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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
GLATTBRUGG, Switzerland, Sept. 2, 2016 (GLOBE NEWSWIRE) — 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 1st, 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@galenica.com
Galenica Investor Relations:
Jörg Kneubühler, Chief Financial Officer
Tel.: +41 58 852 85 29
E-mail: investors@galenica.com
Vifor Pharma Media Relations:
Beatrix Benz, Head of Global Communications & Public Affairs
Tel.: +41 58 851 80 16
E-mail: media@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 undertake s 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
