December 18, 2015
By
Mark Terry
, BioSpace.com Breaking News Staff
London-based
GlaxoSmithKline
announced
today that it had made two separate deals with New York-based
Bristol-Myers Squibb
for two HIV-related assets.
GSK
’s
ViiV Healthcare
, its worldwide HIV business, inked two deals with
Bristol-Myers
. The first, late-stage HIV drug, fostemsavir (BMS-663068), is currently in Phase III clinical trials for patients who have a lengthy treatment history. The compound was given Breakthrough Therapy Designation from the
U.S. Food and Drug Administration (FDA)
. It is expected to be submitted for regulatory approval in 2018.
A second late-stage asset is BMS-955176, a maturation inhibitor. This compound is presently in Phase IIb development for treatment-naïve and treatment experienced patients. A third candidate, BMS-986173, a back-up maturation inhibitor, is also part of the late-stage asset package.
The second deal is for compounds in preclinical and discovery development for HIV. The primary compound in this category is BMS-986197, which has three mechanisms of action: maturation inhibition, an allosteric integrase inhibitor, and a capsid inhibitor.
The deal also allows for some of the
Bristol-Myers Squibb
employees involved in the drug discovery program to transfer to
ViiV Healthcare
.
The late-stage deal includes an upfront payment of $317 million. Additional milestone payments could hit $518 million, and there are tiered royalties on sales.
The preclinical stage deal has an upfront payment of $33 million. Milestone payments could reach $587 million, with additional payments based on sales.
“These acquisitions strengthen our leadership and innovation in HIV, one of our core areas of scientific research at
GSK
,” said
David Redfern
,
GSK
’s chief strategy officer and chairman of
ViiV Healthcare
, in a statement. “The addition of two potential first-in-class late-stage treatments and several promising early clinical development programs strengthens
ViiV Healthcare
’s pipeline and provides us with further new opportunities for growth.”
In June 2015,
Bristol-Myers Squibb
indicated it was shifting its focus away from virus research and concentrating more on immuno-oncology. This sale of HIV assets to
GSK
is consistent with that decision.
“
Bristol-Myers Squibb
has been committed to the HIV community for almost three decades, contributing significantly to the science and to the transformation in the treatment of this disease,” said
Francis Cuss
,
Bristol-Myers Squibb
’s chief scientific officer, in a
statement
. “Given the remaining unmet medical needs in HIV,
Bristol-Myers Squibb
continued its discovery of novel treatment approaches and the agreements with
ViiV Healthcare
now put the development of these potentially first-in-class compounds into the hands of a global specialist company exclusively dedicated to finding new medicines for people living with HIV.”
About 22 percent of
GSK
’s
ViiV Healthcare
is owned by
Pfizer Inc.
and
Shionogi & Co.
According to
BloombergBusiness, in 2014
ViiV
’s earnings alone were worth more than 25 percent of
GSK
’s operating profit.
GSK
had considered spinning off
ViiV
, but abandoned the plan in May after investors indicated they wished
ViiV
to remain as part of the company.
Keyur Parekh
, an analyst with
Goldman Sachs Group Inc.
, wrote in a Friday note, “If successful, the late-stage assets would represent new growth drivers post-2020 as Glaxo’s key HIV products Tivicay and Triumeq mature.”