Drug pricing pressures, regulatory uncertainty and sizeable financings opportunities all may have contributed to an M&A slowdown in 2017 that left the biopharmaceutical industry with the lowest value of completed deals in four years and the lowest number of deals in three.
January set a new record for biopharmaceutical public financings tracked over the last 18 years, with a more than 20 percent increase in the value of follow-on offerings over the second highest January three years ago.
Last year, there were 1,015 biopharmaceutical deals recorded by Cortellis Deals Intelligence, with projected values at signing of $80.89 billion. This total represented a slight 3 percent drop on the deal totals calculated in 2016, and a 24 percent decline over 2015, despite the fact that the deal volume was 24 percent and 12 percent higher than the 2016 and 2015 volumes, respectively.
If ever a statement was made, it was made in 2017 by the FDA with a record number of approvals that dwarfed last year's numbers in every aspect. The most dramatic change was seen through a doubling of the new molecular entities (NMEs) approved, as well as a 37 percent increase in orphan drug approvals. BioWorld reported on the approval of 46 NMEs, in contrast with 2016's 22 NMEs approved. (See BioWorld Insight, Jan. 2, 2017.)
Although the number of complete response letters (CRLs) issued by the FDA to biopharmaceutical companies in 2017 dipped by 23 percent compared to the prior year, extensive planning and robust studies once again offered no foolproof promise of commercial glory.
Although the number of complete response letters (CRLs) issued by the FDA to biopharmaceutical companies in 2017 dipped by 23 percent compared to the prior year, extensive planning and robust studies once again offered no foolproof promise of commercial glory.
PHILADELPHIA – A growing number of therapeutics, upon showing signs of early efficacy, are moving directly into seamless registration trials, replacing the age-old phase I, II and III continuum, speeding the time to approval and potentially reaching ill patients faster.
PHILADELPHIA – Understanding the evolution of cancer and discovering the most specific, immunogenic targets are crucial prerequisites for the discovery of effective therapeutics, especially when tumors continually evade immune surveillance.
PHILADELPHIA – More than a quarter of brain cancer patients participating in a phase I gene therapy trial survived at least three years after treatment, prompting Tocagen Inc. to move directly into a seamless, pivotal trial following the FDA's granting of a breakthrough therapy designation earlier this year.
Shares of Celgene Corp. tanked on Thursday following the company's release of third-quarter financials, which included a slow growth for arthritis/psoriasis drug Otezla (apremilast) and lowered long-term targets. Meanwhile, Amgen Inc. reported $67 million in pre-tax expenses due to Hurricane Maria's toll on the company's Puerto Rico-based manufacturing facility. It also dropped development of its oral cholesterol ester transfer protein (CETP) inhibitor, resulting in a $116 million charge.
