BioWorld International Correspondent

Crucell NV secured two vaccine product deals based on its PER.C6 human cell line over a week's time.

It unveiled an agreement Tuesday to license its veterinary West Nile vaccine to Pfizer Inc. for use in horses. That follows its first ever product agreement, a €30 million pact it signed last week with Aventis Pasteur, the vaccines arm of Aventis SA, of Strasbourg, France, to develop epidemic and pandemic influenza vaccines.

The company's share price rose by more than 20 percent on Amsterdam's Euronext exchange over the past week, from €5.25 to its Tuesday close of €6.50.

The deal with Aventis comprises an up-front payment of €8 million, plus potentially €22 million in milestones, which will be triggered by completion of Phase I, Phase II and Phase III trials and by U.S. and European product registration. Crucell, of Leiden, the Netherlands, also will receive research and development funding and royalties that will range from high single-digit to double-digit percentages, depending on sales volumes. Crucell retains commercialization rights for Japan, which, it said, represents 15 percent of the worldwide influenza vaccine market that was worth €1.2 billion in 2002. However, Aventis has secured global manufacturing rights and will receive royalties from Crucell for sales in Japan.

The deal represents a strategy shift for Crucell, which previously had signaled its intention to continue development of its influenza vaccine program in-house.

"It is our contention that Aventis Pasteur offered us a deal we could not refuse and [that] frees up resources for additional programs," CEO Dinko Valerio said on a conference call last week. The financial terms cover development of the epidemic vaccine only and do not include Crucell's pandemic vaccine, which also is covered by the agreement. "Payments for that are not included in the €30 million. The way we would commercialize that is not stipulated in the information we have disclosed today," Valerio said.

Both the influenza and West Nile programs involve the use of whole killed viruses, expressed in Crucell's recombinant PER.C6 cell line. The platform, the company said, is optimized for large-scale, serum-free production and offers a more straightforward alternative to current production methods, such as embryonated chicken eggs (for influenza vaccines) and mouse brain cells (for veterinary West Nile vaccines).

The agreement with New-York-based Pfizer is much smaller in scale, Louise Dolfing, corporate communications manager at Crucell, told BioWorld International. "Because it's a veterinary vaccine, it's a limited market," she said. The agreement covers only the U.S. and calls for Crucell to receive an up-front license fee, plus it is entitled to milestones, annual fees and royalties on product sales. Additional terms were not disclosed. Pfizer's veterinary medicine arm, Pfizer Animal Health, will be responsible for further development of the product.

Crucell already is developing a West Nile vaccine in cooperation with the Kimron Veterinary Institute of Israel's Department of Agriculture for use in geese in Israel. That is expected to undergo market launch this year. It has preclinical human vaccine development programs under way in West Nile virus, Ebola and malaria, plus several other undisclosed indications.