It’s not easy out there for a drugmaker/developer, no matter what stage of the game you are. From raising seed funds to proof of concept to proxy battles with shareholders to the FDA and USPTO, dangers loom at every step. Let’s take a look at two sides of the coin: companies who have cash and are expanding, and companies on the brink…

The Strong

• British pharmaceutical company BTG has hired three seasoned executives to establish base in the U.S., all in preparation for the company to start selling its own drugs here beginning in 2010. BTG’s model was traditionally to develop drugs up to a certain stage and license them out to bigger players. The focus will now be changing to direct sales. BTG says its plans are to start marketing in the critical care space with DigiFab (for digoxin overdose) and CroFab (snake antivenom). The drugs are currently licensed to Nycomed, but Nycomed will be returning the rights in 2010 as it prepares to slim down for a potential buyout (rumor). BTG also plans to acquire later stage critical care medicines as it expands its business in the U.S. [WSJ]

• Infinity Pharmaceuticals is cash rich, low cash burning, without debt and ready to present the results of its lead cancer program later this year. Infinity recently told the WSJ that it has enough cash to last through 2012, and while it may look for a European partner down the road, it plans to sell its own drugs here in the U.S. CEO Steven Holtzman felt that marketing Infinity’s medicines himself (i.e. the company) would not be unwise or a tightrope walk:

“I challenge people to point to any company that has produced exceptional shareholder value that didn’t maintain marketing rights in the U.S. I don’t think commercialization is rocket science.”

Inifnity’s lead drug PI-504 (retaspimycin hydrochloride), an HSP inhibitor, is in trials for GIST (gastrointestinal stromal tumor) and was recently returned from MedImmune/AstraZeneca. The company plans to report Phase 2 studies in NSCLC in mid-2009 as well as preliminary data from a Phase 1b trial in combination with Taxotere in mid-2009. [WSJ]

On the Brink

• Just months after Zingo was pulled from the market due to manufacturing and stability concerns, Anesiva has received a going concern from its auditors and says it might not make it. Although the company finished 2008 with no debt, it only had about $650K (and some change) in cash. Anesiva said it may need to seek bankruptcy protection if they are “not able to raise additional funding.” The company also faces Nasdaq delisting if they are not able to reach a minimum closing bid price of $1.00 per share . They have until April 13 to resolve the issue. [FierceBiotech]

• Summit Plc of the United Kingdom said that it has not been able to secure additional financing to stay afloat. The publicly traded company has been holding discussions with shareholders and other potential investors for months now with the aim of raising additional equity capital, however it has been unsuccessful to-date. The company has several partnered products, including SMT C1100 for Duchenne muscular dystrophy with BioMarin Pharmaceuticals, SMT D001 for sialorrhoea with Orient Pharma, and SMT 14400 with Evolva Biotech. [Summit website]

• Antares Pharma also received a going concern from its auditor, putting its survival in doubt, The company had this to say:

“The company has not historically generated sufficient revenue to provide the cash needed to support operations, and has continued to operate primarily by raising capital and incurring debt. Given the current economic and market conditions, it will likely be difficult to raise additional funds through debt or equity financings.”

Antares finished 2008 with about $13M in cash and a loss of $12M. [The Philadelphia Inquirer]

• Finally, Delsite filed for Chapter 7 bankruptcy liquidation this week. The Dallas-based company failed to raise $1.5M to get a clinical trial started for its bird flu vaccine, and another $3M to $4M to meet existing financial obligations. In its April 2 bankruptcy filing, Delsite stated it had $1-10M in assets and $10-50M in liabilities. [BizJournals]

And that’s that…

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