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Oracea wins award for cute marketing

Digital Davo — Fri, 30 Oct 2009 13:55:14 +0000

I can’t say that I know how much industry weight is carried by the publication Medical Marketing & Media, but they have awarded Galderma the Gold Award for `Best Individual Product Advertisement in Consumer Press’ for their marketing of Oracea.

Apparently, “in order to drive product demand, the ads needed to educate consumers about the disease state. They also needed to be sensitive to the fact that the condition upsets and frustrates patients.”

The campaign is further praised for `sensitive drawings of people with the condition and an illustration of how the product works under the skin at the root of the problem’.

Further praises included `demonstrating the condition without making it unnecessarily heavy’ and `very charming execution that would make a reader stop to read more.’

I guess it is kind of cute to promote the whole `works from within’ angle. If you want to see the print advertisement you can click on the graphic above or view the video version at oracea.com.

Even though Oracea is a delayed release form of already available treatment, it is clear that Oracea is successfully creating it’s own market segment. In the year ended July 2009 Oracea was responsible for revenue of $104m. Additionally we know that 2 rival pharmaceutical companies, Impax Laboratories and Mylan Pharmaceuticals want to get a piece of the 30+10mg doxycycline market.

So what is Oracea, really ?

I find it fascinating that a company can take an existing product, such as periostat, do some research and development, obtain a handful of patents, identify a market segment by targeting a disease not well serviced, and come up with a product we now know as Oracea.

The new owners of Oracea – Galderma, gladly added Oracea to their rosacea portfolio that already included another of the rare rosacea targetted prescriptions – metrogel.

Of course it is a massive venture to get a new drug through the FDA, but so far it looks like the venture has paid off financially.

All of this despite being able to make an argument that Oracea is comparable to 50mg a day of generic doxycycline.

Oracea worth $104m a year, good news for Sansrosa

Digital Davo — Fri, 25 Sep 2009 03:19:01 +0000

According to a press release via Reuters, sales of Oracea were approximately $104 million for the twelve-month period ending July 2009. This figure is up almost 200% from the previously reported sales of $52.5 million in 2007.

As you can see Oracea is a great source of revenue for Galderma.

I believe that rosacea sufferers are entitled to ask Is Oracea too expensive ? Given that Oracea is only marginally different to 50 mg a day of generic doxycycline, do rosacea sufferers benefit from the availability of Oracea ?

If you have full insurance coverage and cannot benefit from 50mg a day of doxycycline, then perhaps Oracea is for you. Otherwise ask you doctor if Oracea is worth the expense for your situation.

As I have said in the past – products like Oracea will benefit all rosacea sufferers in the long run by proving to Galderma that rosacea is a disease worth their R&D dollars. Many rosacea sufferers are waiting for Galderma’s in-development anti-redness rosacea product know as Sansrosa to become available.

New products like Sansrosa take millions of dollars of effort and many years of work. Good Oracea sales can only encourage Galderma to target rosacea sufferers.

Impax Laboratories joins the generic Oracea battle

Digital Davo — Mon, 21 Sep 2009 13:38:26 +0000

In a further confirmation that the low dose doxycycline market is a becoming a fighting ground, a recent press release states that Impax Laboratories has filed “Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of ORACEA with the U.S. Food & Drug Administration ("FDA").”

This is a challenge to the patents held by Galderma, relating to the Oracea product.

In March we also read that Galderma was suing Mylan Pharmaceuticals, also over alleged Oracea patent infringements.

The announcement of this second ANDA:Generics challenge to Oracea can only be seen as good news for rosacea sufferers. If Oracea was available as a generic drug it would immediately become more affordable and thus accessible to rosacea sufferers.

Abbreviated New Drug Application (ANDA): Generics

An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

The FDA can also grant Galderma an extra 5 years on top of the regular patent period, so the battle over Generic Oracea could indeed last a long time.

Is Oracea different to 50mg doxycycline ?

Digital Davo — Wed, 10 Jun 2009 03:36:08 +0000

I came across the following graph in a recent presentation at the recent AAD meeting and figured it was interesting enough to highlight it here.

The following graph, sourced from Collagenex (who sell Oracea), shows the blood plasma concentration of doxycycline after taking Oracea compared to 50mg once a day of generic doxycycline. The horizontal axis stretches out to 24 hours post dosage. The vertical axis is in nano-grams per milli-litre (ng/mL).

The horizontal grey line is labelled anti-microbial threshold is listed here as a concentration of 1000 nano grams/mL (i.e. 1.0µg/mL). This value of 1 microgram per millilitre is considered to be the concentration at which doxycycline is able to affect bacteria i.e. have an anti-bacterial effect.

