Hovione's $35M CDC Flex line links spray drying to tablets, designed to eliminate scale-up under FDA Q13 guidance.
News|Articles|December 2, 2015
Express Scripts to Offer $1 Daraprim Alternative
Author(s)Caroline Hroncich
Express Scripts announced its plan to offer a $1 alternative to Daraprim, a generic drug used for the treatment of toxoplasmosis.
Advertisement
On Dec. 1, 2015 Express Scripts announced its plan to partner with Imprimis Pharmaceuticals to create an inexpensive alternative to Daraprim, a 62-year-old generic drug used for the treatment of toxoplasmosis.
Toxoplasmosis is a disease caused by single-celled parasite, Toxoplasma gondii, which can cause death from foodborne illness in those with weakened immune systems. Daraprim is primarily used to treat patients with compromised immune systems, such as those with HIV, cancer patients, and pregnant women.
Daraprim made headlines in September 2015, when Martin Shkreli, former hedge fund manager and current head of Turing Pharmaceuticals, hiked the price of the medication from $13.50 to $750 per pill. The hike spurred the House Committee on Oversight and Government Reform to send a letter to Shkreli, requesting information on the nearly 5000% increase.
“Well, it depends on how you define ‘so drastically,'” he said. “Because the drug was unprofitable at the former price, so anyone selling it would be losing money. And at this price it’s a reasonable profit. Not excessive at all.”
Express Scripts is now offering a compounded oral formulation of pyrimethamine, the same active ingredient as Daraprim, for $1 per capsule. The FDA prohibits exact replication of drugs like Daraprim, and this new formulation contains the addition of Vitamin B and leucovorin. The company says the drug will be processed as early as the beginning of December 2015 for patients.
In a press release, the pharmacy benefit manager (PBM) said it is working with the Infectious Disease Society of America (IDSA) and the HIV Medicine Association (HIVMA) to assist physicians in prescribing the Daraprim alternative. Physicians will be required to submit prescriptions for the new compound directly to Imprimis.
Source:
Advertisement
Related to this article
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
Ron Scarboro, Azurity Pharmaceuticals, claims drug reformulation that removes patient barriers must preserve efficacy, urging early cross-functional team alignment.
PharmTech AI Pulse Check episode 2 covers AI data governance, API-gated journals, watermarking limits, and why attribution beats detection in GxP.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Novartis licenses Abogen's mRNA-encoded T-cell engager for autoimmune disease, raising scale-up questions for mRNA-lipid nanoparticle manufacturing.
Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
Advertisement
Advertisement