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: 54752
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#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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This week in Phispers, we look at the growing troubles at Teva. The company plans to divest non-core assets to reduce debt and lay-off 7,000 workers. The FDA approved AbbVie’s Mavyret, a drug that poses considerable challenge to Gilead’s Harvoni and Sovaldi. Meanwhile, Martin Shkreli was found guilty in three out of eight charges; diabetes drug exenatide showed benefit to Parkinson’s disease patients in a study; and in the US, the Senate passed key FDA funding bill.
Teva in dire straits: To lay off 7,000 workers, to sell non-core assets to repay
debt
Teva has been in trouble for quite sometime now. It’s a classic case of a company taking on more debt to spur growth. But it’s fallen into hard times, as three CEOs changed guard this decade.
Last week, the world’s largest manufacturer of generic medicines said it would divest non-core assets to shed a part of its US$ 35 billion debt load. While debt may be historically cheap, it still has to be repaid. And if revenues don’t keep up with payments, the downfall can be rapid for Teva.
Teva had taken on
the debt in order to
dominate all facets of generic drugs, including a US$ 40.5 billion
acquisition of Allergan’s generics business last year. The
Allergan deal added more pressure on drug prices and margins.
Teva also slashed
its earnings goals
for the second time this year. It warned investors it may have to renegotiate
some debt agreements if cash flow worsens. Teva reduced its dividend by 75
percent.
The company also
mentioned that it is in the process of laying off 7,000 workers. Greater competition in the
generic drug business due to increased approvals (of generic drugs) by the US
Food and Drug Administration (USFDA) has led to poor results, the company said.
The continued deterioration of its business environment in Venezuela has made
matters worse.
The plight of Teva
has been worsened due to the leadership crisis — the company has been without a CEO and a CFO for months.
Activist
shareholder Benny
Landa blamed acting CEO Yitzhak Peterburg and the board of directors for leading Teva to disaster. Landa said what is happening in the company is no less than a catastrophe. “I've been saying this for three or four years: the company board of directors is incapable of making big decisions and getting the company back on track,” he said.
Price-gouging Shkreli awaits sentence; found guilty on three out of eight charges
Martin Shkreli — the co-founder of Elea Capital, MSMB Capital, Retrophin and the former CEO of Turing Pharmaceuticals who is more famous for price gouging and for defrauding investors — could spend years in prison due to last week’s investor fraud conviction if the judge focuses on the intended impact of his
crime and on his antics on the social media, say legal experts.
Back
in 2015, Shkreli had raised the price of an infection treatment by 5,000 percent to avoid prison due to an unusual twist to his case — defrauded investors suffered no loss from his crime.
That
could work in Shkreli’s favor, because investor harm is the main factor in determining a sentence for securities fraud in the US. However, a report quotes a law enforcement source as saying that prosecutors will challenge Shkreli's underlying assumption of how to calculate the losses of investors.
While
Shkreli was convicted on three securities fraud and conspiracy counts, he was
acquitted of other charges, including the charge that he conspired to steal US$
11 million in assets from Retrophin.
What’s caught the public eye though is Shkreli’s social media antics. Hours after his conviction, Shkreli declared the mixed verdict by the federal jury on YouTube as an “astounding victory.”
Without showing any sign of remorse, 34-year old Shkreli said: “I’m one of the richest New Yorkers there is, and after today's outcome it's going to stay that way.”
According
to lawyers, such a conduct on social media could backfire at the time of sentencing. “He lacked any remorse, and the judge may avoid appearing lenient when she sentences him,” James Cox, a law professor at Duke University, said.
Diabetes drug exenatide could stop the progress of Parkinson’s disease
In future,
clinicians may be able to stop the progress of Parkinson’s disease with a drug normally used in type 2 diabetes. At present, the drugs used to treat Parkinson’s disease only help in managing the symptoms. They do not prevent brain cells from dying.
In Parkinson’s, the brain is progressively damaged and the cells that produce the hormone dopamine are lost. Legendary boxer Muhammad Ali had died last year at the age of 74 after battling for years with Parkinson’s disease.
In the trial, half
the patients were given
the diabetes drug exenatide and the rest were given a placebo (dummy treatment). All the patients stayed on their usual medication. Those on just their usual medication declined over 48 weeks of treatment. But those given exenatide were stable. And three months after the experimental treatment stopped, those who had been taking exenatide were still better off.
Exenatide,
derived from the saliva of Gila monster, is a glucagon-like peptide-1 (GLP-1)
agonist. It treats type 2 diabetes by mimicking the hormone GLP-1, which
triggers insulin secretion.
According to University College London (UCL) researchers, Parkinson’s patients treated with exenatide did
better on movement tests than patients who received a placebo. If they can prove the drug changes the disease itself, it could transform the way we treat Parkinson’s.
Though the UCL team is “excited”, it has urged caution as any
long-term benefit is uncertain and the drug needs more testing.
FDA approves AbbVie’s Mavyret — a drug that cures Hepatitis C in eight weeks
Last
week, the USFDA approved the first-ever drug that can treat all six major strains of hepatitis C (or HCV) in just eight weeks — AbbVie’s Mavyret. For competitors like Gilead, Mavyret spells bad news. Mavyret is
also being considered a ‘steal’ in the world of HCV drugs, with a price tag of US$ 26,400 for an eight-week treatment course. In comparison, Gilead’s Harvoni costs about US$ 63,000 for eight weeks, though the
discounts bring the net price down to US$ 30,000.
Gilead also has its own ‘pan-genotype’ hepatitis C medicine, Epclusa, in addition to its blockbuster HCV drugs
Sovaldi and Harvoni, that have been at the centre of a
controversy around their steep prices.
With
a combination of two new direct-acting antivirals — glecaprevir and pibrentasvir — Mavyret treats adult Hepatitis C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. According to the FDA, it’s the first pan-genotypic HCV drug with an eight-week treatment duration. Other options cure the disease in 12 weeks or longer.
J&J’s Invokana is CVS Caremark’s preferred diabetes drug
Close on the heels of Express Scripts’ 2018 formulary release, rival pharmacy benefit management (PBM) giant CVS Caremark has published its own list of drugs that are in,
and those that are out. Express
Scripts Holding is the largest PBM organization in the US.
In
the SGLT2 class of drugs to treat diabetes, CVS
removed Eli Lilly and Boehringer Ingelheim’s Jardiance and added Johnson & Johnson’s
Invokana as a preferred option. This, despite the fact that Invokana came with an
increased risk for amputations in a cardiovascular outcomes study finished
earlier this year.