The two inverted curves show the amount of doxycycline that is present in the blood over a 24 hour period. The top grey curve is for 50mg of generic doxycycline and the bottom green curve is for Oracea.

I read this graph to suggest that Oracea is able to maintain a sustained release of the active ingredient doxycycline without venturing into anti-microbial territory. The advantage of a delayed release product is that Oracea can offer the `area under the concentration-by-time curve’ delivery, but at sub-antimicrobial dosage over 24 hours.

That is, Oracea can deliver a dosage of doxycycline that can give measurable results, but keep the concentration of doxycycline in your blood low enough to reduce potential problems associated with antibiotics.

(click image for larger view)

*16 healthy adult subjects, per arm; mean weight 75 kg

† Measured at 7 days

Data on file, CollaGenex Pharmaceuticals, Inc.

What is happening here ?

We do know that antibiotics have non-antibiotic properties. Recent research has found biologic actions affecting inflammation, proteolysis, angiogenesis, apoptosis, metal chelation, ionophoresis, and bone metabolism. Thus a whole new range of clinical applications are being investigated. So it does appear that taking a low dose, or even a sub-antibiotic dose of antibiotics can have real clinical benefits.

A Cheaper Alternative ?

As Oracea is a new prescription product it can be quite expensive, especially if you don’t have comprehensive insurance coverage. One possible alternative you could discuss with your doctor is 50mg a day of generic doxycycline. Whilst this dosage won’t have exactly the same profile in your blood, the benefits and side effects are likely to be close. See your doctor for a better opinion.

I doubt whether we will ever see a trial to prove that the benefits and side effects of Oracea and 50mg of doxycycline are comparable. Therefore it seems unlikely that one can say either way whether the above graph shows an important distinction between the two treatments.

Does it really matter that 50mg a day of doxycycline ventures above the anti-microbial threshold for a couple of hours a day, or that the overall dosage delivered is around twice for the generic ? These are questions that can’t be answered at this stage.

As with all systemic treatments, both Oracea and a low dose of doxycycline can cause unwanted side effects so the supervision of your doctor is important.

Oracea too expensive ?

Digital Davo — Tue, 19 May 2009 02:30:45 +0000

Some interesting comments from KUNC commentator Dr. Marc Ringel via a NPR segment. He raises two points that are worth discussing. Firstly is Oracea really any better than generic doxycycline and secondly what does it say about the pharmaceutical industry (and insurance companies – ed) that a repackaged old product can be so expensive ?

Galderma would say that Oracea is sub-antimicrobial and 50mg doxycycline is a low-dose antibiotic. The distinction is that Oracea will maintain a blood serum level less than 1000 nano grams/mL (i.e. 1.0µg/mL) for the 24 hours post ingestion. 50mg of doxycycline will result in a blood serum level above the `antimicrobial threshold’ of 1.0µg/mL. This can potentially lead to side effects such as antibiotic resistance, abdominal upsets etc., although the amount by which this threshold is exceeded is still relatively small.

At best I would say that the pharmacological benefits of Oracea over 50mg generic doxycycline are are still up for debate.

As to the cost of Oracea, Galderma of course has shareholders like every large pharmaceutical company. Marketing to both health providers and directly to consumers make sense to gain the largest market share possible. Given that they are so few treatments directly targeted at rosacea sufferers it is clear why Galderma wants patients to ask for Oracea by name and for Oracea to be strongly associated as a front line rosacea treatment.

By way of comparison, in Australia pharmaceutical companies are prohibited from marketing prescription brand names directly to the public. Advertisements usually end with a request to ask your doctor for more information. This reduces the pressure doctors feel to prescribe a particular product but may also result in less consumer choice and involvement in their treatment.

In the end, for those with good insurance cover this whole topic is pretty moot as Oracea will be affordable. Additionally those who cannot afford Oracea have a cheap viable alternative in 50 mg of generic doxycycline once a day. See your doctor for more information.

KUNC: The Big Zit Rip-off, Marc Ringel

GREELEY, CO (2009-05-18) Most agree that something needs to be done to overhaul America’s healthcare system. But leave it to KUNC commentator Dr. Marc Ringel to illustrate the problem – through something as small and innocuous as a pimple.

