Crescita Therapeutics (TSX:CTX), is aiming to be a $50-million commercial dermatology company in the next five years, with a portfolio of non-prescription skincare products and prescription drug products for the treatment and care of skin conditions, their diseases and their symptoms.
“We have four pillars in our growth strategy,” Dan Chicoine, executive chairman and interim CEO, says in an interview with BioTuesdays, citing organic growth of existing product lines, strategic acquisitions and/or out-licensing agreements, additional international expansion and contract manufacturing.
Crescita, which was spun out of Nuvo Research in 2016, generated revenue of $2.7-million in the third quarter of 2017. Mr. Chicoine was a former co-CEO of Nuvo.
In its non-prescription business, Crescita is currently selling five products, including two lines dedicated to medical skincare for pre and post-procedure treatments: Pro-Derm and Alyria; Laboratoire Dr Renaud, its flagship brand sold exclusively to professional aestheticians; Premiology 360, a line of high-end aesthetics products and ISDIN.
Laboratoire Dr Renaud is also sold internationally in Korea and Malaysia. The company is working to increase its export activities as part of its four-pillar growth strategy. Across Canada, a nine-member sales force distributes these products to medical spas, pharmacies and professional aesthetic spas.
Crescita also conducts manufacturing and formulation development at its 50,000-square-foot Health Canada-compliant GMP plant in Laval, Quebec, and offers turnkey manufacturing services to third parties from R&D to commercialization.
“The non-Rx business is well positioned for domestic and international growth,” Mr. Chicoine says, adding that the business could reach profitability in 2018.
In its prescription products pipeline, Crescita currently has one FDA-approved product, Pliaglis, which it licensed in April to Taro Pharmaceuticals, the Canadian unit of Taro Pharmaceutical Industries (NYSE:TARO). The agreement gives Taro exclusive rights to sell and distribute Pliaglis and its second-generation formulation, Flexicaine, in the U.S.
Under the accord, Crescita has the potential to earn up to $5.75-million (U.S.) in development and sales milestones, plus double-digit tiered royalties on net U.S. sales.
Pliaglis is a topical local analgesia for superficial dermatological and cosmetic procedures. According to Mr. Chicoine, Pliaglis is the most powerful topical analgesia approved by the FDA, consisting of 7% lidocaine and 7% tetracaine.
Taro plans to launch Pliaglis in the U.S. in 2018, while Crescita is concurrently planning for the product’s Canadian launch and is currently seeking a licensing partner for the product in Mexico.
In December 2015, the company reacquired the development and marketing rights for Pliaglis in the U.S., Canada and Mexico from Galderma Pharma S.A., which owns the rest of the world rights for Pliaglis.
Crescita also licensed Flexicaine to Taro, which is conducting the final clinical requirements prior to filing for FDA approval. Flexicaine is designed for the topical treatment of pain conditions and will seek approval under the same label as Pliaglis.
The Flexicaine formulation, which was developed with Crescita’s Peel & DuraPeel technologies, dries to form a film, which can be easily peeled from the skin once the active ingredients have been delivered to the site of pain.
Crescita’s prescription pipeline also includes two dermatology product candidates: MiCal 1 for the treatment of plaque psoriasis and MiCal 2, with an undisclosed indication.
Crescita is responsible for formulation development/IP of the two products and providing its Multiplexed Molecular Penetration Enhancer (MMPE) technology, which is designed to deliver combinations of FDA-approved excipients through the skin.
The clinical phase of development for both compounds will be fully funded by development partners, Ferndale Laboratories and a leading U.S. contract research organization.
In September, Crescita received statistically significant topline results from a U.S. Phase 2 clinical trial with MiCal 1 in 89 patients with moderate-to-severe plaque psoriasis. A treatment success, using an Investigator’s Global Assessment score, was achieved in 38% of subject’s in the treatment group, compared with 7% of subjects in a control group.
The companies will be seeking an end-of-Phase 2 meeting with the FDA to discuss advancing MiCal 1 to a Phase 3 study next year as well as requirements for future FDA approval.
Mr. Chicoine says MiCal 1 may be out licensed before the start of the pivotal program. Formulation development and preclinical work is nearly finished for MiCal 2, with plans to begin a clinical program in 2018.
“Our business development activities and ongoing and focused on in licensing and/or acquiring new products,” he adds. “Internal growth alone won’t get us to our $50-million revenue target. The key will be international expansion and acquisitions. There are lots of small dermatology companies selling into this market that could be a very good fit for us.”