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Tuesday, August 14, 2018

Outcome image rehab aided by Nielsen deal for 1st point of care media tallies


Outcome Health has inked another partnership aimed at sprucing up its battered reputation. Third-party media tracking powerhouse Nielsen has signed on to measure Outcome’s point-of-care audience—a first for the POC industry, where tracking has lagged behind other media.
Nielsen has now measured patient and companion engagement, wait times and sentiment across 16 specialties in Outcome Health’s network of physician offices in the first of what will be quarterly studies. It’s a move that helps put the POC company more on par with other media channels, like TV and print, in quantitative measurements of audience and engagement.
Outcome has a particular interest in adding transparent tracking and value-adds for clients after a scandal-ridden fourth quarter last year that included media accusations of its misleading advertisers followed by an investor lawsuit alleging fraud. Outcome settled with investors in January. It had already inked a contract with media auditor BPA for quarterly platform recertifications.

“A lot of folks are recognizing that we at Outcome Health are making big investments to really help move the industry forward. The conversations that I’ve had with a handful of agencies since receiving this (new Nielsen) data have been very positive,” said Outcome CEO Matt McNally. “They like the spirit and the transparency, and as we’re also sharing the BPA auditing that we’re doing, they like that we’re bringing more rigor to the point of care category—especially through a collaboration with someone like Nielsen which is obviously a very trusted third-party.”
McNally joined Outcome in June, moving from Publicis Health, where he was president and chief media officer. He said the past six weeks have validated his decision to join the staff whose digital, technological and diversification he respects highly, adding “I love a rebuild story.”
To do the point-of-care tracking with Nielsen, Outcome first provided office locations in its network of connected devices where it displays content and advertising. The measurement firm then set up geofenced areas around those offices and asked mobile users there whether they would be willing to participate in a Nielsen survey.
Nielsen prescreened the audience by asking if they had been to a specific office, and if the answer was yes, asked a battery of questions that included whether the patient noticed or remembered Outcome Health iPads and boards in the waiting and exam rooms.
And they did. The first study found 85% of respondents who visited an office with an Outcome Health TV noticed the TV in the waiting room.

Outcome is now beginning to share those data—along with more specific de-identified information on demographics, disease states and viewership across devices—with its agency partners and pharma clients, McNally said. He called this first survey a 1.0 version and said future reports should offer more data, more details and potentially an ability to answer specific content and viewing questions.
“What we’re trying to do as a parallel to this data is not only validate third-party traffic counts and potential media exposure, but also … how can these insights start to better identify the types of programming and content we should be distributing across our channels?” he said. “And how do we share those insights with our agency partners as well as provider network partners and pharma partners?”

Orchard raises $150 million to expand after Glaxo gene therapy deal


Anglo-American biotech company Orchard Therapeutics has raised a further $150 million to fund its work in gene therapy, building on earlier fundraisings worth more than $140 million.
The new financing comes four months after its acquisition of a portfolio of GlaxoSmithKline rare disease medicines, including the gene therapy Strimvelis for ADA severe combined immune deficiency (ADA-SCID), or “bubble baby” disease.
Gene therapy is a hot area for drug research – highlighted by Novartis’s $8.7 billion acquisition of AveXis in April – but products sold to Orchard are viewed as too niche for GSK as it refocuses its drug research under CEO Emma Walmsley.
Strimvelis has so far been used to treat just a handful of patients since its launch in Europe two years ago.
Orchard, which has previously said it would consider an initial public offering (IPO) as the company develops, said on Monday the latest financing had been led by Deerfield Management, with further money from new and existing investors.
Orchard was incorporated in September 2015 and is focused on ex-vivo gene therapy, in which stem cells are taken from the patient and genetically corrected outside of the body before being transplanted back.

