On November 4, 2019 Alkermes plc (Nasdaq: ALKS) reported that it will present new data from its ARTISTRY clinical development program related to ALKS 4230, an investigational engineered fusion protein designed to selectively expand cancer-fighting immune cells, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting being held Nov. 6-10, 2019 in National Harbor, MD (Press release, Alkermes, NOV 4, 2019, View Source [SID1234550257]). The company will present preliminary clinical data from the ARTISTRY-1 phase 1/2 study investigating ALKS 4230 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors, and study design details and preliminary safety data from the ARTISTRY-2 phase 1/2 study evaluating subcutaneous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab. The SITC (Free SITC Whitepaper) posters and a corporate presentation related to the ALKS 4230 program will be posted on the Investors section of the company’s website, available at www.alkermes.com, on Friday, Nov. 8.

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Alkermes’ planned presentations at SITC (Free SITC Whitepaper) will include:

Poster #447: "ALKS 4230, an Engineered IL-2 Fusion Protein, in Monotherapy Dose-Escalation and Combination Therapy With Pembrolizumab in Patients With Solid Tumors: ARTISTRY-1 Trial," will be presented by Ulka N. Vaishampayan, M.D., Karmanos Cancer Institute at Wayne State University
Poster #441: "ARTISTRY-2: A Phase 1/2 Study of Subcutaneously Administrated ALKS 4230 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors," will be presented by John Powderly, M.D., President and CEO of Carolina BioOncology Institute
The poster sessions will take place in Prince George’s Exhibition Hall (A and B) on Friday, Nov. 8 from 12:30 – 2:00 p.m. ET and 6:30 – 8:00 p.m. ET. For more information, including a complete list of abstracts, please visit the SITC (Free SITC Whitepaper) website at View Source

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently initiated monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.

On November 4, 2019 Santhera Pharmaceuticals (SIX: SANN) reported a strategic change to its management team with the appointment of Dario Eklund as CEO, effective December 1, 2019 (Press release, Santhera Pharmaceuticals, NOV 4, 2019, View Source [SID1234550275]). Thomas Meier will continue as a Board Member and will chair the newly formed Board of Director’s Scientific Committee. He will also serve as a special advisor to Dario Eklund, ensuring a smooth transition in Santhera’s leadership.

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Thomas Meier, PhD, Chief Executive Officer of Santhera, said: "This is a very exciting time for Santhera. Puldysa (idebenone) is under review by the European Medicines Agency as treatment for patients with Duchenne muscular dystrophy (DMD) and vamorolone, a first-in-class steroidal drug, is in a pivotal DMD trial. We anticipate market entries for these products from 2020 onwards and we are gearing up commercial preparations both in Europe and the US. As we transition to become a leader in innovative treatments for rare neuromuscular and pulmonary diseases it is important for Santhera to be led by a CEO with international commercial experience. Dario shares my belief in Santhera’s potential and excitement about the future opportunities for the Company and he will contribute the perfect blend of global commercial expertise and management skills to lead Santhera into the growth phase ahead. As member of the Board I look forward to supporting Dario in his new role."

Dario Eklund joins Santhera from Vifor Pharma, where he most recently served as Chief Commercial Officer with full P&L responsibility for a global business with turnover in excess of CHF 1 billion and more than 1’000 employees. He was a member of Vifor’s Corporate Executive Committee and a member of the Board of Directors of the joint venture with Fresenius Medical Care (Vifor Fresenius Medical Care Renal Pharma). Prior to Vifor, Dario spent a decade in Boston as Vice President and a member of the Executive Committee at Organogenesis Inc., a Nasdaq-listed world leading company in regenerative medicine and cell therapy with three approved products. During his time the company experienced strong growth and rapid expansion with sales coming from Europe and USA (annual growth rates of 20-25% over a decade). He started his career with various roles in sales, global marketing, business development and general management at Novartis and Sanofi in a number of territories.

Elmar Schnee, Chairman of Santhera, said: "On behalf of the Board, I would like to express my sincere appreciation to Thomas for his well-recognized achievements as founder and member of Santhera’s executive team since 2004, first as Chief Scientific Officer and then as CEO. Under his leadership, Santhera developed from a hopeful start-up into a fully integrated pharmaceutical company with a first product on the market and a very promising and innovative rare disease product pipeline addressing neuromuscular and pulmonary diseases with high unmet medical need. We are extremely pleased that he will continue to contribute his drive and scientific excellence as Chair of the Scientific Committee and member of the Board of Directors, supporting our ambition to turn innovative ideas into novel products. As we seek to broaden the scope of our business, Dario is a perfect fit as CEO. He has an exceptional track record as a commercial leader with experience in large pharma and biotech environments, and we are confident that he will successfully lead Santhera as we move along a strong path for the future."

