SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Nov. 20, 2017 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for Adcirca(®) (tadalafil) tablets through May 21, 2018, based on study results submitted by Eli Lilly and Company (Lilly) in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy.

United Therapeutics markets and sells Adcirca for treatment of pulmonary arterial hypertension (PAH) in the United States under a license agreement with Lilly. A U.S. patent for Adcirca will expire November 21, 2017, and FDA's decision provides an additional six months of regulatory exclusivity running from this date, providing an additional six months before FDA can approve a generic version of Adcirca.

Under a previously-announced amendment to its license agreement with Lilly, effective December 1, 2017, United Therapeutics' royalty rate on net product sales of Adcirca will increase from five percent to ten percent, and the company will also be required to make milestone payments to Lilly equal to $325,000 for each $1,000,000 in net product sales.

Because the data submitted by Lilly to FDA does not include PAH patients, United Therapeutics does not anticipate any resulting expansion of the indication for Adcirca to include pediatric patients.

About Adcirca

Adcirca is a phosphodiesterase 5 inhibitor (PDE5i) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with New York Heart Association Functional Class II - III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Important Safety Information for Adcirca

CONTRAINDICATIONS


    --  Nitrates and Guanylate Cyclase (GC) Stimulators: Do not use Adcirca in
        patients taking medicines that contain nitrates or guanylate cyclase
        stimulators (such as riociguat), as the combination could cause a
        sudden, unsafe drop in blood pressure
    --  Hypersensitivity Reactions: Patients with a known serious
        hypersensitivity to tadalafil should not take Adcirca

WARNINGS AND PRECAUTIONS


    --  Cardiovascular: Patients who experience anginal chest pain after taking
        Adcirca should seek immediate medical attention
    --  Cardiovascular: PDE-5is, including tadalafil, have mild systemic
        vasodilatory properties that may result in transient decreases in blood
        pressure. Before prescribing Adcirca, physicians should carefully
        consider whether their patients with underlying cardiovascular disease
        could be adversely affected by such actions. Pulmonary vasodilators may
        significantly worsen the cardiovascular status of patients with
        pulmonary veno-occlusive disease (PVOD) and administration of Adcirca to
        these patients is not recommended
    --  Cardiovascular: The use of Adcirca with alpha blockers, blood pressure
        medications, or alcohol may lower blood pressure significantly and may
        lead to symptomatic hypotension (light-headedness or fainting)
    --  Potential Drug Interactions: Tadalafil is metabolized predominately by
        CYP3A in the liver. Use of Adcirca with potent CYP3A inhibitors, such as
        ketoconazole and itraconazole, should be avoided. For patients on
        Adcirca therapy that require treatment with ritonavir, Adcirca should be
        discontinued at least 24 hours prior to starting ritonavir. For patients
        on ritonavir therapy that require treatment with Adcirca, start Adcirca
        at 20 mg once a day. Use of Adcirca with potent inducers of CYP3A, such
        as rifampin, should be avoided
    --  Special Populations: The use of Adcirca is not recommended for patients
        with severe renal or hepatic impairment. Please see Full Prescribing
        Information for dosing recommendations for patients with mild to
        moderate renal or hepatic impairment
    --  Potential Drug Interactions: Adcirca contains the same ingredient
        (tadalafil) as Cialis®, which is used to treat erectile dysfunction
        (ED) and the signs and symptoms of benign prostatic hyperplasia (BPH).
        The safety and efficacy of combinations of Adcirca with Cialis or other
        PDE-5is have not been studied. Therefore, the use of such combinations
        is not recommended
    --  Vision/Hearing: Patients who experience a sudden loss of vision in one
        or both eyes, which could be a sign of non-arteritic anterior ischemic
        optic neuropathy (NAION), or sudden decrease or loss of hearing after
        taking Adcirca should seek immediate medical attention.
    --  Prolonged Erection: In rare instances, men taking PDE-5is (including
        tadalafil) for ED reported an erection lasting more than four hours.
        Male patients who experience a prolonged erection should seek immediate
        medical attention

ADVERSE REACTIONS


    --  Adverse Reactions: The most common adverse event with Adcirca is
        headache (42% Adcirca vs 15% placebo). Other common adverse events
        (reported by >=9% of patients on Adcirca and more frequent than placebo
        by 2%) include myalgia (14% vs 4%), nasopharyngitis (13% vs 7%),
        flushing (13% vs 2%), respiratory tract infection (13% vs 6%), extremity
        pain (11% vs 2%), nausea (11% vs 6%), back pain (10% vs 6%), dyspepsia
        (10% vs 2%), and nasal congestion (9% vs 1%)

For more information about Adcirca, please see the full prescribing information available at www.adcirca.com, or call 1-800-545-5979.

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 generic competition for Adcirca. 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 November 20, 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.

ADCIRCA is a registered trademark of Eli Lilly and Company.

View original content:http://www.prnewswire.com/news-releases/united-therapeutics-announces-additional-six-months-of-regulatory-exclusivity-for-adcirca-300559136.html

SOURCE United Therapeutics Corporation