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Legal Developments worldwide

Life in life sciences in May – July 2011

July 2011 - 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 May, June and July 2011. Norrbom Vinding provides you with an overview of events:
 
Alk-Abelló A/S
Alk-Abelló, a Danish pharmaceutical company which focuses on allergy prevention, diagnosis and treatment, signed a licensing agreement with US company AllerQuest about the development and marketing of a new diagnostic product for penicillin allergy. Called Minor Determinant Mixture (MDM), the new product will complement PRE-PEN®, currently marketed by Alk-Abelló outside Europe on a licence from AllerQuest. The Danish company will hold the exclusive global rights to the new product.
Alk-Abelló also announced that, as a result of its partnership with the global pharmaceutical company Merck on marketing GRAZAX® in North America, an application has been filed to have the product registered in Canada. This has triggered a milestone payment of USD 5m to Alk-Abelló. GRAZAX® is an allergy vaccine which is still under development – among other things, by virtue of the partnership between Alk-Abelló and Merck.
 
Bavarian Nordic A/S
In June 2011, the Danish vaccine producer Bavarian Nordic announced that it has signed an agreement with Denmark and another European NATO country for the supply of the smallpox vaccine IMVAMUNE®. The size and value of the agreement has not yet been made known. The product has previously been sold in large quantities to the US, Canada and several other countries.
 
Exiqon A/S
Exiqon develops and adapts RNA- and LNA-based screening and diagnostic tests. In June, the company announced that it would increase equity by about EUR 2.7m by a directed issue at market price without pre-emption rights. The new shares will correspond to 5% of the company’s current capital.
Around the same time, Exiqon announced that it had granted Idexx Laboratories a licence to use its patented LNA technology for veterinary disease diagnostics. The intention is to develop tests for diagnosis of infectious diseases in animals. Exiqon will receive upfront and milestone payments and royalties on the sale of the products in question.
 
Evolva
Evolva operates in the field of synthetic biology – i.e. biological systems or products that are not found in nature. Domiciled in Switzerland today, the company is partly rooted in Denmark. In June, the company announced that it has received the first milestone payment under a licensing agreement with the global pharmaceutical company Roche. Roche has licensed Evolva’s technology platform to develop drugs for use in the treatment of cancer and contagious diseases.
 
H. Lundbeck A/S
In May, the Danish pharmaceutical company Lundbeck announced the results of clinical phase III trials involving the compound Lu AA21004. According to Lundbeck, the results support the use of the compound to treat severe depression in adults. Based on these results as well as results from other clinical trials, Lundbeck will continue its development of the compound, hoping to apply for a marketing authorisation in Europe and the US some time during 2012.
In June, Lundbeck announced that other clinical trials on the compound nalmefene have also yielded good results. The compound is effective in the treatment of alcohol abuse and was originally developed by Key Pharmaceuticals and IVAX/Baker Norton in the 1980s and 1990s. Today, Lundbeck holds the global rights. The company is expected to apply for a European marketing authorisation for a drug containing the compound before the end of 2011.
In early summer, there was a lot of media debate about the use of Lundbeck’s sleeping medicine Nembutal®, which contains the substance pentobarbital, in connection with executions in certain US prisons. In early July, the company announced a change to its distribution policy. In future, Lundbeck will screen Nembutal® orders to avoid supplying the drug to prison executions.
 
Neurosearch A/S
Neurosearch specialises in the development of treatments against central nervous system disorders. One of its new and promising drugs is Huntexil® for the treatment of Huntington’s disease (a disease characterised by involuntary writhing movements and often mental changes). In May, however, the company announced that both the US and the European drug authorities had recommended a number of additional clinical trials before the product was approved. The cost of these additional clinical phase III trials are estimated to be in the triple digit millions.
 
Novo Nordisk A/S
Novo Nordisk, the Danish insulin giant, announced in June that its US subsidiary had settled with the US Department of Justice and two individuals on allegations of illegal marketing practices in the US concerning the company’s product NovoSeven®. Novo Nordisk has not admitted any liability in the settlement, but has accepted stricter reporting obligations to the US Food and Drug Administration. NovoSeven® is used in the treatment of various kinds of haemophilia. At the same time, a settlement was made in another matter concerning the company’s marketing of its insulin products.
In July, Novo Nordisk announced that the European Medicines Agency had approved FlexTouch®. FlexTouch® is a prefilled insulin pen containing 300 units of insulin. The product is characterised, among other things, by only requiring little pressure to trigger a unit of insulin, which benefits elderly and weak patients in particular.
 
Zealand Pharma A/S
The Danish biotech company Zealand Pharma specialises in peptide-based drug discovery, with a focus on diseases for which relatively few treatments are available. In June, the company announced that it had granted the German company Boehringer Ingelheim a global licence to develop and market a number of compounds for the treatment of diabetes and obesity. Under the agreement, Zealand Pharma may receive as much as EUR 376m in milestone payments over a number of years.
Also in June, Zealand Pharma announced that one of the compounds covered by the agreement with Boehringer Ingelheim has shown good results in a number of pre-clinical trials with regard to blood sugar regulation.
 
The above does not constitute legal advice and should not be relied upon as such

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