Back in June 2003, Novartis reallocated the promotional dollars behind Clozaril (clozapine), a product used for treatment-resistant schizophrenia that faced significant generic competition to newer brands. Although Novartis offered Duffy other opportunities within the company, he wanted to continue working with the physicians and patients to whom he had devoted the last 13 years of his life as the brand's steward.
Before very long, Duffy was contacted by Neil R. Cutler, MD, founder of the maker of FazaClo, a drug that enhances the clozapine molecule by offering an orally disintegrating tablet delivery system. He asked Duffy to run the commercial side of the company, Alamo Pharmaceuticals, and Duffy accepted.In February 2004, the FDA approved FazaClo, and put Alamo on the map. Duffy had to get the commercial operation off the ground by creating Alamo's sales force, and marketing and distribution functions from scratch.
Here, he talks about that challenge, the company's first product, and working with the government to improve access.
Pharm Exec: The industry is using more orally disintegrating tablets. What are the benefits of that formulation? Duffy: For one, it is very discreet. When patients open the blister packaging, it looks like they're taking a breath mint. The formulation also helps patients to avoid skipping doses, because they can take their medication even if there is no water available—if they're at their job as a cashier in a grocery store or if they're on a subway or bus. Patients don't have to stop and say, "I have to go get some water. It's time to take my medicine." When that happens, they remind themselves, and everybody around them, that they are ill.
FazaClo's minty taste also makes it easier for the patient to remember. Because it appeals to that sense, patients are more apt to say, "Gee, I took my last dose this morning. It's time to take another one now."
What type of patent protection does FazaClo have?
FazaClo is manufactured using the patented OraSolv technology, licensed from Cima Labs. We have two patents on the manufacturing process of the product. This licensed technology presented a unique development opportunity. Often we see brands come onto the market, followed by generics—and that's the end of the story. Here, we have a brand that is followed by generics, fol » lowed by a new patent-protected brand. That also is happening in some other places. Klonopin (clonazepam), for example, was branded in tablets, then followed by generics, and now Roche Laboratories has introduced the new Klonopin wafers.
In our case, it presents some interesting dynamics, particularly with payers, because our patients often rely on Medicaid to pay for their medications.
What are the dynamics?
One of the biggest issues in antipsychotic therapy today is the use of polypharmacy. Harvard recently conducted a study that pointed out that polypharmacy can cause more side effects, have increased costs, and offer no better outcome. So if you have a product that is more effective in a particular disease state and that becomes a generic, and the product loses its champion, then what rushes in to fill the void are other, newer patented products. But they may not be as effective and may require polypharmacy to get the same effect. So the revival of the former champion to its original status and its rightful usage levels will help to reduce polypharmacy and the costs to state payers.
Are payers open to hearing about new formulations of products when generics are available?
It has puzzled them a little bit. We have given numerous presentations to various states, and they have listened carefully. When we lay out our rationale and give them supporting documentation, they begin to see the sense of our proposal, and that it is a viable strategy for the states.