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Clovis Oncology, Inc.

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CLOVIS ONCOLOGY PROVIDES UPDATE ON FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE MEETING TO REVIEW ROCILETINIB FOR TREATMENT OF ADVANCED T790M-POSITIVE MUTANT EPIDERMAL GROWTH FACTOR RECEPTOR NON-SMALL CELL LUNG CANCER
BOULDER, Colo.--(BUSINESS WIRE)--Apr. 12, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.

The Committee recommended that the FDA wait to see results from TIGER-3, Clovis’ ongoing Phase 3, randomized, controlled trial of rociletinib, before making a decision on approval of the treatment. Patient enrollment for the trial is expected to complete in late 2018.

“We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We will work with the FDA to evaluate the best path forward as it continues to review our application.”

The FDA set a target action date of June 28, 2016 under the Prescription Drug User Fee Act (PDUFA). The TIGER-3 trial, Clovis’ confirmatory randomized, controlled Phase 3 study for rociletinib, is ongoing, with patient enrollment expected to complete in late 2018.
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Source: press release, 4/12/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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Patrick J. Mahaffy, President and CEO, commented on the regulatory process for Rociletinib. He stated, "Now let me provide more of an update for each of our products in greater detail. First with rociletinib. Our regulatory filings submitted last July for Rociletinib for the treatment of patients with advanced EGFR mutant T790M positive non-small cell lung cancer remain under review in both U.S. and the EU. In the U.S., we’re actively preparing for the now confirmed ODAC panel discussion to take place on April 12. Our team is working very hard in preparation for the meeting and we remain committed to making this drug commercially available for patients with EGFR driven T790M positive non-small cell lung cancer for whom additional treatment options are very much needed. As I noted earlier, our PDUFA date is June 28, 2016."
Source: Q4 2015 earnings conference call, 2/25/16.

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CLOVIS ONCOLOGY RECEIVES NOTIFICATION OF PDUFA EXTENSION FOR ROCILETINIB
PDUFA goal date extended by three months to June 28, 2016

BOULDER, Colo.--(BUSINESS WIRE)--Dec. 15, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for Clovis’ New Drug Application (NDA) for rociletinib by the standard extension period of three months with the new goal date of June 28, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

Clovis submitted a Major Amendment on November 16, 2015 in response to the FDA’s request for additional clinical data for both the 500mg and 625mg BID dose patient groups for rociletinib. As expected, the FDA extended the PDUFA goal date to allow additional time for review of the new information requested by the Agency.

About Rociletinib

Rociletinib is the company’s novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and EU regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014.
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Source: press release, 12/15/15. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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CLOVIS ONCOLOGY ANNOUNCES REGULATORY UPDATE FOR ROCILETINIB NDA FILING
Mid-Cycle Communication Meeting with FDA completed
Additional clinical information for 500mg and 625mg BID dose groups to be provided by the Company today
BOULDER, Colo.--(BUSINESS WIRE)--Nov. 16, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. The Company will provide this information in a Major Amendment to the FDA by close of business today.

“We remain confident in rociletinib and its potential to treat patients with mutant EGFR T790M-positive lung cancer, said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We will continue to work diligently with the FDA on our NDA submission.”

In the Mid-Cycle Communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses. The New Drug Application (NDA) submitted by Clovis to the FDA contained immature data sets based on both unconfirmed response rates and confirmed response rates. These data sets were updated in the 90 day efficacy update the Company submitted at the end of October.

As the rociletinib clinical trials were rapidly enrolling, Clovis presented interim data publicly and at medical meetings and these data therefore included a data set based primarily on unconfirmed responses. This was also true of the Company’s Breakthrough Therapy designation submission. In the Company’s NDA submission, both immature confirmed and unconfirmed response analyses were submitted. As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected.

In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients’ responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30 percent.

The Company anticipates that the review of this additional information will result in a delay of a potential approval. This additional review could lead to an extension of the Company’s March 30, 2016 Prescription Drug User Fee Act (PDUFA) date.
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Source: press release, 11/16/15. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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CLOVIS ONCOLOGY ANNOUNCES U.S. AND E.U. REGULATORY MILESTONES FOR ROCILETINIB IN THE TREATMENT OF ADVANCED EGFR-MUTANT T790M+ NON-SMALL CELL LUNG CANCER

FDA Grants Priority Review Status to Rociletinib New Drug Application; Assigns Action Date of March 30, 2016

EMA Accepts Marketing Authorization Application for Rociletinib; Awards Accelerated Assessment

BOULDER, Colo.--(BUSINESS WIRE)--Sep. 29, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced two major regulatory milestones for rociletinib, its investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The U.S. Food and Drug Administration (FDA) has accepted Clovis’s New Drug Application (NDA) for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016.

