SEROSTIM Drug Profile

Summary for Tradename: SEROSTIM

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for SEROSTIM
Recent Clinical Trials:	See clinical trials for SEROSTIM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SEROSTIM

See drug prices for SEROSTIM

Recent Clinical Trials for SEROSTIM

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Rochester	Phase 1
Center for Human Reproduction	Phase 1/Phase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1/Phase 2

See all SEROSTIM clinical trials

Recent Litigation for SEROSTIM

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all SEROSTIM litigation

PTAB Litigation

Petitioner	Date
	2017-05-19

See all SEROSTIM litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SEROSTIM Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SEROSTIM Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for SEROSTIM Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Emd Serono, Inc.	SEROSTIM	somatropin	For Injection	020604	10,016,338	2033-03-11	Patent claims search
Emd Serono, Inc.	SEROSTIM	somatropin	For Injection	020604	10,045,943	2034-11-02	Patent claims search
Emd Serono, Inc.	SEROSTIM	somatropin	For Injection	020604	10,154,856	2033-02-06	Patent claims search

SEROSTIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SEROSTIM

Introduction

SEROSTIM, a recombinant human growth hormone (somatropin), has been a subject of significant interest and controversy, particularly in its application for treating HIV-associated wasting and other conditions. Here, we delve into the market dynamics and financial trajectory of SEROSTIM, highlighting key factors, challenges, and future prospects.

Regulatory Challenges

SEROSTIM has faced substantial regulatory hurdles, especially in the European Union. Despite its approval by the US FDA in 1996 for treating HIV-associated wasting, the drug was not granted marketing authorization by the European Medicines Agency (EMA) due to an unfavorable benefit-to-risk balance[1].

Orphan Drug Designation

SEROSTIM was designated as an orphan drug in the EU for treating AIDS wasting, a rare condition. However, the EMA's Committee for Proprietary Medicinal Products (CPMP) distinguished between orphan drug designation and marketing approval, emphasizing that the criteria for these are different[1].

Market Demand and Growth

The global growth hormone drug market, which includes SEROSTIM, has seen significant growth driven by technological advancements, increasing awareness of growth hormone benefits, and rising healthcare spending. The market is expected to continue growing due to factors such as the increasing prevalence of chronic diseases and advancements in healthcare technology[3].

Financial Implications

The cost of SEROSTIM has been a major barrier to its adoption. Despite not being explicitly mentioned by the CPMP as a reason for non-approval, the high cost remains a significant issue in clinical practice. Cheaper alternatives, such as steroids like nandrolone, are often preferred but may not be readily available to patients who need them[1].

Revenue and Sales

While specific revenue figures for SEROSTIM are not readily available, the broader growth hormone drug market is projected to see steady revenue growth. The increasing demand for growth hormone drugs, driven by factors like precision medicine and home care settings, is expected to contribute to this growth[3].

Competitive Landscape

The global growth hormone drug market is competitive, with various players investing in R&D, partnerships, and acquisitions to gain market share. Companies are focusing on innovative treatments, customer-centric services, and expanding their product portfolios to sustain growth[3].

Clinical Use and Efficacy

SEROSTIM is administered subcutaneously and has shown efficacy in improving work output and lean body mass in patients with HIV-associated wasting. However, it is associated with side effects such as arthralgia, myalgia, and edema, which can lead to dose reductions or discontinuations[4].

Patient Access and Compassionate Use

Serono, the manufacturer of SEROSTIM, has committed to ensuring continued access to the drug for European patients enrolled in clinical trials and compassionate use schemes, despite the EMA's decision not to grant marketing approval[1].

Future Prospects

The future of SEROSTIM hinges on several factors, including regulatory appeals, market demand, and competitive dynamics. Serono may consider appealing the EMA's decision or exploring other markets where the drug could be approved. Additionally, the company might focus on other indications, such as lipodystrophy, which is also under investigation[1].

Impact of Technological Advancements

Technological developments in recombinant human growth hormone drugs are expected to drive market growth. Innovations in delivery methods, such as subcutaneous injections, and improvements in safety profiles could enhance the market position of SEROSTIM and similar drugs[3].

Global Market Outlook

The global growth hormone drug market is segmented by region, with North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa being key markets. The market is expected to grow across all geographies, driven by increasing healthcare spending and the adoption of advanced medical technologies[3].

Conclusion

SEROSTIM's market dynamics are complex, influenced by regulatory challenges, high costs, and competitive market forces. While the drug has shown clinical efficacy, its future success depends on navigating these challenges and capitalizing on growing market demand for growth hormone therapies.

Key Takeaways

• Regulatory Hurdles: SEROSTIM faces significant regulatory challenges, particularly in the EU.
• Market Growth: The global growth hormone drug market is expected to grow driven by technological advancements and increasing healthcare spending.
• Financial Barriers: High costs are a major obstacle to the adoption of SEROSTIM.
• Clinical Efficacy: SEROSTIM has shown efficacy in treating HIV-associated wasting but is associated with side effects.
• Future Prospects: The drug's future depends on regulatory appeals, market demand, and competitive strategies.

FAQs

What is SEROSTIM used for?

SEROSTIM is used for treating HIV-associated wasting, a condition characterized by significant weight loss and muscle wasting in HIV patients.

Why was SEROSTIM not approved by the EMA?

The EMA's Committee for Proprietary Medicinal Products (CPMP) did not approve SEROSTIM due to an unfavorable benefit-to-risk balance, despite its orphan drug designation for treating AIDS wasting.

What are the common side effects of SEROSTIM?

Common side effects include arthralgia, myalgia, edema, carpal tunnel syndrome, elevated glucose levels, and elevated triglyceride levels.

How is SEROSTIM administered?

SEROSTIM is administered subcutaneously, typically once daily at bedtime, with dosages based on body weight.

What is the current market outlook for growth hormone drugs like SEROSTIM?

The global growth hormone drug market is expected to grow steadily, driven by technological advancements, increasing healthcare spending, and the rising prevalence of chronic diseases.

Sources

1. Aidsmap: Controversy plagues HIV wasting drug, Serostim, yet again.
2. Merck KGaA: JPMConf Presentation 2020.
3. BioSpace: Growth Hormone Drug Market Demand 2022-2028.
4. EMD Serono: SEROSTIM (somatropin) for injection, for subcutaneous use.