FDA Action Alert: Amicus, Vertex and TherapeuticsMD


This week had three important target action dates, known as Prescription Drug User Fee Act (PDUFA) dates, for the U.S. Food and Drug Administration (FDA)The agency got ahead of its schedule and approved all of these drugs. Let’s take a look.
Amicus Therapeutics and Migalastat for Fabry Disease
The FDA had a PDUFA date of Monday, August 13 for Amicus Therapeutics New Drug Application (NDA) for migalastat, called Galafold, for patients 16 years and older with Fabry disease who have amenable mutations. The drug has both Orphan Drug Designation and Fast Track Designation from the FDA, and Priority Review status. The FDA approved the drug on Friday, August 10.
Fabry disease is a rare, progressive, inherited lysosomal storage disorder caused by a deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), the result of mutations in the GLA gene. It causes specific lipids, mostly GL-3, to accumulate in the heart, kidneys, central nervous system, and skin. This can lead to pain, kidney failure, heart disease, and stroke. The disease affects about 3,000 people in the U.S.
Migalastat is a first-in-class chaperone therapy that has already been approved in the European Union as a monotherapy for Fabry disease in patients with the appropriate mutations. It has also been approved in Australia, Canada, Israel, Japan, South Korea and Switzerland. The drug stabilizes the body’s own dysfunctional enzyme so it can clear the accumulation of the lipids. The company’s lab test, the Galafold Amenability Assay, has classified more than 1,000 known GLA mutations as “amenable” or “not amenable” to treat with migalastat.
Reuters notes, “Amicus on Friday did not provide a U.S. price for Galafold. In an interview prior to the FDA’s approval, Chief Executive John Crowley said the company was committed to keeping new drugs priced at parity with or slightly below existing treatments, rather than charging a premium.”
Vertex Pharmaceuticals and Ivacaftor for Children Ages 12 to <24 Months for CF
Vertex Pharmaceuticals was awaiting the results of a supplementary New Drug Application (sNDA) for its cystic fibrosis (CF) drug ivacaftor in children ages 12 to <24 months. The PDUFA date was Wednesday, August 15. On August 7, the FDA approved the drug combination for use in children ages 2 through 5 years with CF who have two copies of the F508del-CFTR mutation. A Marketing Authorization Application (MAA) line extension for the same application has been submitted to the European Medicines Agency (EMA) with approval expected in the first half of 2019.
Ivacaftor, under the trade name Kalydeco, is approved for the treatment of CF in patients age 2 years and older who have at least one mutation in their CF gene that is responsible to the drug. Ivacaftor is also part of a combination therapy called Symdeko (tezacaftor/ivacaftor and ivacaftor) for the treatment of CF in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to Symdeko.
TherapeuticsMD and its One-Year Vaginal Contraceptive System
The FDA had a PDUFA date of Friday, August 17 on whether to approve Boca Raton, Florida-based TherapeuticsMD’s segesterone acetate/ethinyl estradiol, one-year vaginal system for contraception, Annovera. But the agency approved it on Friday, August 10. The product is in the shape of a ring and combines a novel progestin, segesterone acetate (Nestorone) with a widely used estrogen to prevent ovulation for a full year, or 13 cycles. If approved, it would be the first and only procedure-free, reversible prescription contraceptive to offer a full year of protection against unintended pregnancy.
TherapeuticsMD entered into an exclusive license deal with the Population Council to commercialize the product in the U.S. on July 31, 2018. TherapeuticsMD will pay Population Council milestone payments of $20 million upon FDA approval and $20 million when the first commercial batch is released. Population Council is also eligible for milestone payments and royalties from commercial sales of the system. The Population Council was established in 1952 and is headquartered in New York City. It is a nongovernmental, nonprofit organization focused on stopping the spread of HIV and improving reproductive health through biomedicine, social science, and public health research in 50 countries.
“The U.S. contraceptive market is shifting toward long-acting solutions and we believe Annovera represents an exciting new entrant for women and healthcare providers by providing the first woman-controlled, procedure-free, long-acting, reversible birth control product putting the woman in control of both her fertility and menstruation,” said Brian Bernick, co-founder of TherapeuticsMD, in a statement. “We believe Annovera can help meet the needs of women who are looking for long-acting solutions, including women who have never given birth and women who are not in a monogamous relationship, who are often counseled not to use many of the currently available long-acting contraceptive products.”

Monday, August 13, 2018

U.S. News & World Report Announces 2018-19 Best Hospitals


Mayo Clinic recognized as nation’s No. 1 hospital; updates include more emphasis on patient outcomes.

