New Drug Application and Collaboration
1) What are the pros and cons of Abgenix's collaborating with a partner on ABX-EGF?
Before a new drug can be released to the market, it has to undergo a regulatory process. To complete the process, first the drug company (the sponsor in the process) has to submit information to prove that the drug is safe and effective. Pre-clinical data first has to be submitted before clinical trials can be conducted. After demonstrating the safety and efficacy of the drug through successful clinical trials, the sponsor company submit that information, along with information on manufacturing specifications, drug stability and bioavailability, and suggested packaging and labeling, as a "new drug application" (NDA) to the FDA. The NDA is then reviewed by teams of FDA employees, including physicians, statisticians, chemists, pharmacologists, and other scientists who assess the validity of the sponsor's claims. FDA inspectors also examine the facilities in which the sponsor intends to manufacture the drug The outcome of such process could be "approved", "approvable" (meaning adjustments have to be made), or "not approved".
As one can see from the above process, the testing and regulatory process alone is a long, costly process entailing significant risks for a drug company. Startups often lack the financial resources and expertise to shoulder alone the risks of such process, let alone in situations where they have not gone through this process before.
Collaboration would allow Abgenix to obtain rapid access to complementary assets -- the skills and resources of its collaboration partner to through the testing and regulatory process, and the commercial launching and marketing of the drug afterwards. As a result, ABX-EGF can significantly reduce the time to get ABX-EGF out to market. This is especially important since its competitors Astrazeneca and Genentech were already working on EGF pathway drugs already. By shortening the development time, and retain all the first-mover
Before a new drug can be released to the market, it has to undergo a regulatory process. To complete the process, first the drug company (the sponsor in the process) has to submit information to prove that the drug is safe and effective. Pre-clinical data first has to be submitted before clinical trials can be conducted. After demonstrating the safety and efficacy of the drug through successful clinical trials, the sponsor company submit that information, along with information on manufacturing specifications, drug stability and bioavailability, and suggested packaging and labeling, as a "new drug application" (NDA) to the FDA. The NDA is then reviewed by teams of FDA employees, including physicians, statisticians, chemists, pharmacologists, and other scientists who assess the validity of the sponsor's claims. FDA inspectors also examine the facilities in which the sponsor intends to manufacture the drug The outcome of such process could be "approved", "approvable" (meaning adjustments have to be made), or "not approved".
As one can see from the above process, the testing and regulatory process alone is a long, costly process entailing significant risks for a drug company. Startups often lack the financial resources and expertise to shoulder alone the risks of such process, let alone in situations where they have not gone through this process before.
Collaboration would allow Abgenix to obtain rapid access to complementary assets -- the skills and resources of its collaboration partner to through the testing and regulatory process, and the commercial launching and marketing of the drug afterwards. As a result, ABX-EGF can significantly reduce the time to get ABX-EGF out to market. This is especially important since its competitors Astrazeneca and Genentech were already working on EGF pathway drugs already. By shortening the development time, and retain all the first-mover