Neothetics Initiates Phase 3 Trials for Abdominal Fat Reducing Injectable

Specialty pharmaceutical company Neothetics will begin two Phase 3 trials—AbCONTOUR1 and AbCONTOUR2—of LIPO-202, the first noninvasive drug candidate for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. LIPO-202 is an injectable formulation of salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist that activates ß2-adrenergic receptors on fat cells,...

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Neothetics Initiates Phase 3 Trials for Abdominal Fat Reducing Injectable

Specialty pharmaceutical company Neothetics will begin two Phase 3 trials—AbCONTOUR1...

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Neothetics Initiates Phase 3 Trials for Abdominal Fat Reducing Injectable

Specialty pharmaceutical company Neothetics will begin two Phase 3 trials—AbCONTOUR1 and AbCONTOUR2—of LIPO-202, the first noninvasive drug candidate for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. LIPO-202 is an injectable formulation of salmeterol xinafoate, a long-acting ß2-adrenergic receptor agonist that activates ß2-adrenergic receptors on fat cells, triggering the breakdown of triglycerides stored in the cells and causing lipolysis. Previous studies have indicated that LIPO-202 safely and effectively reduced central abdominal bulging.

AbCONTOUR1 and AbCONTOUR2 are randomized, double-blind, placebo-controlled studies that will assess a total weekly dose of 0.40mcg of LIPO-202 injected over eight weeks. A total of 1,600 patients will be enrolled and randomized 1:1 to LIPO-202 or placebo. The trials will be conducted in approximately 80 sites across the U.S.

The primary efficacy endpoint of both Phase 3 trials will be measured using two independent assessment scales: the Patient-Global Abdominal Perception Scale (P-GAPS) and the Clinician Photonumeric Scale (CPnS). The assessment scales will be used together as a composite to define a responder as a patient who...

Cipher Acquires INNOCUTIS

Cipher Pharmaceuticals has acquired INNOCUTIS, a privately held specialty dermatology company, for $45.5 million in cash. The agreement also includes additional INNOCUTIS management incentive payments of up to $3 million in cash over a three-year period based on the achievement of certain financial performance targets.

“This acquisition marks our commercial entry to the U.S. market and represents an important step toward our goal of creating a leading North American dermatology business,” said Shawn O'Brien, president and CEO of Cipher. “INNOCUTIS provides us with commercial infrastructure, revenue-generating branded prescription products, and a talented team, including a 31-person salesforce that shares our customer-focused philosophy. We see excellent opportunity to drive increased sales and profitability by growing their current branded prescription products, led by Sitavig, and adding new products to the portfolio, including our recently acquired Pruridexin and Dermadexin.”

Elsevier to Publish JID

The Society for Investigative Dermatology (SID) has entered into a publishing agreement with Elsevier, a provider of scientific, medical and technical information products and services. Elsevier will publish the Journal of Investigative Dermatology (JID)—the official journal of the SID and the European Society for Dermatological Research (ESDR)—starting in January 2016.

“The editorial team is very excited at the opportunities presented by our transition to Elsevier,” said Barbara A. Gilchrest, MD, editor at JID since 2012. “With its extensive portfolio of dermatology journals and its technical sophistication, Elsevier can facilitate our outreach to residents and clinician educators while providing excellent guidance and support for all aspects of the journal.”