A Boehringer Ingelheim spokesperson said the company is “very disappointed” with the formulary move “and the potential treatment disruption” and the impact this could have on patients. This decision restricts treatment options for patients who could benefit from Jardiance’s life-saving cardiovascular benefit, the spokesperson added.
CVS removed 17
drugs in 10 classes, with Merck’s Zetia, Daiichi
Sankyo’s Benicar and Teva’s Nuvigil among them. Despite the removals, the company expects 99.76
percent of members will be able to keep using their current treatments.
US Senate overwhelmingly passes reauthorization of FDA’s user fees
In the US last week, Senators voted overwhelmingly to pass a key Food and Drug Administration (FDA) funding bill. The bill is now with President Trump, for his approval.
The Senate passed a five-year reauthorization of the FDA’s user fees in a 94-1 vote, with only Senator Bernie Sanders voting against the measure. The move is in major contrast to the recent rancor surrounding the Senate’s efforts to repeal ObamaCare.
The
funding reauthorizations are based on recommendations from industry groups.
This bill renews FDA’s authority to collect fees from the prescription drug and medical device industries. Together, they account for 25 percent of all FDA funding; and should amount to around US$ 8-9 billion over the next five years.
The
fee helps speed
up the approval of new drugs and devices. This funding reauthorization of FDA’s user fee comes about a month before the current user fee agreement expires.
The White House hasn’t said if it will sign the user fee bill. In a statement of administrative policy issued in July after the bill passed the House, the White House expressed concern with some minor provisions, though it did not threaten a veto.
Impressions: 2374
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#PharmaFlow by PHARMACOMPASS
10 Aug 2017
A review of the Drug Master Files (DMFs) submitted to the United
States Food and Drug Administration (FDA) from October 2016 to March 2017 (the
fourth quarter of 2016 and the first quarter of 2017) indicates an extremely
robust pharmaceutical industry in India. However, the filing make one question
an article we had carried earlier this month on the end of India’s pharma honeymoon.
India filed more than half the DMFs submitted
Indian companies filed more than half (176) of the 345 DMFs
submitted with the FDA. China (60) came a distant second, followed by the
United States (40). While DMF submissions were made from 26 other countries,
the activity levels seen were a far cry from what was seen in India and
China.
In our past compilation for the second and third quarters of 2016,
Macleods Pharmaceuticals (14 DMFs) had pipped MSN Laboratories (13 DMFs) to become the leading filer from
India.
However, in the recent review period, MSN bounced back with 41 DMF
submissions, compared to six for Macleod. Leading Indian pharmaceutical majors
such as Aurobindo,
Sun Pharma, Amneal,
Mylan’s
India operations, Hetero,
Cipla
and Jubilant
had six or more filings each.
Ajinomoto’s
North American operations filed 11 DMFs for various amino acids and led the
submissions for products manufactured in the United States.
Tianjin Weijie Pharmaceutical led the pack from China, with eight DMF
submissions.
Over the review period, a total of 345 submissions were made to the
FDA, almost similar to the 379 DMFs filed during the second and third quarters
of 2016.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
The next FTF challenges
Since APIs form the building blocks of finished formulations, DMF
submissions give a sneak preview into the next possible first-to-file (FTF)
generic challenges to patented drugs.
In
December 2016, Indian drug major Sun Pharmaceutical Industries
announced it will acquire a branded oncology product, Odomzo,
from Novartis
for an upfront payment of US$ 175 million.
A little over three months after the announcement, MSN Labs filed the first DMF for Odomzo’s active pharmaceutical ingredient (API), sonidegib phosphate. Odomzo was approved by the FDA in July
2015 and is indicated for the treatment of adult patients with locally advanced
basal cell carcinoma.
While patents for Novartis’ drugs Tafinlar
and Mekinist
are not scheduled to expire until 2029, Novartis should prepare for a generic
competitor as DMFs were filed for the APIs used in both drugs by MSN Labs. The
drugs had combined sales in 2016 of US$ 672 million.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
In addition, MSN Labs also filed the first DMF for nintedanib esylate, the API used in Boehringer Ingelheim’s idiopathic pulmonary fibrosis treatment,
Ofev, and for cabozatinib (S)-malate, the API used by Exelixis for its kidney cancer treatment — Cabometyx.
While in most cases MSN’s DMF is the first one to get filed, in the case of Helsinn’s
Akynzeo,
which is used to prevent chemotherapy-induced nausea and vomiting, Apicore US also filed a DMF along with MSN.
Although sales forecasts for Bayer’s pulmonary arterial hypertension treatment — Adempas (riociguat) — were lowered as the drug did not get the expected sales start
and planned label expansions did not materialize, this did not stop MSN Labs
from filing the first DMF for this product as well.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Another drug which is struggling to meet analyst expectations is Novartis’ Entresto. Once considered “one of the most important products in the company's history” with an expectation to reach US$ 10 billion in peak sales, the drug generated sales of only US$ 170 million in 2016. Regardless, Mylan filed the first DMF for the API.
Another drug where MSN Labs did not file the first DMF was for AstraZeneca’s
ovarian cancer treatment, Lynparza (olaparib).
Alp Pharm Beijing submitted the DMF for the drug which
generated US$ 218 million in sales in 2016 and a figure Bernstein Research
analyst Timothy Anderson forecasts will grow to US$ 684 million by 2020.
The onslaught on Novartis’ portfolio is not limited to only patented products as Lamprene,
a product which has been on the market since 1986, and not had any generic
competitor, had Zhejiang Huahai file a DMF indicating a generic competitor maybe on the horizon
soon.
Mylan’s Sotradecol
has been the only injectable form of sodium tetradecyl sulfate
on the market since 2004. That monopoly may end soon as the FDA completed the
review of a DMF filed for the API early this year.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Most actively filed products — vortioxetine hydrobromide and dolutegravir sodium
The most actively filed DMFs, with seven filings each, were those
for Takeda’s
depression drug Trintellix (vortioxetine hydrobromide) and GSK’s HIV treatment dolutegravir sodium.
Johnson & Johnson’s diabetes treatment Invokana (canagliflozin), which recently demonstrated that it
decreased the risk of heart attacks and strokes, while increasing the risk of amputation,
particularly of toes, had six new DMFs filed.
There were also six new DMFs filed for apremilast,
five for darunavir
and four each for dapagliflozin
and rivaroxaban.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Filings for new drugs under development
Helsinn is moving ahead with the filing of anamorelin hydrochloride, as it filed DMFs for the API and the 100
mg tablets, a product which was welcomed enthusiastically by oncology experts as it raised hopes to
be a drug for cancer cachexia, the extreme wasting seen at the end stages of
the disease.
