Omrix’s CEO Nissim Mashiach describes the vaccine as ‘an immediate treatment that can be injected directly into the muscle. Healthy people can treat themselves, solving the problem of people with limited mobility who can’t reach hospitals.’Omrix Biopharmaceuticals has won a two-year US National Institutes of Health (NIH) research grant of over $3 million to develop and manufacture an anti-smallpox first aid treatment kit. The kit will be similar to the compact chemical warfare kits containing Atropine injections which were distributed in Israel during the Gulf War.
The product – called high titer – contains a substance called vaccinia immunoglobulin (VIG) that can injected intravenously or into the muscle, Omrix Biopharmaceuticals (Israel) CEO Nissim Mashiach told Globes.
According to Mashiach, Omrix is apparently the first Israeli company to win a NIH R01-type grant, the most prestigious NIH grant for commercially applicable research.
Mashiach says current smallpox treatments are not effective since they are not readily available. In addition the current VIG treatments need professional health care assistance in order to administer the product. This treatment takes a few hours, which doesn’t exist in the case of emergency.
“If a cloud of smallpox is released in a terrorist attack, people won’t be able to walk to a hospital and lie down for a four-hour intravenous transfusion,” explains Mashiach. “An immediate treatment that can be injected directly into the muscle, similar to the Atropine injections in chemical warfare kits, is needed. Healthy people can treat themselves, solving the problem of people with limited mobility who can’t reach hospitals.”
Mashiach said no such treatment currently exists, and there are no competitors in the field. “This is a first aid preventative treatment that does not require a trained medical team.”
Omrix plans to supply the developed product to suitable entities in the U.S. The company is also developing other anti-biological warfare products and treatments for infectious diseases, such as West Nile Fever, using plasma-based antibodies. Omrix was founded in 1995, and is headquartered in Brussels, Belgium with its research and production facilities in Israel.
Mashiach told Globes that Omrix applied for the NIH grant to develop and commercialize its technology platform following contacts with “several U.S. government entities”. NIH research grants totaled $17 billion in 2002. Over half of NIH tenders are open to foreign companies. A condition to awarding a grant to a foreign company is that no U.S. company is conducting similar research.
Globes reported in May that Omrix would supply smallpox vaccine to the Israeli government and had supplied an “initial amount” of vaccine to Germany. Mashiach said, “We wanted to expand this capacity outside Israel.”
Another area in which Omrix has penetrated the American market is in specialized plasma-derived products. The company has developed the first all human derived fibrin sealant for use in liver surgery, which has just been made available in the United States. The CROSSEAL, the human protein, bovine component-free fibrin sealant developed by Omrix was approved for U.S. sales as an adjunct to hemostasis in liver surgery by the Food and Drug Administration and is marketed and distributed through an agreement with the The American Red Cross.
Crosseal, like all fibrin sealants, is derived from human blood plasma and contains the coagulation factors necessary to stop bleeding in surgical settings.
According to an Omrix release, the advantages of Crosseal can be summarized almost as quickly as Crosseal works: it achieves hemostasis quickly and safely; it is easy to prepare and easy to use with targeted delivery; lastly, it is more practical to use because there is less waste.
“Crosseal will significantly help surgeons and nursing staff save valuable time in the operating room,” says Chris Lamb, Vice President and Chief Operating Officer, American Red Cross Plasma Services. “Because Crosseal requires no reconstitution, it can be ready to use with less than one minute preparation time.”
Robert Taub, President and Chief Executive Officer of Omrix emphasized that Crosseal not only achieves hemostasis quickly, but its transparent medium provides a clear tissue field for the surgeon.
During clinical trials, Crosseal stopped bleeding significantly faster than the conventional standard of care. Its efficient hemostatic sealing reduced post-hepatic surgery complications. Crosseal consists of two ready-to-use components – BAC (biological active component) and thrombin. Crosseal delivers its active components in a simple, easy-to-use proprietary pre-assembled applicator device that can be used for both dripping and spraying.
Shipped frozen, Crosseal can be available in one minute when thawed and requires no reconstitution, special heating or stirring devices. It is stable for up to 24 hours at room temperature and, unopened, can be stored in a refrigerator for up to 30 days. It will be available in 1, 2 and 5-milliliter sizes.