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Friday, November 8, 2019

Novo Nordisk buys rights to NASH drug from Japan’s UBE

Novo Nordisk has acquired rights to a preclinical drug that could be used to treat non-alcoholic steatohepatitis (NASH), the fatty liver disease that could generate billions of dollars for the pharma industry.
The Danish pharma has bought an exclusive worldwide licence from Japan’s UBE for UD-014, a selective semicarbazide-sensitive amine oxidase/vascular adhesion protein-1 (SSAO/VAP-1) inhibitor small molecule.
Preclinical tests have shown it can prevent inflammation and oxidation in endothelial cells, a mechanism of action that could be used to treat NASH.
UBE will receive an upfront payment as well as development and sales milestones plus tiered royalties on the annual net sales. Novo Nordisk will be responsible for the further development, manufacturing and marketing of UD-014.
Novo Nordisk is looking to build a presence in NASH, as it is already a major player in metabolic diseases thanks to its many insulins and other drugs used to treat diabetes.
Earlier this year Novo announced a collaboration with Gilead to investigate a combination of its GLP-1 class drug semaglutide with two potential NASH drugs from the US pharma’s pipeline.
NASH is a chronic and progressive liver disease characterised by fat accumulation and inflammation in the liver, which can lead to fibrosis and impaired liver function.
If left untreated, people living with NASH may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality.
There are no approved treatments for NASH, but several big pharma companies have potential therapies in their pipelines.
One of the leaders is Intercept Pharmaceuticals, which in February announced its obeticholic acid had hit its targets in a phase 3 NASH trial, producing a statistically significant improvement in liver scarring without the disease worsening.
Intercept filed the results with the FDA in September and is seeking an accelerated approval, setting up a potential launch early next year following a faster six-month review.
A European filing is due in the coming weeks, the company said in its third quarter results announcement on Tuesday.

Apellis APL-2 shows encouraging action in mid-stage kidney disease study

Preliminary data from an open-label Phase 2 clinical trial, DISCOVERY, evaluating Apellis Pharmaceuticals’ (APLS -4.1%) lead candidate APL-2 in patients with four renal diseases: C3 glomerulopathy (C3G), immunoglobulin A nephropathy, primary membranous nephropathy and lupus nephritis, showed a positive effect. The results were presented at the American Society of Nephrology Kidney Week in Washington, DC.
Six C3G patients receiving APL-2, a C3 inhibitor, experienced a downward trend in proteinuria as measured by the urine protein-to-creatinine ratio (uPCR). Specifically, mean uPCR decreased 48% to 1.05 mg/mg from 2.03 mg/mg at day 84. No safety signals were observed.
The company is developing APL-2 for a range of complement-mediated disorders.

Amid Softer Sales, Tighter Regs, Medical Assets Could Be NYC’s Real Estate Darling

New York City’s commercial real estate market has been grappling with a well-documented slew of challenges in recent years, ranging from tighter regulations to soaring costs. Now some players are banking on healthcare assets as a bright spot for the city.
Medical assets could be a bright spot for New York City. Technological disruption has reshaped how healthcare is provided, along with where medical facilities are built and designed. Procedures and treatment are now increasingly delivered in ambulatory and outpatient centers, as opposed to hospitals, and consumers often want convenient care delivered in a retail-like environment. All these factors are good news for real estate, experts said, with older office buildings and vacant retail space emerging as prime contenders for medical use.
“Medical is one of the shining lights in a market which has been plagued with any number of problems,” said Wexler Healthcare Properties Paul Wexler head. “Whether it’s on the residential side, where the sales market has been suffering, or investment sales side — where the volume of activity is way down  — medical is an asset class which is now very sought-after and desirable.”
The development and market for these assets, changes in technology and the role of life sciences in the city will all be examined at Bisnow’s New York Healthcare & Life Sciences Summit Nov. 21. Advances in the way procedures are performed, as well as a push toward outpatient care, means hospitals and healthcare providers are increasingly looking to create outpatient facilities and easy-access healthcare.
It is an important element for these providers to remain competitive, said Mike Hargrave, a principal at healthcare real estate data company Revista. Nationally, the hospitals, medical office buildings and outpatient real estate is a $1 trillion sector, per the company’s figures. And while there has been significant development in both the traditional, acute-care hospitals and outpatient real estate, the latter has been growing more rapidly: in 2014, 16.6M SF of medical office space was added to the national supply, according to Revista. That number is expected to hit 27M SF in 2020, the most since 2009.
“The rapid increase in technology is enabling the outpatient sector to really have wings under it and grow significantly,” Hargrave said in an interview. “In New York, certainly, they are at the forefront of a lot of the outpatient procedures.”
The Hospital for Special Surgery, for example, just opened its new ambulatory surgery center at Durst Organization’s 600 West 58th St. last summer, and now has more than 80K SF in the building.
At 110 East 60th St., William Macklowe Co. and Dune Real Estate are turning the former office property into a medical office building that will allow for both outpatient and ambulatory care.
“We are in the early innings of great investment, innovation and technology in both healthcare and life sciences — and a different way in which healthcare providers are using their real estate,” William Macklowe Co. CEO Billy Macklowe said.
His firm also redeveloped 156 William St. from office to medical, and has joined with LaSalle Investment Management to build 333 East 61st St. another medical office building. Memorial Sloan Kettering leased the entire building at the start of this year.
Macklowe noted that retail in the city is challenged, multifamily is subject to “governmental intervention” and the office market is extremely competitive.
“[With] medical there is a great demand, institutions are growing and there is only so much space that can accommodate the needs and requirements,” he said.
Sources pointed the challenges in retail and the shifting demands for healthcare as working in tandem. There is widespread retail vacancy across the city — more than double what it was back in 2007, per the Comptroller’s Office — providing an opportunity for both landlords and healthcare providers to take space where they want it.
“Medical users love the idea of gaining some retail exposure. Retail [space] owners love the idea of having this stability and long-term nature of a medical tenancy — medical tenants also will, once settled into a place, usually renew their lease more than 80% of the time,” Wexler said.
He said that at 111 East 57th St., large parts of a 39K SF Borders bookstore was turned into turnkey medical office, and a new ambulatory center on East 63rd Street was previously a movie theater.
“What’s been happening in retail that has really been very problematic is creating many opportunities for medical providers to have a place to practice that they wouldn’t otherwise have,” he said.
That has certainly been the case for Simone Development Cos., which recently bought a retail building in Westchester that will now become a healthcare facility, according to the president of the firm’s healthcare division, Guy Leibler. Though he was not able to provide specifics — the details are due to be announced in the coming weeks — he said the opportunity would not have been there a few years ago.
“It was a retail store, about 25K SF in size, they did go out of business, and that retail store will will soon become, by mid-next year, a healthcare building for a large hospital system to deliver care in a local community,” he said.
He also pointed to Simone’s development of the Boyce Thompson Center in Yonkers, which saw a historic building at 1086 North Broadway that had been empty for several decades turned into a mixed-use retail-medical complex.
“The healthcare providers are trying to bring their healthcare to the corner near you,” Leibler said. “It’s very dynamic, and it’s very disruptive, the industry is changing and will continue to change.”
https://www.bisnow.com/new-york/news/commercial-real-estate/healthcare-prevent-101694

