On June 27, 2016 Medtronic plc (NYSE: MDT), the global leader in medical technology, and HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, reported that the companies have entered into a definitive merger agreement under which Medtronic will acquire HeartWare in a transaction valued at approximately $1.1 billion (Press release, HeartWare International, JUN 27, 2016, View Source;p=irol-newsArticle&ID=2180056 [SID:1234514705]). Under the terms of the agreement, Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58.00 per share, in cash. The boards of directors of both Medtronic and HeartWare have unanimously approved the transaction. The acquisition is expected to close during Medtronic’s second fiscal quarter ending Oct. 28, 2016, subject to the satisfaction of customary closing conditions.

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

                  Schedule Your 30 min Free Demo!

Medtronic’s acquisition of HeartWare will expand Medtronic’s portfolio of diagnostic tools, therapies and services for patients suffering from heart failure, aligning with Medtronic’s Mission of alleviating pain, restoring health and extending life, and is in line with the Company’s strategy to surround the physician with innovative products while focusing on patients and disease states.

HeartWare’s flagship product, the HVAD System, features the world’s smallest full-support ventricular assist device (VAD) and is designed to reduce surgical invasiveness, improve patient recovery times and enhance patient outcomes. In addition, HeartWare has multiple technologies in development designed to offer progressively less-invasive mechanical circulatory support options for patients with end-stage heart failure. Medtronic estimates that the global VAD market is approximately $800 million currently and worldwide is expected to grow in the mid-to-high single digits for CY16-17, and accelerate to high-single/low-double digits beyond CY17.

"The addition of HeartWare’s innovative portfolio adds to our expanding portfolio of diagnostics, therapeutics and services that address heart failure patients," said Mike Coyle, executive vice president and president of the Cardiac and Vascular Group at Medtronic. "The team at HeartWare has established excellent relationships with its hospital customers and built a strong position and reputation in the marketplace. This transaction, once closed, will be a further, important step toward Medtronic offering a complete suite of solutions to address patient needs across the heart failure care continuum."

"Medtronic is the worldwide leader in cardiovascular device technologies. Its expansive expertise in the development of implantable systems and battery technologies, patient monitoring, manufacturing, global regulatory policy and commercialization should help accelerate the development and introduction of our innovative pipeline products, and will expand access to our therapies and offerings to the sizeable heart failure population," said Doug Godshall, president and chief executive officer, HeartWare. "Combining the unique capabilities of the HeartWare team, which has been entirely focused on mechanical support technologies, with the broad strength of the Medtronic organization provides a unique opportunity to enhance growth in the mechanical circulatory support market. All of our stakeholders, including customers, employees, shareholders, and most importantly, patients, will benefit meaningfully from this complementary combination."

Heart failure, also known as congestive heart failure, is a condition or a collection of symptoms in which the heart isn’t pumping enough blood to meet the body’s needs. Heart failure usually develops slowly after an injury to the heart. Some injuries may include a heart attack, too much strain on the heart due to years of untreated high blood pressure, or a diseased heart valve, among others. Heart failure remains a leading cause of hospitalization and death in the United States, and its prevalence continues to increase, affecting more than five million people in the U.S. alone. The cost of heart failure is high. Healthcare expenditures in the U.S. on heart failure are estimated to be approximately $39 billion per year, making it one of the largest expenses to the healthcare system. With the aging of the population, Medtronic estimates that the number of patients with heart failure could exceed eight million by 2030.

"HeartWare’s HVAD System enhances the portfolio of our Cardiac & Vascular Group, a team with a proven track record of executing and a demonstrated ability to scale early stage concepts into large, sustainable end markets," said Omar Ishrak, chairman and chief executive officer of Medtronic. "In addition, from a financial perspective, we are pleased to reach an agreement that meets our acquisition criteria of adding minimal to no net EPS dilution in the near-term, while at the same time creating strong, long-term expected returns for our shareholders."

This acquisition supports Medtronic’s therapy innovation strategic priority. In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

This transaction is expected to meet Medtronic’s long-term financial metrics for acquisitions. Medtronic does not intend to modify its fiscal year 2017 revenue outlook or earnings per share (EPS) guidance as a result of this transaction, although it is expected to provide increased confidence in the company’s ability to deliver on its FY17 revenue growth outlook. In addition, Medtronic expects minimal to no net EPS dilution from this transaction for the first two years as the company intends to offset the expected dilutive impact. The acquisition is expected to be earnings accretive in year three. Medtronic intends to report results from the acquired HeartWare business as part of its Cardiac Rhythm & Heart Failure division within the Cardiac & Vascular Group.

Medtronic’s financial advisor for the transaction is J.P. Morgan Securities LLC, with Ropes & Gray LLP acting as legal advisor. HeartWare’s financial advisor is Perella Weinberg Partners LP, with Shearman & Sterling LLP acting as legal advisor.

