Teva to donate over $15 billion worth of drugs in opioid settlement

Teva Pharmaceuticals is in talks to contribute over $15 billion worth of drugs as part of a settlement to resolve lawsuits alleging it helped fuel the U.S. opioid crisis, a source familiar with the matter told Reuters on Wednesday.

The news follows media reports that major drug distributors McKesson Corp, AmerisourceBergen Corp and Cardinal Health are discussing with governments to settle thousands of opioid-related lawsuits for $18 billion.
The companies, including Teva, are all defendants in a landmark trial set to begin in federal court in Cleveland, Ohio, on Oct. 21, which will be presided over by U.S. District Judge Dan Polster, who has long pushed for a global settlement of the litigation.
The source also said Johnson & Johnson Inc had offered to pay $4 billion to settle claims related to the U.S. opioid epidemic.
Teva has offered to give away generic drugs, including those that help fight opioid overdose, to resolve all of its cases in an agreement that would run over 10 years, Bloomberg reported on Tuesday.
Teva did not immediately respond to Reuters’ request for comment.
If the distributors and Teva settle before the start of the trial, the remaining defendants would be Walgreens Boots Alliance Inc and Henry Schein Inc.
https://www.marketscreener.com/TEVA-PHARMACEUTICAL-INDUS-56537293/news/Teva-to-donate-over-15-billion-worth-of-drugs-in-opioid-settlement-29385820/?countview=0

Schein up on dismissal from antitrust case

Dental products distributor Henry Schein (HSIC +1.5%) is up on below-average volume in response to an initial decision from an administrative law judge dropping the company from a Federal Trade Commission (FTC) antitrust complaint accusing it and fellow distributors Benco Dental Supply Company and Patterson Companies (PDCO +0.9%) of conspiring to refuse extending discounts to buying groups representing dentists.

Judge D. Michael Chappell held that Benco and Patterson were part of the conspiracy but Schein was not citing a lack of evidence to the contrary.

The three companies control over 85% of the U.S. market for sales of dental products and services.

https://seekingalpha.com/news/3506199-schein-2-percent-dismissal-antitrust-case

FDA OK’d record number of generic drugs in F19

The FDA announces that it approved 1,171 generic medicines in fiscal 2019 (12-month period ended September 30), a record total from the previous all-time high of 971 in fiscal 2018. The total consisted of 935 full approvals and 236 tentative approvals. 125 were first generics with no generic competition.

Selected tickers: MYL, PRGO, TEVA, ENDP, AKRX, MNK, RDY, LCI, AMPH, CHRS, AMGN, PJP, PPH, XPH

https://seekingalpha.com/news/3506222-fda-okd-record-number-generic-drugs-f19

Discoveries Enabled by Bionano Genome Imaging System Presenting at Conference

Bionano Genomics, Inc. (Nasdaq: BNGO) today announced that disease researchers using Bionano’s Saphyr system for whole genome imaging will present their results at the American Society of Human Genetics (ASHG) Annual Meeting, between October 15-19 in Austin, Texas.

The impact of analysis using the Saphyr system for ultra-sensitive and ultra-specific genome-wide detection of structural variation will be presented at ASHG with 22 oral and poster presentations and an Educational Event hosted by Bionano.

“ASHG 2019 represents a milestone for Bionano, with a record number of presentations demonstrating novel discoveries through our genome mapping technology,” said Erik Holmlin, Ph.D., CEO of Bionano. “The growing use of the Saphyr system in disease research illustrates the value in identifying genomic variations for deep understanding of disease origin and diagnostic development.”

Optical mapping through Saphyr enables the direct observation of large genomic variations through imaging of fluorescently labeled, megabase-size native DNA molecules. Next-generation sequencing (NGS), in contrast, relies on short-reads that piece together sequence fragments in an attempt to rebuild the actual structure of the genome. NGS often misses large DNA variations, such as deletions, insertions, duplications, and translocations and inversions. Genome mapping resolves these structural variations for more insight into the genetic variations that cause disease.

https://www.globenewswire.com/news-release/2019/10/16/1930240/0/en/Top-Researchers-to-Present-Discoveries-Made-Possible-by-Bionano-s-Saphyr-System-for-Genome-Imaging-Technology-at-the-ASHG-2019-Annual-Meeting.html

Ionis down on delay of Huntington’s disease data readout

Ionis Pharmaceuticals (IONS -5.8%) slips on modestly higher volume in apparent reaction to collaboration Roche’s (OTCQX:RHHBY -1.2%) disclosure that an expected data readout from their joint program, in this case a Phase 2 study evaluating RO7234292 (ISIS 443139), in Huntington’s disease will be delayed until late 2020 or early 2021. Previously, Roche indicated that additional data would be available in H1 2020.

The timeline for results from a Phase 3 trial is still on track. If all goes well, marketing applications will be filed in 2022.

https://seekingalpha.com/news/3506184-ionis-6-percent-delay-huntingtons-disease-data-readout

TELA Bio readies IPO

TELA Bio (TELA) has filed a preliminary prospectus for a $69M IPO.

The Malvern, PA-based med tech firm develops tissue reinforcement materials, branded as OviTex, used in soft tissue reconstruction, including hernia repair, abdominal wall reconstruction and plastic/reconstruction surgery. They are currently cleared for sale in the U.S. and have been sold here since July 2016.

2019 Financials (6 mo.): Revenue: $6.6M (+83%); Operating Expenses: $13.2M (+28%); Net Loss: ($16.0M) (+15%); Cash Flow Ops: ($13.0M) (-20%).

https://seekingalpha.com/news/3506164-tela-bio-readies-ipo

Cabaletta Bio on deck for IPO

Cabaletta Bio (CABA) has filed a preliminary prospectus for a $106M IPO.

The Philadelphia, PA-based biotech develops engineered T cell therapies, chimeric antoantibody receptor (CAAR) T cells, for B cell-mediated autoimmune disorders. The company says its proprietary CABA platform is applicable across 24 of these diseases thus far. Lead candidate is DSG3-CAART for the potential treatment of a rare skin blistering disorder called pemphigus vulgaris. A Phase 1 study should commence in 2020.

2019 Financials (6 mo.): Operating Expenses: $7.8M (+644%); Net Loss: ($12.2M) (-999%); Cash Burn: ($6.1M) (-261%).

https://seekingalpha.com/news/3506176-cabaletta-bio-deck-ipo