San Diego, CA-based Trius Therapeutics is looking to potentially represent the eighth biopharma IPO of the year if they are able to get out in the next month or so. With five companies trading (see matrix below), Trius is queued up alongside Anthera Pharma and Aldagen in an effort to make their Wall St. debut.

Taking a look at the LSDF – Class of 2009 Biopharma IPO Performance Watch List it makes me tingly all over to see the data begin to appear ‘crowded’, and more power to these management teams for electing to lead the market out of this two-year public offering trough. However, despite the all-inclusive class-wide cumulative market cap of $11.4 billion, back out Mead Johnson (NYSE: MJN) or 20% of the 2009 IPO class and then you are looking at a remaining $2.4 billion. Back out another 20% from the class in the form of Talecris (NASDAQ: TLCR) and you are now looking at $582M in market cap spread across the three remaining classmates. Then eliminate Cumberland Pharma (NASDAQ: CPIX) and AGA Medical Holdings (NASDAQ: AGAM) and you are left with $22.7M in market cap allocated to Omeros (NASDAQ: OMER). Omeros has been off oh maybe 30% from their first day offering price of $10, at last check they were trading at $7.70 per share. So obviously a rather brutal foray for Omeros, the Street has certainly not welcomed them warmly relative to their peers. Let’s see if we can spot a trend that may illuminate some rationale driving this negative outcome, shall we?

1. Mead Johnson – a commercial-stage entity
2. Talecris – a commercial-stage entity
3. Cumberland Pharma – a commercial-stage entity
4. AGA Medical – a commercial-stage entity

• Omeros – well…NOT a commercial-stage entity rather, clinical-stage with a Phase III asset

Now, I am no regulatory guru, nor to I even try to play one in the blogosphere, but I can tell you from some accumulated scars that there is a meaningful chasm between NDA submission and market approval. Not only temporally, yeah sure assume ten-months for a PDUFA date response, but do not forget to consider the time and heavy lifting required to get the document submitted following completion of the trial – drafting the NDA is not an immaterial endeavor. That work could easily require three to six-months. And why not book-end it with FDA often requesting “something” more often than not upon their PDUFA response; make it easy here and say another three to six-months for response to the FDA response.

So when an entity is pitching out on the road-show, proudly announcing positive Phase III interim data, keep in mind that they can very easily still be two to three years away from commercialization. And in this author’s humble and unsophisticated opinion believes that the Street is no longer rewarding development and clinical-stage entities, as can be observed with Omeros relative to their class peers.

That said and turning now to Trius Therapeutics, who is yes, to my understanding, a clinical-stage entity with their most advanced asset in Phase II – one may postulate then that in today’s market there will be no record setting capital raise transpiring. What exactly does Trius have cooking…

Trius Therapeutics is a biopharmaceutical company focused on the discovery and development of innovative antibiotics for serious, life-threatening infections, who is preparing to initiate (a) Phase III clinical trial(s) for torezolid phosphate, an IV and orally administered second generation oxazolidinone, for the treatment of serious gram-positive bacterial infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

PRODUCTS IN DEVELOPMENT

Torezolid phosphate (Phase II), a novel prodrug antibiotic, is cleaved in the blood stream to the active compound, torezolid. As a second generation oxazolidinone, torezolid phosphate shares the positive attributes of linezolid, including the availability of IV and oral dosage forms, highly efficient oral absorption, tissue penetration and distribution, and activity against MRSA. However, based on clinical and nonclinical data, it is believed that torezolid phosphate has significant potential advantages over linezolid, including the following:

• Greater Potency
• More Convenient, Shorter and Once Daily Dosing Regimen
• Bactericidal Activity In Vivo
• Activity Against Key Gram-Positive Drug-Resistant Strains and Select Atypical and Gram-Negative Bacteria
• Low Intrinsic Frequency of Resistance
• Favorable and Predictable Pharmacokinetics
• Fewer Drug-Drug Interactions
• Improved Safety Profile for Longer Term Dosing
• No other clinical-stage assets (please correct me if mistaken)

INDICATIONS AND MARKETS PURSUED

• Drug resistance is a key public health problem and also a problem for makers of branded antibacterial products. Traditional antibiotics: quinolones, cephalosporins, and penicillins, have seen their market share erode due to loss of effectiveness, while at the same time they are facing heavy generic competition. Growth is flat and in some cases, sales are declining, the total world market for antibacterial drugs, which represents almost half of the anti-infectives market (anti-fungals, anti-bacterials and anti-virals), is estimated at $24.5 billion for 2009, up 0.7% from 2008. (Source: Kalorama)

Methicillin-resistant Staphylococcus aureus is a bacterium responsible for several difficult-to-treat infections in humans. It may also be referred to as multidrug-resistant Staphylococcus aureus or oxacillin-resistant Staphylococcus aureus (ORSA). MRSA is resistant to a large group of antibiotics called the beta-lactams, which include the penicillins and the cephalosporins.

MRSA is especially troublesome in hospital-associated (nosocomial) infections. In hospitals, patients with open wounds, invasive devices, and weakened immune systems are at greater risk for infection than the general public. MRSA is often sub-categorized as community-acquired MRSA (CA-MRSA) or health care-associated MRSA (HA-MRSA) although this distinction is complex. Some have defined CA-MRSA by characteristics of patients who develop an MRSA infection while other authors have defined CA-MRSA by genetic characteristics of the bacteria themselves. The first reported cases of community-acquired MRSA began to appear in the mid-1990s from Australia, New Zealand, United States, United Kingdom, France, Finland, Canada, and Samoa. The new CA-MRSA strains have rapidly become the most common cause of cultured skin infections among individuals seeking emergency medical care in urban areas of the United States. These strains also commonly cause skin infections in athletes, prisoners and soldiers.

FINANCING (to date ~$50M, not including $27.7M NIAID contract)

The Company announced their first institutional financing in 2007, a $20M Series A round led by Sofinnova Ventures along with InterWest Partners, Prism VentureWorks and Versant Ventures. This was followed by a $30M Series B in 2008 led by Kleiner, Perkins, Caufield and Byers and new investor FinTech Global Capital along with participation from all earlier investors. Then in November of 2009 Trius announced the S-1 filing, this doc can be viewed [HERE]. The offering is led by Credit Suisse Securities, Piper Jaffray (NYSE: PJC), Canaccord Adams and JMP Securities (NYSE: JMP).