Siga's smallpox drug granted Orphan Drug status by FDA
SIGA Technologies, Inc., a biotechnology company, engages in the discovery, development, and commercialization of products for use in defense against biological warfare agents, such as smallpox and arenaviruses. It discovers vaccines and pharmaceutical agents to fight pathogens. The company primarily develops the SIGA-246, an orally administered antiviral drug that targets the smallpox virus. SIGA Technologies also has antiviral programs targeting other Category A viral pathogens, including arenaviruses, lymphocytic choriomeningitis virus, Dengue, the filoviruses, Ebola, and Marburg. In addition, it develops antibiotics to address bacterial adhesion organelles. SIGA Technologies has license agreements and collaborative research arrangements with National Institutes of Health, U.S. Army Medical Research and Material Command, U.S. Army Medical Research Acquisition Activity, Saint Louis University, Oregon State University, and Regents of the University of California. The company was founded in 1995 and is headquartered in New York City.
By Gabriel Madway
Last Update: 2:38 PM ET Dec 20, 2006
SAN FRANCISCO (MarketWatch) -- Siga Technologies Inc. (SIGA :3.99, +0.10, +2.5%) said Wednesday the Food and Drug Administration has granted Orphan Drug designation to SIGA-246, the company's drug for the prevention and treatment of smallpox. The designation will entitle the New York-based company to seven years of marketing exclusivity in the United States if SIGA-246 becomes the first drug of its kind to obtain marketing approval from the FDA.
On March 19, 2007, SIGA Technologies, Inc., a Delaware corporation ("SIGA"), issued a press release pursuant to which it announced that a toddler who inadvertently contracted eczema vaccinatum has been treated with ST-246, SIGA's lead smallpox drug candidate, pursuant to an Emergency Investigational New Drug Application (IND) granted by the U.S. Food and Drug Administration (FDA), and is now improving.
A copy of the press release is attached hereto as Exhibit 99.1, which is incorporated into this Item 8.01 by reference.
SIGA's Smallpox Drug Candidate Administered to Critically Ill Human Patient Monday March 19, 8:00 am ET
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News ) announced today that a toddler who inadvertently contracted eczema vaccinatum has been treated with ST-246, SIGA's lead smallpox drug candidate, pursuant to an Emergency Investigational New Drug Application (IND) granted by the U.S. Food and Drug Administration (FDA), and is now improving.
Due to the absence of smallpox disease in the general human population, the efficacy of ST-246 has been investigated in animals to date. However, the federal Centers for Disease Control and Prevention (CDC) was recently notified that a child had contracted eczema vaccinatum, a potentially deadly illness that can manifest with a generalized skin rash similar to smallpox, following accidental contact with an open skin lesion on a relative who had recently been vaccinated for smallpox using a live vaccinia virus vaccine. The patient developed late-stage manifestations of the disease, including hemorrhagic lesions, respiratory failure, shock and high viral loads in the blood. CDC facilitated communication between SIGA and FDA resulting in provision of ST-246 for the patient under an Emergency IND.
"There is a clear need for an effective therapeutic against smallpox and other orthopox virus diseases," said Dr. Eric A. Rose, Chief Executive Officer of SIGA and Executive Vice President for Life Sciences at MacAndrews & Forbes Holdings Inc., SIGA's largest shareholder. "We will continue to work closely with CDC and FDA to obtain the earliest possible approval for ST-246, so that it can be purchased and widely available whenever needed."
SIGA believes that ST-246 is the most advanced-stage treatment for smallpox currently in development. ST-246 represents a new approach to achieve a novel, orally active, antiviral therapeutic. It has already demonstrated significant antiviral activity in various animal trials, including the complete elimination of human smallpox virus or the related monkeypox virus in several primate studies. SIGA has not yet filed for final regulatory approval for ST-246, although FDA has granted "fast-track" status for the development and FDA review of this product.
Development of ST-246 has been supported by grants from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, the CDC and the Department of Defense.
About SIGA Technologies, Inc.
SIGA Technologies is applying viral and bacterial genomics and sophisticated computational modeling in the design and development of novel products for the prevention and treatment of serious infectious diseases, with an emphasis on products for biological warfare defense. SIGA believes that it is a leader in the development of pharmaceutical agents and vaccines to fight potential biowarfare pathogens. In addition to smallpox, SIGA has antiviral programs targeting other Category A pathogens, including arenaviruses (Lassa fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis), dengue virus, and the filoviruses (Ebola and Marburg).
For more information about SIGA, please visit SIGA's Web site at www.siga.com .
Monday's Small-Cap Winners & Losers By Sarina Penn TheStreet.com Staff Reporter 3/19/2007 2:10 PM EDT
Siga Technologies ( SIGA - Cramer's Take - Stockpickr ) jumped 18% after the Food and Drug Administration made an emergency allowance for its ST-246 smallpox drug candidate to treat a child who had been accidentally infected with eczema vaccinatum, a possibly fatal disease with similarities to smallpox. Shares of New York-based Siga were rising 83 cents to $5.35.
Research Frontiers ( REFR - Cramer's Take - Stockpickr ) was up nearly 15% after selling a nonexclusive license to SmartGlass International for its light-control technology used in windows, skylights, doors and other products. Terms weren't disclosed. Shares of the Woodbury, N.Y., company were gaining $1.30 to $10.22.
Footwear retailer Genesco ( GCO - Cramer's Take - Stockpickr ) was higher after Women's Wear Daily reported that Foot Locker ( FL - Cramer's Take - Stockpickr ) is readying a bid of between $44 and $46 a share for the Nashville-based company, which might be announced as early as this week. The publication also reported that Foot Locker isn't ruling out a hostile takeover. Genesco shares were adding $3.25, or 8.2%, to $42.85. Foot Locker was up 2 cents to $22.11.
