Global Pharma Briefs: News from Asia, Europe, and the US
A roundup of news from Denmark (Lundbeck), Japan (Takeda), and the US (UCB).
Lundbeck to Cut R&D Staff
H. Lundbeck A/S, a Valby, Denmark biopharmaceutical company, is reorganizing its R&D-organization that may result in cut staff cuts of 130-160 positions globally.
The plan follows Lundbeck’s Expand and Invest to Grow-strategy of expanding the company’s operating space and rebuilding its pipeline of potential new medicines to treat brain disorders. Key elements include focusing Lundbeck’s R&D efforts where the science is most promising and on biological platforms were Lundbeck can have expertise. Lundbeck will also use new technologies and build in the neuroscience landscape.
If the changes are carried through, it may lead to a reduction of 130-160 positions globally, including approximately 100 in Denmark. Lundbeck says it has informed the company’s Works Council and its European Works Council about the restructuring plans.
Takeda Released from Divesting Shire’s Pipeline Compound
Takeda has been released from divesting the pipeline compound, SHP647, for treating inflammatory bowel disease and related diseases, and certain associated rights by the European Commission (EC), a commitment that was provided by Takeda to secure regulatory clearance of its $62-billion acquisition of Shire, a deal that was completed in January 2019
Takeda says it will no longer develop the SHP647 compound in any inflammatory bowel disease indication, including ulcerative colitis or Crohn’s disease. The SHP647 clinical trial program will be discontinued over the coming months (as reported on May 29, 2020). New patient enrollment into the study protocols was already stopped in late March (March 2020) due to the risks associated with the COVID-19 pandemic. The trials will be unblinded and not restarted.
In addition, Takeda says it will make SHP647 clinical trial data and biosamples available to the scientific community through the Crohn’s & Colitis Foundation, via the IBD Plexus platform, a research information exchange platform and biobank that centralizes data and biosamples from diverse research studies, subject to applicable local regulations and ethical considerations.
Takeda announced on November 20, 2018, that the EC approved its proposed $62-billion acquisition of Shire conditioned on Takeda fulfilling commitments provided to the EC in connection with the regulatory clearance surrounding future potential overlap in the area of inflammatory bowel diseases between Takeda’s marketed product Entyvio (vedolizumab) and Shire’s pipeline compound SHP647. The divestment of SHP647 was not a condition to the completion of the acquisition, which became effective on January 8, 2019.
Takeda engaged in two formal sale processes spanning 14-months to identify and engage with potential purchasers of SHP647. The first sales process was conducted by Takeda and the second by an independent divestiture trustee, which was appointed under the standard procedure provided for in Takeda’s commitments to the EC. The company says Takeda and the divestiture trustee each engaged with more than 60 potential purchasers, but the sale process was unsuccessful.
UCB Acquires Engage Therapeutics for $125 M
UCB has acquired Engage Therapeutics, a Summit, New Jersey-based clinical-stage pharmaceutical company, for $125 million (subject to certain adjustments), and up to $145 million in further potential milestone payments related to clinical development, submission and launch of Staccato (alprazolam) a treatment for epileptic seizures.
Staccato is an investigational drug (Phase II) designed to be used as a single-use epileptic seizure rescue therapy that combines the Staccato delivery technology with alprazolam, a benzodiazepine. It is a small, hand-held inhaler device designed for easy delivery of alprazolam with a single normal breath potentially providing a way for people with epilepsy and their caregivers to stop an active seizure. The Staccato system vaporizes alprazolam to form an aerosol, with particle size designed for deep lung delivery to produce a rapid, systemic effect.
Engage Therapeutics acquired worldwide rights to Staccato in 2017 under a license agreement with Alexza Pharmaceuticals, a Mountain View, California-based pharmaceutical company focused on acute treatments for central nervous system conditions. In connection with the acquisition, UCB has also entered into an updated license and related commercial supply agreement with Alexza, under which the parties will continue to collaborate in the development and commercialization of Staccato.