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New facility expected to meet all clinical and commercial development needs of lead program KB103
A second, larger cGMP facility expected to be completed in 2020 to meet all anticipated future pipeline production requirements
PITTSBURGH, March 06, 2019 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), a gene therapy company developing medicines to treat dermatological diseases, announced today official opening of Ancoris, its new cGMP facility for clinical and commercial manufacture of its lead product KB103, following a successful trial run and the official inaugural ribbon cutting ceremony, held in Pittsburgh on March 5, 2019. The ribbon cutting ceremony was attended by City of Pittsburgh Mayor William Peduto, representatives from the Office of U.S. Senator Patrick J. Toomey and U. S. Senator Robert P. Casey, and Brett Kopelan, executive director of debra of America, a nonprofit organization providing all-inclusive support to the epidermolysis bullosa (EB) community.
"Completing a successful trial run is another step towards our goal of becoming a fully-integrated gene therapy company and continue to fulfill our commitment to fundamentally treating rare skin diseases in a painless, convenient and effective manner," said Suma M Krishnan, founder and chief operating officer of Krystal. "This facility will be integral for our KB103 program, which we hope to rapidly progress through clinical testing as potentially the first-ever topically applied gene therapy for people suffering from DEB."
The new 4500 square foot Ancoris facility employs more than 25 people and is designed to satisfy the necessary manufacturing requirements for clinical and commercial development of KB103, a best-in-class topically applied 'off the shelf' treatment being developed for people with dystrophic epidermolysis bullosa (DEB). KB103 is currently in a Phase 2 clinical study and topline data from six treated patients are expected in mid-2019.
In addition to the current cGMP facility, Krystal plans to initiate the second phase of its manufacturing strategy with plans to build a second, larger facility in Pittsburgh that will meet all anticipated future research, clinical and commercial demand for future developmental pipeline products. The second facility is expected to be completed in 2020 and will create additional new jobs in the Pittsburgh area.
About Krystal Biotech
Krystal Biotech, Inc. (NASDAQ:KRYS) is a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from dermatological diseases. For more information, please visit http://www.krystalbio.com.
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding the potential of KB103 to treat the underlying causes of DEB, the timetable for bringing GMP manufacturing in-house and the potential for rapid development of the company’s clinical programs. You can identify forward-looking statements because they contain words such as “believes” and “expects.” Forward-looking statements are based on Krystal’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in Krystal’s filings with the Securities and Exchange Commission, including its registration statement on Form S-1 and Form 10-K, as amended from time to time, under the caption “Risk Factors.”
Ashley R. Robinson
Darren Opland, PhD
LifeSci Public Relations
Source: Krystal Biotech, Inc.