Pafolacianine sodium - Generic Drug Details

What are the generic sources for pafolacianine sodium and what is the scope of freedom to operate?

Pafolacianine sodium is the generic ingredient in one branded drug marketed by On Target Labs and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pafolacianine sodium has thirty-five patent family members in twelve countries.

One supplier is listed for this compound.

Summary for pafolacianine sodium

International Patents:	35
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	pafolacianine sodium at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for pafolacianine sodium

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for pafolacianine sodium

Drug Class	Optical Imaging Agent
Mechanism of Action	Fluorescence Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for pafolacianine sodium

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for pafolacianine sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y
On Target Labs	CYTALUX	pafolacianine sodium	SOLUTION;INTRAVENOUS	214907-001	Nov 29, 2021		RX	Yes	Yes			Y	Y

International Patents for pafolacianine sodium

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	029738	СИНТЕЗ И КОМПОЗИЦИЯ АМИНОКИСЛОТНЫХ ЛИНКЕРНЫХ ГРУПП, КОНЪЮГИРОВАННЫХ С СОЕДИНЕНИЯМИ, ПРИМЕНЯЕМЫМИ ДЛЯ НАПРАВЛЕННОЙ ВИЗУАЛИЗАЦИИ ОПУХОЛЕЙ (SYNTHESIS AND COMPOSITION OF AMINO ACID LINKING GROUPS CONJUGATED TO COMPOUNDS USED FOR THE TARGETED IMAGING OF TUMORS)
Israel	240673	סינתזה והרכב של קבוצות קושרות חומצות אמינו מצומדות לתרכובות המשמשות להדמיה ממוקדת של גידולים (Synthesis and composition of amino acid linking groups conjugated to compounds used for the targeted imaging of tumors)
China	105120903	Methods of manufacture and synthesis of amino acid linking groups conjugated to compounds used for targeted imaging of tumors
Israel	240509	דימות פלואורסנטי של מחלות דלקתיות (Fluorescence imaging of inflammatory diseases)
Spain	2765896

Pafolacianine sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pafolacianine Sodium

Introduction to Pafolacianine Sodium

Pafolacianine sodium, marketed as Cytalux, is a groundbreaking fluorescent marker developed by On Target Laboratories, Inc. This innovative drug is designed to target and illuminate cancerous tissue during surgery, particularly in ovarian and lung cancers. Here, we delve into the market dynamics and financial trajectory of this promising therapeutic agent.

Market Need and Potential

Ovarian and lung cancers are among the most challenging to treat due to the difficulty in identifying and removing all malignant tissue during surgery. Ovarian cancer, for instance, accounts for more deaths than any other cancer of the female reproductive system, with over 21,000 new diagnoses and nearly 14,000 deaths estimated in the United States in 2021[5].

The market need for a precise and effective tool to identify cancerous lesions intraoperatively is significant. Pafolacianine sodium addresses this need by binding to folate receptors, which are overexpressed in over 95% of ovarian cancers, and illuminating under near-infrared light, thereby helping surgeons to identify and remove more cancerous tissue[4].

Clinical Trials and Regulatory Approvals

The clinical development of pafolacianine sodium has been robust, with both Phase 2 and Phase 3 trials demonstrating its efficacy and safety. The Phase 3 trial, in particular, showed that pafolacianine sodium identified additional cancer lesions in 27% of patients that would have otherwise been missed, highlighting its potential to improve surgical outcomes[2][3].

In November 2021, the FDA approved pafolacianine sodium injection for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions. This approval was granted under priority review, fast track, and orphan drug designations, underscoring the drug's innovative value and the urgent need it addresses[2][3].

