Business Wire

Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe

Del

Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines.

The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who has received at least two prior platinum-based treatment regimens, has platinum-sensitive disease, and is in a complete or partial response to the most recent platinum-based regimen. In all cases, the patient must have a special clinical need that cannot be met by current licensed available medicines. Patients must be ineligible for Clovis’ ARIEL4 clinical trial or unable to access a participating ARIEL4 site to qualify for Clovis’ early access program.

Questions or inquiries regarding the RAP should be directed to rucaparibaccessEU@caligorrx.com.

About Rubraca ® (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved on an accelerated basis as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In December 2017, the U.S. Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for Rubraca 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.

Rubraca is an unlicensed medical product outside of the U.S.

About Early Access Programs

Early Access Programs provide companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.

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 European Commission approval of rucaparib for the treatment indication and the filing of a variation to the MA for a 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.

Contact information

Clovis Oncology, Inc.
Breanna Burkart
303.625.5023
bburkart@clovisoncology.com
or
Anna Sussman
303.625.5022
asussman@clovisoncology.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Western Union Teams Up with Thunes to Expand Payout Capabilities to Mobile Wallets19.3.2019 01:00:00 CETPressemelding

Western Union (NYSE: WU), a leader in cross-border, cross-currency money movement, has teamed up with Thunes, a cross-border payments network for emerging markets, to enable Western Union customers to send funds directly into mobile wallets around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005639/en/ Senders can now utilise Western Union’s growing digital network or an agent location to send funds directly into a recipient’s mobile wallet. “We are continuously expanding and enhancing our account payout portfolio, providing customers with multiple payout options including bank accounts, cards or mobile wallets,” said Sobia Rahman, Global Head of Account Payout Network for Western Union. “Our goal is to make digital money transfer services more accessible, with a specific focus on enabling mobile transactions.” The collaboration will enable greater financial access for consumers - especially those who lack

Velodyne Demonstrates Lidar Solution for Rich Perception Data Collection on NVIDIA DRIVE Platform19.3.2019 01:00:00 CETPressemelding

Velodyne Lidar, Inc. today announced its surround-view lidar solutions for collecting rich perception data in testing and validation are available on the NVIDIA DRIVE™ autonomous driving platform--allowing full, 360-degree perception in real time, facilitating highly accurate localization and path-planning capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005791/en/ Proven through learning from millions of road miles, Velodyne sensors help determine the safest way to navigate and direct a self-driving vehicle. (Photo: Business Wire) Velodyne sensors’ characteristics are also available on NVIDIA DRIVE Constellation™, an open, scalable simulation platform that enables large-scale, bit-accurate hardware-in-the-loop testing of AVs. The solution’s DRIVE Sim™ software simulates lidar and other sensors, recreating a self-driving car’s inputs with high fidelity in the virtual world. “Velodyne and NVIDIA are at the f

Kohler Celebrates the Details of Design at Milan Design Week 201919.3.2019 00:22:00 CETPressemelding

Kohler, a global lifestyle brand, returns to Milan Design Week to host an enticing sensory experience inside the historic Palazzo Del Senato (via Senato, 10, 20121 Milan, Italy). The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installation will be open April 9 through April 13 from 10am – 7pm daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190318005858/en/ The large-scale immersive exhibit showcases Kohler’s bold approach to design and the brand’s most stunning products through an artful combination of water, technology, texture, and color. The installations feature global debuts of products from KOHLER, KALLISTA, ANN SACKS and ROBERN. (Photo: Business Wire) “Milan Design Week is the ultimate celebration of creativity and innovation among the global design community,” said Jim

ams and Wise Road Capital Advance Further Development for Environmental, Flow and Pressure Sensors Through Creation of a Joint Venture19.3.2019 00:09:00 CETPressemelding

ams (SIX: AMS), a leading worldwide supplier of high performance sensor solutions, and Wise Road Capital, a global Private Equity firm focusing on the semiconductor industry and other emerging high-tech industries, announce today that they have signed an agreement to create a joint venture to advance the development and sales of environmental, flow and pressure sensor solutions for the global market. Under the agreement, employees, IP, sensor products and solutions and related customers will transfer from ams to the joint venture, while Wise Road Capital will provide its expert joint venture guidance, deep market knowledge and strength in channel and customer relationships, especially in China. ams will transfer its current environmental sensor solution portfolio covering air quality, relative humidity and temperature sensing, which are used in automotive, smart building and air quality monitoring infrastructure applications. In addition, the ams ultrasound-based flow sensor solutions,

The We Company FY 2018 Financial Results Conference Call18.3.2019 23:44:00 CETPressemelding

WeWork Companies Inc. (the “Company”), as issuer of its 7.875% Senior Notes due 2025 (the “Senior Notes”), will hold a conference call on Monday, March 25, 2019, at 5:00 P.M. Eastern Time for the benefit of certain qualified participants in order to discuss the Company’s financial results for the fiscal year 2018. Current holders and beneficial owners of the Senior Notes, bona fide prospective purchasers of the Senior Notes who are qualified institutional buyers (as defined in Rule 144A under the Securities Act of 1933) or non-U.S. persons (as defined in Regulation S under the Securities Act of 1933), securities analysts, and market-making financial institutions may gain access to the call information for the conference call by registering on the Company’s secure website at investors.wework.com. Additional information about the call (including dial-in number) will be provided on the secure website. Parties requesting access to the Company’s secure website will be required to provide ce

FANCL Regains Control of Their IT Roadmap by Switching to Rimini Street Support for its SAP Application18.3.2019 23:00:00 CETPressemelding

Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that FANCL, a leading additive-free cosmetics and health food products company in Japan, has switched to Rimini Street support for its SAP ECC 6.0 system. Rimini Street has enabled FANCL to take full control of their ERP roadmap and chart its direction based on the company’s business needs -- like advancing their digital transformation initiatives -- versus continuing to follow a vendor-dictated roadmap. Additionally, FANCL now receives premium-level, ultra responsive support for its current, stable SAP system for a minimum of 15 years from the time the company transitioned to Rimini Street. The company also immediately realized savings of 50 percent in annual support fees. FANCL is able to reinvest this significant cost saving into updating and modernizing the company’