Breathing Easier: Pharma Successfully Leveraging Smoother EU Regulatory Specs

Pharma developer Pulmatrix, Inc. [NASDAQ: PULM], partnership with industry giant Mylan [NASDAQ: MYL]

BOSTON, MA, Aug. 11, 2016 /CNW/ - [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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