"We are thrilled to enter into this license agreement with Ascendis Pharma," said
"Pre-clinical studies in multiple animal models with a lead compound of TransCon-linked treprostinil have already produced encouraging results, demonstrating a sustained release profile supportive of once-daily injection. The application of TransCon technology to treprostinil may also minimize injection site pain and reactions that frequently occur with continuously infused subcutaneous Remodulin," commented
Under the terms of the agreement,
About Ascendis Pharma and TransCon
Ascendis Pharma A/S is an emerging specialty pharmaceutical company which creates improved, patentable versions of marketed drugs. The company is headquartered in
Ascendis Pharma's prodrug technology platform, TransCon, is a proprietary technology enabling transient conjugation of peptides, proteins and small molecules to various carriers. The technology utilizes Ascendis Pharma's proprietary TransCon Linker families, which are a diverse group of structures with inherent self-cleaving properties, making drug release independent of enzyme activity and tissue conditions. Ascendis Pharma's transient conjugation is designed to release drug in the body in a precise, time-controlled fashion, thus creating a long-acting effect for the original unmodified drug.
About Remodulin (treprostinil) Injection
Remodulin is a prostacyclin vasodilator indicated in
In patients with PAH requiring transition from Flolan® (epoprostenol sodium), Remodulin is indicated to diminish the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.
Important Safety Information
Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections, or BSI, and sepsis, which may be fatal. Therefore, continuous subcutaneous infusion is the preferred mode of administration.
Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH. Remodulin is a potent pulmonary and systemic vasodilator. It lowers blood pressure, which may be further lowered by other drugs that also reduce blood pressure. Remodulin inhibits platelet aggregation and therefore, may increase the risk of bleeding, particularly in patients on anticoagulants. Remodulin dosage adjustment may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. Initiation of Remodulin must be performed in a setting with adequate personnel and equipment for physiological monitoring and emergency care. Therapy with Remodulin may be used for prolonged periods, and the patient's ability to administer Remodulin and care for an infusion system should be carefully considered.
Remodulin dosage should be increased for lack of improvement in, or worsening of, symptoms and it should be decreased for excessive pharmacologic effects or for unacceptable infusion site symptoms.
Abrupt withdrawal or sudden large reductions in dosage of Remodulin may result in worsening of PAH symptoms and should be avoided. Caution should be used in patients with hepatic or renal insufficiency.
The most common side effects of Remodulin included those related to the method of infusion. For subcutaneous infusion, infusion site pain and infusion site reaction (redness and swelling) occurred in the majority of patients. These symptoms were often severe and could lead to treatment with narcotics or discontinuation of Remodulin. For intravenous infusion, line infections, sepsis, arm swelling, tingling sensations, bruising, and pain were most common. General side effects ( > 5% more than placebo) were diarrhea, jaw pain, vasodilatation and edema.
For full prescribing information for Remodulin in
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 future commercial and development plans for treprostinil using Ascendis Pharma's TransCon technology and the potential benefits to patients. These forward-looking statements are subject to certain risks and uncertainties and are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the
REMODULIN is a registered trademark of
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