Spectrum Pharmaceuticals (SPPI)

 

Success in the development and marketing of our drugs depends in part upon our ability to maintain, expand and enhance our existing relationships and establish new sources of supply for active pharmaceutical ingredients, or API, or for the manufacture of our finished dose drug products. We do not presently intend to focus our research and development efforts on developing APIs or manufacturing of finished dosage form for our drugs. In addition, we currently have no capacity to manufacture APIs or finished dose drug products and do not intend to spend our capital resources to develop the capacity to do so. Therefore, we must rely on relationships with API suppliers and other CMOs, to supply our APIs and finished dose drug products. We may not be successful in maintaining, expanding or enhancing our existing relationships or in securing new relationships with API suppliers or CMOs. If we fail to maintain or expand our existing relationships or secure new relationships, our ability to develop and market our drug products could be harmed.

 

We rely on contract suppliers to supply our existing products, and will likely do the same for other products that we may develop, commercialize or acquire in the future. Contract suppliers may not be able to meet our needs with respect to timing, cost, quantity or quality. All of our suppliers are sole-source suppliers, including for Zevalin and Fusilev, and no currently qualified alternative suppliers exist.

 

If we are unable to obtain a sufficient supply of our required products and services on acceptable terms, or if we should encounter delays or difficulties in our relationships with our manufacturers, or if any required approvals by the FDA and other regulatory authorities do not occur on a timely basis, we will lose sales. Moreover, contract suppliers that we may use must continually adhere to current good manufacturing practices enforced by the FDA. If the facilities of these suppliers cannot pass an inspection, we may lose FDA approval of our products. Failure to obtain products for sale for any reason may result in an inability to meet product demand and a loss of potential revenues.

 

 

Success in the development and marketing of our drugs depends in
part upon our ability to maintain, expand and enhance our
existing relationships and establish new sources of supply for
active pharmaceutical ingredients, or API, or for the
manufacture of our finished dose drug products. We do not
presently intend to focus our research and development efforts
on developing APIs or manufacturing of finished dosage form for
our drugs. In addition, we currently have no capacity to
manufacture APIs or finished dose drug products and do not
intend to spend our capital resources to develop the capacity to
do so. Therefore, we must rely on relationships with API
suppliers and other CMOs, to supply our APIs and finished dose
drug products. We may not be successful in maintaining,
expanding or enhancing our existing relationships or in securing
new relationships with API suppliers or CMOs. If we fail to
maintain or expand our existing relationships or secure new
relationships, our ability to develop and market our drug
products could be harmed.

 

We rely on contract suppliers to supply our existing products,
and will likely do the same for other products that we may
develop, commercialize or acquire in the future. Contract
suppliers may not be able to meet our needs with respect to
timing, cost, quantity or quality. All of our suppliers are
sole-source suppliers, including for Zevalin and Fusilev, and no
currently qualified alternative suppliers exist.

 

If we are unable to obtain a sufficient supply of our required
products and services on acceptable terms, or if we should
encounter delays or difficulties in our relationships with our
manufacturers, or if any required approvals by the FDA and other
regulatory authorities do not occur on a timely basis, we will
lose sales. Moreover, contract suppliers that we may use must
continually adhere to current good manufacturing practices
enforced by the FDA. If the facilities of these suppliers cannot
pass an inspection, we may lose FDA approval of our products.
Failure to obtain products for sale for any reason may result in
an inability to meet product demand and a loss of potential
revenues.

 

 

Success in the development and marketing of our drugs depends in part upon our ability to maintain, expand and enhance our existing relationships and establish new sources of supply for active pharmaceutical ingredients, or API, or for the manufacture of our finished dose drug products. We do not presently intend to focus our research and development efforts on developing APIs or manufacturing of finished dosage form for our drugs. In addition, we currently have no capacity to manufacture APIs or finished dose drug products and do not intend to spend our capital resources to develop the capacity to do so. Therefore, we must rely on relationships with API suppliers and other CMOs, to supply our APIs and finished dose drug products. We may not be successful in maintaining, expanding or enhancing our existing relationships or in securing new relationships with API suppliers or CMOs. If we fail to maintain or expand our existing relationships or secure new relationships, our ability to develop and market our drug products could be harmed.

 

 

Success in the development and marketing of our drugs depends in
part upon our ability to maintain, expand and enhance our
existing relationships and establish new sources of supply for
active pharmaceutical ingredients, or API, or for the
manufacture of our finished dose drug products. We do not
presently intend to focus our research and development efforts
on developing APIs or manufacturing of finished dosage form for
our drugs. In addition, we currently have no capacity to
manufacture APIs or finished dose drug products and do not
intend to spend our capital resources to develop the capacity to
do so. Therefore, we must rely on relationships with API
suppliers and other CMOs, to supply our APIs and finished dose
drug products. We may not be successful in maintaining,
expanding or enhancing our existing relationships or in securing
new relationships with API suppliers or CMOs. If we fail to
maintain or expand our existing relationships or secure new
relationships, our ability to develop and market our drug
products could be harmed.