April 20, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The last 18 months or so for Redwood, Calif.-based Relypsa have been marked by a rapid change.
In October 2015, the company’s first drug, Veltassa, was approved by the U.S. Food and Drug Administration (FDA) to treat hyperkalemia. Hyperkalemia is high blood potassium found in patients with kidney disease. It’s generally viewed as the first new drug for the disorder in the last 50 years.
Then, in July 2016, the company was acquired by Switzerland-based Galenica AG, for $1.53 billion. Most recently, Scott Garland was promoted to president of Relypsa starting March 31. Garland took time out to talk to me about the company, its science, and the changes it expects as Garland and the company move forward.
The deal with Galenica closed in September 2016. Galenica has a number of divisions, but when it comes to Relypsa, the key is Vifor Pharma, which is Galenica’s pharmaceutical division.
“They’ve said publicly they plan to spin out their retail business, which is known as Galenica Santé. And with that retail spinout, they’re essentially going to form an independent company called Vifor Pharma, and Relypsa will be a part of that. In fact, we’re an integral part of Vifor Pharma,” Garland said.
Relypsa will basically be the U.S. arm of Vifor Pharma’s global footprint. Its operations in California will include all of the commercial functions that existed prior to the acquisition, but also research and clinical development, manufacturing, and technical operations, among other functions.
Garland noted that in the U.S. they plan, at least for the near term, to keep the Relypsa name because it has built up “a lot of brand equity and name recognition with our customers, nephrologists and cardiologists. I’m president of the Relypsa business. Under that business is all the sales, the marketing, medical affairs, finance, human resources, regulatory functions, all the aspects of a pharmaceutical company you would expect.”
Relypsa’s science is based on polymers. That doesn’t mean plastics, necessarily, but refers to large molecules made up of repeating structural units. The company’s technology platform allows for the creation of large sets of related polymers, which can have a number of different properties.
In the case of Veltassa, it is available in a powder form and is mixed with water. The drug, which is made up of spherical, smooth, uniform microbeads, binds with potassium in the gastrointestinal tract, which decreases potassium’s absorption into the bloodstream. It is then excreted.
“For folks with an interest in polymer research, the experience we’ve gained in developing and acquiring approval for Veltassa will help us in the future. It’s a highly effective drug and unique in how it works. We’ll be able to leverage what we’ve learned in that process and apply it to new compounds we’re developing in our research organization,” Garland said.
With the acquisition, there are several products out of Galenica and/or Vifor that could potentially become part of the Relypsa portfolio. “Vifor has a very strong presence in the cardio-renal space globally. They do injectable iron drugs like Injectafer, one of the top-selling iron products, and an oral phosphate binder, Velphoro. And they have several agreements in place outside the U.S. One is with OPKO Health for Rayaldee, a drug for secondary hyperparathyroidism,” Garland said.
Some of those products may ultimately be moved under the Relypsa banner in a co-promotion fashion, although that’s all in the planning stages at the moment and no decisions have been made.
On a shorter-term focus, the company will work to expand Veltassa in the hyperkalemia market space. “Outside the potential competitive dynamic, it’s an undeveloped market and nobody’s been out there talking about it for 50 years. So, the major short-term focus today is developing the market and obviously positioning Veltassa as the right product in that space,” Garland said.
The company also plans to look at co-promotional opportunities in the cardio-renal space. A longer-term prospect is utilizing its proprietary polymer-based technology to develop its own portfolio of products.
“I think with the current technology we have a number of interesting drug candidates that are polymer-based that we could develop,” Garland told BioSpace, adding that there may be licensing deals in the same space in the future.
As Garland sees it, Relypsa has the best of both worlds—it can still maintain the scrappy, independent culture of a Bay Area biotech company while having the deep pockets and resources of a global biopharmaceutical company.
“I think what this offers for scientists or anyone interested in working here,” he told me, “is a unique cultural blend. In my opinion, it still feels like a small entrepreneurial company, with a site-specific culture of its own while also remaining consistent with the overall Vifor culture. A culture that’s very patient and science-driven, which is what a lot of the biotech companies in the Bay Area focus on.”
And as for scientists interested in working at Relypsa, Garland said he went into the office of the company’s head of research and told him he was going to “talk to this guy from BioSpace.”
His research head said, “Tell him this is a really cool place to work for scientists.”
