in India depend almost completely on Chinese PAP
for their paracetamol production and usually only keep three to four months of
inventory.
By the end of
February, their inventory stockpiles had halved and in the event of a continued
supply disruption, their entire inventory pipeline is likely to dry out. In
addition, Chinese paracetamol manufacturers, who export a significant amount of
their bulk ingredient production globally, including to India, are also
currently unable to export. This is beginning to create the potential of panic
among sourcing executives across the world.
Several
antibiotics also in danger of acute shortages
While paracetamol was listed on the API watch list circulated by India’s Department of Pharmaceuticals, our survey has revealed that other products on the list like ciprofloxacin, amoxicillin and azithromycin are also facing severe raw material
shortages. As a result, the prices of these bulk drugs have also increased
sharply.
In a statement to The Economic Times, leading Indian generic manufacturer Mankind Pharma’s chairman and managing director said
amoxicillin is the most commonly used API to manufacture antibiotics and the
company has invested Rs 1 billion (US$ 14 million) in placing irregular orders
with vendors to try and address the potential shortage that is expected. He
went on to say that if the situation continues until April, there will be an
acute shortage.
In a statement to the US House of Representatives last October, Janet Woodcock, the FDA’s Director of Center of Drug Evaluation and Research, said the FDA has determined that there are three WHO Essential Medicines whose API manufacturers are based only in China. The three medicines are: capreomycin, streptomycin (both indicated to treat Mycobacterium
tuberculosis) and sulfadiazine (used to treat chancroid and trachoma).
Streptomycin is also on the watch list published by India’s Department of Pharmaceuticals along with commonly used anti-hypertensives like losartan, valsartan, telmisartan and olmesartan and diabetes treatment metformin.
Intermediates
becoming a problem for generic drugmakers
PharmaCompass’ discussions have also revealed that in many cases while API manufacturing factories in China have returned to work, there are disruptions in the availability of raw materials and/or logistics at sea ports and airports which have led to unavailability of supplies.
While the FDA has a
list of the number of API facilities in China which are in a position to supply
to the United States, Woodcock said in her statement that the FDA “cannot determine with any precision the volume of API that China is actually producing, or the volume of APIs manufactured in China that is entering the US market.”
This visibility
reduces drastically when one has to assess the dependence of each API
manufacturer around the world on China for intermediates. Our discussions have
revealed that it is these intermediates which are becoming a problem for most
API manufacturers, even those based in India.
It was worth
highlighting that a manufacturing process change at an intermediate stage of
commonly used blood pressure medicine valsartan resulted in the recall of
millions of pills as it was found to contain a cancer causing impurity above
acceptable levels. Similarly, in 2008, the adulteration of heparin in China,
which killed 81 people and left 785 severely injured, was an outcome of the
subcontracting of precursor chemicals of Heparin.
Our view
The over-dependence
on China for key starting materials has been the subject of discussion ever
since we launched PharmaCompass. Rosemary Gibson explored this subject
in detail in her book China Rx: Exposing the Risks of America’s Dependence on
China for Medicine.
The restrictions imposed on industrial activity and transportation in China in the first two months of this year has resulted in NASA’s satellite images showing a decline in pollution levels over China.
While China works
towards getting its industrial and transportation engine up and running to 2019
levels, the outbreak has spread to other countries which will further increase
the demand for drugs to fight the virus.
This is a time when
the pharmaceutical industry needs to act responsibly and make decisions which
are in the best interests of patients globally.
Sharing information is one such step — it will allow for drug stockpiles and inventories that exist to be re-distributed to areas which need them most. For, in the event of an urgent need, drugs will become available to those who are most in need.
Impressions: 8184
https://www.pharmacompass.com/radio-compass-blog/covid-19-india-restricts-drug-exports-amid-rising-prices-of-essential-bulk-drugs-fda-announces-first-drug-shortage
#PharmaFlow by PHARMACOMPASS
04 Mar 2020
This week, PharmaCompass
reviews the recently released data on prescription drugs paid for under the
Medicare Part D Prescription Drug Program in the United States in calendar year
2016.
But first, let’s understand what is Medicare.
Medicare is the federal health insurance program in the US. In 2017, it covered 58.4 million people — 49.5 million aged 65 and older, and 8.9 million disabled.
Prescription drug coverage under this
program was started in 2006, and is known as Medicare Part D.
As part of this
coverage, the Centers for Medicare & Medicaid Services (CMS) contracts insurance
companies and other private companies, known as plan sponsors, that offer
prescription drug plans to their beneficiaries with varying drug coverage and
cost-sharing requirements.
In
2017, the Congressional Budget Office (CBO) had estimated that spending on
Medicare Part D would reach US$ 94 billion, or about 16 percent of all Medicare
expenditures for the year.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
According
to the CBO, Medicare Part D is the most significant expansion of the Medicare
program since it was created by Congress in 1965.
With
more than 1.48 billion claims from beneficiaries enrolled under the Part D
prescription drug benefit program under its umbrella, our analysis of Medicare
Part D provides valuable insights into how elderly Americans use prescription
drugs.
Top 10 drugs by
cost: The ones that bore the highest cost burden for Medicare
As in 2015, in 2016
too Gilead’s Hepatitis C treatment — Ledipasvir/Sofosbuvir (Harvoni) — remained the single drug highest payout under the Medicare Part D Prescription Drug Program with a total cost of US$ 4.4 billion.
As Gilead continued
to face competition from AbbVie and Merck in the Hepatitis C space, the spending on Harvoni was down
37 percent from US$ 7.03 billion in 2015.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Celgene’s cancer treatment, Lenalidomide (Revlimid), Sanofi and Merck’s diabetes treatments and AstraZeneca’s Crestor (Rosuvastatin Calcium) for
cholesterol followed Harvoni. All together, they cost the Medicare program over US$ 10 billion.
Generic Name
Number of Medicare Part D Claims
Number of Medicare Beneficiaries
Number of Prescribers
Aggregate Cost Paid for Part D
Claims (In USD)
LEDIPASVIR/ SOFOSBUVIR (HARVONI)
141,665
52,782
12,097
4,398,534,465
LENALIDOMIDE
239,049
35,368
10,382
2,661,106,127
LANTUS SOLOSTAR (INSULIN
GLARGINE, HUM.REC.ANLOG )
5,028,485
1,075,248
245,447
2,526,048,766
SITAGLIPTIN PHOSPHATE
4,742,505
864,442
206,223
2,440,013,513
ROSUVASTATIN CALCIUM
6,012,444
1,560,050
249,981
2,322,724,007
FLUTICASONE/SALMETEROL
5,194,391
1,196,007
275,442
2,319,808,482
PREGABALIN
4,940,115
852,497
267,532
2,098,953,250
RIVAROXABAN
4,403,332
807,820
252,141
1,954,748,890
APIXABAN
4,455,782
826,969
231,631
1,926,107,484
TIOTROPIUM BROMIDE
4,153,162
903,494
235,564
1,818,857,361
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Top 10 drugs by claims: The most commonly
used drugs of 2016
With 46.6 million claims, the thyroid hormone deficiency treatment — Levothyroxine Sodium — retained its position of being the most claimed product under Medicare’s Part D Prescription Drug Program in 2016.