Or you can buy Oracea, a brand-name doxycycline marketed by Galderma Laboratories. Oracea will set you back over $200 a month if you purchase it in this country or about $150 if you shop online and make your buy from a Canadian outfit. To be sure, the dosage of Oracea is 40mg, making it, like the baby bear’s porridge, just right.
…

I cannot imagine, though, how the extra 10 mg in a 50 mg generic doxycycline capsule could cause close to the distress that too-hot or too-cold porridge did to Goldilocks. Nor do I see how Oracea would work better than the plain vanilla generic except, perhaps, for an enhanced placebo effect generated by spending so much money on a product marketed especially to this affliction. A person might figure that such an exorbitantly expensive brand name would just have to work better.

Galderma suing Mylan Pharmaceuticals over Oracea

Digital Davo — Mon, 23 Mar 2009 07:50:20 +0000

Galderma, the makers of Oracea are suing Mylan Pharmaceuticals for allegedly infringing 4 patents related to their sub-antimicrobiotic dose doxycycline product Oracea.

State University of New York, Galderma Sue Mylan

March 20 (Bloomberg) — The State University of New York, Galderma Laboratories LP and New York University sued generic- drug maker Mylan Pharmaceuticals Inc. for allegedly infringing four patents for the drug Oracea, used to treat skin blemishes.

…

“Mylan was aware of the existence” of the patents, and the patent-holders “will be irreparably harmed” unless stopped by a judge, the plaintiffs said in a complaint filed yesterday in federal court in Wilmington, Delaware.

The Bloomberg release specifically mentions the following patents:

7,211,267: Methods of treating acne
7,232,572: A method of treating rosacea in a human in need thereof comprising administering to said human a tetracycline compound in an amount that is effective to treat rosacea, but has substantially no antibiotic activity.
5,919,775: Method for inhibiting expression of inducible nitric oxide synthase with tetracycline
5,789,395: Method of using tetracycline compounds for inhibition of endogenous nitric oxide production

We also know that Collagenex holds up to 6 patents relating to Oracea. One of these patents, which was highlighted by Rosacea News in May 2006, covers treating ocular and facial rosacea at the same time with one treatment.

The market for rosacea treatments is certainly worth fighting for. The current value of rosacea prescriptions is greater than $500m a year. Galderma is well positioned to take advantage of this market, and the even bigger dermatology market with their rosacea products such as Metrogel, Oracea, the upcoming Sansrosa as well as the Cetaphil range.

Update: some more information has surfaced on the details of the claim

SUNY, NYU, Galderma Sue Generics Firm Mylan for Allegedly Infringing Rosacea Rx IP

The suit alleges that Mylan Pharmaceuticals, a business unit of Mylan Laboratories, recently filed an abbreviated new drug application with the US Food and Drug Administration for a generic doxycycline delayed-release capsule.

Though the date of the filing is not clear, the plaintiffs received notification of Mylan’s ANDA on or about Feb. 4 of this year, and said that Mylan claimed in its ANDA that specific claims of the four patents were invalid and would not be infringed by manufacture or sale of the generic product.

Consequently, SUNY, NYU, and Galderma filed their suit, claiming that Mylan’s ANDA filing and allegations within that filing constituted infringement of the patents; and that they would be irreparably harmed if Mylan were allowed to manufacture or sell the generic product. Moreover, the plaintiffs alleged in their complaint that Mylan’s actions are "an exceptional case … because Mylan was aware of the existence of the [patents] at the time of the submission of [the] ANDA."

…

The oldest of the four patents, No. ‘395, was filed on Aug. 30, 1996, and thus would be set to expire on Aug. 30, 2016; while the youngest, No. ‘267, was filed on Feb. 18, 2005, and thus would expire on Feb. 18, 2025, barring any extensions.

… according to Collagenex’s 2007 financial results, released in March of last year just before the Galderma acquisition closed, Oracea had $52.5 million in net sales in 2007.

And some interesting snippets from Mylan Confirms Four First-to-File Challenges

Mylan Pharmaceuticals was sued by Galderma Laboratories Inc., Galderma Laboratories LP, The Research Foundation of the State University of New York and New York University in the U.S. District Court of Delaware in connection with the ANDA filing for Doxycycline Delayed-release (DR) Capsules USP, 40 mg.

Doxycycline DR Capsules are the generic version of Galderma’s adult rosacea treatment Oracea Capsules, which had approximately $82 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health

ho hum: finacea + oracea vs. metrogel 1% + oracea

Digital Davo — Fri, 06 Mar 2009 05:01:12 +0000

The Clinical Trials register has listed a new trial for papulopustular rosacea. The trial, sponsored by Intendis, the manufacturer of Finacea, wants to compare the combination of Oracea and Finacea, with the combination of Oracea and Metrogel 1%.

