April 14, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Bothell, Wash.-based Alder Biopharmaceuticals Inc. announced yesterday that as it is preparing to enter Phase III clinical trials, it plans to hire 30 more employees. The new positions will be for the manufacturing, clinical and regulatory components of the company.
As of time of publication, Alder Biopharmaceuticals had not responded to requests for a statement.
Alder’s major pipeline product is ALD403, a monoclonal antibody therapeutic for the treatment of migraine, autoimmune and inflammatory diseases. ALD403 is wrapping up a Phase IIb trial for the preventative treatment of chronic migraine. In May 2014 the company went public. The company also has a compound, Clazakizumab, that had positive Phase IIb results for the treatment of patients with active psoriatic arthritis. It also has plans to begin a Phase I trial in Cushing’s disease next year.
In January the company wrapped up a follow-on offering that raised about $190.7 million.
Although the company’s initial stock offering wasn’t a spectacular success, analysts seem to be paying more attention to the company’s successes recently. It currently has a Zacks Industry Rank of 45 out of more than 250, and solid earnings and the positive news on the clinical trials have analysts sitting up and taking notice.
It was also reported on April 3, 2015 that the company’s vice president, Jeffrey Smith, sold 3,900 shares of the stock on April 1 for a total value of $106,977.00, an average price of $27.43. Alder has a market cap of $1.02 billion and a price-to-earnings ratio of 89.63.
For the most part the company’s stock has been on a general upswing since going public. Initial prices were about $10.00 per share and hit a high of $30.56 on Jan. 14, 2015. Shares are currently selling for $27.63.
“There’s a huge opportunity there [in the migraine program],” said company chief executive officer Randall Schatzman in a statement. “One of the big focuses is dialogue with the FDA. We’ll be expanding the regulatory group that allows those discussions to happen on an ongoing basis.”
At this point in time, there are no medications that prevent a migraine from occurring, although there are a number of pain medications and other drugs used to treat migraine. Alder’s ALD403 is an injectable antibody that targets the calcitonin gene-related peptide (CGRP). Merck & Co. is also working in this space with a similar compound, but there were liver toxicities associated with that company’s therapeutic.
The market is considered of great enough interest that in 2013 Allergan paid almost $1 billion to buy MAP Pharmaceuticals, which had an experimental drug for migraine headaches called Levadex. Levadex is a reformulation of dihydroergotamine, or DHE, which is generally given to patients intravenously. Levadex, however, is administered through an inhaler. In mid-2014, the FDA rejected the new version of Levadex, called Semprana, because of issues related to the delivery device. The company is revisiting the compound with the FDA and is expecting news in July of this year.
BioSpace Temperature Poll
After last week’s news that Gilead had issued a health advisory to doctors, concern is growing after nine patients taking Harvoni or Sovaldi along with another drug, amiodarone, were treated for abnormally slow heartbeats. One of the patients died of cardiac arrest. Three of the nine patients required a pacemaker. That has BioSpace asking, what next?
