Pipeline 2008

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MM&M takes a detailed look at 258 products in the pipeline, highlighting 17 of them with insights and ratings from top analysts, to provide an overall picture of each therapeutic's potential value

Behind the Profiles
Where possible, each of the profiles includes a rating and comment from Adis R&D Insight, plus a physician outlook from one of the GfK US Healthcare Companies and a financial forecast. The Adis score, based on a 100-point scale, is a way of evaluating the clinical potential of late-stage agents on up to 20 criteria. The higher the score, the greater the potential advantage of the therapeutic over existing products.

Cardiovascular
GENERATING BUZZ
Prasugrel Eli Lilly & Co./Daiichi Sankyo
Indication: Acute coronary syndrome (Ph.III)
What the clinical trials found: A large phase III Triton trial found superior efficacy to BMS/Sanofi-Aventis's Plavix, but also greater risk of dangerous bleeding; two smaller phase II trials were halted.
Adis R&D Insight Rating and Comment: 68. In phase II studies, prasugrel + aspirin therapy has demonstrated a trend toward superiority over clopidogrel + aspirin. The benefits over clopidogrel therapy included a more rapid onset of action, with improved inhibition of ADP-induced platelet aggregation and fewer non-responders. (Source: Wolters Kluwer Health)
What the analysts had to say:
A positive result in isolation may not be enough to significantly alter clinical practice, especially if associated with higher bleeding rates.
—Jami Rubin, analyst, Morgan Stanley
We will continue to assume that prasugrel is approvable by FDA and other regulatory bodies, but this is far from certain given the safety conscious regulatory climate (at least in the US).
—Tim Anderson, MD, senior analyst, BernsteinResearch

Cordaptive (laropiprant/ERN) Merck
Indication: Primary hypercholesterolemia, mixed dyslipidemia (Filed)
What the clinical trials found: Trials showed encouraging efficacy data for lowering bad cholesterol, raising good cholesterol and reducing triglyceride levels. The drug seems to neutralize niacin's flushing effect, though this remains a concern.
Adis R&D Insight Rating and Comment: 77. Use of extended-release niacin (ERN) instead of the immediate-release formulation only slightly reduces the flushing problem. In patients with dyslipidemia, laropiprant/ERN reduced niacin-induced flushing compared with ERN alone, while showing similar therapeutic efficacy to ERN. (Source: Wolters Kluwer Health)
What the analysts had to say:
While we continue to use conservative projections for both Cordaptive and MK-524B (Cordaptive + simvastatin), we see this niacin flushing inhibiting line as potentially targeting a multiple billion-dollar opportunity (pending data on Abbott's Niacin CR).
—Jami Rubin, analyst, Morgan Stanley

Diabetes
GENERATING BUZZ
Byetta (exenatide) long-acting release Amylin/Alkermes/Lilly
Indication: Type-2 diabetes mellitus (Ph.III)
What the clinical trials found: A phase III study suggested that exenatide LAR may offer improved blood glucose control over the currently marketed formulation, Byetta.
Adis R&D Insight Rating & Comment: 70. Exenatide LAR is expected to replace the existing, immediate-release formulation of exenatide (Byetta), also developed by Amylin and Lilly. Byetta requires twice daily subcutaneous administration, so a once-weekly formulation would be a more convenient option. An NDA for exenatide LAR is expected to be submitted in 2009, and if approved, the agent is predicted to supersede Byetta as an adjunctive therapy in patients with type-2 diabetes mellitus.
What the analysts had to say:
In the GLP-1 class, interest will remain high, given the need for better post-prandial control, beta cell preservation and weight control. But competitors will have to demonstrate clear and meaningful benefits for acceptance by physicians, payers and patients.
—David Jacobson, SVP, GfK Market Measures
We believe exenatide LAR has now demonstrated the most convincing clinical profile of all GLP-1s to date. Efficacy appears to be best in class. We forecast $2 billion in peak sales.
—ING Wholesale Banking's Tim Race

Liraglutide Novo Nordisk
Indication: Type-2 diabetes mellitus (Ph.III)
What the clinical trials found: Phase III clinical trials found once-daily liraglutide + glimepiride gave superior glycemic control compared with a rosiglitazone-glimepiride combination and with glimepiride monotherapy. The triple combination of glimepiride, metformin and liraglutide was also superior to glimepiride, metformin and insulin glargine. Notably, three trials demonstrated that liraglutide promoted weight loss and had a good safety profile with no serious adverse events reported.
Adis R&D Insight Rating & Comment: 72. Liraglutide may face direct competition from exenatide LAR. A direct, head-to-head study of liraglutide vs. exenatide, initiated this year, may show which is the more effective agent in maintaining glycemic control and hence provide a better therapeutic option for patients with type 2 diabetes.
What the analysts had to say:
Long-term we have reduced our 2013 sales for liraglutide form $1.3 billion to $1.1 billion reflecting the potential for exenatide LAR to dominate the market. If liraglutide reaches the market, Novo Nordisk is likely to have significant competition to its only major new compound.
—ING Wholesale Banking's Tim Race

