anacor
anacor pharmaceuticals, inc. , palo alto, california, usa. lzane @ anacor. com .
r - release: anacor _ 1. 1 - 3. tgz, r - oldrel: anacor _ 1. 1 - 3. tgz
anacor pharmaceuticals, inc. (nasdaq: anac) - anacor pharmaceuticals to present phase 3 data of tavaborole for the topical treatment of toenail onychomycosis | benzinga
anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small - molecule therapeutics derived from its boron chemistry platform. anacor' s first approved product, kerydin
pfizer to acquire anacor pharmaceuticals for $ 5. 2 billion - the new york times
pfizer inc. is to pay $ 99. 25 per anacor share. that' s a 55% premium over anacor' s friday closing price of $ 64. 03 .
sandoz launches kerdyn tm (tavaborole) topical solution, 5% from anacor pharmaceuticals, inc .
a copy of the presentation will be available on anacor' s website following the oral session .
score a big win for pfizer and its $ 4. 5 billion buyout of anacor pharmaceuticals. the fda wednesday approved anacor' s eczema treatment that is projected to be a $ 2 billion blockbuster .
the article anacor pharmaceuticals announces fda acceptance of tavaborole nda for filing originally appeared on fool. com .
the submission of the nda is a significant milestone for anacor ,
said david perry, anacor' s chief executive officer .
anacor was founded eleven years ago based on the promise of boron chemistry. tavaborole is the first drug in our pipeline to reach this important milestone, and i' d like to acknowledge and thank the entire anacor team for their hard work, dedication and persistence .
a big blow for anacor as its two patents got invalidated by ptab. anacor hold patent rights on its oxaborole antifungal drug tavaborole which got approved by fda in 2014. (kerydin solution 5 %) .
sandoz launches kerdyn tm (tavaborole) topical solution, 5% from anacor pharmaceuticals, inc. | sandoz
anacor have few or more patents claiming composition and approved indication. the snapshot of tavaborole ob has given below :
anacor pharmaceuticals, inc. clinical study of an2728, a novel anti - inflammatory compound, shows efficacy in psoriasis
through a subsidiary, pfizer plans to launch a cash tender offer for all outstanding shares of anacor common stock for $ 99. 25 per share in cash—55% above anacor’s closing stock price of $ 64. 03 on friday .
we appreciate david' s commitment to anacor and the many contributions he has made over the past 12 years to help build anacor into the company it is today ,
board member paul klingenstein said in a press release .
anacor pharmaceuticals inc. president and ceo david perry has left the company as it awaits approval of its first drug .
pfizer' s buyout of anacor pharmaceuticals for $ 5. 2 billion is a bad move - - here' s why
anacor' s stock was up more than 55% on monday morning, trading as high as $ 99. 86 .
anacor pharmaceuticals, inc. clinical study of an2728, a novel anti - inflammatory compound, shows efficacy in psoriasis | biospace
despite two solid successes together, today anacor is using naeja only for microbiology screening. anacor has expanded its internal chemistry group, and like many drug companies big and small these days, it has shifted most of its discovery chemistry outsourcing to asia .
perry had been in his roles with the anacor since 2002, when he cofounded the company. he left the company tuesday .
anacor also expects to launch pivotal studies for another drug, an - 2728, in patients with mild to moderate atopic dermatitis .
while complimentary to its product portfolio, pfizer' s acquisition of anacor could take a long time to pay off for shareholders .
pfizer has completed its acquisition of silicon valley biotech group anacor securing access to its flagship non - steroidal topical pde4 inhibitor crisaborole .
pfizer is acquiring anacor pharmaceuticals. the deal is expected to close in the third quarter. (mark lennihan / associated press )
in july 2014, sandoz announced an agreement with anacor pharmaceuticals, inc. to obtain exclusive rights to commercialize kerydintm in the us .
contact: david perry, chief executive officer of anacor pharmaceuticals, + 1 - 650 - 739 - 0700; or brian reid of weisscomm partners, inc. , + 1 - 703 - 402 - 3626, breid @ weisscommpartners. com, for anacor pharmaceuticalsinc .
“anacor was founded eleven years ago based on the promise of boron chemistry. tavaborole is the first drug in our pipeline to reach this important milestone, and i' d like to acknowledge and thank the entire anacor team for their hard work, dedication and persistence. ”
the fda has approved eucrisa, an eczema treatment developed by anacor pharmaceuticals, which pfizer bought for $ 4. 5 billion in june .
under the terms of the agreement, a subsidiary of pfizer will acquire anacor for $ 99. 25 a share in cash. that represents a 55 percent premium over anacor’s closing stock price from friday. pfizer plans to finance the transaction through existing cash on its balance sheet .
the investments from gsk and schering corporation fulfill each company' s investment obligations pursuant to their respective and ongoing collaborations with anacor. at the conclusion of the financing, the combined ownership of gsk and schering corporation will be less than 20 percent of anacor' s outstanding shares .
anacor pharmaceuticals is a biopharmaceutical company developing novel small - molecule therapeutics derived from its boron chemistry platform to treat infectious and inflammatory diseases. anacor’s most advanced product candidate is an2690, a novel topical antifungal for the treatment of toenail onychomycosis, a fungal infection of the nail and nail bed. anacor also has a portfolio of other topical product candidates in development for the treatment of psoriasis, atopic dermatitis and skin and nail fungal infections .
pfizer inc. (nyse: pfe) and anacor pharmaceuticals, inc. (nasdaq: anac) today announced that they have entered into a definitive merger agreement under which pfizer will acquire anacor for $ 99. 25 per anacor share, in cash, for a total transaction value, net of cash, of approximately $ 5. 2 billion, which assumes the conversion of anacor’s outstanding convertible notes. the boards of directors of both companies have unanimously approved the transaction. anacor’s flagship asset, crisaborole, a differentiated non - steroidal topical pde4 inhibitor with anti - inflammatory properties, is currently under review by the u. s. fda for the treatment of mild - to - moderate atopic dermatitis, commonly referred to as eczema .
pfizer' s buyout of anacor pharmaceuticals for $ 5. 2 billion is a bad move - - here' s why - - the motley fool
anacor also holds the rights to kerydin, a topical treatment for onychomycosis (toenail fungus) that is distributed and commercialised by sandoz in the us .
anacor' s topical treatment for eczema, called crisaborole, is under review by the food and drug administration. if approved, pfizer said it believes peak year sales could reach or exceed $ 2 billion. anacor, based in palo alto, also holds the rights to a topical treatment for toenail fungus called kerydin .
anacor’s drugs would fit with the innovative business, said albert bourla, group president of pfizer’s global innovative pharma and global vaccines, oncology and consumer health care businesses .
anacor pharmaceuticals today announced that it has raised $ 50 million through a preferred stock financing with participation from glaxosmithkline, schering corporation and existing investors including rho capital partners, venrock associates, care capital and aberdare ventures. proceeds from the financing will be used to further develop anacor' s product pipeline based on its boron chemistry platform .
this press release contains forward - looking statements, including statements regarding the progress, timing and results of anacor' s clinical trials, safety and efficacy of anacor' s product candidates, timing and potential approval of anacor' s product candidates and timing and potential commercial success of anacor' s products. these statements constitute forward - looking statements within the meaning of section 27a of the securities act of 1933 and section 21e of the securities exchange act of 1934. the words
may ,
might ,
will ,
should ,
estimate ,
project ,
plan ,
anticipate ,
expect ,
intend ,
outlook ,
believe
and other similar expressions are intended to identify forward looking statements. readers are cautioned not to place undue reliance on these forward - looking statements, which speak only as of the date of this release and anacor undertakes no obligation to update any forward - looking statement in this press release except as required by law. these forward - looking statements are based on estimates and assumptions by anacor' s management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. the following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by anacor' s forward - looking statements: anacor' s ability to timely and successfully launch, either alone or with a partner, kerydin; any issues or delays arising during the course of anacor' s phase 3 studies or other clinical trials relating to an2728; any delay or failure by the fda to approve an2728; anacor' s ability to timely and successfully launch, either alone or with a partner, an2728; and the other risks identified in anacor' s periodic filings, including anacor' s quarterly report on form 10 - q for the quarter ended march 31, 2014 .
hernandez has no complaints about his asian partners. still, he does look back fondly on anacor’s chemistry collaboration with naeja, recalling the quality of its scientists, their excellent communication skills, and the closeness of the interaction between the two firms. “we treated the chemists on the program like they were anacor chemists, ” he says .
anacor also holds the rights to kerydin, a topical treatment for onychomycosis (toenail fungus) that is distributed and commercialized by sandoz inc. in the u. s .
pfizer inc. is acquiring anacor pharmaceuticals inc. , a california company with a potentially lucrative eczema treatment, in a deal valued at about $ 5. 2 billion .
anacor pharmaceuticals is out to change that. the palo alto, calif. - based biotechnology company is developing a family of boron - containing small - molecule drugs. and with the assistance of naeja pharmaceutical, a canadian contract research organization, anacor has licensed one of those molecules to glaxosmithkline and taken another one into phase iii clinical trials .
“today marks the beginning of an exciting new chapter for anacor, which we believe will deliver significant value to our shareholders, ” said paul l. berns, anacor’s chairman and chief executive officer. “we have a deep respect for pfizer, and it is clear that they share our commitment to addressing the significant unmet medical needs in inflammatory disease. we are proud of the innovative company that our team has built and are confident that pfizer will help accelerate anacor’s important mission given the strength of its global platform and resources. ”
pfizer will acquire anacor pharmaceuticals for $ 5. 2 billion, the companies announced monday. anacor has developed a product, currently under review by the food and drug administration, known as crisaborole, to treat eczema. the company, based in palo alto, calif. , also makes a topical treatment called kerydin for a form of toenail fungus .
anacor could eventually be a decent buy. pfizer reckons annual sales of the target’s crisaborole eczema gel may hit $ 2 billion or more. that would put anacor’s value at $ 9 billion, using pfizer’s multiple of 4. 5 times sales. pfizer is also expected to make a handsome profit from kerydin, which attacks fungus that can grow under toenails .
the closing of the tender offer is subject to customary closing conditions, including u. s. antitrust clearance and the tender of a majority of outstanding anacor shares. under the merger agreement, pfizer will acquire any shares of anacor that are not tendered into the offer through a second - step merger to be completed promptly after the close of the tender offer .