But those hopes were recently dashed, as a review of the clinical
data by the European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) found only "marginal" effects and recommended that
the product be refused marketing authorization in Europe.
Now it remains to be seen what the FDA’s verdict on this drug will be.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
AB Science’s Masitinib has been in the news recently as an EMA committee announced the drug, developed for a range of cancers, could not be approved due to “serious failings” in the way clinical studies were conducted.
However, this did not stop Excella GmbH from filing its second DMF for the API.
Multiple sclerosis treatment dimethyl fumarate (Biogen’s Tecfidera) generated
sales of US$ 3.97 billion in 2016 and is projected to achieve US$ 5.56 billion by 2020.
While there are now 28 DMFs filed for dimethyl fumarate, in March
this year Alkermes
announced the initiation of a new phase 3 study
of ALKS 8700, a novel, oral monomethyl fumarate (MMF) prodrug candidate in
development for the treatment of relapsing forms of multiple sclerosis.
It remains to be seen when Alkermes’ product will get approved. However, MSN Labs followed Honour Labs to file the second DMF for this product.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
A new submission for deslorelin acetate
(an injectable gonadotropin releasing hormone super-agonist) indicates there
maybe a new drug development underway for this age-old peptide as currently
there are no approved drugs in the US.
A similar situation seems to exist for taurolidine,
an antimicrobial that seeks to prevent infections in catheters.
Vasudha Pharma’s filing of cisapride monohydrate comes as a surprise. The product, which
was launched by Janssen for increased motility of the
gastrointestinal tract, was later withdrawn from the US market due to concerns of
fatalities linked to cardiac arrhythmias.
The product, however, continues to be exported from India to
countries like Switzerland, Thailand, Mexico, China and Canada.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Our view
The last quarter of 2016 and the first quarter of 2017 clearly
demonstrate an API industry in India and China, which is extremely active with
new product development, regardless of disappointing financial results posted
by major pharma companies and growing concerns over regulatory non-compliances.
Given the market headwinds and increased compliance expectations,
it remains to be seen how many of these DMFs filed actually result in drugs
reaching the market.
Click here to view all the DMF submissions in Q4 2016 and Q1 2017 (Excel version available) for FREE!
Impressions: 5931
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#PharmaFlow by PHARMACOMPASS
22 Jun 2017
This week in Phispers, we bring you news on J&J’s Invokana, a drug that reduces heart risk while increasing the risk of amputation of toes. There is news from Google, which is tying up with India’s Aravind Eye Care System for its artificial intelligence eye doctor initiative. And WHO takes a step towards reducing antibiotic resistance by grouping antibiotics into ‘Access’, ‘Watch’ and ‘Reserve’.
Manufacturing errors trigger drug recalls by Lupin and Dr. Reddy’s in the US
Earlier this month,
we carried an article on the end of India’s pharma honeymoon.
News this week from Lupin and Cipla added another dimension to the problem as manufacturing
errors triggered drug recalls in the United States.
Lupin voluntarily recalled a lot of its birth control pills — Mibelas 24 Fe — in the US. A market complaint indicated a packaging error, making the lot number and expiration
date no longer visible. This product is an oral contraceptive for women.
As a result of the
packaging error, the FDA says the first four days of the birth control packet have four
non-hormonal placebo tablets as opposed to the active tablets. This may place
the user at risk for contraceptive failure and unintended pregnancy.
Similarly, Dr. Reddy’s had to recall hundreds of thousands of cartons of a popular acne medicine — Zenatane — manufactured by Cipla’s plant in Pune.
According to FDA enforcement reports, Dr. Reddy’s is recalling 190 lots, consisting of 778,279 cartons of its Zenatane brand isotretinoin capsules, in four dose sizes. The voluntary Class II recall was initiated in late May after the products failed dissolution testing.
During this period of
turmoil, the Indian company which is generating a lot of positive press is Cadila Healthcare.
Cadila’s US
division Zydus Pharmaceuticals’ subsidiary Nesher Pharmaceuticals has received final FDA approval to
market Nystatin Topical Powder, an anti-fungal
antibiotic used to treat skin infections caused by yeast.
There is more good
news from Zydus Cadila. After years of patent battles, the FDA has approved Zydus Cadila’s generic version
of Shire’s ulcerative colitis drug Lialda.
This came as a rude
shock to Shire investors who had believed the US$ 800 million drug was safe for
a few more years. However, there is a chance that instead of a flood of
generics, the Zydus' generic may be the only competition for Lialda for sometime.
Zydus Cadilla has indicated that its version will have a six-month exclusivity.
J&J’s diabetes
drug saves heart at the cost of toes; Sanofi’s insulin slashes hypoglycemia risks for seniors
Would you like to
sacrifice your toes to save yourself from a heart attack? Well, a diabetes drug
made by Johnson & Johnson (J&J), does just that. The drug — Invokana — decreases the risk of heart attacks and strokes, while increasing the risk of amputation,
particularly of toes.
According to the
results of the 10,142-patient study, funded by J&J, for every three heart
attacks, strokes, or cardiovascular deaths prevented by Invokana, there were
two amputations, 71 percent of them of toes or the lower foot.
While this is a setback to J&J, its rivals — Eli Lilly and Boehringer Ingelheim — who make a similar drug called Jardiance, may be cheering the findings of this
study, performed on sodium-glucose co-transporter 2 (SGLT2) inhibitors. These
drugs prevent the kidney from absorbing sugar from the blood.
But scientists are not sure why the drugs would prevent cardiovascular disease, and it’s unclear why one of them would lead to amputations. “It justifies the need to test each medicine,” Harlan Krumholz of Yale University said.
Another study
examining an at-risk population of seniors who
had switched to basal insulin found Sanofi’s Toujeo to outdo its peers at cutting the risk of
hypoglycemia in older patients.
During a six-month follow-up, the study found that amongst the ‘at-risk’ seniors, those taking Toujeo were 57 percent less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s predecessor, Lantus.
Google ties up
with Indian hospital chain for artificial intelligence eye doctor initiative
Google will soon begin
work on a grand experiment that would use machines to widen access of
healthcare. If successful, this initiative will protect millions of diabetes patients
from an eye disease that leads to blindness.
Last year, researchers at Google had said they had trained image recognition algorithms to detect signs of diabetic retinopathy roughly as accurately as human experts. Left untreated, diabetic retinopathy causes blindness. The software examines photos of a patient’s retina to spot tiny aneurisms that would help detect early stages of the disease.
Google is working
with the Aravind Eye Care System in India, a network of eye hospitals, in order
to integrate this technology.
