Wednesday, October 3, 2018
AtriCure reports Q3 preliminary revenue $49.9M, consensus $46.76M
AtriCure’s preliminary and unaudited revenue for the third quarter of 2018 is expected to be approximately $49.9M, reflecting growth of approximately 18.5% over the third quarter of 2017 (18.6% on a constant currency basis). Based on this preliminary estimate, U.S. revenue is expected to be approximately $39.8M, reflecting growth of 19.1% over the third quarter of 2017. International revenue is expected to be approximately $10.2M, an increase of 16.2% as compared to the third quarter of 2017 (16.9% on a constant currency basis).
https://thefly.com/landingPageNews.php?id=2799369
NY, NJ Warn Of Measles Exposure in Newark Airport, Rockland County
Officials say a passenger who had the measles arrived at Newark Liberty International Airport while he was still infectious.
The traveler was on a flight from Tel Aviv on Sept. 28 and arrived in Terminal B.
“The individual was infectious on that day and may have traveled to other areas of the airport,” the New Jersey Department of Health said in a press release.
The individual then traveled to New Square in Rockland County.
Anyone who was in the airport on Sept. 28 from 5:30 a.m. to 10:30 a.m. may have been exposed, officials said. Officials also said people at the following locations and times could also have been exposed:
Bais Medrash of New Square, 11 Truman Ave, New Square
- Friday, 9/28, between 9 a.m. and 2 p.m.
- Saturday, 9/29 between 11 a.m. and 3 p.m.
- Sunday, 9/30 between 12:30 p.m. and 4 p.m.
- Sunday, 9/30 between 5 p.m. and 9 p.m.
Sukkah adjacent to Avir Yakov Boys’ School, 766 N. Main St, New Square
- Friday, 9/28 between noon and 4 p.m.
- Saturday, 9/29 between 12:30 p.m. and 4:30 p.m.
Refuah Health Center, 728 N. Main St, New Square
- Saturday, 9/29 between 11:30 p.m. and 2 a.m.
- Monday, 10/1 between 12:30 p.m. and 3:30 p.m.
If infected, symptoms could develop as late as Oct. 19.
Officials urge anyone who suspects they were exposed to contact a health care provider before going to visit the doctor or an emergency room. Measles is highly contagious and special arrangements need to be made to protect other patients and medical staff from possible infection.
Symptoms include rash, high fever, cough, runny nose and red, watery eyes. It can cause serious additional serious complications like pneumonia and encephalitis, and infection in a pregnant woman can lead to miscarriage, premature birth or a low-birth-weight baby, officials said.
Measles can be spread through the air through coughing or sneezing, and contact with infected mucus or saliva.
People who have not had the measles vaccine or had measles is at risk.
“Two doses of measles vaccine are about 97 percent effective in preventing measles,” said Dr. Christina Tan, New Jersey’s state epidemiologist. “Getting vaccinated not only protects you, it protects others around you who are too young to get the vaccine or can’t receive it for medical reasons.”
For more information about measles, click here. You can also find out more from the CDC by clicking here.
Next on the split-up agenda? Bayer, if it wants pharma growth, analyst says
Should Bayer consider splitting up now that it has closed its $63 billion acquisition of Monsanto? One analyst thinks so, at least for the good health of its pharma business.
Bayer’s divisions are now trading at a discount, and a breakup could restore them to fair multiples, allow the company to focus and potentially free up cash for licensing deals that would beef up its unexciting pipeline, Bernstein analyst Wimal Kapadia argued in a Tuesday analysis.
The German conglomerate’s shares are weighed down by its multiple divisions, the analyst figures. Assuming fair multiples for its crop and consumer businesses, pharma is trading at a multiple of only five times its EV/EBITDA ratio, far below the EU large-cap pharma sector’s 11 times, according to Kapadia.
