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
https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues
#PharmaFlow by PHARMACOMPASS
29 Apr 2020
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This week, Phispers tells us why David Hung’s taking charge as CEO of Axovant could signal the revival of an Alzheimer’s compound shelved by GSK. While, the FDA has extended compliance date for submitting DMFs in electronic format, there are also indications that there will be more FDA inspections in India. Plus, there is news on companies like Fresenius, Stada, Ajanta Pharma, Merck and Teva. Read on.
FDA
extends compliance date for electronic DMF submissions to May, 2018
On April
7, the US Food and Drug Administration (FDA) announced it is extending the compliance date for submitting DMFs in Electronic Common Technical Document (eCTD)
format to May 5, 2018.
“DMF submissions that are not submitted in eCTD format after this date will be rejected,” the FDA website said.
“Presentations on submitting in eCTD format created prior to April 7, 2017 will have the incorrect compliance date for DMFs,” it added. Electronic submissions of Drug Master Files (DMFs) were supposed to become mandatory from May 5, 2017.
The
news coincides with the US Senate’s confirmation hearing for Scott Gottlieb, on April 7. Gottlieb was President Trump’s nominee to be the next Commissioner of the FDA.
Gottlieb was with the FDA when the regulator launched its Pharmaceutical cGMPs for the 21st Century initiative. Out of five guidance documents
listed as part of this initiative, only one has been finalized.
With
Gottlieb heading back, Ajaz Hussain, (former FDA deputy office director and
president of the National Institute for Pharmaceutical Technology and
Education of NIPTE), Vadim Gurvich (executive
director of NIPTE) and Peter J. Pitts (president of the Center for Medicine in
the Public Interest and a former FDA associate commissioner) shared their
perspective on how Trump and the FDA can create a pharmaceutical manufacturing renaissance in a blog posted on Morning Consult.
Axovant appoints new CEO and revives ghosts of GSK’s billion dollar mistake
After
selling Medivation to Pfizer for US $ 14 billion and
exiting with US $ 354 million for himself, David Hung is now the CEO of Axovant, the company which we wrote about two years ago, as we asked the question — Did a 29-year old show GSK that it made a billion dollar mistake?
Back in December 2014,Vivek Ramaswamy, CEO and Founder of Roivant Neurosciences and Axovant, had bought an old Alzheimer’s drug that GSK had dropped for US $ 5 million. In October 2014, Roivant had spun off a subsidiary by the name of Axovant, which then bought the GSK drug. GSK had shelved the compound — 5HT6 — after testing it in 13 trials and on 1,250 patients.
Six months after purchasing the compound from GSK, and
without doing any clinical development, the drug resulted in the biggest
biotech IPO ever for Axovant, which got valued at US $ 2 billion. Since then,
Ramaswamy has been setting up more companies.
Throughout, Ramaswamy has recruited high-profile executives to run his companies. And who could be more high profile than Hung? The stock market cheered his appointment — Axovant’s stock was up 28 percent
earlier this week after Hung was announced its CEO.
Axovant is looking for positive data that GSK had gathered for its 5HT6 Alzheimer’s drug. And a number of senior players in the industry say Axovant has a decent shot at taking the successful dose back into the clinic. With Hung joining, it seems the drug discarded by GSK does indeed have merit.
Fresenius
in talks to buy Akorn; Stada sold for US $5.6 billion
Fresenius SE said
it is in talks to buy US generic drugmaker - Akorn Inc.
Though discussions are underway, there is no certainty of a deal, Fresenius
said. A spokeswoman for Akorn
declined to comment.
The CEO of Fresenius, Stephan Sturm, who took charge in July 2016, has been expanding the group’s global reach through acquisitions. Last year, the company bought Spanish hospital group IDC Salud Holding SLU, also known as Quironsalud, for US $ 6.11 billion (Euro 5.76 billion) in the company’s largest-ever acquisition.
