Boston Scientific (BSX) and Edwards Lifesciences (EW) announced that the companies have reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted. Under the terms of the agreement, Edwards has made a one-time payment to Boston Scientific of $180M. No further royalties will be owed by either party under the agreement. All other terms remain confidential.
Tuesday, January 15, 2019
Walmart may leave CVS pharmacy networks due to dispute
Walmart (WMT) pharmacies are expected to leave drugstore networks offered by CVS Health’s (CVS) pharmacy-benefit management unit due to a dispute over pricing, impacting people whose employers have CVS-administered drug benefits, as well as Medicaid enrollees with CVS drug coverage, The Wall Street Journal reports. Walmart offers pharmacies in nearly all of its approximately 4,600 U.S. stores. The dispute does not affect the pharmacy networks in CVS Caremark’s Medicare plans nor does it involve Walmart’s Sam’s Club stores, and will not materially impact CVS’s financial results, according to the report. CVS has asked Walmart to remain in its networks through April 30, but a person with knowledge of the matter says that if Walmart does not agree, the split will take effect in early February.
Insmed price target raised to $32 from $20 at Canaccord
Canaccord analyst Dewy Steadman raised his price target on Insmed to $32 from $20 following its “blowout” preannouncement last week. The analyst is cautiously optimistic about 2019 performance as even a rock-bottom base revenue assumption is above consensus revenue. He also believes Arikayce will become core to the NTM treatment paradigm over time, making current valuation an attractive entry points for investors. Steadman reiterated his Buy rating on Insmed shares.
Krystal Biotech announces construction of Pittsburgh GMP facility is complete
Krystal Biotech announced that construction of Ancoris, a new good manufacturing practice, or GMP, facility, is complete. The new facility is located near the company’s headquarters in Pittsburgh and will support clinical and commercial manufacturing of Krystal’s lead product candidate, KB103, for the treatment of dystrophic epidermolysis bullosa, or DEB. The facility will be officially open in Q1 following completion of the first engineering run. The 4,500 square foot facility has been designed to satisfy the necessary manufacturing requirements for commercial development of KB103 and the highest current GMP standards governing commercial production for biopharmaceutical use. The Ancoris facility will be the primary production site to meet projected commercial demand for KB103. In addition, a second phase of the manufacturing strategy has been initiated with plans to build a second, larger GMP manufacturing facility in Pittsburgh that will support the anticipated commercial demand for future developmental pipeline programs. The second facility is anticipated to be complete in 2020.
Menlo gets FDA breakthrough therapy designation for serlopitant
Menlo Therapeutics announced that the FDA has granted breakthrough therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis, or PN. Menlo is currently enrolling patients in two Phase 3 clinical trials to evaluate serlopitant as a treatment for pruritus associated with prurigo nodularis. Data from each trial is expected by Q1 of 2020.
Nymox: new peer review article on development of Fexapotide Triflutate
Nymox Pharmaceutical Corporation reports that a new peer review article has been published in Therapeutic Advances in Urology. The new publication reviews current progress in the development of Fexapotide Triflutate, Nymox’s first-in-class new molecular approach to managing the symptoms of benign prostatic hyperplasia.The new article is entitled “Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia”. According to the article, “For many men suffering from BPH, there remains an unmet need for office-based treatments for BPH that are effective and that have fewer side effects and better safety profiles than existing approved molecular and surgical treatments. Large long-term prospective randomized US studies of FT have shown statistically significant long-term improvement in BPH symptoms and objective outcomes including significant reduction in both spontaneous acute urinary retention as well as the subsequent incidence of BPH surgery. Based on a total of greater than1700 patient treatments including FT and placebo in US trials to date since 2002, FT has been shown to be well tolerated with an excellent safety profile. FT is a well-tolerated and efficacious clinic-based treatment for BPH involving an intraprostatic injection that requires only a few minutes to administer, with no catheter nor anesthesia requirements. FT injection represents a novel, first-in-class BPH treatment modality”.
Societe General applauds Bristol-Myers’ ‘bold’ deal, double upgrades to Buy
As previously reported, Societe Generale analyst Justin Smith double upgraded Bristol-Myers (BMY) to Buy from Sell as he believes investors’ concerns about how the acquisition of Celgene (CELG) could weaken its long-term growth profile are adequately discounted at the stock’s current levels. He also applauds management for making “such a bold strategic move,” contending that improved cash flow and a higher R&D budget for the combined company should help it navigate past medium-term patent expirations while simultaneously growing the dividend. He assigns an 80% probability of the acquisition closing, but “cannot dismiss the risk of counter-bids on either side of this deal,” Smith added. He raised his price target on Bristol-Myers shares to $60 from $47.
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