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.
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https://www.pharmacompass.com/radio-compass-blog/teva-to-market-cannabis-inhaler-fda-makes-quality-metrics-voluntary
#PharmaFlow by PHARMACOMPASS
01 Dec 2016
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Each year,
the US Food and Drug Administration (FDA) approve hundreds
of new medications. A small subset of approvals, classified as novel drugs, are considered to
be truly innovative products that often help advance clinical care.
In 2015, the
FDA approved 45 novel drugs, an all-time record high. PharmaCompass has compiled a list of novel drugs approved by the FDA in 2015.The FDA also approved new dosage forms of existing products in the market (email us if you would like a copy), like the 3D printed version of anti-epilepsy drug, Spritam (Levetiracetam).
This week, PharmaCompass focuses on the new dosage
forms of existing drugs that got approved last year.
Modified blockbusters
Improving the delivery form of a blockbuster drug is something that not only helps patients but often successfully extends the patent life of the cash-generating drugs for Big Pharma. Here are some blockbuster drugs that saw their modified versions being launched in 2015:
Jadenu (deferasirox): With
almost a billion dollars in revenues in 2015, Exjade (deferasirox) was approved in 2005 as a
tablet for use in a suspension. Novartis, the innovator,
got approval in March 2015
for Jadenu, a once-daily oral tablet. Jadenu (deferasirox), a new formulation
of Exjade, is the only once-daily oral tablet for iron chelation. Jadenu has
simplified daily treatment administration for patients with chronic iron
overload.
Nexium
24HR (esomeprazole magnesium): Also
known as the Purple Pill, Nexium – Astra
Zeneca’s blockbuster drug for acid reflux that generated annual sales in America of more than US $ 3 billion – went generic in 2015. In order to extend Nexium’s market, Pfizer and AstraZeneca came together to promote an over-the-counter (OTC) version of Nexium. A capsule version of OTC Nexium was approved in 2014 and is known as
Nexium 24HR. Last year, the FDA granted approval to the tablet form of the
drug.
Iressa
(gefitinib): AstraZeneca re-introduced Iressa in
the US market in 2015. The
FDA had approved Gefitinib in May 2003 for non-small cell lung cancer. Approved
as a third-line therapy, in 2010 the FDA requested AstraZeneca to voluntarily withdraw Iressa tablets
from the market, as post-marketing studies had failed
to verify and confirm clinical benefit. Iressa (gefitinib) is now back in the US as a first-line therapy for a type of lung cancer. However, the patent protection is limited – only one listed patent in the Orange Book which expires next year, and five US Drug Master Files already submitted.
Onivyde (irinotecan): Liposomal formulation of anti-cancer
drugs have been in vogue for some time. Merrimack Pharmaceuticals got its novel encapsulation of Irinotecan in a liposomal formulation approved for the
treatment of patients with metastatic pancreatic cancer, sold under the brand
name Onivyde.
Vivlodex (meloxicam): In October 2015, the FDA approved 5 mg and 10 mg (administered once daily) doses of Vivlodex™ (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID) used for the management of osteoarthritis pain. The previously approved doses for meloxicam capsules were 7.5mg and 15mg. Vivlodex uses a proprietary SoluMatrix Fine Particle Technology™, which contains meloxicam as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
Kalydeco (ivacaftor): A cystic fibrosis drug from Vertex Pharmaceuticals – Kalydeco – has been making headlines
because of its high price (more than US $ 300,000 a year). Price concerns
aside, 2015 saw the launch of a pediatric version of the drug as a ‘weight-based oral granule formulation of Kalydeco that can be mixed in soft foods or liquids’.
Extended release versions
Many of
the approvals granted by the FDA last year were to extended release
formulations (a pill formulated so that the drug is released slowly) of
existing drugs.
Kremers Urban’s
extended release version of Methylphenidate
capsules made headlines last year because of a reclassification of the drug by
the FDA. Under the new classification rating, methylphenidate hydrochloride extended-release tablets can be prescribed but may
not be automatically substituted for J&J’s reference drug Concerta (methylphenidate hydrochloride). Kremers Urban was almost sold last year. But due to this reclassification, investors aborted their US $ 1.53 billion buyout. Kremers Urban was later acquired by Lannett Company Inc.
In
addition, extended-release versions of Aspirin, Carbidopa/Levodopa, Paliperidone Palmitate, Tacrolimus
and Morphine Sulphate also received green signals for a market launch.
First generic opportunities
Last year, PharmaCompass
shared the names of some drugs which had no generic competition and were also
not protected by patents. (Read: “Litigation Free, first generic opportunities list”).
Deferiprone (a drug that chelates iron and is
used to treat iron overload in thalassemia major) met the criteria. But it still
has no generic competitor and is now available as a new dosage form.
Amedra Pharmaceuticals, now owned by Impax Laboratories, has enjoyed the rights to sell Albendazole tablets for almost two decades
without generic competition in the US. Albendazole is a medication used for the
treatment of a variety of parasitic worm infestations. In 2015, patients were
provided access to chewable tablets of Albendazole.
New combinations at work
The FDA also approved
multiple combination drugs where the individual active ingredients had been brought
to market previously.
Most of the combination drugs
approved belong to major pharma players like Novartis, Novo Nordisk, Bristol Myers etc.
Boehringer’s diabetes treatments – Jardiance (empagliflozin) – approved in 2014 and
Tradjenta (linagliptin) approved in 2011, were
combined and the combination drug product Glyxambi was approved in 2015. Another
combination of empagliflozin, with metformin – Synjardy – was also approved in August last
year.
Lesser known companies also
got combination drugs approved. UK-based
development company Vernalis got approval for its cold-cough treatment, Tuzistra XR – an extended release suspension of codeine polistirex and chlorpheniramine
polistirex.
Similarly, US-based biopharmaceutical startup, Spriaso LLC, also
working in the cold and cough therapeutic area, got an extended release tablet
containing codeine phosphate and chlorpheniramine maleate approved.
Symplmed, a company which is
developing various forms of Perindopril, got approval for Prestalia (a
combination of perindopril arginine and amlodipine besylate) for the
treatment of hypertension.
Our view
Each year, the FDA approves several
pharmaceutical drugs in order to improve patient care; and often versions of
these drugs are marketed and distributed across the globe.
PharmaCompass’ list of drugs approved in 2015 is now available – just email us for your copy.
Accelerate your drug development
PharmaCompass has also launched
the Drug Development Assistance tool on its platform.
Simply search for the drug or the active ingredient of your interest, click on the Drug Development icon on the left menu bar and you can see the inactive ingredients used to formulate
the various drug products approved in the United States.
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https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-in-2015-novel-drugs-new-versions-of-existing-drugs
#PharmaFlow by PHARMACOMPASS
14 Jan 2016