On June 24, 2016 Pfizer Inc. (NYSE:PFE) reported that it has completed its acquisition of Anacor Pharmaceuticals, Inc (Press release, Pfizer, JUN 24, 2016, View Source [SID:1234513545]). Under the terms of the transaction, each outstanding share of Anacor common stock has been converted into the right to receive $99.25 net in cash (without interest but subject to required withholding of taxes).

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

                  Schedule Your 30 min Free Demo!

"Now that Anacor is part of Pfizer, we can accelerate our shared commitment to help patients with inflammatory disease, an area of high unmet medical need," said Albert Bourla, Group President, Pfizer Innovative Health. "We believe that Pfizer is in a position to quickly capitalize on the benefits offered by the combination with Anacor, including the potential for a near-term U.S. product launch and subsequent commercialization of crisaborole, a differentiated asset with compelling clinical data. If approved, crisaborole has the potential to be an important first-line treatment option for patients with mild-to-moderate atopic dermatitis and the physicians who treat them."

The transaction is not expected to impact Pfizer’s current 2016 adjusted financial guidance. Pfizer continues to expect the transaction to be slightly dilutive to Adjusted Diluted Earnings Per Share (EPS)(1) in 2017 with accretion to Adjusted Diluted EPS(1) beginning in 2018 and increasing thereafter.

The Offer

The tender offer for all of the outstanding shares of Anacor common stock expired as scheduled immediately after 11:59 p.m., New York City time, on June 23, 2016. Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Pfizer that 39,306,909 shares of Anacor common stock were validly tendered into and not validly withdrawn from the tender offer, including 4,300,427 shares tendered by notice of guaranteed delivery for which certificates were not yet delivered, representing approximately 86.1% of the outstanding shares. All of the conditions to the offer have been satisfied and on June 24, 2016, Pfizer and its subsidiary Quattro Merger Sub Inc. accepted for payment and will promptly pay for all shares validly tendered and not validly withdrawn.

Following its acceptance of the tendered shares, Pfizer completed its acquisition of Anacor through the merger of Quattro Merger Sub Inc. with and into Anacor without a vote of Anacor’s stockholders pursuant to Section 251(h) of the Delaware General Corporation Law. As a result of the merger, Anacor became a wholly-owned subsidiary of Pfizer. In connection with the merger, all Anacor shares not validly tendered into the tender offer (other than treasury shares held by Anacor and any shares owned by Pfizer, Quattro Merger Sub Inc. or any person who was entitled to and has properly demanded statutory appraisal of his or her shares) have been cancelled and converted into the right to receive the same $99.25 per share net in cash (without interest but subject to required withholding of taxes) as will be paid for all shares that were validly tendered and not validly withdrawn in the tender offer. Anacor common stock will cease to be traded on the NASDAQ Global Market.

On June 23, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported nine presentations of rolapitant data at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer, June 23 to 25, 2016, in Adelaide, Australia (Press release, TESARO, JUN 23, 2016, View Source [SID:1234513532]).

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

                  Schedule Your 30 min Free Demo!

"Delayed chemotherapy-induced nausea and vomiting can be a debilitating side effect of chemotherapy. At this year’s MASCC/ISOO Annual Meeting, which is the premier global event for supportive care in cancer, we are pleased that data will be presented that demonstrate the activity of rolapitant in patients at high risk for CINV, including those who are receiving cisplatin- and carboplatin-based chemotherapy for gynecologic and lung cancers," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "With our Marketing Authorisation Application (MAA) for oral rolapitant under review by the European Medicines Agency (EMA) and our New Drug Application (NDA) for intravenous rolapitant under review by the U.S. FDA, we look forward to globalizing our mission of improving the lives of people bravely facing cancer."

Please visit TESARO at Booth #3 for information about VARUBI (rolapitant) and our pipeline.

Presentation Details:

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer
Abstract: MASCC-0318, Poster Presentation, Thursday, June 23, 2016

Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy
Abstract: MASCC-0322, Poster Presentation, Thursday, June 23, 2016

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients aged <65 versus ≥65 years
Abstract: MASCC-0432, Poster Presentation, Thursday, June 23, 2016

Single ascending dose pharmacokinetics of rolapitant administered intravenously at supratherapeutic doses in healthy volunteers
Abstract: MASCC-0489, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of cooperstown cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin [CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in healthy volunteers
Abstract: MASCC-0492, Poster Presentation, Thursday, June 23, 2016

Effects of rolapitant administered intravenously on the pharmacokinetics of digoxin (P-gp) and sulfasalazine (BCRP) in healthy volunteers
Abstract: MASCC-0494, Poster Presentation, Thursday, June 23, 2016

A single-dose bioequivalence study of rolapitant following oral and intravenous administration in healthy volunteers
Abstract: MASCC-0485, Oral Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30 PM

