Phase 3 Data of Merck ZERBAXA® for Pneumonia

ASPECT-NP Clinical Trial Results Demonstrated Non-Inferiority of ZERBAXA to Meropenem for Treating Ventilated Nosocomial Pneumonia in Primary and Key Secondary Endpoints

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first presentation of results from ASPECT-NP, a randomized, double-blind, multi-center Phase 3 clinical trial evaluating the efficacy and safety of ZERBAXA^®(ceftolozane and tazobactam) for the treatment of adult patients with ventilated nosocomial (hospital acquired) pneumonia. The results demonstrated non-inferiority of an investigational dose of ZERBAXA to meropenem, the active comparator, in the primary and key secondary endpoints. Based on these results, Merck has submitted supplemental new drug applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking regulatory approval for ZERBAXA for this potential new indication. The FDA Prescription Drug User Fee Act (PDUFA) date is June 3, 2019. Detailed findings of the ASPECT-NP Phase 3 trial are scheduled to be presented at the 29^th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), on Monday, April 15 at 1:30 pm local time in Amsterdam, Netherlands (Poster P1917).

“ASPECT-NP is unique among registration trials for nosocomial pneumonia, as all patients were intubated and mechanically ventilated and nearly all were treated in the intensive care unit,” said Dr. Marin Kollef, director of Medical Critical Care and Respiratory Care Services of Barnes-Jewish Hospital and the Golman Professor of Medicine at Washington University School of Medicine, St. Louis, MO. “This is a disease state with a high mortality rate, and Merck’s commitment to this trial provides meaningful evidence that helps expand our understanding of the management of this patient population.”

In the U.S., ZERBAXA is currently indicated for the treatment of adult patients with complicated urinary tract infections, including pyelonephritis, caused by certain susceptible Gram-negative microorganisms, and is indicated, in combination with metronidazole, for the treatment of adult patients with complicated intra-abdominal infections caused by certain susceptible Gram-negative and Gram-positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-Results-of-Phase-3-Trial-Evaluating-Merck-s-ZERBAXA-ceftolozane-and-tazobactam-versus-28420264/

Teva’s COPAXONE® 40mg – Favorable Response from European Patent Office

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that a three-member panel of the European Patent Office’s (EPO) Opposition Division upheld patent EP 2 949 335 covering Teva’s COPAXONE® 40mg product in Europe. The Opposition Division will issue its written underlying rationale on the decision within a few months.

COPAXONE® is a highly complex molecule for which consistent proprietary manufacturing methods are required. These determine the composition, purity and batch-to-batch consistency of COPAXONE®. The patent protects the three-times-weekly subcutaneous injection of 40 mg/mL (“40mgTIW”) of glatiramer acetate for the treatment of certain forms of multiple sclerosis.

https://www.marketscreener.com/TEVA-PHARMACEUTICAL-INDUS-56537293/news/Teva-s-COPAXONE-40mg-Favorable-Response-from-European-Patent-Office-Teva-Pharmaceutical-Industri-28399087/

KemPharm up as KP415 NDA nears finish line

KemPharm (NASDAQ:KMPH) is up 15% after hours in response to its announcement that it plans to file a U.S. marketing application later this quarter or in early Q3 seeking approval for KP415 for the treatment of attention deficit hyperactivity disorder (ADHD).

The company recently met with the FDA to discuss the requirements for a New Drug Application (NDA) and the agency said the data package would be sufficient to support a filing.

Management will host a conference call today at 5:00 pm ET to discuss its plans.

https://seekingalpha.com/news/3450164-kempharm-15-percent-hours-kp415-nda-nears-finish-line

Alnylam’s Givosiran study met primary efficacy endpoint in AHP treatment

Alnylam announced “positive complete results” from the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 in development for the treatment of acute hepatic porphyria, or AHP. The full ENVISION results demonstrated a 74% mean and 90% median reduction in the primary endpoint measure of annualized rate of composite attacks in patients on givosiran relative to placebo during the six-month double-blind period. In addition, givosiran achieved statistically significant positive results for five of nine secondary endpoints, with an overall safety and tolerability profile that the company believes is encouraging, especially in this high unmet need disease. Adverse events were reported in 89.6% of givosiran patients and 80.4% of placebo patients; serious adverse events were reported in 20.8% of givosiran patients and 8.7% of placebo patients. Ninety-three of 94% , or 99%, enrolled in the open-label extension period of the study. Based on the ENVISION results, the company plans to complete its rolling submission of a New Drug Application and file a Marketing Authorisation Application in mid-2019.

