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Published on 9/15/2006 in the Prospect News Biotech Daily.

Migenix projects current cash resources to be sufficient through Q3 of 2007

By Jennifer Lanning Drey

Eugene, Ore., Sept. 15 - Migenix, Inc. management said Friday that based on the company's current and planned burn rates they expect current cash resources to sufficiently fund operations through the third quarter of 2007.

At July 31, Migenix had cash, cash equivalents and short-term investments of $14.0 million, compared to $9.4 million at April 30, according to a company news release.

During the first quarter of 2007, Migenix increased its cash position by $8.8 million through the sale of a partial royalty interest to U.S.-based investment funds, Arthur J. Ayres, chief financial officer of Migenix, said Friday during a company conference call.

The company also has the potential to begin receiving new milestone payments over the next two years as clinical trials for potential product candidates advance through the clinic.

"We're now entering a period where clinical results will be our key value driver," said Dr. James M. DeMesa, chief executive officer of Migenix, during Friday's call.

Migenix will begin receiving $21 million in milestone payments due under its dermatology program from Cutanea Life Science when CLS-001 (formerly MX-594AN) enters phase 3 clinical trails for rosacea, he said.

Cutanea has said it expects to complete phase 2 clinical trials of the drug before the end of 2007, according to DeMesa. If approved, Migenix will also get royalties on sales.

Migenix could also begin receiving $27 million in milestone payments in 2008 from Cadence Pharmaceuticals for CPI-226, which is being tested in the prevention of catheter-related infections.

Migenix is scheduled to begin receiving the payments following the Food and Drug Administration's acceptance of the New Drug Application for CPI-226 in the United States and the acceptance of the Marketing Authorization Application in Europe.

Both submissions are expected to be made in the first half of 2008, DeMesa said.

The drug is being developed in the United States under a Special Protocol Assessment agreement with the Food and Drug Administration and has already achieved highly significant superiority results in its first phase 3 clinical trial, DeMesa said.

Upcoming celgosivir results

In the nearer term, Migenix expects to receive two-week clinical results from its 12-week phase 2b study of celgosivir (MX-3253). The drug is being studied in combination with Pegetron (peginterferon alfa-2b plus ribavirin) for treatment of the hepatitis C virus in patients who were non-responders or partial responders to previous treatment with pegylated interferon-based therapy.

Migenix hopes the study will demonstrate a meaningful difference in effectiveness between the triple or double combination therapy compared to the standard of care, or show similar efficacy with lower side effects, DeMesa said.

The final results of the study are expected in the first half of 2007.

Migenix will also collect data in the next few months from a follow-on study of patients from the 12-week trial, he said.

In addition, the company is preparing to study the celgosivir combination in treatment-naïve patients and expects to have final results of that study in the first half of 2007, DeMesa said.

"If recent results of other HCV [hepatisis C] trials and other HCV activities are any indication of potential value, we definitely have a great opportunity for appreciation with positive results in these studies," DeMesa said.

Migenix is a clinical-stage developer of drugs for infectious and degenerative diseases based in Vancouver, B.C., with U.S. operations in San Diego.


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