March 7, 2017
By Mark Terry, BioSpace.com Breaking News Staff
With the end of the 2017 first quarter on the near horizon, speculation is increasing on merger-and-acquisition activity in biopharma. StreetInsider listed eight biopharma companies it thinks are likely targets. Let’s take a look.
Based in Waltham, Mass., Tesaro has been rumored to be the target of an acquisition for a while, but they have warmed up recently. The company was granted Priority Review for its niraparib New Drug Application (NDA) in December by the U.S. Food and Drug Administration (FDA). Niraparib is a PARP inhibitor, a new form of drug treatment. It is being evaluated for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer after response to platinum-based chemotherapy. The PDUFA date is June 30, 2017. It is currently being evaluated in three pivotal trials.
Tesaro is currently trading for $178.20.
Based in Princeton, NJ, Agile Therapeutics is focused on developing new prescription contraception products. Its lead product, Twirla (AG200-15) is a once-weekly prescription contraceptive patch. It also has other transdermal contraceptive products in its pipeline. On January 3, 2017, it announced positive top-line results from its Phase III SECURE clinical trial of Twirla.
Agile is currently trading for $2.14.
Kite Pharma is the leader in CAR-T therapies for cancer treatment. On February 28, 2017, the company reported that its CAR-T candidate axicabtagene ciloleucel (KTE-C19) met the primary endpoints of its Phase III trial. It is being studied in chemorefractory aggressive B-cell non-Hodgkin lymphoma (NHL). There have been three deaths associated with the study. Two were believed to be related to the therapy, one hemophagocytic lymphohistiocytosis and one cardiac arrest. The third, a pulmonary embolism, was determined to be unrelated.
Kite is currently trading for $73.90.
Juno Therapeutics is also a CAR-T company, but it’s been lagging behind Kite. In late January, its stock got jittery over social media rumors of a potential buyout. Prior to July 2016, Juno was the leader in CAR-T, but because of three patient deaths, the FDA placed its Phase II trial of JCAR015 on clinical hold. They were eventually cleared, but the delay pushed its approval back from 2017 to the first half of 2018.
Juno is currently trading for $21.54.
Headquartered in Cambridge, Mass., Acceleron Pharma focuses on rare diseases. Its luspatercept is being studied in Phase III trials for hematologic diseases, myelodysplastic syndromes (MDS) and beta-thalassemia under a global partnership with Celgene (CELG). It also has clinical programs in oncology and neuromuscular diseases, and preclinical work in fibrotic and other serious diseases. On December 22, 2016, it announced it had treated its first patient in a Phase II trial of ACE-083 in facioscapulohumeral muscular dystromphy (FSHD).
Acceleron is currently trading for $28.51.
Based in Victoria, British Columbia, Aurinia Pharmaceuticals announced on March 1 top-line results from its Phase IIb AURA-LV trial in lupus nephritis (LN). At 48 weeks, the trial met endpoints for complete and partial remission.
Aurinia is currently trading for $5.59.
Headquartered in Menlo Park, Calif., Geron Corp has a single, but promising drug, imetelstat (GRN163L). It is a telomerase inhibitor administered by IV infusion. In November 2014, Geron signed an exclusive global license and collaboration deal with Janssen, a subsidiary of Johnson & Johnson (JNJ). This year is an important year for the company. In September 2016, it provided updates on its Phase II trial in intermediate-2 or high-risk myelofibrosis (MF). The company has plans to review more data in the second quarter of this year to determine its path forward. If it makes it to Phase III, it will bring in up to $65 million in milestone payments from J&J. There are additional monies if it makes it further, including $470 million in developmental and regulatory milestones, $350 in sales milestones, and tiered royalties in the double digits. But if the drug fails, everything could tank.
Geron is currently trading for $2.11.
Based in Cambridge, Mass., Genocea Biosciences is focused on vaccines. Its lead candidate is GEN-003, a novel T cell-directed immunotherapy for genital herpes, currently in Phase II trials. It is also working on earlier-stage candidates in immuno-oncology. On January 5, it announced positive clinical data from interim analysis of its placebo-controlled Phase IIb trial of GEN-003. It showed statistically significant improvements versus placebo across multiple clinical endpoints.
Genocea is currently trading for $5.16.
