A roundup of developments and latest news from China (Biocad, Shanghai Pharma), India (Aurobindo, Glenmark, Lupin), and the US (Astellas).

China

Russia’s Biocad, Shanghai Pharma Finalize Joint Venture

Biocad, a Russian pharmaceutical company, has finalized an agreement with Shanghai Pharma, a Chinese pharmaceutical company, for establishing a joint venture for biosimilars and innovative biologics in China.

In June 2019, the companies signed a shareholder agreement and cooperation memorandum. The signing of this joint venture agreement marks the official establishment of the joint venture company and the start of substantive operations.

The joint venture company, SPH-Biocad, has registered capital of $400 million, of which Shanghai Pharmaceuticals invested $200.4 million in cash, providing it with 50.1% of the equity of the joint venture. Biocad contributed $29.94 million in cash, six biomedical products in Greater China, and the permanent and exclusive R&D, production, sales and other commercialization rights of Hong Kong, Macao and Taiwan regions, accounting for 49.9% of the equity of the joint venture company.

Under the agreement, the first six biomedical products include three biosimilar drugs and three innovative biopharmaceuticals. The biosimilar drugs include antineoplastic drugs and rheumatoid arthritis drugs, which have been marketed in Russia, and two of them have been approved for marketing in countries outside of Russia. The innovator biopharmaceuticals are an IL-17 antibody product for psoriasis and ankylosing spondylitis, a PD-1 antibody product, and a GITR (glucocorticoid-induced tumor necrosis factor receptor) antibody product, the first of which was launched in Russia this year (2019).

Biocad has named Shanghai Pharma its exclusive partner in China.

Source: Biocad, Shanghai Pharmaceuticals

India

FDA Cites Aurobindo for Manufacturing Facility in India

Aurobindo Pharma, a Hyderabad, India-based pharmaceutical company, has been cited by the US Food and Drug Administration with seven observations following an inspection of the company’s Unit 7 formulation manufacturing facility in India. The FDA conducted an inspection from September 19-27, 2019.

“We believe none of the observations are related to data integrity,” said the company in an October 7, 2019 notification to the Bombay Stock Exchange. “The Company is confident of addressing these issues within the stipulated timeline.”

Source: Aurobindo Pharma

Glenmark Receives FDA Warning Letter for Manufacturing Facility in Baddi, India

Glenmark Pharmaceuticals, a Mumbai, India-based pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Baddi, Himachal Pradesh, India following an inspection conducted from April 15 to April 19, 2019. The Baddi unit manufactures finished dosage-form products.

The company was earlier informed that the inspection was classified as an “Official Action Indicated” via letter by the FDA, which means regulatory and/or administrative actions will be recommended.

The company says it does not believe that the existing manufacturing and the sale of products from its facility will be impacted. The Baddi facility is expected to contribute $30 million in total sales for this financial year, approximately 7% of total US sales. The company says that there are no major pending approvals from this facility in the next 12 months and that it does not expect there to be a financial impact on the organization on account of this development.

Glenmark says it is committed to work with the FDA to implement all the necessary corrective actions required to address the concerns raised in the letter and is in the process of preparing a detailed response to the FDA.

Glenmark currently has eight manufacturing facilities approved by the FDA: five formulation facilities and three active pharmaceutical ingredient facilities. The company says that none of these facilities, except Baddi, has any outstanding issues with the FDA (as of the October 5, 2019 company notification with the Bombay Stock Exchange).  

Source: Glenmark Pharmaceuticals 

Lupin Receives FDA Warning Letter for Manufacturing Facility in Mandideep, India

Lupin, a Mumbai, India-based pharmaceutical company, has received a US Food and Drug Administration (FDA) Warning Letter for its drug-manufacturing facility in Mandideep, Madhya Pradesh, India, for cGMP violations following an inspection from November 26 to December 4, 2018.

The FDA cited the company for inadequate investigations into out-of-specification (OOS) assay results, insufficient process validation, and an inadequate cleaning process for manufacturing equipment.

The FDA noted that it had cited similar cGMP violations at two other facilities in Lupin’s manufacturing network. On November 6, 2017, the FDA issued a Warning Letter to Lupin’s facilities in Goa and Indore, India. The FDA said that repeated failures over multiple sites reflects that management oversight and control over the manufacture of drugs are inadequate.

Among the actions the FDA is requiring the company to provide are the following: a retrospective, independent review of all invalidated OOS (in-process and finished testing) results for all of its US drug products since July 1, 2016; a trends analysis of its operations and identification of any systemic factors that may be contributing to excessive variation in testing or manufacturing; and a comprehensive and independent assessment of (1) its system for investigating deviations, atypical events, complaints, OOS results, and failures; (2) its current state of control as well as to determine if any process remediation and new validation studies are necessary; and (3) cleaning processes, practices, and validation studies to evaluate the scope of cross-contamination hazards.

Source: Lupin, FDA

United States

Astellas Investing $13 M in US-based Incubators for Biotech Startups

Astellas Pharma has agreed to invest nearly $13 million into two innovation incubators operated by LabCentral, a Cambridge, Massachusetts-based laboratory facility for biotech startups.

Astellas says it will invest $12.5 million to become the only pharmaceutical/biotechnology company among five founding sponsors of a new incubator, which will feature a core lab space where companies can conduct process-development studies and a non-GMP pilot plant, being developed by LabCentral in Cambridge, Massachusetts. The new incubator is expected to be operational in 2021.

Astellas will also invest at least $450,000 over three years to become a Gold Sponsor of LabCentral’s existing incubator, also located in Cambridge, Massachusetts.

Source: Astellas