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No More Itching In N'Awlins; PEG O' My Heart; The Days of Our Lives; Food For Thought
Easing Itching In The Big Easy: Biotech therapies for psoriasis brought some relief in New Orleans this week -- especially Enbrel and Remicade. In Phase II study results presented at the 60th annual American Academy of Dermatology (AAD) meeting, more than half the patients with moderate-to-severe psoriasis who were treated with Immunex Corp.'s Enbrel saw their disease symptoms improve by at least 75 percent over six weeks, compared to five percent of the patients who received placebo.
And, in another study, more than half the psoriasis patients treated with Centocor Inc.'s Remicade experienced a high degree of sustained clinical benefit (a 50 percent improvement in symptoms) for at least six months, showing that the therapeutic may be safe and effective for long-term treatment.
Both clinical studies were conducted by Alice Gottlieb, professor of medicine at the University of Medicine & Dentistry of New Jersey - Robert Wood Johnson Medical School. Both products block tumor necrosis factor-alpha; and both are marketed for treating rheumatoid arthritis. Enbrel, moreover, was approved for treating psoriatic arthritis earlier this year.
But they're not the only contenders vying for a chunk of the psoriasis market: Xanelim, a humanized monoclonal antibody targeted to T cells, and ISIS 2302, a topical antisense inhibitor, are also in the running. According to additional results from two Phase III trials presented at the AAD meeting, about three-quarters of the patients who had responded to Xanelim during the first 12 weeks of therapy maintained or improved their responses when treated for an additional 12 weeks. Xanelim, being developed by Genentech Inc. and Xoma Ltd., was also able to elicit a response in some psoriatic patients after only two weeks of treatment.
Isis Pharmaceuticals Inc.'s antisense compound, which targets intercellular adhesion molecule-1, also works, but it's only moderately effective. In Phase II trials in patients with mild-to-moderate psoriasis, ISIS 2302 demonstrated a positive trend toward improvement after eight weeks. Importantly, however, trial results also showed that the drug produced a statistically significant improvement in plaque thickness. Any future clinical studies will investigate ISIS 2302 as a combination therapy. But the company is buoyed by the fact that topical antisense therapy is effective, especially because its second-generation antisense inhibitor of TNF-alpha for treating psoriasis entered Phase II trials in June 2001. (If you'd like to read more about these four psoriasis therapies -- and many others in development -- see the Signals article, "The Heartbreak Of Psoriasis.")
Life's Easier With Remicade: The market for Remicade -- which is already approved as a therapy for Crohn's disease and rheumatoid arthritis (RA) -- was expanding even as the psoriasis trial results were being discussed in New Orleans. On Feb. 28, 2002, the FDA bestowed yet one more approval on the monoclonal antibody -- this time for improving physical function in patients with RA (when used in combination with methotrexate). Patients might not be able to kick up their heels just yet, but they should find many tasks -- such as buttoning a shirt or opening a cupboard -- much easier to perform. Remicade is also indicated, in combination with methotrexate, for reducing the signs and symptoms and inhibiting progression of joint damage in patients with moderately to severely active RA who have had an inadequate response to methotrexate alone.
HIV/HCV Combo: The nucleic acid amplification test developed by Gen-Probe Inc. and Chiron Corp. for detecting both HIV and Hepatitis C virus (HCV) in whole blood also got a nod from the FDA. The assay, Procleix HIV-1/HCV, can detect all known HIV-1 subtypes and HCV genotypes during the very early stages of infection, before either can be picked up by immunodiagnostic screening tests.
PEG O' My Heart: Enzon Inc. and Inhale Therapeutic Systems Inc. are finally singing a duet. The two firms, once at odds over their respective PEGylation technologies, settled their differences in early January 2002, essentially cross-licensing each other's patents and forming a broad strategic alliance on their own products.
The technology -- attaching polyethylene glycol (PEG) polymers to a broad range of drugs -- has been proven to increase drug circulation in the bloodstream, improve drug solubility and stability and reduce immunogenicity. Three recently approved therapeutics -- Amgen Inc.'s second-generation Epogen, Aranesp, its second-generation Neupogen, Neulasta, and Schering-Plough Corp.'s hepatitis C therapy PEG-Intron -- are PEGylated. So are Enzon's leukemia drug Oncaspar and its treatment for severe combined immunodeficiency disease, Adagen.
As part of the January 2002 agreement, Inhale now has the sole responsibility for licensing Enzon's PEG patents to third parties (and Enzon gets a royalty or share of profits on final sales of any products using its technology). This week, Inhale parlayed this PEG strength into three new alliances: With Pharmacia Corp. (for the RA drug CDP870, developed by the Celltech Group plc); with Eyetech Pharmaceuticals Inc. (for its macular degeneration therapy EYE001, an anti-VEGF aptamer); and with 3-Dimensional Pharmaceuticals Inc. (for its synthetic thrombopoietin peptide mimetic compound).
The Days Of Our Lives: Since December 28, 2001, hardly a day's gone by without some new twist to the ImClone Systems Inc./Bristol-Myers Squibb Co. drama concerning Erbitux. This week, the companies met with the FDA to discuss the best approach for moving ImClone's colorectal cancer drug forward. Also attending the meeting was ImClone's European partner, Merck KGaA.
And everyone -- investors, analysts, patients, the press -- waited anxiously for the outcome. In the end, we learned that the meeting was "very productive," according to an ImClone press release, and that it provided the company with "direction on an approach and a process for resubmitting the BLA," which will include data from Merck KGaA's European clinical trial.
Merck agreed, in its own press release, that the meeting was productive. We've had no such public statement from Bristol-Myers Squibb, though. Nor have we heard how the pharma giant intends to proceed going forward: It's still "actively evaluating its options," according to company spokeswoman Nancy Goldfarb. This comment was ambiguous enough to fuel lots of juicy speculation -- and leaves the ImClone/Bristol-Myers Squibb relationship hanging in the balance.
Top Dog: Veterinarian and pharmacologist Lester M. Crawford, Jr. is the FDA's newly appointed deputy commissioner. Effective Feb. 25, 2002, Crawford will be the agency's highest-ranking official until the Bush Administration finds a permanent commissioner. If Crawford's record is any testament, this is a "food," not a "drug," guy. Crawford most recently served as head of the Center for Food Safety and Nutrition Policy at Virginia Tech. He also served as administrator of the USDA's Food Safety and Inspection Service and director of the FDA's Center for Veterinary Medicine. He's already gotten a ringing endorsement from the Grocery Manufacturers of America. We've not heard from the Pharmaceutical Research and Manufacturers of America, though. Mmmm: Food for thought. |