anacor anticipates that it will complete its review of this phase 2a trial for an2728 and an2898 for the treatment of atopic dermatitis in early 2012. following this review, anacor plans to communicate the next steps in the development plans for one or both of these drug candidates in atopic dermatitis. anacor does not anticipate that costs related to development in atopic dermatitis in 2012 will materially affect the company’s previously stated ability to complete its two phase 3 trials for tavaborole in onychomycosis and its first phase 3 trial for an2728 in psoriasis with its current financial resources .
christopher micetich, now president of naeja, recalls that his scientists tackled the anacor job with gusto. company chemists helped discover the benzoxaborole scaffold, which led to the discovery of an2690, an antifungal now being developed to treat onychomycosis, an infection of the toenail. in 2005, an2690 became the first of anacor’s five boron - containing compounds to enter clinical trials .
given the collaboration’s success with the first scaffold, it’s no surprise that anacor hired naeja again a few years later. by then hernandez was on board, and he and his colleagues were trying to figure out what made an2690 work. anacor’s discovery biology group, led by dickon alley, identified the compound’s target, an enzyme called leucyl - trna synthetase, or leurs. then, working with stephen cusack at the european molecular biology laboratory in grenoble, france, anacor scientists solved the cocrystal structure of an2690 bound to leurs from either bacteria or fungi .
pfizer has agreed to acquire anacor pharmaceuticals for approximately $ 5. 2 billion, the companies said today, in a deal that would expand the buyer’s portfolio of inflammation and immunology drugs .
pfizer’s acquisition of anacor would include its flagship asset crisaborole, a differentiated nonsteroidal topical pde4 inhibitor whose nda is under review by the fda. crisaborole is indicated for mild - to - moderate exczema .
centerview partners and guggenheim securities provided financial advice to pfizer, while wachtell, lipton, rosen & katz provided legal advice. anacor was advised by citigroup and the law firm davis polk & wardwell .
given the safety profile exhibited by an2728 in 13 clinical studies, the positive outcome from the atopic dermatitis trial, and the large unmet medical need in atopic dermatitis relative to psoriasis, anacor intends to focus its an2728 development activities on atopic dermatitis in 2012 and will defer the start of the phase 3 trial in psoriasis. anacor will provide more specific information on these activities in a future communication .
pfizer’s $ 5. 2 billion offer for anacor pharmaceuticals, announced on monday, dodges the drug giant’s bigger issue. the company may have made a good deal for anacor, the maker of eczema and toenail - fungus remedies, even though it’s paying a 55 percent premium. the more important question for shareholders, though, is whether pfizer’s chief executive, ian c. read, will break up pfizer .
tavaborole was patented as a product in us 5, 880, 188 a which had expired. the drug was later licensed to anacor, which initiated the trails and succeded to bring the drug into the market .
anacor is a biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform. anacor has focused initially on developing topical applications of its compounds to treat fungal, bacterial and inflammatory diseases. in addition, the company is developing systemic antiviral and antibacterial therapeutics under a research and development agreement with glaxosmithkline. anacor' s most advanced product candidate is an2690, a novel topical antifungal in development for the treatment of toenail onychomycosis, which is a fungal infection of the nail and nail bed. an2690 is licensed to schering - plough corporation under a worldwide development and commercialization agreement for all indications including the treatment of onychomycosis. for more information visit
under the terms of the merger agreement, a subsidiary of pfizer will commence a cash tender offer to purchase all of the outstanding shares of anacor common stock for $ 99. 25 per share in cash. the closing of the tender offer is subject to customary closing conditions, including u. s. antitrust clearance and the tender of a majority of the outstanding shares of anacor common stock. the merger agreement contemplates that pfizer will acquire any shares of anacor that are not tendered into the offer through a second - step merger, which will be completed promptly following the closing of the tender offer. pfizer expects to complete the acquisition in the third - quarter 2016 .
pfizer closed its buyout of anacor in june, a bite - sized deal it knocked off shortly after it halted its planned buyout of allergan. the company abandoned that plan after tax rule changes made them it less appealing .
the us drugs giant announced earlier this year that it would purchase all of the outstanding shares of anacor common stock for $ 99. 25 per share, equating to a deal value of around $ 5. 2 billion .
now that anacor is part of pfizer, we can accelerate our shared commitment to help patients with inflammatory disease, an area of high unmet medical need ,
said albert bourla, group president, pfizer innovative health .
kerydin was designed to be convenient for patients to use and has demonstrated efficacy in the treatment of the fungal infection, thus allowing growth of new uninfected nail ,
said vince ippolito, chief commercial officer of anacor pharmaceuticals .
in market research conducted by anacor, kerydin' s product profile was received with great enthusiasm by the participating physicians and we believe this response demonstrates the need for a safe topical treatment for onychomycosis of the toenails .
pfizer' s buyout of anacor pharmaceuticals for $ 5. 2 billion is a bad move - - here' s why @ themotleyfool # stocks $ pfe, $ anac. dl, $ sny, $ celg, $ regn
the information contained in this release is as of may 16, 2016. neither pfizer nor anacor assumes any obligation to update forward - looking statements contained in this release as the result of new information or future events or developments .
