GSK plans $100M makeover of US manufacturing site; La Jolla Pharma gets a 'breakthrough' with late-stage drug
→ GSK $GSK announced today that it will be investing $100 million into its facility in Hamilton, MT to expand long-term vaccine manufacturing capabilities. The expansion will boost production capacity of key components of the adjuvant system used in several of its vaccines and foster new jobs, including temporary construction and various permanent positions like scientists, engineers and manufacturing and quality professionals.
“For more than a decade, our Hamilton facility has supported GSK’s adjuvant system development program,” said Jack Bailey, president of US Pharmaceuticals, GSK. “By expanding the adjuvant system production capabilities in Hamilton, we will continue to deliver long-term and sustainable supply for key vaccines, including Shingrix.”
→ The FDA gave the green light to La Jolla Pharmaceutical Company $LJPC today for its breakthrough therapy designation for the new investigational drug product, LJPC-0118, for the treatment of severe malaria.
“We are committed to the rapid development of LJPC-0118 to help patients suffering from severe malaria, a serious and life-threatening disease without a current FDA-approved therapy. We are very pleased to receive the Breakthrough Therapy designation from the FDA and are committed to providing LJPC-0118 to patients in the US,” said George Tidmarsh, La Jolla’s president and CEO.
La Jolla plans to file an NDA with the FDA in the fourth quarter of 2019. In two randomized, controlled, clinical studies, LJPC-0118 was shown to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection.
→ The University of Illinois at Chicago and Deerfield Management announced today the establishment of West Loop Innovations, which will help accelerate the commercialization for therapeutics developed at UIC. Deerfield will provide up to $65 million in translational research funding and commercialization expertise to advance promising UIC discoveries.
“One of our core competencies at UIC is drug discovery,” said TJ Augustine, interim vice chancellor for innovation at UIC. “We have three major drugs in the marketplace, placing UIC among a very small number of research universities. Our new partnership with Deerfield not only adds significant translational research funding, but also brings critical support for the startup companies that will take UIC’s discoveries and turn them into products.”
→ Sources told Reuters that BlackRock $BLK, Bayer’s $BAYRY largest shareholder, will not support the company’s management in a key vote at its AGM on Friday. BlackRock, which owns 7.2% of Bayer’s voting rights, plans to either abstain from or vote against ratifying the management board’s actions during the year under review, the sources said.
“This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalized CAR T and TCR cell therapies for people with cancer. As we advance our industry-leading cell therapy pipeline and seek to help a growing number of people with cancer, expanding and investing in our manufacturing capabilities is essential,” said Tim Moore, executive vice president of technical operations at Kite. “With the Frederick County site, we will have the opportunity to build and design the facility tailored to our own innovative processes and with state-of-the-art features that will enable us to meet the future needs for cell therapies.”