Market Place
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
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Recently, FDA approved therapies to reduce double chin
(yes it’s possible!) and treat patients with bile
acid synthesis disorders through compounds derived from bile acids.
Bile, that bitter, alkaline liquid secreted by livers, has
formed the base for producing Cholic Acid and Deoxycholic Acid, which led to
the recent approvals:
Kythera Pharamceutical’s ATX-101
(Deoxycholic Acid, DCA) injection for submental fat (double chin) and
AskLepion’s CHOLBAM
(Cholic Acid, CA) capsules for the treatment of bile acid synthesis due to
single enzyme defects.
Kythera modified the age old French
practice of mesotherapy (non-surgical
cosmetic medicine treatment), where the combination of
deoxycholic acid and phosphatidylcholine is used to reduce fat by demonstrating
that dexoxycholic acid alone can get the job done. While the combination is
used in mesotherapy, studies have demonstrated that phosphatidylcholine has a limited role in fat reduction, so Kythera’s science doesn’t exactly qualify as revolutionary.
Kythera’s ability to navigate the complex regulatory landscape (they won a unanimous approval 17-0 from the FDA Advisory Committee) seems well worth it as ATX-101’s sales potential of $300 million makes Kythera a potential
takeover target for larger pharmaceutical companies.
The two approvals is a resurgence for bile acid salts
since Cholic Acid has been used for decades to produce Ursodiol
(Ursodeoxycholic Acid), a treatment for gallstones with pharma majors like
Sanofi and Roche having manufactured the active ingredient in the past.
There is more to come in the story of bile
acid salts as they form the base for breakthrough treatments for Nonalcoholic Steatohepatitis (NASH)
- a serious chronic liver disease
which can lead to cirrhosis, eventual liver failure and death.
There are currently no drugs approved
for the treatment of NASH and recent epidemiological studies estimate that more
than 10% of the U.S. adult population has NASH, with more than 60% of patients
(potentially more than 14 million in total) have liver fibrosis, or cirrhosis,
due to progression of the disease.
Intercept Pharmaceuticals, with its modified bile acid
Obeticholic Acid (OCA), has been assigned Breakthrough Therapy status by the
FDA. The effectiveness of Obeticholic Acid and size of the patient population
explains why Intercept has been a darling of the stock market through 2014,
especially as the product is expected to gain approval later this year. Expected
sales
estimates of the potential blockbuster range between $2-4 billion and
explain the $6 billion stock market valuation.
Further upstream, Israel based, Galmed Pharmaceuticals has a compound in Phase IIb clinical trials which couples Cholic Acid with the commonly available fatty acid, Arachidic Acid for the same indication as Obeticholic Acid. After Gilead’s recent
purchase of Phenex Pharmaceuticals for $470 million to get access to their
NASH compound, the potential upside of NASH compounds is HUGE!
We already have established molecule classes like Statins, Sartans & Tinibs, maybe it’s time to get work started on "Cholic chemistry”!
Search our database for Cholic Acid
and Deoxycholic
Acid to find suppliers, pricing information and a lot more…
Impressions: 5616
https://www.pharmacompass.com/radio-compass-blog/move-over-statins-sartans-tinibs-it-s-time-for-cholic-chemistry
#PharmaFlow by PHARMACOMPASS
26 Mar 2015
