Global Briefs: Camurus, Merck & Telix
A roundup of news from Camurus, Merck & Co./Modifi Biosciences and Telix. Highlights below.
Mfg News
* Camurus Receives FDA Complete Response Letter for Contract Mfg Issue
M&A News
* Merck Acquires Modifi Biosciences for $30 M Upfront in $1.3-Bn Deal
General
* Telix Spins off New Radiopharmaceutical Company, Rhine Pharma
Mfg News
Camurus Receives FDA Complete Response Letter for Contract Mfg Issue
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) over manufacturing issues with a third-party manufacturer to Camurus, a Lund, Sweden-based bio/pharmaceutical company, for its new drug application (NDA) for CAM2029 (octreotide), an extended-release injection for treating acromegaly.
The CRL is attributed to facility-related deficiencies identified during a cGMP inspection of a third-party manufacturer completed in September 2024. FDA has communicated that its determination of responses from the facility as satisfactory is needed for a timely resolution of the CRL and approval of the NDA. The CRL did not state any other concerns, including related to clinical efficacy or safety of CAM2029, according to the company.
Source: Camurus
M&A News
Merck & Co. Acquires Modifi Biosciences for $30 M Upfront in a $1.3-Bn Deal
Merck & Co. has acquired Modifi Biosciences, a New Haven, Connecticut-based bio/pharmaceutical company in a deal worth up to $1.3 billion ($30 million upfront and $1.3 billion in milestone payments).
Modifi Biosciences, a Yale University spinout company formed in 2021, is focused on developing direct DNA modification enabled cancer therapeutics. The company has developed a class of small molecules that target cancer cells lacking expression of a key DNA repair protein called O6-methylguanine methyl transferase (MGMT).
Under the agreement, Merck, through a subsidiary, acquired all outstanding shares of Modifi Biosciences for $30 million upfront. Modifi Biosciences shareholders are also eligible to receive potential milestone payments totaling up to $1.3 billion.
Source: Modifi Biosciences
General
Telix Spins off New Radiopharmaceutical Company, Rhine Pharma
Telix Pharmaceuticals, a Melbourne, Australia-based bio/pharmaceutical company, has announced the spin-off of Rhine Pharma, a radiopharmaceutical company.
Rhine Pharma was formed following a collaboration between Telix and Heidelberg University Hospital (UKHD), which created a theranostic compound, RHN0014, which Rhine Pharma is now advancing into a Phase I/IIa theranostic clinical study to evaluate the safety profile and efficacy of both 99mTc-RHN001 and 188Re-RHN001 for treating advanced prostate cancer.
Source: Telix Pharmaceuticals
