Mecasermin rinfabate - Biologic Drug Details

Summary for mecasermin rinfabate

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 mecasermin rinfabate Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Mecasermin rinfabate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Mecasermin Rinfabate

Overview of Mecasermin Rinfabate

Mecasermin rinfabate, marketed under the trade name iPlex, is a biologic drug consisting of a recombinant complex of insulin-like growth factor 1 (IGF-1) and its binding protein, IGFBP-3. This drug is designed to mimic the natural growth factor complex found in the human body, making it a crucial treatment for various growth disorders[3][5].

Development and Approval

Mecasermin rinfabate was developed by Celtrix using proprietary recombinant protein production technology and later acquired by Insmed Pharmaceuticals. The drug has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of severe primary IGF deficiency and for patients with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone[1][5].

Clinical Uses and Efficacy

The primary indication for mecasermin rinfabate is the treatment of severe growth disorders, particularly those resulting from growth hormone insensitivity syndrome (GHIS), also known as Laron syndrome. Clinical studies have shown that mecasermin rinfabate significantly increases growth velocity in children with these conditions. For instance, a prospective, open-label multicenter study demonstrated that patients treated with mecasermin rinfabate experienced a notable increase in annualized height velocity compared to pre-treatment levels[2][3].

Safety and Side Effects

One of the key advantages of mecasermin rinfabate is its reduced risk of acute adverse events, particularly hypoglycemia, which is commonly associated with the administration of unbound recombinant human IGF-1. By forming a complex with IGFBP-3, mecasermin rinfabate prolongs the half-life of IGF-1, thereby mitigating these adverse effects[1][5].

Market Size and Potential

The market size for mecasermin rinfabate is influenced by the prevalence of the conditions it treats. Given that GHIS and severe primary IGF deficiency are rare conditions, the market is relatively niche. However, the drug's potential extends beyond these primary indications, with ongoing research into its use for other serious medical conditions such as amyotrophic lateral sclerosis (ALS), major surgery, organ damage, traumatic injury, cachexia, and severe burn trauma[3][5].

Financial Trajectory

Initial Market Entry and Pricing

Upon its initial market entry, mecasermin rinfabate faced a competitive landscape within the human growth hormone market. The pricing strategy for biologic drugs like mecasermin rinfabate is complex and influenced by various factors, including regulatory approvals, patent protections, and the presence of follow-on biologics (FOBs)[4].

Revenue and Market Share

Despite its efficacy, mecasermin rinfabate's market share has been limited due to several factors. The drug's availability for short stature related indications was restricted due to a patent settlement, which impacted its revenue potential. However, ongoing clinical trials and potential approvals for additional indications could revitalize its financial trajectory[5].

Funding and Grants

Insmed Pharmaceuticals has received significant funding to support the development and clinical trials of mecasermin rinfabate. For example, the company received a $6.5 million grant from the US National Institutes of Health (NIH) and the Muscular Dystrophy Association (MDA) to investigate the drug's efficacy in treating myotonic dystrophy[3].

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of biologic drugs. The approval process for mecasermin rinfabate involved extensive clinical trials and regulatory filings. Changes in regulatory policies, such as those related to FOBs, can significantly impact the market dynamics and financial performance of biologic drugs[4].

Competition from Follow-On Biologics

The entry of FOBs into the market can affect the pricing and market share of innovator biologics like mecasermin rinfabate. However, the extent of this impact is generally lower for biologics compared to conventional generic drugs due to high fixed costs of entry, limited perceived substitutability, and other market barriers[4].

Future Prospects

Mecasermin rinfabate is being studied for several serious medical conditions beyond its primary indications. For instance, it is being investigated as a treatment for ALS and has been made available in Italy for this condition. These potential new uses could expand its market and improve its financial outlook[3][5].

"Mecasermin rinfabate also has potential as replacement therapy for IGF-I, which may become depleted in indications such as major surgery, organ damage/failure, traumatic injury, cachexia and severe burn trauma. It also has potential for the treatment of osteoporosis."[3]

Key Takeaways

• Clinical Efficacy: Mecasermin rinfabate is effective in treating severe growth disorders, particularly GHIS and severe primary IGF deficiency.
• Safety Profile: It reduces the risk of acute adverse events like hypoglycemia by prolonging the half-life of IGF-1.
• Market Potential: The drug has a niche market but potential for expansion into other serious medical conditions.
• Financial Trajectory: Limited by patent settlements and competitive market dynamics, but supported by grants and potential new indications.
• Regulatory Environment: Influenced by regulatory policies and the presence of FOBs.

FAQs

What is mecasermin rinfabate used for?

Mecasermin rinfabate is primarily used for the treatment of severe primary IGF deficiency and growth hormone gene deletion in patients who have developed neutralizing antibodies to growth hormone.

How does mecasermin rinfabate differ from other IGF-1 treatments?

Mecasermin rinfabate forms a complex with IGFBP-3, which prolongs the half-life of IGF-1 and reduces the risk of acute adverse events like hypoglycemia.

What are the potential new uses of mecasermin rinfabate?

Mecasermin rinfabate is being studied for various conditions including ALS, major surgery, organ damage, traumatic injury, cachexia, severe burn trauma, and osteoporosis.

Why is mecasermin rinfabate not widely available for short stature related indications?

Due to a patent settlement, mecasermin rinfabate is being taken off the market for short stature related indications.

What funding has Insmed Pharmaceuticals received for mecasermin rinfabate?

Insmed Pharmaceuticals received a $6.5 million grant from the US NIH and the MDA to investigate the efficacy of mecasermin rinfabate for the treatment of myotonic dystrophy.

Sources

1. PubMed: "Mecasermin rinfabate - PubMed"
2. FDA: "1 PACKAGE INSERT IPLEX™ (mecasermin rinfabate [rDNA origin] injection)"
3. PubMed: "Mecasermin rinfabate: insulin-like growth factor-I/insulin-like growth factor binding protein-3, rhIGF-I/rhIGFBP-3, SomatoKine"
4. Duke University: "The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologics"
5. Wikidoc: "Mecasermin rinfabate - wikidoc"