Orexigen (NASDAQ: OREX) pockets $50 million in upfront cash, may receive as much as $1 billion in regulatory and sales milestone payments, and stands to receive royalties of between 20 and 35 percent of sales
French pharmaceutical firm Sanofi has entered into an agreement with US-based biopharmaceutical company Orexigen Therapeutics (OREX) for the supply of its Contrave tablets in territories outside North America.
Under the commercial supply agreement, Sanofi will act as Orexigen's contract manufacturer for Contrave (32mg naltrexone sustained release (SR) / 360mg bupropion SR) as well as manufacture them at one of several facilities in France.
Orexigen CEO Michael Narachi, "This agreement expands and diversifies our existing commercial supply network and will help ensure we will be ready to supply Contrave globally if approved."
30% reduction in heart attacks
37% reduction in strokes
74% reduction in heart-related deaths
All of these results were statistically significant, making it unlikely they are random or due to chance for Contrave which most lawyers did not like.
Back when Contrave was approved last September, it was said to raise blood pressure and heart rate and was not recommended for anyone with high blood pressure or other heart complications. These interim results certainly suggest the opposite. If further studies prove that Contrave is in fact good for heart health, it would represent a significant win for the obesity drug and be a critical differentiating factor for Contrave versus other weight-management options (e.g. Qsymia, Belviq, and Saxenda) – although what can be shown on the official label is still unknown.
The Light Study randomized 8,910 obese patients with a primary endpoint of evaluating the impact of treatment on the combined incidence of myocardial infarction (heart attack), stroke and CV death in patients taking Contrave versus placebo. For regulatory approval purposes, the Light Study included a pre-planned interim analysis designed to exclude a doubling of CV risk compared to placebo
Bottom line is...Rest is just administrative process as per Piper Jeffry..
(i.e., to rule out a hazard ratio of 2.0 using the upper bound of the 95% confidence interval). This analysis was conducted based on 94 observed and adjudicated major adverse cardiovascular events (“MACE”), which was approximately 25% of the planned MACE for the Light Study (the “25% Interim Analysis”).
For those who came late on Orex.. SEC filling.
Contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (“BMI”) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Importantly, the U.S. package insert for Contrave states that the effect of Contrave on CV morbidity and mortality has not been established.
The Light Study randomized 8,910 obese patients with a primary endpoint of evaluating the impact of treatment on the combined incidence of myocardial infarction (heart attack), stroke and CV death in patients taking Contrave versus placebo. For regulatory approval purposes, the Light Study included a pre-planned interim analysis designed to exclude a doubling of CV risk compared to placebo (i.e., to rule out a hazard ratio of 2.0 using the upper bound of the 95% confidence interval). This analysis was conducted based on 94 observed and adjudicated major adverse cardiovascular events (“MACE”), which was approximately 25% of the planned MACE for the Light Study (the “25% Interim Analysis”). The 25% Interim Analysis was prospectively designed to enable an early and preliminary assessment of safety to support regulatory approval. A larger number of MACE are required to precisely determine the effect of Contrave on CV outcomes.
New interim data on its obesity management drug Contrave. The data shows that the drug may not only help fight obesity, but potentially heart disease as well. Because the data is preliminary, the label for Contrave will not say that it protects heart health, and doctors will not officially be saying that it does either. But our view of the recent data? It is the first long-term cardiovascular (heart safety) outcomes study to show statistically significantly better results on the heart disease front for those taking the drug being studied. - See more at:
Finally "Roche" I told you for Mysimba in Europe, and taking concrete steps toward commercialization of Contrave/Mysimba in ex-US territories."
EC approval, and 31 out of 33 CHMP members voted in favor of the positive recommendation.
The EU is important for Orexigen because Mysimba is the only new oral drug up for approval. Both Arena Pharmaceuticals' Belviq and VIVUS' Qsymia failed to gain CHMP backing, leaving the EU market wide open. Novo Nordisk's Saxenda was recently given a positive CHMP opinion, but it has to be injected.
Europe is also an important market because Orexigen still owns the entire rights to the drug there; it only gets a royalty in the U.S. from its partner Takeda Pharmaceuticals. The biotech has said it plans to license the EU rights as well, which should garner Orexigen some up-front cash.
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Interim analysis on CVOT results for Contrave the original design of the LIGHT study having been dependent on which is the first interim (25% events). These results are Good enough to convince the new patients prescriptions (CVOT safety) compare to other competitors, the rest of the 50% and 75% interims are, for the most part, is " JUST -administrative" procedure on Post Marketing studies.
Tom Cannell has joined as Chief Commercial Officer. As the Company prepares for global commercialization of Contrave® /Mysimba™ (naltrexone HCl / bupropion HCl extended release), Cannell will lead all aspects of Orexigen's global commercial strategy,