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Anacor pharmaceuticals inc anac By jason napodano, cfathe lead product candidate at anacor is tavaborole, currently in phase 3 trials for onychomycosis(Nail fungus).Onychomycosis is primarily caused by fungi(Dermatophytes)That infect the skin, hair or nails.The infection can manifest on the nail plate, nail bed, and the skin surrounding the nail itself.Signs and symptoms include deformation and discoloration of the nail.Besides the obvious physical and social implications, because the nails become thicken, split, or even brittle, it can be painful for patients with onychomycosis to wear shoes. We see onychomycosis as a significant market opportunity for anacor.An estimated 35 million americans have nail fungus, with about 95% of the infections in the toenail.Glaxo's lamisil(Terbinafine), an oral tablet, is the market leading product, with an estimated 80% prescription share.Lamisil, now available as a generic, posted sales of $1.2 billion at its peak(2004).According to ims health, doctors wrote nearly 1.5 million prescriptions for terbinafine in 2010.Still, glaxo estimates that 50% of the market goes untreated, giving competitors a significant opportunity to grow despite generic alternatives. Glaxo has since formulated terbinafine into a cream and spray, approved for athlete's foot and jock itch.Ims health reports over 350, 000 ciclopirox prescriptions annually. Terbinafine is an effective product, with 38% clear nail and mycological cure after 12 weeks.The problem with terbinafine is the systemic exposure and harmful sideeffects, including liver toxicity.The fda recommends patients undergo liver function testing prior to starting treatment with terbinafine, an inconvenience for patients seeking a simple treatment for nail fungus.Topical ciclopirox is a relatively clean drug, but listed efficacy according to the label is low, only 5.5% to 8.5% clear nail and mycological cure at 12 weeks.The ideal product would have the efficacy of terbinafine with a topical administration and clean safety profile. Enter tavaborole, anacor's topical solution currently in two phase iii trials for onychomycosis.Phase ii data with tavaborole suggests efficacy beats by dre outlet online superior to ciclopirox with little to no systemic exposure. Data from an openlabel phase ii program with tavaborole showed 50% patients using a 7.5% solution saw 2 mm clear nail growth and negative fungal cultures after six months.Roughly 25% of the patients saw 5 mm clear nail growth and negative fungal cultures after six months.Fda in 2009 to discuss the phase ii data.Merck has since returned the rights to tavaborole to anacor.The original deal was with scheringplough in 2007.Merck most likely felt as though tavaborole clashed with existing products or did not have peak sales potential large enough to continue the partnership with anacor.We see tavaborole as a specialty promoted product, into podiatrists and dermatologists.For a company like anacor, it's an attractive first product. Anacor's first phase iii trial completed enrollment in november 2011.The second phase iii trial completed enrollment in december 2011.Data from these trials are expected late 2012 and early 2013, respectively.Given the positive phase ii data noted above, we think odds favor a positive outcome.The drug is being designed to have efficacy similar to midpotency corticosteroids and vitamin d analogs, but with improved safety and tolerability, the benefits of which would allow for longer duration of treatment.These two products dominate the topical care market, but each has limitations. An2728 is a novel boroncontaining small molecule that inhibits pde4 and reduces the production of tnfalpha, a precursor of the inflammation associated with psoriasis, as well as other cytokines, including il12 and il23, which are proteins believed to be involved in the inflammation process and immune responses.Tnfalpha inhibitors such as enbrel, humira, and remicade posted sales in excess of $20b in 2010 for the treatment of rheumatoid arthritis and psoriasis.If approved, an2728 would be the first topical nonsteroidal treatment that inhibits tnfalpha.Psoriasis is characterized by thickened patches of inflamed, red skin covered with thick, silvery scales typically found at the elbows, knees, scalp and genital area.Patients can be categorized as mild, moderate or severe, with approximately 80% of patients having mild to moderate forms of the disease.And europe.Current treatment options have varying degrees of efficacy and tolerability.While we do not believe the market is underserved, an effective topical treatment option with a proven mechanism of action through a novel delivery such an2728 or an2898 could gain meaningful market share.And europe.The condition most commonly appears in childhood and it can persist into adulthood.Skin that is broken and chafed from itching allows bacterial or viral access, which leads to secondary infections.Current atopic dermatitis treatments attempt to reduce inflammation