Earnings In Brief

Acorda's Ampyra sales best Wall Street expectations: The firm reported $29.7 million worth of Ampyra has shipped to its network of specialty pharmacies, which is how Acorda books sales, during its first full quarter of sales. FDA approved Ampyra (dalfampridine) in January to improve walking ability in multiple sclerosis patients, and Acorda launched it in March. In its second-quarter earnings call, Acorda said 4,200 doctors have now prescribed the drug. Ampyra's strength helped Acorda beat analyst estimates handily, posting a loss of 18 cents rather than the expected 46 cents. The firm's sales totaled $43.4 million, which also included $13.7 million in gross sales of anti-spasticity drug Zanaflex . The company is looking to in-license a development-stage neurology drug by the end of 2010. A Phase I trial for a remyelination agent, expected to begin this summer, has been delayed due to a vial-filling issue.

Exelixis cuts loss in half: Exelixis reported a $22.6 million net loss in the second quarter, nearly half the size of its loss a year ago. It also doubled its revenues to $47.6 million, mainly due to collaboration fees. The second quarter report was Michael Morrissey's first as the company's new CEO; previously head of R&D, he took over from long-time leader George Scangos, who left in June to run Biogen Idec (¹ (Also see "Exelixis Stays The Course Under New Leadership of Michael Morrissey" - Pink Sheet, 1 Jul, 2010.)). Morrissey - as his predecessor often did - pledged a certain amount of deal-making in the near future, stating that Exelixis would sign one deal in the second half of 2010. The firm's lead compound XL 184, a multi-kinase inhibitor in Phase III for medullary thyroid cancer and earlier stage trials for several other cancers, is once again unpartnered after Bristol-Myers Squibb walked away from co-development in June. Officials attributed the decreased net loss to the significant cost-cutting and layoffs earlier this year and the boost in revenues from the PI3 kinase collaboration with Sanofi-Aventis signed in May 2009.

Alnylam's five-year partnership with Novartis faces a crossroads in October: Novartis owns 13.4 percent of Alnylam and has an option to pay $100 million for a broad non-exclusive platform license. Meanwhile, the biotech reported a second-quarter loss of $14.6 million - a 36 percent improvement over the same quarter in 2009. The firm has three RNA interference-based programs in the clinic, the most advanced in Phase IIb for respiratory syncitial virus. The bump in clinical trial activity pushed up R&D expenses to $28 million, which slightly outpaced revenues of $26.6 million. With no drugs near the market, Alnylam relies on alliance fees and payments for revenue; it also has a funding cushion of $396 million in cash and equivalents as of June 30. Alnylam's Regulus Therapeutics subsidiary, co-owned by Isis Pharmaceuticals, recently entered into a broad development deal with Sanofi-Aventis. Alnylam received 7.5 percent of Sanofi's $25 million upfront fee to Regulus, or $1.9 million, which will be recorded in the third quarter.

AmerisourceBergen will have generic Eloxatin available through March 2011: Under the terms of a patent infringement settlement (² (Also see "Patent Round-Up: Sanofi Settles Eloxatin Suits; Lilly Continues Gemzar Fight" - Pink Sheet, 5 Apr, 2010.)), generic manufacturers Teva, Sandoz, and Fresenius Kabi had to stop selling the colon cancer drug oxaliplatin (Sanofi-Aventis' Eloxatin ) as of June 30. They can't resume sales of the drug, which they launched at risk in August 2009, until August 2012. Wholesalers, however, can continue to sell whatever inventories they have remaining as of June 30. AmerisourceBergen CEO R. David Yost said in a July 27 earnings call that the company "will have sufficient oxaliplatin inventory to meet the needs of our oncologist customers at least through the first half of our fiscal 2011, which begins Oct. 1." Oxaliplatin contributed $25 million to the wholesaler's latest quarterly sales, which totaled a record $19.6 billion, up more than $1 billon from the same period one year ago. However, sales of the generic will be less of a factor going forward, since the average selling price was reduced by 34 percent as of July 1.

McKesson preparing for rapid EHR deployment: The Technology Solutions segment of pharmaceutical wholesaler McKesson can rapidly launch its electronic health record solutions now that the first stage of the meaningful use criteria has been finalized (³ (Also see "CMS Reduces Criteria To Qualify For Electronic Health Record Financial Incentives In Final Rule" - Pink Sheet, 13 Jul, 2010.)). "We are on track to submit our EHR systems for initial certification as soon as we have a clear indication of the process, and we believe we are well positioned to achieve certification of our EHR systems," CEO John Hammergren said during a July 30 earnings call. He noted that physician uptake has been slow. However, as private payers begin to offer financial incentives that will supplement federal bonus payments for meaningful use, EHR vendors could see near-term growth (⁴ (Also see "Private Payers Follow Government Lead In Offering Electronic Health Records Meaningful Use Incentives" - Pink Sheet, 5 Aug, 2010.)). Widespread adoption of EHRs holds significant promise for the pharmaceutical industry, including more targeted clinical trial recruitment and data for post-marketing surveillance and comparative effectiveness research.