pour rappel, extraits du rapport annuel 2012:
Commercialization
COMETRIQ became commercially available in the United States in January 2013 and is being marketed in
the United States principally through a small commercial team with relevant expertise in the promotion,
distribution and reimbursement of niche oncology drugs. We have also fielded a small, outsourced specialty sales
force whose responsibility is to promote COMETRIQ for its approved indication to customers. The wholesale
acquisition cost of COMETRIQ has been set at $9,900 for a 28-day supply. COMETRIQ has been flat priced,
meaning each dosage strength will be priced the same. We currently estimate that there are between 500 and 700
first and second line metastatic MTC patients in the United States each year who will be eligible for
COMETRIQ.
We have scaled our commercial organization so that it is commensurate with the size of the market
opportunity for progressive, metastatic MTC. We have also designed our commercial organization to maintain
the maximum amount of flexibility, and to enable us to quickly scale up if additional indications are approved in
the future. We believe we have created an efficient commercial organization, taking advantage of outsourcing
options where prudent to maximize the effectiveness of our commercial expenditures.
To help ensure that all eligible progressive, metastatic MTC patients have appropriate access to
COMETRIQ, we have established a comprehensive reimbursement and support program called Exelixis Access
Services. Through Exelixis Access Services, we intend: to provide co-pay assistance to qualified, commercially
insured patients to help minimize out-of-pocket costs; to provide free drug to uninsured patients who meet certain
clinical and financial criteria; and to make contributions to independent co-pay assistance charities to help
patients who dont qualify for our co-pay assistance program. In addition, Exelixis Access Services is designed to
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provide comprehensive reimbursement support services, such as prior authorization support, benefits
investigation, and if needed, appeals support.
COMETRIQ is distributed in the United States exclusively through Diplomat Specialty Pharmacy, an
independent specialty pharmacy that will allow for efficient delivery of the medication by mail directly to
patients.
To further support appropriate utilization and future development of COMETRIQ, our Medical Affairs
department is responsible for providing appropriate scientific and medical education and information to
physicians, and preparing scientific presentations and publications, and overseeing the process for ISTs.
EMA Marketing Authorization Application for COMETRIQ
In November 2012, the European Medicines Agency accepted for review our Marketing Authorization
Application, or MAA, for COMETRIQ for the proposed indication of treatment of progressive, unresectable,
locally advanced, or metastatic MTC. The completion of the MAA validation process confirms that the
submission is sufficient to permit a substantive review for marketing authorization in the European Union.
COMETRIQ received orphan drug designation in the European Union from the Committee for Orphan Medicinal
Products for the treatment of MTC in February 2009.