Akorn could complement Fresenius’ Kabi medicines division, which specializes in intravenous drugs, and accounts for about a fifth of the company’s revenue.
Stada sell-off: Stada Arzneimittel AG has been sold to Bain Capital and Cinven for US
$ 5.6 billion (Euros 5.3 billion), after
a long-fought takeover contest. The sell-off will give the equity firms
control of one of the last independent generic-drug businesses in Europe.
The
deal would give buyers access to German and Russian markets for OTC and copycat
medicines. It marks another step in the consolidation of the generics
industry.
FDA inspections in India to rise, says Edelweiss Securities
India’s pharmaceutical sector is the largest supplier of drugs to the US. However, “quality issues are an ongoing challenge for the Indian pharmaceutical industry,” Mary Lou Valdez, FDA’s associate commissioner for international programs wrote in a blog.
Of the 42 warning letters sent out by FDA’s office of manufacturing quality last year, about one-fifth (9) were addressed to Indian facilities. The number could rise over the next three years as the FDA would inspect 190 facilities that it could not inspect in the past five years, wrote Edelweiss Securities.
FDA inspections in India and China have doubled since 2012.
This has led to a spurt in warning letters as well.
GSK to withdraw 600,000 inhalers; no observations for Ajanta
GSK would be voluntarily recalling close to 600,000 Ventolin asthma
inhalers across the US, says the FDA. The recall is due to a leak observed in
some of the products.
The exact number of inhalers to be recalled, as reported by the FDA, is 593,088. These were produced in GSK’s Zebulon, North Carolina manufacturing facility. This is the second time in just over a year that the plant has faced problems with leaking inhalers.
Ajanta Pharma: On Monday this week,
shares of India-based Ajanta Pharma soared by over
5 percent in intraday trading as investors cheered the fact that no observations were issued during a regulatory
inspection at its unit.
“Our formulation facility at Dahej (in Gujarat) was inspected by US Food and Drug Administration (FDA) from April 3 to April 7, 2017. At the end of the inspection, no Form 483 was issued to us,” Ajanta Pharma said in a notification to the stock exchanges.
FDA delivers a blow to Merck’s Januvia marketing plan
In 2015, Merck had come out with a massive 14,724-patient study where the data demonstrated that Type 2 diabetes patients could take its flagship DPP-4 drug — Januvia — without increasing their risk for cardio complications. DPP-4 inhibitors work by blocking the action of DPP-4, an enzyme which destroys the hormone incretin.
Merck wanted to use the
findings of this survey in a label to help distinguish themselves from
same-class rivals like Onglyza, which has risks.
However, the FDA recently nixed the idea, handing the pharma giant a complete response letter
(CRL).
The CRL covered Merck’s blockbuster Januvia as well as its combos with metformin. However, Merck says it
is reviewing the letter and will discuss next steps with the FDA.
Teva’s US $ 3.5 billion buy pays off with FDA approval of Austedo
Last week, the FDA gave its nod for Teva’s promising drug deutetrabenazine, after
putting it on hold ten months back due to certain suspicions regarding some
metabolites found in patients.
Teva had paid US $ 3.5
billion to acquire Auspex two years back. Teva’s deutetrabenazine is the
first deuterated drug to bag
an FDA approval.
A
deuterated drug is a drug where hydrogen has
been replaced by deuterium. A simple swap of six hydrogens with deuterium in an existing drug, Xenazine® (tetrabenzaine), resulted in an improved version of the drug, called deutetrabenzaine
or SD-809 (which had been developed by Auspex).
The
drug will be sold as Austedo. Due to the presence of deuterium, the drug breaks down more slowly in patients. This way physicians can give the drug less
often and at lower doses and still manage great results. The drug is designed
to regulate the levels of dopamine in
the brain.
