The year 2009 was a banner year for clinical-stage biopharmaceutical company Pharmacyclics Inc. (PCYC) with its share price getting nearly quadrupled to more than $3 by the end of December. The stock, which has extended its rally into 2010, has since gained nearly 35% as of Wednesday's closing price of $4.17. Will history repeat itself this year?
Read on to find out more about Pharmacyclics and its upcoming events.
Pharmacyclics went public in October 1995, offering its shares at $12 each. The company has four product candidates in clinical development and two product candidates in pre-clinical development. The investigational drugs include:
- PCI-24781, a histone deacetylase inhibitor, which is in phase II trials in lymphoma patients. A phase I/II study with PCI-24781 in combination with chemotherapy drug Doxorubicin in sarcoma patients has also been planned. Pharmacyclics has a global strategic alliance with French pharmaceutical company Les Laboratoires Servier for developing PCI-24781.
- PCI-27483, an inhibitor of coagulation factor VIIa, which is under phase II study in pancreatic cancer patients receiving treatment with chemotherapy drug Gemcitabine.
- PCI-32765, an inhibitor of Bruton's tyrosine kinase (Btk), currently in a phase I clinical trial in B-cell lymphoma.
- Motexafin Gadolinium or MGd, a radiation and chemotherapy sensitizing agent, which is under two phase II trials for brain tumors namely glioblastoma and pontine glioma.
- The preclinical drug candidates include a series of Btk inhibitors targeting autoimmune and allergic indications; and HDAC8 inhibitors like PCI-34051 and others that are for autoimmune and cancer indications.
Pharmacyclics' most advanced candidate is MGd (Motexafin Gadolinium). The drug candidate works by accumulating selectively in cancer cells, causing the death of those cells.
A phase II study evaluating MGd in combination with radiation therapy in young patients with pontine glioma was started in June 2007. The results from this study are expected in the first half of this year. Pontine glioma is a lethal brain tumor occurring primarily in children.
The other phase II trial of MGd in patients with newly diagnosed glioblastoma in combination with temazolamide and radiation was started in February 2006. Glioblastoma is the most common primary brain tumor in adults. The survival results from this trial are expected in 2011.
MGd, branded as Xcytrin was close to reaching the FDA altar in 2007. In December 2006, Pharmacyclics submitted New Drug Application for Xcytrin in combination with whole brain radiation therapy for the treatment of non-small cell lung cancer patients with brain metastases (i.e., cancer that has spread to the brain from another part of the body). In February 2007, the FDA refused to accept the NDA for Xcytrin citing failure to demonstrate statistically significant differences between treatment arms in the primary endpoint of the pivotal study to support approval.
Making use of the "file over protest" provision permitted by regulation, the company filed its NDA for Xcytrin in April 2007. However, the regulatory agency handed over a non-approvable letter for Xcytrin for the treatment of non small cell lung cancer patients with brain metastases in December of that year. In early 2009, after concluding a review of Xcytrin for the potential treatment of brain metastases from non-small cell lung cancer, the company decided not to pursue that indication.
As mentioned earlier, Pharmacyclics has a global strategic alliance with French pharmaceutical company Les Laboratoires Servier to research, develop and commercialize PCI-24781, small molecule inhibitor of Pan HDAC enzymes.
Under the terms of the agreement crafted in April 2009, Servier acquired the exclusive right to develop and commercialize the Pan HDAC inhibitor product worldwide except for the United States and will pay a royalty to Pharmacyclics on sales outside of the U.S. Pharmacyclics will continue to own all rights within the United States. In May 2009, Pharmacyclics received an upfront payment of $11.0 million from Servier. Excluding taxes, the amount was $10.45 million.
Pharmacyclics is due to receive from Servier an additional $4 million for research collaboration over a twenty-four month period, paid in equal increments every six months. The initial payment of $1 million was received in October 2009. Servier is solely responsible for conducting and paying for all development activities outside the United States. In addition, Pharmacyclics could also receive from Servier up to approximately $24.5 million upon the achievement of certain future milestones up to and including commercialization, as well as royalty payments.
The company has incurred significant operating losses since its inception in 1991, and as of September 30, 2009, had an accumulated deficit of approximately $367.7 million and total cash of $33 million. Pharmacyclics is expected to report its second-quarter results next week. Wall Street analysts expect the company to post a loss of $0.09 per share, narrower than $0.19 per share reported in the comparable quarter a year before.
Pharmacyclics is also expected to make a corporate presentation on February 8 at the 12th Annual Bio CEO & Investor Conference to be held in New York. Stay tuned...
For comments and feedback: editorial@rttnews.com