Market Place
In
its continuous endeavor to bolster the competitiveness of the generics
market, the US Food and Drug Administration (FDA) updated its list of ‘off-patent, off-exclusivity drugs without an approved generic’.
The
agency updates this list every six months to improve transparency and to
encourage the development and submission of abbreviated new drug applications
(ANDAs) in markets that have little competition.
The
latest compilation by the FDA, which was published in June, contains 452
entries with 307 classified as Part I (drug products for which FDA could
immediately accept an ANDA without prior discussion), 136 as Part II (drug
products for which ANDA development or approval may raise potential legal,
regulatory, or scientific issues that should be addressed with the Agency prior
to considering submission of an ANDA) and 9 products being added to the Appendix
which indicates one or more ANDAs referencing NDA drug products that have been
approved since the publication of the previous list.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
Injectables make up one-third of the products in June list
A
total of 69 entries, which were present in the December 2019 compilation, are
missing from the recent compilation posted in June 2020, whereas 25 entries
have been added to the December list. The new additions are an outcome of drugs
for which patents and/or exclusivities expired after December 2019. Products
that have been added include the commonly used anti-cancer drug Docetaxel
as well as the peptic ulcer treatment Esomeprazole Magnesium suspension.
Almost one-third of the products in the latest list —158 out of 452 — are drug products delivered as injectables, while there are 83 entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
In
2017, FDA had announced the Drug Competition Action Plan (DCAP)
to encourage robust
and timely market competition for generic drugs and help bring greater
efficiency and transparency to the generic drug review process, without
sacrificing the scientific rigor underlying their generic drug program.
In
February this year, as part of this initiative, the FDA had
approved the first generic of toxoplasmosis drug, Daraprim
(pyrimethamine),
the drug which made ‘pharma bro’ Martin Shkreli infamous in 2015 after he raised the price of the drug, first approved by FDA in 1953, from US$ 17.50 to US$ 750 per tablet.
To date, the FDA has focused its efforts under
the Drug Competition Action Plan on three key areas:
1. Improving the efficiency of the generic drug development, review, and approval process.
2. Maximizing scientific and regulatory clarity with respect to complex generic drugs.
3. Closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
New guidance on CGTs to improve generic competitiveness
In March 2020, FDA had issued the guidance on Competitive Generic Therapies (CGTs). This guidance describes the process
that potential ANDA applicants should follow to request designation of a drug
as a CGT. It also outlines the criteria for designating a drug as a CGT,
provides information on the actions FDA may take to expedite the development
and review of ANDAs for drugs designated as CGTs, and explains how FDA
implements the statutory provisions providing for a 180-day exclusivity period
for certain first approved applicants that submit ANDAs for CGTs.
An
example of the FDA improving generic competitiveness through their various
initiatives is the case of the suspension form of Pfizer’s
Revatio,
which contains the same active ingredient as Viagra (sildenafil)
and is indicated for the treatment of pulmonary arterial hypertension (PAH).
The
drug was first approved in 2012 and generated sales of US$ 227 million in 2018. Since the approval of the first generic in May 2019, there are now seven approved generics of the drug on the US market. As a result, Pfizer reported a 37 percent drop in sales to US$ 144 million in 2019.
View FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics
Impressions: 57849
https://www.pharmacompass.com/radio-compass-blog/usfda-s-list-of-drugs-that-need-generic-alternatives
#PharmaFlow by PHARMACOMPASS
16 Sep 2020
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Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 54752
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
The U.S.
