July 27, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Fort Washington, Penn.-based Vitae Pharmaceuticals, Inc. , announced today that Boehringer Ingelheim had informed Vitae that it was terminating the two companies’ collaboration and license agreement for orally-active beta secretase (BACE) inhibitors to treat Alzheimer’s disease and other indications.
On Feb. 26, 2015, the company announced that Boehringer Ingelheim had voluntarily placed BI-1181181, a BACE inhibitor, on temporary clinical hold. The drug was underoing a Phase I clinical trial for the treatment and prevention of Alzheimer’s. The trial was halted to investigate skin reactions that some study participants showed during the trial.
“Our partner is working diligently to evaluate and understand this observation,” said Richard Gregg, chief scientific officer of Vitae in a statement in February. “We are confident that the analysis will result in a clear understanding of how to proceed with BI-1181181, and we remain committed to our partner and the BACE program. Depending on the outcome of the evaluation and Boehringer Ingelheim’s decision, we expect that either BI-1181181 or its structurally distinct, Phase I-ready back up will be advanced, with the goal of delivering a medicine with disease-modifying benefits to patients suffering from Alzheimer’s disease.”
Vitae has not indicated specifics as to why Boehringer Ingelheim has terminated the agreement. Prior to this announcement, the company expedited Boehringer to start a Phase II trial for BI-1147560 and VTP-36951 by the end of the year. In pre-clinical testing, the two compounds were shown to be safe and well-tolerated and could lower amyloid beta levels in the brain by more than 90 percent.
“We are grateful for BI’s support for the BACE program, as we have demonstrated significant progress toward the development of an oral BACE inhibitor for Alzheimer’s disease,” said Jeff Hatfield, president and chief executive officer of Vitae in a statement. “With the termination of this agreement, Vitae expects to receive the rights to the BACE program, most notably BI-1147560 / VTP-36951, and to work with BI to effect an orderly transfer. We plan to assess the program to determine the appropriate next steps.”
Vitae and Boehringer Ingelheim are having a tough year working together. In June, Vitae announced that its drug, VTP-34072, a potential add-on therapy for diabetes with Metformin that it co-developed with Boehringer Ingelheim, failed to significantly cut blood sugar levels of patients.
Analysts aren’t very hopeful for the drug. The companies intend to test VTP-34072 alone, as a monotherapy, but Liana Moussatos, an analyst with Wedbush indicated she didn’t expect much unless the trial had “spectacular results.”
“Incyte did a trial on the same target,” said Thomas Shrader, an analyst with Stifel. “The data looked pretty good, but they stopped the program. A chemistry company will always be at the mercy of the targets it uses.”
has been all over the place the past year. Shares traded for $5.75 on Oct. 13, 2014, rose to a high of $21.97 on Dec. 18, 2014, dropped to $11.99 on Jan. 22, 2015, and rose again to $17.34 on Jan. 27, 2015. Shares dropped again on Mar. 9, 2015 to $10.66, rose to a recent high of $16.50 on June 23, 2015 and currently is priced at $9.73 per share.
The company has been given a consensus recommendation of “Buy” from six brokerages. Piper Jaffray analysts maintained an “overweight” rating with a price target of $20.50, down from $23 in a note on Thursday, July 2. Wedbush analysts reiterated a “Buy” rating and a price target of $20, down from $21 on June 29. JMP Securities analysts downgraded from “Outperform” to “Market Perform” on June 29. On June 8, Zacks upgraded from “Sell” to “Hold.”
