Market Place
This week, Phispers takes you to the US, where President Trump’s efforts to repeal and replace Obamacare received a setback. There is also news that the EMA has recommended suspending over 300 drugs due to data integrity concerns at a CRO based in Chennai — Micro Therapeutics — along with news on drug makers like Teva, Pfizer and Stada. Read on.
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scrutiny for Pfizer as injectable facility in India comes under FDA lens
Pfizer’s fill/finish manufacturing facility in
the United States recently received a warning letter
from the US Food and Drug Administration (USFDA). In February 2015, Pfizer had
acquired the site in McPherson (Kansas) through its US $17 billion acquisition of Hospira. Pfizer was aware of Hospira's manufacturing record when it struck the
deal, as the company was issued FDA warning letters on four of the seven continents — Europe, North America, Asia and Australia.
Last
week, a Hospira facility in Visakhapatnam in India, set up to manufacture specialty
injectables at an anticipated cost of US $375-450 million, received 11
observations from the US drug regulator. An inspection by the US FDA took place
at the sterile injectables manufacturing unit between March 9 and 17 this year.
An initial audit had taken place
in 2015, during which 14 observations had been found. The company responded to
the observations in March 2015 and submitted additional support documentation
by the end of May 2015.
“The inspection was found to be acceptable following the FDA's review of the company's responses and support documentation. The company has begun limited commercial production at the facility,” the company had said.
The latest list of FDA
observations includes three repeat observations related to air supply, air
sampling and the root cause for microbial contamination.
Last year, Pfizer had to halt production at its Chennai plant, which was also
obtained as part of the Hospira acquisition, due to quality concerns.
EMA
endorses suspending 300 drugs due to clinical data integrity pitfalls
Late
last year, the European Medicines Agency (EMA) had raised data-integrity concerns over another contract research organization (CRO) in India — Chennai-based, Micro Therapeutics Research Labs.
The concerns had regulators reviewing the data of over 300 generic medicines
being sold across Europe.
Last week, the EMA announced it
is recommending the suspension of more than 300 approvals and applications for generic drugs for
which bio-equivalence studies were conducted at Micro Therapeutic
Research Labs.
The review concluded that data from studies conducted at two sites between June 2012 and June 2016 was “unreliable and cannot be accepted as a basis for marketing authorization in the EU.” However, there is no evidence of harm or lack of effectiveness of these medicines.
EMA’s list of drugs it is recommending for suspension covers
just about every EU member state, including Austria, Belgium, Czech Republic,
Denmark, Finland, France, Germany, Greece, Ireland, Italy, Norway, Portugal,
Spain, The Netherlands and the UK.
Generic drugs recommended for suspension
include those being marketed by Novartis’ Sandoz, Sanofi’s
Zentiva, Teva, Aurobindo Pharma and others. It includes dosage forms
containing the active substances bupropion, voriconazole, betahistine, amlodipine/valsartan, tadalafil and naproxen.
Though
not a manufacturing compliance issue, clinical data-integrity has made
headlines recently as labs across India had their data invalidated due to
data-integrity concerns. Clinical trial
falsification issues at the labs of Quest Life Sciences, GVK Biosciences, Alkem Laboratories, Semler Research Center
and now Micro Therapeutics indicate that a sustained supply of generics can no
longer be taken for granted.
Struggling Teva to slash jobs to improve
profitability
Things haven’t been going right for the Israeli generic drug giant Teva for quite sometime now. First, it’s CEO Erez Vigodman left the company. Second, its books were debt-ridden post the acquisition of Allergan Plc in July 2015. Third,
its R&D has not seen a breakthrough in years. And now, Teva is said to be
going in for major layoffs.
The
Israeli newspaper Calcalist reported that Teva is planning to cut 6,000 staffers (or 11 percent of its global workforce) after Passover. The company, however, denied this by saying it won’t layoff thousands. Instead, Teva said it is ending certain activities, consolidating operations and freezing new recruitments.
