Finding itself in the right place at the right time, Spectrum Pharmaceuticals Inc. gained access to a Phase II product for hormone-dependent cancers, such as prostate cancer, and benign but proliferative disorders such as benign prostatic hypertrophy and endometriosis.
The Irvine, Calif.-based company, which primarily is focused on oncology, acquired an exclusive license from AEterna Zentaris Inc. to develop and commercialize D-63153 for all indications in North America and India. AEterna Zentaris retains exclusive rights in the rest of world.
Its German subsidiary, Zentaris GmbH, out-licensed the product following the breakup of a worldwide development deal with Baxter Healthcare Corp. That arrangement came undone because of recent organizational changes and restructuring at the Deerfield, Ill.-based pharmaceutical firm, allowing Spectrum to slide in as a new partner.
"We don't have any basic research, per se, and we don't discover drugs in test tubes or mice," Rajesh Shrotriya, Spectrum's chairman, president and CEO, said, as he outlined the time and cost difficulties associated with drug discovery efforts at small companies. "Our focus is to do what we do best, which is to identify the drugs that are diamonds in the rough, and run with their clinical development, get FDA approval and put them on the market."
He added that Spectrum further benefited from the Baxter breakup because it received full access to preclinical toxicology and pharmacokinetics evaluations, as well as clinical data to date.
In exchange for D-63153, it provided an undisclosed up-front payment of cash and equity to Quebec City-based AEterna Zentaris, which also is eligible to receive payments upon achievement of certain development and regulatory milestones, as well as eventual royalties. As for any development in Japan, Shrotriya said the companies would share equally in any up-front and milestone payments AEterna Zentaris might receive, as well as royalties from any sales in that territory.
All of the product's clinical trials to date have been conducted in Europe. Spectrum expects to complete one more study overseas, while also filing an investigational new drug application with the FDA to begin U.S. trials within six months.
"We will not allow the pace of development to slow down," Shrotriya told BioWorld Today. "AEterna Zentaris will be involved in the sense that they have a lot of know-how in this area. We will have a drug development committee with members from Spectrum, as well as AEterna Zentaris, and I welcome their input into the drug development program."
But Spectrum will shoulder the costs as it pushes the drug into a competitive market space.
Many current treatments, most of which are marketed by large pharmaceutical companies, work as agonists to LHRH (luteinizing hormone-releasing hormone). Newer products are antagonists to LHRH, and as such are designed to avoid problems LHRH agonists cause, such as flares in testosterone or estrogen levels that initially aggravate the very conditions the drugs are intended to treat.
D-63153 falls into the latter category as a fourth-generation LHRH antagonist, and AEterna Zentaris is involved in the development of two other such products. Some already are marketed for in vitro fertilization, but not for the proliferative disorder market Spectrum plans to target.
"The aim of the treatment of these proliferative disorders," Shrotriya explained, "whether prostate cancer, benign prostatic hypertrophy or endometriosis, is to keep these sex hormone levels as low as possible."
He added that studies have shown that D-63153 also avoids a histamine release associated with another LHRH antagonist, Plenaxis, marketed for prostate cancer by Praecis Pharmaceuticals Inc., of Waltham, Mass., and Schering AG, of Berlin. Shrotriya also noted that D-63153's patents were issued in the last two years, providing a long patent life ahead.
Outside of D-63153, the AEterna Zentaris portfolio includes a marketed product and a variety of other clinical development activities.
Another LHRH antagonist product from AEterna Zentaris, cetrorelix, is marketed for in vitro fertilization as Cetrotide by Serono SA in Geneva, and is in advanced clinical development for uterine myoma, endometriosis and benign prostatic hyperplasia. That development is partnered with Solvay Pharmaceuticals BV, of Brussels, Belgium, and the partners also have an agreement centered on an earlier-stage LHRH antagonist. Yet another LHRH antagonist, teverelix, is partnered with Ardana Bioscience Ltd., of Edinburgh, Scotland. Several Phase II trials are evaluating perifosine, an orally active AKT inhibitor for multiple cancers, through a partnership with Access Oncology Inc., of New York.
On Thursday, its stock (NASDAQ:AEZS) fell 10 cents to close at $4.68.
As for Spectrum, its pipeline includes a Phase III product, satraplatin, in development as a second-line chemotherapy for hormone-refractory prostate cancer. The oral drug, which is being co-developed with GPC Biotech AG, of Martinsried, Germany, has been granted fast-track status by the FDA. Elsamitrucin is in Phase II for non-Hodgkin's lymphoma, while EOquin also is in Phase II for superficial bladder cancer.
The company also expects to soon receive FDA approval for several generic drugs, as it has three abbreviated new drug applications on file with the agency and plans to file three more by the end of the year.
Spectrum's stock (NASDAQ:SPPI) gained 39 cents Thursday to close at $5.24.