COPENHAGEN, Denmark and WASHINGTON, Aug. 26 /PRNewswire/ -- International biopharmaceutical company Bavarian Nordic announced today its interim results for the six-month period ending 30 June, 2004, and other key developments.
Bavarian Nordic noted particular progress has been made to date on their safe, third generation smallpox vaccine program in the US:
The US Food and Drug Administration (FDA) granted Bavarian Nordic an Investigational New Drug (IND) application for IMVAMUNE(TM) to enter further clinical trials. The first-ever trial with IMVAMUNE(TM) in persons with atopic disorders (ie. eczema) is underway. Results from a Phase II study showed that IMVAMUNE(TM) has an excellent safety profile at all three dose levels tested. All study volunteers sero-converted after 2 vaccinations at all doses. Bavarian Nordic submitted its proposal on RFP-2 to the National Institute of Health (NIH) in February. The award announcement is expected in September 2004. Global manufacturing and marketing collaboration with GlaxoSmithKline on IMVAMUNE(TM) established. The US Patent and Trademark Office (PTO) issued a patent to Bavarian Nordic on MVA-BN(R). The patent covers the MVA-BN(R) virus and derivatives thereof exhibiting similar properties, including its use as a smallpox vaccine (IMVAMUNE(TM)), and vector technology for development of recombinant vaccines for the prevention and treatment of other diseases. The US Food and Drug Administration (FDA) granted “fast track” status for IMVAMUNE(TM) (the first and only smallpox vaccine candidate to receive this designation). Report for the period 1 January - 30 June, 2004 Smallpox Vaccine Franchise IMVAMUNE(TM)
In February, Bavarian Nordic submitted its proposal on RFP-2 to the NIH. RFP-2 calls for the production of 3 million doses of MVA using the final validated production process, further clinical development, and validation of animal models. The announcement of the RFP-2 award is expected in September 2004.
In March, the company announced that it had selected IMVAMUNE(TM) as the brand name for its MVA-BN(R) smallpox vaccine.
The US FDA granted Bavarian Nordic an Investigational New Drug (IND) application for IMVAMUNE(TM) to enter further clinical trials. Accordingly, the company started for the first time ever a trial with an MVA vaccine in 60 individuals with atopic disorders in Europe. Persons with atopic disorders, such as eczema, are at risk of suffering potentially severe side effects after vaccination with first and second generation smallpox vaccines.
Earlier in the year, the company reported on a Phase II study which showed an excellent safety profile for IMVAMUNE(TM) at all three doses levels. No serious adverse reactions were reported. These results will support the planned product registration of IMVAMUNE(TM).
A Phase I trial comparing IMVAMUNE(TM) with DryVax(R) (traditional smallpox vaccine) in 90 healthy volunteers is currently underway in the US. Under the auspices of the NIH, this trial will investigate whether the immune response against IMVAMUNE(TM) protects against a subsequent challenge with a DryVax(R) vaccination. Results are expected to be announced in 2005.
Later this year, another Phase I trial which will investigate the safety of IMVAMUNE(TM) in people with HIV will start in the USA. First results are expected in 2005.
Production
During the period, Bavarian Nordic continued to intensify its activities to finalise development of an industrial manufacturing process for the production of MVA-BN(R) vaccines. The MVA-BN(R) manufacturing process has been optimized, up-scaled and standardised. The manufacturing process is expected to ready for production of vaccines on a commercial scale in 2005.
Events after the reporting period (1 July - 25 August, 2004) Global Manufacturing and Marketing
On 15 July 2004, Bavarian Nordic announced an international collaboration with GlaxoSmithKline (GSK) on the production and marketing of IMVAMUNE(TM) (Bavarian Nordic’s smallpox vaccine). GSK will manufacture and market IMVAMUNE(TM) to most international markets, including North and South America, Japan, as well as a number of EU markets including Great Britain and France. Bavarian Nordic will continue to manufacture and market IMVAMUNE(TM) to all German-speaking countries, the Nordic countries, the Baltic States, China, the Middle East and Southeast Asia.
