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Ariad Pharmaceuticals, Inc.

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ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Brigatinib
Brigatinib Granted Priority Review, with a PDUFA Date of April 29, 2017

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 31, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ARIAD’s investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The FDA granted ARIAD’s request for Priority Review and has set an action date of April 29, 2017 under the Prescription Drug User Fee Act (PDUFA).

“The FDA acceptance of our application is an important milestone in our ongoing efforts to discover, develop and deliver highly innovative treatments for patients with rare cancers,” said Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are pleased that our significant R&D investments in brigatinib and our work with the FDA are bringing us closer to potentially offering a treatment option for patients with ALK+ NSCLC who are refractory to crizotinib. We look forward to continuing to work closely with the FDA during the brigatinib NDA review and remain committed to developing critical therapies for unserved and underserved small patient populations suffering from rare cancers.”

ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the filing of the application. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK-positive, ROS1-positive, and EGFR-positive NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.

ARIAD is a small, research-driven biotechnology company. ARIAD has invested more than $1.3 billion in R&D since the Company was founded. In 2015, ARIAD generated $119 million in total revenue and invested $171 million, or 143 percent of revenue, in R&D.
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Source: press release, 10/31/16. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2...

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ARIAD Completes Rolling Submission of New Drug Application for Brigatinib to the U.S. Food and Drug Administration
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 30, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant or intolerant to crizotinib. The Company is seeking accelerated approval for brigatinib from the FDA and has requested a priority review of the application, which, if granted, would allow for approval of brigatinib eight months after the NDA submission, as opposed to 12 months for a standard review.

“Many patients with ALK-positive non-small cell lung cancer eventually develop disease progression,” said Corey Langer, M.D., director of thoracic oncology in the Abramson Cancer Center of the University of Pennsylvania and a professor of Hematology-Oncology in Penn’s Perelman School of Medicine. “We are excited that the brigatinib NDA submission is now complete and are hopeful that brigatinib’s data, including the observation of complete responses and activity in the central nervous system, will provide patients and their oncologists with a new treatment option.”

ARIAD’s NDA submission includes clinical data from its Phase 1/2 and pivotal Phase 2 ALTA trials of brigatinib. Data from the ALTA trial, in which patients who had experienced disease progression on crizotinib therapy were randomized to one of two brigatinib regimens, were presented at the 2016 Meeting of the American Society of Clinical Oncology (ASCO). With a median follow-up of 8.3 months, the data show that, for patients treated with the 180 mg regimen with a seven day lead-in at 90 mg (Arm B), 54 percent achieved an investigator-assessed confirmed objective response, the trial’s primary endpoint. In this arm, the median progression free survival (PFS) exceeded one year (12.9 months). Additionally, a 67% confirmed intracranial objective response rate was achieved in patients with measurable brain metastases. The most common treatment-emergent adverse events (TEAEs; ≥ 25% of all patients in Arm B), regardless of relationship to treatment, were nausea (40%), diarrhea (38%), cough (34%), increased blood creatine phosphokinase (30%), headache (27%) and fatigue (27%). TEAEs, ≥ grade 3, occurring in ≥ 5 percent of all patients in Arm B, were increased blood creatine phosphokinase (9%), hypertension (6%) and pneumonia (5%). A subset of pulmonary adverse events with early onset (median: Day 2; range: Day 1-9) occurred in 6 percent of all patients (≥ grade 3 in 3% of patients); no such events with early onset occurred after dose escalation to 180 mg QD in Arm B.

“With the completion of the brigatinib submission this week, we are excited by its potential, if approved, to offer additional hope to patients and their families,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “We are thankful to the patients and physicians who participated in the clinical trials of brigatinib. We remain grateful to the FDA for granting brigatinib a breakthrough designation and the benefit of a rolling submission process, unique to the U.S. regulatory system.”

Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. ARIAD plans to submit a Marketing Authorization Application (MAA) for brigatinib to the European Medicines Agency (EMA) in early 2017.
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Source: press release, 8/30/16. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2...

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ARIAD Initiates Submission of New Drug Application for Brigatinib to the U.S. Food and Drug Administration Ahead of Plan
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 17, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced the initiation of a New Drug Application (NDA) submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to the U.S. Food and Drug Administration (FDA). ARIAD is seeking U.S. marketing approval of brigatinib for patients with ALK+ non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib, and was granted orphan drug designation by the FDA for the treatment of ALK+ NSCLC. The Company is seeking accelerated approval for brigatinib from the FDA and plans to request a priority review of the application.

“We are ahead of our previously announced schedule for initiating the submission of our brigatinib NDA to the FDA and we are grateful to have breakthrough status from the FDA, which provides the opportunity to utilize the rolling submission process,” stated Paris Panayiotopoulos, president and chief executive officer of ARIAD. “If approved, we believe that brigatinib will become an important new medicine for ALK+ NSCLC patients who have become resistant or intolerant to prior crizotinib therapy and will offer additional hope to these patients and their families.”

ARIAD’s NDA is a rolling submission which will occur in three parts. The initial submission contains all nonclinical portions of the NDA and will be followed by submissions of the chemistry, manufacturing and controls (CMC) and clinical data. The rolling NDA submission is expected to be complete in the third quarter of 2016.
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Source: press release, 6/17/16. http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=2...

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Timothy P. Clackson, Ph.D., SVP and CSO, commented on a potential NDA filing for Brigatinib in the third quarter. He stated, "NDA-enabling studies for Brigatinib are now well underway and we are on track to file for the initial approval of Brigatinib in the U.S in the third quarter of 2016. We are confident about the potential for Brigatinib to be an important differentiated and valuable medicine. Long-term follow-up data from our phase-I/II trial have demonstrated several features, we see as key assets for the molecule. We have seen robust response rates, highlighted by a high proportion of deep responses including complete responses."
Source: Q4 2015 earnings conference call, 2/23/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Brigatinib (AP26113)OncologyNon-Small Cell Lung Cancer (NSCLC)dual inhibitor - anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR)(ALK and EGFR

Mechanism of action: Brigatinib (AP26113) is a small-molecule drug candidate for the treatment of cancer. It is a dual inhibitor of anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR). Aberrant ALK expression is a key feature of certain NSCLCs, neuroblastomas, sarcomas and lymphomas. In preclinical experiments, multiple mutations in ALK were identified that conferred resistance to crizotinib, but not AP26113, including the L1196M "gatekeeper" mutation which has now been observed clinically in patients who initially responded to crizotinib and then relapsed. AP26113 also inhibits activated EGFR in preclinical models, including the T790M "gatekeeper" mutant that confers resistance to current EGFR inhibitors, such as erlotinib. In addition, AP26113 was shown to be specific for mutated EGFR and to avoid inhibition of native (endogenous or unmutated) EGFR; such inhibition is thought to be associated with the known adverse events of other EGFR inhibitors.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-04-29

Results: Pending