Conformis up 6% on FDA nod for new hip replacement system

Conformis (CFMS +6.1%announces FDA clearance of its next-generation 3D-designed Conformis Hip System that, it says, incorporates improvements based on surgeon feedback after 400+ surgeries that began in July 2018.
Full commercial launch is underway.

FibroGen down despite positive roxadustat data in late-stage study

A Phase 3 clinical trial, HIMALAYAS, evaluating FibroGen’s (FGEN -6%) roxadustat in chronic kidney disease (CKD) patients who recently initiated dialysis met both primary endpoints. The data were presented at the American Society of Nephrology Kidney Week in Washington, DC.
The open-label study randomized participants 1:1 to receive either roxadustat or epoetin alfa (originally marketed by Amgen under the brand name Epogen) for up to 4.4 years (mean duration of treatment was 1.8 years).
Results showed that treatment with roxadustat increased mean hemoglobin levels from 8.4 g/dL to 11.0 g/dL compared to an increase from 8.4 g/dL to 10.8 g/dL for epoetin alfa demonstrating its non-inferiority (no worse than).
Roxadustat was also non-inferior to epoetin alfa in terms of the proportion of patients achieving a hemoglobin response during the first 24 weeks of treatment (88.2% vs. 84.4%).
Patients receiving roxadustat also required less monthly intravenous iron on average.
On the safety front, the most frequent roxadustat-related adverse events were hypertension, diarrhea and muscle spasms.
Collaboration partner AstraZeneca (AZN -0.2%) will be presenting data from two Phase 3s, OLYMPUS and ROCKIES, assessing roxadustat for the treatment of anemia in non-dialysis and dialysis-dependent CKD patients at the meeting.
The stock remains under pressure from a bearish report from Plainview published on Monday. Share have lost 11% of their value since then.
Related ticker: Astellas Pharma (OTCPK:ALPMY -1.2%)

Tandem Diabetes down 6% on death of t:slim X2 user

Tandem Diabetes Care (TNDM -5.9%) is down on almost triple normal volume in apparent reaction to an FDA report on an adverse event (death) related to its t:slim X2 Insulin Pump.
According the coroner, the person’s blood sugar was very low at the time of death.
No further details are available.

Viela Bio’s (NYSE:VIE) Quiet Period Set To Expire on November 12th

Viela Bio’s (NYSE:VIE) quiet period is set to expire on Tuesday, November 12th. Viela Bio had issued 7,900,000 shares in its IPO on October 3rd. The total size of the offering was $150,100,000 based on an initial share price of $19.00. During the company’s quiet period, underwriters and any insiders involved in the IPO are restricted from issuing any earnings forecasts or research reports for the company because of regulations issued by the Securities and Exchange Commission. Following the expiration of the company’s quiet period, it’s expected that the brokerages that served as underwriters on the stock will initiate research coverage on the company.
Several equities analysts recently commented on VIE shares. Morgan Stanley started coverage on shares of Viela Bio in a report on Monday, October 28th. They set an “overweight” rating and a $25.00 price target on the stock. Goldman Sachs Group started coverage on shares of Viela Bio in a report on Monday, October 28th. They set a “buy” rating and a $32.00 price target on the stock. Cowen started coverage on shares of Viela Bio in a report on Monday, October 28th. They set an “outperform” rating on the stock. Finally, Guggenheim initiated coverage on shares of Viela Bio in a report on Monday, October 28th. They set a “buy” rating and a $44.00 price target on the stock.