The Ties That Bind − Topical Psoriasis Marketplace

In the past few years, there have been some interesting developments in the topical psoriasis treatment marketplace. Are these developments, which occurred after a popular topical prescription medication went generic, interrelated or just a random series of events? Unlike a box puzzle, where all the pieces fit together perfectly, there is no way to be sure.

Demonstrating the existence of questionable business practices is tough, especially since pharmaceutical companies rarely jump up and down to cheer their pursuit of the profit motive. Still, as a skeptic with years of experience witnessing how far the pharmaceutical industry will go to sell products, I sometimes find myself piecing together pieces of news that might seem unrelated to the casual reader.

Companies with blockbuster drugs anticipate their drug’s loss of patent protection with a strategic set of tactics. In a 2008 report, the European Commission concluded that pharmaceutical companies engage in a wide range of patent strategies designed to block entry of generic competition to their products. One tactic mentioned was paying manufacturers not to market a generic form of the innovator’s drug. Other common tactics include launching fixed- combination products (e.g. Caduet) or line extensions (Ambien CR).

With this in mind, here are some developments that recently caught my eye (possibly because I have psoriasis).

1) Loss of patent protection for Dovonex® (calcipotriene) Ointment. (The ointment, before it went off patent, was marketed by Warner Chilcott in a licensing agreement with Leo Pharma).

2) Introduction of an expensive fixed-combination product, Taclonex®, which consists of Dovonex Ointment (calcipotriene), combined with a topical corticosteroid, betamethasone dipropionate (also marketed by Warner Chilcott in a licensing agreement with Leo Pharma).

3) Launch of Vectical™, a new Vitamin D3 ointment that is similar to Dovonex (Vectical is marketed by Galderma).

4) Updated 2009 American Academy of Dermatology (AAD) guidelines on topical psoriasis treatment.

Here is the storyline in a little more detail.

1) Dovonex Ointment (calcipotriene) goes generic in December 2007. Leo discontinues the ointment which is no longer available in the United States. Warner Chilcott continues to promote Dovonex Cream, which is still patent protected.

2) Taclonex, a new dual-action ointment, is launched in 2006 through an arrangement between Warner Chilcott and Leo. Taclonex is a fixed-combination topical agent containing Dovonex Ointment (calcipotriene) combined with a topical corticosteroid, betamethasone dipropionate. Promotional materials in the UK urge physicians to switch Dovonex Ointment patients to Taclonex Ointment. Leo Pharma claims that this is good for patients because the combination product is more effective.

RXBALANCE COUNTERPOINT
Around the time of the Taclonex launch, Leo Pharma and Warner Chilcott discontinue supplying Dovonex ointment in the United States, even though it was popular with many dermatologists and patients. In fact, many dermatologists, already prescribed the two drugs together, which is a lot cheaper, than a fixed combination. Is it possible that Warner Chilcott and Leo discontinued Dovonex Ointment to knock out competition for Taclonex and so assure its success? Also, check out this link for a UK position on the issue.

3) Galderma introduces Vectical in 2009. The Vectical Home page states that “Vectical is the only vitamin D3 ointment for plaque psoriasis”. It’s singular status as the ‘only’ is the direct result of Leo and Warner Chilcott discontinuing the cheaper Dovonex Ointment.

RXBALANCE COUNTERPOINT
The only difference between Dovonex and Vectical is that Vectical contains a naturally-occurring, active form of vitamin D3 called calcitriol, while Dovonex contains calcipotriene, a synthetic vitamin D3 derivative. This advertisement positions Vectical as if it was a new breakthrough psoriasis treatment, a far cry from the truth. Without competition from a generic Dovonox Ointment, Vectical does well as dermatologists and patients clamor for a Vitamin D3 ointment.

4) New guidelines on the management and treatment of psoriasis with topical therapies are released by the American Academy of Dermatology (AAD) in 2009. These guidelines were written by a group of well-known dermatologists, the majority of whom serve on advisory boards and as clinical investigators, receive honoraria and serve on speaker panels for Galderma and Warner Chilcott. The guidelines specifically address the benefits of a fixed-combination of calcipotriene ointment and betamethsone.

RXBALANCE COUNTERPOINT
Members of national treatment guidelines committees consist of prominent physicians who frequently are paid spokespersons for the drugs they are evaluating in the guidelines. Since treatment guidelines influence the prescribing habits of hundreds of thousands of U.S. physicians, there are enormous financial ramifications to a drug getting favorable coverage in a guideline issued by a national specialty society like the AAD.

While the dermatologists on the 2009 AAD guideline committee take special note of the benefits of fixed-combination products like Tactonel, there is no mention about the decision to discontinue Dovonex Ointment or the impact of that decision on patient care. Instead, the guidelines merely state that “…calcipotriene ointment is no longer commercially available as an individual product in the United States.” However, the new guidelines do tout the benefits of fixed-combination products containing both calcipotriene and betamethasone propionate. The new fixed-combination is certainly convenient, but why doesn’t the AAD make a public comment about the loss of the cheaper option (alternating use of two topical generics)?

Also of note are the strong ties that bind most of the guideline members to drug companies that make treatments for psoriasis. Virtually all the prominent dermatologists on the guideline committee are clinical investigators, published authors, and speakers for industry. Several are clinical investigators, media spokespersons and reviewers of journal supplements for Warner Chilcott and Galderma, the companies that manufacturer Taclonex and Vectical, respectively. Isn’t this a conflict of interest and could this conflict subtly cloud these doctors views or at the very least, the words they choose to voice their recommendations?

In case there are any attorneys reading this blog, please note: I am not claiming Galerma, Leo Pharma, Warner Chilcott or the AAD have engaged in illegal or unethical practices. I merely am using this blog to speculate upon the ties that bind certain events in the psoriasis marketplace.