Ascendis Pharma and Novo Nordisk Announce Global Exclusive License Agreement for TransCon Long-Acting Platform to Develop Metabolic and Cardiovascular Therapies

Nov 05, 2024 10:41 CST Updated 10:41

Ascendis Pharma

Disease Treatment Drug Developer

Novo Nordisk

Insulin Developer and Manufacturer

Breaking News

On November 4, 2024, Ascendis Pharma A/S (Nasdaq: ASND) entered into a collaboration agreement with Novo Nordisk. Under the agreement, Ascendis Pharma A/S will grant Novo Nordisk A/S a global exclusive license to the TransCon technology platform for the development, manufacturing, and commercialization of Novo Nordisk’s proprietary products in metabolic diseases, including obesity and type 2 diabetes, as well as an exclusive license for individual products in cardiovascular diseases.

The agreement includes terms requiring the identification and advancement of certain TransCon technology-based products in metabolic diseases to maintain exclusive rights in this field, as well as additional terms targeting cardiovascular diseases. As a result, Novo Nordisk has also obtained exclusive rights to expand any resulting metabolic disease products into other therapeutic areas.

The lead program in this collaboration is a once-monthly GLP-1 receptor agonist candidate, initially targeting obesity and type 2 diabetes. Under the collaboration, Ascendis Pharma A/S will conduct early development of the TransCon candidate, while Novo Nordisk will be responsible for these early development costs as well as clinical development, regulatory affairs, commercial manufacturing, and commercialization.

Figure 1. Ascendis Pharma A/S News Screenshot

According to the agreement, Ascendis Pharma A/S will receive an upfront payment of up to $285 million, along with development and regulatory milestone payments. Additionally, it is eligible for sales-based milestone payments and tiered royalties on global net sales. For each additional metabolic or cardiovascular disease candidate product, Ascendis Pharma A/S is entitled to receive up to $77.50 million in development and regulatory milestone payments, as well as sales-based milestone payments and tiered royalties on global net sales. The completion of this transaction is subject to regulatory approval, and both parties hope to finalize the deal by the end of the year.

As of 4:00 PM on November 4, 2024, the stock price of Ascendis Pharma A/S was $125.77, with a year-over-year increase of 0.49%.

Figure 2. Stock Quote for Ascendis Pharma A/S on November 4

About the TransCon Technology Platform

TransCon refers to "Transient Conjugation," which can be customized to design Linkers that connect to different parent drugs, transforming them into long-acting formulations administered once a week, once a month, or even once every six months. Through formulation improvements, it enhances the efficacy of disease treatment. A TransCon molecule consists of three parts, namely:

Unmodified Parent Drug

Can be applied in multiple fields such as proteins, peptides, or small molecules, and can modify different prototype drugs into long-acting formulations for once-a-week, once-a-month, or even once-every-six-months application.

Figure 3. Parent Drug

Inert carrier molecules protecting prototype drugs (TransCon Carriers)

It is a self-biodegradable hydrogel that protects drugs through a shielding effect, reducing drug activity to prevent rapid excretion and degradation of the parent drug.

Figure 4. TransCon Carriers

TransCon Linkers

Reversible linkers can transiently bind the parent drug to the carrier. Its release characteristics can be adjusted by modifying the linker structure;

Figure 5. TransCon Linkers

When the three parts mentioned above are combined to form a modified drug, the carrier molecule can keep the parent drug in an inactive state and prevent it from being cleared by the human body. After the modified drug (which can be considered a prodrug) is injected into the body, the active, unmodified parent drug will be released at a specific rate under physiological pH and body temperature, exerting its pharmacological effects on receptors through its original mechanism, while the carrier molecule is cleared through the kidneys.

Figure 6. Mechanism of Action of the TransCon Technology Platform

About Ascendis Pharma A/S

Ascendis Pharma A/S was founded in 2006, with its headquarters located in Copenhagen, Denmark, and went public on Nasdaq in 2015 (Nasdaq: ASND). Ascendis Pharma leverages its innovative TransCon technology platform to develop potential best-in-class therapies, the former having a vast TransCon Linker library. Currently, it focuses on areas such as endocrine rare diseases and oncology. Ascendis Pharma has offices in both Europe and the United States, with a total of 797 employees globally, including 492 engaged in R&D and commercial manufacturing, and 305 in sales and administration.

Currently Ascendis Pharma A/SThe main R&D pipelines are in two major areas: endocrine diseases and cancer. In the field of endocrinology, AscendisPharma A/SThree product candidates in the endocrine rare disease portfolio are under development (TransCon hGH series, TransCon PTH series, and TransCon CNP), with indications including pediatric GHD, adult GHD, Turner syndrome, adult chronic hypothyroidism, and achondroplasia.

In the field of oncology, AscendisPharma A/SClinical development has been initiated for two product candidates: TransCon TLR7/8 Agonist and TransCon IL-2 b/g for systemic administration, which are in clinical Phase II and Phase I, respectively.

Figure 7. Ascendis Pharma A/S Pipeline

Currently, the marketed drug of Ascendis Pharma A/S is Skytrofa® (lonapegsomatropin for injection), which is used to treat growth disorders in children aged one year and above caused by insufficient endogenous growth hormone (GH) secretion. It is administered once weekly via subcutaneous injection and has been approved in the United States and the European Union. In China, Ascendis has partnered with Vivo Capital to establish an innovative biopharmaceutical company, Viptela Pharmaceuticals, granting it exclusive rights to develop, manufacture, and commercialize three endocrine products in Greater China.