生物医药系列产品
数据
资源
版本对比
免费注册
预约演示
免费注册
Bausch + Lomb Will Acquire
XIIDRA
®
2023-06-30
·
交易
·
BioSpace
并购
临床1期
上市批准
临床结果
Acquisition
Represents Significant Opportunity for Growth in Prescription Dry Eye Segment VAUGHAN, Ontario--(BUSINESS WIRE)--
Bausch + Lomb Corporation
(NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced it has entered into a definitive agreement with
Novartis
under which
Bausch + Lomb
will acquire
XIIDRA
XIIDRA
® (
lifitegrast
ophthalmic solution) 5%, a non-steroid eye drop specifically approved to treat the signs and symptoms of
dry eye disease (DED)
focusing on
inflammation
associated with
dry eye
. “This acquisition is a prime example of our strategy in action, as it provides needed scale for the company and transforms our pharmaceuticals business by making us a leader in ocular surface diseases,” said Brent Saunders, chairman and CEO,
Bausch + Lomb
. “The deal is also expected to accelerate margin expansion through a larger mix of pharmaceutical products in our portfolio, provide strong and immediate earnings accretion and presents a clear path to deleverage, making it financially compelling.” The strategic acquisition of
XIIDRA
will complement
Bausch + Lomb
’s existing dry eye portfolio that includes eye and contact lens drops from the company’s consumer brand franchises and its pharmaceutical business that features
MIEBO
™ (
perfluorohexyloctane
ophthalmic solution), which was recently approved by the
U.S Food and Drug Administration
(“FDA”) as the first and only approved eye drop for DED that directly targets tear evaporation.
XIIDRA
and
MIEBO
work differently to target distinct elements of the DED cycle. DED, which is one of the most common ocular surface disorders1, affects approximately 38 million people in the United States alone and approximately 739 million people worldwide.2 As lifestyles change and people are spending more time on digital screens, research demonstrates the overall prevalence of DED in the United States has increased in the past decade, including in younger adult patients (ages 18 to 34).3 “
Dry eye disease
is multi-factorial and can stem from varying root causes, which means differing treatment options are needed,” said Marguerite McDonald, M.D., F.A.C.S., OCLI Vision, Oceanside, N.Y. “With the acquisition of
XIIDRA
and recent approval of
MIEBO
,
Bausch + Lomb
enhances its approach to different facets of
dry eye
and is well positioned to ensure both medicines reach as many patients as possible.” The prescription U.S. DED field is expected to grow at a double-digit compounded annual growth rate over the next five years.4
XIIDRA
XIIDRA
, which generated approximately $487 million in sales in 2022, is patented through 2033. As part of the transaction,
Bausch + Lomb
will also acquire
libvatrep
(also known as
SAF312
), an investigational compound being studied for the treatment of
chronic ocular surface pain
, and AcuStream™ technology, an investigational device that may have the potential to facilitate precise dosing and accurate delivery of certain topical ophthalmic medications to the eye.5,6
Libvatrep
is currently in Phase 2b development with study results expected in the third quarter of 2023. Transaction Details Under the terms of the agreement,
Bausch + Lomb
, through an affiliate, has agreed to acquire
XIIDRA
XIIDRA
,
libvatrep
and AcuStream from
Novartis
for up to $2.5 billion, including an upfront payment of $1.75 billion in cash with potential milestone obligations up to $750 million based on sales thresholds and pipeline commercialization.
Bausch + Lomb
will also bring on the sales force supporting
XIIDRA
.
Bausch + Lomb
has obtained fully committed financing from J.P. Morgan for the transaction and intends to finance the $1.75 billion upfront cash purchase price with new debt prior to closing. The transaction was approved by the Board of Directors at each of the respective companies and is subject to receipt of regulatory approval and other customary closing conditions. The transaction is expected to close by the end of 2023 and will be immediately accretive.
Bausch + Lomb
intends to maintain its strong balance sheet and expects to return to current leverage levels within approximately 24 months of closing. J.P. Morgan served as financial advisor to
Bausch + Lomb
. Wachtell, Lipton, Rosen & Katz advised on legal matters relating to the transaction, and Davis Polk & Wardwell advised on legal matters relating to the financing. WHAT IS
XIIDRA
?
