SuperGen to use Dacogen income as 'financial engine' to develop new clinical candidates

By Jennifer Lanning Drey

Eugene, Ore., May 25, 2006 -SuperGen, Inc. expects licensing fees and royalties paid by MGI Pharma, Inc. on newly approved Dacogen (decitabine) to provide funding that will help the company develop one to two clinical candidates per year, said James Manuso, Ph.D., its president and chief executive officer.

The Food and Drug Administration approved Dacogen on May 3. Upon its first commercial shipment, SuperGen will receive a $20 million payment from MGI. That money will be followed by payments based on 20% to 30% royalty rates that increase by 2.5% for each $50 million tranche of revenues, Manuso said during SuperGen's analyst and investor day presentation held Thursday.

MGI has said it plans to make Dacogen commercially available during the second quarter of 2006.

"The approval of Dacogen provides us a financial engine," said Manuso.

Having closed on a merger with Montigen Pharmaceuticals, Inc. on April 4, SuperGen is focused on developing a robust discovery operation that will lead to development of new drugs and chemical entity intellectual property, said Manuso during the presentation.

"We have a lot of projects that we're moving along toward the clinic. We're focused on developing clinical candidates, and we feel we certainly can meet the goal we have as a discovery group to develop one to two clinical candidates a year in support of one to two phase 1 clinical trials," said Mike McCullar, Ph.D., the company's vice president, strategic planning and development, also speaking during the presentation.

One of its anti-cancer therapy candidates that will most likely to move into Investigation New Drug-enabling studies by next year is a series of compounds that are PIM-1 inhibitors. PIM-1 has been shown to be over-expressed in lymphomas, prostrate, breast, gastric and head and neck cancers, said McCullar in his presentation.

SuperGen is also developing two novel drugs that provide anti-cancer therapy by inhibiting polo-like kinase-1, and the company is approaching having a product candidate in that arena as well, he said.

"We're excited about the progress we've made with this project and hope to select a clinical candidate to move forward with very soon," said McCullar.

Balanced risk

SuperGen plans to manage its risk by balancing early stage discovery opportunities with later stage product in-licensing, said Manuso in his presentation.

In its later-stage product pipeline, SuperGen's lead compound is MP-529, a novel structure, potent inhibitor of aurora kinase, which is over-expressed in many types of tumors, said David J. Bearss, Ph.D., chief scientist for SuperGen. The compound is being developed specifically for oral delivery.

"We have a nice inhibitor that we know a lot about," he said.

MP-529 is an important target for SuperGen that has a lot of competition, said Bearss. The company hopes to have MP-529 in the clinic by late 2007 or early 2007.

SuperGen is also working to develop MP-470, a novel structure tyrosine kinase inhibitor being developed for parental and oral delivery. The company plans to meet with the FDA in the near term in a pre-IND meeting to initiate phase 1, which is expected to begin in early 2007, Bearss said Thursday.

SuperGen's portfolio also includes Orathecin (rubitecan) capsules, an investigational drug intended for the treatment of pancreatic cancer, Nipent (pentostatin) for injection, Mitomycin, and Surface Safe cleaner.

SuperGen is a Dublin, Calif., pharmaceutical company that discovers, acquires and develops therapies for solid tumors, hematological malignancies and blood disorders.

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