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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Piper Jaffray healthcare team remains one of the most highly-regarded investment banking franchises on the Street.
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,
Cannell joins Orexigen after 27 years at Merck where he held a variety of senior leadership roles. He brings strong experience in global commercialization, consumer marketing, and sales operations and management. Recent assignments have included President of Merck Canada and Head of Marketing and Strategy for MSD Japan. Earlier he served in general manager roles for a U.S. sales division and as leader of a Merck business unit, managing a multi-billion dollar product portfolio and thousands of employees. He has strong consumer experience, having served as General Manager, New Commercial Model, U.S., where he designed and successfully piloted an innovative customer centric commercial model for Merck's U.S. business.
Leerink's Paul Matteis maintained an Outperform rating on the shares, noting that last month Orexigen said it was talking with multiple potential partners for the drug in Europe.
European approval of Orexigen Therapeutics Inc.'s (NASDAQ: OREX) anti-obesity drug sets the stage for an overseas partnership deal, an analyst said.
The firm's conclusion remains that Orexigen has gained an additional 7 years of IP protection and an implicit marketing advantage from the interim CV data, and that the latter is in no way compromised from a regulatory or reputational standpoint (with the prescriber community) despite noise on the issue.
They maintained an Overweight rating and $26 price target.
Piper Jaffray Defend Orexigen (OREX) on Contrave Hub was right...He shuts up many analyst and short interest with $26 Price Target.
Commenting of if the company will release or is required to release the 50% interim data, the analyst said, " We’re not sure about the answer to the first, and for the 2nd, by whom? We believe that with the FDA's requirement of the conduct of a second CVOT, and that the original design of the LIGHT study having been dependent on the first interim (25% events), the 50% and 75% interims are, for the most part, "administrative". That said, if the data continue to suggest a CV benefit from Contrave, we suspect that Orexigen may, in the least, file for updated or additional patents based on the new data."
Sanofi is ready to Manufacture and Market ...Takeda already manufacturing and Marketing it in USA. dO YOU SEE ANY REASON FOR AMY DELAY!!
With European approval, Mysimba could dominate against the injectable Saxenda.
European partnership with upfront payments will be a major catalyst.
In the U.S., Contrave now passed Qsymia in both 3rd-party prescription trackers' weekly reports.
Adam Feuerstein @adamfeuerstein Mar 31
So, new patent comes in handy! Contrave still only obesity drug with positive CVOT data. $OREX
Through early March, M&A deals involving biotech and drug companies reached $59.3 billion this year, a 94% increase over the same period a year ago and the highest volume for this stage in any year since 2009, Reuters reports.
But price does matter. Sanofi Chairman Serge Weinberg says the French pharma giant is shying away from deal-making, in part, because target companies are asking too much.
"We looked at potential deals but found the asking prices to be too high for the businesses," Weinberg told Reuters in an interview published Monday. "We have opted for a balanced a strategy of innovation and diversification that makes acquisitions not indispensable."
Analysts at Piper Jaffray raised their price target on shares of Orexigen Therapeutics from $16.00 to $26.00 and gave the company an “overweight” rating in a research note
Orexigen Therapeutics (NASDAQ:OREX) saw a large drop in short interest in the month of March. As of March 13th, there was short interest totalling 34,283,822 shares, a drop of 14.0% from the February 27th total of 39,845,839 shares, American Banking & Market News reports. Based on an average daily trading volume, of 19,739,350 shares, the short-interest ratio is currently 1.7 days. Approximately 33.5% of the shares of the company are short sold.
Several analysts have recently commented on the stock. Analysts at RBC Capital raised their price target on shares of Orexigen Therapeutics from $10.00 to $14.00 and gave the companya “buy” rating in a research note on Friday. Analysts at Leerink Swann raised their price target on shares of Orexigen Therapeutics from $8.00 to $11.00 and gave the company an “outperform” rating in a research note on Wednesday, March 4th. Analysts at Piper Jaffray raised their price target on shares of Orexigen Therapeutics from $16.00 to $26.00 and gave the company an “overweight” rating in a research note on Tuesday, March 3rd. Finally, analysts at Zacks reiterated a “neutral” rating and set a $6.25 price target on shares of Orexigen Therapeutics in a research note on Friday, February 27th. One research analyst has rated the stock with a hold rating and six have issued a buy rating to the company. The stock currently has a consensus rating of “Buy” and a consensus target price of $13.18.