In the United States, Bavarian Nordic will continue to take the lead in the development of IMVAMUNE(TM) under the NIH programme. Aside from this activity, the two companies will closely collaborate and act as commercial partners in future government programmes, including the forthcoming Request for Proposal 3 (RFP-3) expected to outline the US government’s purchase of up to 60 million doses of MVA smallpox vaccine. Bavarian Nordic will produce these 60 million doses of smallpox vaccine.
Patents
On 19 July 2004, Bavarian Nordic announced that it had received a patent from the US Patent and Trademark Office (USPTO) on the company’s proprietary core technology MVA-BN(R). The patent covers the MVA-BN(R) virus and derivatives thereof exhibiting similar properties, the use of MVA-BN as a smallpox vaccine (IMVAMUNE(TM) -- Bavarian Nordic’s smallpox vaccine) and the use of MVA-BN(R) as a vector technology for developing recombinant vaccines against infectious diseases such as HIV, Dengue Fever, Japanese Encephalitis, etc.
“Fast Track” Status for IMVAMUNE(TM)
On 21 July 2004, Bavarian Nordic announced that the US FDA granted fast track status for the development of IMVAMUNE(TM) as a safe smallpox vaccine, the first and only smallpox vaccine candidate to receive this designation. Fast track status gives priority review status to a registration application and allows for filing portions of the registration application ahead of others. Fast track status is intended to facilitate the development and expedite the review of new therapies that are targeted at treating serious and life-threatening conditions.
Continued Momentum in the USA
With the signing of the Project Bioshield Authorization Legislation on 21 July, President Bush secured USD 5.6 billion over the next 10 years for the purchase of next generation countermeasures against smallpox, anthrax, as well as other chemical, biological, radiological and nuclear agents.
At present there are two funding structures in the US for the development and/or acquisition of MVA smallpox vaccines. The first is the ongoing MVA smallpox vaccine research and development programme which is administered by the National Institutes of Health (NIH) and the Department of Health and Human Services (DHHS) through a series of Request for Proposals (RFP).
The second funding source is an “advanced procurement” mechanism under Bioshield which allows for the purchase of unlicensed agents and/or products for the purposes described under Bioshield. It is at the government’s discretion as to how these funds will be used; however, at present approximately USD 890 million exists for such purchases in the approved fiscal year 2004 budget, which ends September 30, 2004. With the start of the US government’s 2005 fiscal year in October 2004, an additional USD 3.4 billion has been allocated for this purpose through the end of fiscal year 2008. The remainder of the Bioshield appropriation will occur during the period 2009 to 2013.
While exact figures allocated for the purchase of MVA smallpox vaccines under Bioshield are not known, it is likely that funding for the DHHS’ RFP-3 (purchase of up to 60 million doses of MVA smallpox vaccine), expected to be issued in 2004, will come from Bioshield.
In addition to the signing of Bioshield, the US government has made considerable efforts to expedite projects under the scope of Bioshield and coordinate governmental programmes to fight bioterror. Since the start of 2004, the following US government bodies/agencies have acted on Bavarian Nordic’s MVA-BN(R) smallpox vaccine development programme:
* NIH - acceptance to review Bavarian Nordic’s proposal under RFP-2 (award announcement expected in September) * NIH - initiation of Phase I trial comparing IMVAMUNE(TM) with DryVax(R) * FDA - approval of IND to conduct further clinical studies with IMVAMUNE(TM) * PTO - granting of patent on MVA-BN(R) * FDA - granting of “fast track” status on IMVAMUNE(TM)
For more information about Bavarian Nordic and its financial results, please visit http://www.bavarian-nordic.com/Bavarian Nordic
CONTACT: United States of America: Kevin Walker of DittusCommunications, +1-202-775-1401, for Bavarian Nordic
Web site: http://www.bavarian-nordic.com/