Cleveland Biolabs ( CBLI - Cramer's Take - Stockpickr ) slid after announcing it sold $30 million worth of shares in a private placement to accredited investors. Shares were off $1, or 9.9%, to $9.19.
CHICAGO, March 19 (Reuters) - An experimental pill appears to be helping a toddler who had a near-fatal skin reaction to his father's smallpox shot, doctors said on Monday.
The drug, an antiviral made by Siga Technologies (SIGA.O: Quote , Profile , Research ) called ST-246, worked when more conventional treatment failed, the doctors said.
The child, still in critical condition at the University of Chicago's Comer Children's Hospital, developed the rare, serious, reaction eczema vaccinatum after being with his father, a soldier vaccinated for deployment in Iraq.
"He's making slow improvement every day. He's still in the pediatric intensive care unit," said Dr. John Marcinak, pediatric infectious disease specialist at the hospital.
"His skin lesions appear to be slowly healing."
The 2-year-old Indiana native was admitted to the hospital on March 3, and the U.S. Centers for Disease Control and Prevention confirmed he was infected with the virus used in the smallpox vaccine.
Smallpox vaccines do not use the smallpox virus, but instead use a related virus called vaccinia that is weakened but can still infect some people. Quote , Profile , Research ). Reuters Pictures
The child was given an intravenous form of vaccinia immune globulin -- developed in the 1960s to treat complications of smallpox vaccinations. He also received a treatment of the antiviral drug cidofovir, made by Gilead Sciences Inc (GILD.O:
But the child was still failing. His mother also had a rash but was not ill and his father reported no adverse reaction.
By then, Marcinak and his team were having daily conference calls with the CDC, various health departments and the Department of Defense. During one, the CDC suggested the hospital try the experimental drug.
The drug has helped monkeys infected with smallpox, but its effectiveness has not been proven in humans.
The child's case is the first report of the serious skin reaction since vaccination against smallpox resumed in 2002, CDC pox virus expert Dr. Inger Damon said. She said he may already have had eczema -- which makes patients especially vulnerable to a reaction to the smallpox vaccine.
The smallpox virus once killed 30 percent of its victims, and disfigured many others. A global vaccination campaign eradicated the disease in 1979.
But some samples remain in government freezers and experts believe it could be used as a biological weapon. The United States resumed vaccinating some people in 2002, including 40,000 civilian health workers and hundreds of thousands of military personnel.
SIGA shares closed up nearly 14 percent on NASDAQ on Monday, at $5.15 a share.
SIGA Technologies Retains Cameron Associates as Investor Relations Advisor Thursday March 22, 1:00 pm ET
Company Seeks to Generate Greater Investor Awareness as its ST-246 Smallpox Treatment Continues Through the FDA Approval Process
NEW YORK--(BUSINESS WIRE)--SIGA Technologies, Inc. (NASDAQ: SIGA - News ), a company specializing in the development of pharmaceutical agents and vaccines to fight biowarfare pathogens, announced today that it has retained Cameron Associates, Inc., a full-service investor relations firm, as its investor relations advisor. Cameron has been retained to assist Siga in broadening its financial market presence and in establishing new relationships with the investment community.
"As we continue to progress through the FDA approval process for our ST-246 smallpox treatment, we face greater demands in communicating with and educating our investor community," stated Dr. Eric Rose, Chairman and Chief Executive Officer of SIGA. "We will be looking to Cameron Associates to help us take a more active stance in how we communicate our value proposition and our business strategy to a wider audience, while providing increased corporate transparency to investors and the public at large. We believe that Cameron's experience with companies of our size and its knowledge of the investment industry will serve our organization and our shareholders well."
Recent Corporate Developments:
February 13, 2007 - SIGA announces launch of a 21-day, escalating, multiple-dose, Phase 1 safety, tolerability and pharmacokinetics human trial of ST-246, its lead smallpox drug
January 31, 2007 - Eric A. Rose, M.D. elected as Chairman of the Company's Board of Directors and CEO effective March 1, 2007
December 20, 2006 - FDA Orphan Drug designation granted for ST-246
November 10, 2006 - SIGA announces $2.3MM in new contracts with the U.S. Air Force
November 9, 2006 - SIGA announces successful results of two independent primate trials (National Institute of Allergy and Infectious Diseases (NIAID) and U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) conducted studies) of its smallpox drug ST-246
October 19, 2006 - SIGA announces $9 million private placement
October 18, 2006 - ST-246 is the first drug ever to demonstrate 100% protection against human smallpox disease in a primate trial conducted at the federal Centers for Disease Control and Prevention (CDC).
October 4, 2006 - SIGA receives 3-year, $16.5 million contract from the NIAID to advance the development of ST-246
September 12, 2006 - SIGA receives $6.0 million grant from the NIAID to support the development of antiviral drugs for Lassa fever virus, which is an arenavirus
August 2, 2006 - SIGA announces $4.8 million grant for the development of ST-246
July 13, 2006 - Successful completion of the initial human safety trial for ST-246
December 13, 2005 - FDA accepts Investigational New Drug (IND) application to begin clinical trials of ST-246 and grants the drug "Fast Track" status
"With the receipt of over $20 million in grants, the SIGA Technologies team has been working very hard to bring ST-246, as well as other drugs, through the development and FDA approval process. We believe that ST-246 is a compelling product in the battle against biological terrorism, which has broad-ranging implications for a company such as ours. In conjunction with Cameron Associates, we look forward to bringing news of our progress in this and other endeavors to the investment community," Rose concluded.
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