princeton, new jersey, september 22, 2014 - sandoz, through its branded dermatology business, pharmaderm, today announced the us launch of kerydintm (tavaborole) topical solution, 5% , developed by anacor pharmaceuticals, inc .
footnotes: 1 for full safety information, please see the kerydintm (tavaborole) topical solution, 5% , prescribing information, available in the product catalog at urltoken. 2 kerydin is a trademark of anacor pharmaceuticals, inc .
pfizer said today it believes anacor’s crisaborole could rack up peak - year sales of $ 2 billion or more. the pharma giant cited positive results from two phase iii studies showing crisaborole achieving statistically significant results on all primary and secondary endpoints .
while i' m all for having pfizer use its cash flow to boost the inorganic growth side of the equation, i' d contend that it vastly overpaid for anacor when it offered $ 5. 2 billion for the drug developer .
( tavaborole) topical solution, 5% , is an oxaborole antifungal approved by the u. s. food and drug administration in july 2014 for the topical treatment of onychomycosis of the toenails. in july 2014, anacor entered into an exclusive agreement with sandoz inc. , a novartis company, pursuant to which pharmaderm, the branded dermatology division of sandoz, distributes and commercializes kerydin in the united states. in september 2014, pharmaderm launched kerydin. anacor' s lead product development candidate is crisaborole topical ointment, 2% , a novel non - steroidal topical anti - inflammatory pde - 4 inhibitor in development for the potential treatment of mild - to - moderate atopic dermatitis and psoriasis. beyond kerydin and crisaborole, anacor has discovered three investigational compounds that it has out - licensed for further development. anacor also has a pipeline of other internally discovered topical and systemic boron - based compounds in early stages of research and development. for more information, visit
we are pleased to complete this financing, which will allow us to advance our five clinical programs and to identify and progress new compounds derived from our boron chemistry platform ,
said david perry, chief executive officer at anacor pharmaceuticals .
there are some major caveats, of course. anacor has not yet won approval for crisaborole from the food and drug administration. a decision is due by january. and pfizer’s estimates might not account for competing drugs and gels coming to market .
these trial results demonstrate that an2728 has the potential to make an important contribution to the treatment of psoriasis ,
said karl beutner, m. d. , ph. d. , and chair of anacor' s clinical advisory board .
pfizer’s financial advisors for the transaction were centerview partners and guggenheim securities, and wachtell, lipton, rosen & katz acted as its legal advisor. citi served as anacor’s financial advisor, and davis polk & wardwell, llp served as its legal advisor .
anacor requested a special protocol assessment (spa) from the u. s. food and drug administration (fda) for the phase 3 trial design of an2728 in psoriasis and has reached concurrence on the major parameters of the phase 3 trial design .
we believe that pfizer is in a position to quickly capitalise on the benefits offered by the combination with anacor, including the potential for a near - term us product launch and subsequent commercialisation of crisaborole, a differentiated asset with compelling clinical data
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anacor pharmaceuticals (nasdaq: anac) announced today that the first patient has been dosed in a phase 2 trial of an2728 and an2898 to determine safety, tolerability and efficacy of the two compounds for the topical treatment of mild - to - moderate atopic dermatitis .
this press release contains forward - looking statements with respect to the fda goal date for anacor' s product candidate, tavaborole. these forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward - looking statements, including risks related to the regulatory approval process of new drug candidates. reference should be made to anacor' s annual report on form 10 - k for the year ended december 31, 2012, filed with the securities and exchange commission under the heading
risk factors
and anacor' s subsequent quarterly reports on form 10 - q for a more detailed description of such factors. these statements reflect the views of anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward - looking statements, whether as a result of new information, future events or otherwise after the date of this press release .
anacor brought in naeja to optimize abx. once again, micetich says, naeja’s medicinal chemists did the job, helping discover a new molecule, an3365, with the aid of x - ray crystallography and computer modeling. naeja also contributed to process chemistry. the chemists followed their original “medchem” synthesis, which used chiral high - performance liquid chromatography, with a gram - scale synthesis based on diastereomeric salt resolution. according to hernandez, anacor later transferred the naeja process to contract manufacturer regis technologies for phase i clinical trial production with only minor modifications .
since anacor pharmaceuticals was founded, they launched one dru g and are currently in the process of approval for another product. in july 2014, the u. s. food and drug administration approved kerydin® (tavaborole) topical solution, an oxaborole antifungal, for the topical treatment of onychomycosis of the toenails. in a july 13 press release, anacor announced that crisaborole topical ointment, non - steroidal topical anti - inflammatory treatment, had positive top - line results from two phase 3 pivotal studies. in a recent press release, chairman and chief executive officer of anacor paul l. berns said, “we currently plan to file a new drug application for crisaborole in the first half of 2016 and, if approved, we believe crisaborole could offer an important treatment option for patients with mild - to - moderate atopic dermatitis. ”
anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small - molecule therapeutics derived from its boron chemistry platform. anacor has discovered six compounds that are currently in development including its lead compounds: tavaborole, a topical antifungal for the treatment of onychomycosis; an2728 and an2898, topical anti - inflammatory pde - 4 inhibitors for the treatment of psoriasis and atopic dermatitis; gsk ‘052 (formerly referred to as an3365), a systemic antibiotic for the treatment of infections caused by gram - negative bacteria, which has been licensed to glaxosmithkline under the companies' research and development agreement; and an8194 which has been licensed to eli lilly and company for an undisclosed animal health application. anacor is also developing an2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections. for more information, visit urltoken .