“This kind of blindness is completely preventable, but because people can’t get screened, half suffer vision loss before they’re detected,” Lily Peng, a product manager with the Google Brain AI research group, said. “One of the promises of this technology is being able to make healthcare more accessible.” There are more than 400 million people worldwide with diabetes, including 70 million in India.
FDA tells Endo to
pull out its opioid pain medication, as Gottlieb attacks addiction
Last week, the US FDA
asked drugmaker Endo Pharmaceuticals to remove its powerful opioid pain medication — Opana ER — from the market, due to “the public health consequences of abuse”.
“We are facing an opioid epidemic — a public health crisis — and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Dr. Scott Gottlieb said. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” he added.
Opioid overdoses killed 33,000
Americans in 2015, with half of those involving a prescription opioid.
Opana ER, which is oxymorphone hydrochloride, is used to manage severe pain. The FDA
approved it for this use in 2006. The drug is about twice as powerful as OxyContin, another often abused opioid.
In 2012, Endo
reformulated the drug to make it more resistant to physical and chemical
tampering. While the drug met the standards for approval, FDA says Endo never
showed that the reformulation would reduce abuse.
Amgen loses bid to delay Novartis’ biosimilar; FDA rejects Coherus’ biosimilar for Neulasta
Amgen lost a case in the Supreme Court of the United States that
sought to delay biosimilars of its rivals. Amgen had argued that its biosimilar rivals
should be forced to delay their 180-day marketing notices until the FDA had
made up its mind on the marketing application.
However, on Monday, the Supreme Court took a decision by determining that the law never imposed a two-tier timing system for these notices. Therefore “the applicant may provide notice either before or after receiving FDA approval.”
This has proven to be
a clear win for Sandoz — the generic unit of Novartis that is fielding an array of copycat biologics. The group is launching a copy of Amgen’s Neupogen. And in the process, Sandoz has
unleashed a fresh wave of biosimilars hitting the US market.
However, Amgen won somewhere else — the FDA rejected Coherus Biosciences’ application for a biosimilar of Amgen’s blockbuster Neulasta (a drug that fights infections in cancer
patients). This action effectively delays any rival until 2018, at the
earliest.
The FDA's response
comes as Amgen gears up for biosimilar competition for Neulasta, which
generated about US$ 4.6 billion in sales last year. The FDA requested Coherus
for a re-analysis of certain data and asked the drug developer for more
manufacturing information.
WHO updates list
of essential medicines; groups antibiotics into three categories
Last week, the World
Health Organization (WHO) released its Essential Medicines List (EML), with a
new advice on which antibiotics to use for common infections and which to
preserve for serious circumstances. Amongst the additions to the WHO Model list of essential medicines
for 2017 are medicines for HIV, hepatitis C, tuberculosis and leukaemia.
The EML is used by
many countries to increase access to medicines. The updated list has added 30
drugs for adults and 25 for children, and specifies new uses for 9
already-listed products. In all, it contains 433 drugs deemed essential to
address the most important public health needs.
This time, WHO has grouped antibiotics into three categories – ACCESS, WATCH and RESERVE – with recommendations on when each category should be used.
Initially, the new
categories apply only to antibiotics used to treat 21 of the most common
general infections. If found useful, it could be broadened in future versions
of the EML to apply to drugs to treat other infections.
Antibiotics in the
ACCESS group must be available at all times as treatments for a wide range of
common infections. It includes drugs like amoxicillin, an antibiotic used to treat infections such as
pneumonia.
The WATCH group
includes antibiotics that are recommended as first- or second-choice treatments
for a small number of infections. For example, the use of ciprofloxacin, used to treat cystitis (a type of
urinary tract infection) and upper respiratory tract infections (such as
bacterial sinusitis and bacterial bronchitis), should be dramatically reduced
to avoid further development of resistance.
The third group, RESERVE, includes antibiotics that should be considered as last resorts, such as colistin and some cephalosporins. These must be used
only in the most severe circumstances when all other alternatives have failed.
Impressions: 3373
https://www.pharmacompass.com/radio-compass-blog/j-j-s-diabetes-drug-reduces-heart-risk-at-the-cost-of-toes-google-s-ai-eye-doctor-initiative
#PharmaFlow by PHARMACOMPASS
15 Jun 2017
This
week, Phispers brings you the latest twist in the Singh brothers-Daiichi 2008
Ranbaxy sell-off saga. There is also news on the benefits of new diabetes and
cholesterol drugs to the heart; amendments to drug regulations in Canada; a
class action suit against Sun and Mylan in the US; and the sale of the
controversial DMD drug by Marathon. Read on.
Singhs fight back; say Daiichi’s profits outweigh losses incurred in buying Ranbaxy
Last
year, a Singapore tribunal had ordered the former promoters of Ranbaxy — Malvinder and Shivinder Singh — to pay Daiichi Sankyo US $ 391 million (Rs
25.62 billion) in damages for concealing information regarding wrongdoings at
Ranbaxy. The Singh brothers had sold their majority stake in Ranbaxy to the
Japanese drug maker in 2008 for US$ 4.6 billion.
Last
week, the Singh brothers hit back at Daiichi. The Singh brothers now claim Daiichi has made
profits that far outweigh the losses it incurred in buying Ranbaxy in 2008.
According to a new application filed in the Delhi High Court,
the Singhs claim Daiichi had availed monetary benefits of around US$ 1.2
billion (Rs 80 billion) during the time it
bought and sold Ranbaxy. This amount is
more than twice the damages Daiichi is seeking through its arbitration
enforcement case against the brothers.
The application further states that such monetary benefits
should have been factored in by the Singapore tribunal in assessing the
damages.
According to this new application, Daiichi made further profits from the sale of its
shares in Ranbaxy to Sun Pharma in 2015.
Singhs have appealed in both the Delhi High Court as well as in Singapore. The brothers claim “substantive
objections” exist under India’s arbitration law to make the order unenforceable.
Data-integrity
violations uncovered at USV in India; more violations at Jinan Jinda in China
USV
Private Limited: Another major Indian pharmaceutical company — 55 year-old USV Private Limited — received an FDA warning letter
after shortcomings were uncovered at its finished pharmaceuticals manufacturing
facility in Dabhel (in Daman) during a June 2016 inspection.
While the FDA questioned the practices at USV’s microbiological laboratory and its way of conducting smoke studies, data integrity violations were yet again cited in the warning letter.
According to the warning letter, at USV “all users could delete or modify files” and investigators uncovered six deleted tests on two different equipment. In another instance, where a sample had “failed identity testing”, USV accepted a passing retest result “without any investigation of the failed result”.