The number of
Medicare Part D claims includes original prescriptions and refills.
Following Levothyroxine Sodium was the lipid-lowering agent — Atorvastatin Calcium — which had 44.5 million Medicare Part D claims that
were filed by almost 9.4 million beneficiaries.
Generic
Name
Number
of Prescribers
Number
of Medicare Part D Claims
Number
of Medicare Beneficiaries
LEVOTHYROXINE SODIUM
669,999
46,617,109
8,091,785
ATORVASTATIN CALCIUM
494,973
44,595,686
9,435,633
AMLODIPINE BESYLATE
497,017
39,913,468
7,802,905
LISINOPRIL
490,452
39,469,840
8,009,954
OMEPRAZOLE
492,951
32,909,236
7,001,160
METFORMIN HCL
611,700
31,007,932
6,394,014
SIMVASTATIN
380,560
29,687,947
6,201,911
HYDROCODONE/ACETAMINOPHEN
660,617
28,595,150
7,265,882
FUROSEMIDE
488,352
27,878,243
5,421,598
GABAPENTIN
555,997
27,627,466
5,363,382
Click here
to access the compilation of Medicare Part D Prescriber Summary Report
Top 10 drugs by prescribers: Medicines that were most popular with
doctors
Among the prescribers, albuterol sulfate (salbutamol) and Diltiazem had
over 900,000 unique providers (or
doctors) prescribing the drug.
Albuterol (salbutamol) is
used to provide quick relief from wheezing and shortness
of breath while Diltiazem is used to prevent chest
pain (angina).
Also
on the list of popular drugs with prescribers is Hydrocodone-Acetaminophen.
With more doctors prescribing Hydrocodone-Acetaminophen (an
opioid) than commonly used antibiotics, such as Cephalexin, Ciprofloxacin and Amoxicillin, the
series of new FDA initiatives to combat the epidemic of opioid misuse and abuse
should change the position of opioids in the top 10 drugs by prescribers in the
coming years.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Generic
Name
Number of
Prescribers
Number of
Medicare Part D Claims
Number of
Medicare Beneficiaries
ALBUTEROL SULFATE
985,427
13,100,354
5,417,718
DILTIAZEM HCL
931,159
8,142,004
1,982,550
POTASSIUM CHLORIDE
879,491
18,945,969
4,278,000
PEN NEEDLE, DIABETIC
677,210
5,281,778
1,795,046
LEVOTHYROXINE SODIUM
669,999
46,617,109
8,091,785
HYDROCODONE/ACETAMINOPHEN
660,617
28,595,150
7,265,882
METFORMIN HCL
611,700
31,007,932
6,394,014
CEPHALEXIN
597,647
5,603,879
3,933,373
CIPROFLOXACIN HCL
594,129
7,000,081
4,851,657
AZITHROMYCIN
591,028
7,958,625
5,734,122
What does the
future hold?
Although the Part D Prescriber PUF (public use file) has a wealth of information on payment and utilization for Medicare Part D prescriptions, the dataset has a number of limitations. Of particular importance is the fact that the data may not be representative of a physician’s entire practice or all of Medicare as it only includes information on beneficiaries enrolled in the Medicare Part D prescription drug program (i.e., approximately two-thirds of all Medicare beneficiaries).
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Last
month, the Office of the Inspector General (OIG)
reviewed
the Part D claims data for the years 2011 to 2015 for brand-name drugs.
The OIG’s report found that the total reimbursement for all brand-name drugs in Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions for these drugs.
With soaring drug prices being an issue for
regular debate in the Unites States and President Trump announcing that his
team will use strategies to strengthen the negotiating powers under
Medicare Part D and Part B, it remains to be seen how the data on prescription drugs paid for under
the Medicare Part D Prescription Drug Program will change in the coming years.
Click here to access the compilation of Medicare Part D
Prescriber Summary Report
Impressions: 2500
https://www.pharmacompass.com/radio-compass-blog/analyzing-over-us-90-billion-of-medicare-prescription-drug-part-d-spending-in-2016
#PharmaFlow by PHARMACOMPASS
05 Jul 2018
This week, Phispers tells us why David Hung’s taking charge as CEO of Axovant could signal the revival of an Alzheimer’s compound shelved by GSK. While, the FDA has extended compliance date for submitting DMFs in electronic format, there are also indications that there will be more FDA inspections in India. Plus, there is news on companies like Fresenius, Stada, Ajanta Pharma, Merck and Teva. Read on.
FDA
extends compliance date for electronic DMF submissions to May, 2018
On April
7, the US Food and Drug Administration (FDA) announced it is extending the compliance date for submitting DMFs in Electronic Common Technical Document (eCTD)
format to May 5, 2018.
“DMF submissions that are not submitted in eCTD format after this date will be rejected,” the FDA website said.
“Presentations on submitting in eCTD format created prior to April 7, 2017 will have the incorrect compliance date for DMFs,” it added. Electronic submissions of Drug Master Files (DMFs) were supposed to become mandatory from May 5, 2017.
The
news coincides with the US Senate’s confirmation hearing for Scott Gottlieb, on April 7. Gottlieb was President Trump’s nominee to be the next Commissioner of the FDA.
Gottlieb was with the FDA when the regulator launched its Pharmaceutical cGMPs for the 21st Century initiative. Out of five guidance documents
listed as part of this initiative, only one has been finalized.
With
Gottlieb heading back, Ajaz Hussain, (former FDA deputy office director and
president of the National Institute for Pharmaceutical Technology and
Education of NIPTE), Vadim Gurvich (executive
director of NIPTE) and Peter J. Pitts (president of the Center for Medicine in
the Public Interest and a former FDA associate commissioner) shared their
perspective on how Trump and the FDA can create a pharmaceutical manufacturing renaissance in a blog posted on Morning Consult.
Axovant appoints new CEO and revives ghosts of GSK’s billion dollar mistake
After
selling Medivation to Pfizer for US $ 14 billion and
exiting with US $ 354 million for himself, David Hung is now the CEO of Axovant, the company which we wrote about two years ago, as we asked the question — Did a 29-year old show GSK that it made a billion dollar mistake?