“anacor is interested in keeping that boron in the final compound, ” says vincent hernandez, who joined anacor in 2005 as a bench scientist and is now the firm’s director of medicinal chemistry. boron generally forms three bonds to pair up the three electrons in its outer shell. but boron also has an empty p orbital that can form a fourth bond, known as a dative or coordinate covalent bond. when interacting with targets, such bonds offer greater stability than the noncovalent interactions of most pharmaceuticals. they are particularly useful in enzyme inhibition, hernandez says .
anacor was founded in 2002 to develop technology created by lucy shapiro, a stanford university bacterial geneticist, and stephen j. benkovic, a pennsylvania state university organic chemist. through a long - standing scientific collaboration, the two researchers had discovered boron - containing compounds that inhibited specific bacterial targets .
anacor released positive top - line phase iii data for the most advanced of its boron - based anti - infectives, the antifungal tavaborole, but the results weren’t good enough for some shareholders who were looking for the compound to best valeant’s antifungal, currently pending at fda with a may action date .
for the hefty sum of $ 99. 25 in cash per share, or a 55% premium to where anacor shares closed on friday. the crown jewel of the $ 5. 2 billion acquisition is crisaborole, a non - steroidal topical anti - inflammatory pde - 4 inhibitor that' s been submitted for regulatory review in the u. s. for mild - to - moderate atopic dermatitis (a type of eczema). crisaborole is also being studied as a treatment for psoriasis. pfizer believes that anacor' s lead compound could generate up to $ 2 billion in peak annual sales .
as for an2690, anacor launched phase iii clinical trials in december 2010. the company had licensed the compound to schering - plough in 2007, in exchange for a $ 40 million payment, but merck & co. returned commercialization rights in early 2010, some six months after acquiring schering - plough .
with this new treatment and others being explored, anacor researchers have the potential to make an impact in their core therapeutic areas of fungal, inflammatory, and bacterial diseases. their research could also potentially have applications in non - core areas, such as parasitic, cancer, and ophthalmic indications and animal health .
anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small - molecule therapeutics derived from its boron chemistry platform. anacor has discovered eight compounds that are currently in development. its two lead product candidates are topically administered dermatologic compounds — tavaborole, a topical antifungal for the treatment of onychomycosis, and an2728, a topical anti - inflammatory pde - 4 inhibitor for the treatment of atopic dermatitis and psoriasis. in addition to its two lead programs, anacor has discovered three other wholly - owned clinical product candidates — an2718 and an2898, which are backup compounds to tavaborole and an2728, respectively, and an3365 an antibiotic for the treatment of infections caused by gram - negative bacteria. we have discovered three other compounds that we have out - licensed for further development — two compounds for the treatment of animal health indications that are licensed to eli lilly and company and an5568, also referred to as scyx - 7158, for human african trypanosomiasis (hat, or sleeping sickness), which is licensed to drugs for neglected diseases initiative, or dndi. we also have a pipeline of other internally discovered topical and systemic boron - based compounds in development. for more information, visit http: / / www. anacor. com .
anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small - molecule therapeutics derived from its boron chemistry platform. anacor has discovered six compounds that are currently in development including its three lead programs: tavaborole, a topical antifungal for the treatment of onychomycosis; an2728, a topical anti - inflammatory pde - 4 inhibitor for the treatment of psoriasis and atopic dermatitis; and gsk 2251052, or gsk ‘052 (formerly referred to as an3365), a systemic antibiotic for the treatment of infections caused by gram - negative bacteria, which has been licensed to glaxosmithkline under the companies' research and development agreement. anacor is also developing an2718 as a topical antifungal product candidate for the treatment of onychomycosis and skin fungal infections and an2898 as a topical anti - inflammatory product candidate for the treatment of psoriasis and atopic dermatitis. in addition, an8194 has been licensed by eli lilly and company and is in development for an animal health application. for more information, visit urltoken .
anacor’s flagship asset, crisaborole, has a new drug application under review by the u. s. food and drug administration (fda), is a differentiated non - steroidal topical pde4 inhibitor with compelling clinical data, and if approved, has the potential to be an important first - line treatment option for patients with atopic dermatitis
kerydin is, to be blunt, an afterthought in this acquisition. anacor forged an agreement with sandoz to help market kerydin back in 2014, and last year total distribution and commercialization segment revenue was $ 69. 7 million. with peak sales estimates of $ 400 million, it' s not going to move the needle much for pfizer .
anacor, meanwhile, already had an approved drug in kerydin, an anti - fungal drug that is marketed in the u. s. by novartis’ generics unit sandoz. the big draw for pfizer, however, was the non - steroidal topical gel crisaborole, which pfizer has said would be the first new eczema treatment approved in 15 years .
anacor’s work - around was a family of cyclic boronic esters known as benzoxaboroles. the firm discovered the esters about eight years ago under a $ 22 million department of defense contract to explore the use of boron chemistry against biowarfare agents such as anthrax. because of their cyclic element, benzoxaboroles have improved solubility and better metabolic stability, hernandez says .
it was hernandez himself who discovered the breakthrough an2690 derivative, known as abx. subsequent preclinical results formed the basis of the gsk collaboration. in october 2007, the pair signed a boron - based anti - infective medicines deal worth $ 12 million up front to anacor and as much as $ 331 million in milestone payments for each product candidate .
