The Leading Source of Diabetes Business News the Long View Fall
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The Leading Source of Diabetes Business News The Long View Fall 2011 • No. 108 Although change isn’t literally in the air for me – here in San Francisco, we still get a few more weeks of summer – autumn brings some notable shifts in the world of diabetes, and I’m looking forward to hearing all about them in companies’ third-quarter financial updates. Perhaps most importantly, Amylin/Lilly/Alkermes’ Bydureon, the first once-weekly diabetes therapy, has now made its debut in several European countries. That means this earnings’ season will be the first chance to hear how the launch has gone, and we’ll get our first real indicator of what to expect in the quarters to come. Will patients flock to the every-seven-days dosage schedule, forcing rival GLP-1 companies to accelerate development of their own once-weekly products (and encouraging Amylin/Lilly/Alkermes to stay on course with their phase 2 once-monthly exenatide)? Or will factors like needle size, injection simplicity – and even the regularity of daily dosing, considered an advantage by some – give the edge to Victoza? (Novo Nordisk certainly isn’t resting on the success of this soon-to- be-blockbuster, having most recently launched Victoza in the swiftly growing Chinese market – a topic we explore in this issue’s interview with Novo Nordisk’s head of China, Ron Christie.) The global GLP-1 contest was already intensely competitive and has become more so, even before Bydureon’s entry to the US or the arrival of new players (e.g., Sanofi’s Lyxumia). The implications extend to novel therapeutic areas like once-weekly insulins and DPP-4 inhibitors, and, even more broadly, get at the $36 billion question: what does it mean to create a drug that is easier for patients to take? Among the very top pharmaceutical sellers, the champion remains Lantus, and we’re always eager to see how quarter-to-quarter shifts impact the biggest products. We expect that 3Q11 will be another market-leading one for Sanofi’s basal insulin, which posted $1.39 billion of revenue in 2Q11 and a whopping $4.6 billion in 2010. (Down the road, it will be interesting to see how the basal insulin market shifts with the introduction of Novo Nordisk’s insulin degludec; for now, we look forward to insights on degludec’s recent US/EU regulatory filing and its upcoming submission in Japan.) But second-place is very much up for grabs between the current runner-up, Takeda’s Actos ($1.15 billion in 2Q11), and the quickly gaining challenger, Merck’s Januvia ($1.10 billion in 2Q11). We expect Januvia to claim the number-two spot in 3Q11, especially given the much-publicized risks of Actos-associated bladder cancer. DPP-4 inhibitors are the hotter class, in terms of revenue growth as well as class expansion. This has been the first quarter of US sales for BI/Lilly’s Tradjenta, and early next year the FDA will rule on Takeda’s resubmission of alogliptin and alogliptin/pioglitazone, the first DPP-4 inhibitor/TZD combination pill. Also on the oral therapies front, the FDA is less than a month away from ruling on BMS/AZ’s dapagliflozin – potentially the first SGLT-2 inhibitor to market, anywhere. Nor will the news be limited to diabetes drugs: other topics of great interest include Vivus’ resubmission of Qnexa (planned for October) and an update on the launch timeline of Insulet’s much-anticipated next-gen OmniPod in Europe. Changes are underway at Diabetes Close Up as well. Under our previous bimonthly model, each issue’s coverage often stopped in the middle of earnings season – so two of the “Big Four” BGM companies might be included in one issue, with the other pair in the issue that came two months later. Now, DCU will be quarterly – one document with every one of the previous season’s earnings updates, and all other big strategic news at companies besides. We’ll continue to offer in-depth interviews with key opinion leaders, top executives, and other members of the diabetarati, as well as recaps of personnel movements and stock trends. Conference coverage will become more limited, however, with each issue of DCU including only high-level themes from one-to-two meetings. (For more comprehensive and timely coverage of conferences, we encourage you to subscribe to our premium service, Closer Look – write to me at kelly.close@closeconcerns if you’d like to learn more.) As I said, I’m excited about the fall lineup of company announcements, but even more so about the changes coming in the next five years – the results of (and reaction to) ORIGIN, the full arrival of SGLT- 2 inhibitors, the rise of biosimilar and next-generation insulin analogs, the advent of disease-modifying complications treatments, the maturation of mobile health, etc. – and all of the