Press Releases

Expanded label marks CSL's ongoing support to US Health and Human Services' pandemic influenza mitigation plan

KING OF PRUSSIA, Pa.--(BUSINESS WIRE)-- CSL Biotherapies, a subsidiary of CSL Limited (ASX: CSL), one of the world's leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company's application for accelerated approval of its seasonal flu vaccine, Afluria(R) (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older. This approval also included labeling for CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine which is an inactivated influenza virus vaccine now indicated for active immunization of persons ages 6 months and older against influenza disease caused by pandemic (H1N1) 2009 virus. This indication is based on the immune response elicited by the seasonal trivalent Influenza Virus Vaccines manufactured by CSL (Afluria(R)). CSL's Influenza A (H1N1) 2009 monovalent vaccine and Afluria are manufactured by the same process. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Afluria.

"The FDA's licensure of CSL Biotherapies' thimerosal-free monovalent pandemic H1N1 vaccine for use in children aged 6 months and older is a critically important milestone," said Paul Perreault, President, CSL Biotherapies. "The U.S. Centers for Disease Control has identified young children as a priority group for pandemic H1N1 vaccine administration. CSL Biotherapies is proud to now be in a position to help in protecting this most vulnerable population of Americans."

CSL's pandemic H1N1 vaccine is available in both thimerosal-free (i.e., preservative-free), single-dose, pre-filled syringes and multi-dose vial (thimerosal containing) formulations, as directed by the U.S. government. The thimerosal-free formulation is available in two dosages:

    --  A 0.25 mL single-dose, pre-filled syringe for use in children 6-35
        months of age;
    --  A 0.5 mL single-dose, pre-filled syringe for use in persons 36 months of
        age and older

About CSL's Influenza A (H1N1) 2009 Monovalent Vaccine

CSL's pandemic H1N1 vaccine was licensed by the FDA for active immunization of adults on September 15, 2009. CSL's Influenza A/H1N1 2009 vaccine is manufactured by a process identical to the one used in manufacturing CSL's FDA-licensed trivalent seasonal influenza vaccine. CSL's pandemic H1N1 influenza vaccine is a purified, inactivated, monovalent influenza virus propagated in embryonated chicken eggs.

CSL Biotherapies is conducting clinical trials in the U.S. of its monovalent H1N1 vaccine in children using a thimerosal-free (i.e., preservative-free) formulation. The studies were designed to determine the safety of CSL's vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in children. The studies will also evaluate the incidence of adverse events up to six months after first injection. The clinical studies are sponsored by CSL Biotherapies and funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority.

Important Safety Information

CSL's Influenza A (H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 6 months of age and older against influenza disease caused by the pandemic (H1N1) 2009 virus. The indication is based on the immune response elicited by the seasonal trivalent influenza virus vaccine manufactured by CSL (Afluria). CSL's Influenza A (H1N1) 2009 monovalent vaccine and Afluria are manufactured by the same process. CSL's H1N1 vaccine should not be administered to individuals with hypersensitivity to eggs, neomycin, polymyxin or anyone who has had a life-threatening reaction to previous influenza vaccination. Vaccination with the H1N1 vaccine may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barre syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give the H1N1 vaccine should be based on careful consideration of the potential benefits and risks. In adults, the most common injection-site reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. In children, the most common local (injection-site) adverse reactions observed in a clinical study with Afluria were pain, redness and swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat. Full prescribing information can be found at www.cslbiotherapies-us.com.

About Influenza and the Novel Influenza A/H1N1 Virus

The emergence of the novel H1N1 flu, which was first detected in humans in April 2009, has proven to be very contagious, spreading worldwide, and has led to the World Health Organization declaring a pandemic on June 11, 2009.

CSL Biotherapies has developed and produced its monovalent Influenza A/H1N1 2009 vaccine drawing on four decades of experience with its proven vaccine production processes.

About CSL Biotherapies

CSL Biotherapies has an initial contract worth $180 million to deliver bulk H1N1 vaccine antigen to the U.S. Health and Human Services Department (HHS), with an option for filling and packaging services out of CSL's Kankakee, Illinois and Marburg, Germany facilities. These facilities have the capability to produce seasonal and pandemic influenza vaccines in thimerosal-free, pre-filled, single-use syringes and in multi-dose vials containing preservative.

