The Swiss pharmaceutical company Roche and its partner MorphoSys can hope for an early approval of an Alzheimer’s drug candidate in the USA.
Gantenerumab received the status of a therapy breakthrough, as Roche announced on Friday evening. Gantenerumab is an IgG1 antibody under development by MorphoSys. This is supposed to remove certain deposits in the brain, which are a feature of Alzheimer’s disease, as the German biotech company announced on Monday. Should Roche be able to bring the product onto the market, MorphoSys will share in the sales success. The shares of the SDAX company, which had been badly shaken for a long time, rose by almost 9 percent on the Monday after the start of trading.
The FDA’s Breakthrough Therapy Designation is designed to accelerate the development and approval process of drugs for serious or life-threatening diseases that preliminary data suggest could represent a significant improvement over existing therapies.
Under the license agreement, according to MorphoSys, Roche is fully responsible for the clinical development and possible commercialization of gantenerumab. MorphoSys is entitled to staggered royalties between 5.5 and 7.0 percent of net sales with gantenerumab as well as potential performance-related, regulatory milestone payments. MorphoSys withholds 40 percent of future royalties on gantenerumab, as regulated in the financing partnership between MorphoSys and Royalty Pharma.
The granting of status was based on previously published study data, Roche had already announced on Friday evening. The results of two pivotal studies with gantenerumab are now expected to be completed in the second half of 2022.
Alzheimer’s is a progressive, fatal brain disease characterized by decreased memory, language, and other thinking skills, and changes in mood and behavior.
At the beginning of June, the US drug authority FDA approved a new drug against Alzheimer’s disease for the first time in almost 20 years: Aducanumab from the US company Biogen. In doing so, the FDA ignored warnings from independent consultants.
The MorphoSys share was strong on Monday, gaining 0.70 percent at times on XETRA to EUR 38.80. For Roche profit-sharing certificates, the Swiss stock exchange is temporarily up by 0.42 percent to 362.10 francs.