“we believe the acquisition of anacor represents an attractive opportunity to address a significant unmet medical need for a large patient population with mild - to - moderate atopic dermatitis, which currently has few safe topical treatments available, ” albert bourla, group president of pfizer’s global innovative pharma and global vaccines, oncology and consumer healthcare businesses, said in a statement .
anacor announced earlier this year that tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two phase 3 pivotal studies of tavaborole to treat onychomycosis topically without concomitant debridement. the only currently fda - approved topical treatment for onychomycosis is approved with concomitant nail debridement, and currently approved oral therapies have been associated with rare but serious safety issues .
if you follow the stock market, you’ve surely taken note of the continually climbing value of anac stock (anacor pharmaceuticals, a biopharmaceutical company based in palo alto, california). the company, founded in 2002, was created around boron chemistry technology developed by dr. stephen benkovic of penn state university and co - founder dr. lucy shapiro of stanford university .
this press release may contain forward - looking statements that relate to future events including the timing for filing of a new drug application, or nda, related to tavaborole and the potential fda approval of tavaborole. these forward looking statements involve known and unknown risks, uncertainties and other factors that could cause actual levels of activity, performance or achievement to differ materially from those expressed or implied by these forward - looking statements, including risks related to regulatory approval of new drug candidates. reference should be made to anacor' s annual report on form 10 - k for the year ended december 31, 2012, filed with the securities and exchange commission under the heading
risk factors
and anacor' s subsequent quarterly reports on form 10 - q for a more detailed description of such factors. these statements reflect the views of anacor as of the date of this press release with respect to future events and, except as required by law, it undertakes no obligation to update or revise publicly any forward - looking statements, whether as a result of new information, future events or otherwise after the date of this press release .
anacor pharmaceuticals (nasdaq: anac) announced today that on july 26, 2013 it submitted its new drug application (nda) to the u. s. food and drug administration (fda) for tavaborole, its drug candidate for the topical treatment of onychomycosis. onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the united states .
“we are pleased to present these positive data at the apma' s annual scientific meeting, the leading annual meeting of podiatrists. as we seek fda approval for tavaborole, we look forward to developing relationships with podiatrists to potentially offer them a new treatment option for the large number of patients who seek treatment for onychomycosis, ” said david perry, chief executive officer of anacor pharmaceuticals .
although velcade has nothing to do with anacor or gsk, perry interprets its approval and growing use as the final proof that boron itself poses no fundamental risk to humans; safety will be determined by the design of individual drugs, just as has been the case with traditional carbon - based compounds. meanwhile, anacor hopes to make its commercial debut with a boron - based drug called an2690 ®, which they hope to use to treat onychomycosis, a fungal infection that affects fingers and toes, causing the nail to become brittle and discoloured with soreness of the surrounding skin. although rarely serious, onychomycosis can cause pain and accounts for half of all nail abnormalities, so any treatment has considerable market potential; phase iii clinical trials are scheduled to begin early in 2009 .
the good news here is pfizer is generating more than enough cash flow to facilitate additional deals, and its oncology segment is on fire with an immuno - oncology offering (avelumab) waiting on the wings. the bad news is i don' t believe its acquisition of anacor was a particularly good move, and i don' t see any immediate benefits to this deal for shareholders .
an2690 is a potent antifungal that doesn’t inhibit bacteria, and the crystal structure showed that this was because the compound wasn’t reaching a key binding site on bacterial leurs. analogs of an2690 that bound there as well, the anacor team reasoned, would have the potential to inhibit bacteria instead of fungi. “that was the beginning of a structure - based drug design program, ” hernandez says .
palo alto, calif. , june 6 / prnewswire / - - anacor pharmaceuticals, a privately held pharmaceutical company, announced today the results from its placebo - controlled phase 1 trial of an2728, a first - in - class topical therapy under investigation for the treatment of psoriasis. the trial showed an2728 to be well - tolerated, with activity comparable to existing topical treatments for psoriasis .
the timing of perry' s departure is odd, considering that anacor is ramping up for potential food and drug administration approval by the end of july of the nail fungus treatment kerydin. the company earlier this month hired vince ippolito as executive vice president and chief commercial officer, noting his experience in launching new products, and perry last week led the company' s quarterly call with analysts .
anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small - molecule therapeutics derived from its boron chemistry platform. anacor has discovered seven compounds that are currently in development. its two lead product candidates are topically administered dermatologic compounds — tavaborole, a topical antifungal for the treatment of onychomycosis, and an2728, a topical anti - inflammatory pde - 4 inhibitor for the treatment of atopic dermatitis and psoriasis. in addition to its two lead programs, anacor has discovered three other wholly - owned clinical product candidates — an2718 and an2898, which are backup compounds to tavaborole and an2728, respectively, and an3365 an antibiotic for the treatment of infections caused by gram - negative bacteria. we have discovered two other compounds that we have out - licensed for further development — one compound for the treatment of an animal health indication that is licensed to eli lilly and company and an5568, also referred to as scyx - 7158, for human african trypanosomiasis (hat, or sleeping sickness), which is licensed to drugs for neglected diseases initiative, or dndi. we also have a pipeline of other internally discovered topical and systemic boron - based compounds in development. for more information, visit urltoken .