The United States headquarters of CSL Biotherapies are located in King of Prussia, PA. Its parent company, CSL Limited, in Melbourne, Australia, has made a $60 million (U.S.D.) investment in plant and equipment to double the manufacturing capacity of the company's Melbourne facility to 40 million doses per season; it is now one of the world's largest influenza vaccine facilities for global markets. CSL Biotherapies, which shares its United States headquarters with its sister company, CSL Behring, is commercializing influenza vaccine products globally.

The CSL Group, which includes CSL Biotherapies, CSL Research & Development, CSL Bioplasma, and CSL Behring, has more than 10,000 employees and operates in 27 countries worldwide. For more information, visit us at www.cslbiotherapies-us.com, or call 1-888-435-8633.

    Source: CSL Biotherapies

DEARBORN, Mich., Nov. 11 /PRNewswire/ -- Ford and Coke Zero are starting off the final race weekend of the season with South Florida's largest NASCAR themed event, Coke Zero Racefest at the Seminole Hard Rock Hotel & Casino in Hollywood, Fla., from 3-11 p.m. on Thursday, November 19, 2009.

The free outdoor event will give fans a chance to see their favorite stars of the Ford and Coca-Cola racing families up close. The event includes appearances by Greg Biffle, Bill Elliott, Matt Kenseth, David Ragan, Dale Jarrett, Elliott Sadler, Ned Jarrett, Kyle Petty, Bobby Labonte, Bobby Allison and more!

Throughout the day, fans of all ages will be able to enjoy live music, interactive racing displays, show cars, team merchandise, vehicle displays, art work by NASCAR artist Sam Bass, and special performances from the Florida Panthers Ice Dancers and Marlins Mermaids. Younger race fans can visit the "Ford Fun Zone" during the day to play games and win prizes.

In addition this year, Coke Zero Racefest is giving car enthusiasts the opportunity to see classic Mustangs from the Ft. Lauderdale Mustang Club, and also test-drive a new 2011 Ford Fiesta.

Coke Zero Racefest is the centerpiece of a weeklong schedule of NASCAR-themed concerts, festivals, parties, fund-raisers, and special events at a variety of locations throughout South Florida. These events culminate with Ford Championship Weekend, November 20-22, the season finales for all three NASCAR series.

Fans who haven't purchased their tickets for Ford Championship Weekend can do so at Coke Zero Racefest or online at www.thechampionshiptrack.com.

For more information on Coke Zero Racefest or on Ford Championship Weekend please contact Jim Brumfield at 313-203-7279, or via email at jbrumfield@pcgcampbell.com.

SOURCE Coke Zero Racefest

NEW YORK--(BUSINESS WIRE)-- Fitch Ratings assigns an 'A-' rating to Philadelphia Parking Authority's (PPA) approximately $130 million airport parking revenue bonds, series 2009. Bond proceeds will be used to refund all of the authority's outstanding 1999 airport parking revenue bonds and fund a debt service reserve. The authority expects pricing to occur during the week of Nov. 16. In addition, Fitch affirms PPA's approximately $195 million airport parking revenue bonds outstanding at 'A-'.

The Rating Outlook on all debt is Stable.

The 'A-' rating reflects the authority's solid operating profile and historically stable demand given its proximity to Philadelphia International Airport. The rating also reflects the authority's monopolistic position as the sole provider of on-site parking at the airport, and demonstrated history of rate-making flexibility. Off-setting credit concerns include a multi-year downward trend in parking transactions, an ample supply of competitively priced off-site airport parking options which primarily competes with the airport for economy parking demand, substantial dependency on a relatively narrow stream of revenue, and low liquidity levels stemming from annual transfers of surplus cash flow to the City of Philadelphia. Annual transfers consistently range from $30 to $35 million, representing approximately 50% of the authority's gross operating revenues in recent fiscal years.