U.S. News & World Report, the global authority in hospital rankings, today released the 2018-19 Best Hospitals rankings. The 29th annual rankings are designed to assist patients and their doctors in making informed decisions about where to receive care.
The 2018-19 rankings compared more than 4,500 medical centers nationwide across 25 specialties, procedures and conditions. This year, a total of 158 hospitals were nationally ranked in at least one specialty. More than 1,100 hospitals were rated high performing in at least one common procedure or condition, and 29 received a high performing rating in all nine procedures and conditions evaluated.
For the third consecutive year, the Mayo Clinic claimed the No. 1 spot on the Best Hospitals Honor Roll. The Cleveland Clinic ranked No. 2, followed by Johns Hopkins Hospital at No. 3. The Honor Roll is a distinction awarded to 20 hospitals that deliver exceptional treatment across multiple areas of care.
For patients seeking care close to home, U.S. News also recognized the Best Regional Hospitalsin 200 metro areas and regions across the U.S., ranking them based on their performance in delivering complex and common care.
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic
3. Johns Hopkins Hospital, Baltimore
4. Massachusetts General Hospital, Boston
5. University of Michigan Hospitals-Michigan Medicine, Ann Arbor
6. UCSF Medical Center, San Francisco
7. UCLA Medical Center, Los Angeles
8. Cedars-Sinai Medical Center, Los Angeles
9. Stanford Health Care-Stanford Hospital, Stanford, Calif.
10. New York-Presbyterian Hospital-Columbia and Cornell, N.Y.
11. (tie) Barnes-Jewish Hospital, St. Louis
11. (tie) Mayo Clinic Phoenix
13. Northwestern Memorial Hospital, Chicago
14. Hospitals of the University of Pennsylvania-Penn Presbyterian, Philadelphia
15. (tie) NYU Langone Hospitals, New York
15. (tie) UPMC Presbyterian Shadyside, Pittsburgh
17. Vanderbilt University Medical Center, Nashville, Tenn.
18. Mount Sinai Hospital, New York
19. Duke University Hospital, Durham, N.C.
20. Brigham and Women’s Hospital, Boston
Top 5: Cardiology & Heart Surgery
1. Cleveland Clinic
2. Mayo Clinic, Rochester, Minn.
3. Smidt Heart Institute at Cedars-Sinai, Los Angeles
4. New York-Presbyterian Hospital-Columbia and Cornell, N.Y.
5. Massachusetts General Hospital, Boston
Top 5: Cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham and Women’s Cancer Center, Boston
5. Cleveland Clinic
Top 5: Orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cleveland Clinic
4. (tie) Rothman Institute at Thomas Jefferson University Hospitals, Philadelphia
4. (tie) Rush University Medical Center, Chicago
“For nearly three decades, U.S. News has strived to make hospital quality more transparent to healthcare consumers nationwide,” said Ben Harder, managing editor and chief of health analysis at U.S. News. “By providing the most comprehensive data available on nearly every hospital across the United States, we give patients, families and physicians information to support their search for the best care across a range of procedures, conditions and specialties.”
The U.S. News Best Hospitals methodologies in most areas of care are based largely or entirely on objective measures such as risk-adjusted survival and readmission rates, volume, patient experience, patient safety and quality of nursing, among other care-related indicators. Prominent changes to the 2018-19 rankings methodology included more emphasis on patient outcomes and patient experience measures. For details on the 2018-19 Best Hospitals methodology updates, read more.
The rankings are produced by U.S. News with RTI International, a leading research organization based in Research Triangle Park, North Carolina. For more information, see the FAQ. The data experts from U.S. News and RTI will also host a panel discussion in Washington, D.C., on November 16 about recent and future updates to the methodology. The panel is among the sessions included in this year’s U.S. News Healthcare of Tomorrow summit, scheduled for November 14-16.
The launch of this edition of Best Hospitals is being sponsored by Fidelity Investments, one of the leading providers of retirement solutions for hospitals and health organizations. The rankings will be published in the U.S. News “Best Hospitals 2019” guidebook (ISBN 9781931469906), available for pre-order now from the U.S. News Online Store and for purchase at other bookstores in late September.
For the full rankings, visit Best Hospitals and use #BestHospitals on Facebook and Twitter.

Aridis Pharmaceuticals Announces Pricing of Initial Public Offering


Aridis Pharmaceuticals, Inc.ARDS, +0.00% a biopharmaceutical company focused on the discovery and development of targeted immunotherapy using fully human monoclonal antibodies, or mAbs, to treat life-threatening infections, today announced the pricing of its initial public offering of 2,000,000 shares of its common stock at a public offering price of $13.00 per share for total gross proceeds of $26.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Aridis. In addition, Aridis has granted the underwriters a 30-day option to purchase up to 300,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. All of the shares are being offered by Aridis. The shares are expected to begin trading on the Nasdaq Capital Market on August 14, 2018 under the symbol “ARDS.”
Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. Maxim Group LLC is acting as lead manager and Laidlaw & Company (UK) Ltd., Northland Securities, Inc. and Seaport Global Securities LLC are acting as co-managers for the offering.

Mallinckrodt management optimistic over long term outlook, says BMO Capital


BMO Capital analyst Gary Nachman kept his Outperform rating and $37 price target on Mallinckrodt, saying that in today’s investor call, the management was optimistic over its long-term outlook for its evolving specialty branded business model. The analyst says the management team is “navigating” through headwinds in Acthar and Generics, anticipating a stream of data in Acthar over the next 12-24 months. Nachman further contends that “much of the business remains underappreciated” if Acthar can achieve better stability through improved engagement and contact with payers.

Alpine Immune Sciences initiated at Raymond James


Alpine Immune Sciences initiated with an Outperform at Raymond James. Raymond James analyst Reni Benjamin initiated Alpine Immune Sciences (ALPN) with an Outperform and $13 price target. Benjamin said the company has a unique platform technology utilizing directed evolution to generate multi-functional single compounds. The analyst believes the platform is on the verge of a significant validation inflection point given a “slew” of preclinical results demonstrating activity in both autoimmune disease adn oncology, combined with early stage partnership with Kite, a Gilead (GILD) company.