La Jolla Pharma Bails On Two Drug Programs, Shifts Focus to Rare Disease
May 8, 2015
By Mark Terry, BioSpace.com Breaking News Staff
La Jolla Pharmaceutical Company , headquartered in San Diego, announced yesterday that it was reprioritizing its development programs and discontinuing two programs.
Company representatives did not respond to requests for an interview by deadline.
After discussions with the U.S. Food and Drug Administration (FDA) regarding the company’s galactin-3 inhibitor program, the company decided to focus on other products. The two compounds, GCS-100 and LJPC-1010, are complex polysaccharide molecules that are difficult to work with using conventional analytical methods. The FDA wanted La Jolla to perform additional chemical characterization before moving to more advanced clinical development. La Jolla, however, has doubts about whether it can develop appropriate analytical methods in the necessary timeframe to satisfy the FDA.
As a result, La Jolla will turn more of its resources to other programs, especially its lead product candidate LJPC-501. This compound is a formulation of angiotensin II that is in a Phase III registration clinical trial for patients with catecholamine-resistant hypotension.
Other products in the angiotensin space include Merck & Co. ’s Cozaar (losartan) and Novartis AG ’ Diovan (valsartan).
Another compound it will focus on is OJPC-401, a formulation of hepcidin for possible treatment of disorders characterized by iron overload. Two other products, LJPC-30Sa and LJPC-30Sb, next-generation gentamicin derivatives for the treatment of bacterial infections and rare genetic disorders, will also receive more attention. The gentamicin compounds were discovered by the Indiana University Research and Technology Center (IURTC).
La Jolla has also inked a second option agreement with IURTC and the University of Alabama at Birmingham to study the drugs in cystic fibrosis and Duchenne muscular dystrophy.
In terms of its original GCS-100 program, it will continue to treat and follow patients currently enrolled in its Phase IIb study in diabetic patients with advanced chronic kidney disease. It will not enroll new patients. It originally had a Phase I trial for LJPC-1010 planned, but will no longer start that trial.
“We are very enthusiastic about LJPC-501 and LJPC-401 and the unmet medical needs that they may fulfill, and we are excited to add our new next-generation gentamicin derivative program to our portfolio,” said George Tidmarsh, president and chief executive officer of La Jolla in a statement. “These product candidates all benefit from strong scientific and clinical rationale, and today’s reprioritization will allow us to sharpen our focus on bringing them closer to patients.”
The FDA required a better understanding of how GCS-100 and LJPC-1010 worked before allowing the company to move into late-stage testing. There is no indication there were safety issues and La Jolla intends to attempt to out-license the two compounds to other companies that may have the resources to advance them.
“While it was a difficult decision to discontinue our galectin-3 inhibitor programs, we believe that this is the right decision for the company and its stakeholders as we evaluate our portfolio opportunities and how best to allocate our resources,” said Tidmarsh in a statement.
Five analysts currently covering La Jolla have given the company a Buy rating with a consensus target price of $36.20. Oppenheimer gave the company an Outperform rating on April 21 with a fixed price target at $43. Chardan Capital on March 2 gave it a fixed price target of $54. Stock is currently selling at $18.56 per share.
The company recently announced its first quarter earnings. As of March 31 the company had $42.7 million in cash, compared to $48.6 million on Dec. 31, 2014. The decrease was mostly due to expenses for operating activities and increased development costs connected to the start of its ATHOS 3 clinical trial, the start of the Phase IIb trial of GCS-100, and the continuing Phase I/II clinical trial of LJPC-501. Additional costs were related to the preclinical costs associated with LJPC-1010 and LJPC-401.
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