Financial Backing and Funding

On Target Laboratories has secured significant funding to support the development and commercialization of pafolacianine sodium. In March 2021, the company announced a $21 million expanded Series B funding round, backed by existing investors including Johnson & Johnson Innovation – JJDC, Inc., H.I.G. Capital, Elevate Ventures, The Hurvis Group, and 3B Future Health Fund. This funding is crucial for completing the ELUCIDATE Trial, a Phase 3 clinical trial evaluating the drug's use in lung cancer, and for driving the commercialization of pafolacianine sodium in ovarian cancer[1].

Market Impact and Adoption

The approval and subsequent market entry of pafolacianine sodium are expected to significantly impact the surgical treatment of ovarian and potentially lung cancers. The drug's ability to identify additional lesions that might be missed by standard visual or tactile inspection can lead to more complete resections, which is a critical factor in improving patient outcomes.

Surgeons and oncologists are likely to adopt this technology given its proven efficacy and the critical need for better intraoperative visualization tools. The FDA's priority review and special designations further validate the drug's potential, which can accelerate its adoption in clinical practice.

Safety and Tolerability

The safety profile of pafolacianine sodium has been favorable in clinical trials. The most common adverse reactions include nausea, vomiting, abdominal pain, and infusion reactions, with the majority of these events being mild or moderate and transient in nature. No drug-related serious adverse events or deaths were reported in the Phase 3 trial[3][5].

Commercialization and Pricing

While specific pricing details for pafolacianine sodium are not yet publicly disclosed, the drug's innovative nature and the value it brings to patient care are likely to support a premium pricing strategy. The cost-effectiveness of the drug will be evaluated based on its ability to improve surgical outcomes, reduce the need for additional surgeries, and enhance patient survival rates.

Future Directions and Expansion

On Target Laboratories is also investigating pafolacianine sodium in the Phase 3 ELUCIDATE trial for the intraoperative detection of lung cancer lesions. This trial, expected to enroll up to 130 patients, will further evaluate the safety, efficacy, and tolerability of the drug in another critical cancer type. Successful outcomes in this trial could expand the drug's indications and market potential[2][4].

Key Takeaways

• Innovative Technology: Pafolacianine sodium is a novel fluorescent marker that targets and illuminates cancerous tissue during surgery.
• Regulatory Approvals: FDA-approved for ovarian cancer with priority review, fast track, and orphan drug designations.
• Clinical Efficacy: Demonstrated ability to identify additional cancer lesions in clinical trials.
• Financial Backing: Secured $21 million in funding for development and commercialization.
• Market Impact: Expected to improve surgical outcomes and patient survival rates.
• Safety Profile: Favorable safety profile with mild to moderate adverse reactions.

FAQs

Q: What is pafolacianine sodium used for? A: Pafolacianine sodium is used as an adjunct for intraoperative identification of malignant lesions in ovarian cancer and is being investigated for use in lung cancer.

Q: How does pafolacianine sodium work? A: It binds to folate receptors overexpressed in cancer cells and illuminates under near-infrared light, helping surgeons identify cancerous tissue during surgery.

Q: What are the common adverse reactions associated with pafolacianine sodium? A: Common adverse reactions include nausea, vomiting, abdominal pain, and infusion reactions, which are generally mild or moderate.

Q: Has pafolacianine sodium received any special designations from the FDA? A: Yes, it has received priority review, fast track, and orphan drug designations.

Q: What is the current status of pafolacianine sodium in clinical trials for lung cancer? A: It is currently being investigated in the Phase 3 ELUCIDATE trial for the intraoperative detection of lung cancer lesions.

Cited Sources

1. On Target Laboratories Secures $21 Million for Development and Commercialization of Pafolacianine Sodium Injection - PR Newswire
2. FDA Approves Pafolacianine Sodium Injection for Ovarian Cancer - OncLive
3. Pafolacianine for identifying malignant ovarian cancer lesions - FDA - FDA
4. FDA Grants Priority Review to Pafolacianine Sodium Injection in Ovarian Cancer - Clearity Foundation
5. On Target Laboratories, Inc. Announces Results of Phase 3 Trial for Pafolacianine Sodium Injection - PR Newswire