FDA banned drug imports from the finished dosage form operations of Emcure
Pharmaceuticals Ltd over concerns related to their manufacturing practices. As our previous analysis, four months ago, “Quality Alerts at Lupin, Hospira, Emcure and Union Quimico Farmaceutica”, had anticipated the problems at Emcure, we were not at all surprised.Now
that Emcure, a top 20 drug maker in India, joins the growing ranks of companies
with compliance concerns, are there others who are likely to get cited next? “Recalling” Emcure Emcure has been involved in
multiple product recalls in recent times and while no warning letters have been
posted yet, the reason for the product recalls were always, compliance concerns
at Emcure. In February 2015, aseptic and GMP practices at Emcure’s operations had impacted product sterility and Emcure’s customer, Sagent Pharmaceuticals had to recall
their Atracurium Besylate injections. At the same time, lack of
assurance of product sterility was the reason cited by Heritage
Pharmaceuticals (Emcure’s subsidiary in the U.S.) when they recalled their batches of Colistimethate & Rifampin injections. Last year, Teva was forced to recall
almost 40,000 bottles of products manufactured at Emcure because
"laboratory testing was not followed in accordance with GMP
requirements." A ban on $500 million
Emcure will impact U.S. pharmaceuticals Emcure's plant in Hinjawadi in
Pune, India has three finished dosage form facilities which, in our assessment,
are covered by the import alert. Emcure’s strength has been on producing injectable products and now it joins a growing list of sterile manufacturing plants where compliance is a concern. Concerns at sterile manufacturing operations of Hospira, Hikma
Portugal, Bedford
(which is now owned by Hikma) and others will make the import ban on Emcure have
a significant impact on the US pharmaceutical market. It is hence not surprising that eight injectable products, made
at Emcure, have been exempted from the import ban, a position usually taken by
the FDA to prevent drug shortages. Privately held Emcure, with almost
$500 million in sales and which counts private equity
players like Bain Capital among its main investors, clearly has a tough road
ahead. Regulatory overhaul
in IndiaIn order to revive the brand image of the pharmaceutical
industry in India, the government is planning to take several measures, which
includes the overhauling
of CDSCO, the regulatory body for drug quality standards in India.With the Indian regulator planning to undertake a massive
drug inspection exercise, there are chances that now, Indian companies will
encounter many more domestic compliance challenges as well. Warning Bells from
the U.S.Last week, the FDA published
the list of companies who have not paid their GDUFA facility fees. The GDUFA
facility fee is paid annually by generic companies to continue to do business
in the United States. Maybe it is time to wonder, why some companies are not paying the FDA? Especially since some on the list have made recent headlines due to problems in international regulatory inspections…While PharmaCompass covered the compliance issues at Polydrug
Laboratories (India) & IDT Biologika (Germany) recently, there are
others whose regulatory concerns are also available for review in the public
domain. Fleming
Laboratories and Smruthi
Organics, have been on the FDA Import Alert list for quite some time now
and Sharon
Bio-medicine was issued a non-compliance report by the EDQM in 2013. Additional warnings
from across the borderWhile not on the GDUFA payment defaulter list, data
integrity concerns at Chinese API manufacturer, Zhejiang
Hisun have already made Health Canada issue a notice to voluntarily quarantine
drugs, made or tested with API from Hisun. Health Canada’s decision was based on a “trusted regulatory partner” so it would not be surprising if we see similar action from other agencies. Signs of European
trouble In Europe, the EDQM has recently
suspended some CEPs of European manufacturers like Polpharma
(metoprolol tartrate & metoprolol
succinate) and Synteco S.p.A
(articaine
hydrochloride & ropivacaine
hydrochloride). A CEP suspension does not always result in a non-compliance
report, however, there is a high degree of correlation between the two
activities. Our viewWhile compliance issues at some of the companies mentioned above have not yet made headlines, at PharmaCompass, we strive to collate the latest industry developments to provide actionable intelligence so that we can continue to be your “trusted information partner”. After all, like Health Canada,
using real-time information and taking a proactive approach towards compliance,
will always ensure the health of patients and in turn generate better business.
