Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.
Novo Nordisk 's ( NVO ) type II diabetes candidate, Xultophy (IDegLira), received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). Xultophy is a once-daily single injection combination of Novo Nordisk's Tresiba (insulin degludec) and Victoza.
The CHMP recommended the approval of Xultophy for the treatment of adults suffering from type II diabetes in combination with glucose-lowering oral drugs, when such drugs (alone or combined with basal insulin) fail to achieve adequate glycemic control.
A response from the EC is expected by Oct 2014. Novo Nordisk intends to launch Xultophy in Europe in the first half of 2015.
We are encouraged by the CHMP's opinion on Xultophy and believe chances of gaining approval are high. Although the European Commission (EC) is not bound to accept the recommendations of the CHMP, it usually does so.
We note that in two phase III studies (DUAL I and II), patients treated with Xultophy experienced a lower rate of hypoglycemia, compared to Tresiba. The patients also achieved body weight reduction compared to basal insulin treatment.
We remind investors that Novo Nordisk's Victoza 3mg is also under review in the EU for the treatment of adults suffering from obesity and overweight adults with comorbidities such as hypertension, dyslipidemia, sleep apnea or type II diabetes.
Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Allergan Inc. ( AGN ), AbbVie Inc. ( ABBV ) and AstraZeneca plc ( AZN ). While Allergan carries a Zacks Rank #1 (Strong Buy), AbbVie and AstraZeneca hold a Zacks Rank #2 (Buy).