The authority's historical operating profile has been stable. Parking revenues grew from $43 million in 2003 to $70.5 million in 2008, at an average annual rate of 9%. The growth in operating revenues primarily reflects the authority's history of raising parking rates as well as its established although uneven demand for airport parking. PPA recorded approximately 2.5 million parking transactions in FY 2009. Following healthy transaction growth during fiscal years 2003-2006, parking transactions have fallen by roughly 15% over the past three years. Recently both transactions and revenue performance have been affected by the economic downturn. Transactions fell to 2.5 million in FY 2009 from 2.8 million in FY 2008 (a year over year decrease of 11%), driven by reductions in enplanements at the airport as well as a decreasing correlation of passenger demand for onsite parking. Parking rate increases in 2008 (FY 2009) to both the economy lots and long-term garage have provided a partial revenue offset to the multi-year decline in transactions. PPA's ability to raise rates provides downside protection as transaction levels fluctuate; however, overall financial health may be pressured as demand continues to soften for short-term and medium-term parking. This situation is further exacerbated by ongoing competition for economy lots. Of the 10 private companies competing with PPA (essentially for economy parkers only), seven offer rates that are lower than the comparable PPA economy rate of $11 per day, including City tax.

Estimated annual debt service obligations on the authority's bonds are front loaded at approximately $17.5 million through fiscal 2019. In 2020 annual debt service decreases marginally to approximately $16 million and drops to approximately $14 million through fiscal 2024. Debt service steps down dramatically in fiscal 2025 to $7.5 million through the maturity of the debt (fiscal 2030). Based on projected net revenues, the authority expects debt service coverage to be near or above 2.9 times (x) in 2009 and remain above 2.5x through the life of the debt. Under various sensitivities, including material reductions in enplanements as well as reductions in travelers' demand for parking, debt service coverage remains strong near 2.0x through MADS.

The authority recently revisited its capital plan, adjusting and decreasing the level of future bonding expected in the near term, although overall sources and uses for the capital plan remain to be clarified. Funding sources now consist entirely of available cash on hand to fund the remaining $18 million in capital outlays. The authority's capital plan focuses on rehabilitation of existing infrastructure and the implementation of credit card enhancements and parking guidance systems, a new technology aimed at maximizing utilization of all the available spaces unoccupied in the parking structures. Longer-term projects focus on garage and economy parking lot expansion, although a timeline and funding sources have not been identified. As of FY 2008, the authority expended approximately $5.6 million on equipment acquisition, and expects to address structural repairs to its garages with recent $10 million in short-term borrowings. In addition, in FY 2008 the authority demolished the airport's unutilized Overseas Terminal and converted the site into an economy parking lot, adding approximately 800 economy spots to the authority's inventory.

The application of the following criteria was used to derive the rating of the above referenced bonds and are available on the Fitch Ratings web site at 'www.fitchratings.com':

--'Rating Criteria for Infrastructure and Project Finance', dated Sept. 29, 2009.

Additional information is available at 'www.fitchratings.com'.

ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: HTTP://FITCHRATINGS.COM/UNDERSTANDINGCREDITRATINGS. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON THE AGENCY'S PUBLIC WEBSITE 'WWW.FITCHRATINGS.COM'. PUBLISHED RATINGS, CRITERIA AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE 'CODE OF CONDUCT' SECTION OF THIS SITE.

    Source: Fitch Ratings

HOPKINS, MN -- (MARKET WIRE) -- 11/11/09 -- Viper Motorcycle Company (OTCBB: VPWI), a wholly owned subsidiary of Viper Powersports Inc., is pleased to announce the release of the 2010 Viper Diamondback 152. 2010 models are a continued result of ongoing development and a joint venture effort with Ilmor Engineering. Product availability will be limited as we move into 2010 and prepare for a formal industry wide launch.

Terry Nesbitt, President of Viper, stated, "The first 2010 models are ready for release and will be shipped immediately to key dealers such as Rick Fairless's Strokers Dallas, Eddie Trotta's Thunder Cycle, Low Country Customs, Ronnie's Harley Davidson, Creagers Cycle Center, Extreme Customs, Victory of Grand Rapids and more."

Nesbitt added, "In an ongoing effort to increase our exposure and add overall value to the Viper brand, we are announcing an innovative merchandising campaign designed to give Viper motorcycles their own space, enabling our brand identity to grow. We are providing to our dealers a branded motorcycle showroom display stand. The high performance 2010 Diamondback Super Cruiser has no equal and will be appropriately displayed. As we move forward preparing for a formal launch, including additional models and large scale production, we will continue to make available to our dealers the best and most effective merchandising tools available in order to increase value in the Viper brand."

