09.05.2019 00:19

Press Release: Novartis to acquire Xiidra(R), expanding front-of-eye portfolio and strengthening leadership in eye care


Novartis International AG / Novartis to acquire Xiidra(R), expanding

front-of-eye portfolio and strengthening leadership in eye care.

Processed and transmitted by West Corporation. The issuer is solely

responsible for the content of this announcement.

-- Xiidra (lifitegrast ophthalmic solution) 5% fits strategically within

industry-leading USD 4.6 billion Novartis ophthalmic pharmaceutical

portfolio, laying groundwork for front-of-the-eye pipeline products

currently in development[1]

-- Xiidra is the first and only prescription treatment approved for both

signs and symptoms of dry eye disease with a mechanism of action that

targets inflammation[2]

-- Xiidra achieved USD 0.4 billion of revenue in 2018 and is well positioned

for blockbuster potential; closing expected in second half of 2019,

subject to satisfaction of customary closing conditions, including

regulatory approvals

-- Deal terms include a USD 3.4 billion upfront payment with potential

milestone payments of up to USD 1.9 billion

Basel, May 9, 2019 - Novartis announced today that it has entered into

an agreement with Takeda Pharmaceutical Company Limited to acquire the

assets associated with Xiidra(R) (lifitegrast ophthalmic solution) 5%

worldwide. Xiidra is the first and only prescription treatment approved

to treat both signs and symptoms of dry eye by inhibiting inflammation

caused by the disease[2]. The transaction would bolster the Novartis

front-of-the-eye portfolio and ophthalmic leadership. Closing of the

transaction is expected in second half of 2019, subject to customary

closing conditions including regulatory approvals. On closing, Novartis

plans a smooth transition of operations and integration of Xiidra into

its pharmaceuticals portfolio.

Dry eye is a common inflammatory disease that, left untreated, can

become extremely painful and lead to permanent damage to the cornea and

vision[3]. This damage manifests in the form of signs that can be

objectively measured by eye care professionals through various clinical

tests (such as corneal staining), and symptoms (such as pain and

discomfort). Xiidra, with its anti-inflammatory mechanism of action, is

the first dry eye treatment approved to treat both the signs of eye

damage and the physical symptoms experienced by patients. Additional

benefits of Xiidra, exhibited in phase III studies, include a timely

onset of action and well-tolerated safety profile.

"Xiidra, with its unique dual benefits, is an example of the type of

innovative advances we invest in for the benefit of patients," said Paul

Hudson, CEO Novartis Pharmaceuticals. "We look forward to leveraging our

well-established commercial infrastructure to bring this medicine to

more patients."

In addition to powering Novartis' ability to serve more patients

suffering from eye disease, the additional commercial experience

established with Xiidra is expected to better position the company for

front-of-the-eye pipeline products currently in development.

Deal terms include a USD 3.4 billion upfront payment with potential

milestone payments of up to USD 1.9 billion. As part of the agreement,

Novartis will be taking on approximately 400 employees associated with

the product.

About dry eye disease

Dry eye disease is a multifactorial disease of the tears and ocular

surface[3]. In the US, it is estimated that more than 34 million people

are impacted by the disease[3]. It is diagnosed by an eye care

professional based on patient-reported symptoms such as eye dryness,

overall eye discomfort, stinging, burning, a gritty feeling or

fluctuating blurry vision, as well as signs of damage to the eye's

surface, which include redness and corneal damage that can be

objectively evaluated by an eye care professional through various

tests[4]. Dry eye disease can interrupt daily activities such as reading,

driving, working, using technology and spending time outside in bright

light and cold or windy conditions[3]. Aging and gender (more prevalent

in females) are recognized as traditional risk factors of dry eye

disease while modern risk factors include prolonged digital/computer

screen time, contact lens wear and cataract or refractive surgery[4],

[5]. Dry eye may be progressive and is one of the most common reasons

people visit eye care professionals[6].

About Xiidra

Xiidra is a prescription eye drop solution designed to treat the signs

and symptoms of dry eye disease[2]. It is dosed twice per day,

approximately 12 hours apart, in each eye[2]. Xiidra is approved to

treat signs and symptoms of dry eye disease in multiple markets

including the US, Canada and Australia. It is under regulatory review in

a number of additional markets.

