Arena Pharmaceuticals had a webcast for analysts and other interested parties this morning; notes and comments on this webcast are included below.

• No agreement with major pharma company yet;
• No advisory committee (also referred to as a panel) meeting scheduled; ARNA will announce if and when they hear it; they will get a 55 day warning from the agency
• Last patient later this month and results later this year
• Supplement to the NDA will be filed post approval
• APD 916 in phase 1; results will be announced in the third quarter
• APD 997 is being evaluated by JNJ
• First quarter financials: R&D expenses have decreased significantly by $24.3 million due to a decrease in clinical trial expenses
  x Manufacturing costs are included in R&D expense
• They will present more data on lorcaserin in future conferences, including the diabetes meeting in Orlando and in Arlington, VA in July
• They will present at a meeting in San Diego a few weeks before the lorcaserin PDUFA date
• Question on the panel: has the FDA suggested a panel is likely? Lief said no, but that September 15 and 16 there is a meeting of the panel, but he hasn't heard anything form the FDA from the FDA.
• The company should hear in late July if they're going to be on the September panel.
• Lief probed on commercial agreement on the company; Lief said he couldn't comment on it. Lief reiterated that Arena has always said that they are ready to launch on their own.
• Worried: if they cannot form a partnership, would there be a soft launch. Lief said he doesn't like soft launches. 7500 physicians account for half of weight loss prescriptions. Arena could reach all of them with a modest sales force of 100 people. He then made a stronger statement: "as I said earlier, we do expect to sign a partnership agreement." He later said that "we expect to form an agreement before approval and before launch."
• Lief commented that nothing has changed in the supplemental data for the ongoing clinical trial of the lorcaserin BLOOM trial; they will file the data as a supplement;
• A competitor (Vivus) suggested that the benchmark for approval, the 5% average weight loss could change; Jack Lief said he didn't want to speculate on the thinking of the FDA and that lorcaserin meets the published efficacy standards. Lief joked that it's nice that "our competitor is changing the FDA guidance for the FDA."
• Additional data on the 120 safety update. The data were submitted; it did include blinded data of an ongoing study; it summarized the most significant adverse events;
• They were asked about the number of major cardiovascular adverse events in the BLOSSOM study; some cardiovascular AE data were presented and more detailed information will be presented in upcoming meetings; the data in the Phase 3 trial show that the AE is low as would be expected from the low risk people selected from the phase 3 study; the company is confident in previous statements that lorcaserin has "really good safety profile."
• Guidance for the 2010 income statement is unchanged
• On the $150 million shelf registration: the spend assumes no partnership with a commercial entity, so the company expects to do "a lot better than that." Lief said they need to be well advanced in anticipation of the PDUFA date and they plan to raise money opportunistically;
• How long will the current cash last? Debt to Deerfield is due in July of 2011; they have already paid the $10 million due in July of 2010. It was paid last year.
• If the BLOOM data is filed before the PDUFA date, will it extend approval by six months? Lief said he won't speak for the FDA: the current NDA was accepted by the FDA for a robust review; Lief doesn't feel that the BLOOM data is necessary to making a decision; the initial submission was acceptable;
• Other companies are waiting until after approval to get a better deal; Lief said that the timing of any agreement is highly speculative; he doesn't think he is compromising anything by signing an agreement before approval; when we see a commercial agreement it "will be a very nice approval for both parties."
• If the PDUFA date is October 22, the launch can happen within 12 weeks after approval; Q1 2011;
• Will the CV data be adjudicated by the fall? Lief said that there would be no adjudication; a colleague said that there would be adjudication if there were certain AE and they don't expect such adjudication to be necessary;
• How are discussions with "reimbursers" going? Ten states cover weight management for Medicade today; Lief believes there is a chicken and edge situation in that once a good drug is available, the value of such a drug will be seen; note that at least two thirds of those that took the drug lost at least 5% and that figure represents 26 pounds, so parties would benefit from reimbursement;
• Is the FDA ok with filing the BLOOM data post approval? Lief said they have discussed the plan with the FDA and they are in agreement;
• As the competitor already has a panel date, has it pushed back partnership discussions for Arena? Lief said that he doesn't think so.

I would view this webcast as being very positive. I drew a number of conclusions from what I heard in the discussions.

I believe that Arena has moved far a long in its discussions with a commercial partner--most likely a major pharma company--to launch its weight reduction drug, lorcaserin; I expect the partnership to be announced soon: certainly before the PDUFA date for the drug;

I concluded that the safety data from the ongoing BLOOM trial is good; Arena doesn't expect to have adjudication on results--a decision by a third party--from which you could conclude that they haven't seen anything that needs explanation;

The current, ongoing trial will conclude later this year, but I think that the results won't be submitted until after the PDUFA date, when a decision would be rendered by the FDA;

I think that the shelf registration for $150 million announced recently is an effort to capitalize on an announcement of a commercial partner for lorcaserin. Arena will likely use the funds to pay down its debt, which has an interest rate of 7.25%.

All in all, I think that the news--what one could infer from what was said--was very positive. I plan to buy back the stock I sold earlier this week when the self registration was announced.