Capromab pendetide - Biologic Drug Details

Summary for capromab pendetide

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for capromab pendetide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for capromab pendetide

Recent Clinical Trials for capromab pendetide

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Sponsor	Phase
Emory University	Phase 2/Phase 3
National Cancer Institute (NCI)	Phase 2/Phase 3
Molecular Insight Pharmaceuticals, Inc.	Phase 1

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Recent Litigation for capromab pendetide

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11
AbbVie Inc. v. Alvotech hf.	2021-04-27

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PTAB Litigation

Petitioner	Date
	2017-12-20

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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 capromab pendetide Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Capromab pendetide Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Capromab Pendetide

Introduction

Capromab pendetide, also known as ProstaScint, is a radioimmunoscintigraphic imaging agent used primarily in the detection and management of prostate cancer. This biologic drug has been extensively studied for its diagnostic utility, particularly in patients with untreated prostate cancer at high risk for pelvic lymph node metastases and those with suspected occult recurrent or residual disease after prostatectomy[1][2][5].

Diagnostic Utility

Capromab pendetide offers improved sensitivity in detecting prostate cancer compared to other noninvasive techniques. It consists of a murine monoclonal antibody (7E11-C5.3) directed against the intracellular domain of human prostate-specific membrane antigen (PSMA), a transmembrane glycoprotein expressed by prostate epithelial cells[1]. The diagnostic performance of capromab pendetide has been evaluated in various clinical settings:

• High-Risk Prostate Cancer Patients: In patients at high risk for pelvic lymph node metastases, capromab pendetide imaging showed sensitivities and specificities ranging from 52% to 62% and 96% to 72%, respectively, as confirmed by pelvic lymph node dissection biopsy results[1].
• Occult Recurrent or Residual Disease: In patients with suspected occult recurrent or residual disease after prostatectomy, capromab pendetide had sensitivities and specificities ranging from 49% to 77% and 71% to 35%, respectively, for detecting cancer in the prostate bed. The scan also identified lesions outside the prostate fossa in almost half of these patients, although too few cases were confirmed to evaluate its effectiveness[1][2].

Clinical Trials and Outcomes

Several clinical trials have evaluated the imaging performance of capromab pendetide:

• Phase 2 and Phase 3 Trials: These trials involved patients with clinically localized prostate cancer at high risk for metastases and those with a high clinical suspicion for occult recurrent or residual prostate cancer. The overall accuracy of capromab pendetide immunoscintigraphy was 68% in detecting pelvic lymph node metastases and 63% in detecting recurrent or residual disease in the prostate bed[5].
• Long-Term Follow-Up: A study on long-term follow-up of patients who underwent capromab pendetide scans found that the positive predictive value of the scan in detecting disease outside the bed was low (27%). The biochemical relapse-free survival (bRFS) rates did not differ significantly between patients with positive and negative scan findings[2].

Pharmacokinetics and Safety Profile

Capromab pendetide is radiolabeled with indium-111. Its pharmacokinetics are characterized by a monoexponential elimination pattern with a terminal-phase half-life of approximately 67 hours. Approximately 10% of the administered radioisotope dose is excreted in the urine during the 72 hours following intravenous infusion. Common adverse events include elevated bilirubin levels, hypertension, hypotension, elevated liver enzymes, and injection site reactions. Human anti-mouse antibodies were reported in 8% of patients after a single dose and in 19% after repeat infusions[1][5].

Market Dynamics and Financial Trajectory

The market dynamics and financial trajectory of capromab pendetide are influenced by several factors:

• Regulatory Environment: The regulatory context for biologics, including capromab pendetide, is complex and subject to legislative changes that can impact market size and entry[3].
• Competition: The biologic drug market is competitive, with generic and follow-on biologics (FOBs) emerging as alternatives. However, the entry of FOBs is limited due to high fixed costs and perceived substitutability issues among physicians and patients[3].
• Market Size: The potential market size for FOB therapies in the category of prostate cancer diagnostics is significant but uncertain. Direct empirical evidence of market share uptake and price effects due to FOBs is limited, with initial uptake being low (e.g., Omnitrope accounting for only about 1% of the human growth hormone market)[3].

Conclusion

Capromab pendetide offers improved sensitivity in detecting prostate cancer but has a low positive predictive value in identifying disease outside the prostate bed. Its pharmacokinetics and safety profile are well-characterized, but its market dynamics are influenced by regulatory and competitive factors. The financial trajectory of capromab pendetide is uncertain due to these market dynamics and the limited empirical evidence on FOBs.

Key Takeaways

1. Diagnostic Utility: Capromab pendetide offers improved sensitivity in detecting prostate cancer, particularly in high-risk patients.
2. Clinical Trials: Phase 2 and Phase 3 trials have demonstrated its effectiveness in various clinical settings.
3. Pharmacokinetics: It has a monoexponential elimination pattern with a terminal-phase half-life of approximately 67 hours.
4. Safety Profile: Common adverse events include elevated bilirubin levels, hypertension, hypotension, elevated liver enzymes, and injection site reactions.
5. Market Dynamics: Regulatory environment, competition from FOBs, and market size uncertainty influence its market dynamics.
6. Financial Trajectory: Uncertain due to limited empirical evidence on FOBs and high fixed costs of entry.

FAQs

1. What is capromab pendetide used for?

   • Capromab pendetide is used as a radioimmunoscintigraphic imaging agent for detecting prostate cancer, particularly in patients at high risk for pelvic lymph node metastases and those with suspected occult recurrent or residual disease after prostatectomy[1][5].

2. How does capromab pendetide work?

   • It consists of a murine monoclonal antibody (7E11-C5.3) directed against the intracellular domain of human prostate-specific membrane antigen (PSMA), a transmembrane glycoprotein expressed by prostate epithelial cells[1].

3. What are the sensitivities and specificities of capromab pendetide in detecting prostate cancer?

   • In patients at high risk for pelvic lymph node metastases, sensitivities ranged from 52% to 62%, and specificities ranged from 96% to 72%[1]. In patients with suspected occult recurrent or residual disease, sensitivities ranged from 49% to 77%, and specificities ranged from 71% to 35%[1].

4. What are the common adverse events associated with capromab pendetide?

   • Common adverse events include elevated bilirubin levels, hypertension, hypotension, elevated liver enzymes, and injection site reactions. Human anti-mouse antibodies were reported in 8% of patients after a single dose and in 19% after repeat infusions[1][5].

5. How does the regulatory environment impact the market dynamics of capromab pendetide?

   • The regulatory environment for biologics is complex and subject to legislative changes that can impact market size and entry. This uncertainty affects the financial trajectory of capromab pendetide[3].

Sources Cited

1. Capromab pendetide. A review of its use as an imaging agent in prostate cancer. PubMed.
2. Long-term follow-up of 111In-capromab pendetide (ProstaScint) in patients with rising PSA levels after prostatectomy. PubMed.
3. The Effect on Federal Spending of Legislation Creating a Regulatory Framework for Follow-on Biologics. Duke University.
4. What is Capromab Pendetide used for? Patsnap Synapse.
5. ProstaScint Kit (capromab pendetide) Kit for the Preparation of Indium In 111 ProstaScint. FDA Label.