Elite Pharmaceuticals makes a number of generics but is preparing to submit file its candidate pain medication Eli-200 with the US Food and Drug Administration (FDA) in December. The product uses Elite’s Abuse Resistant Technology (ART), which comproses a capsule containing the opioid agonist along with naltrexone, an opioid receptor antagonist used to manage alcohol and opioid dependence.
When taken correctly the naltrexone passes through the body allowing the opioid to act and relieve against pain, yet if the capsule contents are crushed or dissolved, the naltrexone is released and blocks the opioid from reaching the receptors in the brain of the abuser.
During a conference call to discuss first quarter fiscal year 2015 financials yesterday, CEO Nasrat Hakim spoke of Elite’s ambitions to launch the drug next August or September following a successful submission and, despite being approached by several third-parties, intends to retain manufacturing control.
“I have made the decision we will be manufacturing ELI-200 ourselves,” he said. “I have had several companies that approached me and asked if they could contract manufacture for us. They have much bigger facilities but I’ve decided the product is staying with us.”
Capacity Expansion
The company has a 30,000sq ft DEA registered oral solid dosage forms facility in Northvale, New Jersey, from which it makes its own products, as well as offers some contract manufacturing itself.
Capacity will become constrained if ELI-200 reaches commercialisation and thus the firm has leased a further 15,000sq ft on the site and, according to an SEC filing, has been granted approval to modify the space “for the storage of pharmaceutical finished goods, raw materials, equipment and documents as well as engaging in manufacturing, packaging and distribution activities.”
EVP of Operations Doug Plassche told investors approximately 2,000sq ft of the new space would be refurbished to house QA operations, whilst the rest would be subject to “fast, low-cost internal construction for manufacturing.”
However, he added: “As a parallel activity, we are developing scope and bid documents for commercial scale manufacturing equipment, as well as evaluating existing commercial sites.”
Elite’s vision for manufacturing may be solely in-house but Hakim is still undecided as to a sales and marketing strategy for ELI-200.
Whilst he said the firm had looked into contracting a salesforce, another option would be “to have a well-established pharmaceutical company that has the capabilities and sales and marketing force of 150 to 200 people that can sell our product in addition to this at some kind of a profit sharing or commission,” though a final decision would be made at the time of filing.