Galenica completes acquisition of Relypsa, strengthening Vifor Pharma's position in cardio-renal therapies
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Vifor Pharma Ltd. /
Galenica completes acquisition of Relypsa, strengthening Vifor Pharma's position
in cardio-renal therapies
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The issuer is solely responsible for the content of this announcement.
* Combination with Relypsa strengthens Vifor Pharma's position as a leading
speciality pharmaceutical company, bringing global rights to hyperkalaemia
treatment Veltassa(®
)
* Vifor Pharma to build on Relypsa's fully-integrated commercial organisation
in key US cardio-renal market by leveraging its extensive and growing
specialty portfolio
Galenica Group today announced that it has completed its previously announced
acquisition of Relypsa, Inc., (NASDAQ: RLYP). The combination of Galenica's
Vifor Pharma business unit with Relypsa will create a significant player in
cardio-renal care in the US and further strengthen Vifor Pharma's growing
international leadership in cardiology, nephrology and gastroenterology
therapies.
Through the acquisition, Vifor Pharma will gain a fully-integrated commercial
organisation in the US. With the combination of the commercial assets and best-
in-class cardio-renal products of Vifor Pharma, Relypsa and Vifor Fresenius
Medical Care Renal Pharma (VFMCRP), Vifor Pharma is positioned to become a major
player in the US in its core therapy areas, leveraging its growing specialty
portfolio.
"By combining the assets, expertise and commercial strengths of Vifor Pharma and
Relypsa, Vifor Pharma is well positioned to become a world-leading specialty
pharmaceutical company focused on nephrology, cardiology and gastroenterology
medicines," said Etienne Jornod, Executive Chairman of Galenica and Vifor
Pharma. "Vifor Pharma's portfolio of specialty products will be further enhanced
by gaining full global rights to Veltassa(®), an important new treatment for
people with hyperkalaemia, and by the ability to increase our visibility with
leading nephrologists and cardiologists in the US market. With a first class
portfolio of products and rapidly growing global commercial presence, Vifor
Pharma is committed to being the partner of choice for patients, clinicians and
companies in our core therapy areas."
As stated in May 2016, preparations continue for the division of the Galenica
Group into two independent listed companies in 2017. The acquisition of Relypsa
affirms the commitment of the Galenica Board of Directors to this strategy,
adding further breadth and scale to the Vifor Pharma specialty portfolio.
Update on Vifor Pharma guidance
When Galenica announced the agreement to acquire Relypsa on July 21, 2016, it
was expected that Relypsa would be consolidated as of October and the guidance
for 2016 was updated on that basis.
However, with the close of the transaction now accelerated to September
1(st), 2016, Galenica intends to further update the 2016 guidance during October
at the latest.
For further information, please contact:
Galenica Media Relations:
Christina Hertig, Head Corporate Communications
Tel.: +41 58 852 85 17
E-mail: media(at)galenica.com
Galenica Investor Relations:
Jörg Kneubühler, Chief Financial Officer
Tel.: +41 58 852 85 29
E-mail: investors(at)galenica.com
Vifor Pharma Media Relations:
Beatrix Benz, Head of Global Communications & Public Affairs
Tel.: +41 58 851 80 16
E-mail: media(at)viforpharma.com
Galenica is a diversified Group active throughout the healthcare market which,
among other activities, develops, manufactures and markets pharmaceutical
products, runs pharmacies, provides logistical and database services and sets up
networks. With its two Business units Vifor Pharma and Galenica Santé, the
Galenica Group enjoys a leading position in all its core business activities. A
large part of the Group's income is generated by international operations.
Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN,
security number 1,553,646).
Additional information concerning the Galenica Group can be found at
www.galenica.com.
Vifor Pharma, a company of the Galenica Group, is a world leader in the
discovery, development, manufacturing and marketing of pharmaceutical products
for the treatment of iron deficiency. The company also offers a diversified
portfolio of prescription medicines as well as over-the-counter (OTC) products.
Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global
presence and a broad network of affiliates and partners around the world.
