Sandoz announces generic Treprostinil Injection now also available for subcutaneous route of administration to treat PAH patients in US

PRINCETON, N.J., May 24, 2021 /PRNewswire/ -- Sandoz today announced Treprostinil Injection, a generic Remodulin^®, is now also available for subcutaneous ("SC") administration to treat patients diagnosed with pulmonary arterial hypertension ("PAH").

Sandoz Treprostinil Injection was the first fully-substitutable AP rated generic version of Remodulin^®* (treprostinil) Injection, sold by United Therapeutics Corporation. Both options for intravenous and SC administration of Sandoz generic Treprostinil Injection are now available at the same specialty pharmacy that dispenses the brand name medicine, and commercialized with Liquidia Corporation (LQDA) ("Liquidia") through a collaboration agreement. Liquidia had previously announced the FDA's 510(k) clearance of the use of a new cartridge with the Smiths Medical's CADD-MS^® 3** pump, which has been used for the SC administration of Remodulin^® for more than 10 years.

"The FDA clearance of a path to bring additional new cartridges required for subcutaneous administration of this medicine means another option for patients who need access to this life-enhancing pulmonary arterial hypertension medicine," said Keren Haruvi, President, Sandoz Inc. "Sandoz has a strong track record for manufacturing high-quality generic medicines and supplying them reliably to the patients who need them."

Since commercial launch two years ago, Sandoz Treprostinil Injection has only been used for intravenous administration. The cartridges required to operate the CADD-MS 3 pump, were not available to patients using generic Treprostinil Injection due to restrictions imposed by other companies. The introduction of the RG 3ml Medication Cartridge has enabled the use of SC administration of Sandoz Treprostinil Injection for the first time.

Scott Moomaw, Liquidia's Senior Vice President of Commercial, said: "We are excited to provide a new option in the parenteral use of Treprostinil Injection. Patients who need and depend on SC administered treprostinil will now, for the first time, have access to a lower cost generic treprostinil. Through our agreement with Sandoz, we will continue to provide the same level of high-touch support and services to our patients, but at a lower cost compared to the branded product."

Sandoz provides patients with their PAH-related support services today.

About 52,000 patients have been diagnosed with PAH in the US,³ with rates expected to rise due to increased survival and diagnosis rates. It is one of five types of pulmonary hypertension (high blood pressure in the lungs). PAH is caused by a narrowing of the arteries that carry blood from the heart to the lungs. This can lead to increased pressure in the blood vessels that deliver blood to the lungs and can also increase the strain on the heart.²

*Remodulin is a registered trademark of United Therapeutics Corporation.
**CADD-MS 3 is a registered trademark of Smiths Medical ASD, Inc.

About Treprostinil Injection
Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration. Treprostinil Injection contains the same active ingredient, same strengths, same dosage form and same inactive ingredients as Remodulin® (treprostinil), and is offered to patients and physicians with the same level of service and support, but at a lower price than the branded drug. Liquidia PAH promotes the appropriate use of Treprostinil Injection for the treatment of PAH in the United States in partnership with its commercial partner, who holds the Abbreviated New Drug Application (ANDA) with the FDA.

Important Safety Information

CONTRAINDICATIONS
None

WARNINGS AND PRECAUTIONS

• Chronic intravenous (IV) infusions delivered using an external infusion pump with an indwelling central venous catheter are associated with the risk of bloodstream infections (BSIs) and sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion is the preferred mode of administration.
• Do not abruptly lower the dose or withdraw dosing.
• Treprostinil Injection may cause symptomatic hypotension.
• Titrate slowly in patients with hepatic or renal insufficiency because such patients will likely be exposed to greater systemic concentrations relative to patients with normal hepatic or renal function.
• Treprostinil Injection inhibits platelet aggregation and increases the risk of bleeding.

ADVERSE REACTIONS

During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g. erythema, induration or rash) were the most common adverse events and occurred in majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and hypotension (14% and 4% respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥3% more than placebo) included headache, diarrhea, jaw pain, edema, vasodilatation, and nausea, and these are generally considered to be related to the pharmacologic effects of treprostinil, whether administered subcutaneously or intravenously. The adverse reactions reported with treprostinil IV included bloodstream infections, arm swelling, paresthesias, hematoma, and pain.

DRUG INTERACTIONS

Treprostinil Injection dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn.

USE IN SPECIFIC POPULATIONS

• Safety and effectiveness of Treprostinil Injection in pediatric patients have not been established.
• It is unknown if geriatric patients respond differently than younger patients. Caution should be used when selecting a dose for geriatric patients.
• There are no adequate and well-controlled studies with Treprostinil Injection in pregnant women.
• It is not known whether Treprostinil Injection is excreted in human milk.

Please see full Prescribing Information for additional safety information.

Indication

Treprostinil Injection is a prostacyclin vasodilator indicated for

• Treatment of pulmonary arterial hypertension (PAH); World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with New York Heart Association (NYHA) Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
• Patients who require transition from epoprostenol to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz
Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.

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References

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