Tuesday, October 2, 2018
LeMaitre downgraded to Neutral from Buy at Roth Capital
Roth Capital analyst David Solomon downgraded LeMaitre to Neutral from Buy, while raising the shares’ price target to $39 from $38, citing valuation after assuming coverage of the stock. The analyst notes that the company announced that it acquired Applied Medical’s vascular clot management business for $14.2M. Among the key takeaways, the analyst highlights that the acquired products bolster its line of embolectomy catheters, and points out that LeMaitre’s appetite for another acquisition remains.
https://thefly.com/landingPageNews.php?id=2798381
Baxter, Mayo Clinic Collaborate to Establish Renal Care Center of Excellence
- Collaboration combines the clinical expertise of Mayo Clinic and Baxter Renal Care Services
- Outpatient clinic to provide chronic kidney disease management, home dialysis and in-center dialysis services
- Project stems from five-year collaboration to advance care across different therapeutic areas
The Baxter and Mayo Clinic’s new renal care center of excellence is located on Mayo Clinic’s campus at Jacksonville, Florida (Photo: Business Wire)
Baxter International Inc. (NYSE:BAX), a global innovator in renal care, and Mayo Clinic today announced a new collaboration to develop a renal care center of excellence in the U.S. The center will serve patients across the continuum of renal care — from chronic kidney disease (CKD) management through transplant — and drive better patient outcomes.
The center is being established at the Mayo Clinic Dialysis Center at the campus in Jacksonville, Florida, where Mayo Clinic’s recognized excellence in care will be integrated with Baxter Renal Care Services’ proven clinical service model and CKD management program. The Mayo Clinic Dialysis Center in Jacksonville provides state-of-the-art dialysis services in a comfortable, home-like facility. The collaboration will also allow for the trial of potentially new, codeveloped products and services.
“The collaboration between Mayo Clinic and Baxter combines the best of our clinical, research and innovation expertise, and is rooted in the shared goal to improve the way we care for patients with serious and complex illnesses,” says Gianrico Farrugia, M.D., CEO of Mayo Clinic in Florida and president-elect of Mayo Clinic. “We are excited to establish this new renal care center of excellence with Baxter.”
For people with kidney disease or kidney failure requiring kidney dialysis, the Mayo Clinic Dialysis Center offers:
- Chronic Kidney Disease Clinic, where a dedicated team of providers work together to provide comprehensive care to people with kidney disorders
- Home dialysis training and support for both home hemodialysis and peritoneal dialysis
- In-center hemodialysis
- Outpatient dialysis services
- Nephrology Nutrition Clinic, where registered dieticians with expertise in kidney disorders provide ongoing guidance for nutritional needs
- Temporary dialysis if patients need treatment while traveling
Baxter Renal Care Services cares for more than 25,000 patients through its clinics across Asia, Europe and Latin America. Baxter Renal Care Services has historically worked closely with local experts to establish clinics where there is a need for centers of excellence that provide comprehensive care to help patients sequence through their therapy journey. These clinics often feature a successful CKD program focused on slowing the progression of kidney disease, as well as Baxter’s latest technologies to support patients’ clinical and lifestyle needs.
The dialysis clinic collaboration is the first launched initiative from the Baxter and Mayo Clinic five-year agreement announced in 2017, allowing the two healthcare leaders to bring together their respective clinical and development expertise. The primary emphasis of the broader agreement focuses on new research and development projects to advance innovation across different therapeutic areas where there are high unmet patient needs, such as renal disease. The initial agreement is for a five-year period, with a five-year renewal option.
New IPO filings include NGM, Arog, Gamida
Three more biotechs filed late Friday to go public on NASDAQ, adding new companies to a 2018 class of IPOs that could surpass 2015’s record for funds raised. The group includes NGM Biopharmaceuticals Inc. (South San Francisco, Calif.), Arog Pharmaceuticals Inc. (Dallas, Tex.) and Gamida Cell Ltd. (Jerusalem, Israel).
NGM, a liver disease and metabolic company, filed to raise up to $75 million in a listing. Among the company’s five clinical candidates, the most advanced, NGM282, is due to begin a Phase IIb trial in 1Q19 to treat non-alcoholic steatohepatitis (NASH). The listing’s underwriters are Goldman Sachs, Citigroup and Cowen.
NGM282, an engineered form of fibroblast growth factor 19 (FGF19), is wholly owned by the company. The company said preliminary results of Phase II studies have shown that the molecule significantly reduced liver fat and improved liver histology and fibrosis.
In 2015, NGM entered a broad collaboration with Merck & Co. Inc. (NYSE:MRK) giving the pharma exclusive, worldwide rights to its program targeting growth differentiation factor 15 (GDF15) and options to other programs, not including those targeting FGF19.
Next year, Merck plans to start two of NGM’s engineered variants of GDF15 to treat obesity, including a Phase IIa trial of NGM386 and a Phase I trial of NGM395.
By year end, Merck may opt to license NGM313, the biotech’s mAb activating the klotho ? (KLB)-FGF receptor 1c isoform (FGFR1c) complex. Preliminary data from a Phase Ib trial showed that NGM313 led to a significant reduction in liver fat in patients with non-alcoholic fatty liver disease (NAFLD).
The biotech’s NGM120, an agonist of GDNF family receptor ? like (GFRAL) designed to inhibit the effects of GDF15 elevations, is due to start a Phase Ib trial next half in cancer patients with anorexia/cachexia syndrome. Merck may opt to license that program after proof of concept (see “Appetite for GFRAL”).
Since beginning operations in 2008, NGM has raised $294.9 million in equity funding. Under its deal with Merck, the pharma has paid NGM $94 million up front, purchased $106 million in equity, and has reimbursed $189 million to NGM for R&D through June 30.
The Column Group is NGM’s largest shareholder with 25%. Merck owns 16%, while Prospect Ventures and Topspin Fund each hold about 9% and Rho Ventures has 7%.
Last month, NGM shuffled its management team. William Rieflin, who had been CEO since 2010, became executive chairman, while CFO David Woodhouse became CEO.
Arog filed to raise up to $74.8 million in its offering. Underwriters are Citigroup, RBC Capital Markets and Nomura. The company’s crenolanib is in two Phase III trials to treat FMS-like tyrosine kinase 3 (FLT3; CD135)-mutant acute myelogenous leukemia (AML). It is also in a Phase III trial to treat patients with gastrointestinal stromal tumors (GIST) with a specific mutation in the platelet derived growth factor receptor ? (PDGFR?) gene. The therapy has Orphan Drug designation in the U.S. and EU and Fast Track designation in the U.S. for both indications.
Gamida hopes to raise $69 million through its listing. BMO Capital Markets, RBC Capital Markets, Needham and Oppenheimer are underwriters. Its lead program is NiCord, which consists of umbilical cord blood-derived ex vivo nicotinamide-expanded hematopoietic stem and progenitor cells. Top-line data are due in 1H20 from a Phase III trial of the product as a universal stem cell graft in blood cancer patients who require a hematopoietic stem cell transplant (HSCT).
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 RARγ 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.
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