Medical Device Daily Contributing Writer

NEW YORK – About 360 companies, including many private and development-stage companies made presentations at last week's Rodman & Renshaw (New York) annual Global Investment Conference in the New York Palace Hotel.

Specialty pharmaceutical companies – firms using a wide range of drug-delivery technologies – represented the dominant category.

A look at some of the categories and companies involved in the 10th annual conference:

Protein/peptide delivery technologies

Medgenics (Misgav, Israel) is developing its tissue-based Biopump platform technology to provide sustained delivery of protein therapy for the treatment of a range of chronic diseases.

The Biopump is produced by extracting a sliver of the patient's dermal tissue which is then processed using a non-immunogenic viral vector to introduce the appropriate gene into the tissue's cells and cause the cells to produce the desired protein. The resulting Bopump is then implanted subcutaneously.

Medgenics has two Biopump products in development: Epodure, which produces erythropoietin for four to six months to treat anemia which is in its second Phase I/II safety and efficacy study, and Infradure, which produces interferon-alpha to treat hepatitis and will enter clinical trials in 2009.

The company plans to outlicense future Biopump products targeting the protein therapy market.

Emisphere Technologies (Tarrytown, New York) is using its Eligen technology for improving the ability of the body to absorb orally delivered small and large molecule drugs. Emisphere reported clinical data which showed that its Eligen vitamin B12 formulation avoids the specialized absorption process that limits absorption of vitamin B12 supplements when taken as tablets.

The company reported in October the initiation of a second Phase III study by Novartis Pharma (Basel, Switzerland) and Nordic Bioscience (Herley, Denmark) for oral salmon calcitonin using the Eligen technology to treat patients with osteoarthritis of the knee. This second study is designed to meet FDA requirements for U.S. registration.

Vyteris (Fair Lawn, New Jersey) has developed the LidoSite prefilled active (iontophoretc) anesthetic patch for the transdermal delivery of lidocaine prior to venipuncture (e.g., IV catheter insertion, blood draw, etc.) and superficial dermatological procedures.

It is the first active patch to receive clearance from the FDA. The company is seeking a marketing product for LidoSite. It was previously marketed by B. Braun Medical (Bethlehem, Pennsylvania).

The company is focusing on developing transdermal peptides and biopharmaceuticals using its SmartPatch technology for their delivery directly into the bloodstream.

Vyteris has a joint development agreement with Ferring Pharmaceuticals (Lausanne, Switzerland/Parsippany, New Jersey) for an active patch to deliver a fertility enhancement peptide hormone. The product will soon enter a Phase II clinical trial.

Vyteris has completed a Phase I trial comparing its SmartPatch iontophoretic delivery of zolmitriptan vs. oral delivery for the treatment of migraines. Positive data was obtained indicating faster onset of relief and higher maintenance levels to prevent recurrence. Zolmitrpitan is currently sold as Zomig by Astra-Zeneca (London).

Access Pharmaceuticals (Dallas) is exploring the use of cobalamin-coated nanoparticles to provide oral availability of macromolecules by facilitating drug absorption. The technology is based on the use of a vitamin B12 coating to enhance the targeting of drugs due to the increased demand for cobalamin at disease sites such as cancer.

Cobalamin-coated nanoparticles provide an opportunity for the oral delivery of peptides and proteins which have no intrinsic oral absorption by utilizing the body's natural uptake mechanisms. The company reported that cobalamin oral insulin showed a reduction in blood glucose levels in an animal model of diabetes.

ProLindac, the company's lead drug candidate, is in a multi-center Phase II trial in Europe in ovarian cancer patients. It applies the principle of nanoparticle prodrugs to enhance delivery of a platinum drug to tumors. ProLindac, a polymer DACH platinum prodrug, uses the active moiety of oxaliplatin, a cancer drug.

Access has received marketing allowance from the FDA for MuGard, an oral rinse for use in treating mucositis. The product has been licensed to Milestone Biosciences (Orlando, Florida).

Miscellaneous delivery technologies

Scolr Pharma (Bothell, Washington) uses its patented controlled delivery technology (CDT) for over-the-counter medications, dietary supplements and prescription drugs. It recently announced completion of its third pivotal trial to evaluate the safety and efficacy of its formulation of 12-hour extended release ibuprofen for the treatment of dental pain following molar extraction.

The FDA has accepted for review the company's abbreviated new drug application for a 12-hour pseudoephedrine tablet. Scolr has a strategic alliance with Perrigo (Allegan, Michigan) to manufacture and market sustained-release nutritional products using its CDT platform.

Prescription drugs that are being developed using CDT are immediate-release raloxifene for the treatment of osteoporosis and extended-release ondansetron to help control nausea associated with chemotherapy and radiation treatments.

Depomed (Menlo Park, California) has developed drugs that utilize its AcuForm drug delivery technology for once-daily administration and controlled release in the upper gastrointestinal tract.

Glumetza (metformin extended release tablets) is used in adults with Type 2 diabetes and is marketed in the U.S. by Santarus (San Diego).

Proquin XR (ciprofloxacin) is sold in the U.S. by Watson Laboratories (Corona, California) for the treatment of uncomplicated urinary tract infection.

Depomed initiated in October a second Phase III trial with DM-5689, a non-hormonal drug for the treatment of menopausal hot flashes.

In July 2008, the company received a pre-clinical development grant from the Michael J. Fox Foundation (New York) to support development of novel gastric retentive controlled release dosage forms of levodopa/carbidopa under the hypothesis that the window for drug absorption in the upper gastrointestinal tract can be optimized using the AcuForm technology.

Novel wound-care products

Nucryst Pharmaceuticals (Wakefield Massachusetts) reviewed its Silcryst atomically disordered nanocrystalline silver technology that is licensed to Smith & Nephew (London) and used for as an antimicrobial coating on Acticoat dressings for acute trauma, burn and chronic wounds. It is being sold in 30 countries.

Nucryst recently received regulatory approval from Health Canada for its Acticoat Flex barrier dressing that provides up to seven days of antimicrobial activity. Its elastic design enables contouring to articulating surfaces such as knee and elbow joints. A market launch in Europe also is expected in 2009 after receipt of regulatory approval.

Oculus Innovative Sciences (Petaluma, California) has developed the Microcyn broad-spectrum antimicrobial platform technology for use in healing of acute and chronic wounds.

Microcyn is a non-irritating, shelf stable solution containing oxychlorine compounds that is described as super-oxidized solution therapy. It has been evaluated in clinical trials and was shown to have 93% efficacy for treating infected diabetic ulcers. It is sold as Dermacyn and has shown the ability to safely treat a wide range of pathogens, including MRSA, viruses, fungi and spores.

Dermacyn has FDA clearance and European Union certification for wound cleansing and reduction of microbial load.

The product was launched in China in September by Sinopharm (Shanghai). Microcyn-Gel is being developed as an antimicrobial topical ointment that maintains a moist wound environment that is conducive to healing.