On March 30, Arena Pharmaceuticals (ARNA) announced somewhat mixed Phase III trial results for its weight-loss drug lorcaserin. Questions immediately arose in several forums about whether lorcaserin would be at an advantage over other late-stage obesity candidates -- Contrave, from Orexigen Therapeutics (OREX), and Qnexa, from Vivus, Inc. (VVUS) – because both Contrave and Orexigen are combinations (albeit reformulated) of existing drugs.
For longtime holders of OREX and VVUS, it’s actually good news that these perennial concerns are getting aired out once again, because it means that new arrivals are coming to the story. First, just to get this out of the way, both OREX and VVUS have over ten years of patent protection on their candidates post-launch, so it’s unlikely that anyone will try to manufacture a copycat. The concern is that doctors may prescribe combinations of the components in generic form instead of the branded drugs. We don’t think so, and here’s why.
Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax). Contrave is a combination of bupropion (marketed as Wellbutrin) and naltrexone (indicated for alcohol and certain drug addictions).
· While some generic versions of these drugs are available or will be by the planned 2010 launch, the specific doses included in Qnexa and Contrave are not available in generic form, nor are there sustained-release formulations, as included in Qnexa and Contrave.
· To approximate the doses, patients would have to take several pills during the day. The advantage in convenience and compliance to a single pill, particularly in a population that’s often already taking various medicines and supplements, is considerable.
· OREX’s market research suggests that after the “fen-phen” debacle, doctors are going to prefer to stick with FDA-approved drugs rather than risk improvising their own off-label cocktails.
· In addition, most primary care doctors are not prescribing naltrexone every day as things stand; the company believes that their comfort level with it is not high. By contrast, Nitromed’s (NTMD) ill-fated BiDil cardiovascular combination included only drugs that doctors were already routinely prescribing.
· All of the above is also why we don’t think there will be a big demand for re-titrating patient-specific doses independently. (Swivelchair, please feel free to expand on this idea further – you’re actually the first person I’ve ever heard bring it up, so you may be on to something.)
· VVUS has not made public an estimate of what Qnexa might sell for, but OREX is shooting for about $5 per day for Contrave. At that price, the generic substitution would be no cheaper. These are relatively expensive generics.
OREX At A Glance:
· Flagship Contrave is moving through Phase III trials for obesity.
· In Phase II trials, Contrave not only caused weight loss but also reduced the prevalence of metabolic syndrome. This is key for potential reimbursement down the road because Contrave confers a medical benefit, and is not merely a cosmetic aid.
· Empatic has initiated Phase IIb trials. It’s about a year behind Contrave in development, but may be even more efficacious.
· From the 48-week Phase II data, it also appears there is little or no weight loss plateau with Empatic. · More data for both Contrave and Empatic is expected in mid-2009, with Contrave NDA submission now planned for mid-2010.
· Two directors made sizable investments in OREX in December on the open market.
· A new CEO, Amgen veteran Michael Narachi, has joined as of March 31, replacing Dr. Gary Tollefson, who resigned in December for health reasons. This seems to us an eminently reasonable period of time to find a CEO. We are pleased that the seat did not languish in interim status.
We’re still hoping that the two-year pivotal results from ARNA will now bring more attention to the entire obesity drug development space and its three-way race. OREX initially rose March 30 on the ARNA news but since has actually slipped over 15%. Current levels present an appealing opportunity to buy OREX, as well as VVUS, at prices representing significant upside.
For longtime holders of OREX and VVUS, it’s actually good news that these perennial concerns are getting aired out once again, because it means that new arrivals are coming to the story. First, just to get this out of the way, both OREX and VVUS have over ten years of patent protection on their candidates post-launch, so it’s unlikely that anyone will try to manufacture a copycat. The concern is that doctors may prescribe combinations of the components in generic form instead of the branded drugs. We don’t think so, and here’s why.
Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax). Contrave is a combination of bupropion (marketed as Wellbutrin) and naltrexone (indicated for alcohol and certain drug addictions).
· While some generic versions of these drugs are available or will be by the planned 2010 launch, the specific doses included in Qnexa and Contrave are not available in generic form, nor are there sustained-release formulations, as included in Qnexa and Contrave.
· To approximate the doses, patients would have to take several pills during the day. The advantage in convenience and compliance to a single pill, particularly in a population that’s often already taking various medicines and supplements, is considerable.
· OREX’s market research suggests that after the “fen-phen” debacle, doctors are going to prefer to stick with FDA-approved drugs rather than risk improvising their own off-label cocktails.
· In addition, most primary care doctors are not prescribing naltrexone every day as things stand; the company believes that their comfort level with it is not high. By contrast, Nitromed’s (NTMD) ill-fated BiDil cardiovascular combination included only drugs that doctors were already routinely prescribing.
· All of the above is also why we don’t think there will be a big demand for re-titrating patient-specific doses independently. (Swivelchair, please feel free to expand on this idea further – you’re actually the first person I’ve ever heard bring it up, so you may be on to something.)
· VVUS has not made public an estimate of what Qnexa might sell for, but OREX is shooting for about $5 per day for Contrave. At that price, the generic substitution would be no cheaper. These are relatively expensive generics.
OREX At A Glance:
· Flagship Contrave is moving through Phase III trials for obesity.
· In Phase II trials, Contrave not only caused weight loss but also reduced the prevalence of metabolic syndrome. This is key for potential reimbursement down the road because Contrave confers a medical benefit, and is not merely a cosmetic aid.
· Empatic has initiated Phase IIb trials. It’s about a year behind Contrave in development, but may be even more efficacious.
· From the 48-week Phase II data, it also appears there is little or no weight loss plateau with Empatic. · More data for both Contrave and Empatic is expected in mid-2009, with Contrave NDA submission now planned for mid-2010.
· Two directors made sizable investments in OREX in December on the open market.
· A new CEO, Amgen veteran Michael Narachi, has joined as of March 31, replacing Dr. Gary Tollefson, who resigned in December for health reasons. This seems to us an eminently reasonable period of time to find a CEO. We are pleased that the seat did not languish in interim status.
We’re still hoping that the two-year pivotal results from ARNA will now bring more attention to the entire obesity drug development space and its three-way race. OREX initially rose March 30 on the ARNA news but since has actually slipped over 15%. Current levels present an appealing opportunity to buy OREX, as well as VVUS, at prices representing significant upside.
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Posted by: Online Pharmacy no Prescription | May 18, 2009 at 12:54 PM
There seems to be a few of these drug combinations to lose weight with. Apparently the one half of Contrave, Bupropion has been known by itself to make one lose weight, but is not prescribed as such. Bupropion is used a an antidepressant or to stop smoking, the fact that naltrexone (the other half of this drug) is used for addiction abuse, I wonder if a doctor would be more inclined to prescribe this medication to one who is overweight and struggling with addictions…
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