The first thing on my mind was to find out if there is still more room for new cholesterol drugs in the marketplace. Specifically I wanted to know if Resverlogix Corp.’s (RVX:TSX) (Zavoico: Buy; Target CA$6.50) RVX-208 could make a dent. “There is a very large potential market in this space,” he says, “Despite the continuing widespread use of statins, which explains the high level of interest. Even with improved control over cholesterol levels with statins, many people still suffer or die from acute coronary events or strokes.” He is particularly positive about the product’s “unique mechanism of action” which makes it so interesting. He points out the fact that there have been “notable failures” in attempts to raise high density lipoprotein (HDL), the “good” cholesterol (HDL-C), and he references recent data from Resverlogix’s phase 2b SUSTAIN trial that RVX-208 “significantly” raised levels of both HDL-C and Apo A-1, the latter of which is an important constituent of HDL-C and helps to move cholesterol from vessels. “That’s why RVX-208 is starting to get noticed,” he says.
Zavoico follows BioCryst Pharmaceuticals Inc. (BCRX:NASDAQ) (Zavoico: Buy; Target $9), and out of curiosity I wanted to know about a preclinical compound, which is not something investors usually have much interest in because they rarely add value to shares. This case could be different. The compound is BCX5191 for hepatitis C (HCV), which is a nucleoside, not a nucleotide. “The fact that BCX5191 is a nucleoside could be an important advantage,” says Zavoico. “It is not a prodrug (an inactive chemical that is subsequently activated in the body by normal metabolic processes), as are the nucleotides, and it has shown high potency, as well as no notable toxicity, in preclinical studies.” BioCryst says that a phase 1 trial is expected to start before year end. “It is a new approach in this space,” he says. “But as far as monetizing this asset, I think it is too early right now.” True, the main value driver for the company today is its phase 2, ready for phase 3, compound ulodesine, a purine nucleoside phosphorylase (PNP) inhibitor, which is being studied in gout. “We expect BioCryst to announce a partnership deal for this asset long before it does so with BCX5191,” he says.
Spectrum Pharmaceuticals Inc. (SPPI:NASDAQ) (Zavoico: Buy; Target $28) recently acquired Allos Therapeutics Inc. (ALTH:NASDAQ), with one marketed product, Folotyn (pralatrexate), which generated $50.5 million in net sales last year. The price tag for Allos was $206 million. Is the new business a value driver for Spectrum? “I believe it is,” says Zavoico. Folotyn is approved for treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). “We think the company can integrate Folotyn sales and marketing within its existing infrastructure for Fusilev (levoleucovorin) and Zevalin (ibritumomab tiuxetan) at minimal cost,” he says.
Threshold Pharmaceuticals (THLD:NASDAQ) (Zavoico: Buy; Target $14.50) delivered some exciting data from its phase 2b study of TH-302 in pancreatic cancer back in February. Given that news, is there any possibility that an early approval could be in the cards? “Definitely,” he says, “But not based on the phase 2b trial by itself since it was not set up as a pivotal trial since overall survival was a secondary endpoint. I envision a phase 3 trial of similar design, and most likely involving one of the two TH-302 doses evaluated in the phase 2b. If you've got success in phase 2b, typically there is no reason to make big changes to the trial design.” Before year end Zavoico expects Threshold to deliver some overall survival data in pancreatic cancer from its phase 2 study of TH-302 plus gemcitabine.
1) George S. Mack personally and/or his family own shares of the following companies mentioned in this interview: None
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