The warning letter goes on to mention that the “FDA cited similar CGMP violations at other facilities in USV’s network.”
In the financial year 2015-16, USV’s total income was US$ 388 million (Rs
25.4 billion). USV’s Indian business contributed 82 percent to the revenue and the rest was from export of APIs and finished dosages.
Jinan
Jinda Pharmaceutical:
The US FDA had placed Jinan Jinda Pharmaceutical Chemistry Company Ltd on its Import Alert list in November 2015. An
inspection conducted six months earlier, by the Italian Ministry of Health, had
uncovered an unofficial and non-controlled storage area that contained mainly
raw materials and finished products, and was made inaccessible to the inspectors.
Since the door of the area had been removed and replaced with a panel fixed
with screws to the wall, the inspection team concluded that there was a serious
risk of data falsification.
A
June 2016 inspection by the FDA
uncovered that when an out of specification (OOS) unknown impurity peak was
found during high performance liquid chromatography (HPLC) testing, the
chemists terminated the analysis. When repeat testing also showed the OOS
impurity peak, the chromatogram was manually edited to hide the presence of the
peak. In another case, where seven sample injections were required to test for
impurities, the analysts permanently deleted the first five sample injections
and then renamed the last two injections and reported that they met
specifications.
With repeated concerns of data-integrity, FDA’s warning letter clearly spells out what is expected from the firm going forward. This includes — “a comprehensive investigation into the extent of the inaccuracies in data records and reporting”; and “a current risk assessment of the potential effects of the observed failures on the quality” of drugs manufactured by Jinan Jinda.
The letter states that Jinan Jinda’s assessment should include “analyses of the risks to patients”. It goes on to add that the company’s management strategy should include the details of the company’s “global corrective action and preventive action plan.”
Drug
makers in Canada to publicly disclose drug shortages
Last week, amendments to Canada’s Food and Drug Regulations came into force, making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations. These will now have to be reported to two websites — DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.
The public-facing website of Canada — www.drugshortages.ca — said: “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a shortage on the communications platform.”
According to Health Canada, the posting of discontinuances on the shortages website “does not alter nor affect regulatory obligations under the Food and Drug Act Regulations to inform Health Canada within 30 days of any drug discontinuances.”
Sun,
Mylan face class action suit in US over price fixing of asthma drug
A class action suit was filed in the Pennsylvania federal court last week by the New York grocery workers’ union against Sun Pharmaceutical Industries
and Mylan. The lawsuit alleged that the two companies conspired to raise the price of a generic asthma medicine — Albuterol, or albuterol sulfate tablets.
Albuterol
is a bronchodilator, used by patients suffering from wheezing.
The suit — filed by the United Food and Commercial Workers local unit — stated that Sun and Mylan had raised their prices for albuterol sulfate over 3,000 per cent between October 2013 and April 2014.
“Beginning in May 2013, defendants caused the price of albuterol sulfate to dramatically increase in unison. The increases were the result of an agreement among them to increase pricing and restrain competition for the sale of albuterol sulfate in the US,” the complaint alleged.
The
New York union also filed another suit for similar charges against Mylan and Sandoz for colluding to raise the cost of another generic asthma medicine — Benazepril HCTZ.
New
age diabetes and cholesterol drugs will also protect your heart
There are new drugs that significantly protect your heart, and reduce the risk of death and hospitalization. Take the case of a newer class of type 2 diabetes drugs — known as SGLT-2 inhibitors — that significantly reduce the risk of death and hospitalization for heart failure as compared to other medicines for diabetes. This was brought out by a study sponsored by AstraZeneca.
SGLT-2 inhibitors work by removing blood sugar via the urine. They are sold under various brand names such as AstraZeneca’s Farxiga,
Eli Lilly and Boehringer Ingelheim’s Jardiance and
Johnson & Johnson’s Invokana.
Similar breakthrough was reached by Amgen through its cardio research that highlighted health benefits of its PCSK9 cholesterol drug — Repatha. This drug was studied by Amgen for two years, across 27,564 patients. “Repatha was able to lower a composite of cardio risks by an average of 20 percent. And the improvement increased with time, growing from a 16 percent risk advantage in year one to 25 percent after 12 months,” a news report said.
In 2015, a clinical trial conducted on Eli Lilly and Boehringer Ingelheim’s Jardiance to reassure it does not cause heart problems instead showed it reduced the combined risk of hospitalization for heart failure or death from heart failure by 39 percent in high risk patients. Since then, this heart benefit has been incorporated in Jardiance’s label.
Meanwhile, AstraZeneca is conducting its own large clinical
trials to determine the heart effect of Farxiga. The results of these trials
are expected in 2019.
After
pricing outrage, Marathon sells DMD drug to PTC Therapeutics
After weeks of public and political outrage over the pricing of its Duchenne muscular dystrophy (DMD) drug — Emflaza — Illinois-based Marathon Pharmaceuticals
said it will sell the drug to PTC Therapeutics.
PTC
Therapeutics will pay US $140 million in cash and stock for
Emflaza. Marathon will also receive payments from the New Jersey-based PTC
on sales of the drug, starting in 2018. DMD is a rare genetic disorder
that causes progressive muscle deterioration and weakness.
On February 9 this year, Marathon received FDA approval for
Emflaza (deflazacort), tablets and oral suspension, to treat patients of DMD,
aged five years and older.
Subsequently, Marathon announced it would charge a list
price of US $ 89,000 a year in the United States for Emflaza. Outside the US,
the drug is available for US $ 1,000 a year.
This led to public outrage, and even the FDA — which had approved Emflaza only in February this year — questioned the drug’s approval. This was the first FDA
approval of any corticosteroid to treat DMD and the first approval of
deflazacort for any use in the US.
Impressions: 2312
https://www.pharmacompass.com/radio-compass-blog/singh-bros-hit-back-at-daiichi-in-ranbaxy-case-new-drug-shortages-legislation-in-canada
#PharmaFlow by PHARMACOMPASS
23 Mar 2017
This week, PharmaCompass brings you a compilation of the Drug Master Files (DMFs) updates at the US Food and Drug Administration (FDA) over the past two quarters. These applications provide an overview of the products active pharmaceutical ingredient (API) manufacturers are investing in. And, they also give a sneak preview into the next possible first-to-file (FTF) generic challenges to patented drugs.
Here are some key findings from our compilation of the FDA’s DMF updates over the second and third quarter of 2016, details of which were provided in July and October:
India leads
the pack, as the number of filings remain the same
Over the period, there were a total of 379 updates of DMFs at the FDA. This number
indicates a pace in filings that is nearly the same as the previous quarters.
