Business Wire

Rucaparib MAA for the Ovarian Cancer Treatment Indication Referred by CHMP to Scientific Advisory Group on Oncology for Review Expected in February 2018

Jaa

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has requested that the Scientific Advisory Group (SAG) on Oncology provide an opinion on aspects of the ongoing Marketing Authorization Application (MAA) relating to a potential conditional approval for rucaparib. The exact date for the SAG meeting has not yet been set but we expect it to take place in early February 2018.

The SAG on Oncology is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue relevant to the work of the Agency that relates to this area.

“We continue to have as our priority the submission and potential approval for the maintenance treatment indication in advanced ovarian cancer in the EU,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We anticipate that initiating the process to submit a new MAA for maintenance next month is the quickest path to provide the potential benefit of rucaparib to more women in the EU with advanced disease. Of course, if we receive an approval for the treatment indication in the second quarter, and we file a variation to the treatment MAA, we anticipate the potential maintenance approval would be swifter.”

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All 106 patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Both the variation to the MAA or a new MAA submission will be based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied. ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant; 2) HRD-positive; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. Both the variation to the MAA or the new MAA filing will be directed at the broader intent-to-treat or “all comers” population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the US Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for rucaparib for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In December 2017, the CHMP referred the rucaparib MAA for the ovarian cancer treatment indication to the SAG on Oncology for review. The SAG meeting to discuss the rucaparib MAA is anticipated in February 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK. Please visit clovisoncology.com for more information.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation of timing for EMA regulatory steps, European approval of rucaparib for the treatment indication and the filing, review and potential approval of an MAA, or variation to the treatment MAA for a second line or later maintenance indication for rucaparib. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions that may affect drug labeling, pricing and reimbursement, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

___________________
i Ledermann, J., MD. ARIEL3: A phase 3, randomised, double-blind study of rucaparib vs placebo following response to platinum-based chemotherapy for recurrent ovarian carcinoma (OC). Presented at 2017 European Society for Medical Oncology Congress in Spain, Madrid. 8 September 2017.
ii Coleman R, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 12 September 2017. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32440-6/fulltext

Contact information

Clovis Investor Contacts:
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
or
Clovis Media Contacts:
US
Lisa Guiterman, 301-217-9353
clovismedia@sambrown.com
or
Christy Curran, 615-414-8668
clovismedia@sambrown.com
or
EU
Ann Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 18:58Tiedote

A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The

Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 18:27Tiedote

Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio

H.I.G. Capital Announces the Sale of Kondor13.7.2018 17:06Tiedote

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced today that one of its affiliates has sold Kondor Limited, a specialist provider of category management solutions for audio and mobile accessory products into the retail and mobile network channels in the UK and Europe, to DCC Technology (which principally trades under the Exertis brand), part of DCC plc, the leading international sales, marketing and support services group. Terms of the transaction were not disclosed. Headquartered in Dorset, England, Kondor distributes audio and mobile accessory products to a broad range of e-tail, retail and mobile operator customers. H.I.G. invested in Kondor in 2014, and has since overseen a full reorganisation of the business. H.I.G. worked in partnership with Kondor to professionalise back office systems, develop Kondor’s access to market data, optimise the company’s product range, improve stock manag

Contactless Technology Powers Fifty Percent of Purchases at 2018 FIFA World Cup Russia™13.7.2018 12:00Tiedote

Visa (NYSE: V), the Official Payment Services Partner of FIFA, today released an analysis of spending inside the 2018 FIFA World Cup Russia™ stadiums from the opening match on June 14 through the semi-finals on July 11. The data highlights the increased consumer adoption of innovative payment technology, as fifty percent of purchases with Visa in tournament venues utilized contactless transactions, including cards, mobile devices and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180713005025/en/ For the 2018 FIFA World Cup Russia™, Visa is the exclusive payment service in all stadiums where payment cards are accepted. In-stadium, fans can pay with contactless Visa credit and debit cards and mobile payment services at the more than 3,500 point-of-sale terminals and 1,000 mobile concessionaires that have been equipped with the latest in payment innovation. (Photo: Business Wire) Visa cardholders on average spent 1,

Brazil Approves AerSafe for Airbus 321 Aircraft to Comply with Fuel Tank Flammability Reduction Rule12.7.2018 22:18Tiedote

AerSale ® announced today that the National Civil Aviation Agency of Brazil (ANAC) has approved the Federal Aviation Administration’s (FAA’s) Supplemental Type Certificate (STC) for the company’s AerSafe™ system on Airbus 321 aircraft (ST04010NY), that complies with the Fuel Tank Flammability Reduction (FTFR) rule. This is the second ANAC STC approval for AerSafe, following approval on Boeing 737 CL aircraft in 2017. In the coming months, AerSafe will be expanded to cover additional aircraft types, to meet the September 2019 deadline of the ANAC regulation, Regulamento Brasileiro da Avaiação Civil (RBAC) nº 121.1117, that applies specifically to passenger aircraft that fly within or into Brazil. AerSale’s STCs for the Boeing 737 CL and NG series (ST02980NY) and Boeing 767 series (ST03599NY) have already been approved by the FAA. “We are pleased that our Latin American customers operating A320 family aircraft are now able to immediately benefit from AerSafe’s numerous advantages,” said

Blockchain-based Adents NovaTrack Issues Token to Standardize Access to Comprehensive Supply Chain Traceability12.7.2018 21:20Tiedote

Adents, leading serialization and track & trace solutions provider, announces the issue of tokens that, combined with its NovaTrack platform, will standardize access to full supply chain traceability. Adents recently released Adents NovaTrack, a marriage of technologies co-developed with Microsoft. The solution utilizes Blockchain, A.I., IoT and serialization functionalities that, when combined, bring comprehensive visibility throughout product distribution chains & life cycles. The result is a solution highly mindful not only in terms of performance and security, but also governance and scalability. With NovaTrack, Adents aims to create an ecosystem of consortium-based blockchains independent from each other, and individually launched on-demand by various supply chain stakeholders (brands, manufacturers, logistics professionals, etc.). Each consortium-based blockchain will provide a secure environment to its participants to share supply chain data and processes. From brands, manufactu

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme