Acambis lodges opposition to MVA patent; closes in on US Govt smallpox vaccine contract

Cambridge-based biotech Acambis plc (ACM.L) said today it has filed an opposition to the European patent issued to Bavarian Nordic A/S relating to the Danish company's MVA technology, MVA-BN.

MVA, Modified Vaccinia Ankara, is a mild smallpox vaccine that has been used in Europe since the late 1970s. The patent was issued on 28 December 2005 by the European Patent Office.

Acambis claims the patent is invalid. Its development partner, Baxter Healthcare SA, which makes Acambis' MVA3000 vaccine in Austria, also filed an opposition to the patent on the same grounds.

Bavarian Nordic has filed suit against Acambis in the US and in Austria alleging that Acambis has used its trade secrets in developing MVA3000 and that it is infringing its patents. Acambis says the allegations are without foundation.

The first hearing in the dispute at the International Trade Commission (ITC) in Washington ended this week.

Acambis CEO Gordon Cameron (pictured) said: "We strongly believe that the patent awarded to Bavarian Nordic in Europe is invalid. This belief is supported by evidence presented at the ITC hearing held over the last two weeks in relation to Bavarian Nordic's US patent for MVA-BN. Filing this opposition is part of our strategy vigorously to defend our freedom to operate in the MVA field, which we will defend in whatever forum necessary."

The MVA vaccine is potentially a major product. Together with Baxter, Acambis submitted a bid for a US Government stockpiling contract for MVA in October 2005 in response to a Request for Proposals issued by the Department of Health and Human Services for making up to 20 million doses of MVA and advanced clinical testing up to and including obtaining a product licence. It also includes options for the purchase of up to 60 million additional doses of MVA and warm-base manufacturing over the longer term.

US Govt contract for ACAM2000

The counter move on the patent comes after news on Tuesday that the US Department of Health and Human Services' Centers for Disease Control and Prevention (CDC) intends to issue a sole source contract to Acambis for the manufacture of soon-to-be licensed ACAM2000 full strength smallpox vaccine.

No further details were supplied in what is called a pre-solicitation notice. Brokers Piper Jaffray were reported as saying they believed the contract would be worth $25m a year, beginning in the fourth quarter 2006.
Acambis said a fortnight ago that it had completed the submission of the ACAM2000 Biologics License Application to the US Food and Drug Administration in April and that it has been in "active discussions" with the CDC on the scope of work required to provide the US Government with a warm-base manufacturing capability. Warm-base manufacturing is intended to maintain Acambis' facilities on a long-term basis in a state of readiness to produce vaccine doses.
Goldman Sachs said the contract could provide a base level of sales and profits that could underpin the outlook for Acambis for the next five years.

Share price wobbles

After the news of the contract filtered through Acambis share price gained 7.5p to 172.75p on Thursday, valuing the company at about £180m. Today it lost some of those gains, slipping 4.5p.

The share price has been steadily declining from a peak of 256.75p in early August last year. Perhaps, as Goldman Sachs said, the increased certainty the ACAM2000 contract will soon be awarded also boosts chances of Acambis winning at least half of the imminent US MVA smallpox vaccine contract. That would surely put some oomph back into its share price performance.

18th May 2006

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