ZARS Pharma

Zars Pharma Product Pipeline
Product Name	Technology	Indication	Status	Marketing Rights
Pliaglis ®	Peel	Dermal Anesthesia (Cosmetic)	Approved (US)	Galderma (WW)
Synera®	CHADD®	Dermal Analgesia (Pediatric)	Launched	ZARS EuroCept (EU/China)
Synera®	CHADD®	Pain Treatment	Conducting Label Expansion Studies	ZARS
Flexicaine™	Peel	Post-Herpetic Neuralgia	Phase 2	ZARS
Steroid DuraPeel™	DuraPeel™	Hand Dermatitis	Phase 2	ZARS
Alprazolam Patch	AmPrivo™	CNS	Phase 2	ZARS
Risperidone Patch	AmPrivo™	CNS	PreClinical	ZARS
Updated19Apr10

Product Description:
Pliaglis® Pliaglis® is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to painful cosmetic procedures such as dermatologic laser surgery and dermal filler injections. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes our Peel technology. Pliaglis should be applied for 20-30 minutes prior to minor dermatological procedures, such as a dermal filler injections, and for 60 minutes prior to major dermatological procedures, such as laser-assisted tattoo removal. Following the application period, Pliaglis can easily be removed from the skin and the procedure can be performed. Pliaglis is approved by the FDA. Galderma owns the worldwide marketing rights to the product.
Synera® Synera® (lidocaine 70mg/tetracaine 70mg topical patch) is a topical patch designed to provide local dermal anesthesia for potentially painful superficial procedures, such as venous access procedures involving needles and immunization injections of children. Synera uses our CHADD® technology and a proprietary local anesthetic formulation that contains lidocaine and tetracaine. The CHADD unit generates gentle heating of the skin and has been demonstrated in a well-controlled clinical trial to contribute to the efficacy of Synera. We are commercializing Synera in the United States and our partner, EuroCept, has recently initiated a pan-European launch of Synera (named Rapydan) in Europe. Synera resembles a small adhesive bandage in appearance and ease of application, and is applied to the skin before painful medical procedures such as venous access, blood draws, needle injections and minor dermatologic surgical procedures. Synera is applied for 20 to 30 minutes prior to venous access procedures and needle injections and for 30 minutes prior to minor dermatological procedures. For more information regarding Synera, please visit www.synera.com.
Flexicaine™ Flexicaine™ is a dermal analgesic cream which combines our Peel technology with a proprietary formulation of lidocaine and tetracaine to safely and effectively anesthetize larger, contoured areas of the body. Flexicaine is designed to provide rapid dermal analgesia to affected skin for the treatment of post-herpetic neuralgia and to provide a more profound anesthetic effect than other available topical treatments. Flexicaine is applied to the affected area for 60 minutes and then removed, providing sustained pain relief for up to 11 hours following removal. In addition to numerous preclinical and pharmacokinetic studies, we completed a Phase 2a efficacy trial demonstrating Flexicaine provided a statistically significant decrease in pain compared to placebo.
Steroid DuraPeel™ Steroid DuraPeel™ is a phase-changing gel designed to deliver a steroid locally for an extended period of time for the treatment of corticosteroid-responsive dermatoses, including hand dermatitis and psoriasis. We believe that the combination of a once-daily application of a topical steroid with our DuraPeel technology may provide important safety and efficacy improvements over current creams and gel products that provide relatively short delivery periods. We recently completed a Phase 2 efficacy clinical trial for this product with excellent results.
Alprazolam Patch Our transdermal alprazolam patch is being developed to treat general anxiety and panic disorder. We have successfully completed several Phase 1 clinical trials demonstrating our alprazolam patch delivers therapeutic levels of alprazolam over three days without the peaks and troughs associated with the traditional oral delivery of alprazolam. This represents a significant clinical acheivement as this is the first transdermal patch that can deliver sustained therapeutic levels of alprazolam. Our alprazolam patch is designed to provide benefits over the existing treatment options by: Delivering more consistent blood levels of alprazolam than oral doses; Improving patient compliance and thus product efficacy; Having fewer side effects during drug tapering and discontinuation; Eliminating the patient’s anxiety of properly timing their dosage observed with oral alprazolam. Risperidone Patch Our transdermal risperidone patch contains a proprietary formulation of risperidone and is designed to treat schizophrenia using our AmPrivo™ patch technology. We believe this product will deliver risperidone across the skin at a controlled rate for up to three days, delivering more consistent blood levels of risperidone than oral doses, offering improved patient compliance, product efficacy, and producing fewer side effects during drug tapering and discontinuation. We are currently performing additional preclinical work on this product.