“The efficiency program is an integral part of Teva’s business reality. The program includes, among other things, ending unprofitable activities and consolidating functions, in addition to freezing recruitment and natural employee turnover,” the company said.
Teva
is also looking for a new CEO to turn around the business after its US $ 40.5 billion acquisition of Allergan’s generic business pushed it into debt.
Trump's plan to repeal and replace Obamacare
suffers a major setback
For
seven years, the Republican Party has pursued repealing Obamacare like an
obsession. But on Friday last, Speaker Paul Ryan and US President Donald Trump withdrew the bill at around 3.30 in the afternoon.
Ryan could not bridge the ideological gap between the center and the far right within the Republican Party. The first presentation of Trumpcare couldn’t pass, as it was not sufficiently hard-hearted for the far-right members of the Freedom Caucus. But Trump and Ryan kept tweaking the bill to appease the hardliners. They even did away with the essential benefit guarantees that health insurance plans in American must now cover. And then the bill lost supporters at the center.
The Bill fell short of around a dozen votes to get a winning
vote count. The Congressional Budget Office had said the bill would deprive 24
million Americans of insurance coverage, while only saving the federal
government US $ 151 billion.
Meanwhile,
Trump sought to spread blame for the failure of his first attempt at replacing Obamacare. He said: “Bad things are going to happen to Obamacare. There's not much you can do to help it”.
On Sunday morning, Trump wrote on Twitter: “Democrats are smiling in DC that the Freedom Caucus, with the help of Club for Growth and Heritage, have saved Planned Parenthood & Obamacare.”
However, latest reports signal that Trump hasn’t given up hope. On Tuesday, he spoke to a “semi-bipartisan” group of Democratic and Republican senators and their spouses in the White House, where he signaled support for another run at a new GOP health care bill. Trump hopes a second
go-around will be more successful.
Stada CEO finds his car bugged amid takeover
talks
Germany’s Manager Magazin reported last week that
the chief executive of German drugmaker Stada — Matthias Wiedenfels — found a bugging device in his car.
Stada
has faced pressure to overhaul its strategy and has also received two takeover
approaches. Wiedenfels, who became the CEO of Stada last summer, also received
anonymous letters containing photographs that depict him in private or
confidential business situations, the magazine said.
The
magazine, which did not cite sources or give information on those behind the
bugging, said the incidents took place in the second half of 2016. Stada,
however, did not comment on this report.
Stada
is the subject of takeover approaches from two private equity consortia. It has
postponed the structured auction to give the bidders a chance to improve their
offers which last valued the company at $3.9 billion.
Over
1,100 drugs in Australia to become cheaper from next month
From
April 1, millions of Australians will benefit from reduced prices of more than 1,100 medicine brands. Vital drugs have been added to Australia’s Pharmaceutical Benefits Scheme (PBS).
The price of drugs used in conditions like high cholesterol, Parkinson’s disease, depression, breast cancer, eczema and psoriasis will cost lesser. For instance, 467,000 Australians using rosuvastatin for high cholesterol
will save 22 percent per script.
According to Australia’s Health Minister Greg Hunt, “sick Australians will save $500 million (US $ 383 million) over four years and up to $200 (US $ 153 million) a year each on the cost of medicines.”
The country also
plans to list new drugs on its PBS. These include drugs for two rare cancers — Hodgkin’s lymphoma, and an advanced type of skin cancer — and treatments for psoriasis, arthritis, schizophrenia and iron deficiency. Hunt said the savings for patients would be "considerable".
Impressions: 2558
https://www.pharmacompass.com/radio-compass-blog/trumpcare-receives-a-blow-ema-to-suspend-300-drugs-due-to-clinical-data-integrity-violations-in-india
#PharmaFlow by PHARMACOMPASS
30 Mar 2017
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Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3086
https://www.pharmacompass.com/radio-compass-blog/dr-reddy-s-expansion-plans-for-api-production
#PharmaFlow by PHARMACOMPASS
03 Apr 2015
