HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced
that it has reached agreement with Genzyme, a Sanofi company (EURONEXT:
SAN and NYSE: SNY), to settle pending U.S. litigation with regard to the
production and sale of generic formulations of RENVELA® (sevelamer
carbonate 800 mg tablet and oral suspension 2.4g and 0.8g) and RENAGEL®
(sevelamer hydrochloride 400 mg and 800 mg tablets). Under the terms of
the settlement, Genzyme has agreed to grant Impax a license to sell a
generic version of RENVELA® tablets on March 16, 2014 or earlier under
certain circumstances. Genzyme has also agreed to grant Impax a license
to sell a generic version of RENVELA® for oral suspension and of
RENAGEL® on September 16, 2014 or earlier under certain circumstances.
The Company believes that it is the first to file an ANDA with a
paragraph IV certification with respect to the sevelamer carbonate 800
mg tablet product, and expects to be entitled to 180-days of market
exclusivity prior to the launch of additional ANDA products. Upon the
agreed-upon launch dates, Global Pharmaceuticals, Impax’s generic
division, intends to commercialize the products.
RENAGEL® and RENVELA® are both indicated for the control of serum
phosphorus in patients with chronic kidney disease on dialysis.
As reported by Sanofi, net sales of RENAGEL® and RENVELA® were 415
million € ($512 million based on a current exchange rate of $1.257) from
April 1, 2011 to the end of the year. In the first half of 2012, net
sales of RENAGEL® and RENVELA® were 312 million € ($392 million based on
a current exchange rate of $1.257).
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical
company applying its formulation expertise and drug delivery technology
to the development of controlled-release and specialty generics in
addition to the development of branded products. Impax markets its
generic products through its Global Pharmaceuticals Division and markets
branded products through the Impax Pharmaceuticals Division.
Additionally, where strategically appropriate, Impax has developed
marketing partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a full
range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web site
at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, fluctuations in the Company’s revenues and operating income,
the Company’s ability to successfully develop and commercialize
pharmaceutical products, reductions or loss of business with any
significant customer, the impact of consolidation of the Company’s
customer base, the impact of competition, the Company’s ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the Company’s
Taiwan facility, the effect of foreign economic, political, legal and
other risks on the Company’s operations abroad, the uncertainty of
patent litigation, increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and
demand for new pharmaceutical products, the difficulty of predicting
Food and Drug Administration filings and approvals, the Company’s
inexperience in conducting clinical trials and submitting new drug
applications, the Company’s ability to successfully conduct clinical
trials, the Company’s reliance on third parties to conduct clinical
trials and testing, the availability of raw materials and impact of
interruptions in the Company’s supply chain, the use of controlled
substances in the Company’s products, disruptions or failures in the
Company’s information technology systems and network infrastructure, the
Company’s reliance on alliance and collaboration agreements, the
Company’s dependence on certain employees, the Company’s ability to
comply with legal and regulatory requirements governing the healthcare
industry, the regulatory environment, the Company’s ability to protect
the Company’s intellectual property, exposure to product liability
claims, changes in tax regulations, the Company’s ability to manage the
Company’s growth, including through potential acquisitions, the
restrictions imposed by the Company’s credit facility, uncertainties
involved in the preparation of the Company’s financial statements, the
Company’s ability to maintain an effective system of internal control
over financial reporting, any manufacturing difficulties or delays, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines and other risks described in the Company’s
periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and Impax undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
Source: Impax Laboratories, Inc.