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Medtronic to Expand Heart Failure Portfolio with Acquisition of HeartWare International

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.

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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.

Advanced Accelerator Applications Announces FDA Priority Review for Lutathera

On June 27, 2016 Advanced Accelerator Applications S.A. (NASDAQ:AAAP) ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine (MNM), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) and granted Priority Review for Lutathera, a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults (Press release, Advanced Accelerator Applications, JUN 27, 2016, View Source [SID:1234513596]). The Prescription Drug User Fee Act (PDUFA) target action date is December 28, 2016.

Priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

The Lutathera NDA is based on the results of a randomized pivotal Phase 3 study, NETTER-1 that compared treatment using Lutathera with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under Octreotide LAR treatment and overexpressing somatostatin receptors. The NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR. Efficacy and safety data from a large Phase I-II trial conducted in more than 1,200 patients in NET indications is also part of the NDA.

"We are encouraged that the FDA has granted Priority Review for Lutathera as a potential treatment for GEP-NETs," said Stefano Buono, Chief Executive Officer of AAA. "We believe this action emphasizes the need to improve the lives of these patients."

About Neuro Endocrine Tumors (NETs)

Neuro Endocrine Tumors, also known as NETs, are a group of tumors originating in the neuroendocrine cells of many different organs. NETs can remain clinically silent for years delaying the diagnosis in a large number of patients. These cancers are rare but they are the second most common type of gastrointestinal malignancy and their incidence is increasing. The estimated incidence of NETs for the combined populations of the United States and the European Union is approximately 47,300.

NETs are classified as orphan diseases by U.S. and European regulatory authorities, meaning that they affect a relatively small population of individuals in the relevant jurisdiction. In the United States, orphan drugs are defined as drugs that treat diseases or conditions that affect 200,000 or fewer individuals in the country. In the European Union, orphan drugs are defined as drugs that treat diseases or conditions that affect fewer than five out of 10,000 individuals in the European Union.

About Lutathera

Lutathera (or lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy ("PRRT"), which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides. This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Lutathera was also granted fast-track designation by the FDA in April 2015 for the treatment of inoperable progressive midgut NETs. Lutathera is also currently administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP) for midgut NETs. In an analysis of the Phase 3 trial’s primary endpoint of PFS assessment, completed by the Company in September 2015, the Lutathera arm of the trial demonstrated a significant improvement in PFS compared to the PFS for Octreotide LAR 60 mg arm, suggesting a significant therapeutic effect for patients with midgut NETs. NDA and MAA submissions to the FDA and EMA are currently under review.

Jazz Pharmaceuticals Announces Expiration of HSR Waiting Period for Proposed Celator Pharmaceuticals, Inc. Acquisition

On June 27, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), with respect to its proposed acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: CPXX) expired effective June 24, 2016, at 11:59 p.m. (Eastern Daylight Time) (Press release, Jazz Pharmaceuticals, JUN 27, 2016, View Source;p=RssLanding&cat=news&id=2180005 [SID:1234513579]).

As previously announced on May 31, 2016, Jazz Pharmaceuticals and Celator entered into a definitive merger agreement under which Jazz Pharmaceuticals has commenced a tender offer for all of the outstanding shares of Celator at $30.25 per share in cash, representing total consideration of approximately $1.5 billion. The expiration of the HSR waiting period satisfies one of the conditions required to consummate the tender offer. The closing of the tender offer remains subject to other customary conditions, including the tender of a majority of the outstanding shares of Celator common stock.

The tender offer and withdrawal rights will expire at one minute following 11:59 p.m., New York City Time, on July 11, 2016, unless the tender offer is extended or terminated earlier in accordance with the terms of the definitive merger agreement. The Offer to Purchase dated June 10, 2016, relating to the tender offer has been filed with the United States Securities and Exchange Commission ("SEC") and can be viewed online, along with any amendments thereto, at www.sec.gov.

ZIOPHARM Completes Enrollment in Second Patient Cohort and Initiates Enrollment in Third Cohort in Phase 1 Study of Gene Therapy Candidate Ad-RTS-hIL-12 in Brain Cancer

On June 27, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported the successful completion of enrollment in the first and second dosing cohorts as well as the initiation of enrollment in a third cohort in the Company’s ongoing multi-center Phase 1 study of Ad-RTS-hIL-12 + orally administered veledimex to treat recurrent or progressive glioblastoma (GBM) or grade III malignant glioma (Press release, Ziopharm, JUN 27, 2016, View Source [SID:1234513578]). Ad-RTS-hIL-12 + veledimex is a novel viral gene therapy candidate for the controlled expression of interleukin 12 (IL-12), a critical protein for stimulating an anti-cancer immune response.

The primary objective of the study is to determine the safety and tolerability of a single intratumoral Ad-RTS-hIL-12 injection activated upon dosing with oral veledimex. Secondary objectives are to determine the maximum tolerated dose, the immune responses elicited, and assessment of biologic response. The first cohort of seven patients received 20 mg doses of veledimex, the second cohort of six patients received 40 mg doses of veledimex, and the third cohort will receive 30 mg doses of veledimex to refine the effect of activating the immune response within the tumor. The resultant immunologic activity that follows IL-12 expression in the brain suggests that no further dose escalation will be necessary and the optimal dosing may be reached sooner than initially anticipated.

Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM, commented: "With the RheoSwitch (RTS) technology, the only switch currently in the clinic that operates on gene transcription, we have demonstrated the ability for veledimex to cross the human blood brain barrier and activate production of IL-12 in GBM tumors in a dose-dependent manner, giving us the potential to precisely tune the balance between activity and tolerability."

Data from 11 patients with recurrent high-grade gliomas were recently presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. All of these patients failed at least two prior lines of therapy and underwent partial resection leaving residual tumors, in certain cases with significant tumor burden. Ad-RTS-hIL-12 was administered through direct injection into the brain tumor and veledimex was taken orally to activate the production of IL-12 from the tumor site and stimulate an immune response.

As of May 18th, the date of data collection for the ASCO (Free ASCO Whitepaper) presentation, overall median follow up was 6.2 months, with 10 of 11 recipients alive. IL-12 in the bloodstream was measured and was found to be proportional to the amount of veledimex administered, demonstrating that this orally-delivered activator crossed the blood brain barrier to turn on the RheoSwitch technology in a dose-dependent manner.

To date, toxicities in both dose cohorts were consistent with those previously reported, with a higher incidence of grade 3 or greater adverse events in the 40 mg dose group. All related side effects were reversed upon cessation of veledimex. No subsequent deaths have been reported.

The Company expects to present updated results from the study at a scientific meeting later in the year.

"Overall survival remains the gold standard of therapeutic success in glioblastoma, particularly in high-grade, recurrent disease, where survival is too often measured by just a few months," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "We remain encouraged by the outcomes of Ad-RTS-hIL-12 as a single agent tuning the immune system in this GBM study. We believe that these early results also have positive implications for our combination approach utilizing this novel gene therapy with immune check point inhibitors. We look forward to additional follow up as we work to fine-tune dosing levels using the RheoSwitch technology."

Ad-RTS-hIL-12 + veledimex has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with malignant glioma.

About Glioblastoma

Glioblastoma is an aggressive primary brain tumor affecting approximately 74,000 people worldwide each year.i, ii Recurrent glioblastoma is an aggressive cancer with one of the lowest 3-year survival rates, at 3%, among all cancers.iii For patients who have experienced multiple recurrences the prognosis is particularly poor, with a median overall survival (OS) of 6-7 months, while OS in patients that have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy, is approximately 3-5 months.iv, v

LabCorp Announces Launch of New Companion Diagnostic for Non-Small Cell Lung Cancer

On June 27, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the availability of a new application for the companion diagnostic associated with the use of Tarceva for the treatment of certain patients with non-small cell lung cancer (NSCLC) (Press release, LabCorp, JUN 27, 2016, View Source [SID:1234513576]). The Roche cobas EGFR Mutation Test v2 is the first blood-based test approved for clinical use in the U.S. to detect certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients. LabCorp played a key role in making the test available upon approval by the U.S. Food and Drug Administration (FDA) and is the only national laboratory currently offering the test.

“The availability of this test demonstrates LabCorp’s industry-leading position in the commercialization of companion diagnostics,” said David P. King, chairman and chief executive officer of LabCorp. “The success and growth of our companion diagnostics business continues to differentiate us from our competitors as we carry out our mission to improve health and improve lives.”

The cobas EGFR Mutation Test v2, which was approved by the FDA on June 1, 2016, can be used on either plasma obtained from a routine blood collection or on tumor tissue obtained from a surgical biopsy. The test identifies epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations in patients with NSCLC who may benefit from first-line treatment with Tarceva. The availability of a less-invasive, blood-based test gives physicians a powerful new treatment option for patients who may not be able to undergo surgical biopsy or who cannot provide a tumor specimen for other reasons.

“The FDA approval of the cobas EGFR Mutation Test v2 for plasma-based testing offers a minimally invasive option for patients with NSCLC,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “Partnering with key labs ensures that patients can be tested conveniently.”

“LabCorp is pleased to add this important new test to our menu of world-class diagnostics,” said Marcia Eisenberg, Ph.D., chief scientific officer of LabCorp Diagnostics. “Knowledge is power for patients and their physicians, and tests like this can help patients access targeted, personalized treatment.”

Lung cancer is the leading cause of cancer death in the U.S. among both men and women, accounting for about one-third of all cancer deaths, more than the other common cancers combined (breast, prostate and colon cancers). More than 80% of all lung cancers in the US are NSCLC, and 10%-20% of these have EGFR mutations.

The cobas EGFR Mutation Test v2 is now available for patient testing nationwide from LabCorp and Integrated Oncology, a member of the LabCorp Specialty Testing Group.

Tarceva is developed and commercialized by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.

COBAS is a registered trademark of Roche.

Tarceva is a registered trademark of OSI Pharmaceuticals.