It seems clear from this that Intendis would like to position Finacea as a viable alternative to Metrogel. This makes good sense when you consider that Metrogel was responsible for generating sales of about $75 million in 2004.

NCT00855595: Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-Inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-Inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea

Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycycline (40mg)daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.

Whilst sales of pharmaceuticals and thus returns to shareholders are a huge driving force in the big pharma market, this sort of venture is really just tinkering at the edges of rosacea research.

What we all long for, naturally, is real innovation. Real innovation costs big dollars too though, so in the end we do actually benefit from any increases in sales that these sorts of trials will hopefully lead to.

EC approves Oracea for sale in Europe

Digital Davo — Tue, 29 Jul 2008 09:19:36 +0000

The news sites are buzzing with the announcement that the European Commision has granted marketing authority for Oracea. The first domestic approvals for Oracea will be granted in Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg, and the Netherlands. MediGene has the rights to sell Oracea throughout Europe. Local approvals are expected within 30 days.

This news follows on from the announcement in April of a positive opinion by the EMEA.

Potentially good news for those in Europe who would like to try Oracea. I feel I should again point to my comments about the why these sorts of press releases are really not that interesting to rosacea sufferers.

Oracea approved for much of Europe

Digital Davo — Mon, 28 Apr 2008 07:00:08 +0000

In the news this week is an announcement that Oracea is on its way to being approved for sale in Germany, UK, Italy, Austria, Ireland, Sweden, Finland, Luxembourg and The Netherlands.

European Regulatory Authority (EMEA) Recommends Granting Of Marketing Authorization For MediGene’s Drug Oracea

MediGene AG announced that the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) has concluded the approval procedures for Oracea for the treatment of rosacea by issuing a positive opinion. The formal marketing authorization by the European Commission is therefore expected within the next few weeks.

I find it hard to get excited about Oracea press releases. Do we really need all this hooplah about just another antibiotic ? I sometimes feel that Oracea is a bit of a straw tower. Surely everyone out there knows that you can just take a similar dose of generic doxycycline and get the same benefits for a fraction of the cost ? Rather than just continue to be a bit grumpy, here are some reasons that I think Oracea might actually be a good thing for rosacea sufferers.

Low Dose Doxycycline: because of the development and testing of Oracea the concept of a low dose, or sub-antibiotic dose of doxycycline has come to prominence. Proving that it was still possible to get a therapeutic benefit from a low dose has been an achievement. The documented reduction in side effects from a low dose was also worth proving.

Benefits targeted at rosacea: The makers of Oracea, Collagenex previously held a patent related to another low dose doxycycline called Periostat. This drug was mainly prescribed for gum disease. Much of the supporting research around Periostat was motivated by treating gum disease. Periostat could be used to treat rosacea, but that would be off-label – something that some doctors would avoid. The patent relating to Periostat expired, so Collagenex looked to create a replacement product.

Oracea was developed from the start as a treatment for rosacea. Thus we now have some research telling us what dose is considered to be `low-dose doxycycline’, what benefits can be expected for rosacea sufferers and also proof of the long term safety.

Further R&D possible: by purchasing Oracea in large volumes, rosacea sufferers are sending a message to the parent company (Collagenex, which is now owned by Galderma) that this is a market that is worth investing in. Collagenex currently has another drug for rosacea in test: COL-118, or Sansrosa as it is also known. If profits from Oracea are channeled into new ground breaking drugs then that is obviously good for all rosacea sufferers.

Galderma buys CollaGenex for $420m

Digital Davo — Tue, 26 Feb 2008 14:12:55 +0000

Collagenex is set to become a subsidiary of the much bigger Galderma, after CollaGenex agreed to a merger. So 2 of the biggest pharmaceutical companies involved with make rosacea treatments are to become the same company.

Galderma has long been associated with rosacea treatment, and is best known for the metronidazole based topicals metrogel, metrocream and metrolotion. CollaGenex has become known in recent years for their promotion of the oral rosacea treatment Oracea. Further, Collagenex is developing the Sansrosa technology as topical treatment for the redness and flushing of rosacea.

Galderma was formed in 1981 as a joint venture between Nestle and L’Oreal.

It seems like an excellent fit to me with both offering complimentary products. Additionally it is also good news for the creation of new rosacea treatments as the combined resources of the 2 companies can be targeted toward new products.

Read some further news coverage:

Rosacea » oracea

Oracea wins award for cute marketing

So what is Oracea, really ?

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