Shortly after signing a worldwide licensing agreement with
Belgian company Ablynx for an autoimmune disorder candidate,
) has entered into another deal, this time with Galapagos.
The agreement with Galapagos covers the discovery, development
and commercialization of novel potentiator and combination
therapies for cystic fibrosis (CF). Technologies and resources of
both companies will be used for the discovery and
commercialization of oral drugs that will address the main
mutations in CF patients, including F508del and G551D.
AbbVie and Galapagos will aim to identify compounds that
correct defects in expression of (corrector) and/or increase the
activity (potentiator) of the main mutations in the cystic
fibrosis transmembrane regulator (CFTR) protein. The F508del
mutation is most common with 90% prevalence among CF
Financial & Other Details
AbbVie will make an upfront payment of $45 million to
Galapagos initially. On the completion of pre-determined
success milestones, AbbVie and Galapagos will be equally
responsible for phase III development and funding. However,
Galapagos is entitled to receive up to an additional $360 million
on the achievement of development, regulatory and sales
milestones. Galapagos will also receive tiered double-digit
royalties on net sales.
AbbVie and Galapagos are looking to initiate phase I studies
at the end of 2014. Once candidates under this agreement
are approved, AbbVie will handle commercial activities. However,
exclusive rights in China and South Korea and co-promotion rights
in Belgium, the Netherlands, and Luxembourg will be held by
The CF Market
CF is an inherited chronic disease estimated to affect about
70,000 people across the world. Several companies are currently
working on bringing CF treatments to market. Among approved
treatments, most notable is
) Kalydeco, which is available in the U.S., Canada and Europe for
the treatment of CF patients (≥ 6 years) who have the G551D
mutation. Kalydeco is a CFTR potentiator. Vertex Pharma is
currently working on expanding Kalydeco's label and is evaluating
it as a monotherapy, in combination with VX-809 (a CFTR
corrector) and VX-661 (a CFTR corrector).
This is the second collaboration between AbbVie and Galapagos
who already have an agreement for the development of autoimmune
disease candidate, GLP0634, for Crohn's disease and rheumatoid
arthritis. AbbVie, with its expertise and commercial strength,
should make a strong development and commercialization partner
Meanwhile, this deal gives AbbVie a chance to expand and
strengthen its pipeline. However, it will be several years before
a product developed under the AbbVie-Galapagos CF collaboration
reaches the market. Vertex Pharma, with several phase III studies
for CF ongoing, already has a significant head start.
AbbVie currently carries a Zacks Rank #3 (Hold). While we are
positive on AbbVie's strong late-stage pipeline, dividend yield
and growth strategy, we remain concerned about its dependence on
Humira. We believe AbbVie will continue pursuing in-licensing
deals and collaborations to boost its pipeline.
) look well-positioned. While Roche is a Zacks Rank #1 (Strong
Buy) stock, Eli Lilly is a Zacks Rank #2 (Buy) stock.
LILLY ELI & CO (LLY): Free Stock Analysis
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VERTEX PHARM (VRTX): Free Stock Analysis
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