You have been diagnosed with HIV. As a result of your HIV therapy and disease, you undergo disfiguring body changes characterized by accumulation of subcutaneous fat on the back (buffalo hump), loss of subcutaneous fat, or lipoatrophy (sunken cheeks, buttocks wasting) and excess visceral fat accumulation (potbelly)…changes associated with lipodystrophy.
Are you more likely to die of AIDS or a heart attack? Studies show you are twice as likely to experience a heart attack or diabetes than non-HIV patients. This is due to high levels of “bad” cholesterol and triglycerides & low levels of “good” cholesterol, as well as irregular glucose accumulation in your blood—the culprit? Lipodystrophy once again—a metabolic disorder related to growth hormone deficiency.
You can fill in your sunken cheeks by using FDA approved cosmetic drugs, like Sculptra ® by Sanofi Aventis, but what about your health risk and avoiding embarrassing stares at yourpregnant-like potbelly? You desperately search and discover an off-label Growth Hormone (GH) injection infamous for reducing VAT along with putting you at high risk for diabetes, but there are no FDA approved treatments for lipodystrophy, that is until…
The First Solution
Founded in 1993, Theratechnologies (OTC:THTCF) www.theratech.com, Le Prix Santé 2009 Award winning Canadian company will be the first to market a treatment for lipodystrophy—Tesamorelin (TH9507). NDA acceptance was 12 August 2009. FDA response is expected at the end of March 2010.
Successful clinical trials prove Tesamorelin can reduce visceral fat (VAT) by 18% over a 52 week period–imagine reducing your body weight from 200 lbs to 164 lbs– stabilize your cholesterol and triglyceride levels without interfering with glucose levels, and even build 2.87 lb (1.3kg) of muscle mass. You have a 10%-14% chance of experiencing injection site redness, injection site itchiness, and joint pain.
"Furthermore, Tesamorelin selectively reduces VAT without affecting SAT: which may be important for those patients that suffer from both lipoatrophy and excess abdominal fat accumulation." — Dr. Steven Grinspoon, Professor of Medicine, Harvard Medical School, Director of the Massachusetts General Hospital Program in Nutritional Metabolism, and Lead Investigator for the Tesamorelin trial in the United States.
HIV participants also expressed significantly greater satisfaction with their overall appearance.
Now you are 6-8 months away from sliming your potbelly without worsening your sunken cheeks and buttocks and building muscle mass so you can look normal, as well as minimizing your health risk of a heart attack/diabetes.
Or are you? Is THTCF capable of making Tesamorelin available to you and sustaining growth?
• FDA does not approve the drug: Involving a world renowned expert from Harvard to lead successful clinical trials, NDA acceptance and a straightforward regulatory pathway increases the probability of approval.
• Reimbursement challenges could affect revenue and are addressed by a survey conducted by Boston Healthcare which concluded that: “It is likely that most payers will provide reimbursement for a product such as Tesamorelin to patients that need treatment providing that payers are assured that the medication is being used appropriately.” More than 60% of HIV-positive individuals in the U.S are on Medicare or Medicaid.
• Threat of competition is low: A competitor with an HIV cure, lipodystrophy cure/one-time treatment, a drug with significant improvements to Tesamorelin, all without adverse effects, are some threats to the success of Tesamorelin. But these treatments are not likely to develop in the near future.
• Threat of substitutes is low: Liposuction is not possible for VAT, only SAT, which leaves diet and exercise as a substitute; the strong competitive advantage of Tesamorelin with minimal alternatives should result in high demand for the product.
• Exit barriers are low: Although THTCF has a specialized expertise, it does not prevent them from entering non-HIV related markets, just in case a powerful competitor dominates the HIV market.
The Product (How it works)
Tesamorelin is a synthetic analogue of growth hormone-releasing factor (GRF) that acts on pituitary cells in the brain, triggering the formation and secretion of growth hormone (GH). In other words, rather than direct injection of GH which can bypass the pituitary’s natural regulation process causing adverse effects, Tesamorelin controls GH secretion at the pituitary source, providing a more favorable outcome.
THTCF's existence since 1993 along with their business strategy and operations indicate they are capable of not only generating revenue, but sustaining profitable growth.
Clearly there is significant need for lipodystrophy treatment that can improve overall appearance, minimize health risk without interfering with current HIV treatment—Tesamorelin is well-positioned to be the first solution.
What Causes Lipodystrophy?
Early studies suggested that lipodystrophy was associated with the use of protease inhibitors (PIs), a class of commonly prescribed anti-HIV drugs. However, other studies have shown that lipodystrophy also occurs in people who have never taken PIs. Evidence now suggests that lipodystrophy is linked to the concurrent use of nucleoside reverse transcriptase inhibitors (NRTIs) and PIs.
Other risk factors for lipodystrophy include:
* age — older people are at higher risk for lipodystrophy
* race — whites are at higher risk for lipodystrophy
* sex — males are more likely to experience fat loss in their arms and legs, while females tend to have an increase in abdominal and breast fat
* length and severity of HIV infection — the longer you have been infected and the more severe your infection, the higher your risk for lipodystrophy
* a baseline body mass index (BMI) in the obese range or significant weight changes are risk factors for lipodystrophy
* baseline immune system health and immune system recovery after starting anti-HIV medications are also risk factors
Which Anti-HIV Drugs Are Most Likely to Cause Lipodystrophy?
Zerit (stavudine, d4T) is one NRTI that has been specifically shown to cause fat loss. PIs may increase the risk of fat accumulation. The longer you take NRTIs and PIs, the greater your chance of developing lipodystrophy.
How Will My Doctor and I Know if I Have Lipodystrophy?
A diagnosis of lipodystrophy is usually made by examining your body for fat changes. Your doctor may measure the circumference of your arms, thighs, waist, hips, and neck before you start medication and then periodically throughout your treatment. Abdominal magnetic resonance imaging (MRI) or CT scans can assess abdominal fat; however, there are currently no specific recommendations for routine assessment and monitoring of lipodystrophy.
How Is Lipodystrophy Treated?
There are currently no clearly effective treatments for lipodystrophy. However, if you have lipodystrophy, you may benefit from:
* Changes in your anti-HIV medications — People with lipodystrophy may benefit from changes to their HIV treatment regimens. If you are taking Zerit, switching to Ziagen (abacavir, ABC) may help reduce lipodystrophy. PIs may be replaced with non-nucleoside reverse transcriptase inhibitors (NNRTIs), which are not associated with lipodystrophy. However, the results of switching drugs are uncertain; you and your doctor may decide that changing medications is not right for you. Be sure to talk with your doctor before stopping or switching any medications.
* Diet and exercise — Changes to your diet and exercise regimen may help build muscle and reduce fat accumulation.
* Medications — If you have insulin resistance and are hyperglycemic (see Hyperglycemia Fact Sheet), the drug Glucophage (metformin) may help decrease abdominal fat.
* Injections, implants, and surgery — If you have fat wasting, you may benefit from injections of human growth hormone (hGH) to boost muscle size in your arms and legs. Injections of fat or synthetic fat substitutes like Sculptra can fill out sunken cheeks, as can cosmetic cheek implants. However, most of these treatments, along with surgery to remove fat accumulation, are still being studied and do not yet have FDA approval for the treatment of HIV-related lipodystrophy. Sculptra is the only treatment that is currently approved; it received FDA approval in August 2004.
www.theratech.com press releases and website
Disclosure: Long Theratechnologies Inc.