Additionally, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rociletinib. Europe’s Committee for Medicinal Products for Human Use (CHMP) granted Clovis an accelerated assessment for the drug, which reduces the time limit for CHMP to reach an opinion from 210 days to 150 days. Accelerated assessment is granted in recognition of the likelihood that a therapeutic will be of major public health interest in the EU, given the importance of therapeutic innovation in a patient population that exhibits a high unmet need.

Rociletinib is the company’s novel, oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Data from both the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. and EU regulatory submissions for the treatment of advanced mutant EGFR T790M-positive lung cancer. Rociletinib was given Breakthrough Therapy designation by the FDA in May 2014.
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Source: press release, 9/29/15. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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CLOVIS ONCOLOGY COMPLETES U.S. AND E.U. REGULATORY SUBMISSIONS FOR ROCILETINIB FOR THE TREATMENT OF ADVANCED EGFR-MUTANT T790M+ NON-SMALL CELL LUNG CANCER
New Drug Application submitted to U.S. Food and Drug Administration and Marketing Authorization Application submitted to European Medicines Agency

BOULDER, Colo.--(BUSINESS WIRE)--Aug. 3, 2015-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it has submitted its New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. Rociletinib is the Company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

In addition, Clovis has also submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for rociletinib for the treatment of adult patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

There is a validation period before both applications are formally accepted, after which the review commences.

“The submissions of our first NDA and MAA for rociletinib represent a major step forward for our company,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “These two submissions – completed on the same day, no less -- were made possible through the tremendous commitment and hard work of Clovis employees and our clinical collaborators at leading U.S. and international academic institutions over the last many months, and I am grateful for their tireless efforts. We are actively preparing for what we hope to be our first U.S. commercial launch, and the opportunity to address the needs of patients with T790M-positive EGFR-mutant non-small cell lung cancer. We are also actively building our commercial organization in Europe to prepare for a potential launch next year.”

QIAGEN, Clovis’ companion diagnostic partner, intends to file a supplemental PMA application of its approved therascreen EGFR test with the FDA to allow for regulatory approval of the companion diagnostic concurrent with rociletinib approval. Analytical performance of the therascreen EGFR test has been established for 21 EGFR mutations, including the most prevalent resistance mutation, T790M. The test supports efficient laboratory workflow with real-time PCR technology on the FDA approved Rotor-Gene Q MDx, which is part of QIAGEN’s QIAsymphony family of laboratory solutions.
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Source: press release, 8/03/15. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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CLOVIS ONCOLOGY INITIATES ROLLING NDA SUBMISSION TO THE FDA FOR ROCILETINIB IN THE TREATMENT OF ADVANCED EGFR-MUTANT NON-SMALL CELL LUNG CANCER
NDA submission is expected to complete by late July

BOULDER, Colo.--(BUSINESS WIRE)--Jul. 1, 2015--

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the U.S. Food and Drug Administration (FDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test. Rociletinib is the Company’s novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014. Clovis agreed with FDA that the submission would be a rolling NDA and has filed the first component for potential accelerated approval of rociletinib in the U.S. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. The Company intends to complete the NDA submission by late July 2015.

“The initiation of this rolling submission represents a very important first step toward our biggest milestone of 2015 – the submission of our first NDA for rociletinib as treatment for patients with T790M-positive EGFR-mutant non-small cell lung cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We look forward to completing the NDA by the end of July, and are actively preparing for our first commercial launch.”

In addition, the Company intends to complete the Marketing Authorization Application (MAA) for rociletinib to the European Medicines Agency at the end of July.
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Source: press release, 7/01/15. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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Patrick J. Mahaffy, President and CEO, gave guidance for the regulatory filing for Rociletinib in NSCLC. He stated, "We remain on track to submit both our NDA and MAA submissions in mid 2015 and as a reminder, Rociletinib was granted break through therapy designation in May of last year. We do have meetings planned with the PMDA in Japan regarding the registration path and we will be in a position to update that plan later this year."
Source: Q4 2014 earnings conference call, 2/25/15.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Rociletinib (CO-1686) EGFR mutationOncologyNon-Small Cell Lung Cancer (NSCLC) (1st line)Epidermal growth factor receptor (EGFR) inhibitorEpidermal growth factor

Mechanism of action: Rociletinib (CO-1686) is an orally available small molecule, irreversible inhibitor of epidermal growth factor receptor (EGFR) with potential antineoplastic activity. EGFR inhibitor CO-1686 binds to and inhibits mutant forms of EGFR, including T790M, thereby leading to cell death of resistant tumor cells. Compared to other EGFR inhibitors, CO-1686 inhibits T790M, a secondary acquired resistance mutation, as well as other mutant EGFRs and may have therapeutic benefits in tumors with T790M-mediated resistance to other EGFR tyrosine kinase inhibitors. This agent shows minimal activity against wild-type EGFR, hence does not cause certain dose-limiting toxicities.

Phase of Development: III

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2019-10-01 - 2019-12-31

Results: Pending