Dynavax relieves Crucell of vaccine manufacturing unit

Dutch biotechnology firm Crucell has announced it will sell vaccine manufacturer Rhein Biotech to US company Dynavax for around $12m (€10m) as it chooses to focus on specialised vaccines such as those for Ebola and malaria.

Although Crucell has yet to make a profit since it floated in 2000, it is sticking to its strategy of concentrating on infectious diseases, following a major shift in 2003 when it moved away from oncology.

Rhein's key products are hepatitis B vaccines, which Berna, the company which Crucell snapped up in January in a $450m merger, has deemed "non-strategic", since it already has a DNA recombinant hepatitis B vaccine called Hepavax-Gene, made using the company's yeast production technology.

Not surprisingly, this expertise in vaccines for hepatitis B proved appealing for Dynavax, which already had a supply contract with Berna for hepatitis B surface antigen that the Berkeley-based company uses for its vaccine Heplisav.

However, this agreement will now end since Dynavax will receive from Rhein an EU good manufacturing practice (GMP)-certified vaccine manufacturing facility, control over the production of hepatitis B surface antigen and potentially other antigens to support clinical and commercial programs, management and personnel with proven expertise in biopharmaceutical product development and production, and a complementary pipeline of vaccine and antiviral products.

These include SuperVax, a two-dose hepatitis B vaccine, Theravax, a development-stage therapeutic vaccine for treatment of chronic hepatitis B, and a development-stage vaccine to prevent cytomegalovirus infection.

Last year GlaxoSmithKline, which has aggressively entered the sector with several acquisitions, predicted that the global vaccine market could quadruple in size by 2015 to $30bn to $42bn from its current level of around $9bn.

"Given the cost of pharmaceutical manufacturing, it is typical for young companies to outsource many aspects of their production," Dynavax spokeswoman Jane Green told In-PharmaTechnologist.com.

"However, as a company reaches a more mature stage in its life cycle, it can choose to bring more expertise and capacity in-house, and this is what we have decided to do, it is a big step forward for us."

Dynavax expects ongoing revenue from the industrial services business of Rhein, cost synergies from the combined operations, and the elimination of Dynavax's costs to Berna related to the development of Heplisav, to offset the additional operating expenses associated with the business of Rhein in the near term.

The company also said that the acquisition costs of the transaction will be recovered in the long term by reductions in cost of goods for Heplisav and the elimination of financial obligations to Berna under the prior licensing and supply agreement.

Rhein shareholders are expected to approve the transaction, set to close in the second quarter of 2006.