24.10.2012 - The competition for PAH treatments will become fierce. Actelion and Bayer both plan to market new treatments for this rare disease.
Good news for PAH (pulmonal arterial hypertension) patients: two new drugs are planned for market release. The Swiss biotech Actelion submitted a new drug application to the FDA for its Opsumit macitentan treatment. The filing is based on data from a Phase III study, which proved to be able to reduce the risk of a morbidity or mortality event compared to placebo. A low-dose of Opsumit reduced the risk by 30%, while the high dose had a 45% reduction. The compound is a tissue-targeting endothelin receptor antagonist and is thought to replace revenues from Tracleer, Actelion’s best-seller which will lose patent protection in 2015.
At the same time as Actelion announced the application, German pharma Bayer AG announced that its compound riociguat met the primary endpoint in a Phase III study. The oral soluble guanylyl cyclase (sGC) stimulator led to an improvement in a six minute walk test enhancing the patient’s walk distance to 36 meters. Bayer plans to submit regulatory filing for riociguat in the first half next year. Analysts said that macitentan might become the next first-line treatment and expected high revenues. Riociguat however might become a second line option and get additional competition from Pfizer’s Sildenafil, which is already approved for PAH and acts via the same pathway.
29.07.2015 Newly founded Mereo BioPharma has acquired three mid-stage clinical assets from Novartis. In turn, the Swiss pharma concern will hold a stake in the UK company. Other investors are also on board.
24.07.2015 Biotech companies across Europe continue to raise cash on the public markets, generating €3bn in total financing proceedings in the first half of 2015. Compared to 2014, this is almost twice as much.
23.07.2015 US money keeps flowing into Europe's biotechs. As the race for the peanut allergy market heats up, NASDAQ listed French biotech DBV has announced the successful closing of US$281m (€256m) share offering for its allergy products.
16.07.2015 Sanofi has announced plans to restructure its business in five standalone global business units starting in January 2016. The goal is to promote growth and help the company launch a catalogue of new drugs over the next five years.
15.07.2015 GlaxoSmithKline (GSK) has become the first drugmaker to join the Francis Crick Institute. It is a consortium made up of six scientific and academic institutes to conduct research and drug development in the UK. The new institute is set to become a world-leading centre of biomedical research and innovation.
10.07.2015 Karolinska Development has slashed the reported value of its portfolio by almost half by revising its valuation model for early stage companies and divesting its shares in pain med maker Pharmanest.
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