Activist ValueAct raises stake in Horizon Discovery

Activist hedge fund ValueAct Capital has nearly doubled its stake in Horizon Discovery Group, buying an additional 7.5 million shares from Woodford Investment Management.

ValueAct, which now holds less than 10 percent, said in a statement it was exploring the possibility of appointing a member of its team to the life science company’s board.

“Horizon Discovery is one of the leading players in its field and is highly supportive of the Company’s ongoing efforts to contribute to improved healthcare,” it said in a statement.

Horizon said in a separate statement that it has had a dialogue with ValueAct over time and believes its board is “very strong, well governed and appropriately constituted”.

In May, biotech firm Abcam walked away from a takeover offer after Cambridge-based Horizon rebuffed a 270 million pound ($355 million) deal, rejecting its rationale.

Earlier on Monday, Horizon, which mostly deals with gene editing applications, said its half-year core loss before one-off items narrowed from last year.

It also forecast full-year revenue to be slightly ahead of consensus expectations and said it expects negative EBITDA before exceptional items for the first half of the year to be offset by positive EBITDA for the second half.

Shares of Horizon Discovery closed at an 8-month high of 236 pence on Monday.

https://www.marketscreener.com/HORIZON-DISCOVERY-GROUP-P-16118015/news/Horizon-Discovery-Activist-ValueAct-raises-stake-in-Horizon-Discovery-27272648/

White House OKs ambulatory surgery center safety database

The White House has approved HHS’ plan to launch a patient safety database for ambulatory surgery centers, as more of the facilities pop up across the country and represent a bigger share of healthcare providers.

The ambulatory surgery center database will be similar to other HHS programs in place hospitals, nursing homes and pharmacies. The Office of Management and Budget posted an approval notice Friday for the ASC database.

HHS’ Agency for Healthcare Research and Quality wanted to launch the databasebecause ASCs are treating a growing number of patients and federal regulators want to ensure patient safety.

The database will store information from surveys of surgical center staff on patient safety culture. For instance, staffers will be asked if their management regularly develops action plans for adverse outcomes and whether all of the staff members involved in a surgery get to weigh in on post-care recovery plans.

There were 5,532 Medicare certified centers in 2016, up 3.5% from 5,344 in 2011, according to federal data. From 2011 to 2016, the number of ASCs grew at an average annual rate of 1.3%. Roughly 3.4 million Medicare enrollees receive care at ASCs annually. However, spending has grown about 27%, from $3.4 billion to $4.3 billion, over that five-year period as the facilities provide more services and see more patients.

AHRQ’s request came months after a joint investigation by Kaiser Health News and USA Today raised concerns about the quality of care and safety at ASCs. The news outlets discovered that more than 260 patients have died since 2013 after outpatient procedures at surgery centers across the country.

ASCs support creating the database, as the surveys will help ensure surgery centers are providing the best care possible, according to William Prentice, CEO of the Ambulatory Surgery Center Association.

http://www.modernhealthcare.com/article/20180917/NEWS/180919908

CMS plans to stop hospitals from rejecting ASC patient transfers

The CMS issued sweeping regulation Monday meant to ease Medicare regulations. The overall goal is to reduce administrative burden on providers and ease access to care for patients. Collectively, the CMS estimates the provisions will save providers $1.12 billion every year.

The CMS wants to prevent hospitals from rejecting patients being transferred from competitive ambulatory surgical centers. Currently, surgical centers must have a written transfer agreement with a hospital or ensure all physicians performing surgery have admitting privileges in a nearby hospital. The CMS proposes removing that requirement, citing complaints from the “largest ASC trade association.”

Also under the rule, the CMS wants to allow providers that belong to a health system to avoid their own quality reporting and have a universal quality assessment and performance improvement, or QAPI, program. A similar proposal for infection control programs is also in the rulemaking.

More than half of all U.S. hospitals belong to multi-hospital health systems, and about 60% of all hospital admissions occur in system hospitals.

“While a wide range of quality improvement mechanisms can be applied in individual hospitals, there has been a lack of actionable information that leaders of multi-hospital systems can leverage to improve quality across their systems,” the agency said in the rule.

The rule also eliminates duplicate reporting for transplant programs to submit data and other information to Medicare. That policy, the CMS said, has led to transplant programs avoiding performing transplants for certain patients, causing some organs to go unused.

The CMS also wants to streamline access for X-ray services by replacing four different qualifications with a single, streamlined criterion that focuses on the skills and abilities of the technologist.

The public has until Nov. 20 to comment on this rulemaking.

Since announcing its Patients Over Paperwork initiative last year, the agency has taken action to address 55% of the 624 topics considered burdensome by the industry. Another 16% of the topics remain under consideration and 29% were either referred to another agency or did not require further action.

The CMS projects these moves have saved providers nearly $5.2 billion and reduced 53 million in paperwork hours through 2021.

http://www.modernhealthcare.com/article/20180917/NEWS/180919900

Teva Migraine Treatment Approved by the FDA Ready to Roll in 2 Weeks

The U.S. Food and Drug Administration (FDA) approved Teva Pharmaceutical Industries’Ajovy (fremanezumab) to prevent migraine on Friday, September 16.

“Migraine is a disabling neurological disease that affects more than 36 million people in the United States,” said Stephen Silberstein, director, Jefferson Headache Center at Thomas Jefferson University Hospital and lead investigator of the Phase III clinical trial program for the drug, in a statement. “About 40 percent of people living with migraines may be appropriate candidates for preventive treatment, yet the majority of them are untreated. I am pleased to have another treatment option that may allow my patients to experience fewer monthly migraine days.”

The drug is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand.

