MediciNova shares have jumped after FDA ‘fast track’ designation for methamphetamine-addiction drug candidate. But we recommend holding tight for now; buying MNOV after the company issues new common stock, a move we expect soon.

http://sandiegobiotechnology.com/topics/5830/medicinova-on-the-move/

Trius (TSRX): dump or double down? Three Q&As

The share price of Trius Therapeutics (TSRX) has rebounded almost fully from its 10 percent dip in the New Year that was triggered by its public offering of 7 million shares; however, uncertainty about the company’s lead investigational drug is a lingering February hangover.

The San Diego-based biotech grossed $34 million in the public offering; and mutual funds, institutional investors, insiders, and other large players purchased newly minted shares of Trius for $4.75 a share, which they can now flip for a combined profit of roughly $3.5 million. But small investors face a dilemma:

should they dump their diluted shares, double down, or do nothing?
Your answer hinges on these three questions:

– What is the toxicity profile of Trius’ lead drug tedizolid? Name-brand and generic antibiotics currently used to treat MRSA have toxic side effects, especially with long-term usage. If tedizolid is significantly safer, which early trials show is the case, it could have a major advantage over other antibiotics.

– Will the FDA approve tedizolid? The question isn’t rhetorical, because if there’s one sure thing about the FDA, it’s that there are no sure things. The FDA approved 16 new antibiotics between 1983 and 1987, but only one in 2008-2009, primarily due to large biotechs abandoning antibiotic research and development.

– Assuming that the FDA approves tedizolid, possibly by 2015, how effectively will it be able to compete against its main competitor linezolid (Zyvox), a chemically similar drug made by Pfizer (PFE)? Linezolid’s current annual sales are $1.2 billion, but those sales have stagnated due to safety concerns and are expected to plummet when linezolid goes off-patent in 2015. Will generic forms of linezolid drag down sales of tedizolid, too?

The answers are already emerging.

Read about the six key advantages of Trius’ tedizolid over Pfizer’s linezolid at:

http://sandiegobiotechnology.com/topics/5733/trius-dump-or-double-down-on-maker-of-mrsa-antibiotic/

sandiegobiotechnology.com/topics/5733/trius-dump-or-double-down-on-maker-of-mrsa-antibiotic/[tag]insert-text-here[/url]

Sangamo BioSciences (SGMO) has several "function cures" of HIV in its clinical trials. SGMO has protected IP in the zinc finger nuclease and TALENs gene-editing platforms. These platforms are "disruptive" in that they represent a way to cure several diseases, rather than treat them. More: http://bit.ly/WayJpR

Illumina's acquisition in September of BlueGnome makes more sense when you consider that millions of infertile women will soon get the biggest baby boost in a generation from preimplantation genetic diagnosis (PGD). This technology, which BlueGnome has pioneered, identifies a woman's healthiest embryos at in vitro fertilization (IVF) clinics. New studies show that PGD doubles the chances of a woman in her mid-30s to early-40s delivering a single, healthy baby per IVF attempt to nearly 60 percent. The current U.S. average is 31 percent. BlueGnome has developed technologies needed for a 24-hour PGD test. The full story is at:

https://sandiegobiotechnology.com/topics/5411/embryo-genetic-test-doubles-rate-of-one-in-vitro-fertilization-baby/

Pfizer's maraviroc in "cure for HIV" drug category.

Top scientists say a "CCR5 antagonist," if not maraviroc, then a next-generation version of it, could be part of the long-awaited cure for HIV.

Some background:

Mutations in human genes cause muscular dystrophy, but a mutation in the CCR5 gene has a huge health benefit: people with it are almost completely resistant to HIV infection. Since that discovery was made in 1996, Pfizer and other companies have become focused on developing a treatment that mimics the effects of a CCR5 mutation.

Here is a summary I wrote describing CCR5 antagonists and the race for a cure for HIV: http://bit.ly/OGbWQn