SAN DIEGO and OSAKA, Japan, Sept. 2 /PRNewswire-FirstCall/ —
Orexigen® Therapeutics, Inc. (Nasdaq:
OREX) and Takeda Pharmaceutical Company Limited (TSE: 4502),
today announced that they have entered into an exclusive
partnership to develop and commercialize Contrave® (naltrexone
SR/bupropion SR), Orexigen’s investigational drug for the treatment
of obesity, in the United States, Canada and Mexico.
Contrave is a combination therapy believed to address both
biological and behavioral drivers of obesity. The central pathways
targeted by this treatment are involved in controlling the balance
of food intake and metabolism, and regulating reward-based eating
behavior. Orexigen submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for Contrave on March
31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date
has been set for January 31, 2011.
Under the terms of the agreement, Orexigen will receive an
upfront cash payment of $50 million from Takeda, and Takeda will
obtain an exclusive marketing right from Orexigen in the United
States, Mexico and Canada while Orexigen retains the right to
co-promote with Takeda in the United States. Orexigen will be
eligible to receive payments of over $1 billion upon achieving
certain regulatory and sales-based milestones. Assuming Contrave is
commercialized, Takeda will pay tiered double-digit royalty
payments on net sales in the Territory.
Under the terms of the agreement, Orexigen and Takeda will work
together on ongoing development of the product, with Orexigen
leading pre-approval activities, and Takeda leading post-approval
activities. The parties will share in the costs of any future
development of the product.
“Takeda is an ideal partner for Contrave given its proven track
record in commercializing innovative medicines and its commitment
to the treatment of