A look ahead for some local biotech firms

January 18, 1998|By Mark Guidera | Mark Guidera,SUN STAFF

Here's a sampling of what's ahead for some of Maryland's better known biotechnology companies:

* MedImmune Inc. -- This Gaithersburg-based biotechnology company is one of the state's best positioned and could move into the black if the federal Food and Drug Administration approves its Synagis, a powerful drug to treat a potentially life-threatening respiratory infection in infants. MedImmune plans to seek European regulatory approvals for the drug this year.

The company also hopes to land FDA clearance early this year to launch human clinical trials for vaccine candidates it's developing for human papilloma virus, or HPV. The company is seeking regulatory approvals to market one vaccine for the viral infection, a leading cause of cervical cancer.

MedImmune also plans to move forward with completing and getting FDA approvals for its new $50 million manufacturing plant in Frederick where it plans to produce batches of its drugs for clinical trials and marketing.

* North American Vaccine Inc. -- The highest priority for this Beltsville-based developer of vaccines for infectious diseases is the U.S. marketing launch of Certiva, its whooping cough vaccine. Wall Street has taken a dim view of the company because it has taken so long for Certiva to land FDA approval, which is still pending. That has given competitors a jump on the market.

The company also has on its plate continuing pivotal U.S. human trials on a combined vaccine for diphtheria, tetanus, whooping cough (pertussis) and polio.

* Guilford Pharmaceuticals Inc. -- The highest priority of this promising Baltimore company is advancing research on a group of promising compounds called neuroimmunophilin ligands to treat neuro-degenerative diseases, such as Parkinson's and Alzheimer's diseases.

Biotechnology industry giant Amgen Inc. is paying Guilford $35 million for rights to the compounds, which appear to have protective powers, and $13.5 million over three years for research.

Guilford also hopes to launch human clinical trials on two promising new products. One, Naaladase, appears to regenerate neurotransmitters damaged during stroke and other head traumas. The other is a biodegradable chemotherapy-loaded wafer for the treatment of ovarian cancer.

* Human Genome Sciences Inc. -- This Rockville genomics firm, which is expanding into a diversified bio-pharmaceutical outfit, hopes to greatly leverage its huge genomics database this year.

On the priority list: FDA approval to begin a clinical trial on a protein-based drug that HGS believes could prove useful in blocking the effects of chemotherapy on platelets and other bone marrow. The company filed in late December for approval of what would be its first ever clinical trial on a drug candidate. Look for HGS to seek FDA approval for another clinical trial this year on a protein-based drug to speed wound healing.

The company also hopes to spin off a new firm based on a gene therapy it has identified as having potentially large commercial interest, said HGS spokeswoman Kate De Santis.

* Osiris Inc. -- This Baltimore company, which is at the forefront of efforts to develop tissue regeneration therapies, sees 1998 as "major transition year" in which the company will mature rapidly, said chief executive officer James S. Burns.

High on the priority list: revisiting the stock market to see if it is more receptive to an initial public offering. Osiris canceled its IPO in December because of an unfavorable market.

Another goal for Osiris will be the launch its first human clinical on a therapy -- this one to help cancer patients' bone marrow stroma, where disease-fighting white blood cells are born, recover quickly after chemotherapy.

* Oncormed, Inc. -- This Gaithersburg-based genetic testing and information service company is moving fast to shift into the burgeoning "gene characterization" business, which helps pharmaceutical companies and others determine which genetic discoveries may be valuable for guiding development of drugs and other medical treatments.

The company, which has a deal with California-based Affymetrix Inc. to develop a computer chip that can rapidly analyze DNA for genetic mutations linked to breast and ovarian cancers, is hoping to land deals with drug companies needing the service, said Dr. Leslie Alexandre, vice president for corporate affairs.

* Martek Inc. -- The mantra in 1998 for this Columbia-based biotech, which sells and develops products made from microalgae, will be sales, sales, sales, said chief financial officer Steven Dubin.

Look for Martek to focus on marketing and building sales for its food additive products, such as its oils rich in key fatty acids, and rolling out a new product, a line of fluorescent pigments for use in laboratory research.

Dubin says marketing will focus on landing more buyers for its DHA and ARA oils, which have key fatty acids needed for brain and other body functions. These oils are sold to most of the major infant formula manufacturers for use in products sold overseas (The additives aren't approved for infant food use in the United States). DHA is also sold to mass marketers of adult food supplements, which use the oil in Neuromins, a supplement touted as "brain food."

Pub Date: 1/18/98

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