Spectrum raises $25M as it builds on Zevalin, Fusilev franchises to fund oncology pipeline
This article was originally published in Scrip
Spectrum Pharmaceuticals, a US company which markets two oncology products and seeks to develop a broad pipeline, has raised $24.8 million through the exercise of long-term warrants issued in 2005. The warrants were priced at $6.62.
The firm claims that the proceeds add to an already strong balance sheet – one necessary for commercial expenses for its marketed US products and a product in development. As of 16 September, it had nearly $160 million in cash, cash equivalents and investments, up from approximately $119 million as of 30 June.
What is most significant about Spectrum is that for a small-sized biotech it has two oncology drugs FDA approved and on the market, plus two others in late-stage trials.
Spectrum's marketed products include Zevalin (ibritumomab tiuxetan) for non-Hodgkin's lymphoma. There is also Fusilev (levoleucovorin)- a folate analogue - which was initially indicated for use after high-dose methotrexate therapy in patients with osteosarcoma, and in late April, gained FDA approval for use in combination with 5-fluorouracil as a palliative treatment of patients with advanced metastatic colon cancer (scripintelligence.com, 2 May 2011). There had already been off-label use for the colon cancer indication. For the six months ended 30 June, Spectrum had revenue of $89 million, including $68.6 million in product sales from Fusilev and $14.3 million from Zevalin, along with $6.2 million in licensing fees.
The Zevalin product is gaining adoption for first-line use for NHL and is meeting sales projections, Roth Capital Partners analyst Joseph Pantginis stated in a recent research note. With regard to the Fusilev product and the colon cancer indication, Spectrum is expected to begin actively marketing the product – with the only concern, the analyst said, "whether Fusilev will be able to garner market share from the generic leucovorin market". The firm had been benefiting from a generic leucovorin shortage, but that shortage is expected to end shortly. On a wider scale, Dr Pantginis views positively the fact Spectrum looks to mitigate risk by having a broad pipeline of candidates.
Spectrum plans to initiate this year studies of Zevalin in diffuse large B-cell lymphoma.
The company has two oncology candidates in late-stage testing: apaziquone, a synthetic prodrug for non-invasive bladder cancer in Phase III, and belinostat, a novel HDAC inhibitor for peripheral T-cell lymphoma. The company claims it is no track to file US NDAs with the FDA for these candidates in 2012. The Japanese oncology specialist Nippon Kayaku previously acquired Asian rights to apaziquone.
Among candidates in the pipeline is SPI-1620, being investigated as an adjunct to chemotherapy. Spectrum recently presented Phase I safety and tolerability results at the International Conference on Endothelin, in Cambridge, UK. The drug was administered in combination with docetaxel to 30 patients with various solid tumour types, including prostate, breast, gastrointestinal, female reproductive, and pancreatic cancers, and lead to five partial responses. The compound is a novel anti-tumour endothelin-B agonist agent; Spectrum expects to initiate a Phase II trial in 2012.