We had seen 180 DMFs updates in the last quarter (Q4) of 2015 and 190 in the first quarter (Q1) of 2016.
During the last
two quarters, the DMF updates were led by Indian companies, such as Macleods Pharmaceuticals (14 DMFs), MSN Labs (13 DMFs), Hetero
(12 DMFs), Lupin (9 DMFs), Cipla and Biophore. The other prominent companies were Mylan and Teva.
Companies
with compliance issues stay away
Unlike previous
quarters, where
companies with compliance problems continued to submit DMFs, the last two
quarters were slightly different, since companies like Zhejiang Hisun and Ipca
Laboratories did not submit DMFs.
However,
Emcure Pharmaceuticals — whose Pune facility was inspected by
the FDA last year and a warning letter was issued to the company for violations of current good manufacturing practices (cGMPs) in March this year — submitted one DMF (for Phytonadione)
While
China shut down antibiotic manufacturing in the Shijiazhuang
city, raising concerns about the global supply chain’s dependence on China, Sinopharm Weiqida Datong
Pharmaceutical, located about 300 kilometers away from Shijiazhuang, filed DMFs for the key building blocks of antibiotic manufacturing — 6-APA and 7-ACA.
Once
again, this filing reinforces the dependence of global
antibiotic manufacturing on China.
Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!
Imminent FTF challenges
The
FTF challenges to Alvimopan Dihydrate (Merck’s Entereg), Apremilast (Celgene’s Otezla), Bosutinib (Pfizer’s Bosulib), Daclatasvir
Dihydrochloride (Bristol-Myer
Squibb’s Daklinza), Elvitegravir (an ingredient in Gilead’s Vitekta,
Stribild, Genvoya), Ibrutinib (AbbVie’s
Imbruvica), Ospemifene (Shionogi’s Osphena), Perampanel (Eisai’s Fycompa), Pomalidomide (Celgene’s Pomalyst), Regorafenib (Bayer’s Stivarga), Tofacitinib (Pfizer’s Xeljanz) and
Vortioxetine
Hydrobromide (Takeda’s Trintellix) seem to be imminent in
view of the recent filings of DMFs.
Roche’s 2014 acquisition of
InterMune for US $ 8.3 billion to gain rights to Esbriet (pirfenidone)
is likely to come under attack as three more DMFs were submitted during the
period under review.
The ink wasn’t dry on the deal papers of Pfizer’s US $1 4 billion acquisition of Medivation in August this year, when two more companies — Watson Pharma (now Allergan) and Scinopharm — submitted filings for Enzalutamide, the product for
which Pfizer paid all that money. This takes the total number of US submissions
for this product to seven.
Apixaban and Canagliflozin are most actively filed products
The most actively updated DMFs in the past six months were for the APIs of Bristol-Myer Squibb’s new-age anticoagulant Eliquis (Apixaban)
and Johnson & Johnson’s diabetes treatment Invokana (Canagliflozin). Sixteen DMFs were submitted for Apixaban along with nine for
Canagliflozin.
Products
like Dimethyl Fumarate and Teriflunomide — which were the
most frequently filed DMFs in our previous reports — continued to see vigorous filing activity.
Synbias Pharma made a submission
for Nelarabine, the only
submission for a Novartis product that was approved in 2005
and for which the only listed patent is expiring in June 2017. Similarly DSM’s submission of Dexpanthenol is the only DMF
listed for a product used in a variety of injectable and intravenous solution
products.
Established
pharmaceutical companies like Quimica Sintetica and Piramal Healthcare made submissions for products — Benznidazole and Norprostol — which are currently not approved in the United States, indicating the possibility of development projects being underway.
Our view
With drug filings ranging from multiple FTFs to cannabis derivatives,
updates over the two quarters have shown that regardless of the compliance
news, activity in the API industry is extremely robust.
You can view the PharmaCompass compilation of
the new DMF filings by clicking here or simply by sending us an email to get
your own Excel version of the new submissions.
Click here to view all the updates of the second and third quarter of 2016 (Excel version available) for FREE!
Impressions: 4464
https://www.pharmacompass.com/radio-compass-blog/us-dmf-filings-indicate-a-robust-api-industry-with-multiple-first-to-file-challenges
#PharmaFlow by PHARMACOMPASS
08 Dec 2016
This week, the
biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs. But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed
countries to make its drugs and Valeant terminated the salesforce for its female libido pill. Pharmaceutical
Whispers (Phispers) brings you the latest news from across the world. Pfizer-Allergan terminate
merger; Allergan signs licensing deal with HeptaresOn Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate
the deal. Allergan, which is run from New Jersey but has a legal
domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger
would have moved the Pfizer headquarters from New York to Dublin, saving the
pharma behemoth billions of dollars in taxes. As per news reports, Pfizer will need to pay a US $ 400
million fee to Allergan for expenses relating to the deal. Though the US
Treasury decision and the termination of the Pfizer-Allergan deal represents a
victory for President Barack Obama, whose administration proposed tougher rules
aimed at curbing tax inversions, Allergan is not wasting time. Just hours after Allergan backed away from the US $ 160
billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global
rights to a portfolio of drugs for neurological disorders from the UK's
Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans
to barrel ahead with new pacts to bolster the company's pipeline. Pfizer, Celltrion win approval for biosimilar of J&J’s RemicadeNot all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade.
