United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System
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`United Therapeutics Announces FDA
`Approval Of Third Generation Nebulizer
`For The Tyvaso® Inhalation System
`
`NEWS PROVIDED BY
`United Therapeutics Corporation
`○
`Oct 23, 2017, 06:00 ET
`
`SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 23, 2017 /PRNewswire/
`-- United Therapeutics Corporation (NASDAQ: UTHR) today announced approval by the
`U.S. Food and Drug Administration (FDA) of a new inhalation device, called the TD-
`300/A, for use with Tyvaso® (treprostinil) Inhalation Solution (Tyvaso).
`
`Tyvaso was originally approved by the FDA for the treatment of pulmonary arterial
`hypertension (PAH) in 2009, under a New Drug Application covering a drug-device
`combination product consisting of Tyvaso drug product, as well as an ultrasonic
`nebulizer and accessories referred to as the Tyvaso Inhalation System. Tyvaso is the
`most-prescribed inhalation therapy for PAH in the United States, and since its launch,
`United Therapeutics has been working on improvements to the Tyvaso Inhalation
`System to aid patient compliance and enhance ease of use.
`
`The TD-300/A is a significant step forward on that front. Designed based on patient and
`physician feedback, the new device has a cleaner, more ergonomic design that
`includes single button operation, an intuitive user interface for adjusting breath counts,
`a color, graphical display that leads patients through the inhalation process and
`displays time since last treatment, and an internal, rechargeable battery. 
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`https://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953....
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`Liquidia's Exhibit 1076
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`United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System
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`"We are extremely proud of this new device, which is just one example of our
`commitment to improving the ease of administration of treprostinil therapy so that
`more patients can benefit from our medicine," said Martine Rothblatt, Ph.D., Chairman
`and Chief Executive Officer of United Therapeutics. "We are not resting on our laurels
`with this device, however. We recently launched a new program to develop a small,
`metered dose inhalation device for treprostinil, and are planning to study the
`administration of inhaled treprostinil on a pro re nata 'as needed' basis, to provide
`more flexibility for patients to use inhaled treprostinil where they need it, when they
`need it. And of course, we are continuing the development of our advanced delivery
`devices for Remodulin®, such as our RemUnity™ subcutaneous pump, and RemoPro™,
`a prodrug formulation of treprostinil."
`
`"Tyvaso is an important element of our continuum of care, which provides a range of
`treprostinil therapy options across a spectrum of PAH patients," said Michael
`Benkowitz, President and Chief Operating Officer. "The launch of the TD-300/A,
`planned for mid-2018, will further optimize Tyvaso therapy for patients and, we believe,
`reduce the rate of therapy discontinuation associated with the current nebulizer."
`
`About Tyvaso
`
`Tyvaso is a prostacyclin vasodilator indicated for the treatment of PAH (WHO Group 1)
`to improve exercise ability. Studies establishing effectiveness included predominately
`patients with New York Heart Association (NYHA) Functional Class III symptoms and
`etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective
`tissue diseases (33%).  The effects diminish over the minimum recommended dosing
`interval of 4 hours; treatment timing can be adjusted for planned activities.
`
`While there are long-term data on use of treprostinil by other routes of administration,
`nearly all controlled clinical experience with inhaled treprostinil has been on a
`background of bosentan (an endothelin receptor antagonist) or sildenafil (a
`phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12
`weeks in duration.
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`https://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953....
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`Liquidia's Exhibit 1076
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`United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System
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`The efficacy of Tyvaso has not been established in patients with significant underlying
`lung disease (such as asthma or chronic obstructive pulmonary disease). Patients with
`acute pulmonary infections should be carefully monitored to detect any worsening of
`lung disease and loss of drug effect.
`
`Tyvaso is a pulmonary and systemic vasodilator. In patients with low systemic arterial
`pressure, Tyvaso may cause symptomatic hypotension.  Tyvaso dosage should be
`titrated slowly in patients with hepatic or renal insufficiency, as exposure to treprostinil
`may be increased in these patients.  Tyvaso inhibits platelet aggregation and increases
`the risk of bleeding.
`
`Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor, such as
`gemfibrozil, may increase exposure to treprostinil. Co-administration of a CYP2C8
`enzyme inducer, such as rifampin, may decrease exposure to treprostinil. Increased
`exposure is likely to increase adverse events, whereas decreased exposure is likely to
`reduce clinical effectiveness.
`
`Co-administration of the CYP2C8 enzyme inhibitor gemfibrozil increases exposure to
`oral treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases
`exposure to oral treprostinil. It is unclear if the safety and efficacy of treprostinil by the
`inhalation route are altered by inhibitors or inducers of CYP2C8. 
`
`Limited case reports of treprostinil use in pregnant women are insufficient to inform a
`drug-associated risk of adverse developmental outcomes.  However, there are risks to
`the mother and the fetus associated with pulmonary arterial hypertension. It is not
`known whether treprostinil is excreted in human milk.
`
`The most common adverse events seen with Tyvaso in ≥4% of PAH patients and more
`than 3% greater than placebo in the placebo-controlled clinical study were cough (54%
`vs 29%), headache (41% vs 23%), throat irritation/ pharyngolaryngeal pain (25% vs 14%),
`nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%).
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`https://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953....
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`Liquidia's Exhibit 1076
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`United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System
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`About United Therapeutics
`
`United Therapeutics Corporation is a biotechnology company focused on the
`development and commercialization of innovative products to address the unmet
`medical needs of patients with chronic and life-threatening conditions. [uthr-g]
`
`Forward-looking Statements
`
`Statements included in this press release that are not historical in nature are "forward-
`looking statements" within the meaning of the Private Securities Litigation Reform Act
`of 1995. Forward-looking statements include, among others, statements regarding the
`timing of the anticipated launch of the TD-300/A device, and its impact on the rate of
`therapy discontinuation for Tyvaso, as well as further research and development efforts
`into new devices for Tyvaso and Remodulin, into a prodrug formulation of treprostinil
`and into the administration of inhaled treprostinil on a pro re nata basis.  These
`forward-looking statements are subject to certain risks and uncertainties, such as those
`described in our periodic and other reports filed with the Securities and Exchange
`Commission that could cause actual results to differ materially from anticipated results.
`Such forward-looking statements are qualified by the cautionary statements,
`cautionary language and risk factors set forth in our periodic reports and documents
`filed with the Securities and Exchange Commission, including our most recent Annual
`Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form
`8-K. We claim the protection of the safe harbor contained in the Private Securities
`Litigation Reform Act of 1995 for forward-looking statements. We are providing this
`information as of October 23, 2017, and assume no obligation to update or revise the
`information contained in this press release whether as a result of new information,
`future events or any other reason.
`
`TYVASO and REMODULIN are registered trademarks of United Therapeutics
`Corporation. REMUNITY and REMOPRO are trademarks of United Therapeutics
`Corporation.
`
`https://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953....
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`Liquidia's Exhibit 1076
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`United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso® Inhalation System
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`SOURCE United Therapeutics Corporation
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`https://www.prnewswire.com/news-releases/united-therapeutics-announces-fda-approval-of-third-generation-nebulizer-for-the-tyvaso-inhalation-system-300540953....
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`Liquidia's Exhibit 1076
`Page 5
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