Back in December 2014,Vivek Ramaswamy, CEO and Founder of Roivant Neurosciences and Axovant, had bought an old Alzheimer’s drug that GSK had dropped for US $ 5 million. In October 2014, Roivant had spun off a subsidiary by the name of Axovant, which then bought the GSK drug. GSK had shelved the compound — 5HT6 — after testing it in 13 trials and on 1,250 patients.
Six months after purchasing the compound from GSK, and
without doing any clinical development, the drug resulted in the biggest
biotech IPO ever for Axovant, which got valued at US $ 2 billion. Since then,
Ramaswamy has been setting up more companies.
Throughout, Ramaswamy has recruited high-profile executives to run his companies. And who could be more high profile than Hung? The stock market cheered his appointment — Axovant’s stock was up 28 percent
earlier this week after Hung was announced its CEO.
Axovant is looking for positive data that GSK had gathered for its 5HT6 Alzheimer’s drug. And a number of senior players in the industry say Axovant has a decent shot at taking the successful dose back into the clinic. With Hung joining, it seems the drug discarded by GSK does indeed have merit.
Fresenius
in talks to buy Akorn; Stada sold for US $5.6 billion
Fresenius SE said
it is in talks to buy US generic drugmaker - Akorn Inc.
Though discussions are underway, there is no certainty of a deal, Fresenius
said. A spokeswoman for Akorn
declined to comment.
The CEO of Fresenius, Stephan Sturm, who took charge in July 2016, has been expanding the group’s global reach through acquisitions. Last year, the company bought Spanish hospital group IDC Salud Holding SLU, also known as Quironsalud, for US $ 6.11 billion (Euro 5.76 billion) in the company’s largest-ever acquisition.
Akorn could complement Fresenius’ Kabi medicines division, which specializes in intravenous drugs, and accounts for about a fifth of the company’s revenue.
Stada sell-off: Stada Arzneimittel AG has been sold to Bain Capital and Cinven for US
$ 5.6 billion (Euros 5.3 billion), after
a long-fought takeover contest. The sell-off will give the equity firms
control of one of the last independent generic-drug businesses in Europe.
The
deal would give buyers access to German and Russian markets for OTC and copycat
medicines. It marks another step in the consolidation of the generics
industry.
FDA inspections in India to rise, says Edelweiss Securities
India’s pharmaceutical sector is the largest supplier of drugs to the US. However, “quality issues are an ongoing challenge for the Indian pharmaceutical industry,” Mary Lou Valdez, FDA’s associate commissioner for international programs wrote in a blog.
Of the 42 warning letters sent out by FDA’s office of manufacturing quality last year, about one-fifth (9) were addressed to Indian facilities. The number could rise over the next three years as the FDA would inspect 190 facilities that it could not inspect in the past five years, wrote Edelweiss Securities.
FDA inspections in India and China have doubled since 2012.
This has led to a spurt in warning letters as well.
GSK to withdraw 600,000 inhalers; no observations for Ajanta
GSK would be voluntarily recalling close to 600,000 Ventolin asthma
inhalers across the US, says the FDA. The recall is due to a leak observed in
some of the products.
The exact number of inhalers to be recalled, as reported by the FDA, is 593,088. These were produced in GSK’s Zebulon, North Carolina manufacturing facility. This is the second time in just over a year that the plant has faced problems with leaking inhalers.
Ajanta Pharma: On Monday this week,
shares of India-based Ajanta Pharma soared by over
5 percent in intraday trading as investors cheered the fact that no observations were issued during a regulatory
inspection at its unit.
“Our formulation facility at Dahej (in Gujarat) was inspected by US Food and Drug Administration (FDA) from April 3 to April 7, 2017. At the end of the inspection, no Form 483 was issued to us,” Ajanta Pharma said in a notification to the stock exchanges.
FDA delivers a blow to Merck’s Januvia marketing plan
In 2015, Merck had come out with a massive 14,724-patient study where the data demonstrated that Type 2 diabetes patients could take its flagship DPP-4 drug — Januvia — without increasing their risk for cardio complications. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
Merck wanted to use the
findings of this survey in a label to help distinguish themselves from
same-class rivals like Onglyza, which has risks.
However, the FDA recently nixed the idea, handing the pharma giant a complete response letter
(CRL).
The CRL covered Merck’s blockbuster Januvia as well as its combos with metformin. However, Merck says it
is reviewing the letter and will discuss next steps with the FDA.
Teva’s US $ 3.5 billion buy pays off with FDA approval of Austedo
Last week, the FDA gave its nod for Teva’s promising drug deutetrabenazine, after
putting it on hold ten months back due to certain suspicions regarding some
metabolites found in patients.
Teva had paid US $ 3.5
billion to acquire Auspex two years back. Teva’s deutetrabenazine is the
first deuterated drug to bag
an FDA approval.
A
deuterated drug is a drug where hydrogen has
been replaced by deuterium. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine
or SD-809 (which had been developed by Auspex).
The
drug will be sold as Austedo. Due to the presence of deuterium, the drug breaks down more slowly in patients. This way physicians can give the drug less
often and at lower doses and still manage great results. The drug is designed
to regulate the levels of dopamine in
the brain.
Impressions: 3020
https://www.pharmacompass.com/radio-compass-blog/ghosts-of-gsk-s-billion-dollar-mistake-return-new-date-for-electronic-submissions-of-dmfs
#PharmaFlow by PHARMACOMPASS
13 Apr 2017
In October
2016, the US Food and Drug Administration (FDA) inspected a facility in India
belonging to Granules India that manufactures pharmaceutical
formulation intermediates (PFIs) and finished dosage forms (FDFs). The FDA had
no observations.
Three months later, Portugal’s health authority — INFARMED — inspected the same site and detected non-conformities in good manufacturing practices (GMPs).
According to an alert published
on the INFARMED website, the observations were related to granulation and
primary packaging of tablets in batches of drugs related to paracetamol and metformin supplied by Granules to Mylan, Bluepharma and Sandoz. The agency recommended the
suspension and recall of certain batches from the market in Portugal.
Last week, based on “General GMP Observations” of “regulatory partner(s)”, Health Canada placed Granules India’s facility located in Gagillapur (near Hyderabad) on its inspection tracker. Health Canada’s inspection tracker provides updates on the actions the regulator is undertaking to assess and manage potential risks arising from inspections of drug manufacturing facilities.
According to
Granules, their facility in Gagillapur contributes over 50 percent to their revenues and “has the world’s largest PFI capacity along with an industry-leading batch size of six tons. In addition, the Gagillapur facility has one of the largest single-site finished dosage capacities in the world for their respective products.”
