The Newest Obesity Drug Player

VIVUS (NASDAQ: VVUS  ) and Arena Pharmaceuticals (NASDAQ: ARNA  ) had better check their rearview mirror because Novo Nordisk (NYSE: NVO  ) looks ready to submit a new obesity drug to the Food and Drug Administration around the end of the year.

The drug, Victoza, is new to obesity, but it's already approved to treat diabetes.

In a trial of overweight or obese people who don't have diabetes, Victoza produced an 8% decline in weight compared to a 2.6% loss for those who got placebo. The FDA also likes to see the number of people able to lose 5% of their body weight on the drug to be at least double the amount that are able to meet that threshold while taking placebo, which Novo Nordisk met as well: 64% of patients taking Victoza lost at least 5% of their body weight compared to 27% of those on placebo.

Here's how Victoza stacks up against VIVUS' Qsymia, Arena's Belviq, and Orexigen's (NASDAQ: OREX  ) Contrave, which is finishing up a cardiovascular safety trial and could be approved to treat obesity before Victoza.

Drug

Weight Loss on Drug

Weight Loss on Placebo

Placebo Adjusted Weight Loss

Victoza

8%

2.6%

5.2%

Qsymia

9.8%

1.2%

8.6%

Belviq

5.8%

2.5%

3.3%

Contrave

6.1%

1.3%

4.8%

Source: Novo Nordisk and the FDA.

Take the comparisons with a grain of salt since the trials enrolled different patients and had slightly different trial designs, but the take home point is there: Victoza looks like it can compete.

Competing on other factors
Victoza is injected once a week, while the other obesity drugs are taken orally on a daily basis. Whether that's a benefit or negative is debatable. Some people will probably prefer to not have to deal with their drug on a daily basis, but for others the needle will be a no-go.

Safety is always a concern given that obesity isn't an immediate life-threatening issue. Qsymia produces the highest weight loss, but it also has the most severe side effects. Novo Nordisk said withdrawals from the trial due to adverse events were below 10% in both treatment groups, but the company didn't go into further detail.

The decision of which drug to use may also come down to price, especially if the drugs continue to be covered by insurance at a low rate. Victoza is expected to cost about $25 per day as an obesity treatment compared to around $5 per day for Belviq and Qsymia. Of course, if Novo Nordisk can do a better job at getting insurance coverage -- and being already covered for diabetes might help -- the patients won't care because they'll only be paying the copay, not the full cost of the drug.

The real benefit
The trial tested non-diabetics, but the study highlights one of the benefits of using Victoza over other diabetes medications in obese and overweight patients. GlaxoSmithKline's (NYSE: GSK  ) Avandia and Takeda's Actos actually cause weight gain, and other diabetes drugs like the DDP-4 inhibitors don't help with weight loss.

Doctors may also be interested in using it in non-diabetics, simply because it's a diabetes medication. In the Victoza trial, 69% of the patients diagnosed with pre-diabetes at the start of the trial no longer showed signs of pre-diabetes after taking Victoza, compared to 33% for the placebo-treated group.

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Read/Post Comments (9) | Recommend This Article (6)

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  • Report this Comment On May 28, 2013, at 4:11 PM, 1yossi1 wrote:

    Victoza is an injectable drug and injectable drugs can never compete with tablets!

    No one likes to inject himself every day!

    Victoza is much more dangerous than Belviq.

    The main concern regarding Victoza is Pancreatitis:

    http://www.victozapancreatitis.com/

    From the FDA website: “Animal data that showed a rare type of thyroid cancer known as medullary thyroid cancer associated with Liraglutide (Victoza)”.

    http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo...

    Did you check the huge cost of Victoza per day?

    NO CHANCE for reimbursement imo.

    Belviq is a blockbuster for sure and no article will be able to save the shorts that are trapped and desperate!

    Areniacs are not going to sell cheap and launch is only 10 days from now.

    The efficacy of (the safer option) Bel/Phen combo drug will be higher than Victoza!

  • Report this Comment On May 28, 2013, at 8:28 PM, MRJOSEPHD wrote:

    Brian,

    It is foolish to even bring up Victoza. People will never inject themselves to lose weight. People hate needles. The best drug on the market without a doubt is Belviq!

  • Report this Comment On May 29, 2013, at 4:32 AM, Jm262 wrote:

    It's great to see so many people trying to come up with any reason to short ARNA. Makes me feel more confident in my position in it.

  • Report this Comment On May 29, 2013, at 5:10 AM, 1yossi1 wrote:

    Victoza will NEVER be used to treat obesity!

    Please note that for treating Diabetes the dose is only 1.2 to 1.8 mg Liraglutide (Victoza):

    http://www.drugs.com/dosage/liraglutide.html

    http://reference.medscape.com/drug/victoza-liraglutide-99944...

    For treating obesity (and get better efficacy than Belviq) you need to use 3 mg (about double dose)!

    That makes it even much more dangerous than 1.8mg!

    Please do your homework Brian.

  • Report this Comment On May 29, 2013, at 9:55 AM, MRJOSEPHD wrote:

    Victoza is already available and nobody will use a needle to lose weight. Also too many life threatening risk! BELVIQ is the king of the obesity space.

  • Report this Comment On May 29, 2013, at 10:33 AM, bmc007 wrote:

    I agree with all the above comments. ARNA's time has come, it's as simple as that!

  • Report this Comment On May 29, 2013, at 11:59 AM, Cebulski527 wrote:

    I used Victoza and it is not a big shot.The needle is like the tip of a needle. I liked using it because I received great results.Sugar and everything was in tack. The only reason I stopped was account of my insurance.There are chances with every drug you take.

  • Report this Comment On May 29, 2013, at 2:22 PM, MRJOSEPHD wrote:

    By the way Brian did you know the following about Victoza:

    "In 2010, Novo Nordisk breached the ABPI's code of conduct by failing to provide information about side effects of Victoza, and by promoting Victoza prior to being granted market authorization.[15]

    In 2012, the non-profit consumer advocacy group Public Citizen petitioned the U.S. Food and Drug Administration (FDA) to immediately remove liraglutide from the market because it concluded that risks of thyroid cancer and pancreatitis outweigh any documented benefits.[16]"

    And again, related to "cancer risks".

    "On April 2, 2009, an FDA advisory panel reviewed the significance of malignant C-cell carcinoma (also known as medullary thyroid cancer, involving the parafollicular cells of the thyroid gland) and thyroid C-cell focal hyperplasia in rats and mice. Some[who?] say the tumors were caused by a nongenotoxic, specific receptor-mediated mechanism to which rodents are particularly sensitive, whereas nonhuman primates and humans are not.[7][8]

    The Victoza label carries a Black Box Warning:

    Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza only to patients for whom the potential benefits are considered to outweigh the potential risk.[9] ”

    The FDA said serum calcitonin, a biomarker of medulliary thyroid cancer, was slightly increased in liraglutide patients, but still within normal ranges, and it required ongoing monitoring for 15 years in a cancer registry.[10]

    Novo Nordisk has reminded healthcare professionals of the serious risks associated with the use of Victoza. Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors in rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.[11]"

    http://en.wikipedia.org/wiki/Liraglutide

  • Report this Comment On May 29, 2013, at 6:14 PM, 1yossi1 wrote:

    "Victoza is injected once a week" ? ? ?

    Not true! Victoza is injected once a day!

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