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Several biotech and pharmaceutical companies have reached significant catalysts in the first half of December including positive clinical-trial results and, most excitingly, FDA approvals.
Top-line clinical data
AbbVie (NYSE:ABBV), a research-based biopharma company, recently completed the second of six Phase 3 trials on its investigational three direct-acting-antiviral (3D) regimen ribavirin in patients with chronic genotype 1 hepatitis C virus. The oral hepatitis C therapy cured 96 percent of patients considered “difficult-to-treat.” The study comprised 394 patients who had failed to respond to pegylated interferon and ribavirin treatment.
The impressive results will help the company retain a enviable position in “a highly competitive race to deliver new treatments for the serious liver disease,” noted a Reuters report, which listed Gilead Sciences, Inc. (NASDAQ:GILD), Bristol-Meyers Squibb Co (NYSE:BMY), and Merck & Co p(NYSE:MRK) as potential rivals in this market.
AbbVie, formed this year after splitting from Abbot Laboratories, saw its share price spike more than 5 percent Tuesday once the results hit the wires. The company’s stock value has grown more than 50 percent since its January inception. “Results from the remaining four studies in AbbVie’s phase III program will be available in the coming months, supporting regulatory submissions starting in the second quarter of 2014,” stated the news release.
Puma Biotechnology Inc’s (NYSE:PBYI) latest clinical-stage update sent shares soaring nearly 75 percent. The development-stage biopharma has a breast cancer treatment drug, PB272 (neratinib), in Phase 2 clinical trials for patients with newly diagnosed Stage 2 or higher breast cancer.
The goal of the study is to determine if adding investigational drugs to standard chemotherapy proves more successful than standard chemotherapy. The 300-patient trial results show that neratinib, when combined with paclitaxel and followed by doxorubicin and cyclophosphamide, should demonstrate a high rate of success in late-stage trials. The neratinib arm delivered a p-value of 0.053, or a 94.7 percent probability of superiority over the current standard of treatment according to Bayesian predictive models.
“Based on the results from the I-SPY 2 TRIAL, neratinib is now eligible for the upcoming I-SPY 3 Phase III trial,” stated the press release. “Full results of the I-SPY 2 TRIAL for PB272 will be presented at a future scientific meeting.”
CytRx Corporation’s (NASDAQ:CYTR) stock price exploded Wednesday, rising 68 percent to $4.02 a share by the closing bell after the company released Phase 2b clinical trial results for its investigational cancer treatment. The biopharma R&D company said aldoxorubici improved the survival rates in patients with untreated soft tissue sarcoma compared to standard chemotherapy alone by at least 80 percent. The therapy also has indications for the treatment of Glioblastoma mutliforme and Kaposi’s sarcoma.
The therapy works by combining doxorubicin (standard chemotherapy drug) with linker-molecules, targeting tumors with up to 400 times the normal dose of doxorubicin without increasing toxicity, explained a Reuters report. CytRx holds exclusive global rights to the linking technology. Full results of the study are set to be releases at the American Society of Clinical Oncology conference in June 2014.
Achieving FDA approval
Gilead Sciences Inc. (NASDAQ:GILD) received FDA approval for its hepatitis C drug, sofosbuvir, which will be marketed under the brand name Sovaldi as a once-a-day pill. The drug, a nucleotide analog inhibitor that blocks the protein the hepatitis C virus (HCV) needs to replicate itself, has been approved for the treatment of four separate strains of HCV. Sovaldi can be used as part of a combination therapy with either ribavirin or with both ribavirin and interferon.
With “more than 3.2 million people affected by HCV and another 17,000 identified each year”, the market for HCV treatments is “enormous and expected to grow rapidly,” notes Forbes contributor Melanie Haiken. A recent Bloomberg report estimates that Sovaldi “may generate more than $6 billion in annual sales as it leads a market for drugs that work faster to combat the disease with fewer side effects.”
Zogenix Inc. (NASDAQ:ZGNX) also received approval from the FDA this week for its supplemental new drug application for a 4 mg dose of SUMAVEL DosePro. SUMAVEDL DosePro is the first and only needle-free delivery system of subcutaneous sumatriptan for the treatment of central nervous system disorders and pain such as acute migraines and cluster headaches.
SUMAVEL DosePro became available in a 6 mg dose in January 2010 with more than 225,000 total prescriptions by the third quarter of this year, according to the pharmaceutical company’s press release. The 4 mg dose sumatriptan injection is intended to lessen the possible side effects of the drug and is expected to hit the market in June 2014.
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.