Market Dynamics and Financial Trajectory for Phospholine Iodide
Introduction
Phospholine Iodide, also known as echothiophate iodide, is an ophthalmic medication used to treat glaucoma and other eye conditions. The drug has a complex history marked by supply chain issues, discontinuation, and a recent change in manufacturer. Here, we delve into the market dynamics and financial trajectory of Phospholine Iodide.
Historical Context and Use
Phospholine Iodide was originally approved in 1960 and has been used to treat increased intraocular pressure (IOP) in glaucoma patients, as well as conditions like accommodative esotropia and aphakic glaucoma, particularly in children[1][4].
Supply Chain Issues and Discontinuation
Pfizer, the sole manufacturer of Phospholine Iodide, faced significant challenges due to an unstable supply chain. The manufacturing process required multiple external partners, which led to intermittent shortages and stock-outs over the years. Despite efforts by ophthalmological societies to mitigate these issues, Pfizer announced the discontinuation of Phospholine Iodide in February 2021, citing the unsustainable nature of the supply chain[1][4].
Impact on Patients and Ophthalmologists
The discontinuation of Phospholine Iodide posed a critical challenge for patients, especially those with rare forms of glaucoma like infantile aphakic glaucoma. For these patients, the drug was often the only non-surgical treatment option. Ophthalmologists expressed concerns about the lack of alternative treatments and the potential increase in surgical interventions[4].
Financial Considerations
The decision to discontinue Phospholine Iodide was not based on safety concerns but on financial and logistical viability. The complex manufacturing process and declining prescription numbers made it economically unfeasible for Pfizer to continue production. The company estimated that only about 100 patients in the U.S. were using the medication at the time of discontinuation[4].
Market Dynamics: Generic and Branded Drugs
The case of Phospholine Iodide highlights broader issues in the generic and branded drug markets. Generic drug manufacturers often face low profit margins, which can lead to reduced production and increased prices as fewer companies remain in the market. This dynamic can result in price hikes and reduced availability of essential medications[2].
New Manufacturer: Fera Pharmaceuticals
In a significant development, Pfizer entered into an agreement with Fera Pharmaceuticals, a specialty pharma company, to manufacture and market Phospholine Iodide. This deal ensured the continued availability of the drug, albeit with concerns about potential price increases. Fera Pharmaceuticals, founded by former Sandoz U.S. CEO Frank DellaFera, specializes in underserved therapeutic categories and has committed to maintaining the drug's availability[4].
Regulatory Support
The U.S. Food and Drug Administration (FDA) played a crucial role by granting an extended shelf life for Phospholine Iodide from 24 months to 36 months, facilitating its continued use. This regulatory support was essential in ensuring that patients could still access the medication[4].
Alternative Treatments
While Phospholine Iodide remains a unique treatment option, alternative therapies are available for glaucoma patients. These include prostaglandins, beta-blockers, cholinergics, alpha adrenergic inhibitors, carbonic anhydrase inhibitors, Rho kinase inhibitors, and nitric oxides, as well as laser treatment and surgery. However, these alternatives may not be as effective for certain rare conditions treated by Phospholine Iodide[4].
Price Considerations
The cost of Phospholine Iodide is significant, with a 5-milliliter bottle priced around $100. The transition to Fera Pharmaceuticals has raised concerns about potential price increases, given the lack of transparency regarding the financial terms of the deal[4].
Industry Expert Insights
David Walton, an ophthalmologist at Massachusetts General Hospital, emphasized the unique success of Phospholine Iodide for specific patient groups and criticized Pfizer's handling of the discontinuation. His comments highlight the need for pharmaceutical companies to be more responsible in managing the lifecycle of critical medications[4].
Conclusion
The story of Phospholine Iodide underscores the complexities of pharmaceutical market dynamics, particularly for niche and critical medications. The drug's journey from discontinuation to being picked up by a new manufacturer illustrates the challenges and opportunities in the eye care therapeutic category.
Key Takeaways
- Supply Chain Instability: The discontinuation of Phospholine Iodide was primarily due to an unstable supply chain.
- Financial Viability: Low profit margins and declining prescription numbers made continued production unfeasible for Pfizer.
- New Manufacturer: Fera Pharmaceuticals has taken over the manufacturing and marketing of Phospholine Iodide.
- Regulatory Support: The FDA extended the shelf life of Phospholine Iodide to ensure continued availability.
- Alternative Treatments: Various other treatments are available for glaucoma, but they may not be as effective for certain conditions.
- Price Concerns: The transition to Fera Pharmaceuticals has raised concerns about potential price increases.
FAQs
Q: Why did Pfizer discontinue Phospholine Iodide?
A: Pfizer discontinued Phospholine Iodide due to an unstable supply chain and declining prescription numbers, making the production economically unviable.
Q: What is the current status of Phospholine Iodide?
A: Phospholine Iodide is now manufactured and marketed by Fera Pharmaceuticals after Pfizer discontinued it.
Q: What are the alternative treatments for glaucoma patients who used Phospholine Iodide?
A: Alternative treatments include prostaglandins, beta-blockers, cholinergics, alpha adrenergic inhibitors, and other therapies, as well as laser treatment and surgery.
Q: How much does Phospholine Iodide cost?
A: A 5-milliliter bottle of Phospholine Iodide costs around $100.
Q: What regulatory support has been provided for Phospholine Iodide?
A: The FDA extended the shelf life of Phospholine Iodide from 24 months to 36 months to ensure its continued availability.
Sources
- Ophthalmology Times: "Drugmaker pulling the plug on Phospholine Iodide"
- American Academy of Ophthalmology: "The State of Generic Drugs"
- Review of Optometry: "PRESSURE GRADIENTS"
- BioSpace: "Fera Pharma Pounces on Abandoned Pfizer Pediatric Glaucoma Drug"
