Sandoz exclusively launches treprostinil injection, the first generic version of Remodulin®, in the US

PRINCETON, N.J., March 25, 2019 /PRNewswire/ -- Sandoz today announced the US availability of Treprostinil Injection, the first fully substitutable AP rated generic version of Remodulin®* (treprostinil) Injection, sold by United Therapeutics Corporation, including 180 days of marketing exclusivity for the product.

Treprostinil is indicated for Pulmonary Arterial Hypertension (PAH); World Health Organization (WHO) Group 1 to diminish symptoms associated with exercise. PAH is a progressive disease, resulting in heart failure and shortened life expectancy. About 52,000 patients have been diagnosed with PAH in the US, with rates expected to rise due to increased survival and diagnosis rates1.

"Pulmonary Arterial Hypertension is a rare disease that primarily affects women, many in their 30s and 40s, and can have a significant impact on their quality of life as it worsens over time," said Carol Lynch, President of Sandoz Inc. "At Sandoz, we believe in reimagining the care of patients by bringing complex generics, like treprostinil, to US patients and providing access to cost-effective, high-quality medicines."

Sandoz will collaborate with RareGen, LLC to commercialize Treprostinil Injection, which is supplied in 20 mL multi-dose vials in four strengths – containing 20 mg, 50 mg, 100 mg, or 200 mg (1 mg/mL, 2.5 mg/mL, 5 mg/mL or 10 mg/mL). RareGen, LLC is backed by PBM Capital Group; PBM Capital Group is a healthcare investor and operator.

According to United Therapeutics Corporation FY 2018 results, global sales for Treprostinil were approximately USD 599 million in 20182.

Important Safety Information

CONTRAINDICATIONS
None.

WARNINGS AND PRECAUTIONS (Serious Side Effects)

  • Continuous intravenous (IV) infusion of Treprostinil Injection can be delivered via an external infusion pump using a tube placed in a big blood vessel (central vein) within the chest. Intravenous delivery is associated with the risk of bloodstream infections and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion delivered just beneath the skin is the preferred method of delivery.
  • You should not stop or change your Treprostinil Injection dose without consulting your doctor first, as this may cause your PAH symptoms to worsen.
  • In some cases, your blood pressure may become too low. If you also take other drugs that lower your blood pressure, the risk is increased. You should discuss all of your symptoms with your doctor, including those associated with low blood pressure.
  • If you have liver or kidney problems, your ability to tolerate Treprostinil Injection may be affected.
  • Because Treprostinil Injection can reduce the blood's ability to clot, it may increase your risk of bleeding, especially if you are taking anticoagulants (blood thinners).
  • If you are pregnant, or planning to become pregnant, you should consult with your physician as it is not known if treprostinil will harm your unborn baby or if Treprostinil Injection passes into your breast milk.
  • Other medical conditions and medicines may affect your use of Treprostinil Injection by increasing the risk of side effects or decreasing the drug's effectiveness. It is important to tell your doctor about your medical conditions and any medicines you may be taking.

ADVERSE REACTIONS
During clinical trials with SC infusion of treprostinil, infusion site pain and infusion site reaction (e.g., redness of the skin, hardness of the skin, or rash) were the most common adverse events and occurred in the majority of those treated with treprostinil. Infusion site reactions were sometimes severe and led to discontinuation of treatment. Rash and low blood pressure (4% and 14% respectively) were also commonly reported with SC infusion of treprostinil. Other common adverse events (≥9% of patients in the treprostinil arm) with either SC or IV treprostinil included headache, diarrhea, jaw pain, edema (swelling), vasodilatation (widening of the blood vessels), and nausea. The adverse reactions with treprostinil IV included bloodstream infections, arm swelling, tingling or prickling sensation, bruising, and pain.

DRUG INTERACTIONS
If you are taking gemfibrozil (for high cholesterol), rifampin (for infection), or other drugs that affect liver enzymes, your doctor may need to adjust your Treprostinil Injection dosage.

USE IN SPECIFIC POPULATIONS
If you are pregnant, planning to become pregnant, or breast-feeding, talk with your doctor about whether you should use Treprostinil Injection.

Full prescribing information is available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c80bb38-e8db-4138-9f0d-dbbf9c673185

INDICATION
Treprostinil Injection is a prescription medication used in adults with pulmonary arterial hypertension (PAH); World Health Organization (WHO) Group 1 to reduce symptoms associated with exercise. PAH is high blood pressure in the arteries of your lungs. Treprostinil was studied mainly in patients with New York Heart Association (NYHA) Functional Class II-IV symptoms.

In people with PAH who need to switch from epoprostenol sodium, Treprostinil Injection is approved to slow the worsening of symptoms. The risks and benefits of each drug should be carefully considered before switching.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 labelling in any market, or at any particular time. 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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; 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 and a pioneer in the emerging field of prescription digital therapeutics. Our purpose is to pioneer access to healthcare by developing and commercializing novel, affordable approaches that address unmet medical need. Our broad portfolio of high-quality medicines, covering all major therapeutic areas and increasingly focused on value-adding differentiated medicines, accounted for 2018 sales of USD 9.9 billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

Sandoz is on Twitter. Sign up to follow @Sandoz global at http://twitter.com/Sandoz_Global.

*Remodulin is a registered trademark of United Therapeutics Corporation.

1 Source: DataMonitor (2016).
2 Source: United Therapeutics Corporation 2018 Annual Financial Results.

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