Avadel Pharmaceuticals Announces Divestiture of Pediatric Business
12 2월 2018 - 11:07PM
Cerecor to acquire Avadel’s pediatric assets
Avadel Pharmaceuticals plc (NASDAQ:AVDL) (“Avadel” or “the
Company”) today announced that it has entered into an asset
purchase agreement with Cerecor, Inc (“Cerecor”) whereby Cerecor
will acquire the Avadel pediatric portfolio. In connection with
this transaction, Avadel and Cerecor will enter into a license and
development agreement pursuant to which Avadel will develop up to
four product formulations for Cerecor using Avadel’s LiquiTime™ and
Micropump® technologies. Under the asset purchase agreement,
Cerecor will acquire the Company’s four commercial pediatric
products, Karbinal™ ER, Cefaclor for Oral Suspension,
Flexichamber™ and AcipHex® Sprinkle™, and Cerecor will assume
Avadel’s remaining payment obligations to Deerfield CSF, LLC,
including a $15 million note due in 2021 and its related interest
payments, as well as a 15% annual royalty on net sales of the four
pediatric products. The Company expects the deal to be accretive to
EPS in 2018.
Mike Anderson, Avadel’s Chief Executive Officer
commented, “We made significant progress developing our pediatric
business over the last two years. The script growth and revenue
numbers were up substantially in 2017, particularly for Karbinal
ER. However, after strategically evaluating our business
objectives, we have made the decision to focus our efforts on
expanding our urology, sleep and hospital based products. Our
pediatric products align with Cerecor’s objective to become a
leading U.S. pediatric pharmaceutical company and with the addition
of our sales team will expand their commercial footprint.”
Mr. Anderson continued, “We will also enter into
a license and development agreement to provide four new
pediatric-focused product formulations using our Micropump and
LiquiTime technologies to be selected by Cerecor. We believe they
will be an excellent commercial partner and our team looks forward
to working together during the development process.”
Under the development agreement, Avadel expects
to complete the initial bioequivalence studies within 18 months.
Cerecor will reimburse Avadel for any costs associated with the
development of the four products in excess of $1 million and, upon
transfer of the product formulations, will assume all remaining
development costs and responsibilities associated with regulatory
approval and marketing. If any products receive approval, Cerecor
will pay Avadel quarterly royalties based on a percentage of net
sales in the mid-single digits.
Avadel expects the transaction to close before
February 28, 2018, subject to the satisfaction of certain closing
conditions including the delivery of certain third-party guarantees
and consents.
About Avadel Pharmaceuticals
plc:
Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a
branded specialty pharmaceutical company that seeks to develop
differentiated pharmaceutical products that are safe, effective and
easy to take through formulation development, in-licensing /
acquiring new products and by utilizing its drug delivery
technology; ultimately, helping patients adhere to their prescribed
medical treatment and see better results. The Company is
headquartered in Dublin, Ireland with operations in St. Louis,
Missouri, United States and Lyon, France. For more information,
please visit www.avadel.com.
Safe Harbor: This press release
contains forward-looking statements, including, but not limited to,
statements related to Avadel’s sale of its pediatric assets to
Cerecor and Avadel’s ability to consummate the closing of such
transaction, the accretive impact of such transaction on Avadel’s
results of operations, Avadel’s ability to develop four new
pediatric products under its development agreement with Cerecor,
Avadel’s business strategy and development plans, expected net
sales growth of its marketed products, expected financial
performance in future periods, expected timing of clinical,
regulatory and commercial events, and other statements that are not
historical facts. These forward-looking statements are based on
Avadel’s current expectations and inherently involve significant
risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks that
Avadel’s actual future financial and operating results may differ
from its expectations or goals; Avadel’s ability to grow net sales
from existing products; the availability of coverage and adequate
reimbursement and pricing from government and third-party payers
and risks relating to Avadel’s ability to successfully implement
its business strategies; risks associated with drug development and
regulatory approvals; potential delays in clinical trials,
including due to enrollment rates or adverse events; risks that
results from on-going or future clinical trials may be inconsistent
with results from prior pre-clinical studies or clinical trials;
risks in the ability to recruit, train and retain qualified
personnel; competition, including potential generic competition;
the ability to protect intellectual property and defend patents;
regulatory obligations and oversight, including any changes in the
legal and regulatory environment in which Avadel operates and those
risks detailed from time-to-time under the caption “Risk Factors”
and elsewhere in Avadel’s filings and reports with the SEC. Avadel
undertakes no duty or obligation to update any forward-looking
statements contained in this press release as a result of new
information.
Contacts: |
Michael F. Kanan |
|
Chief Financial Officer |
|
Phone: (636) 449-1844 |
|
Email: mkanan@avadel.com |
|
|
|
Lauren Stival |
|
Sr. Director, Investor Relations & Corporate
Communications |
|
Phone: (636) 449-5866 |
|
Email: lstival@avadel.com |
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