Market Place
This week, Phispers brings you news on J&J’s plans to acquire Actelion and Teva’s new medical cannabis inhaler due for launch in Israel. There are pharma deals from across the globe, such as Roche’s decision to sell its South Carolina plant and Catalent’s acquisition of Accucaps.M&A Compass: Roche sells API plant; Catalent laps up
Accucaps; Teva
announces layoffsSwiss drug maker Roche is selling its
active pharmaceutical ingredients (API) plant in South Carolina (US) to Patheon NV, a
leading global provider of high-quality drug development and delivery solutions
to the pharmaceutical and biopharma sectors. The deal will save 200 jobs in South Carolina. Patheon has also
entered into a multi-year supply arrangement with Roche. Meanwhile, Catalent, Inc has acquired Accucaps Industries Limited, a Canada-based developer and manufacturer of over-the-counter (OTC), high potency and conventional pharmaceutical softgels. The acquisition is subject to approval by the Canadian government. It will substantially complement Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity.While Patheon and Catalent are making acquisitions, Teva
announced layoffs, and Pfizer cancelled its expansion plans in Ireland. Two
ministers of Malta announced that Teva
Pharmaceutical Industries will be laying off over 200 workers before the end of 2017.
Earlier this year, Teva had acquired Actavis Generics and recently informed the government of its decision to start “consolidating production” around its 30 plants in Europe and that it would also lay off workers in Malta.Meanwhile, Pfizer has cancelled a planned US $ 425 million
expansion of its Grange Castle plant in Dublin, a development which would have
led to permanent employment for 350 people and 1,250 jobs during construction.Pfizer is one of Ireland’s largest private sector employers. It had sought permission earlier this year for a major extension to the plant. However, the plans have been shelved due to failure of a high-profile, late-stage pipeline drug to lower cholesterol.Teva to market medical
cannabis inhaler in Israel
For the first time, the medical cannabis sector managed to comply with the pharmaceutical standards for inhalation. Israel’s Teva Pharmaceuticals has partnered with Tel Aviv-based Syqe Medical to market medical cannabis in Israel for pain management. The dose is administered with the help of an inhaler — the most efficient means of administering cannabis.Teva will be the exclusive marketer and distributor of the inhaler in Israel. The inhaler, which is pending approval from Israel’s ministry of health, will be available for home use.J&J approaches Actelion for acquisition; Actelion says no
guarantee of the deal
Last week, Switzerland’s leading biopharmaceutical company — Actelion Ltd — confirmed that it has been approached by the US healthcare titan Johnson & Johnson for a possible takeover. Actelion is focused on the
discovery, development and commercialization of innovative drugs, and is a
leader in the field of pulmonary arterial hypertension (PAH).However, Actelion said there is no guarantee of the deal. Actelion chief executive Jean-Paul Clozel desires
to keep the company independent after building it from scratch. And news
reports say J&J will have to pay a steep premium if a takeover is to
succeed.Actelion's rare-disease focus makes it an attractive target,
since its drugs face less price pressure than other more widely used medicines.
There are other reasons why the takeover looks improbable. First, Actelion’s market capitalization far outstrips its net present value. Second, President-elect Donald Trump’s proposed repatriation holiday may come in the way of J&J making the acquisition.Drugs in India fail quality standards; Vietnam bans major
Indian manufacturersThis was a bad week for Indian pharma. Drug regulators of seven
Indian states alleged that 27 medicines — sold by 18 major drug companies — are of “substandard” quality. These were cited with false labelling, wrong quantity of ingredients, discoloration, moisture formation, failing dissolution test and failing disintegration test.The tests on the 27 medicines were done by drug regulators of
Maharashtra, Karnataka, West Bengal, Goa, Gujarat, Kerala and Andhra Pradesh.