Approximately 1000 patients were treated with Xiidra in four

vehicle-controlled 12-week trials[2]. Each of the four studies assessed

the effect of Xiidra on both the signs and symptoms of dry eye disease

at baseline, week two, six and 12[2].

In three of the four studies, a larger reduction in the eye dryness

score (EDS) was observed with Xiidra at six and 12 weeks[2]. In two of

the four studies, an improvement in EDS was seen with Xiidra at two

weeks[2]. At week 12, a larger reduction in inferior corneal staining

score (ICSS) favoring Xiidra was observed in three of the four

studies[2]. The most common adverse reactions reported in 5 to 25

percent of patients were instillation site irritation, altered taste

sensation (dysgeusia) and reduced visual acuity[2].


This press release contains forward-looking statements within the

meaning of the United States Private Securities Litigation Reform Act of

1995. Forward-looking statements can generally be identified by words

such as "to acquire," "expanding," "strengthening," "strategically,"

"laying groundwork," "pipeline," "in development," "well positioned,"

"potential," "expected," "subject to," "closing conditions," "would,"

"plans," "look forward to," "position," "aim," or similar terms, or by

express or implied discussions regarding potential completion of the

announced acquisition of Xiidra, regarding potential future milestone

payments, or regarding potential future revenues from Xiidra or the

other products in the Novartis ophthalmic pharmaceutical portfolio and

pipeline. You should not place undue reliance on these statements. Such

forward-looking statements are based on the current beliefs and

expectations of management regarding future events, and are subject to

significant known and unknown risks and uncertainties. Should one or

more of these risks or uncertainties materialize, or should underlying

assumptions prove incorrect, actual results may vary materially from

those set forth in the forward-looking statements. There can be no

guarantee that the proposed acquisition of Xiidra will be completed in

the expected form or within the expected time frame or at all. Nor can

there be any guarantee that Novartis will be required to make any

milestone payments for Xiidra in the future. Neither can there be any

guarantee that Novartis will be able to realize any of the potential

strategic benefits, synergies or opportunities as a result of the

acquisition. Nor can there be any guarantee that Xiidra or other

products in the Novartis ophthalmic pharmaceuticals portfolio and

pipeline will be commercially successful in the future. In particular,

management's expectations regarding these products could be affected by,

among other things, unexpected regulatory actions or delays or

government regulation generally, including an unexpected failure to

obtain necessary government approvals for the acquisition of Xiidra, or

unexpected delays in obtaining such approvals; the potential that any

other closing conditions for acquisition of Xiidra might not be met; the

potential that the strategic benefits, synergies or opportunities

expected from the acquisition of Xiidra, including the potential impact

of the acquisition of Xiidra on the success of potential future products,

may not be realized or may take longer to realize than expected; the

uncertainties inherent in the research and development of new healthcare

products, including clinical trial results and additional analysis of

existing clinical data; our ability to obtain or maintain proprietary

intellectual property protection; safety, quality or manufacturing

issues; global trends toward health care cost containment, including

government, payor and general public pricing and reimbursement

pressures; the particular prescribing preferences of physicians and

patients; uncertainties regarding actual or potential legal proceedings,

including, among others, potential legal proceedings with respect to the

proposed acquisition; and other risks and factors referred to in

Novartis AG's current Form 20-F on file with the US Securities and

Exchange Commission. Novartis is providing the information in this press

release as of this date and does not undertake any obligation to update

any forward-looking statements contained in this press release as a

result of new information, future events or otherwise.

About Novartis in ophthalmology

Novartis is reimagining the treatment and prevention of visual

impairment and blindness. By working to push the boundaries of medicine

and technology, we aim to develop life-changing gene therapies,

next-generation pharmaceuticals, and transformative technologies for

diseases and conditions spanning every area of eye disease, including

front and back of the eye.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives.

As a leading global medicines company, we use innovative science and

digital technologies to create transformative treatments in areas of

great medical need. In our quest to find new medicines, we consistently

rank among the world's top companies investing in research and

development. Novartis products reach more than 750 million people

(MORE TO FOLLOW) Dow Jones Newswires

May 08, 2019 18:20 ET (22:20 GMT)

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