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Cutis Health Announces Acquisition of Doral

April 6, 2016

Atlanta GA: Cutis Health, LLC, a specialty pharmaceutical company based in Atlanta acquires Doral (Quazepam) from Sciecure Pharma, Inc. In addition to the product New Drug Application (NDA), the acquisition includes significant inventory with extended dating. “We are pleased to re-introduce Doral to the US market as a treatment option with a broader approved insomnia indication and additional clinical advantages compared to currently available products” said Dr. Barry Patel, Co-Founder of Cutis Health.

Doral is a benzodiazepine approved for all three types of insomnia: difficulty falling asleep, difficulty staying asleep and early morning awakening. Doral was developed and introduced by Schering Plough in the 1980s and has been used by healthcare providers to successfully treat millions of people suffering from the different types of insomnia.

The U.S. insomnia market consists of approximately 50 million prescriptions annually, with over 95% filled generically. The overwhelming majority of these prescriptions are filled with zolpidem (e.g. Ambien®) and temazepam (e.g. Restoril®). Doral provides a clinical alternative to both market leaders with broader indications and less rebound insomnia. Dr. Wade Smith, Co-Founder of Cutis Health stated, “The acquisition of Doral provides a significant lead asset for our representatives while our pipeline progresses”. Cutis will be launching Doral through its unique model of distribution consisting of Independent pharmacies.

About Cutis Health

Cutis Health is a specialty pharmaceutical company focused on acquiring, developing and commercializing prescription and non-prescription products through independent pharmacies. For general information, please visit the company’s website: www.cutishealth.com.

About Doral (Quazepam)

Indication
Doral (Quazepam) is indicated for the treatment of insomnia characterized by difficulty falling asleep, frequent nocturnal awakenings, and/or early morning awakenings.

Important Safety Information (ISI)

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions (5.1), Drug Interactions (7)]. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

Doral can produce daytime impairment, and this risk increases with dose and concomitant use of other CNS depressants. If insomnia worsens or fails to remit after 7 to 10 days of treatment, this might be indication of an underlying illness. Doral is contraindicated in patients with a known hypersensitivity to quazepam or other benzodiazepines, established or suspected sleep apnea, or chronic pulmonary insufficiency. Rare cases of severe anaphylactic reactions including angioedema and dyspnea have been reported. Complex behaviors, such as sleep driving or sleep eating, have been reported with the use of sedative-hypnotics. Immediately evaluate the onset of any new behavioral changes. Benzodiazepines may worsen depression, and appropriate precautions should be considered in at risk patients. For a full list of warnings and precautions, please refer to the full prescribing information.

Visit www.DoralRx.com for more details and full prescribing information.

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