The good news is that the initial public offering (IPO) market keeps looking good for biopharma, as three more firms priced Wednesday, with two of those, both rare disease firms, pricing at the high end or above their proposed ranges. That makes nine IPOs so far this year; in comparison, only six IPOs had priced during the first four months of 2013, which turned out to be a record-breaking year for biopharma IPOs. (See BioWorld Insight, Dec. 30, 2013.)
The bad news is the stunning Nasdaq debuts of last week – both Dicerna Pharmaceuticals Inc. and Ultragenyx Pharmaceutical Inc. saw their shares trading up by more than 100 percent at opening – were not to be repeated Wednesday, as U.S. stocks fell across the board.
Auspex Pharmaceuticals Inc. got the warmest reception by far, with its newly listed shares (NASDAQ:ASPX) opening Wednesday at $15, a more-than-respectable 25 percent jump from the $12-per-share IPO price, the high end of the company’s previously proposed range. The San Diego-based company, which initially filed for a $69 million IPO last year, increased the number of shares offered to 7 million to boost its haul to $84 million, or $94.8 million if underwriters Stifel and BMO Capital Markets exercise their full overallotment option. (See BioWorld Today, Dec. 24, 2013.)
Proceeds are expected to support its ongoing phase III study of SD-809 (dutetrabenazine), a deuterium-tweaked version of vesicular monoamine transporter 2 inhibitor tetrabenazine, in chorea associated with Huntington’s disease (HD). That 90-patient study is being supported by an open-label trial designed to provide long-term safety data for SD-809, which is aimed at offering less frequent dosing, with improved tolerability, reduced drug interactions and a reduced need for genotyping for drug-metabolizing enzymes. (See BioWorld Today, Nov. 9, 2012.)
Pending positive data, Auspex hopes to file for FDA approval under the 505(b)(2) pathway in the fourth quarter of 2014, with commercial launch sometime in 2015.
The company’s shares closed Wednesday at $15.66.
LUKEWARM WELCOME FOR UNIQURE
Though it’s also targeting the hot rare disease space, Uniqure BV didn’t fare quite as well in its Wall Street debut. True, the firm priced its offering of 5.4 million at $17 apiece, above its previous range of $13 to $15, and shares (NASDAQ:QURE) traded as high as $17.75 during the day; however, they fell to $14.61 by market close.
The lukewarm reception on the U.S. market likely has to do with regulatory uncertainties relating to the Dutch company’s gene therapy product Glybera (alipogene tiparvovec). Despite hard-won European approval in 2012 – the protracted process ended up bankrupting original Glybera developer Amsterdam Molecular Therapeutics Holdings NV – it’s not yet clear how the FDA might review a regulatory submission. (See BioWorld Today, Nov. 5, 2012.)
In its S-1 filing, disclosed in late December, Uniqure said it plans to submit an investigational new drug application in the first half of this year, seeking approval of the gene therapy, which is based on adeno-associated viral vector, in the ultra-orphan indication lipoprotein lipase deficiency. (See BioWorld Today, Jan. 3, 2013.)
Meanwhile, the commercial launch of Glybera in the EU is expected in the first half of this year, where it will be marketed by partner Chiesi Farmaceutici SpA.
Uniqure, which is raising $92 million in its IPO, with up to another $13.8 million if underwriters Jefferies, Leerink Swann and Piper Jaffray exercise their full overallotments, will use proceeds to build out the manufacturing facility in Lexington, Mass., and to begin a phase I/II trial of a second gene therapy product, AMT-060, in hemophilia B.
GENOCEA PRICES $66M IPO
The third firm to price its IPO Wednesday, Genocea Biosciences Inc., sold 5.5 million shares at $12 apiece, coming in at the low end of its proposed range, for proceeds of about $66 million to advanced its T-cell vaccine technology.
The Cambridge, Mass.-based firm is offering underwriters Citigroup, Cowen and Co., Stifel and Needham & Co. LLC an option to purchase up to 825,000 additional shares, which would raise another $9.9 million.
Proceeds will be used to support the Genocea’s vaccines in development for herpes simplex virus 2 (HSV-2) and pneumonia. In early December, the company started a phase I study of GEN-004 for pneumococcus (Streptococcus pneumoniae), the first vaccine designed to block infections caused by all pneumococcus strains.
But most of the excitement in Genocea’s pipeline right now stems from its protein subunit vaccine for HSV-2, especially after phase I/IIa data presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in September showed that three doses of the GEN-003 vaccine reduced the frequency of viral shedding of up to 51 percent (p < 0.001).
Its vaccine technology is designed to harness the power of T-cell immunity, and the company has earlier-stage programs in chlamydia, HSV-2 prophylaxis and malaria.
Genocea, which filed to go public last year aiming to raise $75 million, saw its shares (NASDAQ:GNCA) open at $11.70, down slightly from the IPO price. Shares close Wednesday at $11.00.