https://thefly.com/landingPageNews.php?id=2892173

Alnylam to hold a conference call

In conjunction with the Givosiran Phase 3 data being presented at the EASL 54th Annual International Liver Congress, management holds a conference call to discuss the presentation on April 13 at 8 am.

https://event.webcasts.com/starthere.jsp?ei=1236641&tp_key=20c92a38d8
https://thefly.com/landingPageNews.php?id=2889703

Clovis discontinuing Phase 2 trial of rucaparib in metastatic bladder cancer

Clovis Oncology, Inc. (“Clovis”) is discontinuing its sponsored Phase 2 open-label monotherapy clinical trial evaluating rucaparib in recurrent, metastatic bladder cancer (CO-338-085 (“ATLAS”)). The decision is based on recommendations by an independent data monitoring committee (“DMC”) following its review of preliminary efficacy data for 62 patients enrolled and treated in the study, which demonstrated that the objective response rate in the intent-to-treat population does not meet the protocol-defined continuance criteria, and suggests that treatment with monotherapy rucaparib may not provide a meaningful clinical benefit to patients. Therefore, the DMC recommended to stop enrollment to the study, and Clovis has decided to terminate the ATLAS trial early. The recommendation of the DMC was not based on the safety profile of rucaparib in this study population.

Clovis is continuing to evaluate the potential for rucaparib in combination with other agents for the treatment of advanced bladder cancer. Clovis also plans to enroll patients with advanced bladder cancer and selected genetic mutations in a planned pan-tumor trial of rucaparib expected to begin in the second half of 2019.

https://www.streetinsider.com/Corporate+News/Clovis+Oncology+%28CLVS%29+says+its+discontinuing+Phase+2+open-label+monotherapy+clinical+trial+evaluating+rucaparib+in+recurrent%2C+metastatic+bladder+cancer/15367847.html

Merck in Definitive Agreement to Acquire Versum Materials (VSM) for $53/share

Merck, a leading science and technology company, has signed a definitive agreement to acquire Versum Materials, Inc. (NYSE: VSM) for $53 per share in cash. The business combination has been unanimously approved by the Executive Board of Merck and by Versum’s Board of Directors.

“With this transaction, Merck will be optimally positioned to capitalize on long-term growth trends in the electronic materials industry. Our combined business shall deliver leading-edge innovations to our customers around the globe,” said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck.

Seifi Ghasemi, Chairman of Versum, said: “The Merck-Versum transaction offers compelling and certain value for our shareholders and will provide long-term benefits for our customers and employees. This exciting business combination will create increased scale, product and service depth, enhanced global presence, strengthened supply chain and combined R&D capabilities, driving leading innovation. We look forward to joining together our respective businesses and talented teams.”

Versum is one of the world’s leading suppliers of innovation-driven, high-purity process chemicals, gases and equipment for semiconductor manufacturing. The company reported annual sales of approximately €1.2 billion ($1.4 billion) in FY2018, has approximately 2,300 employees, and operates 15 manufacturing and seven research and development facilities throughout Asia and North America. Versum has achieved revenue and adjusted EBITDA compounded annual growth in excess of 10% over the last three fiscal years with industry-leading adjusted EBITDA margins at 33%.

The business combination is expected to significantly strengthen Merck’s Performance Materials business sector, creating a leading electronic materials player focused on the semiconductor and display industries. The business combination rebalances the company’s diversified three pillar portfolio of Healthcare, Life Science and Performance Materials while executing on Performance Material’s previously communicated transformation program.

The combined companies and their customers and employees will benefit from increased scale, product portfolio, innovation and services depth, globally. In addition, with the combined business, the Performance Materials business sector will strengthen its global supply chain.

Merck intends to maintain Versum’s Tempe, AZ headquarters as the major hub for the combined electronic materials business in the United States, complementing Merck’s already strong footprint and track record as a top employer in the U.S. Over the past decade, the company has invested approximately $24 billion in the U.S. through acquisitions alone, including the successful acquisitions of Millipore in 2010 and Sigma-Aldrich in 2015. Versum employees will become an integral part of a leading electronic materials business and will benefit from new and exciting development opportunities within a truly global science and technology company.

The agreed upon price reflects an enterprise value (EV) for Versum of approximately €5.8 billion, implying an EV/2019 EBITDA multiple of approximately 13.7x based upon consensus estimates and a pro-forma multiple of 11.6x including €75 million of identified annual run-rate cost synergies. The business combination is expected to be immediately accretive to earnings per share pre (EPS pre) and accretive to reported EPS in the third full year after closing.

https://www.streetinsider.com/Corporate+News/Merck+Signs+Definitive+Agreement+to+Acquire+Versum+Materials+%28VSM%29+for+%2453+per+Share/15365998.html