That wouldn’t be much of a problem if Bayer’s drug business had enough cash or a robust pipeline. But it doesn’t. “Hard to get excited” is the Bernstein analyst’s evaluation of Bayer’s pharma franchise in the long term.
Johnson & Johnson-partnered oral anticoagulant Xarelto is the main cash cow for Bayer for years to come. It contributed €3.3 billion ($3.8 billion) in 2017 sales, and consensus currently has pegged it at around €5.2 billion in peak sales, partly thanks to recent data that showed it can cut the incidence of major limb problems in peripheral artery disease patients.
Regeneron-partnered eye drug Eylea has also continued to grow strongly for Bayer, which owns ex-U.S. rights. Bayer has upped its peak sales guidance to €2.5 billion, and Kapadia projects Eylea could maintain that level for several years before it goes off patent around 2025.
But other newly launched products will no longer add much. Cancer therapies Xofigo and Stivarga have been performing below expectations. Pulmonary hypertension drug Adempas, another product touted by Bayer, might come €100 million short of management’s forecast of €500 million. And its cancer drug Nexavar—along with its hemophilia (cue Jivi) and multiple sclerosis franchises—all face competitive threats.
Perhaps what’s more worrisome, though, is the outlook for new assets that could soften the blow of Xarelto and Eylea patent losses down the road. Bernstein’s pipeline review “suggests no game changers and we have to wait for catalysts,” the analyst wrote. Despite Bayer management’s estimate of €6 billion in peak sales for its pipeline assets, Bernstein figures €4 billion is more realistic.
So what could the company do to turn things around? A spinoff, suggested Kapadia.
According to Kapadia, Bayer’s other options are few, because its hands are tied in trying to pay off debt it took on for the Monsanto buyout. Because of that, Kapadia thinks it’s almost impossible for Bayer to pull off any €2 billion-plus deals before 2020, and trying to land a large M&A deal after 2020 would also be highly risky, because Bayer’s lesser presence in the U.S. means it’s unable to achieve much in the way of synergies compared with its European peers.
Separating pharma from the crop business could thus be “the best strategy” to restore the pharma division to trade at fair multiples, and “our sense speaking to investors who have met management recently suggests this is not off the table,” wrote Kapadia.
An animal health sale could be more realistic, though. Using Pfizer’s Zoetis and Eli Lilly’s Elanco as benchmarks, Kapadia suggests Bayer’s animal health business would be worth at least €7 billion: “This can either be stage one of the Healthcare vs. Crop separation or, at a minimum, free up cash for licensing deals in Pharma.”
Kapadia’s far from the only analyst to prod a Big Pharma toward a split. Goldman Sachs’ Jami Rubin famously challenged Pfizer CEO Ian Read to consider the prospect and urged Johnson & Johnson to do the same thing. Though both companies have shed their share of business units, Pfizer actually did consider a big split but ultimately decided to stay together, at least for now.
More recently, RBC Capital Markets analyst Randall Stanicky made a detailed case for an Allergan split-up, given its languishing shares and cash-cow aesthetics business.
BrainStorm Data Support Platform as Best-In-Class Strategy in ALS
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative adult stem cell therapeutics for debilitating neurodegenerative diseases, announced today that members of its executive team will present at the Northeast Amyotrophic Lateral Sclerosis (NEALS) Conference in Clearwater, Florida and the Cell & Gene Meeting on the Mesa 2018 Conference in La Jolla, California, both taking place today, October 3, 2018.
Chaim Lebovits, President & Chief Executive Officer, will also be attending the MidCap Investor Event® sponsored by CF&B Communication in Europe on October 8-9, 2018 in Paris, France, and will be available for one-on-one meetings with potential institutional investors. To schedule a meeting, please use the Contact link on BrainStorm’s website at www.brainstorm-cell.com.