Product Description:

Pliaglis®
Pliaglis® is a topical local anesthetic cream that provides safe and effective local dermal anesthesia on intact skin prior to painful cosmetic procedures such as dermatologic laser surgery and dermal filler injections. This product consists of a proprietary formulation of lidocaine and tetracaine that utilizes our Peel technology. Pliaglis should be applied for 20-30 minutes prior to minor dermatological procedures, such as a dermal filler injections, and for 60 minutes prior to major dermatological procedures, such as laser-assisted tattoo removal. Following the application period, Pliaglis can easily be removed from the skin and the procedure can be performed. Pliaglis is approved by the FDA. Galderma owns the worldwide marketing rights to the product.

Synera®
Synera® (lidocaine 70mg/tetracaine 70mg topical patch) is a topical patch designed to provide local dermal anesthesia for potentially painful superficial procedures, such as venous access procedures involving needles and immunization injections of children. Synera uses our CHADD® technology and a proprietary local anesthetic formulation that contains lidocaine and tetracaine. The CHADD unit generates gentle heating of the skin and has been demonstrated in a well-controlled clinical trial to contribute to the efficacy of Synera. We are commercializing Synera in the United States and our partner, EuroCept, has recently initiated a pan-European launch of Synera (named Rapydan) in Europe.

Synera resembles a small adhesive bandage in appearance and ease of application, and is applied to the skin before painful medical procedures such as venous access, blood draws, needle injections and minor dermatologic surgical procedures. Synera is applied for 20 to 30 minutes prior to venous access procedures and needle injections and for 30 minutes prior to minor dermatological procedures.

For more information regarding Synera, please visit www.synera.com.

Flexicaine™
Flexicaine™ is a dermal analgesic cream which combines our Peel technology with a proprietary formulation of lidocaine and tetracaine to safely and effectively anesthetize larger, contoured areas of the body. Flexicaine is designed to provide rapid dermal analgesia to affected skin for the treatment of post-herpetic neuralgia and to provide a more profound anesthetic effect than other available topical treatments. Flexicaine is applied to the affected area for 60 minutes and then removed, providing sustained pain relief for up to 11 hours following removal. In addition to numerous preclinical and pharmacokinetic studies, we completed a Phase 2a efficacy trial demonstrating Flexicaine provided a statistically significant decrease in pain compared to placebo.

Steroid DuraPeel™
Steroid DuraPeel™ is a phase-changing gel designed to deliver a steroid locally for an extended period of time for the treatment of corticosteroid-responsive dermatoses, including hand dermatitis and psoriasis. We believe that the combination of a once-daily application of a topical steroid with our DuraPeel technology may provide important safety and efficacy improvements over current creams and gel products that provide relatively short delivery periods. We recently completed a Phase 2 efficacy clinical trial for this product with excellent results.

Alprazolam Patch
Our transdermal alprazolam patch is being developed to treat general anxiety and panic disorder. We have successfully completed several Phase 1 clinical trials demonstrating our alprazolam patch delivers therapeutic levels of alprazolam over three days without the peaks and troughs associated with the traditional oral delivery of alprazolam. This represents a significant clinical acheivement as this is the first transdermal patch that can deliver sustained therapeutic levels of alprazolam.

Our alprazolam patch is designed to provide benefits over the existing treatment options by:

Delivering more consistent blood levels of alprazolam than oral doses;
Improving patient compliance and thus product efficacy;
Having fewer side effects during drug tapering and discontinuation;
Eliminating the patient’s anxiety of properly timing their dosage observed with oral alprazolam.

Risperidone Patch
Our transdermal risperidone patch contains a proprietary formulation of risperidone and is designed to treat schizophrenia using our AmPrivo™ patch technology. We believe this product will deliver risperidone across the skin at a controlled rate for up to three days, delivering more consistent blood levels of risperidone than oral doses, offering improved patient compliance, product efficacy, and producing fewer side effects during drug tapering and discontinuation. We are currently performing additional preclinical work on this product.

Products