XIIDRA
XIIDRA
(
lifitegrast ophthalmic solution
) 5% is a prescription eye drop used to treat the signs and symptoms of
dry eye disease
. IMPORTANT SAFETY INFORMATION Do not use
XIIDRA
XIIDRA
if you are allergic to any of its ingredients. Seek medical care immediately if you get any symptoms of an
allergic reaction
. The most common side effects of
XIIDRA
XIIDRA
include
eye irritation
, discomfort or blurred vision when the drops are applied to the eyes, and an unusual taste sensation. To help avoid eye injury or contamination of the solution, do not touch the container tip to your eye or any surface. If you wear contact lenses, remove them before using
XIIDRA
and wait for at least 15 minutes before placing them back in your eyes. It is not known if
XIIDRA
XIIDRA
is safe and effective in children under 17 years of age. Click here for full Prescribing Information for
XIIDRA
XIIDRA
. WHAT IS MIEBO?
MIEBO
™ (
perfluorohexyloctane ophthalmic solution
) is used to treat the signs and symptoms of
dry eye disease
. IMPORTANT SAFETY INFORMATION Patients should remove contact lenses before using
MIEBO
and wait for at least 30 minutes before reinserting. It is important for patients to use
MIEBO
exactly as prescribed. It is not known if
MIEBO
is safe and effective in children under the age of 18. The most common eye side effect seen in studies was blurred vision (1% to 3% of patients reported blurred vision and
eye redness
). Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information for
MIEBO
. About
Bausch + Lomb
Bausch + Lomb
is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853,
Bausch + Lomb
has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries.
Bausch + Lomb
is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. For more information, visit and connect with us on Twitter, LinkedIn, Facebook and Instagram.
Bausch + Lomb
Forward-looking Statements This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “will,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in
Bausch + Lomb
’s filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. In addition, such risks and uncertainties include, but are not limited to, the following: uncertainties relating to the timing of the consummation of the proposed transaction with
Novartis
(the “Transaction”); the possibility that any or all of the conditions to the consummation of the Transaction may not be satisfied or waived, including failure to receive required regulatory approvals; the effect of the announcement or pendency of the Transaction on
Bausch + Lomb
’s ability to maintain relationships with customers, suppliers, and other business partners; the impact of the Transaction if consummated on
Bausch + Lomb
’s business, financial position and results of operations, including with respect to expectations regarding margin expansion, accretion and deleveraging; and risks relating to potential diversion of management attention away from
Bausch + Lomb
’s ongoing business operations. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof.
Bausch + Lomb
undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. References 1. National Eye Institute. Dry Eye. Last updated April 8, 2022. Accessed May 2, 2023. 2. Downs P. 2020 Dry Eye Products Market Report: A Global Analysis for 2019 to 2025. Market Scope; 2020. 3. Modern technology and a multi-screen lifestyle viewed as important factors in rising prevalence of
dry eye disease
. News release. PR Newswire; October 17, 2016. Accessed October 4, 2022. 4. U.S.
dry-eye
size including aqueous supplements, secretagogues, corticosteroids,
LFA-1 antagonists
,
calcineurin inhibitors
calcineurin
inhibitors across anti-inflammatory and non-anti-inflammatory drug classes. Source: DRG (12/2022); Expert interviews; Analyst reports. 5. Quiroz-Mercado H, Ivri E, Gonzalez-Salinas R, et al. Clinical evaluation of a novel electromechanical topical ocular drug delivery system: two phase 1 proof of concept studies. Clin Ophthalmol. 2020;14:139-147. 6. Data on file. AcuStream repetitive acute and real-time delivery study. Novartis, 2022. © 2023 Bausch + Lomb.
更多内容,
请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
机构
Acquisition Corp.
Bausch & Lomb, Inc.
Novartis AG
[+3]
适应症
DED
炎症
眼睛疼痛
[+3]
靶点
CaN
药物
利非司特
全氟己基辛烷
Libvatrep
[+2]
标准版
¥
16800
元/账号/年
新药情报库 | 省钱又好用!
立即使用
来和芽仔聊天吧
热门报告
特应性皮炎深度解析:药物开发、专利分析与风险评估
智慧芽生物医药
2024年7月全球首批及特殊审评药物报告
智慧芽生物医药
GPRC5D靶点专利调研报告
智慧芽生物医药
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台,助您全方位提升您的研发与决策效率。
开始免费试用
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台,以API或者数据包形式对外开放,助您更加充分利用智慧芽新药情报信息。
试用数据服务