PHARMACEUTICALS
Big Pharma: new technology and product licensing agreements
Global pharmaceutical companies continue to realign their businesses and develop new strategies to improve performance, one of their key activities being the in-licensing or co-development of new products. We review some of the significant deals completed so far this year.
T
here have been many examples this year of global pharmaceutical companies establishing strategic alliances with other pharmaceutical companies or new biotech companies for the in-licensing of technologies or products to boost pipelines. For example, in August, Pfizer and AstraZeneca entered into an agreement in which Pfizer acquired over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD). Pfizer has acquired the exclusive global rights to market NEXIUM for the approved over-the- counter indications worldwide. The agreement includes an upfront payment of $250 million to AstraZeneca, plus milestone and royalty payments to AstraZeneca based on product launches and sales.
NEXIUM, a proton pump inhibitor, was launched by AstraZeneca in Europe in 2000 and in the USA in 2001. AstraZeneca continues to manufacture and market the prescription product, as well as supply Pfizer with the OTC product upon the receipt of regulatory approval. A Marketing Authorisation Application for OTC NEXIUM in a 20mg tablet form was filed with the European Medicines Agency in June and a US NDA for the product in 20mg delayed release capsules is targeted for the first half of 2013. If approved, Pfizer expects to commericalise the product in the USA beginning in 2014 with launches in other markets to follow.
In addition, both companies are exploring the potential for a strategic partnership that could include similar agreements for other AstraZeneca prescription brands for which OTC versions might be appropriate. The companies have signed an agreement giving Pfizer a right of first refusal regarding OTC rights for Rhinocort Aqua, a pump spray containing the glucocorticosteroid budesonide for the treatment of non-infectious rhinitis such as hay fever and house dust mite allergy.
38 sp2 Inter-Active September/October 2012 Merck & Co HIV drug agreements
In July, Merck & Co signed two licensing agreements for investigational HIV drug candidates and announced plans to initiate a Phase 2 study for a proprietary investigational next-generation non-nucleoside reverse transcriptase inhibitor, MK-1439.
One of the agreements is with Chimerix Inc, a company based in Research Triangle Park, North Carolina, USA, for CMX157, an investigational oral nucleoside reverse transcriptase inhibitor currently in Phase 1 clinical development. Under the agreement, Merck received an exclusive worldwide licence and is responsible for development and commercialisation of CMX157. Separately, Merck & Co signed an agreement with Japanese company Yamasa Corporation to develop EFdA (4’-ethynyl-2- fluoro-2’-deoxyadenosine), a novel nucleoside reverse transcriptase inhibitor candidate in preclinical studies showing antiviral activity towards highly resistant HIV strains. The companies have agreed that in return for an upfront fee and future milestone payments Merck receives exclusive worldwide licence rights to the candidate, which was discovered in collaboration with a group led by HIV research scientist Dr Hiroaki Mitsuya of Kumamoto University’s Center for AIDS Research.
GSK and Amicus expand Fabry disease collaboration
Also in July, GlaxoSmithKline and Amicus Therapeutics announced an expansion of their collaboration to develop and commercialise the investigational pharmacological chaperone migalastat HCl for Fabry disease. The expanded alliance includes co- development of all current and future formulations of migalastat HCl for Fabry disease, including a co-formulation of migalastat HCl with GSK/JCR Pharmaceutical Co, Ltd’s investigational enzyme replacement therapy (ERT) for the disease;
commercialisation arrangements for all future Fabry products, in which Amicus will have commercial rights to all Fabry products in the USA and GSK will commercialise all products in the rest of the world; and increased GSK ownership in Amicus with an $18.6 million investment in common stock, bringing GSK’s total ownership stake in Amicus to 19.9 per cent. Fabry disease is an inherited lysosomal storage disease that is currently estimated to affect about 5,000 to 10,000 people worldwide. It is caused by deficiency of an enzyme called alpha-galactosidase A (alpha- Gal A), which breaks down a complex lipid called globotriaosylceramide (GL-3). Reduced or absent levels of alpha-Gal A activity leads to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin, and this is believed to cause the various symptoms of Fabry disease, including pain, kidney failure, and increased risk of heart disorders and stroke. Amicus and GSK are now committed to the parallel development of three different uses of migalastat HCl for Fabry disease: First, migalastat HCl monotherapy, for which Phase 3 global registration studies are currently underway in patients with genetic mutations that are amenable to chaperone monotherapy. Results from one of these studies expected in the third quarter of 2012 will be used to support an NDA submission to the FDA and, if approved, Amicus will be responsible for the US commercial launch of the product. Second, migalastat HCl co-administered with ERT, for which a Phase 2 study is currently ongoing. In January 2012, Amicus announced positive preliminary results from the study. Third, migalastat HCl co-formulated with a proprietary preclinical ERT. Amicus and GSK, in collaboration with JCR, are developing migalastat HCl co- formulated with a proprietary recombinant human alpha-Gal A enzyme (JR-051). This ERT was developed by JCR and licensed to GSK for all markets outside Japan. Preclinical
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