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DewDiligence

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Sunday, 08/06/2006 2:18:07 PM

Sunday, August 06, 2006 2:18:07 PM

Post# of 19309
Xigris Struggles to Overcome Problems in Sepsis Market

[Now the GTC has entered the fray in sepsis, it helps to know what the competition is. To date, that competition is basically one drug: Xigris from LLY. This write-up from late 2002 (intended to be a promotion for a report by Datamonitor) illuminates some of the reasons why Xigris has been a commercial flop and there is a large unmet need for something better.]

http://www.bioportfolio.com/news/datamonitor_29.htm

>>
The once lauded drug Xigris is struggling to recover from a series of setbacks, despite existing in a potentially lucrative market with little competition. After disappointing US sales, Xigris has now been launched in Europe. Datamonitor's Michael Randle asks if Eli Lilly can take advantage of its status as the only approved severe sepsis treatment and breathe new life into its sleeping giant.

Every day 1,400 people worldwide die from severe sepsis, a devastating syndrome characterized by an overwhelming systemic response to infection, which can rapidly lead to organ dysfunction and ultimately death. In Europe, severe sepsis is associated with deaths on a scale similar to that for lung cancer, breast cancer or colon cancer every year.

Xigris' nearest competitor, Chiron and Pharmacia's tifacogin, failed late-stage clinical trials at the end of 2001—leaving this massive market wide open. Many investment analysts expected the drug's sales to break through the $1 billion blockbuster threshold. However, following its US launch in November 2001, sales of Xigris have been flat with total US sales for the first half of 2002 at $44.6 million.

Xigris did not enjoy the best of beginnings but Eli Lilly has attempted to overcome these obstacles and planned for a new start with the launch of the drug in Europe.

Early problems

Lilly suffered its first setback in October 2001 when an FDA advisory panel was unable to recommend approval for Xigris following a split vote. Lilly already had massive hopes for the treatment, especially since the company planned to use the drug to revive earnings after the loss of Prozac's patent protection.

The panel were concerned that the Prowess study, on which the drug's application was based, had the patient entry criteria changed halfway through the trial, which may have exaggerated Xigris's efficacy results.

The delay to the drug's launch did not help its sales which for the year-to-date period ending February 28, 2002 reached just $14 million, bringing total sales to $35 million since the drug's launch in late November 2001. Industry analysts had already predicted sales of between $300 and $500 million in 2002.

The company attributed the slow uptake to the complexity of sepsis. Xigris was only approved for use in treating severe sepsis, a definition that is relatively new to the medical world. Physicians were apparently unsure which patients qualified for the severe tag; hospitals therefore, took longer than expected to develop treatment protocols and place the product on their formularies.

Criticism abounds

Lilly's explanation for Xigris' stuttering start was possibly too simplistic however. In the company's Prowess clinical trial Xigris only reduced the absolute risk of death by 6% [from 31% to 25% at 28 days]. It seems that, with a $6,800 price tag, this was insufficient to persuade physicians to prescribe the drug outside the most severe cases.

In 3.5% of Xigris-treated patients (compared to 2% of placebo treated patients), the drug also increased the risk of serious bleeding events. Such side effects have led to a laundry list of absolute contraindications for Xigris (including any 'active' bleeding), imposing serious limitations on its potential market. But perhaps the worst drawback [in the U.S. market] is the fact the drug must be started within 48 hours of the onset of sepsis: often sepsis is not recognized until much later.

Lilly has however, always looked to defend the potential of treatment with Xigris, as Clifford Hall, senior marketing manager at Eli Lilly's Critical Care European Operations said to Datamonitor, "When it is considered that cancer treatments which achieve even the slightest survival extension are hailed, a 6% increase in the absolute risk of death where there has previously been no improvement does represent a real advance in the standard of sepsis treatment."

"Antibiotics are used to control the infection as a standard treatment but no other pharmaceutical compound has been proven to reduce mortality rates in sepsis patients," added Eli Lilly's European Team Physician, Dr Jonathan Janes.

Xigris's fight back

Xigris continued its fight back through the recent decision of US Medicare to grant reimbursement for Xigris. The treatment became the first and only new medical product to be granted new technology status from the Centers for Medicare and Medicaid Services (CMS).

This designation will allow hospitals that use Xigris in the treatment of Medicare patients with life-threatening severe sepsis to receive additional reimbursement. This development should help revive interest among hospital physicians, as it cuts the cost of the drug to $3,400.

"Receiving new technology status for Xigris is an important interim step in our long-term goal of making positive changes in the reimbursement hospitals receive for treating adult patients with life-threatening severe sepsis. Specifically, our primary goal is to work with CMS to facilitate the creation of the new DRG for severe sepsis," said Elaine K Sorg, Lilly US critical care business unit leader.

In August 2002, Xigris also received Marketing Authorization from the European Commission in all 15-member [now 25!] states of the EU. The drug is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. [The key word in the label is “multiple”; i.e. two or more failed organs.]

A new dawn?

Xigris may be able to have a greater impact in Europe than it had in America. The drug has a much clearer indication - for use in adult patients with two or more organs dysfunction. This will help physicians diagnose when the treatment is applicable, in contrast to the previous problem of a poorly defined illness. Xigris will also benefit from the wider European license, which does not confine its use to within 48 hours of the onset of the infection.

Analysts remain skeptical as to whether this will lead to the rebirth of Xigris however. [They were right to be skeptical—the commercial uptake to date has been poor.] Given the cool response to Xigris in the US, its reception in the more cost-constrained European countries could be even less welcoming.

Worse still for Xigris, although the threat of Chiron/Pharmacia's tifacogin has receded, competition may soon be on its way in other forms, including ICOS/Suntory's Pafase, Abbott's afelimomab and Protherics' CytoTAb target tumor necrosis factor. [GTC investors should keep track of these programs.]

Xigris received a further blow at the hands of a report in the New England Journal of Medicine, which argued that the drug should not be widely used until a new study confirms its benefits. The report was based on the opinions of scientists at the Massachusetts General Hospital, the National Institutes of Health and the University of Texas Southwestern Medical Center.

As a result of the existing attitude towards Xigris and despite its approval in Europe, Datamonitor expects Xigris sales to fall well below analysts' consensus forecasts of $300 million in 2002 - and significantly below the widely publicized forecasts of over $500 million.

Eli Lilly nevertheless, continues to react to such setbacks. The company has launched the largest severe sepsis trial ever to take place, the Address study. The study will investigate the effectiveness of Xigris in 11,000 adult severe sepsis patients who have a lower risk of death across approximately 1,000 clinical trial sites.

The primary objective of the Address trial will be to demonstrate that, compared to placebo and conventional care, Xigris can reduce mortality at 28 days in adult patients with severe sepsis who have a lower risk of death. Given the continued lack of effective therapies for sepsis patients Eli Lilly will be hoping to expand the area in which Xigris is used and possibly revive its fortunes.
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