both an2728 and an2898 have demonstrated efficacy in human clinical trials of psoriasis ,
said david perry, chief executive officer of anacor pharmaceuticals .
pre - clinical studies suggest that they may also be effective in treating atopic dermatitis. this trial is intended to understand the potential of each compound to treat the disease, and, if effective, determine which compound to progress further in development .
a further description of risks and uncertainties relating to pfizer and anacor can be found in their respective annual reports on form 10 - k for the fiscal year ended december 31, 2015 and in their subsequent quarterly reports on form 10 - q and current reports on form 8 - k, all of which are filed with the u. s. securities and exchange commission (the “sec”) and available at urltoken .
we are pleased to announce the fda approval of kerydin, which provides an important new topical treatment option for the millions of people in the united states who are infected with onychomycosis of the toenails ,
said paul berns, chief executive officer of anacor pharmaceuticals .
we expect to launch kerydin in the u. s. , either alone or with a partner, as early as the end of this quarter .
taking this step by step, pfizer really is getting two assets: kerydin and cirsaborole. anacor does have other topical anti - inflammatory products in development, but they' re all in the discovery or preclinical stages of development. aside from these two therapies, the only other drug in clinical studies is an3365 for infections caused by gram - negative bacteria, and it' s far too early to tell if this clinical therapeutic is effective .
anacor pharmaceuticals (nasdaq: anac) announced today preliminary results from its phase 2b trial of an2728 for the treatment of mild - to - moderate plaque - type psoriasis. the trial enrolled 68 subjects randomized in a 2: 1 ratio, an2728 to vehicle. subjects treated with an2728 showed improvement over vehicle at each of the recorded timepoints during the 12 - week study period with peak efficacy of 26% occurring after six weeks of treatment with an2728 .
prior to anacor’s experimentation with boron, researchers had limited understanding of the physical properties of the chemical element, despite its occurrence in many natural substances, such as fruits, vegetables, milk, and coffee. in their early years, the company explored the potential uses of boron in drug development and found that their boron platform had potential applications in the treatment of multiple diseases including bacterial, fungal, viral, and parasitic infections as well as inflammatory diseases .
anacor conducted two separate phase 3 studies of tavaborole on patients with distal subungual onychomycosis affecting 20 to 60 percent of the target great toenail. approximately 600 patients aged 18 years and older with no upper age limit (the oldest subject was 88 years old) were enrolled in each study and randomized two - to - one to receive either tavaborole or the vehicle control. patients were instructed to apply tavaborole solution or the vehicle to the toenail once daily for 48 weeks .
as announced earlier this year, tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two phase 3 pivotal studies without concomitant debridement. anacor is seeking approval for tavaborole from the food and drug administration (fda) and will file a new drug application imminently. currently, there is only one fda - approved topical treatment for onychomycosis, a fungal infection of the nail and nail bed, which affects approximately 35 million people in the united states .
it was while working under the defense contract that anacor hired naeja to assist the two chemists on its staff. at the time, naeja was a three - year - old contract research firm run by ronald micetich and his son christopher. based in edmonton, alberta, the firm is staffed by chemists and biologists from a variety of nations who have found canada welcoming to highly educated immigrants. about three - quarters of its staff are chemists, and almost all have ph. d. s .
we are pleased with the results of this study and we are on track with our plans to file an nda in the middle of this year ,
said david perry, chief executive officer of anacor .
in both phase 3 trials, tavaborole demonstrated better efficacy than ciclopirox lacquer, the only approved topical treatment for onychomycosis. importantly, ciclopirox lacquer requires concomitant nail debridement. if approved, tavaborole could offer patients and prescribers a safe, effective and convenient topical treatment option for onychomycosis .
“these data confirm the safety of an2728 and the potential for it to be used on areas of the body that are susceptible to side effects from steroids and tend to be sensitive to irritation from vitamin d analogs, ” said david perry, ceo of anacor pharmaceuticals. “all of the clinical studies we have done to date on an2728 in psoriasis and atopic dermatitis support that it could be a potentially safe and effective topical treatment for patients who suffer from mild - to - moderate psoriasis or atopic dermatitis. ”
the payoff for all of the work was a licensing deal with gsk. last july, the british firm paid anacor $ 15 million and exercised its option to take over development of an3365. david j. payne, vice president of gsk’s antibacterial drug discovery unit, lauded the compound, now renamed gsk2251052, as having “the potential to be the first new - class antibacterial to treat serious hospital gram - negative infections in 30 years. ” gsk chemists have since developed a stereospecific synthesis for commercial - scale production .
