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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 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.

12 Comments

  • Morgan on Oct 26, 2010 Reply

    I’d be interested to learn a bit more about natural remedies. I have been reading about seaweed powder baths but am a little dubious without any 3rd party research.

  • Mark on Jul 08, 2010 Reply

    Lydia,

    Indeed you deserve kudos for your knowledge, research, and recognition of the theatrics staged in the realm of pharmaceuticals. It is a pleasure to read your piece and the way you have presented it without spin or slant.

    I personally suffer from mild to mediocre plaque Psoriasis and was searching for references on the web recommending a superior replacement for the greasy Triamcinalone Acetonide ointment currently scripted. But I found your blog irresistible, revealing the root driving forces at work, behind their masks of benevolence.

    The information you bring to the surface is enlightening to say the least. Certainly the patient is unaware of the big picture schemes that someone at your layer can detect, if equipped with the intellect and skill set to do so. Thank you for your thoughtfulness in sharing it.

    It seems another example of how our capitalist society consistently evolves to saturate itself with greed on every facet.

    Best regards.

    Mark
    South MD USA

  • Martin Woodside on May 01, 2010 Reply

    Lydia Green:

    I would like to add a bit more (corrected) information to my above post. I followed your blog with interest but had neglected to observe that your are a trained pharmacist thus my additional post.

    First of all I misspelled the doctors name once and spelled it correctly once. It is Dr. Jenny Murase . She did her trials at UCLA IRVINE but has moved on to other settings in the years since.

    My first 5-6 years I used Premarin Vaginal cream as a topical skin application and then switched to Estrogel because it is less greasy and does not rub off on my clothing etc. I did appreciate how the Premarin cream kept my skin soft but There is no benefit (to the skin) by topical application. The benefit is derived from dermal absorption of the hormone into my system.

    My doctors observe my sucess but generally I self regulate my dosage. I have always been able “to tell” when my psoriasis wants to become active (usually in the fall) and I increase the amount and then taper off at other times. It has worked well. (Except for the PMS type mood swings caused when levels change). I now have a better understanding of what women go through. (smile).

    I vary dose between 2 to 4 grams daily (pump dispenser) (0.06% 17b estradiol).

    Further study indicates that I will probably have a much higher rate of psoriasis if I should ever discontinue the hormonal treatment. I do not plan to stop. The side effects are minor compared to the severe raging psoriatic arthritis I would otherwise have. (I probably would not be alive today)

    I am a healthy active miracle survivor by fluke coincidence of discovering Dr. Murase’s information via the internet.

    I will be forever greatful to professionals who make such information available to the general public.

    I refer to you as well Lydia Green.

    Profound thanks.

    Arnie M.
    Canada
    Best regards and feel free to ask me more

  • Martin Woodside on May 01, 2010 Reply

    Estrogen helps some people to keep psoriasis in remission. It certainly works for me. (I am a male 50-60 years of age)

    I have had life long psoriasis which I learned to live with just fine until around 2000 I got (the rare) psoriatic arthritis. It raged through my joints and disabled me. Dovonex healed the psoriasis (took 3 months) and the arthritis retreated with it and I am active again.

    My daughter inherited my psoriasis and the only 2 times in her life she was free of symptoms was when she was pregnant (hormones). I did research and discovered that Dr. Jenny Morase found similar results in clinical trials.

    Based on that I persuaded my doctor to prescribe topical estrogel that I have used now with good results for almost 10 years.

    Things were going so well that I became complacent in 2005 and did not renew the estrogel prescription . Two months later my psoriasis was back with a vengance. Lesson learned.

    I continue to use estrogel and am psoriasis free for 10 years (except for 2005) and plan to continue for life. There have been some side effects (slight breast growth) (PMS type symptoms (no-kidding) but at nearly 60 years of age I accept them happily compared to being in a wheelchair or dead. (The arthritis was severe in my case).

    As far as I know, this is the ONLY known medication that keeps psoriasis IN REMISSION . Sun tan , sea salts etc never worked for me.

    Search Dr. Jenny Murase for more accurate information. Mine was not a clinical trial but I forwarded my experience (as a male) to her and she was thrilled.

    Ironically my daughter is unable to benefit from HRT because her mother died young from breast cancer and she is succeptable.

  • Anonymous on Feb 24, 2010 Reply

    Thanks Lydia for this article. It is the most comprehensive piece I have found anywhere. I was caught by surprise this week when I found out that the dovonex ointment was discontinued. While researching, I read that Sandoz started the production of a generic Calcipotriene solution for treatment of the scalp a while ago, and I was hoping that they would also decide to produce the ointment soon. After reading your article however, I think that Sandoz probably received incentives from Warner Chilcott and Galderma to stay out of the profitable oitment market.

  • Anonymous on Feb 23, 2010 Reply

    Very interesting blog. I would add that psoriasis management involves the alternate use of steroids and non-steroidal treatments. It is important to stop using steroids for a period of time because a) skin gets used to steroids and they will no longer work; and b) it is not good to use steroids on a regular basis. To my knowledge, Dovonex and Vectical are the only non-steroidal topical medications on the market. Additionally, in my experience (I have moderate/severe psoriasis), ointments work better than creams. Taking Dovonex ointment off the market has forced me to pay higher prices for the Vectical. What a game these pharmaceutical companies play with our healthcare! It is infuriating.

  • Lydia Green on Jan 01, 2010 Reply

    If anyone wants to contact me, I have added a way to contact me via email. Go to “About Me”
    and Click on “View my complete profile” and you will see an email icon.

  • Anonymous on Nov 06, 2009 Reply

    Lydia,
    How may i get in contact with you? i don’t want to leave my email address for the world to see. do you have one buried somewhere that i may access? thanks.

  • ADAM on Oct 31, 2009 Reply

    Lydia – I would also be interested in additional information on the topic. Is there somethwere I can email you on this for more info? Is it possible to import the dovonex ointment from outside the US?

  • Anonymous on Sep 11, 2009 Reply

    Having just paid $400 for a tube of Vectical, I’m wondering, what is stopping the generic companies from producing generic calcipotriene?

  • Lydia on Jul 02, 2009 Reply

    Anonymous,

    I didn’t know how to contact you, but if you send me your email, I will respond.

  • Anonymous on Jun 26, 2009 Reply

    Lydia, this is very interesting. Do you have further information on this topic I may read? Thank you.

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