The transaction is expected to close in the fourth quarter, pending approval from regulatory agencies and GelTex shareholders. Genzyme expects that at least four fundamental factors will propel the product's exponential growth: Since these compounds are high-molecular-weight polymers, they are unlikely to be absorbed into the blood stream.
Genzyme General expects that the acquisition of GelTex may result in a one-time charge in the fourth quarter ofrelated to the write-off of in-process research and development.
After approval, Genzyme could capitalize the investment and amortize it over the life of the venture. With regard to RenaGel, an expeditious response from the FDA would occur one year after filing, that is, in Polymer technology has wide ranging applications, and polymer-based products enjoy a relatively quick development pathway and have proven to be very safe.
The product is being developed and will be commercialized in Japan and other Pacific Rim countries by Chugai Pharmaceuticals and Kirin Pharmaceuticals under agreements with GelTex.
In a study to be published next month, Allan Collins of the University of Minnesota showed a significant improvement in morbidity and observed improved trends in mortality among Medicare patients treated with Renagel compared with patients treated with calcium binders.
The phase III trials measured the effect of the drug on a large sample of hundreds of patients over several years.
Kidney-failure market Inthere were nearly 1 million patients in the United States with chronic renal failure; of those, an estimatedrequired dialysis to survive. Its leading product in development is a toxin binder known as GT for Clostridium difficile C.
The uncertainty surrounding FDA approval was compounded by the impact of changing regulations and governmental policies as well as by the arrival of competing compounds.
In pre-clinical studies, these compounds have shown they can inhibit lipase with a potency in the range of that of known inhibitors. Two years later, the company launched a recombinant form of Ceredase and started to enter new markets—surgical, pharmaceutical, diagnostic, and genomic products—through strategic alliances, joint ventures, and acquisitions.
Genzyme expects that this technology will be a consistent and productive source of product candidates to feed its therapeutics pipeline.
The acquisition is expected to begin adding to earnings in As Carpenter commented in an interview for the Boston Business Journal:would combine capabilities of Genzyme and GelTex Pharmaceuticals to market GelTex’s first product, RenaGel.
GelTex was an early-stage biotech research company with two products in its pipeline. GelTex had neither the capital nor the marketing organization to launch RenaGel. Early inGenzyme Corporation began negotiations with Geltex Pharmaceuticals in an attempt to launch a joint venture to market Geltex's first product, RenaGel.
Geltex was a young biotech research company with only two products in its pipeline, and they didn't have the resources necessary to. Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
GelTex had 45 employees at the time of the joint-venture deal with Genzyme and had committed to a strategic alliance for RenaGel with two partners: Chugai Pharmaceuticals for marketing and distribution in Asia, and Dow Chemical for drug manufacturing.
Early inGenzyme Corporation began negotiations with Geltex Pharmaceuticals in an attempt to launch a joint venture to market Geltex’s first product, RenaGel. Genzyme General (Cambridge, MA) and GelTex Pharmaceuticals Inc.
(Waltham, MA) announced on September 11 that Genzyme will acquire GelTex.
The transaction is expected to close in the fourth quarter, pending approval from regulatory agencies and .Download