Takeda kicks off trial for Zika vaccine
Takeda Pharmaceutical is testing its Zika virus vaccine candidate, TAK-426, in a Phase 1 clinical trial. The Osaka, Japan-based company’s first trial for the vaccine comes 15 months after the Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, awarded it a contract to develop it.
“We are pleased to reach this important milestone, which reflects our commitment to addressing the Zika threat, as well as the significant capabilities of Takeda’s global organization,” Takeda global vaccine business unit president Rajeev Venkayya said. “This progress could not have been possible without the ongoing support of, and collaboration with, BARDA.”
The World Health Organization notes that the virus has spread to more than 84 countries, territories or subnational areas, including the United States. Takeda said that initial data from the trial are expected in 2018, with the aim of beginning Phase 2 studies as soon as possible after if the data supports it.
Takeda said that in addition to its work on the Zika vaccine, it is undertaking vaccine programs to address such illnesses as dengue, norovirus and polio.
Teva restructures, shuffles executive team
On the heels of its appointing a new CEO, Teva is restructuring itself and naming new executives in an effort it said would create strategic alignment across its portfolio, regions and functions and drive profits as it continues to face headwinds.
“Teva is taking decisive and immediate action to address external pressures and internal inefficiencies,” Teva president and CEO Kåre Schultz said. “Our new company structure will enable stronger alignment and integration between R&D, operations and the commercial regions, allowing us to become a more agile, lean and profitable company.”
Under the new structure, the global generics and specialty medicines groups will be integrated into a single commercial organization covering North America, Europe and growth markets. Each region will manage the entire portfolio from OTC to specialty and generic pharmaceuticals. Generic and specialty R&D wings also will be combined into a single global group responsible for all R&D across generics, specialty and biologics. The company also will have a newly formed Marketing and Portfolio function, which will oversee communication between regions, R&D and operations for all products. Teva said the new organizational structure would rely on a leaner infrastructure in its finance, legal, HR and global brand and communications
Along with the new organization, Teva has created a new executive team. The company has named interim CFO Mike McClellan as its executive vice president and CFO, named Hafrun Fridriksdottir — most recently chief commercial officer for global specialty medicine — executive vice president of North America commercial. The company’s European generics president and CEO Richard Daniell is now executive vice president of European commercial and Gianfranco Nazzi will move to the executive vice president of growth markets commercial position from his role as presient and CEO of Teva’s generic group’s growth markets division. Addtionally, Sven Dethlegs is now executive vice president of global marketing and portfolio, having most recently been global head of respiratory medicines and COO of Teva Global Operations.
“The new management team will position Teva for turnaround in the short to medium term. We are already working on a detailed restructuring plan for Teva and will share it in mid-December,” Schultz said. “It remains our absolute priority to stabilize the company’s operating profit and cash flow in order to improve our financial situation, while being focused on short-term revenue and cash generation, and at the same time, ensure we deliver on our commitment to supply high-quality medicines to patients around the world.”
With the structural changes, Michael Hayden, Rob Koremans and Dipankar Bhattacharjee will retire, effective Dec. 31.
Upsher-Smith relaunches Klor-Con powder
Upsher-Smith, the Maple Grove, Minn.-based subsidiary of Japan’s Sawai Pharmaceuticals, has re-introduced its Klor-Con (potassium chloride for oral solution). The company received approval from the Food and Drug Administration for the product that joins its generics portfolio. The company noted that the relaunched product would be available with a new NDC number.
The product has a U.S. market size of $98 million for the 12 months ended September 2017, according to data from IQVIA.
‘The past six months have been particularly exciting for Upsher-Smith as we have transitioned from a privately-owned company to an integral part of the Sawai Group, a globally driven, publicly traded Japanese Company," Upsher-Smith president and CEO Rusty Field said. “The ANDA approval of KLOR-CON® Powder along with other recent ANDA approvals demonstrate our commitment to expanding our portfolio of quality, high-value generic products.”