Ironwood, Aegerion, and MannKind Corporation Face Stiff Headwinds: Analyst
August 17, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Biotech is volatile by nature, but a recent analysis of three life science companies demonstrate how the challenges can come from outside the company.
Writing for The Motley Fool, Todd Campbell took a look at three companies: Ironwood Pharmaceuticals , Aegerion Pharmaceuticals, Inc. and MannKind Corporation Each company has had recent successes, but Campbell analyzes their potentially damaging challenges headed their way.
Cambridge, Mass.-based Ironwood Pharmaceuticals markets a product called Linzess (linaclotide) for the treatment of irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). The company recently signed an agreement with Allergan Inc. to co-promote Viberzi (eluxadoline) in the U.S., a separate deal complementary to their ongoing co-development and co-commercialization of Linzess.
“This collaboration enables Ironwood and Allergan to work together to bring forward two innovative medicines demonstrated to improve the abdominal pain and bowel dysfunction that defines IBS-C and IBS-D, two types of IBS that impact nearly 30 million adult Americans,” said Bill Meury, executive vice president of commercial, North American brands for Allergan in a statement.
In addition, sales in this year’s second quarter rose 79 percent in the U.S. to $112.1 million. The company, however, faces potential stiff competition from New York, NY-based Synergy Pharmaceuticals, which has a constipation drug, plecanatide, in clinical trials. On July 30, the company announced positive top-line results from the second of two pivotal Phase III clinical trials for the one-a-day tablet in patients with CIC. Synergy expects to file its first new drug application (NDA) in January 2016.
Some of the client data suggests it may have a lower rate of side effects than Ironwood’s Linzess.
Aegerion Pharmaceuticals, headquartered in Cambridge, Mass., markets Juxtapid, used to treat homozygous familial hypercholesterolemia (HoFH), or high cholesterol that is caused by a rare genetic disease. Juxtapid has a price tag of $295,000 per year. In the second quarter of this year, the company indicated sales had risen 59 percent to $57.1 million.
The U.S. Food and Drug Administration (FDA) recently approved Regeneron Pharmaceuticals, Inc. and Sanofi ’s Praluent for cholesterol, and has a $14,600 price tag, which payers will undoubtedly prefer over Aeregion’s Juxtapid. Similarly, Amgen ’s Repatha is expected to gain FDA approval soon.
Campbell’s third company is Valencia, Calif.-based MannKind Corp. MannKind produces Afrezza, a rapid-acting inhaled insulin to treat diabetes. It was approved by the FDA in 2014 and went on the market in the U.S. in a partnership with Sanofi in February of this year. Campbell notes that, “So far, sales have been more of a trickle than a flood, as headwinds tied to lung screening requirements have proven to be stronger than feared. As a result, Afrezza sales totaled just one million euros in the first quarter and two million euros in the second quarter.”
Campbell’s concern is that Sanofi has dumped $150 million up front and another potential $775 million in milestones, and the company may get jittery if sales don’t pick up.
However, MannKind announced on July 31 that it was tripling its manufacturing capacity for Afrezza, adding two additional filing lines. A 12-unit cartridge was recently approved, and approval of the new strength dosage is expected in the third quarter.
“With the completion of the validation effort,” said Hakan Edstrom, president and chief executive officer of MannKind in a statement, “we can support a demand of more than 300 million cartridges per year. The addition of the 12 unit cartridge will provide patients with another option to receive their prescribed dose.”
However, Sanofi’s leading diabetes product, Lantus, which generated $7.78 billion in revenue in 2013 alone, faces patent expiration this year and is expecting competition from generic version. The deal with MannKind is generally viewed as a stepping stone in rounding out its diabetes treatment portfolio in the face of stiffer competition.