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Chiron Grants Nonexclusive HCV License to InterMune & Limits HCV Research
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"Agreement Further Enables Development of HCV Therapeutics to Address Disease"
This is press release issued by Chiron corp. Following the press release is a notice that the FDA was investigating Chiron for complaints that they hinder HCV research due to requiring licensing fees for any HCV therapeutic research. Jules Levin, NATAP
EMERYVILLE, Calif.--(BUSINESS WIRE)--09/13/2004--Chiron Corporation (Nasdaq:CHIR) today announced that Chiron had granted a nonexclusive license to InterMune, Inc. for the research, development and commercialization of therapeutics against hepatitis C virus (HCV) drug targets. Financial terms of the agreement were not disclosed.
"We are pleased to have worked with InterMune to reach this agreement," said Ursula Bartels, Chiron's general counsel. "Making our HCV technology available to develop small-molecule therapeutics will help to address the toll from this terrible disease. Chiron is committed to meeting this major medical need, both through its broad licensing policy and through its own small-molecule therapeutic program."
In June, Chiron granted a nonexclusive license to its HCV technology to Prosetta Corporation, the first agreement providing a "no entry cost" option for use of the company's HCV technology. The licensing terms are intended to provide flexibility to licensees by confirming the availability of no up-front or annual payments. In 2003, Chiron granted nonexclusive licenses to its HCV technology to Boehringer-Ingelheim International GmbH, Gilead Sciences, Pfizer, Rigel Pharmaceuticals, and Vertex Pharmaceuticals. The company has also granted a license to F. Hoffmann-LaRoche for use in nucleic acid testing to screen whole blood donations for HCV. Chiron's efforts to combat HCV include the Procleix(R) System, which screens whole blood donations for HCV, HIV-1, and hepatitis B, and which Chiron markets and develops in collaboration with Gen-Probe Incorporated. In addition, Chiron is currently conducting two Phase I trials for HCV vaccine candidates and has a small-molecule therapeutic in pre-clinical testing.
About Hepatitis C
In 1987, Chiron scientists Michael Houghton, Ph.D.; Qui-Lim Choo, Ph.D.; and George Kuo, Ph.D., cloned and first identified HCV as the cause of transfusion-related non-A, non-B hepatitis. This breakthrough marked the first time a virus was cloned before it had been grown in tissue culture or otherwise isolated. The Chiron scientists received the prestigious Lasker Award in recognition of this discovery. Since the initial work, Chiron has been granted more than 100 HCV-related patents in over 20 countries, including patents directed to hepatitis C polypeptides encoded throughout the genomes of HCV. Such polypeptides can be used in a variety of medical applications, including blood screening, clinical diagnosis, vaccines and as therapeutic targets for drug screening. More than fifteen companies have been granted nonexclusive licenses to Chiron's HCV technology for drug screening and diagnostic purposes, including Bristol-Myers Squibb, GlaxoSmithKline, Japan Tobacco Inc. and Gilead.
About Chiron
Through its global Blood Testing, Vaccines and BioPharmaceuticals businesses, Chiron Corporation addresses human suffering with more than 50 diverse products to detect, prevent and treat disease worldwide. The company's consistent success has come from its pioneering science, skill in delivering innovations in biotechnology and disciplined business approach. Chiron believes that science has the power to improve people's lives and harnesses that power to transform human health.
This year, Chiron Vaccines celebrates 100 years of advancing medicine with the anniversary of two founding companies. In 1904, Emil von Behring and Achille Sclavo independently started companies in Germany and Italy, respectively, dedicated to the research, development and manufacture of vaccines to protect humanity from infectious disease. As the fifth-largest vaccine manufacturer in the world, Chiron remains dedicated to the legacies of von Behring and Sclavo to prevent disease and develop new vaccines to improve human health globally.
This news release contains forward-looking statements, including statements regarding sales growth, product development initiatives, new product indications, new product marketing, acquisitions, strategies, policies, and in- and out-licensing activities that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-Q for the quarter ended June 30, 2004, and the form 10-K for the year ended December 31, 2003, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, stock-price and interest-rate volatility, and marketing effectiveness. In particular, there can be no assurance that Chiron will increase sales of existing products, successfully develop and receive approval to market new products, or achieve market acceptance for such new products. There can be no assurance that Chiron's out-licensing activities will generate significant revenue, nor that its in-licensing activities will fully protect it from claims of infringement by third parties. In addition, the company may engage in business opportunities, the successful completion of which are subject to certain risks, including shareholder and regulatory approvals and the integration of operations.
Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today.
NOTE: Procleix is a registered trademark of Chiron Corporation.
Feds review complaints that Chiron hinders HCV research
By Paul Elias / AP Biotechnology Writer
Saturday, February 28, 2004
http://www.detnews.com/2004/health/0402/29/health-76978.htm
SAN FRANCISCO -- Industry scientists have complained for years that Chiron Corp. has hindered the fight against hepatitis by creating a virtual commercial monopoly over drug research.
Now, federal health officials are reviewing the 14-year-old government agreement that gave Chiron so much control over research that seeks to help the 170 million people afflicted with the disease.
Chiron holds 100 patents in 20 countries related to hepatitis C. Competitors complain they've abandoned plans to enter the field because Chiron demands too much money to access its technology. Chiron has successfully sued many companies for infringing its patents related to the virus.
Those patents credit Chiron scientists with discovering the hepatitis C virus -- despite the fact that a scientist from the Centers for Disease Control and Prevention contributed much to the original research.
But the CDC signed away to Chiron most of the commercial control of the virus for a little more than $2.2 million in 1990.
"There have been a number of individuals in the scientific community that are involved in the prevention, treatment and research of hepatitis C that have said the agreement is having an impact on the scientists' ability to address hepatitis C," said CDC spokesman Tom Skinner. "We are looking into whether or not the agreement we have in place with Chiron is having an impact and, if so, what kind of impact."
Skinner couldn't provide any names of complaining scientists, details of what was being reviewed or what projects may be affected. He said he was unsure if the CDC's inquiry would ever expand beyond informal discussions.
Skinner's not even sure what recourse the CDC may have 14 years after signing the contact and said other CDC officials weren't available to comment.
What's more, many companies involved in hepatitis C research are reluctant to publicly discuss Chiron's tactics. Most have been sued at one time or another by Chiron, and several have settled their lawsuits in recent months and say they just want to get on with the research.
Still, the CDC concern highlight the ongoing tension between the U.S. patent system and free scientific inquiry.
The CDC inquiry also illustrates how sophisticated the government and universities have become in the last decade with intellectual property originating in their labs.
The CDC, for instance, claims ownership of the SARS virus and its entire genetic content after its researchers helped map the bug's genome. Rather than try to profit from it, the CDC wants to prevent others from monopolizing the field the way Chiron does with hepatitis C.
"The intellectual property was pretty new and at that time everybody was learning how to deal with it," said former CDC official Walter Dowdle, one of three government officials to sign the Chiron deal. "This was very early in the intellectual property business between companies and government."
Though academic scientists say they've encountered few problems working with the company, they still can't turn their discoveries into drugs without industry help.
Chiron said the CDC hasn't notified it of any review and defended its handling of its patents. Spokesman John Gallagher said the Emeryville-based company has deals with 13 competitors that allow them to pursue hepatitis C drugs with Chiron's patented technology.
Gallagher said Chiron makes its technology freely available to nonprofit research scientists, many of whom credit the company with funding hepatitis C science meetings and supporting academic endeavors.
"I would challenge anyone to show us anyone who has done as much as Chiron has," Gallagher said.
Hepatitis C is a blood-borne virus, often contacted by sharing needles, and can lead to chronic liver disease and liver cancer. Disease rates have fallen in the United States but are on the rise in developing nations.
Chiron's scientists in 1987 developed a technique to clone multiple versions of the elusive hepatitis C virus, which allows researchers to easily generate billions of viruses to research. Chiron received a patent for the discovery three years later.
The CDC filed a competing patent application, listing government scientist Dan Bradley as a co-discoverer. But in 1990, the government and Bradley withdrew their claims as co-inventors and renounced all rights after Chiron paid the CDC $1.9 million and Bradley $337,500.
In 1994, Bradley unsuccessfully sued Chiron in an attempt to undo the deal. He dropped his quest after losing a federal appeal four years later. Bradley, who has left the CDC, couldn't be reached through his lawyer.
"I have always thought Dan Bradley got a raw deal by being excluded from the patent," Scripps Research Institute researcher Dr. Frank Chisari said in an e-mail interview. "That dispute was settled a long time ago after a great deal of pressure by Chiron lawyers."
While Chisari said he had no problems personally with Chiron, he added: "I believed then and I believe now that Chiron scientists wouldn't have cloned the viral genome when they did if Dan Bradley and his colleagues at the CDC hadn't provided them with meticulously pedigreed material containing the genome."
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