Orthofix announces FDA approval for M6-C Artificial Cervical Disc

Orthofix Medical announced FDA approval of the M6-C artificial cervical disc for patients suffering from cervical disc degeneration. The M6-C artificial cervical disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018. “With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients,” said Orthofix President and CEO, Brad Mason. “In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity ELITE allograft, a market-leading allograft developed in partnership with MTF Biologics. The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth.” Orthofix expects to release the M6-C artificial cervical disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The M6-C artificial cervical disc received CE Mark approval for distribution in the European Union and other international geographies in 2006 and there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.

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Spectrum initiated at Cantor Fitzgerald

Spectrum initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Spectrum Pharmaceuticals with an Overweight rating and $19 price target. The analyst has confidence that poziotinib can show a differentiated response in the pivotal Phase 2 study and believes the value for Rolontis is being underappreciated. This “provides some floor to the valuation,” Young tells investors in a research note. With no approved drugs for exon 20, the analyst thinks the efficacy bar is relatively low.

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Mylan patent challenge on Tecfidera potential positive for Alkermes: Cantor

Cantor Fitzgerald analyst Brandon Folkes views the institution of Mylan’s (MYL) inter partes review challenge of Tecfidera’s ‘514 patent as a potential positive for Alkermes (ALKS). The analyst has assumed Biogen’s (BIIB) Tecfidera ‘514 patent holds through 2028, and thus had ascribed a “more-modest” value to Alkermes’ royalty from BIIB098 sales. If Mylan is successful in its IPR challenge, says the analyst, it could provide $4-$7 per share upside to his current Alkermes price target of $33. Biogen reported Tecfidera revenues of $4.3B for 2018, $3.3B of which was generated in the U.S. Alkermes is entitled to a mid-teen royalty on worldwide sales of BIIB098, Folkes tells investors in a research note titled “Giving ALKS a Hall Pass to Support the Away Team This Time.” However, he believes the market has discounted the contribution of the BIIB098 royalty to Alkermes, “given the uncertainty about how the product may be included in a Tecfidera life cycle extension given the ‘514 patent runs to 2028.”

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Endo announces FDA requested further stay of ongoing litigation

Endo International announced that the FDA has requested a further stay of Endo’s ongoing litigation against the FDA through March 15. That litigation challenges the FDA’s authorization of the bulk compounding of drugs, including vasopressin, that have not satisfied the legal requirements under Section 503B of the Drug Quality and Security Act amendments to the Federal Food, Drug, and Cosmetic Act. One of Endo’s subsidiaries, Par Sterile Products, manufacturers the only vasopressin product currently approved by the FDA, Vasostrict. The suit was most recently stayed on January 7 for the duration of the government shutdown.
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MacroGenics downgraded to Neutral on ‘baked in’ approval at Wedbush

Analyst David Nierengarten downgraded MacroGenics to Neutral from Outperform, while raising his price target on the shares to $26 from $20, following positive topline results from the pivotal Phase 3 SOPHIA trial evaluating margetuximab in 3/4L HER2-positive metastatic breast cancer. Overall, the topline readout met Nierengarten’s cautiously optimistic expectations for a statistically significant increase in PFS that would warrant BLA submission in 2H19 and subsequent approval. The analyst argued that the current stock reaction approaches his increased and already de-risked valuation.
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VBI Vaccines: DSMB recommendation to continue VBI-1901 study

VBI Vaccines announced that the independent data and safety monitoring board, or DSMB, completed its third and final safety assessment of Part A of the ongoing Phase 1/2a clinical study of VBI-1901 in recurrent glioblastoma, or GBM, patients. After reviewing the complete safety data from the fully enrolled, high-dose patient cohort, the DSMB unanimously recommended the continuation of the Phase 1/2a study without modification. Part B of the study, which is expected to enroll a cohort of up to 10 additional patients, will be an extension of the optimal therapeutic dose level from Part A of the study. The company will define the optimal dose following availability of expanded immunologic data and survival data from all three dose cohorts in Part A, which are expected later in the first half of 2019.
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Avadel Pharmaceuticals exits Noctiva, reduces workforce by over 50%

Avadel Pharmaceuticals announced a corporate restructuring to assure the financial health required to maximize the value of FT218, currently in Phase III development for the treatment of excessive daytime sleepiness, or EDS, and Cataplexy in patients suffering from Narcolepsy. Avadel expects to realize $70M-$75M in cost reductions in 2019 as compared to 2018 as a result of the restructuring plan, driven primarily by exiting Noctiva. Noctiva’s performance since launch has been highly disappointing despite a substantial investment of resources. Once fully implemented, the plan will lower the company’s cost structure by $80M-$90M in 2020 and beyond when compared to 2018. Avadel estimates it will incur approximately $10M-$15M of one-time pre-tax charges for severance and other costs related to the restructuring, primarily during the first half of 2019. The company’s cash and marketable securities balance as of December 31, 2018 was approximately $100M. The company’s workforce will be downsized by more than 50% as part of the restructuring. The focus of the remaining company and corresponding resources include FT218 and hospital products related capabilities and functions. Separately, Avadel Specialty Pharmaceuticals, a subsidiary, responsible solely for the sales, marketing and distribution of Noctiva, has made a voluntary filing under Chapter 11 of the United States Bankruptcy Code. This action is not expected to materially impact any other aspect of the company’s business, including the ability to operate its sterile injectables hospital business and complete the FT218 Phase III clinical trial. As part of this action, Avadel expects to record in Q4 a pre-tax non-cash impairment charge of approximately $66M related to Noctiva intangible assets.
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