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Therapeutic Protein Manufacturer Sets Up Shop in San Diego

As the U.S. Food and Drug Administration begins establishing processes for approving generic biotech drugs, companies such as Phage Pharmaceuticals Inc. are already beginning to put their manufacturing processes to the test.

On May 24, Phage announced its entrance into the San Diego market with a therapeutic protein manufacturing plant that will serve as its headquarters. Phage acquired the plant, along with other assets, from the defunct Phage Biotechnology Corp. of Las Vegas for an undisclosed amount.

“We hope to bring to the table a better way of making proteins,” newly hired President Allan Goldberg said in an interview last week. Goldberg, a co-founder of numerous biotech companies including ZyStor Therapeutics Inc. of Milwaukee, is part of the New York City-based management team of BioMed Transition Partners.

Goldberg says Phage’s process, using bacteria to manufacture proteins, could provide an advantage over current techniques that rely on mammalian cells that carry risk of human infection.

The nine-person company plans to offer its manufacturing services to other companies introducing generic biotech drugs, known as biosimilars, to the market. Additionally, Phage said it would advance its own clinical-stage drug candidates with the help of a pharmaceutical partner. Phage would retain the manufacturing responsibilities, while the partner would develop and commercialize the biotech drug.

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Achieving Its Primary Goal: Anadys Pharmaceuticals Inc. said May 21 that its experimental hepatitis C drug met its primary goal in a small, midstage Phase 2 study, sending the company’s shares up 7 percent to $2.40. The stock is listed as ANDS on Nasdaq.

In the latest study of 34 hepatitis C patients, 75 percent had no detectable levels of the virus in their bloodstream after 12 weeks of twice-daily treatment with the Anadys drug, compared with 63 percent in the placebo group.

The results appeared to appease investors, who reacted strongly to the company’s earlier data, which demonstrated an unusually high placebo response. In February, the company reported a 73 percent response rate in a study of 30 hepatitis C patients on the drug’s lowest dose, compared with a 71 percent response in the placebo group.

In its most recent study, Anadys said it identified the anomaly. An abnormally large number of patients who carry a genetic marker making them more responsive to the standard of care were enrolled in the study.

“Coupled with the favorable tolerability profile seen at 200 milligram (twice daily doses), we believe that these results establish ANA598 at 200 milligram (twice daily doses) as one of the most attractive agents in Phase 2 HCV development today,” said Chief Executive Officer Steve Worland.

Estimates show that 650,000 of the 3.2 million Americans living with HCV infections have failed previous therapies.

Decision Resources Inc., a research and advisory firm for pharmaceutical and health care issues, predicts that the market for HCV drugs will grow to nearly $7.7 billion worldwide by 2013.

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Grant to Support Research: Sorrento Therapeutics Inc. said May 21 that it has been awarded a two-year federal government grant worth $600,000 to support its development of new antibody drugs and vaccines for combating Staph infections, including MRSA.

The advanced technology small-business grant, awarded by the National Institute of Allergy and Infectious Diseases, will support Sorrento’s research into signaling peptides known as AIPs thought to play a key role in controlling bacterial virulence.

The Centers for Disease Control and Prevention has identified the antibiotic-resistant superbug MRSA as a growing cause for concern. A study released last year by Duke University Medical Center found a 35-fold increase in risk of hospital readmission due to MRSA-related surgery infections.

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Waiting for an Answer: Cadence Pharmaceuticals said recently that it should have an answer from the FDA on its intravenous painkiller Ofirmev by Nov. 4.

In February, the agency issued a complete response letter to the company after it found deficiencies at its third-party manufacturing facility, a Cleveland, Miss.-based plant run by health care giant Baxter. Cadence said it resubmitted its application May 4 after meeting with FDA reviewers and Baxter.

Another San Diego biotech, Halozyme Therapeutics, also encountered trouble with a Baxter plant this month when an inspection turned up glass flakes in vials of Halozyme’s pediatric dehydration drug, prompting a recall of 3,500 vials. Inspectors found nylon and human skin in the Cadence product, according to an FDA inspection report.

“We believe a 6-month review is more likely as FDA will probably opt to re-inspect the Baxter facility,” Gary Nachman, a biotech analyst with Leerink Swann LLC wrote in a note to investors.

Cadence reported having cash and cash equivalents of $68 million as of the first quarter, enough to get through approval, the company said.

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