For more information about Vifor Pharma, please visit www.viforpharma.com.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery,
development and commercialisation of polymeric medicines for patients with
conditions that are often overlooked and undertreated and can be addressed in
the gastrointestinal tract. The Company's first medicine,
Veltassa(®) (patiromer) for oral suspension, was developed based on Relypsa's
rich legacy in polymer science. Veltassa is approved in the United States for
the treatment of hyperkalaemia. Veltassa has intellectual property protection
until 2030 in the United States and 2029 in the European Union. More information
is available at www.relypsa.com.
Patiromer powder for oral suspension (US brand name: Veltassa(®)) is an oral
potassium binder approved in the US for the treatment of hyperkalaemia, a
potentially life-threatening condition defined as abnormally elevated serum
potassium. This investigational medicine has been studied in both treatment and
prevention studies, primarily in patients with CKD, and/or heart failure, as
well as patients with diabetes and hypertension. Patiromer is not absorbed and
acts within the gastrointestinal tract. It binds to potassium in exchange for
calcium, primarily in the colon. The potassium is then excreted from the body
through the normal excretion process.
Hyperkalaemia, or abnormally elevated levels of potassium in the blood, is a
serious condition that can lead to life-threatening cardiac arrhythmia and even
sudden death. There are often no warning signs, meaning a person can unknowingly
experience spikes in potassium levels recurrently and be at risk for these
cardiac events. It is frequently prevalent in patients who suffer from CKD,
hypertension, diabetes and/or heart failure. Patients with CKD or heart failure
are at particular risk for developing hyperkalaemia, especially those treated
with renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase
blood potassium levels in patients taking these medicines.
Important Safety Information
The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa
binds to many other orally administered medications, which could decrease their
absorption and reduce their effectiveness. Other oral medications should be
administered at least 6 hours before or 6 hours after Veltassa. Doctors should
choose Veltassa or the other oral medication if adequate dosing separation is
not possible.
Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity
reaction to Veltassa or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel
obstruction or impaction, including abnormal post-operative bowel motility
disorders, because Veltassa may be ineffective and may worsen gastrointestinal
conditions. Patients with a history of bowel obstruction or major
gastrointestinal surgery, severe gastrointestinal disorders, or swallowing
disorders were not included in clinical studies.
Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In
clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3
percent of patients treated with Veltassa. Approximately 9 percent of patients
in clinical trials developed hypomagnesemia with a serum magnesium value <1.4
mg/dL. Doctors should monitor serum magnesium and consider magnesium
supplementation in patients who develop low serum magnesium levels.
Adverse Reactions
The most common adverse reactions (incidence > 2 percent) were constipation,
hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to
moderate hypersensitivity reactions were reported in 0.3 percent of patients
treated with Veltassa and included edema of the lips.
For additional Important Safety Information and Veltassa's full Prescribing
Information, please visit www.relypsa.com/veltassa/prescribing-information.
Forward-Looking Statements
The statements included in this press release contain forward-looking
statements, which are generally statements that are not historical facts.
Forward-looking statements can be identified by the words "expects,"
"anticipates," "believes," "intends," "estimates," "plans," "will," "outlook"
and similar expressions. Forward-looking statements are based on management's
current plans, estimates, assumptions and projections and speak only as of the
date they are made. Galenica undertakes no obligation to update any forward-
looking statement in light of new information or future events, except as
otherwise required by law. Forward-looking statements involve inherent risks and
uncertainties, most of which are difficult to predict and are generally beyond
the control of Galenica, including the following: (a) the risk that the
transaction disrupts current plans and operations; (b) difficulties or
unanticipated expenses in connection with integrating Relypsa into Galenica; (c)
the risk that the acquisition does not perform as planned; and (d) potential
difficulties in employee retention. Actual results or outcomes may differ
materially from those implied by the forward-looking statements as a result of
the impact of a number of factors, many of which are discussed in more detail in
the public reports of each company filed with the SEC or the SIX Swiss Exchange.
Press Release (PDF):
http://hugin.info/148637/R/2039262/760107.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Vifor Pharma Ltd. via GlobeNewswire
Datum: 02.09.2016 - 07:11 Uhr
Sprache: Deutsch
News-ID 492405
Anzahl Zeichen: 11520
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Kategorie:
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