April 1, 2007 (Vol. 27, No. 7)

Roth Conference Showcases Potential Winners in the Long-Term Life Science Stock Market

Biotechnology, drug discovery, and drug delivery were in the spotlight when Roth Capital Partners hosted its “19th Annual Stock Conference” recently.

About 300 companies from diverse industry sectors made presentations during the conference. The average market cap of the presenting companies was approximately $360 million in keeping with Roth’s goal of finding undiscovered and under-followed companies that may become tomorrow’s Wall Street leaders.

Drug Delivery Companies

SkyePharma (www.skyepharma.com) uses drug delivery technologies to improve the dosing characteristics of pharmaceutical products that are deemed safe and effective. In December, the FDA approved SkyePharma’s Foradil® Certihaler™ (formoterol fumarate inhalation powder) for the treatment of asthma. The product, co-developed by SkyePharma and Novartis, is approved in 27 countries.

“By reformulation, SkyePharma can often improve the therapeutic effect, minimize side effects, and render dosing more convenient for the patient,” said the company’s CEO, Frank Condella, who added that the company is focusing on oral and inhalation drug delivery, primarily in the areas of asthma and chronic obstructive pulmonary disease. The company is also working on timed-release tablets and solubilization technology that is designed to overcome the low bioavailability of many promising drug leads, as well as IDD® drug delivery systems, which consist of a micrometer- to sub-micrometer-sized, water-insoluble drug core stabilized with phospholipids with or Matrixx Initiatives (www.matrixxinc.com) develops “novel and proprietary drug delivery systems to give consumers better ways to get better,” stated Carl Johnson, president and CEO. Zicam, the company’s wholly owned subsidiary, offers Zicam® and Nasal Comfort branded products for a range of common afflictions. These offerings include Zicam Cold Remedy with a portable unit dose delivery, homeopathic allergy/sinus products that help people build up a natural resistance, cough-relief products in spray and meltable tablet form that eliminate chewing and drinking water, and multi-symptom cold and flu relief products in predose spoon form to mix with a beverage.

The Nasal Comfort line has a level of sodium chloride in the solution greater than that found in the nasal membranes. As a result, the cells of the nasal membrane diffuse fluid that, in effect, reduces the swelling of the membrane, allowing for BioSphere Medical (www.biospheremed.com) offers minimally invasive diagnostic and therapeutic applications based on bioengineered microsphere technology. The spherical co-polymer formulation enables highly targeted vascular delivery for treatment of benign uterine fibroids through occlusion of the blood supply and malignant primary liver cancer, explained Richard Faleschini, president and CEO.

Using a minimally invasive transcatheter procedure called uterine fibroid embolization, Embosphere® microspheres are injected into uterine arteries, blocking blood flow to the fibroid, thus shrinking it over time. The drug is effective for large and multiple fibroids, thereby reducing the need for hysterectomies, Faleschini said. Hepasphere™ expanding microspheres treat liver cancer by absorbing contrast media and saline solutions and selectively bonding with positively charged material through an ionic interaction process. The company also makes Quadrasphere expanding microspheres, which are used to treat hypervascularized tumors and peripheral arteriovenous malformations.

Halozyme Therapeutics (www.halozyme.com) produces recombinant human enzymes for drug delivery, palliative care, oncology, and infertility, explained David Ramsay, CFO. The company’s portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. Enhanze, Halozyme’s drug delivery technology, temporarily degrades hyaluronic acid (HA), a space-filling, gel-like substance that is a major component of tissues throughout the body, facilitating the penetration and diffusion of other drugs that are injected subcutaneously, intramuscularly, or intravenously.

Halozyme’s recombinant human enzymes may replace current animal slaughterhouse-derived extracts that carry potential risks of animal pathogen transmission and immunogenicity. The company has received FDA approval for two products: Cumulase®, a recombinant human hyaluronidase for cumulus removal in the in vitro fertilization process and Hylenex for use as an adjuvant to increase the absorption and dispersion of other injected drugs.

