The Wall Street Journal - December 6, 1995

GLAXO'S NEW AIDS DRUG EPIVIR IS ALREADY AVAILABLE TO PATIENTS

Glaxo-Wellcome's Epivir (3TC, lamivudine) was made available to patients shortly after the drug's approval under the FDA's accelerated approval system on Nov. 17. The industry publication The Pink Sheet says that one dose of Epivir will cost $3.11, which will bring annual cost of treatment to an estimated $2,270 per year, but Glaxo says that it will also offer a financial assistance program to anyone who cannot afford treatment. Epivir is intended to be used in combination with Retrovir, another AIDS drug marketed by Glaxo. Epivir is a "reverse transcriptase inhibitor" antiviral, which is the same chemical class as Retrovir, but the difference between the drugs is that the efficacy of both drugs increases when used together when compared to Retrovir alone. The FDA says that AIDS patients should consider treatment with Epivir when there is clinical evidence of disease progression. The rather large patient population that this could potentially includes asymptomatic HIV patients considering drug therapy and patients whose disease is progressing while undergoing monotherapy with Retrovir.

Epivir was jointly developed by Glaxo and BioChem Pharma Inc. [BCHXF-NASDAQ-$39 1/4]. BioChem will receive royalties on sales of the drug which have been estimated in the $300 to $500 million range annually. If in the future, Epivir is shown to increase the effectiveness of other AIDS drugs including nucleoside analogs, non-nucleoside analogs and protease inhibitors, significantly higher sales for Epivir could result. Experts say that future revenues of the drug will also depend on how well combination therapies including Epivir reduce resistance of the AIDS virus. Additionally, sales will also be contingent on when, during the course of the disease, drug therapy is advised. Currently, treating AIDS is problematic because the virus mutates rapidly enabling it to build up resistance to drug treatment. It is believed that the effectiveness of Retrovir fades quickly with HIV changes, which has caused physicians to limit the drug's use early in patients' disease progression. Currently, Retrovir is only approved for patients with CD-4 counts lower than 500 and physicians have been hesitant to treat patients "off-label." Glaxo says that it is currently conducting head-to-head Phase IV studies of Epivir in various combinations, including protease inhibitors.

PATIENTS WITH AIDS-RELATED KS HAVE NEW OPTION: SEQUUS PHARM'S DOXIL

In other AIDS-related treatment news, Sequus Pharmaceuticals, Inc. [SEQU-NASDAQ-$13 1/4] received FDA marketing clearance for its cancer drug Doxil under the FDA's accelerated approval system on Nov. 17. Doxil (doxorubicin HCl liposome injection) will be labelled for the treatment of Kaposi's sarcoma (KS) in AIDS patients whose KS has progressed while on chemotherapy. Analysts at Lehman Brothers, Inc. estimate that sales of Doxil for this second-line KS indication will be $10 to 15 million annually. Reportedly, the company plans to price Doxil at roughly the same price that Bristol-Myers Squibb [BMY-NYSE-$84 1/2] charges for its widely-used cancer agent Taxol. The company has been gearing up to market the product with a newly formed 22-member sales staff.

"FDA market clearance of Doxil is a significant milestone for patients with Kaposi's sarcoma," Sequus' CEO Dr. I. Craig Henderson indicated after the drug's approval. Dr. Henderson added that "Doxil is a new pharmaceutical product that provides real hope for the people with AIDS-related Kaposi's sarcoma for whom conventional therapy, even therapy with doxorubicin, failed or who could not tolerate conventional chemotherapy." According to Sequus, the company is committed to conducting a post-marketing controlled clinical trial designed to verify and describe the exact clinical benefit of Doxil. Kaposi's sarcoma is the most commonly diagnosed malignancy in people living with HIV. Doxil could ultimately prove useful treating other diseases and trials are currently underway to look at the drug's effect on treating breast and ovarian cancer.

LA ROCHE'S LEUKEMIA DRUG VESANOID IS FIRST IN NEW CANCER DRUG CLASS

Hoffman La Roche's [Z.ROC] cancer agent Vesanoid became the first of a new class of oncologic agents approved when the FDA gave the company the green light on Nov. 22 to market the drug for the treatment of acute promyelocytic leukemia (APL). According to La Roche, Vesanoid (tretinoin, all-trans retinoic acid) is the first vitamin A derivative to receive a cancer treatment indication in the U.S. But due to the small patient population for which Vesanoid is intended to treat, analysts see limited sales potential in the range of $50 to $60 million. Vesanoid will also have to compete with an established therapy, Glaxo's Wellferon, which has been available in the U.S. since 1986. The drug is not for long-term use and will be restricted to in-patient treatment of a small subset of the 800 people in the U.S. who suffer from APL.

La Roche says that Vesanoid is distinct from other cancer compounds because the drug has a unique mechanism of action causing leukemic cells to "differentiate" to mature cells and be eliminated. Once the leukemic cells are separated and eliminated by Vesanoid, the body can produce healthy, maturing cells. Unfortunately, in clinical trials, roughly 25% of patients treated with Vesanoid experienced RA-APL syndrome, a sometimes fatal disorder. Roughly 800 new cases of APL are diagnosed in the U.S. annually with approximately 2,000 new cases diagnosed worldwide. La Roche filed a New Drug Application for Vesanoid with the FDA in July 1994 and data for approval came from three open label clinical studies and a compassionate use program. The drug is administered orally in 10 mg gelatin capsules at 45 mg/m2 daily until complete remission is achieved, for a maximum of 90 days.

LIPOSOME CO.'S FUNGAL INFECTION TREATMENT TO BE LAUNCHED NEXT MONTH

On Nov. 20, the FDA gave clearance to The Liposome Co.'s [LIPO-NASDAQ-$18 3/8] new drug Ablecet, a treatment for a fungal infection called aspergillosis. Ablecet, whose chemical name is amphotericin B lipid complex and was formerly called ABLC, will be indicated for patients who do not respond well to conventional amphotericin B therapy. Ablecet is the first Liposome Co. drug to receive FDA approval in the U.S. and analysts at Vector Securities International, Inc. estimate that Ablecet will generate revenues of $150 million by 1998. Company officials said that it plans to have the product available to physicians early in 1996.

Abelcet is the liposomal version of amphotericin B, which has been marketed for many years for the treatment of systemic fungal infections. Liposome Co. says that conventional amphotericin B is generally considered the treatment of choice for aspergillosis.
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