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Thread: oracea approved.

  1. #1
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    Default oracea approved.

    While reading this please note the current U.S market size, with this much money in this large of a demograph, why wouldnt drug companys throw a hell of alot more money at this problem, is it the fact that they can just tweek formulations for cheap then drill the demograph....I really hope we dont get stuck in a cycle like this, which is what I am seeing. Anyways happy reading



    May 30, 2006 07:00 AM US Eastern Timezone
    CollaGenex Pharmaceuticals Receives FDA Approval for Oracea(TM); Commercial Launch to Dermatologists of First Orally-Administered Treatment for Rosacea Planned for July 2006
    NEWTOWN, Pa.--(BUSINESS WIRE)--May 30, 2006--CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced that the U.S. Food & Drug Administration (FDA) has approved Oracea(TM) for the treatment of inflammatory lesions (papules and pustules) of rosacea in adult patients. Oracea is the first FDA-approved, orally-administered, systemically-delivered drug to treat rosacea, a dermatologic condition that affects an estimated 14 million adults in the U.S. CollaGenex plans to launch Oracea to the dermatology community in July 2006.


    Klaus Theobald, M.D., Ph.D., chief medical officer of CollaGenex, said, "Rosacea is a chronic inflammatory skin condition affecting the facial appearance of millions of people. Our New Drug Application for Oracea included highly significant results from two pivotal Phase III clinical trials that demonstrated the efficacy and safety of this anti-inflammatory drug in the treatment of the inflammatory lesions of rosacea in adult patients. Oracea provides dermatologists and rosacea-sufferers a safe and effective treatment with the convenience of once-a-day oral administration."

    Colin Stewart, president and chief executive officer, stated, "Oracea is the first of a series of dermatology products we have in development, and we are very pleased that our NDA was approved by the FDA within 10 months of submission. Sufficient quantities of Oracea capsules have been manufactured for launch and can now be packaged for distribution to the trade in July. Over the past six months, we have built a first-rate specialty sales force to launch Oracea, and all of our representatives were fully trained and in their territories by the end of April. This is an extremely exciting time for CollaGenex, and we look forward to providing dermatologists and their patients with this exciting new therapy to treat rosacea."

    About Rosacea

    Rosacea is a dermatologic condition that affects approximately 14 million adults in the U.S. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules and pustules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin. The current U.S. market size for rosacea is estimated to be approximately $500 million.

    About Oracea

    Oracea is a 40 mg, unique capsule formulation of doxycycline, USP, dosed once-a-day and containing a combination of immediate and delayed release beads. The NDA approval was based primarily upon the safety and efficacy results of two Phase III, double-blinded, placebo-controlled clinical trials. These studies enrolled a total of 537 patients in 28 centers across the U.S. In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20% mean reduction, respectively, in patients receiving placebo. The differences were clinically and statistically highly significant (p less than 0.001 in each study). Side effects of the drug were similar to placebo.

    About CollaGenex

    CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing proprietary, innovative medical therapies to the dermatology market. CollaGenex's professional dermatology sales force markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc., Alcortin(TM) (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort(TM) (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the Company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex is preparing to launch Oracea, the first FDA-approved systemic product for the treatment of rosacea, and is conducting a 300-patient, Phase II dose-finding study to evaluate its second dermatology candidate, incyclinide, for the treatment of acne. CollaGenex is also developing COL-118, utilizing the technology acquired in the SansRosa acquisition, as a preclinical topical compound for the treatment of redness associated with rosacea and other skin disorders.

    CollaGenex also currently sells Periostat(R), which the Company developed as the first pharmaceutical to treat periodontal disease by inhibiting the enzymes that destroy periodontal support tissues and by enhancing bone protein synthesis, and Atridox(R), Atrisorb FreeFlow(R) and Atrisorb-D FreeFlow(R), which are products of QLT Inc., the successor to Atrix Laboratories, Inc., for the treatment of adult periodontitis.

    Research has shown that certain tetracyclines can be chemically modified to remove their antibiotic effects while retaining the properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is evaluating various chemically modified tetracyclines (so called "IMPACS" compounds because they are Inhibitors of Multiple Proteases And CytokineS") to assess whether they are safe and effective in these applications. The Company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the Restoraderm(R) technology, a unique, proprietary dermal drug delivery system, and plans to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.