Dario Eklund, CEO elect of Santhera, commented: "It’s an exciting time to be joining the Santhera team and to help drive its next phase of development. With two late-stage DMD drug candidates covering essentially the entire disease spectrum in all patients, Santhera is poised to become the world leader in an area where the unmet medical need is significant. I am looking forward to leading a strong and dedicated team and working alongside the Board and management team of Santhera to deliver on the Company’s vision."

On November 4, 2019 Agilent Technologies Inc. (NYSE: A) reported that it will release fourth quarter fiscal year 2019 financial results after the stock market closes on November 25 (Press release, Agilent, NOV 4, 2019, https://www.agilent.com/about/newsroom/presrel/2019/04nov-gp19023.html [SID1234550225]). The company will also host a live webcast of its investor conference call in listen-only mode.

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Date: Monday, November 25, 2019
Time: 1:30 PM (Pacific Time)
Web access: www.investor.agilent.com

To listen to the call online, select the "Q4 2019 Agilent Technologies Inc. Earnings Conference Call" link in the "News & Events — Events" portion of the Investor Relations section of the Agilent website. The webcast will remain on the company site for 90 days.

In addition, Agilent will be hosting the following upcoming webcasts for the investment community.

Piper Jaffray 31st Annual Healthcare Conference
Wednesday, December 4, at 8:30 a.m. (ET)
Lotte New York Palace, New York
Bob McMahon, Agilent chief financial officer

Evercore ISI 2nd Annual HealthCONx
Thursday, December 5, at 8:00 a.m. (ET)
Four Seasons Boston, Boston, Mass.
Bob McMahon, Agilent chief financial officer

Links to join the webcasts will be available in the "News & Events — Events" portion of the Investor Relations section of the Agilent website.

On November 4, 2019 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of "Quality, Affordable Self-care Products", reported that its Board of Directors declared a quarterly dividend of $0.21 per share, payable on December 17, 2019 to shareholders of record on November 29, 2019 (Press release, Perrigo Company, NOV 4, 2019, View Source [SID1234550241]).

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On November 4, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported strategic actions to reposition the Company with a focus solely on its ENHANZE drug delivery technology (Press release, Halozyme, NOV 4, 2019, View Source [SID1234550258]).

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In order to implement this strategic shift, Halozyme will immediately initiate an organizational restructuring to halt development activities for PEGPH20 and close its oncology operations. As a result, Halozyme expects the following:

Headcount will be reduced by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020.
Restructuring and other cost saving efforts will result in savings of $130 to $140 million in 2020 compared with the Company’s most recent guidance for 2019 operating expenses excluding cost of goods sold.
Upon completion of the restructuring and after booking all related one-time charges, Halozyme anticipates becoming a sustainably profitable company beginning in the second quarter of 2020.
Projected annualized operating expenses excluding cost of goods sold of between $65 million and $75 million will be achieved by the fourth quarter of 2020.
The Company expects to book separation and contract termination fees in the fourth quarter of 2019 and will provide further details during its third quarter 2019 financial results webcast and conference call on Tuesday, November 12.

The go-forward organization will comprise approximately 120 employees focused on driving the continued growth of ENHANZE, specifically in areas that are critical to supporting partners such as manufacturing, quality, regulatory and product development. An additional 12 employees will continue promoting the Company’s commercial drug Hylenex.

The Company’s ENHANZE business continues to grow with three commercial products and 11 products currently in clinical trials. Halozyme will provide a more detailed update for its ENHANZE business during its third quarter financial results webcast and conference call.

Halozyme’s Board of Directors has also authorized the initiation of a capital return program to repurchase up to $350 million of the Company’s outstanding common stock over the next three years. The timing of share repurchases and the number of shares of common stock that are repurchased will depend on market conditions and other factors. Repurchases may be commenced or suspended at any time or from time-to-time at the Company’s discretion without prior notice. Repurchases may be made through both public market and private transactions. The Board will regularly review this capital return policy in connection with a balanced capital allocation strategy.

"Our mission now is to transition our strategy to focus on our high-growth, high-margin ENHANZE drug delivery technology platform," said Dr. Helen Torley, president and CEO of Halozyme. "Our ENHANZE business is well positioned for this growth, supported by strong partnerships with leading brands and a promising development pipeline. As a result, Halozyme now has a clear path to near-term, sustainable profitability with strong cash flows and high growth prospects. In addition, our share repurchase program reflects our continued commitment to creating value for our shareholders and to implementing a capital return philosophy aligned with our new company profile."

Dr. Torley continued, "The results of the well-designed and well-executed HALO-301 study were not what we wanted or expected. I wish to extend my deep appreciation for all who supported this study and made it possible, in particular the patients, their families, our investigators and their staff, our investors and the Halozyme team."

The actions taken by the Company follow the results of its HALO-301 Phase 3 clinical study, which were disclosed in a separate press release issued today.

Conference Call and Webcast Information
Halozyme will webcast a conference call today at 8:30 a.m. ET / 5:30 a.m. PT to discuss its plans to focus strategy on its ENHANZE drug delivery technology. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers) using passcode 3069304. A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3069304.