Baxalta: Baxter's newly named biopharma spinout has had its ups and downs

First there was AbbVie ($ABBV), the new biopharma company created by the big Abbott ($ABT) split. And now comes Baxalta, the new moniker for Baxter's ($BAX) drug spinoff, which is reportedly plotting a big move to the Boston/Cambridge hub.

Once in business on its own next year, Baxalta will have sales of $6 billion, trade under the symbol $BXLT and push a pipeline strategy concentrated heavily on bleeding disorders, particularly hemophilia. Last year the total R&D budget at the company hit $1.25 billion, a substantial amount but not close to the top 10 pharma R&D budgets in the industry. John Orloff, a biopharma vet who recently migrated from a troubled Merck Serono R&D group--where he was head of clinical development--is heading up the R&D side of the business under CEO Ludwig Hantson.

John Orloff

Baxter hasn't done a very good job of detailing its R&D strategy in biopharma, or what comes next after the split. The company didn't respond to a query from FierceBiotech. But recent events offer plenty of clues about Baxalta's direction, whether it stays put in Deerfield, IL or heads to the Boston hub, joining a mass migration of biopharma R&D into Massachusetts.

Just a few weeks ago Baxter's R&D group heralded a successful late-stage study for BAX 855, one of several long-acting hemophilia drugs that are now in or close to the market. In Europe, regulators require a pediatric study ahead of an approval, so that will delay things there. There's a factor VIIa program in late-stage studies as well and an early-stage gene therapy program underway--a hot topic in the growing gene therapy business. Baxter bought out Chatham Therapeutics last spring for $70 million to get full control of their gene therapy effort. And last April BAX 111 hit its primary endpoint in a Phase III study for von Willebrand disease, an inherited bleeding disorder.

In a follow-up to a 2012 rejection, Baxter came back and won a recent FDA panel vote--by 15-1--on HyQvia. The combo pill matches Baxter's human immunoglobulin and Halozyme's recombinant human hyaluronidase and will be used to counter disorders that weaken the immune system.

Baxter made a $60 million upfront investment in Cell Therapeutics ($CTIC) late last year to gain a stake in pacritinib, the toubled biotech's newest drug hopeful targeted at myelofibrosis. And Baxter has been busy in the biosimilars field as well. The biosimilars startup Coherus Biosciences inked a $246 million deal last fall to develop a knockoff of Amgen's blockbuster Enbrel for Baxter. And close to 4 years ago Baxter agreed to pay Momenta Pharmaceuticals $33 million in cash and potentially more than $419 million in milestone payments and other fees for a separate biosimilars development pact. Last fall, though, Baxter dropped one of the three programs--the cancer drug M511--under development in the deal.

Baxter has had setbacks along the way, perhaps most noticeably in Alzheimer's. Back in the spring of 2013 Gammagard joined the long lineup of Alzheimer's drugs that had failed in late-stage studies, falling well short of success in patients with a mild to moderate case of Alzheimer's.

Baxter committed $565 million to a deal (with $50 million of that paid upfront) with Onconova on rigosertib, but early this year a late-stage study of the drug for high-risk myelodysplastic syndromes failed to achieve a statistically significant improvement in overall survival compared to standard supportive care. Baxter also invested in Regado, a biotech which pushed an anticoagulant into Phase III, only to scrap the study recently due to safety issues. 

Not long after AbbVie split away from Abbott, the executive team executed some big development deals, most recently nabbing a deal to buy out Shire and absorb its rare drug division. Baxalta may not have such grand ambitions, but a split like this can herald a spike in deal activities as the new company tries to make a name for itself. -- John Carroll, editor-in-chief. (email | Twitter)

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