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Monday, April 15, 2019

Eagle Pharmaceuticals Expands Licensing Agreement for BENDEKA™ with Teva

Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq: EGRX) today announced that it has expanded its existing BENDEKA™ (bendamustine hydrochloride) licensing agreement with Teva Pharmaceuticals International GmbH (“Teva”). Under the terms of the revised licensing agreement, beginning on October 1, 2019, Eagle’s royalty payment will increase from 25% to 30% of BENDEKA net U.S. sales, provided that BENDEKA’s orphan drug exclusivity has not been rescinded, withdrawn or waived by such date. The royalty rate will increase by one percentage point on each anniversary of October 1, 2019 until it reaches 32%, and it will remain at 32% thereafter.
The revised agreement, effective April 13, 2019, also extends the U.S. BENDEKA royalty term until it is no longer sold in the United States. The previous U.S. royalty term was set to expire in 2025. The extended term recognizes the strength of the bendamustine patents with expiries through 2033, and the value of the product beyond the original ten-year period. As part of the agreement restructuring, Eagle will continue to manufacture BENDEKA for the U.S. market for so long as it is sold in the United States and has agreed to assume a portion of the BENDEKA-related patent litigation expenses.
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SCYNEXIS to Discuss Case Studies in Candida auris on Conference Call

SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced results showing evidence of activity of the company’s lead product candidate, ibrexafungerp, against fungal infections in multiple settings and indications. These include case studies showing treatment with oral ibrexafungerp resulting in full clearance of Candida auris infections. The findings were described in one oral presentation and five poster presentations at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), April 13-16, 2019, in Amsterdam, Netherlands.
“We are encouraged by the data shared at ECCMID 2019 and ibrexafungerp’s potential to be a new treatment in the fight against difficult-to-treat and resistant fungal infections,” said David Angulo, M.D., Chief Medical Officer of SCYNEXIS. “This additional evidence of clinical activity of ibrexafungerp in a variety of infection types further highlights its versatility and its potential to address unmet needs. We are heartened by the recent attention given to Candida auris, as we believe that increased awareness combined with new treatments are the keys to success in the fight against this serious global health threat.”
The five ibrexafungerp poster presentations are as follows:
The ECCMID 2019 posters are available on the SCYNEXIS website and on the ECCMID 2019 website.
One oral presentation (#L0010), showcasing results from the first interim analysis of 20 patients with various Candida infections from the FURI study will be given by Dr. Oliver Cornely on Tuesday, April 16, from 11:00-12:00 CET.
Conference Call Details
SCYNEXIS will hold a conference call today at 4:15 p.m. ET to discuss the ibrexafungerp data presented at ECCMID 2019. SCYNEXIS management will be joined by the following global thought leaders:
  • Oliver Cornely, M.D., Professor of Internal Medicine and Medical Director, Clinical Trials Center Cologne at the University of Cologne in Germany;
  • Jose Vazquez, M.D., Division Chief and Professor of Medicine and Infectious Diseases, Augusta University, Georgia; and
  • Deven Juneja, M.D., Assistant Professor, Department of Critical Care at the Max Super Specialty Hospital in New Delhi, India. Due to prior commitments, Dr. Juneja is unable to join today’s call but kindly recorded his remarks.
U.S. Dial-in Number: 844-309-3707
International Dial-In Number: 661-378-9467
Conference ID: 2870577
The slide and audio webcast can be accessed by visiting the Investors section of the Company’s website at http://ir.scynexis.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 30 days.
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BeiGene should be owned, especially after latest pullback, says Piper Jaffray

After hosting a dinner with management, Piper Jaffray analyst Tyler Van Buren continues to recommend that investors own BeiGene shares, “especially after this latest pullback.” Management noted that an “exhaustive analysis” of all of the data for approved BTK inhibitors suggests that zanubrutinib is likely to demonstrate statistically superior efficacy and improved, acalabrutinib-like safety and tolerability in the ongoing Phase III head-to-head Waldenstrom’s trial, Van Buren tells investors in a research note. Further, the analyst is “unconcerned” by the recent Revlimid generic “noise” and continues to have confidence in the Chinese product launches later this year. “Significant value” can be created by BeiGene launching zanubrutinib and tislelizumab in China and the U.S. while partnering in other territories, says the analyst. He keeps an Overweight rating on BeiGene with a $170 price target.
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Medidata initiated at William Blair

Medidata initiated with an Outperform at William Blair. William Blair analyst Jeffery Garro started Medidata Solutions with an Outperform rating saying the company is enabling the digital transformation in the biopharmaceutical space.
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Biofrontera reports Q1 preliminary revenue up 46% to EUR6.8M

Biofrontera reports preliminary revenue for the Q1. The preliminary unaudited revenue of the Company for the Q1 around EUR6.8M. This represents a revenue growth of approximately 46% compared to the previous year period, with pure product sales increasing by around 48%. The increase marks the fourth consecutive quarter-over-quarter revenue growth despite the traditionally weaker Q1. Preliminary unaudited product sales in the U.S. are expected to be approximately EUR5.2M, compared to EUR3.4M in the same period in 2018. Q1 product sales in Germany increased by approximately 72% to EUR1.1M. Revenue generated in the remainder of Europe will be flat at around EUR600,000, compared to the same period last year. This effect is due to the elimination of re-imports within the EU.
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Global Medical REIT initiated at Stifel

Global Medical REIT initiated with a Buy at Stifel. Stifel analyst Chad Vanacore initiated Global Medical REIT with a Buy rating and a price target of $11, citing the company’s expected “fast growth, improving portfolio and attractive dividend.” The analyst anticipates the REIT to generate “faster than average investment growth via acquisitions of higher yielding healthcare assets in less competitive markets.” Vanacore also believes that Global Medical REIT is “relatively undervalued” compared to its peers, forecasting an “improved valuation multiple and net asset value” to be driven through external growth and further portfolio diversification.
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WellCare initiated with a Neutral at Credit Suisse

Credit Suisse analyst A.J. Rice started coverage of WellCare (WCG) with a Neutral rating and a $307 price target. While the analyst forecasts WellCare growing revenue and EPS by roughly 29% and 22% this year, with revenue of more than $26B and EPS reaching $13.35, he believes the pending Centene (CNC) deal limits upside over near to immediate term.
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