In-Licensing
Fabre-Kramer does not engage in drug discovery activities. Therefore, all of its portfolio compounds are the result of its in-licensing activities. We have completed eight (8) such licensing transactions to date, and have acquired intellectual property and assets from major pharmaceutical companies, small developing pharmaceutical companies, academic and medical institutions, and individual inventors/discoverers. As a privately-held company, Fabre-Kramer is able to make decisions quickly on opportunities it finds to be a fit with its therapy focus and business objectives. In general, we seek products that have been in at least Phase I or Phase II clinical trials, are intended to treat large populations of patients in one or more psychiatric or neurological indications. We have occasionally in-licensed pre-clinical compounds that we feel offer unusually attractive opportunities.
Development
Fabre-Kramer’s expertise is concentrated around clinical development of psychotropic compounds. Its principals and advisors are world-renowned clinical investigators of this class of drugs and have designed and conducted many pivotal trials and contributed numerous additions to the knowledge base in the field. We leverage this expertise to increase the odds of success in development programs we develop and manage for compounds we have acquired. We have relationships with highly regarded investigators all over the world and closely monitor and oversee the CROs that we use to conduct our studies. We have expert consultants in all relevant fields of development including intellectual property, manufacturing, regulatory, legal, and other areas to assist in our development programs. We are consistently able to develop compounds faster, cheaper and more effectively than other companies using this approach.
Out-Licensing
At present, Fabre-Kramer has no desire to develop its own marketing capabilities. We seek to partner our portfolio compounds with third parties who can provide the people and financial resources to optimize our compounds market potential. Every product we in-license to develop we believe has the potential to generate in excess of $1 billion in peak year annual sales. These products require significant resources to bring to market effectively. We strive to develop our compounds to the early to mid Phase III level, in most cases, and then begin to seek partners to fund the remaining Phase III and IV clinical activities and to market the product upon FDA or other regulatory authority approval. We seek to negotiate terms with our partners that are consistent with industry norms for compounds at this stage of development with similar commercial potential. Fabre-Kramer can be very flexible in terms of the structure of its licensing transactions, and, as is the case in our in-licensing activities, can move very quickly to consummate transactions.