Viper Powersports designs, manufactures and markets a line of premium American V-Twin Super Cruiser motorcycles, V-Twin aftermarket engines and other related aftermarket products through an independent dealer network. Joint venture partner Ilmor Engineering (www.ilmor.com) provides technical developmental support for the proprietary 152 cubic inch Viper V-Twin engine, utilizing their 25 years of engine design expertise, ensuring Viper's long term success as America's newest domestic OEM of motorcycles. Viper Powersports and Viper Motorcycle Company's websites are www.viperpowersports.com and www.vipermotorcycle.com.

The foregoing material may contain forward-looking statements. We caution that such statements may be subject to uncertainties and that actual results could differ materially from the foregoing statements. Readers accordingly should not place undue reliance on these forward-looking statements which do not reflect anticipated or unanticipated events or circumstances occurring after the date of these forward-looking statements.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1112818

FOR MORE INFORMATION CONTACT:
Terry Nesbitt
President
Viper Motorcycle Company
Tel: 612-328-1558
E: tnesbitt@vipermotorcycle.com

NEW YORK--(BUSINESS WIRE)-- Fitch Ratings affirms and assigns a Stable Rating Outlook to the senior student loan notes of the Pennsylvania Higher Education Assistance Agency (PHEAA) series 2006-2 Trust. The trust has been producing excess spread, and the parity for the senior notes are at 104.69% as of Sept. 30, 2009 and increasing. A complete list of rating actions follows at the end of this press release.

Fitch's Global Structured Finance Rating Criteria were used to review the ratings and the affirmation is based on the performance of the trust in-line with the expectation. The existence of auction rate securities has not had a significant impact on the trust performance. The Stable Outlook is based on Fitch's expectation that with the significant buildup of parity for the senior notes the ratings will remain stable for the next two years. The subordinate student loan notes, which are currently rated 'A', will be reviewed separately upon the completion of the updated basis risk analysis.

The collateral supporting the PHEAA series 2006-2 Trust notes consist entirely of federally guaranteed student loans originated under the Federal Family Education Loan Program (FFELP). FFELP loans are guaranteed at least 97% of principal and accrued interest, depending on the loan origination date. The loans are 100% serviced by AES, which does not carry a Fitch Seller/Servicer Rating.

Fitch affirms the ratings and assigns Outlooks to the following senior classes of Pennsylvania Higher Education Assistance Agency series 2006-2 Trust notes:

--Senior class A-1 at 'AAA'; Outlook Stable;

--Senior class A-2 at 'AAA'; Outlook Stable;

--Senior class A-3 at 'AAA'; Outlook Stable.

The following applicable criteria report is available on Fitch's web site at 'www.fitchratings.com': 'Global Structured Finance Rating Criteria' dated Sept. 30, 2009.

Additional information is available at 'www.fitchratings.com'.

ALL FITCH CREDIT RATINGS ARE SUBJECT TO CERTAIN LIMITATIONS AND DISCLAIMERS. PLEASE READ THESE LIMITATIONS AND DISCLAIMERS BY FOLLOWING THIS LINK: HTTP://FITCHRATINGS.COM/UNDERSTANDINGCREDITRATINGS. IN ADDITION, RATING DEFINITIONS AND THE TERMS OF USE OF SUCH RATINGS ARE AVAILABLE ON THE AGENCY'S PUBLIC WEBSITE 'WWW.FITCHRATINGS.COM'. PUBLISHED RATINGS, CRITERIA AND METHODOLOGIES ARE AVAILABLE FROM THIS SITE AT ALL TIMES. FITCH'S CODE OF CONDUCT, CONFIDENTIALITY, CONFLICTS OF INTEREST, AFFILIATE FIREWALL, COMPLIANCE AND OTHER RELEVANT POLICIES AND PROCEDURES ARE ALSO AVAILABLE FROM THE 'CODE OF CONDUCT' SECTION OF THIS SITE.

    Source: Fitch Ratings