A comparative Phase IV study of Merck & Co. and Schering-Plough’s Zetia (ezetimibe) and Abbott’s Niaspan (niacin) was stopped early last month, according to a notice posted on the US National Institutes of Health’s online registry of clinical trials. The posting indicated that an “independent steering committee has stopped the trial based on results of a pre-specified, blinded interim analysis,” and that the decision was not due to safety concerns. Merck’s shares fell as much as 5 percent on the news.

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Abbott is listed as one of the trial’s sponsors and collaborators, though spokespeople for the drugmaker, as well as those for the joint venture between Merck and Schering-Plough, said they did not know why the study ended and were not involved in the decision. The trial’s lead investigator, Allen Taylor, declined to disclose the reason for the termination, adding that more information may be provided at a later date.

The randomised ARBITER 6 – HALTS trial began in November 2006 with a planned enrollment of 400 patients who had atherosclerotic coronary or vascular disease, or who were at high cardiovascular risk due to certain other medical conditions. The study, which was expected to conclude later this year, was designed to compare HDL- and LDL-focused dyslipidaemia treatment strategies on carotid atherosclerosis. The primary endpoint was change in carotid intima-media thickness after 14 months, according to the NIH registry.

Commenting on the development, Wells Fargo Securities analyst Larry Biegelsen speculated that “Niaspan likely performed better than Zetia in the HALTS study,” estimating that positive data could eventually add as much as $400 million in sales for Abbott’s product. In addition, Natixis Bleichroeder’s Jon LeCroy, who said a positive or negative outcome for either drug could lead to a rise or fall in prescriptions of up to 20 percent, remarked: “We are now assuming that this trial significantly favoured Niaspan and, as a result, we are decreasing our sales estimates for both Zetia and [Merck and Schering-Plough's] Vytorin.” Analyst Barbara Ryan of Deutsche Bank stated, however, that the negative impact on Merck’s stock was “extremely premature and probably unwarranted.”

Zetia generated revenue of $2.2 billion last year, while Niaspan garnered $786 million in sales.

Source: FirstWord

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At an annual business briefing on Tuesday, Merck & Co. announced plans “to diversify its portfolio by creating a new division, Merck BioVentures…for both follow-on and novel biologics.” The company also reported that it anticipates filing three new drugs for FDA approval in 2009. “Next year will continue to be a period of fundamental transformation that establishes Merck as a different competitor for the next decade,” stated CEO Richard Clark.

The drugmaker noted that it will invest $1.5 billion in Merck BioVentures by 2015, with the goal of having at least five follow-on biologic candidates in Phase III development by 2012. The company indicated that the new unit will use technology Merck obtained in its 2006 acquisition of GlycoFi.

Commenting on the move into generic biologics, Sanford C. Bernstein analyst Timothy Anderson said: “Pfizer is doing it. Novartis is obviously leading the way, and now Merck.” Moody’s analyst Michael Levesque remarked that “Novartis and Teva are further along,” adding, however, that “Merck has vast financial resources to try to catch up despite the pressure on its earnings.”

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Merck stated that its first follow-on biologic programme, MK-2578 for anaemia, is currently undergoing clinical development and that the company expects to launch the treatment in 2012, if approved. Jon LeCroy, an analyst at Natixis Bleichroeder, remarked that the drug could be a major product “if they get it through,” and commented that although no US regulatory process currently exists for the approval of generic biologics, Merck’s involvement in the field “could definitely make things move.”

Peter Kim, president of Merck Research Laboratories said that US regulators will likely require extensive study before allowing generic substitution for biologics, but that the company’s development technology could allow it to launch the anaemia compound two years before competitors who are working on similar treatments.

In addition, Kim noted that the drugmaker expects to file migraine drug telcagepant for FDA approval next year, as well as rolofylline for acute heart failure. The company also plans to file for marketing authorisation for an investigational dyslipidaemia treatment being developed in partnership with Schering-Plough which combines Pfizer’s Lipitor with Merck’s and Schering-Plough’s Zetia; however, the executive said that Merck will not launch the compound, if approved, until Lipitor loses patent protection in 2011.

The company indicated that it has nine compounds in Phase III development, 15 in Phase II testing and 23 in Phase I trials. Merck also said that it is on track to achieve its objective of $2 billion in emerging market sales by 2010 and that it is making “significant investments in key emerging markets, including China and India.”

Source: FirstWord

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