SOMERSET, CATALENT N.J.–(BUSINESS WIRE), Inc. (Catalent) (NYSE:CTLT), the global leader in delivery technologies and drug, biologics and healthcare development solutions, today announced that its 100% subsidiary Catalent Pharma Solutions, Inc. (the “Catalent Operating Subsidiary”) has completed a modification to its priority secured credit facilities to obtain its subsidiary`s interest rate at 100% U.S. dollars and euros. reduce the appropriations denominated. The new rate for temporary loans denominated in US dollars is libor (subject to a floor of 1.00%) plus 2.75%, which is 0.50% lower than the previous interest rate (and its amendment also removes tiered pricing based on a measure of catalent operating subsidiary`s overall debt ratio), and the new rate applicable for euro-denominated loans is LIBOR (subject to a floor of 1.00%) plus 2.50%. which is 0.75% lower than the previous rate (and for which the “step” pricing has also been removed). The manufacturing agreement with Catalent is good news for the company and patients, as it is expected to reduce the likely significant demand for NurOwn after approval. The company`s next expected message is the release of Topline data for the Phase 3 SSA study, with these results expected before the end of November 2020.
Without any changes to our model, our valuation remains at US$33 per share as we look forward to the results of the Phase 3-SD study. Catalent is the global leader in advanced delivery technologies and drug, biologics and consumer health product development solutions. With more than 80 years of service to the industry, Catalent has well-identified expertise to bring more customer products to market faster, improve product performance and ensure a reliable clinical and commercial supply. Catalent employs more than 9500 people, including more than 1400 scientists, at more than 30 sites on 5 continents and achieved an annual turnover of $1.85 billion in fiscal 2016. Catalent is headquartered in Somerset, N.J. For more information, see www.catalent.com. On October 22, 2020, BrainStorm gave cell therapeutics, Inc. (NASDAQ:BCLI) an agreement with Catalent, Inc. (CTLT) to manufacture NurOwn® currently being evaluated in a Phase 3 clinical study in patients with amyotrophic lateral sclerosis (ALS). The agreement provides for Catalent to produce NurOwn`s clinical delivery of CGMP at its new 32,000-square-foot cell therapy production site in Houston, TX.
After NurOwn`s FDA approval, we assume that the companies will extend the agreement to the production of NurOwn`s commercial deliveries from the same facility. Investors:Catalent, Inc.Thomas Castellano, email@example.com. . . . The brainstorm study used a lipopolysaccharide-induced mouse model (LPS) and showed that intratracheal administration of NurOwn-derived exosomes resulted in a statistically significant improvement in functional lung regeneration, a reduction in inflammatory cytokines, and an attenuation of lung damage. These results suggest that exosomes derived from NurOwn are more effective than exosomes from uninclusured MSM and may be effective in treating ARDS in patients with COVID-19. This press release contains statements that are both historical and forward-looking. All statements, except statements relating to historical facts, are or may be considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.