Schering/Zonagen end Vasomax agreement
Executive Summary
Schering-Plough and Zonagen mutually terminate worldwide licensing agreement for experimental oral erectile dysfunction therapy Vasomax and other phentolamine-based technologies, Zonagen announces July 15. The decision coincides with the submission of final results from a one-year mechanistic study of phentolamine-induced brown fat proliferations in rats, which Zonegan maintains show no effect. The study was designed to allay FDA's concerns raised by an earlier two-year rat carcinogenicity trial; FDA deemed Vasomax "not approvable" in May 1999 and subsequently placed the drug on clinical hold (1"The Pink Sheet" Aug. 16, 1999, p. 32)...
You may also be interested in...
Zonagen/Schering-Plough Vasomax
FDA places hold on clinical trials of Vasomax (phentolamine) pending analysis of data from a two-year rat carcinogenicity study, expected to be completed in the fourth quarter. Preliminary findings show a high proliferation of "brown fat" in the rats. A fully enrolled, 12-week Schering study of Vasomax for erectile dysfunction has been permitted to continue. Another proposed 12-week Schering study and a Zonagen Phase II trial of phentolamine for female sexual dysfunction are being placed on hold. The companies anticipate the hold will cause a six-month delay in regulatory filing
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.