On August 31, 2018 Shire plc (LSE: SHP, NASDAQ: SHPG) reported that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion (Press release, Shire, AUG 31, 2018, View Source [SID1234529240]). The franchise includes the global rights to ONCASPAR and ex-US and ex-Taiwan rights to ONIVYDE, as well as Oncology pipeline assets. David Lee, who was previously the head of Shire’s Global Genetic Diseases and Oncology franchises, will continue with Servier as CEO of its new US commercial subsidiary, Servier Pharmaceuticals.

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"The closing of this transaction demonstrates the value embedded in our portfolio and our continued focus on executing against our strategic priorities," said Dr. Flemming Ornskov, Shire CEO. "I am confident that Servier will continue to bring these important therapies to patients worldwide. I would like to thank David Lee and all those transferring to Servier for their ongoing commitment to meeting the needs of the oncology community, and we wish them continued success."

The Oncology sale proceeds are expected to enable Shire to further reduce its leverage. Shire previously announced a leverage target of Non GAAP Net Debt to EBITDA of below 2.5x by the end of 2018. Shire will update its financial guidance, including the impact of the Oncology sale, as part of the Q3 earnings announcement later this year.

Shire first announced its plans to sell its Oncology franchise to Servier on April 16, 2018. This transaction constitutes a Class 2 transaction for the purposes of the U.K. Listing Rules and, as such, Shire shareholder approval was not required. The transaction was approved by the Board of Directors; the Board initiated the potential sale of the Oncology franchise in December 2017.

For further information please contact:

Investor Relations
Christoph Brackmann [email protected] +41 41 288 41 29
Sun Kim [email protected] +1 617 588 8175
Scott Burrows [email protected] +41 41 288 4195

Media
Katie Joyce [email protected] +1 781 482 2779
Annabel Cowper [email protected] +41 79 630 8619

On August 31, 2018 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a biotechnology company pioneering the development of a new class of ready-to-use cellular therapies, reported second quarter 2018 financial results (Press release, Rubius Therapeutics, AUG 31, 2018, View Source [SID1234529444]).

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As of June 30, 2018, Rubius had cash, cash equivalents and marketable securities of $181.7 million. This amount excludes $257.9 million of proceeds after deducting underwriting discounts and commissions from Rubius’ initial public offering (IPO), which closed in July 2018. Based upon its current operating plan, Rubius expects its existing capital resources will be sufficient to fund operations into 2021.

"We have made significant progress over the course of this year – the highlight of which was the closing of our IPO," said Pablo J. Cagnoni, M.D., chief executive officer of Rubius Therapeutics, Inc. "The IPO proceeds give Rubius the resources to execute against our vision of creating life-changing cellular medicines to treat patients with rare diseases, cancer and autoimmune diseases. We are on track to file our first Investigational New Drug application for RTX-134 during the first quarter of 2019, for the treatment of patients with phenylketonuria, a rare disease affecting approximately 16,500 people in the U.S."(1)

Recent Business Highlights

Initial Public Offering

· On July 23, 2018, Rubius closed its IPO, raising $257.9 million of proceeds after deducting underwriting discounts and commissions. The proceeds from this offering, together with existing cash, cash equivalents and marketable securities are expected to be used:

·to purchase, renovate, customize and operate its manufacturing facility;

· to advance RTX-134 through a Phase 1/2a clinical proof-of-concept trial;

· to advance and expand its RED PLATFORMä and its research and development pipeline, including early discovery efforts and IND-enabling studies, and to initiate additional proof-of-concept trials in rare diseases, cancer and autoimmune diseases; and for working capital and other general corporate purposes.

Manufacturing Facility

· On July 31, 2018, Rubius purchased an existing 135,000-square foot manufacturing facility in Smithfield, Rhode Island.

· The company plans to invest approximately $95.0 million through 2020, which includes the $8.0 million purchase price.

Strategic Hires and Internal Capabilities

·Continued to build a leading scientific team and attract experienced leadership to deliver against Rubius’ vision, including the hiring of Pablo J. Cagnoni, M.D., as chief executive officer.

· Strengthened internal capabilities in discovery, platform and therapeutic development and manufacturing.

Second Quarter Financial Results

Cash, cash equivalents and marketable securities totaled $181.7 million as of June 30, 2018, compared to $104.3 million as of December 31, 2017. The increase in cash reflects the net proceeds from Rubius’ Series C preferred stock financing during the first quarter of 2018, offset by its cash used in operations during the period. Research and development expenses were $12.0 million during the second quarter of 2018, compared with $4.8 million for the second quarter of 2017. The increase was attributable to costs incurred in preparation of Rubius’ planned Phase 1/2a clinical trial of RTX-134 in phenylketonuria, as well as an increase in headcount in its research and development function and an increase in external manufacturing and research costs to improve and expand its manufacturing capabilities, prepare for clinical scale production and expand its in vivo testing to support clinical candidate selection. General and administrative expenses were $16.3 million during the second quarter of 2018, compared to $4.2 million for the second quarter of 2017. The increase was primarily due to an increase in stock-based compensation and increases in personnel costs and professional fees as Rubius prepared to operate as a public company.

On August 31, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conferences during September and invited investors to participate by webcast (Press release, Exact Sciences, AUG 31, 2018, View Source [SID1234529313]).

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Baird 2018 Global Healthcare Conference, New York
Fireside chat on Wednesday, Sept. 5, at 12:15 p.m. ET
Morgan Stanley 16th Annual Global Healthcare Conference, New York
Fireside chat on Wednesday, Sept. 12, at 4:15 p.m. ET

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On August 30, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, CEO, Peter Lawrence, President and COO, Brian Schwartz, CMO and Head of R&D and Marc Schegerin, Senior Vice President and Head of Strategy, Finance and Communication, will participate in Citi’s 13th Annual Biotech Conference on September 6, 2018, at the Four Seasons Hotel in Boston, MA (Press release, ArQule, AUG 30, 2018, View Source [SID1234529188]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On August 30, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, CEO, and Dr. Brian Schwartz, CMO and Head of Research and Development, will participate in investor meetings and scientific panel discussions at the B. Riley FBR Healthcare Conference on September 4, 2018, at the New York Marriott East Side Hotel in New York City (Press release, ArQule, AUG 30, 2018, View Source [SID1234529189]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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