The product will be co-marketed by Pfizer in the United States, a relationship
Pfizer accessed through its acquisition of Hospira last
year. Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug. The European Medicines Agency also issued
a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint
venture between a unit of the Samsung group and Biogen, has
become a force in the biosimilar drugs industry. In fact, South Korea too is
emerging as a hub for biosimilar production. Last week, Bioepis filed a lawsuit
against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales
were US $ 6.5 billion. Glaxo not to patent drugs
in poorer countriesIn an unusual step, GlaxoSmithKline said it wants to make it
easier for manufacturers in the world's 48
least-developed countries to copy its medicines. The company said it would not
file patents in these countries in the hope that by removing the fear of
patent litigation and by allowing independent companies to make and sell
versions of its drugs in those areas, it would widen
public access to these drugs. In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead
has adopted a similar model, of granting
generic licensing agreements in developing countries, for
its blockbuster Hepatitis C treatment, Sovaldi. The end of the female
Viagra?Valeant Pharmaceutical, still reeling from all its
accounting and price-gouging problems, has terminated
the sales force for the female libido pill that it acquired last year for US
$ 1 billion. The drug – Addyi (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report. In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees. Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India
Inspection at Alkem: In July 2015,
the European Union banned the marketing of around 700 generic medicines for alleged
manipulation of clinical trials conducted by India's pharmaceutical
research company GVK Biosciences. And this year, another laboratory is under
the lens of EU regulators.A routine inspection by the European Medicines Agency in
March 2015 of the Department of Bioequivalence of Alkem Laboratories,
a major generic drugs manufacturer in India, raised
concerns regarding study data used to support the marketing authorization
applications of some drugs in the EU. Rusan Pharma back in
news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs). The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices. This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.” Non-compliant
sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s
facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin
from a non-EU GMP compliant source (Hebei
Dongfeng Pharmaceutical Company Limited, China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma. In addition, several documents were found within a pile of
rubble which included an original batch repacking record. A large number of
active substances were manufactured at the site, such as chloramphenicol,
chloramphenicol
palmitate, erythromycin,
erythromycin
ethylsuccinate, roxithromycin,
ciprofloxacin
HCl etc. Catalent’s compliance problems delay OPKO’s new drug launchWith more than 40 manufacturing facilities around the
world, Catalent
is a preferred manufacturing partner for several major pharmaceutical companies
across the world. OPKO Health,
Inc., one of Catalent’s customers submitted its application for RAYALDEE® (calcifediol)
to the FDA. In the complete response letter (CRL) issued to the company, the
FDA indicated observations of
deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval. According
to a news
report, OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25. Meanwhile,
Catalent began production of essential drugs at its French
plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches. Safety warnings for
new age diabetes drugs -- saxagliptin and alogliptin Last
year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2
inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass
had asked the question, “Diabetes: Which new drug is the safest?”. At
the time Merck succeeded in demonstrating
the cardiovascular safety of Januvia®, which was not the case for other
products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin). This
week the FDA issued a
safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the
evaluation of two clinical trials determined that more patients
who received saxagliptin or alogliptin-containing medicines were hospitalized
for heart failure compared to patients who received an inactive treatment
called a placebo. Blockbuster drug
approval expected soon for non-alcoholic fatty liver The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high
likelihood that it will get approved. While the drug is being reviewed for use in patients with
primary biliary cirrhosis, a rare liver disease, late-stage studies are
underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which
has no approved treatment. Obeticholic acid (OCA) is listed as one of the top 10
possible blockbuster drugs by FierceBiotech with an expected
sales in 2020 of US $ 1.6 billion. Gilead is also actively building its liver disease pipeline
and this week, the company paid
US $ 400 million upfront to acquire an early-stage pipeline of liver
disease drugs from privately held Nimbus Therapeutics. Heart-disease science
turns over its headScience is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol. If a drug lowers the bad cholesterol and increases the good
one, the risk of heart disease should reduce significantly. Specialists were stunned by the results of a study
of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.” The drug’s maker, Eli Lilly,
stopped
the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision. As per the study, participants taking the drug saw their LDL
levels fall to an average of 55 milligrams per deciliter from 84. Their HDL
levels rose to an average of 104 mg per deciliter from 46. Yet 256 participants had heart attacks, compared with 255
patients in the group who were taking a placebo. Ninety-two patients taking the
drug had a stroke, compared with 95 in the placebo group. And 434 people taking
the drug died from cardiovascular disease, such as a heart attack or a stroke,
compared with 444 participants who were taking a placebo.
Impressions: 2998
https://www.pharmacompass.com/radio-compass-blog/phispers-pfizer-allergan-end-megamerger-gsk-wants-to-make-copying-its-drugs-easier-more
#PharmaFlow by PHARMACOMPASS
07 Apr 2016
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: 56504
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
PharmaCompass has assessed the second quarter US Drug Master
File (DMFs) filings. In our view, with five potential first-to-file (FTF)
applications along with another five DMFs challenging markets that have been
monopolized for decades, the pharmaceutical industry in the United States
should brace itself for some serious shakeups. Unlike the first
quarter of 2015 where 241 new DMF filings were listed on the USFDA site,
this quarter saw a reduction of almost 35 percent in the DMFs filed. As DMFs
form a critical part of the regulatory submissions made by generics to
challenge innovator companies, a reduction in filings, in the recent quarter,
seems to bear no correlation with the disruption the market will potentially
witness in times to come. The ‘first-to-file’ disruptors Profits in the generic pharmaceutical business are highly dependent on how quickly a drug is introduced in the market. The ‘first-to-file’ generic is a coveted position, since the company is legally granted
a 180-day period of market exclusivity, where no other generic can be in the
market. This six month exclusivity invariably leads to windfall gains for the
company.This quarter DMFs were received by the FDA, which could potentially drive the first-to-file challenges against J&J’s blockbuster Inovkana (canagliflozin), Eisai’s Belviq (lorcaserin
hydrochloride), Incyte’s Jakavi (ruxolitinib
phosphate), Celgene’s Pomalyst (pomalidomide) and Akorn’s Zioptan (tafluprost).However, given the complexities involved in bringing a
generic product to market, the first DMF filing does not always result in the
first generic challenge to the brand drug. The second DMFs filed for a product
are also strong contenders which must not be ignored. For example, Glenmark
recently filed their DMF for tofacitinib,
almost 18 months after serial-DMF filing by MSN
Pharmaceuticals. But Glenmark
has moved ahead by already getting their DMF reviewed by the FDA. Similarly, while Alp Pharma Beijing’s dapagliflozin, Perrigo’s ferric citrate and Amino Chemicals’ miglustat
are the second DMFs to be received by the FDA, the innovator should start
counting the days before they are plagued by generic challengers. Exclusively
not-patentedFor several years, Indian companies have been leading many
first-to-file generic challenges in the United States. However, as they have
scaled up in size, the same companies have also obtained rights to some
exclusive markets in the United States; either through acquisitions or
alliances. Sun Pharmaceutical’s US
$ 230 million acquisition of dermatology specialist Dusa was triggered by the successful sales of Dusa’s photo-chemotherapy treatment, Levulan. German Midas Pharma GmbH’s filing will not only subject Sun’s market domination to generic competition, the fact that there are six other DMFs filed for this product (of which none of the filings have come from Indian or Chinese companies) indicates a change in the way the industry is beginning to operate. Like Sun Pharmaceutical’s monopoly of Levulan, Dr. Reddy’s has enjoyed no competition for their topical treatment, Cloderm (clocortolone
pivalate) since 2011 when they purchased the rights for the product by
making an
upfront payment of US $ 36 million to Canadian, Valeant Pharmaceuticals. Dr. Reddy’s needs to start monitoring the progress of Italian Trifarma’s filing since this is the fifth time a DMF for this product has been received by the FDA.Indian companies aside, Aspen’s Leukeran, Bausch & Lomb’s Zirgan, Mission Pharmaceuticals’ Thiola and GSK’s topical treatment Abreva have
all marketed their products without any competition. The DMF filings of this
quarter indicate that generics have narrowed in on the profits being made and
the market dynamics for these products will change in the future. Down, but not outIntriguingly, companies like Apotex
Pharmachem, Emcure
Pharmaceuticals and Global Calcium
are currently on the FDA Import Alert list and banned from exporting products
to the United States since they did not operate in
conformity with the current good manufacturing practices (GMP's). However, these companies are definitely optimistic about
their future since they have all filed new DMFs this quarter. It remains to be
seen if the bans will get lifted in the near future.This quarter also saw Dr. Reddy’s get creative in their challenge to Japanese Astellas Pharma’s leaky bladder treatment, Myrbetriq (mirabegron).
