Product news roundup from Datamonitor
pharmafile | April 18, 2007 | News story | Sales and Marketing |
Changing of the guard in HIV treatment
The HIV market is forecast to grow from $7.1 billion in 2005 to an estimated $10.6 billion in 2015. This growth is to be driven by a combination of several factors, including an increase in the number of people diagnosed, and the launch of several new drugs and drug classes which offer new hope to patients who otherwise would have, at best, limited, or possibly no therapeutic, options left.
Over the next 10 years, the HIV market is set to undergo significant changes, with the launch of several new products such as Atripla, the first product combining three drugs from two different classes into one convenient once-a-day pill. Meanwhile, despite countless efforts by governments and non-government organisations, the total number of people living with HIV continues to increase. According to UNAIDS, over the past year alone, a staggering 65,000 patients were newly infected and 30,000 patients were reported to have died from AIDS.
Rising incidence: The rise in prevalence has been driven by a number of factors, including a growing number of heterosexual transmissions, immigration from countries with a high HIV prevalence and a growth in high-risk sexual behavior among men who have sex with men. As new lines of therapy become available, patients who currently have limited or even no therapeutic options left will have a greater choice, which should lead to a decline of the HIV/AIDS mortality rate.
At the same time, new diagnostic tests, campaigns to increase HIV awareness and the destigmatisation of the disease are expected to increase the percentage of the infected population receiving treatment.
New product launches: Of the recently launched products, Atripla, a fixed dose combination of Truvada and Sustiva, has been the first drug to combine the components of highly active antiretroviral therapy (HAART) into a single pill that can be taken once-daily and is set to dominate in the first-line treatment market. It has been developed through a unique collaboration between Gilead (Truvada's originator) and Bristol-Myers Squibb, which developed Sustiva.
New classes of drugs such as Pfizer's Celsentri/maraviroc (CCR5 inhibitor) and Merck's Isentress/raltegravir (integrase inhibitor), which are expected to be launched in 2007 and 2008 respectively, are to be used – at least initially – in late-stage therapy, a market that is currently dominated by Roche's Fuzeon, the only entry inhibitor approved so far. However, Fuzeon's cumbersome administration – it has to be injected twice daily and frequently causes side-effects such as injection site reactions – has led to a slow uptake, with first year sales of only $35 million in 2003.
Although sales increased to $249 million in 2006, its use is still restricted because of its high cost and the limited number of patients in salvage therapy. The launch of newer products, such as Celsentri, Isentress as well as new generation NNRTIs and PIs like Tibotec's TMC125 and Prezista, all of which are orally bio-available and less expensive, will have a significant negative impact on the sales of Fuzeon. Despite the latter's proven synergy with some of these new drugs, its use is expected to become even more limited to patients with no other available treatment options.
Regardless of the line of therapy these new drugs will eventually be used in, they will contribute to the significant increase in the value of the antiretroviral market. It is more than likely that the majority of new products will at least initially be reserved for use in late-stage therapy. Nonetheless, their availability will extend treatment options for patients with more advanced HIV and those with AIDS. As a result, patients' life expectancies will improve and therefore an increase in the value of the total antiretroviral market can be expected.
Related links
Bristol-Myers Squibb Company: LSA company report
Merck & Co., Inc. : LSA company report
Pfizer Inc: LSA company report
Commercial Insight: HIV – Change of guard
Pipeline Insight: HIV – Extending treatment options
Stakeholder Insight: HIV – A way of life
Idenix reports mixed hepatitis research
Idenix Pharmaceuticals has reported mixed data from two mid-stage studies of its hepatitis C treatment valopicitabine in combination with pegylated interferon alfa-2a.
The drug produced disappointing results in one study, but in another ongoing study, the data was more encouraging.
One study showed that when valopicitabine was combined with pegylated interferon the therapy worked no better then the current standard of care ribavirin. Of patients treated with valopicitabine in combination with pegylated interferon, none achieved a sustained virologic response, compared to one patient retreated with pegylated interferon and ribavirin.
The primary endpoint of the other study was sustained virologic response, defined as maintained viral clearance six months after treatment is stopped. At the end of the treatment period, 53% of patients treated with 200 mg/day valopicitabine plus pegylated interferon achieved undetectable HCV levels.
Idenix said that the treatment still holds promise. The company believes the data warrant further studies to assess if the addition of ribavirin and potentially another investigational agent to this treatment regimen could offer some of the patients a viable treatment option.
Related links:
Pipeline Insight: Hepatitis C – Protease inhibitors to drive market expansion
Stakeholder Insight: Hepatitis in China – Liver Let Die?
Roche says data points to efficacy of anaemia drug
Roche has said that new data regarding its drug Mircera has highlighted its efficacy and safety for use in renal anaemia associated with chronic kidney disease.
According to these analyses, Mircera corrected and maintained haemoglobin (Hb) levels in patients with chronic kidney disease (CKD). The drug also maintained Hb levels in dialysis patients, regardless of congestive heart failure status and exhibited a safety profile that is consistent with that of standard treatments such as erythropoiesis stimulating agents.
"The goal in treating renal anaemia is to safely maintain target haemoglobin levels," said Steven Fishbane, associate director of Nephrology at Winthrop University Hospital. "These data analyses clearly demonstrate that Mircera corrected low haemoglobin levels, and maintained target haemoglobin levels with the added convenience of up to once-monthly dosing."
The research was an overview of six global studies that compared Mircera with epoetin alfa or beta and with darbepoetin alfa. This overview showed that the efficacy of Mircera was equivalent to that of the comparator agents, but required less frequent administration.
Roche filed applications with the regulatory authorities in the US and in the European Union in April 2006 seeking approval for the use of the treatment for anaemia associated with CKD in patients on dialysis and not on dialysis.
Related links:
Roche Holdings Ltd: LSA company report
Kidney Transplantation – Switching to calcineurin inhibitor-free immunosuppression
Hypertension and Diabetic Kidney Disease – Prevalence, current treatment and future options
