Inhaled-Drug Maker Savara Buys European Biotech With Two Candidates

Xconomy Texas — 

Austin—Savara Pharmaceuticals, a privately held drug developer with an inhaled formulation of an antibiotic for a type of lung infection, is announcing today that it is acquiring two new drug programs. The Austin, TX-based company also is seeking new funding that could precede an initial public offering.

“Now that we have multiple products in the pipeline, we will begin the process of raising a mezzanine round with the eye toward potential IPO,” says Savara’s CEO Rob Neville.

In an all-stock deal, Savara is purchasing Serendex Pharmaceuticals, a Danish drug developer that has two inhalation-based therapies in clinical development. Serendex will no longer exist, and the employees of the company will transfer to a newly formed Savara entity that will remain in Denmark, Neville says.

With the deal, Savara is gaining ownership of a late-stage inhaled treatment for pulmonary alveolar proteinosis, a rare lung disease known as PAP that causes phospholipid and protein build-up in the lung’s air sacs. Savara is also getting a preclinical inhaled treatment that aims to treat a form of bleeding into the portion of the lungs where oxygen exchange happens.

Even with the new drugs, the primary focus of Savara will be on its lead candidate, a treatment it calls AeroVanc. Savara says AeroVanc will be the first inhaled antibiotic for the methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people with cystic fibrosis. In March, Savara Pharmaceuticals announced $20 million in Series C funding that it will use to take its inhaled version of the antibiotic to late-stage clinical trials later this year.

Meanwhile, patients are already being enrolled for a Phase 2/3 trial in Europe and Japan for Molgradex, the PAP treatment that Savara acquired in the Serendex deal. Savara is in the process of determining what information from a previous Phase 1 study and the ongoing Phase 2/3 studies it might be able to be used to seek regulatory approval in the U.S. from the FDA, says chief operating officer Taneli Jouhikainen.

In February 2015, Savara announced it met the primary endpoint in a Phase 2 trial AeroVanc, which attempted to measure if the drug could reduce the density of MRSA—bacteria that commonly cause infections—in patients’ sputum compared to a placebo. Cystic fibrosis causes mucus to build up in the lungs, among other problems, making it fertile ground for infection-causing bugs like MRSA or pseudmonas aeruginosa, as Xconomy’s Angela Shah wrote when covering Savara’s $10 million Series B in 2014.

AeroVanc would be an inhaled version of a generic drug that has been around for more than 50 years, vancomycin. The drug has typically been administered intravenously, though there are other oral applications.

Savara, founded in 2007, contends that inhaling the drug directly to the lungs will deliver more of the treatment to the problem area, potentially increasing its effectiveness. Plus, the method reduces the likelihood of exposing the drug to other areas of the body, which the company hopes will reduce side effects. The AeroVanc device is meant to be convenient, too, the company says.

As a part of the acquisition, Serendex was delisted from the Olso Stock Exchange—the company went public in 2014—and became a pass-through entity within Savara, Neville says. Stockholders of Serendex will become percentage shareholders of Savara, he says. The deal also includes milestone payments if Molgradex and the preclinical candidate are successful, but Neville declined to disclose details about them.