Category: Paclitaxel Manufacturer

Biolyse Pharma was the first to discover that paclitaxel could be extracted from the needles of the Canadian yew bush, Taxus canadensis. This discovery predates the marketing of any other paclitaxel and is of tremendous importance to the future availability of the drug at a bearable cost to the health care system.

THE PACLITAXEL STORY

Today, Biolyse Pharma is the industry leader in the research and development of injectable Paclitaxel products for use in cancer treatments.

Since Biolyse researchers first discovered that Paclitaxel could be produced from Taxus canadensis the company has gained fourteen years of valuable experience with the product. In September of 1994, Biolyse obtained authorization from the Federal Health Protection Branch (HPB) to administer its Paclitaxel for Injection, to patients under a clinical trial program.

Paclitaxel is a chemotherapeutic agent that is currently prescribed worldwide to treat the most aggressive forms of ovarian, lung and breast cancer, as well as AIDS related Kaposi’s sarcoma. Paclitaxel belongs to the chemical group known as taxanes, a family of molecules found in various natural sources. Paclitaxel is considered by the scientific and medical community as a ‘first line of defense’ in the treatment of cancer. In 1992, both the American and Canadian National Cancer Institutes called paclitaxel “the most important new drug we have had for cancer treatment in the last 15 years”.

Paclitaxel is an anti-cancer compound originally obtained from the bark of the Pacific yew tree, Taxus brevifolia. This species of yew takes decades to grow and the current process of drug extraction destroys the tree. Recently, the Pacific yew was declared an endangered species due to the species’ lengthy maturation time combined with the high demand for the drug and excessive harvesting techniques used to produce it.

Attempts to find new sources of the complicated chemical structure of paclitaxel have resulted in a chemical synthesis of this naturally occurring molecule. While this seems like a feasible solution, some concerns can surface. Often during the chemical synthesis of a molecule, a product may arise that seems identical but may have minute differences in the angles between atoms, the length or strength of bonds, or the finished shape of the whole molecule. Even minuscule differences in any of these areas could affect the overall behavior of the molecule, and thus its overall effect. Unfortunately, the paclitaxel molecule is large and complex, requiring many complicated steps to create, which could theoretically lend themselves to errors and the introduction of impurities. In view of these concerns, Biolyse committed itself to find a better solution.

Due to the scarcity of naturally occurring paclitaxel, extreme efforts were made to find alternative sources of the drug. Biolyse Pharma was the first to discover that paclitaxel could be extracted from the needles of the Canadian yew bush, Taxus canadensis. This discovery predates the marketing of any other paclitaxel and is of tremendous importance to the future availability of the drug at a bearable cost to the health care system.

Harvesting of Taxus canadensis for the production of paclitaxel does not damage the bush and the techniques used actually promote its proliferation. The Canada yew is not an endangered species and can be found throughout Atlantic Canada, Quebec, Ontario, portions of Manitoba and various areas of North Eastern America. As such, Biolyse has a constant, renewable source of natural paclitaxel, rather than depending on a synthetic, and possibly unreliable version of the compound.

BIOLYSE PACLITAXEL FOR INJECTION FROM TAXUS CANADENSIS

Biolyse Pharma’s Paclitaxel for Injection is an anti-cancer drug that has proven effective against breast and lung cancer in clinical testing. Biolyse developed the technology of extracting paclitaxel from Taxus canadensis, commonly known as the Canada Yew or ground hemlock, in such a manner that yields a large amount of biomass, without harming the plant itself. This ground-breaking technology provides Biolyse with a plentiful and renewable source of high-quality primary materials and ensures that it will be able to make paclitaxel more available to the world market.

Since 1988, Biolyse Pharma has been producing paclitaxel and other taxanes in steadily increasing quantities. In the summer of 1994, Biolyse received permission by the Canadian Federal Health Protection Branch (HPB) to begin clinical trials with natural paclitaxel from Taxus canadensis in cancer treatment centres across the country. Since 1996, Biolyse has supplied large clinical markets with Paclitaxel for Injection. In August of 2001, a Notice of Compliance was granted by Health Authorities, distinguishing Biolyse as the first pharmaceutical company to sell natural Paclitaxel for Injection in Canada.

The main objective of Biolyse is to ensure that an adequate supply of Paclitaxel for Injection will be available to oncologists and their patients at a reasonable price. This will be accomplished by minimizing costs during the extraction process, identifying economies of scale in production, and by refining the technology at every step in production.