The drug makers include Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma, Alkem Labs, Cadila Healthcare, Emcure Pharma, Hetero Labs, Morepen Labs, Macleods Pharma, Wockhardt Pharma and Zydus Healthcare.The drug brands alleged to be substandard are: antipsychotic drug
Stemetil
and antibiotic drug Pentids
from Abbott India, anti-bacterial medicine Althrocin
by Alembic Pharma, migraine medication Vasograin by Cadila Pharma, cough syrup Ascoril by Glenmark Pharma, worm infection drug Zentel
by GSK India, arthritis medication Hydroxychloroquine
(HCQS) by Ipca Labs, anti-inflammatory medication Myoril
by Sanofi Synthelabo, and Torrent Pharma’s hypertension drug Dilzem.In Parliament, the minister of state for health said that drugs,
which are banned in other countries, have been allowed to be sold in India subject to
certain provisions. The drugs which have been allowed in India are nimesulide, analgin and pioglitazone. What was worse, Vietnam blacklisted 39 Indian drug companies,
including Aurobindo Pharma, Cadila and Macleods Pharmaceuticals for
quality standard violations. The Vietnamese drug regulator has also banned
companies in Bangladesh and South Korea. The regulator has listed the names of
blacklisted companies on its website.FDA’s quality metrics programme to be voluntary till 2018Last week, the US Food and Drug Administration (FDA) released a revised version of its proposal to
collect quality metrics data from drug manufacturers in response to protests
from the industry.As per the revised draft, the program will begin with a voluntary
phase that will run into 2018, after which the FDA intends to make the program mandatory.The revised draft guidance also narrows the scope of the program by
cutting the number of metrics the agency plans to ask for. It also grants more
flexibility with quality metrics to drug companies that are reporting by both
product and site."The revised draft guidance includes the following changes
from the earlier draft guidance: Adoption of a phased-in (voluntary) approach,
reduction in the number of data elements requested (i.e., reduction in
reporting burden), support for both product reports and site reports,
modifications to the quality metrics data definitions, addition of clarifying
examples for the definitions, addition of comment fields, and clarification of
special considerations for non-application and OTC (over-the-counter) product
reporting," the FDA said.EMA publishes results of two more clinical studiesThe European Medicines Agency (EMA) has published clinical data for two more medicines — Armisarte and Caspofungin — on its clinical data website. The clinical data website was launched on October 20, 2016, when the EMA had added clinical data for Kyprolis
and Zurampic.
The website is in line with the EMA’s policy on the publication of clinical data.Armisarte,
a hybrid product (a product that is similar to its reference product but is
available in a different pharmaceutical form), is indicated for the treatment
of malignant pleural mesothelioma lung cancer and advanced non-small-cell lung
cancer.Caspofungin Accord, a generic product, is indicated for the
treatment of invasive candidiasis, invasive aspergillosis and other fungal
infections when the patient is febrile and neutropenic.Pharmaceuticals most counterfeited category, says reportA new report cites pharmaceuticals as the most targeted category for
counterfeiting. Globalization and the booming use of the internet is giving a
boost to counterfeiting.The report has been launched by online brand protection firm, NetNames. Titled The Risks of
the Online Counterfeit Community, the report looks at online
counterfeiting. It warns that no brand can afford to underestimate the
sophistication of fraudsters in the digital world.The size of the counterfeit market for pharmaceuticals is
estimated at US $ 200 billion, followed by electronics (US $ 169 billion) and
food (US $ 49 billion). According to NetNames, one in six products bought online is fake. And one-third
of all counterfeit seizures in the EU are linked to internet distribution
channels.According to NetNames, there are up to 50,000 internet pharmacies
in operation. Around 95 per cent of
these do not comply with laws and industry standards. Meanwhile, 90 per cent of
drugs purchased online come from a different country than what the website
claims. According to the report, the internet provides counterfeiters
with anonymity, virtually no barriers to entry, low overheads, easier
distribution with more frequent, smaller consignments sent by mail, and fewer
risks of being caught. And the desire by consumers to seek out big brands
online at discount prices, is providing counterfeiters with a ready target
audience and the opportunity to further the fraudsters' reach and potential
profitability.Trump announces Tom Price as health secretaryThis week, America’s President-elect Donald Trump announced Republican US Representative Tom Price as his Health and Human Services
Secretary. Price is an orthopedic surgeon from Georgia.Seema Verma, the founder of a health policy consulting company,
will lead the Centres for Medicare and Medicaid Services, which is part of
Health and Human Services (HHS).Meanwhile, Trump is expected to name Steven Mnuchin, a former Goldman Sachs partner and Hollywood financier, as his nominee for the post of Treasury Secretary. Mnuchin, who spent 17 years at Goldman Sachs before leaving in 2002 to launch a hedge fund, served as Trump's campaign finance chairman. Billionaire investor Wilbur Ross, known for his investments in distressed industries, is expected to be named Commerce Secretary.
