Two large pharmaceutical companies venture into the development of human growth hormone and other biosimilar products. Critical Pharmaceuticals of Europe recently announced that it will develop a nasal spray of human growth hormone (hGH) using its proprietary technology. The company was able to get £1.5m funding from Wellcome Trust. Pharmaceutical companies are interested in investing in HGH development because of its large market. In 2007, the estimated sales of HGH worldwide reached $2.8 billion. HGH is commonly used for the treatment of growth disorders but it is also popular among athletes.

The chief executive officer of Critical Pharma, Lisbeth Illum said in a press release that the market for HGH represented a major opportunity for their company. She said that the project addresses a large unmet medical need and demand for biological products continue to grow which represents 30% of new drugs. She noted that 98% of the products available in the market including HGH are administered through injection which can cause patient compliance. “Current therapies require daily injections and are strongly disliked by patients and their carers. We believe Critical Pharmaceuticals’ CriticalSorb™ technology has the potential to enable the non-invasive delivery of not just human growth hormone but many other biological drugs with at least equivalent efficacy,” she added.

The company’s CriticalSorb™ technology was proven to enable the efficient delivery of biological drugs with exceptional bioavailabilities during preclinical studies. It is also considered as a “GRAS” material which means that it is generally regarded as safe for drugs administered orally or intravenously.

In its press release, the company will be supported by Wellcome Trust in the development of nasal human growth hormone through phase 1 proof of concept study in human volunteers and determine the long term nasal tolerability of CriticalSorb. The head of Business Development Technology Transfer Division of Wellcome, Richard Seabrook, said that technologies for non-injectable administration of complex drugs like human growth hormone are desperately needed. “We are very pleased to be funding this application of CriticalSorb™ which may avoid patient discomfort and improve eventual outcomes for this patient population. We look forward to Critical’s results,” Seabrook added.

Meanwhile, Access Pharma is also expected to release its new drug at the end of this year. The company developed a Vitamin B12 based nanopolymer drug delivery system for the oral administration of large molecules such as insulin, human growth hormone (hGH), and erythropoietin (EPO) in preclinical animal models. This unique delivery mechanism uses the the body’s vitamin B12 absorption system in a Trojan Horse manner. With this method, it has a potential to eliminate the usual procedure of injecting drugs like HGH, insulin and EPO.

Mike Havrilla, writer for biotech industry wrote in his column that Access is also in the process of validating its insulin product before it finally enters into formal licensing negotiations. “A long-acting, basal insulin product (similar to the activity profile of Lantus insulin) is the most advanced in terms of achieving oral bioavailability of about 80-90% after initially achieving results in the 30-40% range, he said. According to the company, there are two bio-pharmaceutical companies currently conducting preclinical studies on their basal insulin product.

Trackback URI | Comments RSS