Issue link: https://www.e-digitaleditions.com/i/1469783
Recent news about companies that support development of orally inhaled and nasal drug products, including regulatory approvals, new indications for OINDPs and results of clinical studies. 8 June 2022 Inhalation (DPI) formulation development simpler, faster and easier to man- age. A coordinated and aligned suite of services will leverage the expertise and complementary skill sets of the three partners. ose services will range from initial con- sultancy and problem statement development to a stepwise for- mulation development program. Individual services will include solid-state characterization and sono-crystallization of APIs and studies to optimize formulation, blending and filling. Positive phase III results for AstraZeneca and Avillion's asthma therapy LONDON, UNITED KING- DOM—Avillion LLP has an- nounced that full results from the MANDALA phase III trial of AstraZeneca's PT027 have been published in e New England Journal of Medicine in advance of presentation at the American oracic Society (ATS) 2022 International Conference. In re- porting, PharmaTimes Online noted that PT027 is a poten- tial first-in-class inhaled, fixed- dose combination of albuterol, the short-acting beta 2 -agonist albuterol and the inhaled corti- costeroid budesonide. At two dif- ferent strengths of budesonide, the results demonstrated a sta- tistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma. e drug is being developed by Avillion and AstraZeneca under a 2018 clinical co-development agreement. In addition, the part- nership has recently expanded to include a new decentralized, randomized trial in patients with mild asthma, which is anticipated to begin in the coming months. continued on page 34 e expansion is in response to the growing interest in the potential for nose-to-brain drug adminis- tration, and as an alternative route for the delivery of systemic drugs, rescue therapies and vaccines. Kindeva Drug Delivery to acquire iPharma Labs WOODBURY, MINNESOTA— Kindeva Drug Delivery an- nounced it has entered into a definitive agreement to acquire iPharma Labs, Inc., based in San Francisco's Bay Area. is acquisi- tion will combine iPharma's exper- tise and track record in inhalation formulation and development of liquid, dry powder and propel- lant-based therapies with Kinde- va's global expertise in developing, commercializing and manufactur- ing inhaled therapies. e entire team at iPharma will join Kindeva at closing and will continue to op- erate from their existing location. e transaction is expected to close in the first half of 2022. Kin- deva has a history in inhalation treatment that includes develop- ment of the world's first pressur- ized metered dose inhaler (pMDI) in 1956. iPharma was founded in 2016 by a group of former em- ployees of Inhale/Nektar era- peutics. Together as Kindeva, the combined organization will sup- port customers from early research and development through clinical and commercial manufacturing and launch, and work to bring in- halation technologies sustainably into the future. Three companies partner to offer DPI formulation development NEW YORK, NEW YORK— DFE Pharma (an excipients solu- tion provider), Harro Höfliger (an equipment supplier) and Ster- ling (an API manufacturer) have announced a new partnership, named "Inhalation Together" (INTO). ey intend to provide R&D services to pharmaceutical companies in the respiratory field and make dry powder inhalation INDUSTRY NEWS Alembic Pharmaceuticals receives FDA approval VADODARA, INDIA—Accord- ing to Business Standard, Alem- bic Pharmaceuticals announced it has received final approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Applica- tion (ANDA) for arformoterol tartrate inhalation solution, 15 mcg (base)/2 ml unit-dose vial. Co-developed with Orbicular Pharmaceutical Technologies, the long-acting beta 2 -adrenergic ago- nist is indicated for long-term, twice-daily (morning and evening) maintenance treatment of bron- choconstriction in patients with chronic obstructive pulmonary dis- ease (COPD), including chronic bronchitis and emphysema. e company noted the approved drug is therapeutically equivalent to the reference listed drug product (RLD), Brovana Inhalation Solu- tion, 15 mcg/2 ml from Sunovion Pharmaceuticals Inc. Catalent expands Morrisville, NC facility SOMERSET, NEW JERSEY— Catalent announced it has com- pleted a significant expansion of nasal capabilities at its Morrisville, Research Triangle Park (RTP), North Carolina, US facility to pro- vide services for the development and manufacturing of unit-dose and bi-dose nasal spray products. It is the first phase of an invest- ment at the site to expand and modernize the company's nasal drug delivery capabilities, sub- stantially increasing technology and capacity to support projected growth for existing and future cus- tomers. New technologies include a flexible, high-speed micro-vial filling line, automated inspection and high-speed assembly line, which are intended to allow seam- less transition for all clinical and commercial manufacturing within an ISO 7 environment and spray testing development and release.