according to anacor’s researchers, boron has two unique qualities that give it advantages in the drug discovery process. “first, boron has a unique geometry that allows compounds made from it to have two distinct shapes, giving boron - based drugs the ability to interact with biological targets in novel ways and to address targets not amenable to intervention by traditional carbon - based compounds. and second, boron' s enhanced reactivity as compared to carbon allows the molecules to hit targets that are difficult to destroy with carbon chemistry. ”
palo alto, calif. - - (business wire) - - anacor pharmaceuticals, inc. (nasdaq: anac) today announced that the u. s. food and drug administration (fda) has approved the new drug application for kerydin™ (tavaborole) topical solution, 5% , the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails. onychomycosis is a fungal infection of the nail and nail bed that affects approximately 35 million people in the united states, according to podiatry today .
anacor pharmaceuticals (nasdaq: anac) announced today that its abstract “pivotal phase 3 safety and efficacy results of tavaborole (formerly an2690), a novel boron - based molecule for the topical treatment of toenail onychomycosis” was accepted for oral presentation at the 2013 apma annual scientific meeting (the national) to be held in las vegas, nevada. max weisfeld, dpm, will present the data from tavaborole' s phase 3 studies on monday, july 22, 2013 during the evidence - based medicine and oral abstracts session .
“we believe the acquisition of anacor represents an attractive opportunity to address a significant unmet medical need for a large patient population with mild - to - moderate atopic dermatitis, which currently has few safe topical treatments available, ” said albert bourla, group president of pfizer’s global innovative pharma and global vaccines, oncology and consumer healthcare businesses. “crisaborole is a differentiated asset with compelling clinical data that, if approved, has the potential to be an important first - line treatment option for these patients and the physicians who treat them. ”
in both of its phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and in march 2016, the fda accepted for review anacor’s new drug application seeking approval of crisaborole for the potential treatment of mild - to - moderate atopic dermatitis in children and adults. the prescription drug user fee act (pdufa) goal date for the completion of the fda’s review is january 7, 2017. if approved, pfizer believes peak year sales for crisaborole have the potential to reach or exceed $ 2. 0 billion .
this early - stage trial demonstrated definitive anti - inflammatory activity in humans. we are encouraged that the compound decreases tnf - alpha, a cytokine known to be important in psoriasis, by the inhibition of pde4, a well - validated anti - inflammatory target ,
said karl beutner, anacor' s chief medical officer .
a topical compound that effectively targets tnf - alpha would have great promise, and we intend to initiate further clinical trials to characterize the clinical utility of this drug in psoriasis and other inflammatory skin diseases .
“we are encouraged by this preliminary data demonstrating the safety and efficacy of both an2728 and an2898 in atopic dermatitis and believe it supports further development of one or both of these compounds in this indication, ” said david perry, anacor’s chief executive officer. “due to the large number of children who suffer from atopic dermatitis, safety is a critical consideration in the treatment of this disease. given the promising profiles of an2728 and an2898, we believe that both compounds have the potential to become safe and effective alternatives to existing treatments for atopic dermatitis. ”
anacor, a privately held, clinical - stage pharmaceutical company, is developing novel product candidates for inflammatory, fungal and bacterial diseases based on its proprietary, small - molecule, boron - based chemistry. the company' s lead product is an2690, which is in phase 2 trials for onychomycosis, a fungal infection of the nail and nailbed. ancor has entered into an exclusive, worldwide agreement with schering - plough corporation to develop and commercialize the drug. the company is also conducting clinical trials with two anti - inflammatory product candidates, an2728 and an0128
) - - anacor pharmaceuticals (nasdaq: anac) today announced positive preliminary results from the second of two phase 3 trials of tavaborole (known as study 302). tavaborole is a topical anti - fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the united states. results from the first phase 3 trial (known as study 301) were announced on january 29, 2013. in both studies, tavaborole achieved statistically significant and clinically meaningful results on all primary and secondary endpoints.
anacor pharmaceuticals is a biopharmaceutical company focused on discovering , developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform . it is based in palo alto , california , united states . anacor was founded in 2002 based on technology created by lucy shapiro at stanford university and stephen benkovic at pennsylvania state university . cofounder david perry served as ceo and president from 2002 to 2014 , and took the company public in 2010 . since then , the company has generated a pipeline of both topical and systemic boron-based compounds of which five are currently in clinical development . in may 2016 , pfizer announced it would acquire anacor pharmaceuticals for $ 5.2 billion , expanding the company 's portfolio in both inflammation and immunology drugs areas . 
anacor pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. it is based in palo alto, california, united states. anacor was founded in 2002 based on technology created by lucy shapiro at stanford university and stephen benkovic at pennsylvania state university. cofounder david perry served as ceo and president from 2002 to 2014, and took the company public in 2010. since then, the company has generated a pipeline of both topical and systemic boron-based compounds of which five are currently in clinical development. in may 2016, pfizer announced it would acquire anacor pharmaceuticals for $ 5.2 billion, expanding the company's portfolio in both inflammation and immunology drugs areas.
anacor pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. it is based in palo alto, california, united states. anacor was founded in 2002 based on technology created by lucy shapiro at stanford university and stephen benkovic at pennsylvania state university. cofounder david perry served as ceo and president from 2002 to 2014, and took the company public in 2010. since then, the company has generated a pipeline of both topical and systemic boron-based compounds of which five are currently in clinical development. in may 2016, pfizer announced it would acquire anacor pharmaceuticals for $ 5.2 billion, expanding the company's portfolio in both inflammation and immunology drugs areas.