Impressions: 3282
https://www.pharmacompass.com/radio-compass-blog/teva-to-market-cannabis-inhaler-fda-makes-quality-metrics-voluntary
#PharmaFlow by PHARMACOMPASS
01 Dec 2016
Share
With Novartis shutting two plants in Germany and one in India by 2016-end, the global reliance on China for bulk drugs has increased even further, raising serious concerns over safety, supplies and national security. Which
plants? Last week, Novartis announced it will be shutting three plants of its generic business – Sandoz – by the end of 2016. The first plant is in India and the other two are located in Germany, in Gerlingen and Frankfurt. Frankfurt,
manufacturer of a key antibiotic intermediateThe Frankfurt plant is where Sandoz manufactures
7-ACA
(7-aminocephalosporanic acid), the core chemical structure (building block)
for producing a whole host of cephalosporin antibiotics. The reason given for closure -- prices of the cephalosporin active pharmaceutical ingredients (APIs) and intermediates have collapsed as Asian competitors have dumped excess capacity on the market. The shutdown of the Frankfurt facility
means that the global reliance on China for APIs, used to produce antibiotics
(such as cephalosporin) and especially
7-ACA, will increase only further. Chinese
APIs are already a security threat for India India produces a third of the world's
medicines, mostly in the form of generic drugs. However, according to an Oct 2014 report
by a Boston Consulting Group (BCG) and Confederation of Indian Industry (CII), more
than 90 percent of the key raw materials (intermediates and APIs) that go into
making at least 15-odd essential drugs come from China.The drugs listed include the most commonly used painkiller such as paracetamol, aspirin; antibiotics such as amoxicillin and ampicillin, cephalexin, cefaclor, ciprofloxacin, ofloxacin, levofloxacin; first line diabetes drug metformin; and antacid ranitidine. There are no domestic producers left for many drugs such as penicillin-G, and its derivative 6-aminopenicillanic acid, or 6-APA.Since India is still receiving a large quantity of 7-ACA from Germany (confirmed by the import statistics available on the PharmaCompass database), 7-ACA and its derivatives were not mentioned in this report.As per news reports, the Indian government
is now worried about over-dependence on imports from China. "Any
deterioration in relationship with China can potentially result in severe
shortages in the supply of essential drugs to the country. Additionally, China
could easily increase prices of some of these drugs where it enjoys virtual
monopoly," said Bart Janssens, partner, BCG, in a news
report published in The Economic Times. Recognizing the national healthcare
security challenge facing India, the Department of Pharmaceuticals (DoP) has
decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients.’ As part of this initiative, the Indian government intends
to build
cluster parks to boost India’s self-reliance on Chinese imports. Quality,
environmental concerns over Chinese AntibioticsChinese supplies of 7-ACA have been plagued
with multiple issues in the past. In 2012, for instance, several Chinese drug
companies were accused of manufacturing 7-ACA using contaminated ‘gutter oil’, instead of more
expensive soybean oil. Gutter oil is reprocessed oil manufactured from waste oil and animal fat collected from restaurants’ fryers, drains, grease traps and slaughterhouses. Chinese restaurants can get through a lot of cooking oil and this waste oil fuels a highly profitable gutter oil black market as there are few other outlets, such as biofuel production, for this by-product.Similarly, antibiotic pollution in the rivers of China is a serious cause of concern for the Chinese. Our previous analysis, “Antibiotic
resistant superbugs: deadlier than cancer and closer to you than you think” provides a detailed overview regarding the challenge being faced. However, with growing focus on antibiotic pollution in China, a shutdown of factories failing pollution norms would be a severe setback for the global antibiotic supply chain. In addition to these challenges, quality concerns have been raised during international regulatory inspections of some of the leading antibiotic producers in China, like Zhuhai
United and North
China Pharmaceutical Company. South
African stock outs of essential drugs a global concernThe outcomes of these challenges are already being felt in countries such as South Africa which are facing an acute shortage of critical drugs. According to a report
published in Groundup, drug shortages in South Africa’s health facilities have become a crisis. The story mentioned the situation in a hospital (Stanger Hospital) in Ilembe District KwaZulu Natal, where 200 products were out of stock. These included various doses of morphine, some antibiotics and antiretrovirals, especially paediatric ones, used to treat HIV. “About a hundred patients per week are going without ranitidine which prevents stomach ulcers. Several Ilembe facilities are even out of stock of paracetamol tablets,” the Groundup report said. There are multiple reasons for the drug stock
outs. However, unprofitability because old, off-patent products are being sold by
manufacturers at prices very close to the cost of production has played a major
role. Firms are abandoning such products and seeking higher return
alternatives. In addition, due to quality failures suppliers are unable to provide lifesaving medications to the South African population. Our
ViewThe problems of stock outs and quality concerns in South Africa can easily expand across the world and can’t be addressed until the global pharmaceutical industry reduces its reliance on China for bulk drugs and intermediates. It remains to be seen if the threat to the global supply chain will make Novartis reconsider its decision or drive a national government to buy the Frankfurt facility.
Impressions: 7491
https://www.pharmacompass.com/radio-compass-blog/novartis-plant-shut-down-creates-urgency-to-find-alternatives-to-chinese-apis
#PharmaFlow by PHARMACOMPASS
30 Jul 2015
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