Despite the approval, Teva is running behind in this area. In May, the FDA approved Amgen andNovartis’ Aimovig (erenumab-aooe) for the prevention of migraines in adults. It was the first-and-only FDA-approved treatment designed to prevent migraines by blocking the calcitonin gene-related peptide receptor (CGRP-R). Aimovig 70 mg is self-administered once a monthly by way of Amgen’s SureClick autoinjector.

Ajovy may, however, have an advantage. It’s also injectable, but it only requires injections once every three months. However, in June, the company halted a Phase III clinical trial of the drug for prevention of chronic cluster headaches. They indicated at the time that it wasn’t likely to hit the primary goal of reducing the average number of cluster headaches in the 12-week treatment period. However, it proved to be effective in preventing migraine.

Eli Lilly is also developing a migraine drug in the same class, with an FDA action date of September 27.

Teva indicates they are ready to go with the drug and expect it to hit the market within the next two weeks. The U.S. Wholesale Acquisition Cost (WAC) for the drug is $575 per monthly dose and $1,725 for a quarterly dose. It will be available through retail and specialty pharmacies. Teva has also stated that commercially insured patients may pay as little as $0 until the offer expires. For patients looking for financial support, the company offers Teva Shared Solutions, with more details available at AJOVY.com.

Brendan O’Grady, head of Teva’s North America commercial operations, told Reuters, “We felt that $575 was an appropriate price.” It’s also the price Amgen and Novartis are charging for Aimovig.

A consensus of analyst projections compiled by Bloomberg estimates sales of around $500 million by 2022. Bloomberg writes, “Ajovy’s launch could help Teva, the world’s largest generic drugmaker, eventually replacing declining sales of Copaxone, its aging star product. Investors have tracked the new drug’s trajectory as one of the few channels of growth for the debt-laden pharma giant. Chief Executive Officer Kare Schultz embarked on a massive cost-cutting plan last year and placed debt repayment as his top priority, in effect shelving designs to increase sales in the coming two years.”

Part of Schultz’s cost-cutting measures have included laying off more than a quarter of Teva’s workforce and closing or selling 10 of its factories. In August, the company indicated its net debt had dropped from $35 billion to $28.4 billion.

In a statement, Schultz said, “This is an important day for Teva and complements our long-standing history of helping patients living with diseases of the central nervous system. The approval of Ajovy helps us to continue to provide access to important medicines and to deliver on our commitment to our key stakeholders — patients, employees and shareholders.”

https://www.biospace.com/article/fda-action-alert-migraine-treatment-approved-by-the-fda-ready-to-roll-in-2-weeks/

BeiGene initiated at Guggenheim

BeiGene initiated with a Buy at Guggenheim. Target $214.
https://thefly.com/landingPageNews.php?id=2791649

Array BioPharma, Deciphera, ImmunoGen initiated at Guggenheim

Guggenheim calls Array, Deciphera, ImmunoGen top biotech picks. Guggenheim initiated coverage of the biotechnology sector, initiating and assuming coverage of 17 biotechnology stocks, and saying it is bullish on the sector longer term and expects continued growth. The firm’s coverage focuses on the oncology therapeutic category, with Guggenheim calling Array Biopharma (ARRY), Deciphera Pharmaceuticals (DCPH), and ImmunoGen (IMGN), which all have key catalysts coming in the first half or 2019, its top picks.
https://thefly.com/landingPageNews.php?id=2791671

Janssen INVOKANA, VOKANAMET Euro label to include positive cardio data

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted approval to update the INVOKANA(canagliflozin) and VOKANAMET (canagliflozin and metformin) labelling to include changes to the indication statement for the treatment of adults with insufficiently controlled type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise.

The decision means that the product information now includes data on the reduction in major adverse cardiovascular (CV) events (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with type 2 diabetes mellitus (T2DM) who had either a history of CV disease or at least two CV risk factors, in addition to the existing study results on improving glycemic control.

‘We hope this approval will not only provide clinicians with a more detailed overview of canagliflozin but also help them when making informed treatment decisions which are most appropriate for their patients. Type 2 diabetes mellitus is one of the most common forms of diabetes and accounts for the majority of diabetes cases worldwide so it is extremely important that we continue improving outcomes for these patients,’ said Dr. Jose Antonio Buron, Vice-President Medical Affairs EMEA, Janssen-Cilag Farmaceutica, Lda.

The EC’s decision follows a recommendation from the Committee for Medical Products for Human Use (CHMP) that was based on data from the CANVAS Program, the largest completed CV outcomes trial to date for an SGLT2 inhibitor.[1] The study, which included over 10,000 patients started in 2009, met its primary endpoint and showed canagliflozin significantly reduced the combined risk of CV death, myocardial infarction and non-fatal stroke, versus placebo in adult patients with T2DM who had either a history of CV disease or at least two CV risk factors.1

Canagliflozin also significantly lowered the risk of hospitalisation for heart failure and demonstrated improved renal outcomes.1 Adverse events reported in the CANVAS Program were generally consistent with the known safety profile of canagliflozin.1 However, the study found that, in patients with T2DM who had established CV disease or at least two risk factors for CV disease, canagliflozin was associated with an approximately 2-fold increased risk of lower limb amputation with the rate of amputation over standard of care being 0.63/100 patient years for canagliflozin versus 0.34/100 patient years for placebo which corresponds to an additional risk of 0.29/100 patient years.1The risk of amputations across the class has previously been investigated by the EMA, and this is reflected in a warning in the labelling of SGLT2 inhibitors.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-European-Commission-expands-labelling-for-Janssen-s-INVOKANA-and-VOKANAMET-to-in-27272242/