In a recent
interview, C. Krishna Prasad, managing director of Granules India, said there
were no issues related to data integrity and INFARMED is scheduled to re-inspect
the Gagillapur facility this week.
Data
integrity concerns at ACS Dobfar’s
Italian facility
The FDA’s April 2016 inspection of ACS Dobfar’s
operations in Brazil — Antibioticos do Brasil (ABL) — led to the issuance of a warning letter in December. Among other observations, the FDA investigators found that the filling zone for sterile injectable product was not sufficiently robust. Therefore, it didn’t protect the drugs being manufactured there (such as during the times when operators entered the final filling area).
Almost immediately after the warning letter was issued, an inspection of the same facility by the Italian Regulatory Agency (AIFA) found it not-compliant for the manufacture of the active ingredient — Cephalexin Sodium Sterile. AIFA also recommended the
suspension of the Certificate of Suitability issued for ceftazidime pentahydrate with sodium carbonate for injection.
The inspectors
found ABL failed to ensure a good level of maintenance and cleaning of the
final crystallization area and there was a poor level of training, low
knowledge and awareness of good manufacturing practices (GMP) along with lack of supervisory
control.
The
non-compliance report also mentions that some non-authorized and fraudulent
activities were stopped before inspectors entered certain manufacturing areas.
Fraudulent activities were not limited to Brazil, as ACS Dobfar’s Italian drug manufacturing facility — FACTA Farmaceutici SpA — had FDA investigators uncover data-integrity violations during a January 2016 inspection.
The warning
letter issued to FACTA mentions that for multiple lots of sterile drug product,
where the original data showed failing results, the data reportedly showed
passing results.
The company was found storing original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. The analyst told investigators that original data was first recorded in the “unofficial” spreadsheet and later transcribed to an “official” form.
Investigators also observed many
copies of uncontrolled blank and partially-completed cGMP forms and also
documented that employees at FACTA used paper shredders to destroy critical
laboratory and production records.
It is worth mentioning that FACTA’s EU GMP certification was renewed by the Italian regulators after an inspection that was conducted at the same time as the FDA inspection.
Data integrity concerns confirmed at Divi’s Laboratories in India
Divi’s Laboratories’ Unit-II situated in Visakhapatnam, Andhra Pradesh — one of the biggest manufacturing facilities for the major producer of active pharmaceutical ingredients (APIs) — was inspected by the US FDA from November 29 to December 6, 2016.
The regulators
issued a Form 483 with five observations.
While data integrity concerns had been widely reported in news media,
Health Canada confirmed the violations by placing the company on its inspection
tracker last week.
FDA’s warning letter comes to haunt Dr. Reddy’s
South Korean biotech firm — Mezzion Inc — filed a suit for damages
against Dr. Reddy’s in New Jersey state court alleging that it hid “significant deficiencies in its FDA cGMP practices” and misrepresented its compliance.
Mezzion has stated in its suit that “Dr. Reddy's repeatedly represented to Mezzion that it was compliant with FDA regulations” whereas the FDA issued a warning letter to Dr. Reddy's.
During an FDA inspection at Dr. Reddy's facilities in India, the FDA identified numerous data integrity violations and also uncovered a previously unknown and uncontrolled “Custom QC laboratory” (CQC), which engaged in a “practice of substituting repeat tests after failing results.”
Mezzion further states: “Dr. Reddy’s misconduct was the sole reason given by the FDA to deny approval of Mezzion’s new drug application (NDA) for udenafil for the treatment of erectile dysfunction (ED)”. As a result, Mezzion has incurred delays and was forced to seek new manufacturers and suppliers for udenafil and the udenafil finished product, in order to resubmit its udenafil New Drug Application (NDA) to the FDA for approval.
FDA’s warning letters to
manufacturers in UK and India
Porton Biopharma, UK: A
warning letter was
issued to the UK-based Porton Biopharma by the US FDA for manufacturing violations related to Erwinaze (asparaginase Erwinia chrysanthemi) — an orphan biologic which was developed by Porton and licensed to Jazz Pharmaceuticals.
According to the warning letter, the FDA had previously performed an inspection of Porton’s facility in January 2015 and found similar concerns. The inspection between March 7 and 18, 2016,
which triggered the warning letter,
had FDA investigators observe continued deficiencies, including metal particles
which penetrated a few batches of Erwinaze, another batch containing paper or
cardboard fibers and a possible microbial contamination.
While Porton
believed that vial stoppers were the source of the metal scraps, the FDA
investigators were not convinced.
Erwinaze
generated around US $ 43 million in the third quarter for Jazz Pharmaceuticals, accounting for more than 10 percent of the company’s revenues.
CTX Life Sciences, India: The FDA issued a warning letter to CTX Life Sciences in India after making observations of rust, insects, damaged interiors, and/or drug residues in pieces of manufacturing equipment identified as “clean”.
Investigators also found that the API were released without testing because the necessary laboratory equipment was out of order. While the company had decided to release batches “on conditional basis and as soon as UV maintenance issue rectified analysis shall be performed” the investigators could find no trace of the testing.
Our view
Last week, in
our compliance round up, we had reported the shredding of documents at Hetero Labs in India. And this week, similar issues have surfaced in
Italy.
It’s clear that corrupt practices of data integrity are spreading across the industry and are no longer confined to a region.
At the same time, while both European and US regulators reached a similar outcome on the compliance status of Antibioticos do Brasil, the divergent views at Granules India and FACTA Farmaceutici indicate the urgency for regulators to establish a consistent global evaluation standard for pharmaceutical manufacturing.
Impressions: 9420
https://www.pharmacompass.com/radio-compass-blog/eu-suspends-drugs-from-granules-indian-facility-where-fda-had-no-concerns
#PharmaFlow by PHARMACOMPASS
02 Feb 2017
In less than three weeks, Donald Trump will assume office as the
President of the United States. He has mentioned that he wants Medicare (a
national social insurance program) to directly negotiate the price it pays for prescription drugs.
Medicare provides health insurance to Americans aged 65 or more, who
have worked and paid into the system through the payroll tax. It also provides
health insurance to younger people with some disabilities or end-stage renal
disease and amyotrophic lateral sclerosis.
In 2015, Medicare provided health insurance to over 55 million Americans — including 46 million people aged 65 or more, and nine million younger people.
As we flag off the New Year, PharmaCompass
provides insights into drug prices and prescription patterns in the US in order
to help professionals make informed decisions. We believe that the cost of
medicines in the US, which have been a subject of much public outcry and
discussions in the recent years, will continue to be scrutinized during 2017.