After having filed a DMF last year, they re-filed again recently, with a
different polymorphic form, to potentially circumvent the patents around this
product. Our supportGeneric pharmaceutical companies are continuously looking
for opportunities where they can get the maximum possible market share in the
fastest way possible. While the number of manufacturers of active pharmaceutical
ingredients (APIs) keep increasing, we are also witnessing an increase in the cost
of regulatory support required to sustain the production of these APIs. The industry is becoming more challenging – identifying target markets is becoming a science which requires high-level management focus. In order to help you, PharmaCompass will share its compilation of this quarter’s DMF filing list. Just send
us an email by clicking here and we’re happy to support you in every possible way.Last week, the FDA also announced the fee dues (as on
October 1, 2015), as per the Generic Drug User Fee Act (GDUFA). We are sharing
the amounts due, in case you have not been able to access this information.
FISCAL YEAR AND FEE TYPE
2014 (Rate)
2015 (Rate)
$ & %
Difference from previous year
Abbreviated New Drug Application
$63,860
$58,730
-$5,130 (-8.0%)
Prior Approval Supplement
$31,930
$29,370
-$2,560 (-8.0%)
Drug Master File
$31,460
$26,720
-$4,740 (-15.1%)
Finished Dosage Form Facility
$220,152 (Domestic)
$247,717 (Domestic)
$27,565 (12.5%)
$235,152 (Foreign)
$262,717 (Foreign)
Active Pharmaceutical Ingredient
Facility
$34,515 (Domestic)
$41,926 (Domestic)
$7,411 (21.5%)
$49,515 (Foreign)
$56,926 (Foreign)
Impressions: 5140
https://www.pharmacompass.com/radio-compass-blog/generic-challenges-the-next-first-to-files-gdufa-dues-fy-2016-and-more
#PharmaFlow by PHARMACOMPASS
13 Aug 2015
Diabetes: Which New Drug is the Safest? FDA Issues Safety Warning on oral Antidiabetic Blockbusters.
Recently launched type 2 diabetes molecules, canagliflozin, dapagliflozin, and empagliflozin, were
served a deadly blow as the FDA recently issued a safety warning regarding their use, leading to a potential life-threatening condition. As almost all diabetes products have some side effect or
the other, we are wondering, which
next generation diabetes drug is the safest?
The recent warning of the U.S. Food and Drug Administration (FDA) says that: “type 2 diabetes medicines canagliflozin, dapagliflozin, and
empagliflozin may lead to ketoacidosis, a
serious condition, where the body produces high levels of blood acids called
ketones, that may require hospitalization”.
The FDA warning
is a severe setback as it limits the options available to reduce
blood sugar without the need for needles.
Ketoacidosis, typically affects type 1 diabetes
patients, but patients using these new molecules were type 2 diabetes and have
developed ketoacidosis. All of the cases highlighted by the FDA involved people
with type 2 diabetes, even if the
condition manifested itself slightly differently than in patients with type 1 diabetes.
These
drugs, are also known as SLGT2 inhibitors. They have been on track for
blockbuster sales and are sold under different brand names.
Table// Brand names for SLGT2 inhibitors (canagliflozin,
dapagliflozin, and empagliflozin):
Company Name
Single Ingredient
Fixed-dose Combination
Johnson & Johnson
Invokana® (canagliflozin)
Invokamet® (canagliflozin and metformin)
AstraZeneca
Farxiga® (dapagliflozin)
Xigduo XR® (dapagliflozin and metformin)
Boehringer
Jardiance® (empagliflozin)
Glyxambi® (empagliflozin and linagliptin)
Blockbuster sales:
Johnson & Johnson, the first to get approval for their SGLT2
inhibitor (canagliflozin) in the United States, reported in 2015 first quarter sales of $278
million, almost triple of their sales for the same period last year.
The quarter-on-quarter growth was almost 40%!
AstraZeneca, on the other hand, had to contend with a dapagliflozin
drug stock out in Canada “due to higher than anticipated demand”.
Actually, the overall sales estimates, for this
class of drugs, have been variable with some analysts believing the annual
sales will be US$2 billion, while others, expect them to reach US$5 billion.
Adverse side
effects:
Despite these success stories, SGLT2 inhibitors have had a bumpy ride in
the approval process with potential cancer risk,
leading to the rejection of the initial dapaglifloxin application by the FDA. This
category of molecules have also been
linked to increased rates of genital and
urinary tract infections, along with kidney damage and cardiovascular issues.
So who will benefit?
All this bad news on SGLT2 drugs could be positive for
another class of anti-diabetic molecules called DPP4 inhibitors.
Merck & Co’s Januvia® (sitagliptin) and Janumet® (sitagliptin and metformin) dominate this category of products with almost $6
billion in 2014 sales. In addition this year, Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was
not the case for other DPP4 inhibitors like AstraZeneca’s Onglyza® (saxagliptin)
and Takeda’s Nesina® (alogliptin).
While Merck’s Januvia has its own set of concerns (there have
been reports of acute pancreatitis), the risks compare
mildly when associated with other new anti-diabetes drugs.
For Takeda’s other diabetes drug, Actos® (pioglitazone), lawsuits related to cancer risks drove
the company to its first annual loss in six decades. They paid a settlement
of $2.4 billion last month.
While Actos® continues to remain on the market, safety concerns will impact the future sales of diabetes medicines, as they all battle one
of the biggest epidemics challenging public health.
Impressions: 4174
https://www.pharmacompass.com/radio-compass-blog/diabetes-which-new-drug-is-the-safest-fda-issues-safety-warning-on-oral-antidiabetic-blockbusters
#PharmaFlow by PHARMACOMPASS
21 May 2015
