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Anacor Pharmaceuticals, Inc. (Pfizer)

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March 22, 2016
Anacor Pharmaceuticals Announces FDA Acceptance of NDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis
PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review Anacor's New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development 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.

"We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are suffering with mild-to-moderate atopic dermatitis," said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. "We look forward to working with the FDA during its review of the crisaborole NDA."

In July 2015, Anacor announced the positive top-line results from its two Phase 3 pivotal studies of crisaborole. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015, Anacor announced the top-line results from its long-term safety study, in which crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.
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Source: press release, 3/22/16. http://investor.anacor.com/releasedetail.cfm?ReleaseID=961687

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January 7, 2016
Anacor Pharmaceuticals Submits New Drug Application to the FDA for Crisaborole Topical Ointment, 2% for the Treatment of Mild-to-Moderate Atopic Dermatitis
PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

"The submission of the NDA for crisaborole topical ointment, 2% represents an important milestone for our atopic dermatitis development program, as we continue to leverage our boron chemistry platform to pursue innovative new therapies," said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. "We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are suffering with mild-to-moderate atopic dermatitis and we look forward to working with the FDA during its review of the crisaborole NDA."

In July 2015, Anacor announced the positive top-line results from its two Phase 3 pivotal studies of crisaborole. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015, Anacor announced the top-line results from its long-term safety study, in which crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.
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Source: press release, 1/07/16. http://investor.anacor.com/releasedetail.cfm?ReleaseID=949345

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October 29, 2015
Anacor Pharmaceuticals Announces Top-Line Results From Long-Term Safety Study of Crisaborole Topical Ointment, 2% in Patients With Mild-to-Moderate Atopic Dermatitis
Crisaborole, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months
Anacor now expects to submit a New Drug Application for crisaborole to the U.S. Food and Drug Administration in the first quarter of 2016
PALO ALTO, Calif.--(BUSINESS WIRE)-- Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced top-line results from the long-term safety study of Crisaborole Topical Ointment, 2% (formerly AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

"We are very pleased with the results of this successful study which confirmed the safety profile of crisaborole demonstrated in the Phase 3 pivotal studies when used intermittently for up to 12 months," said Lee Zane, M.D., Anacor's Senior Vice President and Chief Medical Officer. "This study adds significantly to our robust clinical database, which now includes data from over 2,000 subjects treated with crisaborole across its clinical development program."

Crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the positive Phase 3 pivotal studies reported in July 2015. No treatment-related serious adverse events were reported and most adverse events were graded as mild in severity, and transient. The most common treatment-related adverse events reported by at least 2% of subjects were atopic dermatitis (3.1%) and application site pain (2.3%).

"The safety profile demonstrated by crisaborole when used for the long-term management of mild-to-moderate atopic dermatitis in patients as young as 2 years old could be extremely relevant to prescribing physicians and patients," said Adelaide Hebert, M.D., Professor of Dermatology and Pediatrics at The University of Texas Health Science Center at Houston, who was one of the clinical investigators in the multicenter trial. "Atopic dermatitis, or eczema, is a chronic skin condition characterized by recurrent flares. Currently, the most common topical prescription treatments, corticosteroids and calcineurin inhibitors, carry concerns about their long-term safety, so their continuous application for long periods of time is not recommended. If crisaborole is approved, it has the potential to dramatically change how this disease is managed."

"We want to thank all of the clinical investigators, patients and their families who participated in this study," continued Lee Zane, M.D., Anacor's Senior Vice President and Chief Medical Officer. "With the successful completion of this important study, we now expect to file the NDA in the first quarter of 2016."

Anacor currently expects to present additional details from this study at a future medical meeting.
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Source: press release, 10/29/15. http://investor.anacor.com/releasedetail.cfm?ReleaseID=939414

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
AN2728 Atopic DermatitisAllergyAtopic DermatitisPDE4 inhibitorPDE4

Mechanism of action: AN2728 is a novel boron-containing small molecule that inhibits PDE4 and reduces the production of TNF-alpha, a precursor of the inflammation associated with psoriasis, as well as other cytokines, including IL-12 and IL-23, which are proteins believed to be involved in the inflammation process and immune responses.

Phase of Development: III

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-01-07

Results: Pending