Merck & Co. Inc. has strengthened its cardiopulmonary pipeline with its $10 billion acquisition of London-based-Verona Pharma plc. The deal brings Merck Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease. The maintenance drug is the first inhaled nonsteroidal therapy for a respiratory disease combining a bronchodilator and anti-inflammatory mechanism into one molecule. Ohtuvayre is in clinical trials for non-cystic fibrosis bronchiectasis. Verona’s stock (NASDAQ:VRNA) had swelled 20% at midday, with shares going for $104.80 each. The deal is the second largest of the year, with Johnson & Johnson’s $14.6 billion acquisition of Intra-Cellular Therapies Inc. at the head of the line.
Rhythm scores in phase II with obesity prospect bivamelagon
Shares of Boston-based Rhythm Pharmaceuticals Inc. (NASDAQ: RYTM) were trading at $83.22, up $18.08, or 27%, on positive top-line results from its phase III trial testing bivamelagon (formerly LB5-4640), an oral melanocortin-4 receptor agonist, in patients with acquired hypothalamic obesity. Bivamelagon gained statistically significant and clinically meaningful reductions in body mass index (BMI) at 14 weeks of treatment, consistent with BMI reductions won with Rhythm’s same-mechanism Imcivree (setmelanotide) in similar patient populations. Rhythm in-licensed bivamelagon from LG Chem Ltd. in January 2024. Imcivree gained its first U.S. FDA approval for weight management in late November 2020.
Optimism prevails despite talk of 200% biopharma tariff
The U.S. Commerce Department isn't expected to complete its section 232 investigation to build a national security case for imposing tariffs on biopharmaceuticals until the end of the month, but that didn’t stop President Donald Trump from once again teasing a “very high” tariff for medicines and their ingredients. “We’re going to give people about a year, year and a half to come in, and after that they’re gonna be tariffed if they have to bring the pharmaceuticals into the country at a very high rate, like 200%,” Trump said yesterday. Although that’s far higher than the 25% biopharma tariff Trump first proposed, the Street appears to be cautiously optimistic. ”We think this announcement is positive for the biopharma sector, because tariffs will not be implemented immediately … and it is unclear if the administration will follow through in the future,” Leerink Partners LLP analyst David Risinger wrote.
Actithera raises $75M series A for FAP-targeted radiopharmaceuticals
Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP). FAP is recognized as an important radiopharmaceutical target, being highly overexpressed in cancer associated fibroblasts in the stroma of many solid tumors, while having limited expression in healthy cells.
JCR’s third deal with Alexion gives rights to AAV capsids
Under a new licensing deal announced July 8, JCR Pharmaceuticals Co. Ltd. granted Alexion Pharmaceuticals Inc. rights to its adeno-associated virus (AAV) capsids for use in up to five of Alexion’s genomic medicines programs. If Alexion, Astrazeneca plc’s rare disease arm, exercises rights to all five targets, JCR could receive an aggregate of $825 million in milestone payments, including up to $225 million in R&D milestones and up to $600 million in commercial milestones. Hyogo, Japan-based JCR will also receive an undisclosed up-front payment from Boston-based Alexion, along with potential tiered royalties on net sales if products are successfully commercialized.
More Chinese ADCs enter the clinic as biotech race heats up
China has proved to be a fertile ground for innovation as evidenced by some big deals in the antibody-drug conjugate (ADC) space, and the number of candidates entering clinical trials in China or being advanced in the U.S. by Chinese companies. As previously reported by BioWorld, the U.S. National Security Commission on Emerging Biotechnology is urging Congress to reinvest in American biotechnology because “the U.S. is dangerously close to falling behind China,” according to a May 8 report.
HELP sends CDC nominee on her way to Senate vote
With today’s U.S. Senate Health, Education, Labor and Pensions (HELP) Committee party-line vote of 12-11, Susan Monarez’s nomination is headed to the Senate floor where she could become the first CDC director to go through the confirmation process. That’s thanks to a provision in the bipartisan PREVENT Pandemics Act that was signed into law in 2022. The no votes in the committee weren’t so much against Monarez, who served in the Biden administration as deputy director of the nascent Advanced Research Projects Agency for Health, or ARPA-H, as they were against Health and Human Services Secretary Robert Kennedy and his actions undermining vaccine confidence.
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