Anthera acquires troubled Sollpura from Lilly
This article was originally published in Scrip
Anthera Pharmaceuticals acquired Sollpura (liprotamase), a non-porcine pancreatic enzyme replacement therapy (PERT) with a long and troubled history in exocrine pancreatic insufficiency (EPI), from Eli Lilly for an undisclosed price.
Hayward, California-based Anthera will sub-license the treatment for EPI to Alkira Therapeutics, a new subsidiary, which will raise capital to finance a Phase III clinical trial needed for US FDA approval. The FDA rejected a new drug application (NDA) for Sollpura in 2011, requesting another trial to confirm safety and efficacy that are differentiated from currently available treatments for EPI (scripintelligence.com, 19 April 2011).
EPI is characterized by low absorption of fat and other nutrients due to low levels of digestive enzymes produced by the pancreas. The condition is common in diseases such as cystic fibrosis, chronic pancreatitis and pancreatic cancer.
Anthera said EPI affects more than 150,000 people in the US who, with the help of health care payers, spend $600m annually on enzyme replacement therapies. Children with untreated EPI, especially those who have the condition on top of cystic fibrosis, can develop nutritional deficiencies and long-term developmental problems.
In fact, the Cystic Fibrosis Foundation originally licensed Sollpura to Altus Biologics in 2001. But the foundation regained its rights to the PERT following Altus's bankruptcy, so it licensed the therapy to Alnara Pharmaceuticals in 2009 before Alnara was acquired by Lilly.
"Sollpura's chemical characteristics, unlike currently available PERTs, make it ideal for powder formulation as either a capsule or sachet product, which can be conveniently co-administered with a variety of food products," Anthera president and CEO Paul Truex said in a 14 July statement from the company issued after the stock market closed.
"Our intention with Sollpura is to provide a new convenient choice for adults and children with cystic fibrosis who either have difficulty in swallowing pills or are forced to use nasogastric tubes to ensure appropriate absorption of nutrients," Mr Truex said.
The Anthera subsidiary Alkira will be responsible for royalty payments related to Sollpura, assuming the FDA approves the therapy for EPI.
Chuck Olson, most recently vice president of manufacturing and technical operations at NGM Biopharmaceuticals, will be the president of Alkira in charge of shepherding Sollpura through the end of Phase III. Mr Olson previously worked at Genentech, Bayer, NexBio, Coherus Biosciences, Cell Genesys, BioMarin, Onyx Pharmaceuticals, Compass Biotech and Anthera.
Anthera's own pipeline also is limited to a single, late-stage clinical candidate. Phase III data for blisibimod in systemic lupus erythematosus (SLE) are expected this year (scripintelligence.com, 25 October 2013).