Tuesday, October 2, 2018
EpiPen shortage shows company, regulator failure, FT says
The worldwide shortage of EpiPens shows a failure by Mylan (MYL), the company that owns the rights to the auto-injectors, and the regulators to monitor them, the Financial Times says, in an opinion piece by Michael Skapinker. Mylan did not pay enough to sub-contractor Pfizer’s (PFE) performance and unnecessarily early expiration dates on the EpiPens increased sales but contributed to the shortage, according to Skapinker.
https://thefly.com/landingPageNews.php?id=2798217
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
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