Impressions: 4531
https://www.pharmacompass.com/radio-compass-blog/emcure-s-import-alert-is-there-a-way-of-knowing-who-will-be-next
#PharmaFlow by PHARMACOMPASS
16 Jul 2015
Legally
cultivated cannabis, in some parts of the United States, resulted in a boom,
which could never have been previously imagined. Just last year, there were so
many growers that, in the state of Washington alone, more
than 20,000 kg of marijuana (cannabis) was available, which didn’t have any takers!Last year also saw the stock
market recognize the value of little known, GW
Pharmaceuticals, a UK based company, focused on developing medicines from
marijuana. Their product, Sativex, already
approved in 27 countries is currently awaiting USFDA approval. With Wall Street valuing GW Pharmaceuticals at almost $2
billion, is there a future for marijuana based medicines? Increasing production
of legal marijuanaMarijuana or cannabis, is ‘still’ classified as schedule 1 drug, which means that the Drug Enforcement Agency (DEA), believes there is no currently accepted medical use and the drug isn’t safe to use even under medical supervision. However, with all the research interest, the DEA has proposed a
massive increase in the amount of marijuana production. It will hopefully
allow, that the demands of the researchers will finally be met. Highly
curative?There
are two key active ingredients inside Marijuana, Cannabidiol (CBD) and Tetrahydrocannabinol (THC). While the potency of marijuana is linked to the amount of Tetrahydrocannabinol (THC) inside it, Cannabidiol (CBD) which isn’t responsible for the high, is the one considered to have the wider scope for medical applications. Epidiolex// treatment of epilepsy in
children?An orally-administered liquid
containing CBD has received orphan drug status in the US, under the brand name Epidiolex. GW Pharmaceuticals, the
developer of Epidiolex is also performing their second
Phase III clinical trial to demonstrate its effectiveness in the treatment
of epilepsy in children. Sativex// treatment
of spasticitySativex, a mixture of THC and CBD, is approved for sales in
countries for the treatment of spasticity (muscle spasms and stiffness) related
to multiple sclerosis; a disease that affects 1.3 million people worldwide, of
which up to 80% suffer from spasticity.In addition to THC and CBD, GW
Pharmaceuticals, has also developed a portfolio of products based on the other
cannabinoids found in the plant. Marinol// approved in
1985GW Pharmaceuticals isn’t alone since synthetic derivatives of THC have also been on the market for years. Dronabinol
(brand name: Marinol), approved in 1985 for prevention of nausea and vomiting
during chemotherapy, is estimated to have current sales
of almost $450 million. After the initial launch, the
product also got approval for appetite and weight loss in patients with HIV/AIDS.
The product got reclassified, in
1998 by the DEA, from a Schedule II drug to a Schedule III one which allowed
access to a wider patient base. An open ‘high-way’ for businessInsys
Therapetuics, another player in this space, who had their novel,
more bio-available formulation of Dronabinol rejected by the FDA, still commands a market valuation of almost $3
billion. Plant based medicines, like Paclitaxel,
Docetaxel,
Morphine,
Codeine
have made billions for the pharmaceutical industry in the past and the market
valuations of GW Pharmaceuticals and Insys Therapeutics indicates similar
expectations for developing medicines from marijuana. With many other cannabinoids in the plant, raw material
availability no longer as restricted as in the past, licensing
opportunities on new indications available from the National Institute of Health (NIH)– it is just a matter of who hits the marijuana ‘high-way’ first?
Impressions: 2261
https://www.pharmacompass.com/radio-compass-blog/marijuana-based-medicines-highway-to-pots-of-gold
#PharmaFlow by PHARMACOMPASS
16 Jul 2015
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
Many companies have been actively developing Cabazitaxel (Jevtana Kit®), a prostate cancer drug that belongs to the same class of molecules as off-patent blockbusters Paclitaxel (Taxol®) and Docetaxel (Taxotere®).
Sanofi, the originator, has been struggling with sales of this molecule, as it has never lived up to its blockbuster expectations, with lackluster global sales of 273 million euros in 2014. The major part of the sales, 142 million euros, have been in Europe, where sales showed an increase of 28.2% over the previous year. Sales last year in the United States, on the other hand, grew only 5.8% and were 91 million euros.
Lately, Sanofi received notice when Breckenridge Pharmaceutical, Inc., announced Paragraph IV ANDA litigation (1st generic filing) for Cabazitaxel. The first generic challenge followed the National Health Services’ (NHS) decision in the UK to remove the drug from the Cancer Drugs Fund approved list of medicines, because of its poor cost-effectiveness. Cabazitaxel, most often used after Docetaxel treatment (against cancers) has failed, has been priced at about $5,500 per treatment cycle, which is almost twice the cost of Docetaxel.
With almost 9 companies having filed USDMFs for the different polymorphs of Cabazitaxel and significant development activity on this product in India, as shown by the import-export trade data, it remains to be seen if the investment will provide the anticipated returns, since Sanofi definitely does not seem to be having the same experience.
Impressions: 6082
https://www.pharmacompass.com/radio-compass-blog/cabazitaxel-the-market-overcrowding-begins
#PharmaFlow by PHARMACOMPASS
11 Mar 2015
