Coherus Files of Patent Infringement Against Amgen re Humira Biosimilar

Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, today announced it has filed suit against Amgen in the United States District Court (Delaware) alleging that Amgen’s Humira® biosimilar, Amgevita™, infringes Coherus’ U.S. patents 10,155,039; 10,159,732; and 10,159,733. Each of the asserted Coherus patents is directed to stable formulations of adalimumab.

“Coherus recognized early on the central role intellectual property would play in advancing biosimilars to market,” said Denny Lanfear, Chairman, CEO and President of Coherus. He continued, “One important element of our IP strategy for advancing our Humira® biosimilar (CHS-1420) is reflected in the success we’ve achieved in patenting our innovations in the field of adalimumab formulation. We believe in the strength of our IP and we intend to protect it.”

Coherus’ Humira® biosimilar candidate, CHS-1420, is among a number of significant biosimilar candidates in Coherus’ pipeline of high-value treatments for patients in need, including biosimilar candidates directed to Enbrel®, Lucentis®, and Eylea®.

Coherus is currently preparing its biologics license application for CHS-1420 for submission to the U.S. Food and Drug Administration, with anticipated filing in late 2019. Upon the expected U.S. market launch of CHS-1420 in late 2023, the company believes it will be well-positioned to effectively leverage the commercial infrastructure it has already deployed for its recent U.S. launch of UDENYCA™ (pegfilgrastim-cbqv). The company continues to evaluate options and potential strategies for ex-U.S. commercialization of CHS-1420.

https://www.marketscreener.com/COHERUS-BIOSCIENCES-INC-18460920/news/Coherus-BioSciences-Announces-Filing-of-Patent-Infringement-Suit-Against-Amgen-Directed-to-Amgen-s-H-27916093/

Agreement reached to temporarily open government, Drudge Report says

An agreement has been reached to reopen the government on a temporary basis with an announcement set for this afternoon, Drudge Report says, citing a source.

https://thefly.com/landingPageNews.php?id=2853981

Organogenesis to Sponsor Jan. 30 Webinar on Chronic Wounds and Biofilms

Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, will sponsor a January 30 WoundSource webinar, “Chronic Wounds and Biofilms: Advancing Assessment and Treatment” led by Gregory Schultz, PhD, Professor of Obstetrics and Gynecology and Director of the Institute for Wound Research at the University of Florida.

Webinar attendees will review the latest research on the prevalence of biofilms in chronic skin wounds and the underlying mechanisms of biofilm in wounds which inhibit healing. The webinar will also address the concept of Biofilm-Based Wound Care and the STEP-DOWN-THEN-STEP-UP approach for effective therapies in treating chronic wounds.

An important voice in the field of biotechnology and regenerative medicine, Dr. Schultz is a former president of the Wound Healing Society and co-author of more than 400 scientific publications. Dr. Schultz’s research specializes in understanding the inhibiting effects of bacterial biofilms and molecular regulation on the healing of chronic wounds.

“As a company committed to promoting evidence-based care, Organogenesis looks forward to sponsoring this educational forum featuring Dr. Gregory Schultz, a respected clinical leader and widely cited biofilm subject matter expert,” said Brian Grow, Chief Commercial Officer for Organogenesis. “Given the significant wound healing challenges posed by biofilms, this in-depth examination of the latest research and best practices is sure to provide actionable insights for the wound care clinician.”

For event details, including registration information, please visit the WoundSource event registration page.

Ligand Partner Seelos Therapeutics Becomes a Public Company

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner Seelos Therapeutics, Inc. (NASDAQ: SEEL) announced that it has closed a reverse merger with Apricus Biosciences Inc. The combined company changed its name to Seelos Therapeutics, Inc., is publicly traded on the Nasdaq Capital Market under the trading symbol “SEEL,” and will focus on the development and commercialization of central nervous system (CNS) therapeutics with known mechanisms of action in areas with high unmet medical need. Seelos is led by Chairman and Chief Executive Officer Raj Mehra, Ph.D. In conjunction with the reverse merger transaction, Seelos issued common stock and warrants for an aggregate purchase price of $18 million.

In September 2016, Ligand licensed rights to four programs to Seelos, which include:

• SLS-006 (formerly known as aplindore): first-in-class, small molecule, partial dopamine agonist for Parkinson’s disease. SLS-006 has successfully completed Phase 2 studies. Seelos intends to meet with the U.S. Food and Drug Administration (FDA) and the European Medicines Authority (EMA) to discuss plans for pivotal registration studies to commence in 2019. SLS-006 has shown efficacy in early-stage Parkinson’s disease patients as a monotherapy and as a potential adjunctive therapy in late-stage Parkinson’s disease patients upon co-administration with a low dosage of L-Dopa.
• SLS-008: once-daily, oral CRTh2 (Chemo-attractant Receptor-homologous molecule expressed on Th2 cells) that focuses on an undisclosed pediatric orphan indication. Seelos intends to file an Investigational New Drug (IND) application with the FDA for this pediatric orphan indication.
• SLS-010: oral histamine 3 receptor inverse agonist that has shown activity in narcolepsy and related disorders.
• SLS-012: Captisol-enabled injectable acetaminophen therapy for post-operative pain management.

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with CNS disorders. The company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York City. For more information, reference Seelos filings with the Securities and Exchange Commission.

https://www.biospace.com/article/releases/ligand-partner-seelos-therapeutics-becomes-a-public-company/

Hill-Rom FQ1 beats consensus

Hill-Rom Holdings (HRC) Q1 results: Revenues: $683.5M (+2.1%); Product sales and service: $611.6M (+6.3%); Rental revenue: $71.9M (-23.9%).

Net Income: $42.2M (-52.2%); EPS: $0.62 (-52.7%); Non-GAAP EPS: $1.02 (+10.9%); CF Flow Ops: $116M (+24.6%).

The consensus non-GAAP EPS and Revenue Estimate were $0.98 and $676.43M, respectively.

Previously: Hill-Rom Holdings beats by $0.04, beats on revenue (Jan. 25)

https://seekingalpha.com/news/3425987-hill-rom-fq1-beats-consensus

ResMed downgraded to Underweight from Neutral at JPMorgan

JPMorgan analyst David Low downgraded ResMed to Underweight and lowered his price target for the shares to A$13.40 from A$15.50 following the company’s fiscal Q2 results. Goldman Sachs this morning also downgraded ResMed.

https://thefly.com/landingPageNews.php?id=2853621

Deutsche Bank hits pause on Illumina, downgrades to Hold from Buy.

 Deutsche Bank analyst Dan Leonard downgraded Illumina to Hold from Buy and cut his price target for the shares to $310 from $350. Forward revenue expectations lack upside potential while the "pace of newsflow to motivate further enthusiasm" for the company's total addressable market opportunity could slow, Leonard tells investors in a research note. The analyst feels it is "time to hit the pause button" with respect to Illumina shares.


https://thefly.com/landingPageNews.php?id=2853679