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Janus Pharmaceuticals, Inc. Announces Successful Phase II Study In Shingles


12/4/2006 12:28:53 PM

LOS ANGELES--(BUSINESS WIRE)--Janus Pharmaceuticals Inc. (Janus), a company focused on the discovery and development of drugs to treat a variety of topical diseases, today announced positive results of its ARYS-0502 study of topical ARYS-01 Cream for the treatment of patients with primary Herpes Zoster (Shingles) episodes. "We are greatly excited about these results," Dr. Norifumi Nakamura, CEO of Janus, announced. "Despite the fact that this was an under-powered study for efficacy, and the first time an agent with this mechanism of action has been evaluated in this population of patients, these data do show remarkably consistent improvements in all the clinical and surrogate markers in all efficacy parameters that suggests topical ARYS-01 Cream can alter the pathophysiology of Herpes Zoster."

The ARYS-0502 study was a Phase II, placebo controlled, safety, efficacy and absorption evaluation of ARYS-01 cream with the test material applied twice daily for 7 days in patients with a primary Shingles episode. After the first 3 days of treatment, all subjects initiated Valtrex oral standard of care antiviral treatment concomitantly with test material treatment. The results exhibited a 30% reduction in rash area in the ARYS-01 Cream treatment group compared to placebo in the initial 3 days of treatment, prior to initiation of Valtrex. Impressively, the course of rash healing showed a near statistically significant difference (p=0.07), with rashes in the placebo group having a much higher median percentage (60%) transitioning through the crusting stage than rashes in the ARYS-01 Cream group (15%), which healed without crusting. In addition, patients receiving topical ARYS-01 Cream exhibited a marked reduction in severity of acute, nociceptive Zoster-associated pain in the first month, compared to Placebo, as evaluated by the Brief Pain Inventory (BPI). In addition to Safety, pharmacokinetics (PK) and efficacy assessments, changes in Varicella Zoster Virus expression was also measured using polymerase chain reaction (PCR) which showed a corresponding course of virus inhibition.

The active ingredient of ARYS-01 Cream is Sorivudine, an antiviral nucleoside analog which was originally discovered by Yamasa Corporation of Chiba, Japan, and is being developed as a topical formulation by Janus under a joint development agreement with aRigen Inc. of Tokyo, Japan. aRigen, a drug discovery and development company with focus on infectious diseases, is developing ARYS-01 globally, and has several patents to cover the production method and use of the topical formulation for the treatment of herpes zoster.

Haruhiko Machida, Ph.D., Director & Chief Development Officer at aRigen Inc., stated, "These results provide the evidence we needed to push ahead with Phase II/III trials to further validate my lifelong belief that topical ARYS-01 cream antiviral therapy can be an effective and possibly safer treatment for Herpes Zoster compared to oral antiviral therapy." According to Dr. Machida, Janus Pharmaceuticals Inc. will be launching a Phase II/III trial in the US in the first quarter of 2007, and is targeting the NDA for ARYS-01 cream for early 2009.

About Shingles

Shingles is the reactivation of varicella zoster virus (VZV), which leads to eruption of a painful rash over an area of skin. More than 95% of people are infected with VZV at one time of life or another. Primary VZV infection manifests as varicella (chickenpox). The virus then establishes a latent infection of the sensory ganglia from which it may reactivate years later to produce the clinical syndrome of shingles. Shingles affects some 1 million people per year in the United States and many patients develop an excruciating painful condition called post-herpetic neuralgia which is often difficult to manage. Current treatment options are with oral antiviral drugs such as Acyclovir or Valtrex.

About Janus Pharmaceuticals Inc. (www.januspharma.com)

Janus Pharmaceuticals, Inc. (Janus) is a specialty pharmaceutical company founded in 2004 that has a growing portfolio of topical pharmaceutical products for the treatment of infectious diseases. Janus currently has three products in development: JA-001, topical ARYS-01 cream for treatment of shingles; JA-002, a gel formulation of a novel proprietary antibiotic targeting prevention and treatment of bacterial infections of the skin; JA-003, an antibiotic cream for the treatment of acne. In addition, Janus will be developing JA -004, an anti-fungal for the treatment of Tinea Pedis (Athlete's Foot), and JA-005, an anti-fungal for the treatment of Onychomycosis (Nail Fungus). Janus is also actively pursuing the acquisition of additional products which will complement their growing product portfolio. Led by an accomplished management team and board located in the US and Japan, Janus has trans-Pacific network and resources in the biopharmaceutical industry.

Contact:

Janus Pharmaceuticals, Inc. US Office Joseph M. Golemme, 1-626-568-0762 Fax: 1-626-568-8667 jgolemme@januspharma.com or

Japan Office Kyaw Min Oo, 81-3-4360-8358 Fax: 81-3-4360-8201 kmo@januspharma.com

Source: Janus Pharmaceuticals Inc.



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