On October 22, 2020, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) announced an agreement with Catalent, Inc. (CTLT) for the production of NurOwn®, which is currently undergoing a Phase 3 clinical trial in patients with amyotrophic lateral sclerosis (ALS). The agreement calls for Catalent to manufacture cGMP clinics for the clinical supply of NurOwn at its new 32,000 square metre cell therapy production site in Houston, TX. After FDA approval from NurOwn, we assume that the companies will extend the agreement to the production of Commercial Supplies from NurOwn from the same facility. Catalent is the world`s leading provider of advanced delivery technologies and development solutions for medicines, biologics and consumer health products. With more than 80 years at the service of the industry, Catalent has a proven tracking ground for bringing more customer products to market faster, improving product performance and ensuring a reliable clinical and commercial supply of products. Catalent employs more than 9,500 people, including more than 1,400 scientists, at more than 30 sites on five continents and generated annual sales of $1.85 billion in fiscal 2016. Catalent is headquartered in Somerset, N.J. For more information, see www.catalent.com.
Investors:Catalent, Inc.Thomas Castellano, firstname.lastname@example.org The production agreement with Catalent is good news for the company and patients, as it should relieve the likely significant demand for NurOwn after approval. The company`s next expected news is the release of topline data for the Phase 3-Als study, the results of which are expected before the end of November 2020. Without changing our model, our valuation remains at $33 per share, as we look forward to the results of the S ALS Phase 3 study. SOMERSET, N.J.— (BUSINESS WIRE) –Catalent, Inc. („Catalent“) (NYSE:CTLT), the world`s leading provider of advanced supply technologies and drug development solutions, Biologists and Consumer Products, today announced that its wholly owned subsidiary Catalent Pharma Solutions, Inc. (Catalent Operating Subsidiary) has completed a modification of its major secured credit facilities to reduce the interest rate on its long-term loans denominated in U.S. dollars and denominated in euros. The new interest rate for long-term loans denominated in U.S.
dollars is LIBOR (subject to a floor of 1.00%) plus 2.75%, which is 0.50% lower than the previous interest rate (and with which „no“ prices are actually disbursed on the basis of a measure of CataleNt Operating Subsidiary`s overall leverage ratio, and the new interest rate applicable to long-term euro-denominated loans is LIBOR (subject to a floor of 1.00%) 2.50%, or 0.75% less than the previous rate (for which „no“ prices were also removed). . . . This is an exciting development for the company, as we believe that patient demand will be very high if the Phase 3 clinical trial is successful and NurOwn is FDA approved. A high-quality manufacturing partnership therefore shows that BrainStorm is serious about meeting this demand and not letting access to therapy be a topic for patients. . The amendment also includes a 1.0% advance premium in the event of an additional taker event (as defined in the amendment) on the day or before the anniversary of the six-month amendment. As a result of this change, there are no changes to deadlines or agreements.
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