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Galt Pharmaceuticals Announces Acquisition of Cutis Health

January 22, 2017

Atlanta, GA: Galt Pharmaceuticals, LLC announces the acquisition of Cutis Health, LLC. The transaction includes Cutis Health's prescription and non-prescription products as well as its intellectual property and registered marks. Dr. Barry Patel, President & CEO of Galt, stated, “Integrating the Cutis Health brand and generic products into the unique Galt Independent Pharmacy distribution network will create synergistic partnerships that ultimately help patients meet unmet treatment needs” As part of the deal, Galt will assume the existing Cutis Health labeler assignment and Cutis Health products currently in the distribution channels. Galt will assume the existing Cutis Health contracts, commitments and labeler assignment. Inventory currently not in distribution channels will be relabeled under Galt Pharmaceuticals branding before distribution.

The agreement transitions an NDA (Doral®), unnamed ANDAs and a generic OTC Monograph product (lidocaine 4% cream) to Galt. “While Doral will be actively promoted by our representatives working on behalf of independent pharmacies, the generic monograph products will continue to be distributed through competitive wholesaler pricing and large purchasers” stated Galt Chairman, Dr. Wade Smith. As an example of the competitive pricing, the generic lidocaine 4% cream packaging provides twice the unit dose tubes at significantly lower pricing than existing brands.

About Galt Pharmaceuticals

Galt Pharmaceuticals is a specialty pharmaceutical company focused on acquiring, developing and commercializing brand and generic prescription and non-prescription products through independent pharmacies Learn more at www.galtrx.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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