and itchiness to maintain the protective integrity of the skin.Combinations of antibiotics, antihistamines, topical corticosteroids and topical immunomodulators, roundout the current standard of care.This type of mixedpharmacology creates issues with compliance and sideeffects / tolerability.There is also a backup compound in an2898 under development. Phase iia data in mildtomoderate atopic dermatitis announced in december 2011 show bts solid results for both an2728 and an2898.The primary endpoint for both compounds was successfully achieved after 28 days of twicedaily treatment, with 64% of an2728treated lesions showing improvement in atopic dermatitis severity index score versus 24% for vehicle(P = 0.05)And 71% of an2898treated lesions showing improvement in adsi score versus 14% for vehicle(P = 0.01).There were no severe adverse events reported that were considered related to either study drug.We expect anacor to make a decision shortly on advancing one of these compounds into phase ii shortly. Phase iib data in mildtomoderate plaquetype psoriasis was released in june 2011.The 68 subject trial showed encouraging signs of efficacy and tolerability.An2728 was superior to the control at each of the recorded timepoints during the 12week study period, with peak efficacy of 26% occurring after six weeks.The company also recently announced that a maximal use systemic exposure study in patients with psoriasis met its preliminary safety endpoint.The data confirms the safety and tolerability of the drug in patients susceptible to sideeffects from steroids and/or vitamin d analogs. Between psoriasis and atopic dermatitis, we see an2728 and an2898 as having peak sales potential north of $500 million.The most recently approved novel topical treatments for atopic dermatitis were topical immunomodulators, protopic(Tacrolimus)And elidel(Pimecrolimus), approved in 2000 and 2001, respectively.These types of infection typical occur in the hospital setting and have limited treatment options.This is an enormous market opportunity.Each year, with over 100, 000 deaths.The new england journal of medicine also indicates that gramnegative bacteria are responsible for more than 30% of hospitalacquired infections and account for approximately 70% of hospitalacquired infections in the intensive care unit.Ims health estimates that there were 45 million days of gramnegative therapy administered in the united states in 2009.It's a near $10 billion pharmaceutical market. Anacor reported results from a phase i study on in june 2010.Results showed the antibiotic to be safe and welltolerated.In june 2011, gsk initiated two separate phase 2b trials of in complicated urinary tract infections(Cuti)And complicated intraabdominal infections(Ciai). The phase iib trial in cuti is a multicenter, randomized, doubleblind, multidose study of the safety, tolerability, and efficacy of in the treatment of adult subjects with febrile lower cuti and acute pyelonephritis.Will be compared to imipenemcilastatin, an antibiotic commonly used to treat serious cuti.Gsk anticipates enrolling approximately 200 patients. The phase iib trial in ciai is a multicenter, randomized, doubleblind, multidose study of the safety, tolerability and efficacy of gsk '052 in the treatment of ciai in adults.Gsk '052 will be compared to meropenem, an iv therapy that is approved for use in the treatment of subjects with ciai.Gsk anticipates enrolling approximately 200 patients. Unfortunately, glaxo recently halted enrollment in both these programs due to recently identified microbiological finding in a small number of patients in the cuti trial.Glaxo is in the process of obtaining additional information in order to better understand the data.Enrollment in the ciai trial has been halted as well while glaxo investigates the findings.Glaxo expects to resume enrollment in the trials once it has concluded its investigation, assuming a path forward is found.The contract provides up to $94 million in funding for up to four years to support studies to evaluate the efficacy of gsk '052 against bioterrorism threats, phase ii clinical trials for ventilatorassociated pneumonia, and phase iii trials for complicated intraabdominal infections. Anacor is eligible to receive further development milestones up to $69.0 million, commercial milestones up to $175.0 million and doubledigit tiered royalties with the potential beats by dre pro sale to reach the midteens on annual net sales of.The collaboration was recently expanded to include tuberculosis and malaria using anacor's boron chemistry platform.We think if glaxo can get back on track in the two above phase ii programs, it provides meaningful upside to the anacor story. Related Links: http://qqw0715.spazioblog.it/220453/Spotlight+on+steve+madden+michael+kors+sale+taschen.html http://www.purevolume.com/listeners/qianqianwen/posts/715397/any+damage+to+the+christian+louboutin+homme+case http://plugins.righthere.com/beats-dre-outlet-store-critical-event/

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