Medicare data for 2014
Medicare Part D, also known as the Medicare prescription drug benefit — the program which subsidizes the costs of prescription drugs and prescription drug insurance premiums for Medicare beneficiaries — published a data set (for calendar year 2014) which contains information from over one million healthcare providers
who collectively prescribed approximately US $121 billion worth of prescription
drugs paid for under this program.
For each prescriber and drug, the dataset
includes the total number of prescriptions that were dispensed (including
original prescriptions and any refills), and the total drug cost.
The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees. It’s based on the amounts paid by the Part D plan, the Medicare beneficiary, other government subsidies, and any other third-party payers (such as employers and liability insurers).
The total drug cost does not reflect any manufacturer rebates paid to Part D plan sponsors through direct and indirect remuneration or point-of sale rebates. In order to protect the beneficiary’s privacy, the Centers for Medicare & Medicaid Services (CMS) did not
include information in cases where 10 or fewer prescriptions were dispensed.
Top
Ten Drugs by Cost, 2014 [Most expensive for Medicare]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Sofosbuvir
109,543
33,028
7,323
$3,106,589,192
Esomeprazole Magnesium
7,537,736
1,405,570
286,927
$2,660,052,054
Rosuvastatin Calcium
9,072,799
1,752,423
266,499
$2,543,475,142
Aripiprazole
2,963,457
405,048
130,933
$2,526,731,476
Fluticasone/Salmeterol
6,093,354
1,420,515
281,775
$2,276,060,161
Tiotropium Bromide
5,852,258
1,211,919
253,277
$2,158,219,163
Lantus
Solostar
(Insulin Glargine)
4,441,782
972,882
224,710
$2,016,728,436
Sitagliptin Phosphate
4,495,964
789,828
190,741
$1,775,094,282
Lantus
(Insulin Glargine)
4,284,173
787,077
223,502
$1,725,391,907
Lenalidomide
178,373
27,142
9,337
$1,671,610,362
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Average Cost per Claim, 2014 [Most expensive drugs]
Drug Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Average Cost Per Claim
Adagen
13
$1,224,835
$94,218
Elaprase
100
$6,560,225
$65,602
Cinryze
1,820
194
196
$96,155,785
$52,833
Carbaglu
60
$2,901,115
$48,352
Naglazyme
129
$6,189,045
$47,977
Berinert
538
73
68
$25,685,311
$47,742
Firazyr
1,568
269
232
$70,948,143
$45,248
H.P. Acthar
9,611
2,932
1,621
$391,189,653
$40,702
Procysbi
314
41
47
$12,542,911
$39,946
Folotyn
15
$598,210
$39,881
Top
Ten Drugs by Claims, 2014 [Most Commonly Used by Patients]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Lisinopril
38,278,860
7,454,940
464,747
$281,614,340
Levothyroxine Sodium
37,711,869
6,245,507
416,518
$631,855,415
Amlodipine Besylate
36,344,166
6,750,062
451,350
$303,779,661
Simvastatin
34,092,548
6,768,159
387,651
$346,677,118
Hydrocodone-Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Omeprazole
33,032,770
6,707,964
475,122
$529,050,385
Atorvastatin Calcium
32,603,055
6,740,061
419,327
$747,635,818
Furosemide
27,133,430
5,176,582
456,047
$135,710,772
Metformin HCl
23,475,787
4,509,978
364,273
$203,948,989
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Top
Ten Drugs by Prescribers, 2014 [Most Popular with Doctors]
Generic Name
Total Claim Count
Beneficiary Count
Prescriber Count
Total Drug Cost
Hydrocodone/Acetaminophen
33,446,696
8,005,790
677,865
$676,296,988
Ciprofloxacin HCl
7,253,018
4,926,835
568,201
$46,728,353
Amoxicillin
6,298,980
4,384,899
557,614
$31,193,739
Cephalexin
5,040,219
3,529,303
557,048
$36,987,401
Azithromycin
7,339,954
5,274,010
544,625
$70,699,119
Prednisone
11,032,986
4,505,821
536,108
$86,537,932
Tramadol HCl
14,250,227
4,272,724
515,816
$125,343,514
Sulfamethoxazole /Trimethoprim
4,833,758
3,090,944
500,790
$29,231,511
Gabapentin
22,143,641
4,298,609
486,754
$492,557,255
Amoxicillin/Potassium Clav
3,551,452
2,710,244
478,361
$61,713,432
The findings from CMS
data
The CY 2014 data represented a 17 percent
increase compared to the 2013 data set and a substantial part of the total estimated prescription drug spending (as estimated by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, or ASPE) in the United States — at about US $ 457 billion in 2015, which was 16.7 percent of the overall personal healthcare services.
Of that US $ 457 billion, US $ 328 billion (71.9 percent) was for retail
drugs and US $ 128 billion (28.1 percent) was for non-retail drugs.
The drug pricing process in the US is complex and
reflects the influence of numerous factors, including manufacturer list prices,
confidential negotiated discounts and rebates, insurance plan benefit designs,
and patient choices.
An IMS study found that across 12 therapy classes widely used in Medicare Part D,
medicine costs to plans and patients in Medicare Part D are 35 percent below
list prices.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
While the CMS does not
currently have an established formulary, Part D drug coverage excludes drugs
not approved by the US Food and Drug Administration, those prescribed for off-label
use, drugs not available by prescription for
purchase in the US, and drugs for which payments would be available under Parts
A or B of Medicare.
Part D coverage
excludes drugs or classes of drugs excluded from Medicaid coverage,
such as:
Drugs used for anorexia, weight loss, or weight gain
Drugs used to promote fertility
Drugs used for erectile dysfunction
Drugs used for cosmetic purposes (hair growth, etc.)
Drugs used for the symptomatic relief of cough and colds
Prescription vitamins and mineral products, except prenatal vitamins and fluoride preparations
Drugs where the manufacturer requires (as a condition of sale) any associated tests or monitoring services to be purchased exclusively from that manufacturer or its designee
Our view
The Medicare program is designed such that the
federal government is not permitted to negotiate prices of drugs with the drug
companies, as federal agencies do under other programs.
For instance, the Department of Veterans Affairs — which is allowed to negotiate drug prices and establish a formulary — has been estimated to pay (on an average) between 40 to 58 percent less for drugs, as opposed to Medicare Part D.
If Trump administration kick starts direct
negotiations on Medicare drug prices with drug companies, 2017 will surely turn
out to be a year for the pharmaceutical industry to remember.
View the Medicare Part D National Prescriber Summary Report, Calendar Year 2014 (Excel version available) for FREE!