benefits they will bring to patients. Here’s to gains in knowledge, innovations in therapy, and improvements in care: year by year, and season by season. Gratefully, Kelly L. Close Major Headlines Novo Nordisk – Submits degludec and degludecPlus in US, EU – page 10 Roche – Receives 510(k) clearance for maltose-independent strips – page 11 Orexigen – Agrees with FDA on path to regulatory approval for Contrave – page 12 Vivus – Reaches agreement with FDA to re-submit Qnexa in October 2011 – page 13 Abbott – Announces discontinuation of FreeStyle Navigator CGM in US – page 18 Takeda – FDA, EMA caution against bladder cancer risks associated with Actos – page 28 Pfizer – Launches Biocon’s biosimilar products in India, updates pipeline – page 33 Amylin/Lilly/Alkermes – Re-submit Bydureon to FDA – page 40 Lilly – Launches Bydureon in UK; multiple linagliptin approvals – page 45 FDA – Releases draft guidance on mobile medical applications – page 47 FDA – Releases guidance on low glucose suspend pumps – page 56 Animas/Dexcom – Receive CE Mark approval for Animas Vibe pump/CGM – page 62 Diabetes Close Up #108 ~ Fall 2011 ~ The Long View ~ www.closeconcerns.com 2 In This Issue 1. Quotable Quotes in Diabetes.....................................................................................................................6 2. diaTribe FingerSticks ................................................................................................................................ 7 3. DCU Company Watch................................................................................................................................8 . FDA – Releases report detailing how it will spur drug and medical device innovation . Catabasis – Initiates phase 1 trial for anti-inflammatory therapy CAT-1004 in type 2 diabetes . Sanofi – Sponsors study that will use PositiveID’s iglucose mobile device . Sangamo – Drops SB-509 from clinical develoment after unsuccessful phase 2b study . Novo Nordisk – Submits degludec and degludecPlus in the US, EU . Roche – Receives 510(k) clearance for maltose-independent Accu-Chek Aviva Plus test strips . BMS/Ambrx – Partner to develop FGF-21 derivatives for type 2 diabetes . Orexigen – Agrees with FDA on path to regulatory approval for Contrave . Vivus – Reaches agreement with FDA to re-submit Qnexa in October 2011 . GI Dynamics – Raises over $80 million USD through IPO and US private placement . Metabolic Solutions – Announces positive topline data from phase 2a trial . JDRF – Sponsors $100,000 challenge to spur development of glucose-responsive insulin . Takeda – Advances its once-weekly DPP-4 inhibitor SYR-472 into phase 3 trials in Japan . LifeScan – Debuts OneTouch SelectSimple blood glucose meter in India . Dr. APJ Abdul Kalam – Urges parents that diabetes is a disorder that can be corrected . Sanofi – Provides strategy update on new formulation of insulin glargine, other plans . BI/Lilly – Decide not to commercialize Trajenta in Germany due to healthcare reform . Ultizyme – Researchers develop self-powered, standalone glucose sensor . Abbott – Announces it will permanently discontinue the FreeStyle Navigator CGM in the US . D. Medical – Sales remain below $200,000; US and Canadian revenue anticipated in 3Q11 . Medtronic – Diabetes Care revenue grows 14%, bolstered by int’l; work continues on Veo IDE . Santarus – To assume broad responsibilities for Glumetza under new deal with Depomed . GSK/Sirtris – Independent researchers report positive preclinical data for SRT-1720 . Perrigo – Diabetes remains a major area of interest . Zealand – Lixisenatide and glucagon/GLP-1 dual agonist ZP2929 progress discussed . Nestlé – Double-digit growth in emerging markets; weak US sales in Jenny Craig franchise . Arena – Results from cancer analyses reported; company expects to file MAA in 1H12 . Lexicon – Over 100 patients screened for the phase 2b study for LX4211 . Ligand – Management evaluating one-off licenses for early-stage diabetes programs . Amylin/Takeda – Discontinue development of pramlintide/metreleptin . Halozyme – Announces new development track of PH20 dosage prior to pump therapy . Osiris – Phase 2 data expected for Prochymal in type 1 diabetes in 2H11 . Novo Nordisk – Victoza very strong, modern insulin growth slows . Takeda – FDA and EMA caution against bladder cancer risks associated with Actos . MannKind – Results include discussion of positive meeting with FDA . Biodel – Phase 1 study shows significantly faster absorption vs. Humalog . AstraZeneca – Initiates phase 1 study evaluating AZD2820 as a treatment for obesity . Isis – No updates on metabolic pipeline in 2Q11 call . XOMA – No further updates on XOMA 052 for type 2 diabetes; focus on preclinical candidates . CVS Caremark – Pharmacy Advisor program enrollment reaches 11.2 million members . Dexcom – Revenue