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with lung cancer
Abstract: MASCC-0321, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer
Abstract: MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from 11:00 AM to 12:30 PM

About VARUBI (Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full the U.S. prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is currently under review by the FDA, with a target action date under the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An MAA for oral rolapitant is currently under review by the EMA. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

On June 23, 2016 ArQule, Inc. (Nasdaq:ARQL) reported that preliminary data from the ongoing phase 2 portion of a phase 1/2 trial in intrahepatic cholangiocarcinoma (iCCA) with our proprietary fibroblast growth factor receptor (FGFR) inhibitor, ARQ 087, will be presented on June 30, 2016 at the ESMO (Free ESMO Whitepaper) 18th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, ArQule, JUN 23, 2016, View Source [SID:1234513506]). This is a biomarker driven trial designed to enroll at least 20 patients in iCCA with FGFR2 genetic alterations. The company has been granted orphan drug designation by the U.S. Food and Drug Administration and European Medicine’s Agency for ARQ 087 in this indication.

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

                  Schedule Your 30 min Free Demo!

Presentation Details
Abstract Number: 340 (PD #19)
Poster Title: ARQ 087, an Oral Pan-Fibroblast Growth Factor Receptor (FGFR) Inhibitor, in Patients with Advanced and/or Metastatic Intrahepatic Cholangiocarcinoma (iCCA)
Poster Discussion Time: June 30, 2016 from 11:00 a.m. to 11:30 a.m. CEST
Poster Presentation Time: June 30, 2016 from 5:10 p.m. to 5:40 p.m. CEST
Location: Exhibit Hall

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC)1. Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. The average age adjusted incidence rate for iCCA is approximately one in 100,000 per year in the United States and Europe2,3.

About FGFR and ARQ 087

ARQ 087 is a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor ("FGFR") family with demonstrated efficacy in FGFR2 genetic alterations. The FGFR pathway is disrupted in several ways in human cancer, thus providing numerous therapeutic targets for an inhibitor of this pathway. ARQ 087 has demonstrated in vivo inhibition of tumor growth and downstream signaling in tumors whose growth is driven by FGFR targets.

Signals of single agent activity with this drug were observed in phase 1a testing. Phase 1b expansion cohorts with ARQ 087 include patients with cholangiocarcinoma and adrenocortical tumors, as well as those with FGFR translocations, amplifications and mutations. Clinical development of ARQ 087 has advanced into phase 2 for intrahepatic cholangiocarcinoma (iCCA) following the observation of two confirmed responses in this patient population in the phase 1 portion of the program.

On June 23, 2016 Mylan N.V. (NASDAQ, TASE: MYL), one of the world’s leading pharmaceutical companies, reported a €1 million donation to the Princess Máxima Center for Pediatric Oncology, a new national cancer center currently being built in Utrecht, the Netherlands (Press release, Mylan, JUN 23, 2016, View Source [SID:1234513522]).

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

                  Schedule Your 30 min Free Demo!

The donation from Mylan will support the Princess Máxima Center in its mission of treating and curing children with cancer by enhancing research efforts and supporting patients and their families while at the center for treatment.

Mylan Executive Chairman Robert J. Coury commented, "Mylan’s mission is to set new standards in healthcare and provide access to high quality medicine to patients around the world; however, our mission starts with the communities in which we operate, and we have had the privilege to serve customers and patients in the Netherlands for more than 17 years. The mission of the Princess Máxima Center is closely aligned with Mylan’s and I would like to commend Prof. Pieters for his vision and leadership in raising the standard of care for cancer in the Netherlands and ensuring children with cancer have equal access to the best care available."

Mylan CEO Heather Bresch added, "Every two days a child dies from cancer in the Netherlands and one in four children does not survive their fight with this disease. Through our commitment to providing access to oncology medications to patients around the world, we strive to do our part to help treat and cure cancer, and we believe our partnership with The Princess Máxima Center is just one of the ways we can go beyond medicine to deliver better health for a better world."

Professor Pieters, member of the board of the Princess Máxima Center commented, "We are grateful to Mylan for their generous support of the Princess Máxima Center, which is focused on treating children with cancer using the best possible methods, while also preventing the development of negative side effects in young patients, both now and over the long term. By bringing together expertise in care and research in the Princess Máxima Center, the Netherlands will become a leader in the field of pediatric oncology both in Europe and globally. It is a position that will help us fulfill our ambition: to cure every child with cancer. I am delighted that our collaboration with Mylan will further support the care we provide and our continued research."

Matean Niël, Mylan country manager in the Netherlands added: "I am thrilled to see Mylan supporting a cause in the Netherlands that puts people and patients first. Mylan’s support of the Princess Máxima Center creates a lot of pride among our hundreds of employees based in Bunschoten, Weesp and Zwolle. This initiative reflects our local commitment to institutional care in the Netherlands."