Vericel Announces FDA Acceptance for Filing of BLA for MACI for the Treatment of Symptomatic Cartilage Defects in the Knee
March 09 2016 - 7:46PM
Vericel Corporation (NASDAQ:VCEL), a leading developer of
patient-specific expanded cellular therapies for the treatment of
severe diseases and conditions, today announced that the U.S. Food
and Drug Administration has accepted for filing its recently
submitted Biologics License Application (BLA) for MACI™ (matrix
applied characterized autologous cultured chondrocytes), the
company’s investigational autologous cellular product intended for
the treatment of symptomatic cartilage defects of the knee in adult
patients. The FDA provided a PDUFA (Prescription Drug User
Fee Act) goal date of January 3, 2017. In addition, the FDA
communicated that it is not currently planning to hold an advisory
committee meeting to discuss the application.
“The FDA’s acceptance of the MACI BLA for review represents
another important milestone toward our goal of providing a new
treatment option for the repair of symptomatic cartilage defects of
the knee in adult patients,” said David Recker, MD, chief medical
officer of Vericel. “We look forward to continuing to work
closely with the FDA during the BLA review process for MACI in the
United States.”
About MACIMACI (matrix applied characterized
autologous cultured chondrocytes) is a third-generation autologous
chondrocyte implant (ACI) product intended for the treatment of
symptomatic cartilage defects of the knee in adult patients.
MACI is an autologous implant consisting of autologous cultured
chondrocytes seeded onto a resorbable Type I/III collagen membrane.
Autologous cultured chondrocytes are human-derived cells which are
obtained from the patient’s own cartilage for the manufacture of
MACI.
MACI is an investigational product that was studied in the
pivotal Phase 3 clinical trial SUMMIT (“Superiority of MACI Implant
to Microfracture Treatment”) and the three-year SUMMIT Extension
trial. SUMMIT was a two year, prospective, multicenter,
randomized, open-label, parallel-group clinical trial designed to
evaluate the safety and efficacy of MACI to reduce pain and improve
function compared with arthroscopic microfracture in the treatment
of patients (n = 144) with symptomatic Outerbridge Grade III or IV
focal cartilage defects. The SUMMIT Extension trial evaluated
the safety of both treatments for an additional three years.
About Vericel CorporationVericel Corporation is
a leader in developing patient-specific expanded cellular therapies
for use in the treatment of patients with severe diseases and
conditions. The company markets two autologous cell therapy
products in the U.S.: Carticel® (autologous cultured chondrocytes),
an autologous chondrocyte implant for the treatment of cartilage
defects in the knee, and Epicel® (cultured epidermal autografts), a
permanent skin replacement for the treatment of patients with
deep-dermal or full-thickness burns comprising greater than or
equal to 30% of total body surface area. Vericel is also
developing MACI™, a third-generation autologous chondrocyte implant
for the treatment of cartilage defects in the knee, and
ixmyelocel-T, a patient-specific multicellular therapy for the
treatment of advanced heart failure due to ischemic dilated
cardiomyopathy. For more information, please visit the
company’s website at www.vcel.com.
Epicel® and Carticel® are registered trademarks and MACI™ is a
trademark of Vericel Corporation. © 2016 Vericel
Corporation. All rights reserved.
This document contains forward-looking statements, including,
without limitation, statements concerning anticipated progress,
objectives and expectations regarding the commercial potential of
our products, intended product development, clinical activity
timing and regulatory pathway and timing, and objectives and
expectations regarding our company described herein, all of which
involve certain risks and uncertainties. These statements are
often, but are not always, made through the use of words or phrases
such as "anticipates," "intends," "estimates," "plans," "expects,"
"we believe," "we intend," and similar words or phrases, or future
or conditional verbs such as "will," "would," "should,"
"potential," “can continue,” "could," "may," or similar
expressions. Actual results may differ significantly from the
expectations contained in the forward-looking statements. Among the
factors that may result in differences are the inherent
uncertainties associated with competitive developments, integration
of the acquired business, clinical trial and product development
activities, regulatory approval requirements, the availability and
allocation of resources among different potential uses, estimating
the commercial potential of our products and product candidates and
growth in revenues and improvement in costs, market demand for our
products, and our ability to supply or meet customer demand for our
products. These and other significant factors are discussed in
greater detail in Vericel’s Annual Report on Form 10-K for the year
ended December 31, 2014, filed with the Securities and Exchange
Commission ("SEC") on March 25, 2015, Quarterly Reports on Form
10-Q and other filings with the SEC. These forward-looking
statements reflect management's current views and Vericel does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this release except as required by law.
CONTACT:
Chad Rubin
The Trout Group
crubin@troutgroup.com
(646) 378-2947
or
Lee Stern
The Trout Group
lstern@troutgroup.com
(646) 378-2922
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