Smart Biotech Management For Clinical Trial Paths

Includes: CELG, INSV, NWBO
by: Brian Ganch

The administering of clinical trials in the biopharmaceutical industry can be an extremely lengthy, pricey, and resource-intensive process for the organizations participating, especially for the smaller start-up firms. In order to commercially penetrate the markets of other nations, a drug must first be approved by the regulatory bodies of those nations, a process which often involves more clinical trials. This has sent top management of some firms looking for creative ways to reduce expenses and pressure on their organizations while guiding their product through the clinical process in multiple countries. One idea is to forge negotiations and agreements with the various regulatory agencies, health organizations, and GMP contractors in order to share clinical trial data, manufacturer products, and other information. Sharing this data would result in fewer trials, faster commercialization time and significantly less expense. It is the smart and resourceful CEO that attempts this path in an effort to utilize his stakeholders' investments in the most efficient manner. Here are some examples of such efforts:

The Celgene Corporation (NASDAQ:CELG) is a global biopharmaceutical company focused on the discovery, development, and commercialization of products used to treat cancer, immune diseases, and inflammatory conditions. In 2008, Celgene received expedited marketing approval from the European Medicines Agency (EMA) for its Vidaza drug, an injection used to treat myelodysplastic syndrome (a group of conditions where the bone marrow produces misshapen blood cells without making enough healthy functioning blood cells) and acute myeloid leukemia (cancer that affects white blood cells).

In February of 2008, Vidaza's Marketing Authorization Application was approved for review by the EMA under the Accelerated Assessment Procedure. This accelerated assessment can significantly shorten review time by the Committee for Medicinal Products for Human Use, allowing the therapy to hit the market quickly, saving both time and money for the company. This approval led to a large increase in Vidaza's sales, boosting it from $207 to $387 million in one year. Celgene last traded at 70.72 with a 52 week range of 51.70 - 80.42 and a market cap. of 31.15B.

Northwest Biotherapeutics (NASDAQ:NWBO) is a developmental stage biotech company focused on immunotherapies that use a patient's own cells to produce therapeutic vaccines for treating cancer. On April 12, 2012, NWBO announced its partnership with King's Health Partners, a highly respected organization based out of London that has extensive clinical and research expertise. Serving over 1.5 million patients every year, this partnership opens up the very important U.K. market for Northwest Biotherapeutics.

The King's Health Partners' focus is on improving the treatment of patients by quickly and effectively processing the information learned from trials and research. This efficiency is beneficial to both the patient and the biotech looking to tap into the market without spending years and capital on more research and trials.

The partnership reached by NWBO with the King's Health Partners and other European regulatory agencies allows the European sites to be added to the current trials that are already underway in the US, with all of the data being shared among the participating markets. This saves NWBO more than a year of time by not having to create a parallel trial for the European market, while also strengthening the research by having both US and European data compiled into one package.

With a market cap. of 44.58 million, Northwest Biotherapeutics last traded at 0.28 and has a 52 week range of 0.16 - 0.89.

InSite Vision Company (OTCQB:INSV) is a company using this ease of data sharing and swiftness of approval from regulatory authorities in Europe to their advantage. InSite develops new ophthalmic treatment options for a wide range of eye problems such as ocular infection, pain, inflammation, and glaucoma. With interest in expanding to the European market, InSite presented regulatory authorities in Sweden and the UK with a full background of the clinical data from the U.S. trials on two of InSite's leading Phase III products, AzaSite Plus and DexaSite. Because these regulatory bodies view European patients as identical to North American patients, InSite officials believe that there will be no need to run clinical trials in Europe. Depending on how the US trials end up, InSite could potentially file for a centralized approval process in Europe without any additional trials. This is very important in having the product hit the market quickly while opening up a new revenue stream for the company.

Another creative way in which InSite is looking to save money is through unilateral data sharing. The concept comprises of a company who maintains rights in one market, North America for example, and out licences to Asia and Europe will still be able to retain the right to use all of the data by the other regions, and the other regions will have access to the North American data as well. This strategy not only cuts costs for everyone's clinical development, but also contributes to a safer, more effective final product.

InSite last traded at 0.38 with a 52 week range of 0.31 - 0.90 and a market cap. of 50.14 million.

Through creative negotiations and an understanding of the regulations of a new market, resourceful companies have the ability to get their products in the hands of more patients quickly, saving time and money for the company while providing incentives for investors.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.