Impressions: 3020
https://www.pharmacompass.com/radio-compass-blog/ghosts-of-gsk-s-billion-dollar-mistake-return-new-date-for-electronic-submissions-of-dmfs
#PharmaFlow by PHARMACOMPASS
13 Apr 2017
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
Africa represents the last geographic frontier where high growth is still achievable. Over the past two decades, Africa has emerged from a troubled history to become one of the world’s fastest growing economic regions, states a McKinsey report (Africa: A continent of opportunity for pharma and patients). A
quick glimpse of the gold mine in AfricaAfrica has one of the highest number of notified cases for diseases like AIDS and tuberculosis (TB), which provides sizable opportunities for the industry given the enormous size of the patient population. The South African government has plans of scaling
the number of people getting treatment for AIDS from
3 million to 4.6 million by the end of 2016. In December 2014, the government issued an $860
million tender for supply of AIDS drugs and only
four companies were the main beneficiaries! The African’s growthAfrica’s GDP (Growth Domestic Product), already the size of Russia’s, has a working age population, which is already 30% more than that of Europe and the size is expected to double in the next five years. Africa’s pharmaceutical economy has been forecasted to grow at an estimated 9.8% compounded growth when compared with 2% for the United States and 1% for Japan. While the size of the African pharmaceutical economy is significantly smaller than established markets, by 2020 the total size is expected to be between $44 billion and $66 billion.Although Africa is a big continent, McKinsey
simplifies life by suggesting that companies should focus on specific countries,
as more than 2/3 of the African growth has come from just 10 out of 54
countries. - Africa’s top 10: Algeria, Egypt, Kenya, Ivory Coast, Libya, Morocco, Nigeria, South Africa, Sudan, and Tunisia.In addition, the strong support of
governments advocating the use of generic drugs, along with physicians and
pharmacists getting used to prescribing generics, has the industry booming. The
generic business in Algeria and Morocco is forecasted to grow at a minimum growth
rate of 22%. Africa?
How does one get started?South Africa is currently embroiled in an
ongoing political crisis caused by severe drug
shortages. Lifesaving drugs for AIDS and TB along with common antibiotics
like benzyl
penicillin, heart medicine digoxin,
anti-asthma salbutamol
inhalers, anti-epileptic sodium
valproate, vaccines etc., have all encountered shortages.“The shortages at district hospitals have forced doctors to give medication to some patients, leaving others to suffer in agony. Paracetamol, a very basic painkiller, is also in short supply.”, reported news channel,
News24.With over 150
product lines in shortage, the South African government has taken radical
measures like flying
in 20 key medicines, accelerating the approval process and automatically allowing registration of suppliers who are WHO prequalified to overcome the 15 month approval timeline for drug applications. South African regulators will continue to inspect all
local and some international API sites despite relaxing facility assessment
rules last week. Our ViewConcerns
raised by the South African media, regarding API sourcing
constraints, delays in formulation manufacturing or managing changing product
demand can easily be addressed if the pharmaceutical industry decides to
develop their African business.However, not everything will be smooth
sailing since Africa faces challenges of civil unrest, dependency
of countries on oil prices, concerns over non-payment of bills and outbreaks of
epidemics like Ebola. McKinsey also
states that talent is scarce and finding a reliable local partner is critical
to success.Concerns aside, companies like Aspen, Hikma, Mylan, Cipla
Medpro, have already made significant inroads into the African market. While India’s Cipla envisions a billion
dollars from Africa by 2024 and Canada’s Valeant is in advanced talks to acquire Egyptian drugmaker, Amoun
Pharmaceutical Co. for about $700-800 million, the African opportunity has already started getting attention.For those on the sidelines, a lists of
products currently in shortage, is available
online and the only question is who bets bigger on Africa first!
Impressions: 2577
https://www.pharmacompass.com/radio-compass-blog/plan-an-african-safari-to-discover-the-world-s-fastest-growing-pharmaceutical-opportunity
#PharmaFlow by PHARMACOMPASS
18 Jun 2015