SCOLR Pharma (www.scolr.com) offers a suite of patented CDT® controlled-delivery technologies applicable to modified oral dosage forms, each focusing on specific barriers to optimize drug administration, according to Daniel O. Wilds, president and CEO. “The common rationale underpinning all these systems is the ability to dissociate or modify the site, duration, and magnitude of drug action from the inherent physical limitations and chemical properties of the drug molecule itself,” he explained.

SCOLR’s self-correcting matrix delivery systems use the basic ionic interaction between polymers and additives to preferentially hydrate and influence peripheral hardening of the gel matrices with a progressive shift in gel formation toward the central core, thus controlling erosion and dissolution. The release rate from these systems is not adversely affected by ionic strength, tablet hardness, pH, hydrodynamics, and other physiological parameters.

Preliminary results from pilot bioavailability testing of SCOLR’s refined 24-hour CDT-based ondansetron tablets indicated that the formulation enables a once-daily, sustained-release tablet that prevents chemotherapy- and radiation-related nausea and vomiting.

Diagnostic Focus

AspenBio Pharma (www.aspenbiopharma.com)is developing novel drugs and diagnostics for animals and humans, including a human appendicitis blood test, for which positive results from preliminary clinical trials were recently reported, said president and CEO Richard Donnelly. The AppyStat™ blood test identifies emergency room patients with appendicitis at a high sensitivity level by detecting a marker in the blood associated with appendicitis. The company is also developing AppyScreen™ as a point-of-care appendicitis test for physicians’ offices.

Elite Pharmaceuticals (www.elitepharma.com) is engaged in the development and manufacture of oral controlled-release pharmaceuticals. The company licenses products using its timed-release, pulsed-released, and taste-masking technologies for pellets, capsules, tablets, granules, and powders, said Bernard J. Berk, chairman and CEO.

Elite manufactures and receives a royalty on Lodrane 24®, a once-a-day antihistamine being distributed by ECR Pharmaceuticals The company also has a pipeline of six products for cardiovascular episodes, pain, allergy, and infection. OxyNal, a pain-management drug in clinical trials, has been designed to prevent potential abuse.

Emisphere Technologies (www.emisphere.com) specializes in the oral delivery of therapeutic molecules that are usually degraded or poorly absorbed in the gastrointestinal tract and across other biological membranes. The drug delivery platform, known as eligen® technology, is based on the use of synthetic chemical compounds, Emisphere delivery agents, carriers that have no known pharmacological activity themselves. Studies have shown that the technology enables the delivery of a therapeutic molecule without altering its chemical form or biological integrity or damaging the intestinal membrane.

Emisphere has designed and synthesized a library of over 4,000 carriers. It has demonstrated oral delivery for heparin, insulin, human growth hormone, and a small molecule for treating bone disease in humans, as well as oral delivery of over 60 compounds in animal models.

Hemispherx Biopharma (www.hemispherx.com), which has 140 patents, focuses on RNA-based therapeutic solutions for chronic diseases and immune system disorders. The company’s platform technology includes large- and small-agent components for potential treatment of various chronic viral infections, reported William Carter, Ph.D., CEO.

Alferon-N™, an injectable drug produced by Hemispherx, has FDA approval for the treatment of human papilloma virus. Another injectable, Ampligen®, is designed for the emergency treatment of chronic fatigue syndrome. The company is also working on oral Alferon and intranasal Ampligen for biodefense situations, including the treatment of avian flu, SARS, ebole, hepatitis, and other viral infections that have threatened to reach pandemic levels.

Cortex Pharmaceuticals (www.cortexpharm.com) focuses on novel drug therapies for neurological and psychiatric disorders, said Roger Stoll, Ph.D., chairman, president, and CEO. Cortex has an alliance with Organon for the treatment of schizophrenia and depression. In conjunction with Les Laboratoires Servier, Cortex is developing Ampakine® compounds to treat the neurodegenerative effects associated with aging and disease, including mild cognitive impairment, Alzheimer’s disease, and anxiety disorders.

Cortex’ Ampakine compounds act to increase the strength of signals at connections between brain cells by up-regulating glutamate. “Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain’s neurotransmitter system,” Dr. Stoll explained. He also reported that the company was submitting new data to the FDA on the use of a compound for treating ADHD and that another compound was showing promise for treating Huntington’s disease in animal studies.

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