Neurobiological Technologies, Inc. And Nordmark Arzneimittel GmbH & Co. KG Complete GMP Snake Facility In Germany For Production Of Viprinex(TM) (Ancrod)
Published: Dec 04, 2006
EMERYVILLE, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) , today announced the completion of a snake facility in Moorrege, Germany, near Hamburg. The facility, owned and operated by NTI's partner, Nordmark Arzneimittel GmbH & Co. KG (Nordmark), houses snakes that will provide the venom used to produce Viprinex, which is being studied by NTI as a potential treatment for acute ischemic stroke.
Mr. Freiman, president and CEO of NTI stated, "A home was needed for the snakes used to produce Viprinex and we decided with Nordmark, that it was necessary to create one of the world's few GMP (good manufacturing practice) facilities for reptiles. This state-of-the-art facility currently houses 100 snakes and is expected to eventually be home to 1,500 vipers."
Mr. Freiman, added, "We joined forces with Nordmark because of their experience in dealing with biological processes, as well as animal sourced biologicals. The two companies shared the expense of this facility at a cost of 4.5 million euros. There should be no question about our commitment to this project. The resulting facility is world class and we believe meets the most stringent standards of regulatory agencies around the world. I could not be more pleased with Nordmark's hard work to bring this about."
The snakes are milked once a month and their venom will be purified at a separate facility to obtain the active ingredient of Viprinex. The venom has strong anticoagulant activities, along with the ability to break-up blood clots associated with stroke and reduces the viscosity of blood. Snakes are housed in separate rooms, each with its own air handling system, together with independent temperature and humidity controls. This is done to protect the snakes from colony infection. The snake rooms are maintained under negative pressure to prevent the release of any contaminants, including airborne viruses, into the common areas. To make the snakes feel at home, day breaks each morning at 6 a.m., when neon tube lighting is automatically switched on. This helps maintain a natural rhythm for the snakes. The temperature is kept at a constant 28 degrees Celsius and humidity levels are kept at 79 percent, which emulates the jungle environment of the snakes.
Experienced snake handlers are gowned, as if in a sterile environment, and must go through a prescribed routine to prevent contaminants from entering the snake rooms.
Viprinex (Ancrod) is currently being studied in two Phase III global trials known as Ancrod Stroke Program I (ASP-I) and Ancrod Stroke Program II (ASP-II) and is actively recruiting patients.
About Neurobiological Technologies, Inc.
NTI is a biotechnology company engaged in the business of acquiring and developing central nervous system related drug candidates. The Company is focused on therapies for neurological conditions that occur in connection with ischemic stroke, brain cancer, Alzheimer's disease and dementia . The Company's strategy is to in-license and develop later-stage drug candidates that target major medical needs and that can be rapidly commercialized. NTI's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy. For further information, please visit NTI's website at www.ntii.com
NOTE: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: risks related to clinical trials and the regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, the risks associated with the cost of clinical development efforts, and other risks detailed from time to time in our Annual Report of Form 10-K and other filings with the Securities and Exchange Commission. Actual results may differ materially from those projected. These forward- looking statements represent our judgment as of the date of the release. We disclaim any intent to update these forward-looking statements.Neurobiological Technologies, Inc.
CONTACT: Paul E. Freiman, CEO of Neurobiological Technologies, Inc.,+1-510-595-6000; or Marlon Nurse, VP of Porter, LeVay & Rose,+1-212-564-4700
Web site: http://www.ntii.com/