Impressions: 7923
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05 Jan 2017
FDA uncovers systemic data manipulation in China; India’s pharma lobby rubbishes report on pollution
This week, Phispers brings you news about Wockhardt and how its
turnaround plans are going awry. There is also news about Novo Nordisk ending
development of an oral form of insulin, data manipulation at Beijing Taiyang,
the latest on treatment of high cholesterol and lots more.
Novo ends
development of oral insulin, slashes long term growth forecast
Novo Nordisk – the world’s biggest maker of insulin – slashed its long-term profit-growth forecast by half due to pressure on prices in its largest market – the US. The company is also ending development of an oral form of insulin, which has long been an unattainable dream for the global
pharmaceutical industry.
The Danish pharma company will be relying
more on in-licensing early stage projects and working with external academic
collaborators. Moreover, the company will focus more on diabetes and obesity
adjacent conditions such as nonalcoholic steatohepatitis (NASH), cardiovascular
disease and chronic kidney disease.
In the US, Novo is experiencing payer
difficulties that have resulted in disappointing performance of its modern
insulins. The profit-growth estimate was trimmed to 5 percent from the 10 percent projected in
February this year, as it lost key contracts. The company also saw some
products being excluded from insurance-coverage plans as it promised large
rebates in the US on 2017 prices.
While Novo controls almost half the
global market for insulins, the intermediaries who negotiate prices for insured
patients in the US are opting for cheaper alternatives.
Lower prices and escalating competition
from biosimilars have dimmed prospects for Novo, Sanofi and Eli Lilly & Co.
These pharma companies have been forced to deepen rebates and discounts.
Systemic data
manipulation uncovered at Chinese API manufacturer
The
FDA has issued a warning
letter to Beijing Taiyang Pharmaceutical Industry, a manufacturer of active pharmaceutical ingredients such as diphenyhydramine hydrochloride, a commonly used ingredient in cold preparations.
The warning letter states that FDA investigators “observed systemic data manipulation across the facility.” The investigators documented “unexplained deletions of laboratory test results, discovered that analysts repeated tests until they obtained acceptable results and that the company failed to investigate results that were out-of-specification.”
The
FDA investigators
observed, through a window, a warehouse containing numerous drums bearing the company’s label. “When the investigators
requested access to this warehouse, Beijing Taiyang’s staff barred them from
entering the warehouse to examine the containers,” the letter adds.
The following
day, when FDA investigators were given access to the warehouse, they observed
that a significant number of drums had been removed and were not available for
inspection. The firm also relied on falsified and manipulated test results to
support batch release and stability data.
The FDA had
placed Beijing Taiyang on its import alert list in April of this year.
Wockhardt’s compliance foibles haunt biotech startup Cempra
Wockhardt’s
ambitious turnaround plans received a serious setback last week when Cempra, a
clinical-stage pharmaceutical company focused on developing antibiotics, learnt
that the US Food and Drug Administration (FDA) may not allow it to use an active
pharmaceutical ingredient (API) produced by Wockhardt for approval and in the
commercial use of its product Solithromycin.
Two of Cempra’s products are in advanced clinical development. One of them – Solithromycin – has been successfully evaluated in two Phase 3 clinical trials for community acquired bacterial pneumonia (CABP). Its applications for approval have been accepted by the FDA and the EMA.
The setback to Cempra was the result of an
in-person meeting held with the FDA in late October. The reason for the FDA
decision was an import alert placed on a Wockhardt manufacturing facility in August 2016, several months after Cempra’s New Drug Applications (NDA) with Wockhardt had been submitted and accepted for review by the FDA. Cempra began an active dialog with the FDA to determine if the API produced at Wockhardt prior to the import alert was adequate for the NDA.
While Cempra plans to provide the FDA with data from API sourced from another supplier, the news is a serious setback for Wockhardt’s ambitious turnaround plans to fix its compliance issues and become an antibiotic research powerhouse.
Sanofi-Regeneron’s potential blockbuster runs into manufacturing problems
Last week, Sanofi and Regeneron Pharmaceuticals’ Sarilumab – a product in development for the treatment of moderately to severely active rheumatoid arthritis (RA)—received a setback. The two companies announced that the
US FDA has issued a Complete Response Letter (CRL) regarding the Biologics
License Applications (BLA) for Sarilumab.
The CRL refers to certain deficiencies identified during a routine
good manufacturing practice (GMP) inspection of the Sanofi facility in Le Trait
(France) where Sarilumab is filled and finished. Satisfactory resolution
of these deficiencies is required before the BLA can be approved.
However, Sarilumab performed extremely well in a head-to-head
clinical study against AbbVie’s world best-selling drug, Humira.
The manufacturing glitch was also the only negative in Sanofi’s better than expected earnings report which was released last week in which Sanofi announced that it would exit its European generics business in the next 12 to 24 months.
Cholesterol woes: Raising HDL can’t save you, and new drugs don’t work.
Last year, two new drugs – Rephata and Praluent – that lower cholesterol, came on the market. Back then, analysts had estimated sales of more than US $ 3 billion a year. Working by blocking a protein called PCSK9, the drugs would clear out LDL, or bad cholesterol.
While Sanofi and Regeneron launched Praluent, which is said to succeed where the traditional treatment – an inexpensive class of drugs called statins – fails, Amgen launched Rephata with a similar mechanism of action.
A year on, doctors are reluctant to write prescriptions until they
are sure of the benefits. Similarly, insurers are unwilling to pay for these
drugs.
“These launches so far are close to, if not the biggest, wastes of development and commercial investment in recent industry history,” Geoffrey Porges, a biotech analyst at Leerink, an investment bank specialising in healthcare told STAT News.
There was more bad news for patients suffering from high
cholesterol. A study
published this week has found little evidence that raising HDL, widely known as
good cholesterol, protects against heart attacks and strokes.
The study was published in the Journal
of the American College of Cardiology. The drug industry has repeatedly failed to design a pill that might improve patients’ lives by increasing HDL.
A decade ago, Pfizer spent more than US $ 800 million to get the
HDL-boosting medication torcetrapib into
late-stage trials, only to find that more patients died on the drug than on
placebo. Roche was next to fail when its drug, dalcetrapib, came up
short in a 16,000-patient trial in 2012. And last year, Eli Lilly shut down a
study testing its evacetrapib on 12,000 patients after discovering that the
drug had no effect on heart attack and stroke.
Pfizer fined for violating environmental laws in the US
For the second time in recent years, Pfizer has been fined by the American authorities for violating the
Clean Air Act at a manufacturing plant in Barceloneta, Puerto Rico.
Pfizer
was fined US $ 190,000 for failing to disclose information about hazardous
chemicals that were used at the concerned plant.