    To receive additional information on the Company, please visit our Web site at www.collagenex.com which does not form part of this press release.

    Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's plans, timing and success related to the launch of Oracea for the treatment of inflammatory lesions of rosacea, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in the most recent Form 10-Q for the quarter ended March 31, 2006 under the section "Risk Factors" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex' expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    Periostat(R) and Restoraderm(R) are registered trademarks and IMPACS(TM), and Oracea(TM) are trademarks of CollaGenex Pharmaceuticals, Inc.

    All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.

    Novacort(TM) and Alcortin(TM) are trademarks of Primus Pharmaceuticals, Inc.

    Pandel(R) is a trademark of Taisho Pharmaceuticals.

    Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered trademarks of QLT USA, Inc.

  2. #2
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    Hmmm, well I guess we cant grill Collagenex to hard as they are pretty much the only pharm actively on a mission to sort rosacea. There are probably many others, but none that Im aware of (not that I necessarily would!).

    But I do get your point totally. Oracea does sound like a big bowl full of nothing! Lets hope that Im proven wrong.

    BB

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    It sounds to me like they took something that is already in use to treat acne, and spun it with a different name for the rosacea market.

    I think if another company comes out with a new drug, Collagenex will simply buy them out. Isn't that what happened to SanRosa?

    On the one hand, I wish this drug would be boycotted altogether, putting pressure on them to put forth the effort and their already-acquired gobs of money to make something better. But on the other, I do feel fortunate not to have papulopustular rosacea, and I hope this new drug is able to successfully treat those who do.

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    Senior Member redhotoz's Avatar
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    I thought the big 'whoo haa' about Oracea is that it is a *slow release* formula, different than taking regular low does Doxycycline or Periostat? My understanding is that this would mean we would get the anti-inflammatory effect without our 'good bacteria' being attacked, as happens with regular antibiotics.

    I haven't read enough about it really but at least they are specifically targetting Rosacea, which surely has to be a good thing!

    Heck, some of us use a nasal spray on p&p and glaucoma eye drops on our face! Would be nice to think a doctor could look up Roscaea and find specific products, especially designed for Rosacea, rather than us having to do the leg work ourselves. Yeah, well, it may be a long way off before we can go to a GP and get the *best* treatment possible, from the flick of a button on the doc's computer but I think it's encouraging to know they are looking at the potential market in Rosacea. Maybe we are no longer considered a 'cosmetic probelm'?

    Just wait til I write to my Derm and tell him that I HAVE proved that controlling Rosacea can be done naturally. Hah! Would love to see the look on his face when he reads my letter! Of course, I need to allow at least 6 months before I write to him, but I've alrady drafted a letter in my mind!

    Jen
    Currently trying: Apr 06 Bee Wilder's Candida (natural healing) Diet; May 06 Home made red LED array; Aug 06 ZZ ointment.

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    Bob
    I wasnt grillin em, just frustrated, because the rosacea market is huge, not a billion dollar market like psoriasis, but getting there, it would seem that company would be clamering to sink their teeth into a treatment that actually works to get a slice of this action and possibly corner this market. I digress, In actuallity, I have seen quite a few new studies being performed and maybe some of these psoriasis treatments could cross over to rosacea but I must reiterate the frustration is always there.
    I just hope that collagenex just didnt want their patent back on doxy, that would really be upsetting.
    J

  6. #6
    Senior Member Miki's Avatar
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    im definetly gonna try it when it comes out, but my expectations are very low.

  7. #7
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    no lessions or pimples here so this stuff would be useless for me , i'm seriosly considering ETS , especially that it's fully covered by NFZ (narodowy fundusz zdrowia or national health care in poland ) wi'll se how few other react to it as more people from our forum line up for it

    ps.i'm totally aware of sites like the truth about ets and others that point out very rare but serius side effects , its just that there is a point where you have to ask your self whats better , living on the edge of suacide with a ton of personal and financial problems all due to the fuc... flushes and permanent rednes or a chance at normal life
    "na zdrowie" and be cool - literally

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