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Monday, December 10, 2018

Gilead Sciences Names Daniel O’Day Chairman and Chief Executive Officer


– Mr. O’Day Brings Global Pharmaceutical Leadership Experience Across Geographies and Therapeutic Areas —
— Appointment Effective March 1, 2019 —

Gilead Sciences, Inc. (Nasdaq: GILD) announced todaythat its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. Mr. O’Day is currently the CEO of Roche Pharmaceuticals. He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe.
The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until Mr. O’Day’s start date of March 1, 2019. Mr. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer.
“Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future,” said John C. Martin, PhD, Chairman, Gilead Sciences Board of Directors. “He is uniquely qualified to take on this role given his track record of success in highly scientific and competitive therapeutic areas, deep understanding of the evolving healthcare environment around the world, and unwavering commitment to driving innovation across all aspects of a business, which will serve Gilead and our stakeholders well. Additionally, Dan brings expertise and values that are aligned with our organization, and I, along with Gilead’s entire Board, am confident in his ability to work alongside our talented leadership team and deliver on our ambitious goals.”
After joining Roche Pharmaceuticals in 1987, Mr. O’Day held various positions in the United States before moving to Roche headquarters in Switzerland in 1998. During his time in Switzerland, he held leadership roles in Global Marketing and Lifecycle Management. In 2001, he moved to Tokyo to become Head of Corporate Planning for Roche Pharmaceuticals in Japan and later moved to Denmark to serve as General Manager. He became President of Roche Molecular Diagnostics in California in 2006 and subsequently returned to Roche headquarters to lead the Diagnostics Division before assuming his current position. He is a member of the corporate executive committee of F. Hoffmann La Roche AG and a member of the boards of Shanghai Roche Pharmaceuticals Ltd., Roche (China) Holding, Roche Pharma Schweiz AG, Genentech, Inc., Chugai Pharmaceuticals Co., Ltd., Flatiron Health, Inc., and Foundation Medicine, Inc. Additionally, he has served as a member of the board of the European Federation of Pharmaceutical Industries and Associations. Mr. O’Day holds a Bachelor of Science in Biology from Georgetown University in Washington, D.C. and an MBA from the Columbia Business School at Columbia University in New York.
“I have long admired Gilead for its work to develop medicines that have fundamentally changed the way HIV and viral hepatitis are treated. The company has successfully grown into a global organization, providing access to people around the world, while maintaining its focus on innovative science,” said Mr. O’Day. “Together with the Board, leadership team and Gilead’s 11,000 employees, I look forward to building on this in ways that I believe will – in keeping with Gilead’s mission – transform the lives of millions of individuals.”
As previously announced, Dr. Martin will step down from the company’s Board of Directors, effective March 1, 2019, Mr. O’Day’s first day of employment. Also as previously announced, John F. Milligan, PhD, will step down from his role as President and Chief Executive Officer and as a member of the Board at the end of 2018.

WuXi, Brii in Research Link for Novel Bispecific Antibody Immunotherapeutics


Wuxi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced today a strategic collaboration with Brii Biosciences (Brii Bio), an innovative biotechnology company operates in China and the US, focusing on accelerating innovation and optimizing access to serve the need of Chinese patients and public health, to discover and develop bispecific antibodies to treat infectious diseases and other immunologic disorders.
This collaboration will further integrate the advantages of the two companies and expedite the development of Brii Bio’s pipeline. Under the terms of the exclusive research agreement, Brii Bio has the access to WuXi Biologics’ entire antibody platform capabilities including the WuXiBody™ technology to discover novel bispecific antibodies. WuXi Biologics will also be the exclusive development and manufacturing partner of any novel bispecific antibodies discovered from the WuXiBody™ Platform.
“Discovery of novel immunotherapeutics modulating the host immune responses represents an untapped paradigm that may improve the treatment of infectious diseases,” said Dr. Zhi Hong, Co-founder and Chief Executive Officer of Brii Biosciences, “WuXi Biologics has successfully grown and expanded its capability and capacity in biopharmaceutical, which will enable us to translate target insight to key therapeutic modalities and innovate in China for the world.”
“We are pleased to enable Brii Bio in developing and manufacturing bispecific therapeutics through the proprietary WuXiBody™ Platform that tackles technical hurdles of bispecific platforms and tremendously reduces the cost of making these biologics, therefore offer novel treatments for unmet medical needs,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “The collaboration is expected to develop and manufacture life-saving biologics targeting different diseases, and then benefit patients around the world.”

