October 2008 Issues

Transcatheter Cardiovascular Therapeutics (TCT)

Summary: Stents (p. 1) – Xience/Promus have captured more than half the DES market and are likely to grow further at the expense of Taxus and Cypher. Medtronic’s Endeavor is likely to grow somewhat with the launch of rapid exchange. There is a lot of price competition in DES but no real price erosion. ♦ Percutaneous valves (p. 12) were a hot topic at TCT but adoption in the U.S. remains years away, and regulatory hurdles are still formidable. In Europe , a rising sea is carrying both Edwards and CoreValve up with it. ♦ Circulatory assist devices (p. 19) – Hospitals increasingly are getting Abiomed’s Impella, but most expect to use it for only 1-2 procedures per month. Newness and cost are limiting factors, but doctors consider it “very cool.” ♦ Peripheral artery disease (p. 20) – There continues to be a lack of sufficient data on atherectomy devices, and stents continue to fracture. Doctors are hoping for some new “breakthrough technology.” ♦ Imaging (p. 22) – Fractional flow reserve (FFR) got a big boost from the FAME trial. ♦ Anticoagulants (p. 24) – A ream of positive data was presented on The Medicines Company’s Angiomax, but it still may take time for that to translate to increased use. ♦ Regulatory issues (p. 25) – The focus is now on percutaneous valves, and the FDA wants to see more and better data.

Alemtuzumab in Multiple Sclerosis -- Quick Pulse

Summary: On October 23, 2008 , the New England Journal of Medicine published the results of the Phase II CAMMS-223 trial of Genzyme/Bayer’s alemtuzumab vs. Merck Serono’s Rebif (44 μg TIW) in relapsing-remitting multiple sclerosis (RRMS). There were no surprises in the data, just slightly more detail than previously presented. Alemtuzumab (which is FDA-approved as Campath to treat chronic lymphocytic leukemia) was given by IV infusion over three to five days once a year.

World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS)

Summary: The 2 new PML cases with Biogen Idec/Elan’s Tysabri have not impacted physician or patient willingness to use Tysabri, but questions have been raised about the use of plasma exchange in suspected or confirmed PML patients because both these patients developed immune reconstitution inflammatory syndrome (IRIS). ♦ Neurologists are still very excited about Genzyme/Bayer’s alemtuzumab. Though ITP and Grave’s disease are more manageable than PML, alemtuzumab is expected to have a strict risk management program. ♦ Merck Serono’s cladribine is likely to be the first oral agent, but the side effect to watch is shingles. ♦ Novartis’s oral fingolimod continues to show excellent efficacy but numerous side effects, and experts predicted it also will require a serious risk management program. ♦ Acorda Therapeutics’ fampridine showed good data in its second Phase III trial, and doctors predicted 1 in 5 MS patients are likely to take it long term.

Heart Failure Society of America (HFSA)

Summary: ICD and CRT referrals by heart failure specialists are flat and expected to stay that way. ♦ There have been reports of header/lead problems with Boston Scientific’s new ICD, Teligen. ♦ Abiomed’s Impella Recover is catching on, perhaps slower than the company might like but steadily, perhaps more at the expense of CardiacAssist’s Tandem Heart than IABP. ♦ Orqis Medical’s Cancion aortic flow pump is intriguing, but it needs better data for FDA approval. ♦ CytoKinetics’ CK- 1827452 holds promise as both an IV and oral inotrope, and data at HFSA looked good, but experts believe it needs more study, and questions were raised about the ongoing pivotal trial in Russia/Georgia. ♦ Use of CPAP for sleep apnea in heart failure patients is expected to increase over the next year. ♦ Doctors are dubious about the outlook for Amgen’s RED-HF trial of Aranesp in anemia of heart failure. ♦ ARCA biopharma may have more than just another beta blocker with bucindolol; doctors are willing to do genetic testing to determine responders.