Q1 Earnings Calls, In Brief

Forest hopes for Lexapro adolescent depression indication: Forest plans to submit an sNDA for Lexapro (escitalopram) to add an indication for adolescent depression, President Larry Olanoff said during a fourth quarter fiscal year 2008 earnings call April 15. Lexapro sales increased 9 percent this quarter to $577 million from $530 million in the year-ago quarter. Forest has a number of drugs in late-stage development in its pipeline, including aclidinium, in development for chronic obstructive pulmonary disease, ceftaroline for serious hospital infections, linaclotide for chronic constipation, RGH-188 for schizophrenia and bipolar disorder and milnacipran for the treatment of fibromyalgia. Forest projects spending $625 million in fiscal 2009 on R&D, and excluding initial licensing payments, plans to boost R&D spending by 27 percent from 2008 levels. No stroke signal for Forest's pulmonary disease drug: While Pfizer/Boehringer Ingelheim's chronic obstructive pulmonary medication Spiriva (tiotropium bromide monohydrate) may be linked to stroke, according to a March 18 alert from FDA's MedWatch, Phase II and III study data for Forest's aclinidium are not raising any concerns, said Olanoff. "We are not seeing anything to raise any alarms and are still waiting to determine whether it's a real finding even with Spiriva," he said. He also pointed to the drug's patient population - elderly people, many who have a long smoking history and are already prone to cardiovascular events. FDA has not contacted Forest about stroke signals and the company expects to be able to make an accurate estimation for rate of strokes with the drug.

Moving forward with Bystolic: During the April 15 call, Forest had several updates on the beta blocker Bystolic (nebivolol) that it partners with Mylan, which was approved late last year (¹ (Also see "Forest Hopes Efficacy In Blacks And Tolerability Will Set Bystolic Apart" - Pink Sheet, 7 Jan, 2008.), p. 5). Forest reported sales of $11 million during the quarter, mostly initial stocking by wholesales. Forest explained it was the first quarter of sales and was impacted by sampling, and maintains it is encouraged by early uptake and positive response by physicians. The firm also recently had a preliminary communication with FDA to delineate a path forward for an additional indication of congestive heart failure. When asked about the possibility that new JNC-8 treatment guidelines may recommend Bystolic and carvedilol as first-line beta blockers, Olanoff said the company is trying to submit a "high-quality" trial published in Europe that has "clearly a strong result in terms of a combined morbidity and mortality endpoint." FDA has communicated that it is willing to look at the study and consider it to support a filing. According to Forest, the agency is considering the firm's argument that "given the current environment, the ability to do another study exactly of that sort or of the more traditional nature would be difficult."

Roche looks for treasure in Piramed: Roche will acquire a new class of signal transduction inhibitors with potential in cancer indications through the acquisition of privately-held Piramed Pharma for $160 million plus $15 million in milestone payments, Swiss drug maker announces April 15. Deal gives Roche phosphatidylinositol 3-kinase inhibitors already in early development with Genentech. PI3-kinase is a "hot target," Pharmaceuticals CEO William Burns says during Roche's April 17 first quarter call. Sharply lower sales of Tamiflu , down 64 percent to CHF 278 million ($276.3 million), weighed on Roche's top line, which declined 4 percent to CHF 10.9 billion ($10.82 billion) in the quarter. "Underlying growth outside of Tamiflu to government was growing at 1.5 times the world market," Burns pointed out. Key products like Herceptin , Avastin , Rituxan , Tarceva and Boniva contributed double digit gains.

Abbott's triple threat: Abbott expects to drive growth during the remainder of the year through new launches including the introduction of the next-generation fenofibrate TriLipix , extended-release Vicodin CR and the drug-eluting stent Xience V , all of which are under review at FDA, the firm says March 16 during a first quarter call. Humira sales surged 53.7 percent to $878 million in the quarter following approval of two new indications for plaque psoriasis and juvenile arthritis. Consolidated sales increased 13.8 percent to $6.8 billion in the period, including a favorable 5.5 percent benefit from currency. Sales in the U.S. were sluggish, up 3.7 percent to $3.04 billion, reflecting the entry of generics of the antibacterial Omnicef (cefdinir) in May 2007. Net earnings increased 34.5 percent to $937.9 million.

J&J's partnership situation for Velcade: Takeda's impending acquisition of Millennium would not impact "in any way" J&J's arrangement as the exclusive overseas marketer of Velcade , CFO Dominic Caruso reported during J&J's first quarter earnings call April 15. J&J reported $182 million in overseas sales of the proteasome inhibitor during the first quarter of 2008, an increase of 49.9 percent year-over-year, exclusive of currency impact. The U.S. is another matter, and Caruso says the company is taking a "wait and see" approach. Domestically, J&J co-promotes Velcade (bortezomib) under several arrangements that have various expiration dates and generally can be renewed annually by either partner. J&J "would be happy to continue co-promoting the product with Millennium or the new entity, as the case may be," Caruso says. It is a matter of "what the new thinking is" at Millennium if the transaction goes through. In any case, U.S. sales of Velcade for J&J are only $2 million in the first quarter of '08.