In early 2014, the Environmental Protection Agency (EPA) had found that Pfizer stored certain substances — in this case, ammonia and methylamine — that exceeded permitted amounts. This triggered a requirement to file a plan, which Pfizer failed to do and had to be fined. The substances were also used without properly being disclosed to the EPA.
Pharmexcil refutes report on drug-resistant
bacteria
Growing
antimicrobial resistance (AMR) is one of the gravest threats to human health.
Global deaths because of drug-resistant infections are projected to reach 10
million per year by 2050, with cumulative economic losses of US $100 trillion.
A new report by campaigning organisation – Changing Markets – titled ‘Superbugs in the Supply Chain - How pollution from antibiotics factories in India and China is fueling the global rise of drug-resistant infections’ has revealed
the presence of drug-resistant bacteria at pharmaceutical manufacturing sites
in India.
On-the-ground research and analysis of water samples found high levels of drug-resistant bacteria at sites in three Indian cities: Hyderabad, New Delhi and Chennai. Out of 34 sites tested, 16 were found to be harboring bacteria resistant to antibiotics, the report says. At four of the sites, resistance to three major classes of antibiotics was detected, including antibiotics of ‘last resort’, those used to treat infections that fail to respond to all other medicines.
The report says antibiotics manufactured at or near these sites are being exported to United Kingdom’s National Health Service (NHS), French hospitals, and pharma majors including US distribution giant McKesson and French company Sanofi’s generics arm Zentiva.
The report cites
Hyderabad-based Aurobindo Pharma as one of the worst offenders. However, Pharmaceuticals Export Promotion Council of India (Pharmexcil), which is part of India’s ministry of commerce, has termed the report as “fabricated” and “backed by vested interests” to malign the Indian pharma industry—the world’s largest producer of antibiotics.
Aurobindo Pharma’s wholetime director M Madan Mohan Reddy is the chairman of Pharmexcil.
EMA probes Wanbury Pharma; French agency ANSM warns about fake GMP certificates
Mumbai-based
drug manufacturer Wanbury Pharma, which is one of the largest exporters
of diabetes drug metformin, had been served a show-cause notice by the Maharashtra Food and Drug Administration
last week for allegedly re-labelling its drugs that were being exported to
Brazil, Mexico, Bangladesh and Pakistan.
Wanbury has now
come under the lens of the European Medicines Agency (EMA). The EMA is learnt
to be investigating the allegations made by the Maharashtra FDA.
Meanwhile, the
ANSM (French agency for the safety of health products) has been informed of the
use of several falsified GMP certificates under its letterhead for import and export activities of active substances. “Because of a recent increase in observed cases, the ANSM reminds stakeholders that the authenticity of GMP certificates should be checked on EudraGMDP Community database,” the ANSM website says.
Teva
takes a shot at delaying generic Copaxone by writing to FDA
Teva Pharmaceutical has submitted a document to the US FDA explaining
the differences between its original multiple sclerosis drug Copaxone and the generic
product being marketed by Momenta and Sandoz.
In order to enter the
market, the generic version of Copaxone requires both FDA approval and legal
confirmation that it does not violate Teva's patent.
According to analysts,
the document is designed to delay the entry of a 40-mg generic version of
Copaxone into the market (20mg generic Copaxone is already on the market). The
document is also likely to undermine the confidence of FDA officials, leading
to considerable delay in approval of the Momenta's generic drug for 40 mg
Copaxone.
Teva is currently in a
court case concerning the patents that protect Copaxone against generic
competition (for the 40mg version). However, most analysts believe Teva will
lose the case, and that the generic product will be allowed to enter the market
in 2017.
Former Valeant CEO and CFO being probed for accounting fraud
In the US, an ongoing criminal probe into Valeant Pharmaceuticals is focusing on the extent to which the former chief executive officer – Michael Pearson – and former chief financial officer – Howard Schiller – allegedly hid a relationship with a specialty pharmacy – Philidor Rx Services – from insurers.
Pearson was the key
driver behind Valeant’s growth, which relied
on price-gouging as a growth strategy. Pearson bought older medicines and hiked
their prices manifolds to push up profits.
Federal prosecutors are reportedly exploring potential charges of accounting fraud in connection with Valeant’s ties with Philidor Rx Services, a Bloomberg news report said. Valeant used its ties with Philidor to steer
prescriptions and boost reimbursements for its medicines.
For now, the probe is
examining actions taken by Pearson and Schiller, though sources say others,
such as Philidor executives, may also be charged.
Impressions: 4715
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#PharmaFlow by PHARMACOMPASS
03 Nov 2016
This week, Phispers gets you news on illegal exports of Metformin in India, Hillary Clinton’s stance on price gouging, a report’s recommendations on reducing India’s dependence on Chinese APIs, Pfizer’s patent dispute case in the UK and more.
Aspen Pharma fined for price
gouging in Italy
Last week,
Italian antitrust authorities fined South Africa-based drug maker Aspen Pharmacare nearly US $ 5.5 million for
halting supplies of several cancer drugs. This is being seen as a negotiating
tactic designed to hike prices by as much as 1,500 percent.
The
products whose supplies were halted are: Leukeran 2 mg (chlorambucil);
Alkeran 50 mg / 10 mg powder and solvent (melphalan);
Alkeran 2 mg (melphalan); Purinethol 50 mg (mercaptopurine);
and Thioguanine 40 mg (thioguanine).
The
price-gouging episode began after Aspen purchased the drugs from GlaxoSmithKline. It then began negotiations with
the Italian Medicines Agency over pricing for the cancer medicines. According
to the Italian Competition Authority, Aspen also used the threat of a shortage
to achieve the prices it had sought, because the drugs temporarily disappeared
from the market.
