Tuesday, October 2, 2018
GlaxoSmithKline: Albiglutude ‘superior’ to placebo in Harmony Outcomes study
GSK and the Duke Clinical Research Institute announced publication of results from the Harmony Outcomes study which assessed the cardiovascular safety and efficacy of albiglutide, a GLP-1 receptor agonist, in patients with type 2 diabetes and cardiovascular disease. Results were presented at the European Association for the Study of Diabetes congress 2018 with simultaneous publication in The Lancet. The study was initiated in July 2015 and GSK remained committed to completing it following an announcement in July 2017 of GSK’s intention to cease further R&D, manufacturing and sales activity for albiglutide. Prior studies of GLP-1 receptor agonists when used in patients with diabetes and CV disease had provided inconsistent results regarding the potential benefit, and GSK believed that the data generated from this study could contribute important new evidence to the field. The primary outcome showed that albiglutide, administered subcutaneously once-weekly in 9463 patients over a median period of 1.6 years, was superior to placebo in reducing the risk of major adverse cardiovascular events by 22% when used in addition to standard of care in patients with type 2 diabetes and cardiovascular disease. Dr John Lepore, Senior Vice President R&D Pipeline, GSK said: “Harmony Outcomes was an important study for us to complete to generate new data and insights about the role of the GLP-1 receptor agonist class in the management of patients with diabetes and cardiovascular disease. GSK continued to invest in this study following a decision last year to cease all other activities on albiglutide, and we continue to explore opportunities to divest this medicine to a company with the right expertise and resources to realise its full potential for patients.”
https://thefly.com/landingPageNews.php?id=2798225
MEDNAX (MD) Buys Leading Nevada Radiology Practice
MEDNAX, Inc. (NYSE: MD), today announced the acquisition of Radiology Specialists, LTD, a private radiology physician group based in Las Vegas. This marks the Company’s seventh radiology services practice acquisition and first in the state of Nevada, further establishing MEDNAX Radiology Solutions as a recognized leader in radiology, an innovator in health care informatics and a pioneer in telemedicine.
Comprising 25 board certified and fellowship trained physicians, the practice provides a broad range of diagnostic and interventional radiology services, including body imaging, neuroradiology, musculoskeletal imaging, cardiac imaging, breast imaging, pediatric radiology, nuclear medicine and image guided therapy. For more than 50 years, it has partnered with Sunrise Health, servicing Sunrise Hospital & Medical Center, Southern Hills Hospital & Medical Center, Sunrise Children’s Hospital and MountainView Hospital.
“As a leading, high-performance radiology practice notably serving Nevada’s only Comprehensive Stroke Center, we recognize that our continuing success relies upon timely adaptation to a dynamic radiology environment, with the groups most responsive to change at a distinct advantage,” said Sean D. Beaty, M.D., president of Radiology Specialists. “In partnering with MEDNAX, we are confident that we will successfully navigate the many current challenges that radiology practices face. MEDNAX shares our mission to provide measurable, high-quality radiology services to achieve the greatest possible benefit for the patients, clinicians and facilities that we serve.”
Upon completion of the transaction, MEDNAX’s affiliated radiologists will read more than 11.5 million studies annually.
This was a cash transaction, and it is expected to be immediately accretive to earnings. No additional terms of the transaction were disclosed.
With this acquisition, six physician group practices have become part of MEDNAX in 2018.
Clementia Commences Phase 1 for Eye Drop Formulation
Clementia Pharmaceuticals Inc. (NASDAQ: CMTA), a clinical-stage biopharmaceutical company innovating treatments for people with ultra-rare bone disorders and other diseases, today announced the initiation of a Phase 1 clinical trial evaluating an eye drop formulation of palovarotene in healthy volunteers. Palovarotene, an RARĪ³ agonist, is Clementia’s lead product candidate and is also being developed as an oral therapy for the treatment of patients with ultra-rare bone disorders, including fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).
“We are very excited to initiate our third clinical development program, an eye drop formulation of palovarotene, beginning with this Phase 1 study in healthy volunteers,” said Clarissa Desjardins, Ph.D., president and chief executive officer of Clementia. “Palovarotene has been shown to exert multiple effects in various tissues, including anti-fibrotic effects in ocular tissues. Our preclinical work has indicated that an eye drop formulation of palovarotene may potently increase tear production and decrease corneal damage, and we look forward to advancing this program in human studies.”
This study will evaluate the safety, tolerability, and pharmacokinetic (PK) profile of single and multiple ascending doses of palovarotene ophthalmic solution in healthy volunteers. Data from this trial are expected in the first quarter of 2019. Clementia will utilize the data obtained in this study to inform the design of a proof of concept efficacy trial evaluating palovarotene in dry eye disease, which is expected to begin in 2019.