NEALS Annual 2018 Conference
Poster entitled, “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”
Poster entitled, “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”
- Date: Wednesday, October 3, 2018
- Time: 3:45 pm to 5:45 pm Eastern Time (Clearwater, Florida)
- Location: Opal Foyer in the Opal Sands Resort, Clearwater, Florida
- Presenter: Ralph Kern, M.D., MHSc, Chief Operating Officer & Chief Medical Officer
- Key Academic Collaborators:
- Massachusetts General Hospital: James Berry, M.D. and Merit Cudkowicz, M.D.
- University of Massachusetts Medical School: Robert Brown, M.D. and Margaret Ayo Owegi, D.O.
- Mayo Clinic: Anthony Windebank, M.D. and Nathan Staff, M.D., Ph.D.
- For more information: https://goo.gl/zikHA2
Cell & Gene Meeting on the Mesa 2018 Conference
Scientific Workshop entitled, “Successful Strategies in the Design and Delivery of Cell & Gene Therapy Clinical Programs.”
Scientific Workshop entitled, “Successful Strategies in the Design and Delivery of Cell & Gene Therapy Clinical Programs.”
- Date: Wednesday, October 3, 2018
- Time: 7:15 am to 8:45 am Pacific Time (La Jolla, CA)
- Location: Estancia La Jolla Hotel, La Jolla, CA
- Workshop Panel Speakers:
- Peter Altman, Ph.D., President and CEO, BioCardia
- Blake Anson, Ph.D., Director, Strategic Alliances, Fujifilm Cellular Dynamics
- Robert Deans, Ph.D., Chief Technology Officer, BlueRock Therapeutics
- Gisèle Deblandre, Ph.D., Scientific and Project Management Director, MaSTherCell
- Felix Hsu, SVP and Head, Advanced Therapies Unit, WuXi AppTec
- Hardy Kagimoto, M.D., Chairman and CEO, Healios
- Dan Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine; Director of Cell Therapy, UC San Diego
- María Pascual, VP Regulatory Affairs and Corporate Quality, TiGenix
- Joseph Petroziello, VP, Scientific and Corporate Communications, BrainStorm Cell Therapeutics
- Edward Wirth, M.D., Ph.D., Chief Medical Officer, Asterias Biotherapeutics
- For more information: https://goo.gl/3M4L8b
ObsEva SA reports additional positive Phase 3 results of IMPLANT 2 trial
- Phase 3 IMPLANT 2 trial results showed Live Birth Rate increased by up to 35% with Nolasiban treatment
- Nolasiban safety profile not different from placebo in IMPLANT 2
- European MAA submission confirmed to be targeted for 4Q:19, commercial planning underway
- Nolasiban is a novel therapy and the first therapy of its kind to improve clinical pregnancy and live birth rates in women undergoing IVF
Novartis licenses 3 anti-infective programs to Boston Pharmaceuticals
Novartis International AG / Novartis licenses three novel anti-infective programs to Boston Pharmaceuticals . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.
- Clinical and pre-clinical stage programs focused on addressing growing need for new treatments against drug resistant Gram-negative bacteria
- Agreement is part of Novartis strategy to partner with like-minded innovators to further develop new medicines to address global health challenges
- Research and development for new medicines to treat tropical diseases continues through the Novartis Institute for Tropical Diseases
Gilead announces approval of Biktarvy in Hong Kong
Gilead Sciences announced that the Hong Kong Department of Health has approved Biktarvy, a once-daily single tablet regimen, or STR, for the treatment of HIV-1 infection in adults. Hong Kong is the first market in Asia to approve Biktarvy. The triple-combination, single-tablet therapy combines the potency of the novel integrase strand transfer inhibitor, or INSTI, bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor backbone – Descovy. BIC/FTC/TAF provides a convenient once-daily dosing STR without regards of food. Furthermore, BIC/FTC/TAF’s use is not restricted by the patient’s baseline viral load, CD4 cell count or HLA-B 5701 status.
https://thefly.com/landingPageNews.php?id=2798881
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