Zosano launches Phase 2/3 study of zolmitriptan for cluster headache

Enrollment is underway in a 120-subject Phase 2/3 clinical trial evaluating Zosano Pharma’s (ZSAN +3.5%) C213 (zolmitriptan) for the acute treatment of cluster headache.

C213 is a patch worn on the skin based on the company’s ADAM technology, drug-coated titanium micro-projections that deliver the drug through the skin. It is the same approach used with migraine patch Qtrypta.

The co-primary endpoints are the proportion of patients achieving pain relief within 15 minutes and the proportion of patients achieving sustained pain relief (15 minutes to 60 minutes).

The estimated completion date is April 2021.

https://seekingalpha.com/news/3509144-zosano-launches-phase-2-3-study-zolmitriptan-cluster-headache

Fresenius hemodialysis system nabs accelerated review status in U.S.

The FDA designates Fresenius Medical Care North America’s new hemodialysis system, Endexo, designed to prevent blood clotting without the use of blood thinners, a Breakthrough Device.

Endexo inhibits the adsorption (formation of thin film) of protein and platelets by virtue of its polymer design made of surface-modifying molecules.

Fresenius in-licensed global rights to Endexo from Interface Biologics in July 2010.

Breakthrough Device designation, akin to Breakthrough Therapy status for drugs, allows for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and priority review of the marketing application.

The company is a unit of Fresenius Medical Care AG & Co. KGaA (FMS +0.1%).

https://seekingalpha.com/news/3509151-fresenius-medical-care-hemodialysis-system-nabs-accelerated-review-status-u-s

AstraZeneca Upgrades Outlook Despite Slide in Profit

AstraZeneca PLC (AZN.LN) said Thursday that third-quarter net profit fell, while sales increased as it raised its guidance.
Profit in the period was $299 million, down from $431 million in the prior year. Revenue climbed 16% to $6.13 billion. Core earnings per share, a closely-watched company measure that strips out exceptional items, rose 40% to 99 cents, edging ahead of the 97 cents expected by analysts.
The drug maker said that its reported net profit was hit by increased legal provisions, while comparables were made more difficult by a positive $436 million legal settlement the year before.
Product sales in China, a market that has been a key focus for Chief Executive Pascal Soriot, grew by 40% at constant exchange rates.
Meanwhile, revenue from the pharmaceutical company’s oncology portfolio, which has been key to returning the business to sales growth after years of declines, increased by 48% excluding currency effects. The drug that generated the most revenue in the category was Tagrisso, with total sales of $891 million in the quarter.
Astra upgraded its full-year outlook for the year. The company said it now expects to product sales to grow by a low to mid-teens percentage at constant exchange rates. Previously it guided for low double-digit percentage growth.

https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-Upgrades-Outlook-Despite-Slide-in-Profit-29446236/

Bristol-Myers Gets EU OK for Opdivo Flat Dosing in Melanoma

Bristol-Myers Squibb Co. (BMY) Thursday said the European Commission approved a flat-dosing schedule for its cancer drug Opdivo in adults with the skin cancer melanoma.
The New York biopharmaceutical company said the approval covers a dosing of 240 milligrams infused over 30 minutes every two weeks or 480 milligrams infused over 60 minutes every four weeks for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The European Medicines Agency’s Committee for Medicinal Products for Human Use last month recommended approval of the flat-dosing schedule.

https://www.marketscreener.com/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Myers-Gets-EU-OK-for-Opdivo-Flat-Dosing-in-Melanoma-29448053/

FDA OKs expanded use of Glaxo’s Zejula

The FDA has approved the use of GlaxoSmithKline’s (GSK +1.3%) PARP inhibitor Zejula (niraparib) in patients with advanced  ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency-positive (HRD+) status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

This is the first indication for a PARP inhibitor beyond BRCA-positive patients in a late-line setting.

The announcement was made by licensee Zai Lab Limited (ZLAB), owner of commercialization rights in China, Macau and Hong Kong.

Glaxo acquired global rights to Zejula via its $5.1B acquisition of TESARO in January.

https://seekingalpha.com/news/3509121-fda-oks-expanded-use-glaxos-zejula

Regeneron down 1% on Amgen’s discounted Repatha

Regeneron Pharmaceuticals (REGN -1.2%) slips on light volume in early trade in reaction to competitor Amgen’s (AMGN -0.3%) announcement that it has terminated its original list price for high cholesterol med Repatha (evolocumab) and will exclusively distribute the PCSK9 inhibitor at the 60% lower list price of $5,850 per year.

The company introduced the lower price a year ago but continued certain contracts with payers and PBMs based on the original list price in order to minimize potential supply chain disruptions, adding that all PBMs and health plans enjoy  equivalent or better net pricing on the lower list price option on Repatha.

Regeneron’s PCSK9 inhibitor is Praluent (alirocumab), being co-commercialized with partner Sanofi (SNY +0.9%). The companies have been locked in a battle for market share since the FDA approved the products at nearly the same time in 2015.

https://seekingalpha.com/news/3509130-regeneron-1-percent-amgens-discounted-repatha

West Pharmaceutical EPS beats by $0.08, beats on revenue

West Pharmaceutical (NYSE:WST): Q3 Non-GAAP EPS of $0.79 beats by $0.08; GAAP EPS of $0.75 beats by $0.06.

Revenue of $456.1M (+5.7% Y/Y) beats by $6.07M.

Press Release

https://seekingalpha.com/news/3508904-west-pharmaceutical-eps-beats-0_08-beats-revenue