Sunday, December 9, 2018

Daiichi Sankyo Updates Phase 1 Results of Breast Cancer Med at SABCS


. Updated analysis from ongoing phase 1 study of [fam-] trastuzumab deruxtecan (DS-8201) demonstrated a confirmed overall response rate of 44.2 percent and a disease control rate of 79.1 percent in 43 evaluable patients with heavily pretreated HER2 low metastatic breast cancer
・ A further subgroup analysis of 38 patients whose disease was also hormone receptor (HR) positive showed a 47.4 percent confirmed overall response rate and 81.6 percent disease control rate
・ No anti-HER2 therapies are currently approved for HER2 low expressing breast cancer, and plans for a phase 3 study are underway
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that updated safety and efficacy data from the ongoing phase 1 study with [fam-] trastuzumab deruxtecan, an investigational HER2 targeting antibody drug conjugate (ADC), were presented for a subgroup of patients with heavily pretreated HER2 low expressing metastatic breast cancer during a Poster Session at the 2018 San Antonio Breast Cancer Symposium(SABCS) (#P6-17-02).
The updated analysis of 43 evaluable patients with HER2 low expressing metastatic breast cancer (IHC 2+/ISH- or IHC 1+), who received [fam-] trastuzumab deruxtecan at a recommended expansion dose of 5.4 or 6.4 mg/kg, demonstrated a confirmed overall response rate of 44.2 percent (19/43 patients) and a disease control rate of 79.1 percent (34/43 patients). Preliminary estimate of median duration of response was 9.4 months (range: 1.5+, 23.6+), and median progression-free survival was 7.6 months (95 percent CI: 4.9, 13.7). A total of 54 patients with heavily pretreated (median 7.5 prior anticancer regimens) HER2 low breast cancer have received ≥1 dose [fam-] trastuzumab deruxtecan 5.4 or 6.4 mg/kg in the study and 23 patients remain on treatment as of data cut-off on October 12, 2018.
‘While anti-HER2 therapies play an important role in the treatment of HER2 positive breast cancer, they historically have not demonstrated effectiveness against tumors that express lower levels of HER2,’ said Shanu Modi, MD, Breast Medical Oncologist, Memorial Sloan Kettering Cancer Center and study investigator. ‘These data offer preliminary evidence of [fam-] trastuzumab deruxtecan activity in HER2 low expressing breast cancers, and based on further study, we are beginning to consider the implications for how we classify and treat these patients.’
A further subgroup analysis of 38 evaluable patients whose disease was also hormone receptor (HR) positive demonstrated a confirmed overall response rate of 47.4 percent (18/38 patients) and a disease control rate of 81.6 percent (31/38 patients) with [fam-] trastuzumab deruxtecan. Preliminary estimate of median duration of response was 11.0 months (range: 1.5+, 23.6+), and median progression-free survival was 7.9 months (95 percent CI: 4.4, 13.7) in this patient subgroup. A total of 45 patients with HR positive, HER2 low breast cancer have received ≥1 dose [fam-] trastuzumab deruxtecan 5.4 or 6.4 mg/kg in the study and 21 of these patients remain on treatment as of data cut-off.
‘There are no anti-HER2 therapies currently approved for HER2 low expressing breast cancer, which represents about half of all breast cancers,’ said Gilles Gallant, BPharm, PhD, Vice President, DS-8201 Global Team Leader, Oncology Research and Development, Daiichi Sankyo. ‘Based on these data, plans for a phase 3 trial in patients with HER2 low metastatic breast cancer are underway, adding to our broad development program evaluating [fam-] trastuzumab deruxtecan in HER2 expressing breast cancers and other tumor types.’
Updated overall safety data as of October 12, 2018 for all breast cancer patients in the ongoing phase 1 study were also reported at SABCS. Among 170 patients who received at least one dose of [fam-] trastuzumab deruxtecan 5.4 or 6.4 mg/kg for advanced breast cancer in the dose expansion or dose escalation part of the study (regardless of HER2 status), the most common adverse events (≥30 percent, any Grade) included nausea (79.4 percent), decreased appetite (54.1 percent), alopecia (46.5 percent), vomiting (45.9 percent), fatigue (42.4 percent), anemia (40.0 percent), constipation (38.2 percent) and diarrhea (38.2 percent). A total of 50.0 percent of the breast cancer patients experienced a Grade ≥3 adverse event and 22.9 percent had a serious adverse event, including 2.9 percent of patients who experienced an adverse event that lead to death.

Gilead Sciences to hire Roche executive O’Day as new CEO


Drugmaker Gilead Sciences Inc will name Roche Holding AG executive Daniel O’Day as its new chief executive officer, according to a source familiar with the matter.

The announcement of O’Day’s hiring could come as early as Monday, the source said.
It is not clear when O’Day, currently the CEO of Roche Pharmaceuticals, will start at Gilead.
The news of O’Day’s hiring comes about four months after Gilead said in July that it’s Chief Executive John Milligan and Chairman John Martin would step down at the end of the year.
Martin, who preceded Milligan as Gilead CEO, said he planned to leave the board when a new CEO joins the company.
Up to Friday’s close, the company’s shares have fallen nearly 14 percent since Milligan and Martin’s departures were announced by Gilead in July.

Roth Capital Starts CorMedix (CRMD) at Buy


Roth Capital analyst Jerry Issacson initiates coverage on CorMedix (NYSE: CRMD) with a Buy rating

Unilever downgraded to Underweight from Neutral at JPMorgan


JPMorgan analyst Celine Pannuti downgraded Unilever to Underweight and lowered her price target for the shares to EUR 44.50 from EUR 46. The analyst views consensus expectations as elevated.
https://thefly.com/landingPageNews.php?id=2834189

Gilead to hire Roche’s Daniel O’Day as next CEO


WSJ report