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Monday, February 3, 2020

United Therapeutics’ dinutuximab flunks cancer study

United Therapeutics (NASDAQ:UTHR) announces that Unituxin (dinutuximab) failed to achieve the primary endpoint in a Phase 2/3 clinical trial, DISTINCT, evaluating the GD-2 targeting monoclonal antibody, combined with chemo agent irinotecan, in patients with relapsed/refractory small cell lung cancer (SCLC).
The combination failed to extend overall survival (OS) compared to irinotecan or topotecan alone.
No new safety signals were observed.
Complete data will be submitted for presentation at future medical conferences and publication.
The FDA OK’d Unituxin in March 2015 for pediatric high-risk neuroblastoma. It is also pursuing a label expansion to use Unituxin, combined with irinotecan and temozolomide, for pediatric patients with relapsed/refractory neuroblastoma. It expects to meet with the FDA in H1 and file a supplemental marketing application shortly thereafter.
https://seekingalpha.com/news/3537157-united-therapeutics-dinutuximab-flunks-cancer-study

Teva’s Ajovy successful in two migraine studies in Japan

Teva Pharmaceutical Industries (NYSE:TEVA) announces positive results from two Phase 2/3 clinical trials in Japan evaluating Ajovy (fremanezumab) in patients with chronic and episodic migraine.
The studies met the primary and all secondary endpoints.
Detailed data will be submitted for presentation at future medical conferences and publication.
Otsuka Pharmaceutical Co., Ltd. (OTCPK:OTSKF) is the exclusive licensee in Japan under a May 2017 agreement.
https://seekingalpha.com/news/3537165-tevas-ajovy-successful-in-two-migraine-studies-in-japan

Humana forms JV to expand primary care centers

Humana (NYSE:HUM) Partners in Primary Care and Welsh, Carson, Anderson & Stowe (WCAS) have entered into the joint venture (JV) that will expand access to value-based primary care for Medicare patients.
The JV will develop and operate senior-focused, payor-agnostic, primary care centers, which will be managed and operated by Humana’s wholly-owned subsidiary, Partners in Primary Care.
WCAS together with Humana, is making an initial commitment of ~$600M to the JV. WCAS will have majority ownership in the new company whereas Humana will own a small minority stake.
Partners in Primary Care will receive a management fee, including performance-based incentives, for the management of all JV centers.
In addition, the agreement includes a series of put and call options through which Partners in Primary Care may acquire WCAS’s interest in the JV.
https://seekingalpha.com/news/3537174-humana-forms-jv-to-expand-primary-care-centers

Alpha Pro Tech increases N-95 face mask production

Alpha Pro Tech (NYSEMKT:APT) is exponentially ramping up production of its N-95 Particulate Respirator face mask in response to a significant increase in customer demand and level of orders resulting from the outbreak of Wuhan coronavirus (2019-nCoV).
The company has commenced additional face mask production at its Salt Lake City, Utah facility, and anticipates further production line increases in early February.
The N-95 face mask filters at least 95% of airborne particles.
Shares are up a fraction premarket.
https://seekingalpha.com/news/3537191-alpha-pro-tech-increases-nminus-95-face-mask-production

Coronavirus outbreak-related actions rippling through global economy

The effects of the coronavirus outbreak in China, specifically the actions taken by governments and certain private sector companies to contain the spread of the respiratory ailment, are being felt across a wide swath of the globe’s economy.
Governments in the U.S., Europe and Asia have restricted visitors to China while returning citizens are screened (mostly for high temperatures) for potential infection.
Major airlines, including American, United and Delta, have suspended flights to China.
Pharmaceutical, financial and tech companies are pulling out expatriate employees.
Apple plans to close all of its stores and corporate offices in China through February 9. It is also dealing with work stoppages at factories that produce components for its wares sold around the world.
Levi Strauss & Co., McDonald’s and Starbucks have closed thousands of outlets around China, in part to comply with the government’s request for people to remain off the streets.
The demand for crude oil has dropped, leading to a 16% tumble in prices since the outbreak was announced (China is the world’s largest importer). Refinery use plummeted 15% last week alone.
Chinese markets dropped sharply on Monday after reopening for the first time since January 23. The benchmark Shanghai Composite Index was off 7.7%, its steepest one-day decline since August 2015.
Many global firms are cueing their actions from the World Health Organization (WHO) which declared the outbreak a public health emergency last week despite it being less deadly than SARS and still largely confined to Wuhan (there have been ~140 reported cases in ~20 ex-China countries thus far).
About 14,500 Chinese have been infected to date, although this figure is certainly underreported, with ~700 deaths. For comparison purposes, the flu epidemic in the U.S. in 2017/18 infected 48M Americans and killed 61K.
https://seekingalpha.com/news/3537193-coronavirus-outbreak-related-actions-rippling-through-global-economy

GW Pharma files U.S. application for expanded use of Epidiolex

GW Pharmaceuticals (NASDAQ:GWPH) has filed a supplemental marketing application in the U.S. seeking approval to use Epidiolex (cannabidiol) oral solution to treat seizures associated tuberous sclerosis complex, a rare inherited disorder characterized by the growth on non-cancerous tumors in many parts of the body.
The FDA approved Epidiolex in June 2018 for Lennox-Gastaut syndrome and Dravet syndrome.
https://seekingalpha.com/news/3537202-gw-pharma-files-u-s-application-for-expanded-use-of-epidiolex

Catalent +2% premarket on raising guidance and revenue beat

Catalent (CTLT) Q2 results: Revenues: $721.4M (+15.8%).
Net Income: $34.3M (-30.0%); EPS: $0.23 (-30.3%); non-GAAP Net Income: $72M (+10.1%); non-GAAP EPS: $0.45 (unch); CF Ops: $145.9M (+72.7%).
FY 2020 Guidance: Revenue: $2.87B – 2.95B from $2.78B – 2.88B; non-GAAP Net Income: $307M – 331M from $300M – 330M; non-GAAP EBITDA: $711M – 735M from $700M – 730M.
Shares are up 2% premarket.
https://seekingalpha.com/news/3537205-catalentplus-2-premarket-on-raising-guidance-and-revenue-beat