Betting the Pharma - Pharmaceutical Executive

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Betting the Pharma


Pharmaceutical Executive


NEKTAR: BIOTECH DO-OVER

When Pfizer yanked Exubera, its billion-dollar inhaled insulin fiasco, in 2007 and dumped it back on Nektar, ending a 13-year-long partnership, the drug-delivery shop in San Carlos, CA, promptly lost 150 people, including the head of its top-selling pegylation business. Thus began Nektar's transformation into what CEO Harold Robin is pleased to call "a world-class drug development company." With all that belt-tightening, which included the sale of its pulmonary business unit to Novartis for $115 million, Nektar ended 2008 $400 million in the black—not bad for a born-again biotech. By July, its stock had almost doubled in price. Now the company's lead product, a pegylated version of the pain drug Naloxone, has completed Phase II trials; if approved, it would be the first oral analgesic for opiod-induced constipation.

ACHAOGEN: SUPERBUG SWATTER

This San Francisco biotech is developing a new antibiotic arsenal against the growing global superbug crisis, including methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative bacteria. Achaogen's lead product, a tricked-out, new-dosing version of the old aminoglycoside class of antibiotics, is set to enter Phase II next year against K. pneumoniae, E. coli, and MRSA. The biotech also has several preclinical programs, including broader spectrum follow-on neoglycosides, the first-ever oral antibiotic for community-acquired MRSA, and novel agents against Gram-negative and biothreat bugs. Under CEO J. Kevin Judice (a veteran of both Genentech and Theravance, where he led the team that discovered telavancin), Achaogen has snagged $100 million in backing from VC firms, the NIH, the defense department, and other public funds.

ZAFGEN: AN ANTI-FAT PILL

After the giant flop of Sanofi-Aventis' Acomplia, pharma has lost its appetite for a chemical approach to weight loss. Targeting the brain has proved too complicated, while aiming at the bowels, like Alli, is too messy. This Boston-based startup deserves at hand, at least, for finding a wholly original approach: with angiogenesis inhibitors that failed to eliminate cancer tumors but might just shrink adipose tissue enough to win FDA approval for obesity. Zafgen's preclinical success in mice models—obese critters not only lost 25 percent of their fat cells but also reduced caloric consumption as much as 80 percent—has garnered considerable press this year. The startup also hired a high-profile CEO, Tom Hughes, who helped win EU (though not FDA) approval for Novartis' DPP-4 inhibitor, Galvus, in the equally sticky category of diabetes; plus an even newer CFO, Matthias Jaffe—signs that it's serious about partnering on clinical trials.

NEUROCRINE: ON THE MEND-OMITRIOSIS

If a Big Pharma were looking for a late-stage drug to plug a leak from patent loss, it could do worse than shopping at Neurocrine. The San Diego–based biotech has completed a whopping four out of five Phase II studies of its GnRH antagonist, elagolix, for endomitriosis, a painful condition occurring mainly among women of childbearing age when endometrial cells are deposited outside, rather than in the lining of, the uterus. Elagolix would be the first orally administered version of the hormone. Although elagolix missed hitting one end point with statistical significance, Phase III trials are expected to get rolling early next year, including a head-to-head comparison with standard-of-care injectable Lupron. A nod from FDA would certainly help Neurocrine forget the pain of the NDA for its insomnia drug indiplon, which got torn apart two years ago.


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