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Life in life sciences in October – November 2011

January 2012 - Intellectual Property. Legal Developments by Norrbom Vinding Law Firm, member of ius laboris.

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Life sciences
Danish companies in the life sciences sector formed strategic alliances, were granted product approvals and took other initiatives in October and November 2011. Norrbom Vinding provides you with an overview of events:
Alk-Abelló A/S
The Danish allergy vaccine developer Alk-Abelló is collaborating with Merck, Sharp & Dohme (MSD) to develop, register and commercialise a number of tablet-based vaccines against grass, ragweed and house dustmite allergy. In early November, MSD presented the data from two clinical phase III studies on its ragweed allergy vaccine. The results of both studies were consistent with expectations. The company is therefore expected to apply for a marketing authorisation for the vaccine in the US sometime during 2013.
Bavarian Nordic A/S
Another Danish biotech company, Bavarian Nordic, initiated clinical phase III studies in November on the cancer vaccine PROSTVAC®. The vaccine has shown a potential to extend the life of patients with advanced prostate cancer. The trials are expected to take 24 months. At the same time, Bavarian Nordic issued new shares in order to make the agreed milestone payments to some of the vaccine developers.
In early October, Bavarian Nordic also announced that, via its US subsidiary, it had obtained the rights in new cancer vaccine candidates developed by the National Cancer Institute and the National Institutes of Health in the US. Under the arrangement, Bavarian Nordic will manufacture vaccine products for a number of pre-clinical and clinical trials to be carried out by the National Cancer Institute. One month later, the company announced that clinical trials on one of the substances covered by the arrangement showed promise.
Finally, Bavarian Nordic announced in late October that it had received a performance-based milestone payment of USD 25 million from the US Government because the company had scaled up for industrial production – i.e. production according to a defined scale and/or quality parameters – of the smallpox vaccine IMVAMUNE®, which is sold to the US and various other countries.
H. Lundbeck A/S
The Danish pharmaceutical company Lundbeck has formed a strategic partnership with with the Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd. The parties, who are also active in the treatment of mental diseases, will collaborate on various projects, including to develop and commercialise some Otsuka drug candidates. The partnership will also include a more long-term research and development collaboration. The strategic partnership is considered one of the most important agreements ever entered into by Lundbeck. In mid-October, Lundbeck also announced that it has set up a research centre in China.
October was the month of good news: The US Food and Drug Administration approved one of Lundbeck’s own products, OnfiTM. The drug is used for supplementary treatment of seizures associated with the Lennox-Gastaut syndrome – a rare and severe form of epilepsy. Because of the rarity of the disease, Lundbeck’s product has been designated an orphan drug. This means that the US Food and Drug Administration is prohibited from approving a competing product for a seven year period.
Later in November, the US Food and Drug Administration announced that it would proceed in its examination of an application for a marketing authorisation for one of the drug candidates that is covered by the new strategic partnership between Lundbeck and Otsuka, more specifically the substance aripiprazole for the treatment of patients with schizophrenia.
Novo Nordisk A/S
The Danish insulin giant Novo Nordisk announced in early November that the results of its clinical phase III studies on the relative new insulin product, DegludecPlus, were favourable.
Novo Nordisk also announced later the same month that it would no longer carry out animal trials when quality testing batches of products shipped from Novo Nordisk's facilities.
Novozymes A/S
Novozymes announced in late October that it has sold the subsidiary Novozymes Biopharma Sweden to the US-owned Repligen Corp. Novozymes Biopharma Sweden is located in Lund, Sweden.
One month later, Novozymes announced that its new R&D facilities in Brazil had opened. The new facilities are intended to focus on the development of new enzyme-based solutions within bioenergy.
The above does not constitute legal advice and should not be relied upon as such

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