Global Pharma Briefs: News from Asia, Australia, Europe, and the USBy
A roundup of developments from Australia (CSL), Germany (Bayer), India (Lupin, Wockhardt), and the US (GE).
CSL Partners with University of Queensland to Develop Coronavirus Vaccine
CSL, a biotechnology company for vaccines and medicines to treat hemophilia and immune deficiencies, has partnered with Australia’s University of Queensland’s development program for a coronavirus vaccine. CSL will provide technical expertise as well as a donation of CSL’s Seqirus’ proprietary adjuvant technology, MF59, to the university’s preclinical development program.
Adjuvants are used in vaccines to create a stronger immune response and to speed vaccine production and output. Seqirus’ adjuvant technology has been used in seasonal and pandemic influenza vaccines. The University of Queensland will use the adjuvant to test the viral protein it is developing with its molecular clamp technology.
In parallel with this initiative, CSL is monitoring the safety and security of its employees in Wuhan, China. where the outbreak of COVID-19 first occurred, as well as its 600 employees in China. CSL has also committed a donation of RMB 1 million ($143,433) to the China Red Cross in support of efforts to combat the epidemic.
Bayer and Nuvisan To Create New Research Unit in Berlin
Bayer has entered into a definitive agreement to transfer a large part of its Berlin, Germany-based small-molecule research unit to Nuvisan, a service provider for clinical studies, laboratory services and contract manufacturing with several sites and clinics in Germany and France. The strategic partnership will lay the foundation for a brand-new research entity to be established by Nuvisan in Berlin, according to Bayer.
The Berlin-based research unit with around 400 workplaces comprises a team specialized in small-molecule research. The research center comes with capabilities and capacities spanning the drug-discovery value chain, including lead discovery, medicinal chemistry, pharmacology, drug metabolism and pharmacokinetics, investigational toxicology, and animal management. Bayer will retain research activities in Berlin, which remains the headquarters for the company’s Pharmaceuticals Division and one of its global research sites.
Bayer and Nuvisan say they will cooperate closely in the coming years to build the new research center. The transaction is expected to close mid-2020, subject to successful completion of the consultation process with the employee representatives and the preparations for taking over the research activities. Financial terms were not disclosed.
Lupin Receives Form 438 from FDA for its Mfg Facility
Lupin, a Mumbai, India-based pharmaceutical company, has received a Form 483 from the US Food and Drug Administration (FDA) with two observations following an inspection of its Pithampur, India (Unit-I) manufacturing facility. The inspection was carried out between February 3, 2020 and February 11, 2020.
Lupin has 15 manufacturing sites, seven research centers, and more than 20,000 employees globally.
India’s Wockhardt To Sell Its Mfg Plant to Dr Reddy’s for $260 M
Wockhardt, a Mumbai, India-based pharmaceutical company, is divesting part of its domestic branded business to Dr. Reddy’s Laboratories for INR 1,850 crore ($260 million). The divestment includes 62 products and related business, assets and liabilities, including a manufacturing facility in Baddi, Himachal Pradesh, India.
The company is divesting 62 products and line extensions, along with related business assets and liabilities, contracts, permits, intellectual properties, employees, marketing, sales and distribution in its Domestic Branded Division in India, Nepal, Bhutan,Sri Lanka and Maldives.
The business being transferred reported operational revenue of INR 377 crore ($52.9 million), which is 15% of the consolidated revenue for the nine months ending December 31, 2019.
The divestment is expected to be completed in May 2020, subject to shareholders’ and lenders’ approvals and other requisite approvals under applicable law. Wockhardt’s Board of Directors has approved the transaction.
After the divestment, Wockhardt will continue to own all its international operations in the UK, the US, Ireland and other locations through its step-down subsidiaries. It will own its formulation plants in the following: Waluj, Shendra and Chikalthana in Aurangabad; and Bhimpore and Kadaiya in Daman. It will also own its bulk drugs plant in Ankleshwar, India and manufacturing facilities at all existing international locations. It will own research and development centers in Chikalthana, Aurangabad, India and existing facilities in international locations. It will own a significant part of domestic branded business constituting chronic and specialty portfolios.
GE’s Vineti Completes $35 M Financing for Personalized Therapeutics
Vineti, a digital platform for personalized therapeutics co-founded by GE and the Mayo Clinic, has completed a $35-million Series C investment to support further enhancement of the company’s automation and analytics offering, new software product development, and global commercial expansion. The financing is led by Cardinal Health, with participation from Novartis Pharma AG and Kite, a Gilead company, as well as existing Vineti investors (Canaan Partners, Threshold Ventures [formerly DFJ], Section 32, LifeForce Capital, Casdin Capital, and Hive Ventures) along with other undisclosed entities.
A representative of Cardinal Health will join Vineti’s Board of Directors, and representatives of Novartis and Kite will join as board observers. The new capital will be used to further expand Vineti’s platform into other high-value, high-complexity therapeutic supply chains. The funding will also support Vineti’s continued expansion in Europe and Asia-Pacific to provide a global solution to industrialize personalized therapies in clinical development to the commercial stage.