Funds will pay for FDA PDUFA fees, other development costs.
Spectrum Pharmaceuticals has received $10 million in new investments from two existing institutional investors in a direct offering that will allow it to pay the FDA’s prescription drug user fee for products in its oncology pipeline as well as other costs.
The offering included some 170,000 shares at a price of $5.83, the company reported, and Spectrum has now issued more than 38.7 million shares. The company said it will net $9.5 million from the transaction.
Spectrum has been commercializing the radioimmunotherapeutic Zevalin in a joint venture with Cell Therapeutics under the company RIT Oncology, formed on December 8. The company paid $15 million in two payments to Cell Therapeutics for a 50 percent stake in the joint firm.
“Patients achieving a complete remission (CR) after induction chemotherapy who received Zevalin consolidation achieved a median progression-free survival benefit of greater than 67 months, compared to 30.8 months in the control arm,” says Rajesh C. Shrotriya, Spectrum chairman, president and CEO. “The addition of Zevalin as a consolidation therapy could represent a significant advancement and a changing treatment paradigm for patients with non-hodgkin’s lymphoma.”
Spectrum has already received FDA approval for the compound, indicated for the treatment of Non-Hodgkin’s lymphoma, as well as Fusilev, an injectable therapy that the company has developed for complementary treatment in osteosarcoma.
Six other compounds are in Phase I and Phase II trials, the company says, partially funded in a previous round of financing completed on May 29 that raised $20 million from three institutional investors.