It would
be interesting to see the price rise in the US market for these products since Chlorambucil
and Thioguanine have no generics in the United States. Clinton’s team had debated attacking FDA commissioner Califf, reveals WikiLeaks
Around
this time last year, the pharmaceutical industry had come under severe
criticism for price gouging. And, if emails released by WikiLeaks are to be believed, Hillary Clinton’s campaign team had debated attacking Dr. Robert Califf, over his ties with various drug makers. Back then, Califf had been nominated to head the US Food and Drug Administration. Earlier this year, Califf got named as FDA commissioner.The email thread, pertaining to September 21-26, 2015, suggests how the issue had become a factor in her campaign. Through these emails, few members of Clinton’s team had weighed the pros and cons of picking a fight that would “fit into the larger themes we are trying to promote,” an email written by Clinton’s campaign press secretary had said.Similarly, a senior policy advisor had written: “We could certainly signal that we want someone willing to stand up to pharma.”Califf was
the founding director of the Duke Clinical Research Institute, which conducts
studies for companies. He has authored numerous papers with industry
researchers. Two years ago, several large drug makers had partly supported his
salary, while many others paid him for consulting work. These
email exchanges took place amid rising outrage over price gouging, triggered by
Martin Shkreli (founder and former CEO of Turing Pharmaceuticals). In September
last year, Clinton had taken a jab at Shkreli through a tweet, for hiking the
price of the antimalarial drug Daraprim by more than 5,000 percent. Clinton’s campaign staff had tweeted: “FYI – We have started the war with Pharma!!” Last
month, Clinton issued a plan to contain prescription drug pricing. She proposed
a federal panel of officials to determine if price increases for certain drugs
are justified, authorize the federal government to directly purchase drugs
through imports of competing drugs from other countries, and fine offending
companies. India initiates action against two Metformin
makers for illegal exports
The Food
and Drug Administration of Maharashtra, India has initiated action against two pharmaceutical companies – Pharmaceutical Products of India Ltd and Wanbury – for illegally rebranding and exporting a diabetic drug to Mexico, Brazil, Bangladesh and Pakistan.A part of the bulk drug – metformin hydrochloride – was being manufactured by Pharmaceutical Products of India, based in Tarapur. It was manufacturing 300,000 kilos of metformin hydrochloride for export every month. The company, however, did not have an export licence. On further investigation, the department found that the drug was sold to another firm – Wanbury in Patalganga – that had an export licence. The modus operandi was clear – Wanbury had an export licence and orders worth 650,000 kg per month of metformin HCL, but had a shortfall of 350,000 kg in manufacturing capacity, which was being fulfilled by Pharmaceutical Products of lndia. “Wanbury would just stick their labels on the drugs supplied by the latter without any quality checks,” said a Maharashtra FDA official. “Such unholy alliances can have disastrous effects on the country's drug export sector,” the official added. The companies have been charged under the Drugs and Cosmetics Act. Industry watchers share how
deregulation brings further risks
Last week,
in Speak Pharma, Bernard Plau, CEO of
Akovia Consulting, talked about how fraud broke the trust of regulators. And this week, industry watchers – Dinesh Thakur and Prashant Reddy Thikkavarapu – share how deregulation by the Drug Controller General of India (DCGI) brings further risk, in an article published on The News Minute, titled “Deregulation of the pharma industry in the time of scandals’.
Since the Ranbaxy scandal, there have been several
other scandals in the Indian pharmaceutical industry, and these have involved
big names such as Sun, Dr. Reddy’s, Wockhardt, GVK Bio and Alkem. These companies have come under
scrutiny from foreign drug regulators.
Thakur and
Thikkavarapu say two kind of scandals have plagued the Indian pharma industry. The
first is related to data fabrication by contract research organisations (CROs)
that conduct bioequivalence (BE) testing. The second type involves drug
companies indulging in fabrication of data during quality testing.
“Instead of increasing regulatory scrutiny, the DGCI has been on a drive to reduce the regulation governing the Indian pharmaceutical industry in the name of ‘Make in India’,” they added.
Indian trade body study suggests
ways of reducing dependence on Chinese APIs
A study
undertaken by trade body Assocham and market research firm RNCOS has
highlighted how India’s overwhelming dependence on China for APIs has emerged as a worrisome area. The study has recommended steps that can help reduce imports of APIs from China – which stand at Rs 138.53 billion (US $ 2.08 billion), or 65.29 percent of the total API imports of Rs 212.16 billion (US $ 3.18 billion).
“This is all the more disconcerting in the face of louder narrative against reducing trade gap with China, which is well over US $ 51 billion,” the study says.
One of the main reasons for huge API imports from China is the low cost of manufacturing and subsidy there. Moreover, India levies negligible import fee. “The import fees should be increased in line with other counterparts”, the paper said.
The
existence of multiple regulatory authorities for renewal of licences by India’s bulk drug manufacturers is also affecting production. “Therefore a single committee of various government departments should be formed to regulate the industry through a single window and audit of plants,” the study said. It also recommended developing mega parks for APIs across the country.
More bad news for Teva as it mulls acquisition of Korea’s CelltrionLast week,
PharmaCompass covered Teva’s misadventure in Mexico. Little did we know that more bad
news awaited Teva. Just one month after Teva paid Regeneron US $ 250 million to get access to a new pain drug – fasinumab, the FDA has put its clinical trial on hold. The news
comes at a time when Teva is said to be considering the acquisition of South Korea’s Celltrion in order to strengthen its biosimilar portfolio. Going forward, biosimilars are said to be a key element of Teva’s overall strategy.
Teva and Regeneron’s fasinumab was being studied in a Phase IIb trial in chronic low back pain, among others tests including osteoarthrosis pain. The FDA is now asking the two partners for “an amendment of the study protocol” after seeing a case of adjudicated arthropathy (a disease of the joint) in a patient receiving high-dose fasinumab, who had advanced osteoarthritis.The two
companies said they would now set about designing a pivotal Phase III study in
chronic low back pain that specifically excludes patients with advanced
osteoarthritis in the hope this was a one-off related to this disease. Pfizer loses appeal in a UK patent
dispute case over Lyrica
Pfizer lost an appeal in a UK patent dispute over Lyrica, one of the company’s top-selling drugs. The Court of Appeal upheld a 2015 verdict that had struck down key patent claims on Lyrica by Pfizer and cleared Allergan Plc’s Actavis generic unit of infringing it.
The
disputed patent covers the use of pregabalin for the treatment of pain. The business was bought by Teva this year. In 2015, Lyrica – which is also used to treat epilepsy – generated sales of US $ 4.8 billion for Pfizer.
Pfizer has
also sued Dr. Reddy’s Laboratories and Teva Pharmaceutical Industries
over their generic pregabalin products. These days, Lyrica is used more for
pain than for its original indication as a seizure drug.
Pfizer now
hopes to take its fight to the UK Supreme Court. “We maintain our belief in the validity and importance” of the patent, said Pfizer spokeswoman.
Explosion at BASF’s biggest plant in Germany kills twoOn October
17, an explosion and fire at chemicals maker BASF's production site in Germany is said
to have killed at least two people and severely injured six.
The explosion occurred at around 11.20 am local time, on a supply line connecting a harbor and a tank depot on the Ludwigshafen site. BASF is the world’s biggest chemicals company and the Ludwigshafen site, which is situated around 80 km south of Frankfurt, is the world's largest chemical complex, covering an area of 10 square km. The site employs 39,000 workers. Located on the Rhine river, the Ludwigshafen site receives many of its raw materials by ship.
The
company said it was unclear so far what caused the explosion. BASF is also
unclear about the financial impact of the explosion.
Impressions: 4737
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#PharmaFlow by PHARMACOMPASS
20 Oct 2016