Edwards Lifesciences downgraded to Neutral from Buy at Guggenheim
Guggenheim downgraded Edwards Lifesciences to Neutral citing valuation.
https://thefly.com/landingPageNews.php?id=2798189
Illumina price target raised to $380 from $350 at Piper Jaffray
Piper Jaffray analyst William Quirk raised his price target for Illumina to $380 and keeps an Overweight rating on the shares. The analyst is now more confident in his projections for the company and moved his earnings multiple to 60 times from 55. He is forecasting overall sequencing spend to increase 22% from $259M in 2018 to $317M in 2019 and 25% to $397M in 2020. Most of the programs are currently focusing on large scale human sequencing, and thus the majority will gravitate to Illumina’s NovaSeq systems, Quirk tells investors in a research note titled “How Sequencing Is Taking Over The World.”
https://thefly.com/landingPageNews.php?id=2798143
Lilly Phase 3 Studies Show Lispro Met Efficacy Endpoint in Type 1 & 2 Diabetes
Readouts from two phase 3 clinical trials demonstrated that Eli Lilly and Company’s (NYSE: LLY) Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog® (insulin lispro) and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes.
URLi is Lilly’s novel mealtime insulin formulation that was developed to help better control blood glucose levels after meals by more closely mirroring the way insulin works in people without diabetes.
The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in people with type 1 and type 2 diabetes, respectively. The primary efficacy endpoint of non-inferiority to Humalog, as measured by A1C reduction from baseline, was met in both studies at 26 weeks. In both populations, URLi demonstrated superior reduction in glucose excursions at both one and two hours during a meal test. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.
“Despite progress in insulin and diabetes management, many people with diabetes find controlling high blood sugar levels after meals frustrating. If approved, URLi will be a new option in mealtime insulin therapy designed to help keep blood sugar in range after eating,” said Thomas Hardy, Senior Medical Director, Insulins Product Development, Lilly Diabetes. “We are encouraged by these data showing that URLi was non-inferior to Humalog in controlling A1C, an overall measure of glucose control, while significantly lowering blood glucose levels during a meal test.”
In both studies, URLi showed overall safety and tolerability similar to Humalog. Lilly plans to present detailed results from these studies in 2019. Based on these results, Lilly will submit URLi to regulatory authorities in 2019
Monday, October 1, 2018
Merit Medical Signs Agreement to Acquire Cianna Medical
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, today announced that it has signed a definitive merger agreement to acquire Cianna Medical, Inc., headquartered in Aliso Viejo, California. The transaction has been approved by the board of directors of both companies, and is subject to the satisfaction or waiver (in accordance with the provisions of the merger agreement) of certain closing conditions, including the approval of Cianna Medical stockholders, clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. It is anticipated that the transaction will close during the fourth quarter of 2018.
The deal structure includes an upfront payment of $135 million with potential earn-out payments of an additional $15 million for achievement of supply chain and scalability metrics, and up to an additional $50 million for achievement of sales milestones.
Based on management’s current estimates, in 2019 the proposed transaction, if consummated, would be non-accretive to Merit earnings per share on a GAAP basis in the range of ($0.06-$0.10) per common share and accretive to Merit earnings per share on a non-GAAP basis in the range of $0.08–$0.13 per common share, with anticipated GAAP gross margins of 55-65% and non-GAAP gross margins of 70-75% on the Cianna Medical products, accretive to both Merit’s GAAP gross margin and non-GAAP gross margin in the range of 55-130 basis points, and add revenues in the range of $50-$56 million. NOTE: Non-GAAP earnings per share accretion and non-GAAP gross margin are non-GAAP financial measures. Information about how Merit uses non-GAAP measures in its business, and an explanation of how these measures relate to their most directly comparable GAAP financial measures, is included under the heading “Non-GAAP Financial Measures” below.
Cianna Medical is a leader in wire-free breast localization and has been focused on breast conservation for 11 years. Cianna Medical develops, manufactures and markets innovative medical products designed to reduce costs, improve quality and reduce the anxiety and stress breast cancer treatments place on women and their families. Its research, development and commercialization teams developed the first non-radioactive, wire-free breast localization system and the world’s only technology that utilizes RADAR in human tissue. Its SCOUT® and SAVI® Brachy technologies are FDA-cleared and address unmet needs in the delivery of radiation therapy, tumor localization and surgical guidance.
The SCOUT® device has grown from $1 million in revenues in its 2015 debut to a projected $29 million in revenues in 2018. Current estimated market share is approximately 5% with no revenues currently outside the United States.
“This transaction adds to Merit a technology leader in breast tumor localization that is precise, highly directional, and visible,” said Merit’s Chairman and Chief Executive Officer Fred P. Lampropoulos. “With more than 350 initiations and 45,000 wire-free localizations to date, the SAVI SCOUT® is complementary to Merit’s strategic biopsy initiatives. The product has FDA clearance and is the subject of a pending application for CE mark approval. We believe there are substantial global growth opportunities for the Cianna Medical products, especially considering Merit’s expansive global footprint.”
“Merit plans to keep substantially all of Cianna Medical’s commercial and R&D teams in place and to enhance overall coverage in areas currently underserved by Cianna Medical,” Lampropoulos said. “We want to maintain the momentum of the Cianna Medical team while adding enhanced logistical and clinical support.”
“Additionally, Merit intends to market the SAVI® BRACHY, which uses thin tubes to deliver radiation to lumpectomy sites,” Lampropoulos said. “Merit only markets the catheter and is not involved in radiation seeds or the transport thereof. The product has both FDA clearance and CE mark approval. Merit’s medical advisors believe this is an underutilized technology.”
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