Valeant Pharmaceuticals International has acquired U.S. rights for lymphoma treatments Targretin® (bexarotene) capsules and Targretin gel 1% from Eisai for $65 million up-front, plus additional payments tied to undisclosed milestones, the companies said today.
In addition, Eisai has transferred the New Drug Application for Targretin to Valeant, which agreed in return to oversee all regulatory obligations associated with the product in the U.S. However, Japanese-owned Eisai will retain its rights to Targretin outside the U.S., where it will continue to supply product for its sales subsidiaries and distribution partners.
Approved in 1999, Targretin capsules and gel were developed by Ligand Pharmaceuticals, which sold exclusive worldwide rights to those drugs and two other cancer treatments to Eisai in 2006 for $205 million. Targretin capsules and gel are used to treat the skin problems arising from cutaneous T-cell lymphoma (CTCL) when at least one systemic therapy has not worked. Targretin gel is also indicated for patients unable to tolerate other therapies.
But an effort to expand the indication for the Targretin drugs met last year with negative publicity: Two studies in the New England Journal of Medicine warned the families of Alzheimer’s patients not to use the drugs off-label for the disease despite an earlier study from Case Western Reserve University showing that the drug rapidly cleared beta-amyloid from the brains of mice. Even if families of patients wanted to use Targretin off-label for Alzheimer’s, they may have been deterred by the reluctance of insurers to cover off-label use—no small issue given the drug’s reported annual cost of about $14,000.
“Eisai believes that this divestiture agreement with Valeant, a pharmaceutical company with strengths in dermatology, will lead to maximization of the agent’s product and patient value in the United States,” the company said in its own statement on the deal. “In addition, the agreement will enable Eisai to strategically reallocate resources to other mid-to-long-term business growth areas.”
Over the past two years, Eisai has coped with the loss of patent protection for the Alzheimer's disease drug Aricept in the U.S. and Europe. Aricept sales plunged by about half during FY 2011 to ¥147.1 billion (about $1.6 billion) from ¥290.4 billion ($3.1 billion).
In response, Eisai has shifted to Japan the commercialization focus of Aricept and proton pump inhibitor Pariet (AcipHex), whose FY 2011 sales fell 7.7% from the previous year, to ¥126.4 billion (about $1.4 billion) from ¥136.9 billion (about $1.5 billion). Eisai granted exclusive rights to Minophagen Pharmaceutical to develop and commercialize Targretin in Japan in March 2011. Minophagen’s development and commercialization rights expanded in April 2012 to regions that include Asia, Oceania, the Middle East, and Eastern Europe.
Eisai also expanded its oncology offerings by focusing on anticancer agent Halaven, discovered and developed in-house; and developed the epilepsy drug E2007 (perampanel). Eisai’s oncology products collectively racked up ¥93.1 billion (about $998.7 million) in FY 2011, up nearly 16% from ¥80.3 billion ($861.3 million) in FY 2010.
Those and other moves followed Eisai’s implementation of its mid-term strategic plan “HAYABUSA,” under which Eisai also committed to entering all of the world's 20 largest pharmaceuticals markets, including emerging countries, and supply its products to more than 500 million patients.
The sale of Targretin rights was Eisai’s second divestment snice December, when it sold U.S. rights to its antineoplastic agent Gliadel® Wafer (carmustine intracranial implant wafer) to Arbor Pharmaceuticals.
“In emerging and developing countries, we will carry out the provision of products at affordable prices that match the actual social, economic, and healthcare environments in each country, build partnerships with governments, international organizations, and implement other initiatives,” Haruo Naito, Eisai’s president (representative corporate officer) and CEO said in a May 2012 message posted on the company’s website.