Pharma developer Pulmatrix, Inc. [NASDAQ:PULM], partnership with
industry giant Mylan [NASDAQ:MYL]
BOSTON, MA, Aug. 11, 2016 /PRNewswire/ -
[NASDAQ:PULM]: It's been less than two months since
the Brexit vote, and the fears regarding the UK's departure from
the European Union, and its regulatory body seem to have quelled.
Regardless, business and development in the EU is moving forward as
it did before.
(Photo - http://photos.prnewswire.com/prnh/20160811/397444)
While a majority of Brits indicated that they were unhappy with
the EU's seemingly heavy-handed laws and regulations, it seems that
in some areas the EU is actually a clearer pathway to important
regulatory approvals. In particular, the EU leads the way in
approving new drugs in the field of respiratory research.
Back in January 2010, the European
Medicines Agency (EMEA) launched its Committee for Medicinal
Products for Human Use (CHMP)'s Bioequivalence guidance for
COPD/asthma drugs, which opened doors for several drug developers
to access a first world market for respiratory drugs, without the
costly barriers of the US FDA's seemingly endless trials.
The PK bioequivalence pathway doesn't exist in the USA the way it does in the EU. By utilizing
this route, drug developers can achieve regulatory approval faster
than the US FDA's lengthy approval timeline. This results in
expedited approval in major EU markets, which leads to more rapid
commercialization—a necessary step for many smaller drug developers
with smaller pockets than their industry giant peers.
Pharma developer Pulmatrix, Inc. [NASDAQ:PULM], through a
partnership with industry giant Mylan [NASDAQ:MYL], is seizing upon
this EU opportunity with PUR0200, a bronchodilator believed to be
using the same active ingredient as BI's Spiriva in order to treat
chronic obstructive pulmonary disease (COPD).
For a junior pharma the size of Pulmatrix, the EU's PK
bioequivalence pathway is the most sensible direction. While its
collaborator on PUR0200, Mylan, has deep enough pockets to get
approvals anywhere in the world, Pulmatrix and its market cap of
just under $30 million has a beacon
of hope in the form of the EU regulatory body.
But it's best not to let Pulmatrix's size fool you, as it has
garnered interest from more than just Mylan in the past.
Where Pulmatrix excels is in its patented delivery method,
iSPERSE, which came out of company R&D for the US military to
develop an aerosol product to stave off contagions.
This novel dry powder method has been found to have several
benefits, including a steep reduction in required dosages.
According to its inventor, iSPERSE can deliver 3x more drug per
inhalation than traditional technologies. Much of this can be
attributed to it being far easier to breathe in, thus giving a
significant advantage with patients with compromised lung
function.
Pulmatrix's PUR0200 has already demonstrated some of these
advantages clinically in COPD patients by showing that Pulmatrix's
formula can deliver a matching effective dose of the active
ingredient, while only utilizing 20% of the drug. The end result of
the dosing for the lungs is identical to that of Spiriva, but with
less drug required and reduced ingestion by swallow.
"We've demonstrated that we can use on average up to 80% less of
the drug, and still achieve the exact same dosing directly to the
lungs," says William Duke Jr., CFO
of Pulmatrix.
"Any time that you can use less of the active ingredient, it's
better for the body."
Spiriva's listed side effects include sore throat, cough, dry
mouth, and respiratory tract and sinus infections. For those
suffering with COPD, any relief from that list of side effects is
seen as worthy of hope and praise.
It's not unreasonable to expect that Mylan will indeed move
forward based on the recently announced positive data on clinical
PK Bioequivalence in a 7-way crossover study of PUR0200. With the
successful results from the PUR0200 testing in hand, the clock is
now ticking on Mylan, which has 6 months to exercise its option on
the drug which includes all rights for it outside of the US.
The market in sales for the once daily bronchodilator predecessor
product is $2 billion in the EU and
$5 billion globally. Pulmatrix
retains the US rights and is in active conversations about
partnering those as well.
This formula for success has already worked for Mylan, as it
recently was successful in developing a substitutable generic
version of Advair. Now Mylan is awaiting a verdict from the FDA by
March 28 of next year regarding
USA approval for their
product.
"When we put this offer out to bid, and there were a number of
different pharma companies who wanted to engage and come to the
table," says Duke.
"One of the reasons we were excited to work with Mylan is
because they've had previous success in the EU with this PK
bioequivalence proof pathway, with a form of Advair."
It's likely that Pulmatrix will also look to take an expedited
approach for EU and US approval for another drug in development,
PUR1900, which is an anti-fungal medication designed to aid
subjects afflicted with cystic fibrosis (CF) as well as severe
asthmatics. Since PUR1900 is a reformulation of an approved oral
anti-fungal medication—intended to make a better version of the
drug while improving safety and tolerability—the company can follow
505(b)2 development requirements.
"Right now there's nothing on the market by way of an inhaled
anti-fungal medication," says Duke.
"For fungal infections of people with severe lung disease, the
only course of therapy right now that's being marketed is oral
dosing. The issue with the oral dosing is that it does work
but with challenging therapeutic threshold margins, and it comes
with a lot of side effects. As a result, patients end up not
necessarily fully adhering to the course of therapy because of the
side effect profile or worse yet having a recurrence of
infection."
With some added revenue possibilities coming from PUR0200, and
an affordable EU pathway as an option, there's a possibility that
Pulmatrix can go it alone on PUR1900, at least in the earlier
stages.
An early market analysis focusing solely on CF patients, pegged
an inhaled anti-fungal treatment netting peak sales of $250 million per year. However, by adding in the
potential treatment of asthma sufferers, suddenly PUR1900 looks
like a potential blockbuster product.
The last time a developer was this close to an inhalable
anti-fungal was Nektar Therapeutics [NASDAQ:NKTR] prior to selling
its respiratory portfolio to Novartis AG [NYSE:NVS] back in October
of 2008, when the antifungal program was shelved.
As Pulmatrix, and other junior pharma companies like it press
on, look for more development to come in this space, and more
relief for those in need of this kind of breath of fresh air.
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