Arena’s BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) study for patients suffering from diabetes is now complete and the results are expected in late 2010. This study was a one-year, randomized, double-blind and placebo controlled Phase III trial on 604 patients with Diabetes Mellitus Type II who were overweight or obese and taking oral diabetes medications. These results will be filed as a Supplemental NDA (sNDA) after LORQESS (Lorcaserin) is approved. This study is of paramount importance for LORQESS to have an indication specific for the treatment or prevention of diabetes. Arena must clinically prove that taking LORQESS will improve HbA1c and Fasting Glucose to receive an indication for diabetes. If this proves to be the case, which was shown in BLOOM and BLOSSOM, then LORQESS could be covered by most Payers for the treatment of diabetes or the prevention of diabetes.
What would that mean for Arena and LORQESS? Let’s take a look at the statistics for the diabetes epidemic facing our country, and the rest of the westernized world for that matter.
“Data from the 2007 National Diabetes Fact Sheet (the most recent year for which data is available)
Total: 23.6 million children and adults in the United States—7.8% of the population—have diabetes.
Diagnosed: 17.9 million people
Undiagnosed: 5.7 million people
Pre-diabetes: 57 million people
New Cases: 1.6 million new cases of diabetes are diagnosed in people aged 20 years and older each year.
Cost of Diabetes
$174 billion: Total costs of diagnosed diabetes in the United States in 2007
· $116 billion for direct medical costs
· $58 billion for indirect costs (disability, work loss, premature mortality)
After adjusting for population age and sex differences, average medical expenditures among people with diagnosed diabetes were 2.3 times higher than what expenditures would be in the absence of diabetes.
The American Diabetes Association has created a Diabetes Cost Calculator that takes the national cost of diabetes data and provides estimates at the state and congressional district level.
Factoring in the additional costs of undiagnosed diabetes, pre-diabetes, and gestational diabetes brings the total cost of diabetes in the United States in 2007 to $218 billion.
• $18 billion for the 6.3 million people with undiagnosed diabetes
• $25 billion for the 57 million American adults with pre-diabetes
• $623 million for the 180,000 pregnancies where gestational diabetes is diagnosed”
So using these statistics, there are at least 17.9 diagnosed Type II DM patients in 2007 + another 4.8M probably diagnosed in 2008-2010 for a total of 22.7 potential DIAGNOSED TIIDM patients. In addition to the diagnosed Type II population, there are a whopping 57M+ Americans on the cusp of becoming TII. That equates to 80M TII and Pre-TII DM patients that are a top candidate for Lorcaserin.
The #1 way to prevent Type II DM is to lose weight. In the course of treatment, first orals are prescribed and then Insulin therapy. If BLOOM-DM clinically demonstrates that we reduce HbA1c, Fasting Glucose and show that patients in the trial were able to reduce their oral medications, then LORQESS will be a first line treatment in the prevention and treatment of diabetes.
One of the patients in the Phase III trials for LORQESS is a contributing editor to the medical website, MedPage Today. He wrote about his experience on the drug before the study was unblinded to share with the readers of medpagetoday.com, http://www.medpagetoday.com/PrimaryCare/Obesity/12772 . He also wrote about the results of BLOOM and his experience here: http://www.medpagetoday.com/PrimaryCare/Obesity/13506 . The author lost an impressive 52lbs on Lorcaserin and was able to reduce his diabetes medication by 75%. He references clinical studies done in Europe that showed a 10% weight loss resulted in TII DM patients reducing their oral medications by at least 50%. LORQESS results in an average of 8% and 1 in 3 patients lose at least 10% of their body weight.
Now you can see why BLOOM-DM is so important for LORQESS. The drug will be a success in the market given its trifecta of great safety, tolerability and efficacy but with BLOOM-DM, the label and market expand greatly.
Think about these numbers.
22,700,000 Diagnosed Type II DM patients in the US. On LORQESS, we can expect the following impact to that patient population.
15,140,900 Patients will lose at least 5% of their body weight while also improving HbA1c and Fasting Glucose.
7,491,000 Patients will lose at least 10% of their body weight and cut their oral diabetes medications by at least 50%. A proportion of these patients may also lose enough to no longer be classified as Type II.
Diagnosed Type II Diabetes costs $116B in direct medical costs. LORQESS has the potential to significantly reduce that number.
At least 57,000,000 Americans have pre-diabetes. The key for preventing full blown Diabetes is to reduce weight and positively impact Fasting Glucose and HbA1c. LORQESS can be a key tool in this fight. On LORQESS, we can potentially have the following impact.
38,019,000 Pre-diabetics will lose at least 5% of their body weight, improve HbA1c and Fasting Glucose. This will drastically lower the risk of these patients becoming a full blown diabetic.
18,810,000 Pre-diabetics will lose at least 10% of their body weight likely removing them from the pre-diabetic classification all together.
Pre-diabetics costs $25B a year to treat. LORQESS will have a significant impact to this population of Americans.
Of course not all 80M Americans who are a Type II Diabetic or Pre-diabetic will be on LORQESS and that isn’t my point. My point is to demonstrate that the market for a Diabetes indication for LORQESS is literately huge. Arena will be at full capacity, with expansions, of 5B pills a year with just 6.8M patients, which is approximately $7.5B in annual sales. That is less than 10% of Diabetics or Pre-diabetics that would need to be on the drug to reach $7.5B in annual gross sales. Europe has close to the same diabetic population as the US. China has over 70M Type II Diabetics in 2008 with a 10.8% rate of death. LORQESS will be an important and valuable tool in the fight to prevent diabetes and the results from BLOOM-DM is a big key to make that happen.
Disclosure: Long ARNA