UCB to Expand Epilepsy Portfolio With Strategic Acquisition of Midazolam Nasal Spray From Proximagen

Brussels (ots/PRNewswire) -

- Midazolam Nasal Spray (USL261), is a nasally administered
investigational midazolam formulation intended as a rescue
treatment of acute repetitive seizures (ARS) in patients with
epilepsy, which has completed Phase 3 clinical development and is
ready to be filed as a New Drug Application (NDA) in the course of
2018.
- USL261[1] already granted orphan drug and fast track designation by
the United States Food and Drug Administration, due to the high
unmet need for patients and caregivers.
- Nasal administration could provide significant value to patients
who currently have limited treatment options.
- Acquisition of USL261 complements UCB's already successful
anti-epilepsy drug portfolio, enhancing the company's position as a
global leader in epilepsy.

UCB today announced an agreement to acquire the rights to
Proximagen's Midazolam Nasal Spray (USL261)[1], an anti-epilepsy drug
(AED) developed as an intended rescue treatment for acute repetitive
seizures (ARS, also known as serial, recurrent or cluster seizures)
in patients with epilepsy.

USL261[2] is a novel investigational midazolam formulation, which
has been specifically designed for intranasal delivery without active
inhalation. It has been granted orphan drug designation and fast
track designation by the United States Food and Drug Administration
(FDA), reflecting the significant unmet need which currently exists
for ARS rescue treatment.

Rectally administered benzodiazepines, such as diazepam, are
commonly prescribed for the treatment of ARS. However, whilst this
has traditionally provided patients and caregivers with a much-needed
treatment option, this route of administration may be cumbersome and
problematic in social settings. A treatment administered nasally
would provide important additional treatment options.

USL261 has demonstrated strong results in a significant Phase 3
clinical trial[3] program and the intention is to file USL261 as a
New Drug Application (NDA) in the course of 2018.

"There is a real and pressing need for effective and convenient
rescue treatments in ARS that rapidly end ongoing seizures as well as
those that prevent seizure reoccurrence," explained Jean-Christophe
Tellier, CEO of UCB. "Midazolam Nasal Spray has delivered strong
Phase 3 results; our acquisition of this program, when approved, will
expand and diversify the treatment choices we are able to provide to
the epilepsy community, complementing our strong internal portfolio
and building on our extensive knowledge, passion and expertise in the
field of epilepsy."

UCB estimates that more than 150,000 people with refractory
epilepsy also experience ARS.[4]

These types of seizures pose multiple risks to patients, which
include repeated emergency room related hospitalizations each year
and possible evolution into status epilepticus, a potentially
life-threatening seizure state.

"Rescue treatment options for acute repetitive seizures have
historically been very limited. As a global leader in epilepsy, with
a pioneering commitment to improving patient value, UCB was the
natural choice to progress the development journey of midazolam nasal
spray," said Bill Pullman, Chief Scientific Officer and President,
Proximagen. "In making this important new medicine available,
following approval, UCB will be delivering an effective rescue
treatment option for patients and caregivers living with ARS. I'd
like to take this opportunity to thank our investigators, along with
the teams at Upsher-Smith and Proximagen who have brought us to this
major milestone," said Mark Evenstad, Executive Chairman of ACOVA,
Inc., parent company of Proximagen.

UCB believes USL261[5] has the potential to complement its already
successful portfolio of epilepsy medicines, significantly improving
its ability to provide additional treatment choice and value to
millions of people living with poorly controlled seizures.

Under the terms of the agreement, UCB will make an upfront cash
payment of $150 million. In addition, Proximagen is eligible to
receive contingent payments of up to $220 million based on certain
regulatory approval and sales-based milestones.

The transaction is expected to close in the second quarter of
2018, subject to the satisfaction of customary closing conditions
including the satisfaction of the notification and waiting period
requirements of the Hart-Scott-Rodino Act.

Lazard is acting as financial advisor to UCB. Covington & Burling
LLP is acting as legal counsel to UCB. BMO Capital Markets Corp. is
acting as financial advisor to Proximagen. Ballard Spahr LLP is
acting as legal counsel to Proximagen.

About UCB in Epilepsy

UCB has a rich heritage in epilepsy with over 20 years of
experience in the research and development of antiepileptic drugs. As
a company with a long-term commitment to epilepsy research, our goal
is to address unmet medical needs. Our scientists are proud to
contribute to advances in the understanding of epilepsy and its
treatment. We partner and create super-networks with world-leading
scientists and clinicians in academic institutions, pharmaceutical
companies and other organizations who share our goals. At UCB, we are
inspired by patients, and driven by science in our commitment to
support patients with epilepsy.

About UCB

UCB, Brussels, Belgium (http://www.ucb.com ) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases in immunology and neurology. With around
7,500 people operating in 40 countries, the company generated revenue
of EUR4.5 billion in 2017. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news

About Proximagen

Proximagen LLC, a member of the ACOVA family of companies located
in Plymouth MN (USA), specializes in the development of novel small
molecule therapeutics in the areas of CNS, pain and inflammation. As
part of the Upsher-Smith Laboratories family of companies prior to
the sale of its generics business in 2017, Proximagen has a long
heritage in drug development.

Forward looking statements

This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. All statements,
other than statements of historical fact, are statements that could
be deemed forward-looking statements, including estimates of
revenues, operating margins, capital expenditures, cash, other
financial information, expected legal, political, regulatory or
clinical results and other such estimates and results. By their
nature, such forward-looking statements are not guarantees of future
performance and are subject to risks, uncertainties and assumptions
which could cause actual results to differ materially from those that
may be implied by such forward-looking statements contained in this
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differences include: changes in general economic, business and
competitive conditions, the inability to obtain necessary regulatory
approvals or to obtain them on acceptable terms, costs associated
with research and development, changes in the prospects for products
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candidates, changes in laws or regulations, exchange rate
fluctuations, changes or uncertainties in tax laws or the
administration of such laws and hiring and retention of its
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Additionally, information contained in this document shall not
constitute an offer to sell or the solicitation of an offer to buy
any securities, nor shall there be any offer, solicitation or sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to the registration or qualification
under the securities laws of such jurisdiction. UCB is providing this
information as of the date of this document and expressly disclaims
any duty to update any information contained in this press release,
either to confirm the actual results or to report a change in its
expectations.

There is no guarantee that new product candidates in the pipeline
will progress to product approval or that new indications for
existing products will be developed and approved. Products or
potential products which are the subject of partnerships, joint
ventures or licensing collaborations may be subject to differences
between the partners. Also, UCB or others could discover safety, side
effects or manufacturing problems with its products after they are
marketed.

Moreover, sales may be impacted by international and domestic
trends toward managed care and healthcare cost containment and the
reimbursement policies imposed by third-party payers as well as
legislation affecting biopharmaceutical pricing and reimbursement.

1. USL261 has not been submitted to or approved by the FDA. These
statements solely reflect the opinions of the authors.

2. Id.

3. This statement has not been submitted to the FDA and solely
reflects the opinions of the authors.

4. Haut SR. Current Opinion in Neurology 2015, 28:143-150

5. USL261 has not been submitted to or approved by the FDA. These
statements solely reflect the opinions of the authors.

ots Originaltext: UCB Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Chad Martinson
CEO
ACOVA, Inc.
Director
Proximagen
LLC
T +1(952)977-8717
cmartinson@AcovaHealth.com
UCB Investor Relations
Antje Witte
Investor Relations
UCB
T +32.2.559.94.14
antje.witte@ucb.com or Isabelle Ghellynck
Investor Relations
UCB
T +32.2.559.9588
isabelle.ghellynck@ucb.com

Original-Content von: UCB Pharma, übermittelt durch news aktuell