Saxagliptin Bristol-Myers Squibb/AstraZeneca/Otsuka
Indication: Type-2 diabetes mellitus (Ph.III)
What the clinical trials found: Preliminary six-month data from a phase III study in patients with type 2 diabetes, which was poorly controlled with metformin, showed that add-on, once daily saxagliptin was safe and well tolerated. The compound significantly improved glycemic control compared with metformin alone. Saxagliptin is currently in phase III multi-center clinical trials worldwide. BMS and AZ plan to file an NDA with the FDA in the first-half of 2008. Studies are assessing the compounds as monotherapy, as an adjunct to diet and exercise, and as an add-on therapy in combination with metformin, sulfonylurea or thaizolizinediones.
Adis R&D Insight Rating & Comment: 74. It remains to be seen whether saxagliptin will have a successful run in the diabetes market. Its future depends on the results from pending clinical trials and its ability to outperform other gliptins already on the market.
What the analysts had to say:
Saxagliptin is emerging as a serious competitor to Merck's Januvia.
—Rodman & Renshaw's Michael King
Saxagliptin could add $750 million to peak US sales by 2017.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

Central Nervous System
GENERATING BUZZ
Fingolimod Novartis
Indication: Multiple sclerosis (Ph.III)
What the clinical trials found: In a two-year phase II study, Novartis reported a relapse rate reduction of more than 50% vs. placebo, with 77% of patients remaining relapse-free over two years.
Adis R&D Insight Rating and Comment: 80. First in a new class,  fingolimod is designed for once-daily, oral administration, compared with conventional MS drugs requiring injections/infusion; would be the first ever approved oral MS drug.
What the analysts had to say:
Providing a significant reduction in relapses and disability progression would make it, along with Mylinax (Ivax/Serono), a popular potential new MS product.
—Kim Lazarus, VP, GfK Market Measures
Fingolimod could add $801 million to US peak sales by 2016.
—Datamonitor

Valdoxan/AGO178 (agomelatine)Novartis
Indication: Depression (Ph.III)
Adis R&D Insight Rating and Comment: 65, sleep disorders. Agomelatine is a highly potent and selective agonist at melatonin receptors. Its abuse potential should be low.
What the analysts had to say:
Agomelatine's unique mechanism of action is expected to provide significant anti-depression efficacy and offer sleep benefits.
—Geoff Penney, VP, GfK Market Measures

XP 13512Astellas/GlaxoSmithKline
Indication: RLS (Ph.III); neuropathic pain (Ph.II)
What the clinical trials found: Results from the initial phase I trials demonstrated good tolerability and favorable pharmacokinetics compared with Pfizer's Neurontin (gabapentin).
What the analysts had to say:
Neuropathic pain conditions are notoriously difficult to treat, so the higher efficacy potential of XP 13512 is a real plus.
—Geoff Penney, VP, GfK Market Measures

Oncology
GENERATING BUZZ
Nexavar (sorafenib)Onyx/Bayer
Indication: Hepatocellular carcinoma (HCC) (Filed)
What the clinical trials found: In the phase III SHARP trial, treatment resulted in superior overall survival with no demonstrable difference in serious adverse event rates vs. placebo.
Adis R&D Insight Rating and Comment: 83. Sorafenib, a compound with a unique, dual mechanism of action, has demonstrated therapeutic activity in a range of major cancer types (renal, liver, malignant melanoma). Administered as a twice-per-day tablet, it has a favorable toxicological profile and efficacy as monotherapy or in combination with chemo. (Source: Wolters Kluwer Health)
What the analysts had to say:
This new treatment option is likely to lead to a rapid and dramatic shift in the treatment paradigm for advanced HCC.
—Bill Bowman, JD, VP, GfK Market Measures
HCC could add $350 million to peak sales by 2014, melanoma $400 million by 2016, NSCL $750 million by 2017 and renal $180 million by 2012.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

DenosumabAmgen
Indication: Preventing cancer metasteses, cancer-related bone damage (Ph.III)
What the clinical trials found: Previous studies showed it was sustained in the blood and prolonged inhibition of bone resorption for three months.
What the analysts had to say:
Denosumuab is poised to compete in the cancer supportive care arena with Novartis' injectable bisphophonate Zometa.
—Bill Bowman, JD, VP, GfK Market Measures
Denosumuab's cancer indications could add $681 million to peak global sales by 2016. —Datamonitor

HuMax CD20 (ofatumumab)
GenMab/GlaxoSmithKline
Indication: Hematologic malignancies (Ph.III)
What the clinical trials found: In a previous phase I/II trial, the objective response rate to ofatumumab was 50% in CLL patients.
Adis R&D Insight Rating and Comment: 63, non-Hodgkin's lymphoma; 63, CLL. (Source: Wolters Kluwer Health)
What the analysts had to say:
GSK is expected to deploy its massive resources to compete with Genetech and Biogen Idec's blockbuster Rituxan.
—Bill Bowman, JD, VP, GfK Market Measures
HuMax CD20 could add $236 million to peak sales by 2010.
—Bear, Stearns International Limited-European Equity Research

Respiratory
GENERATING BUZZ
Alvesco (ciclesonide) Nycomed
Indication: Asthma (Approved)
What the clinical trials found: Studies showed an antiasthmatic efficacy similar to that of budesonide and fluticasone propionate.
Adis R&D Insight Rating and Comment: 64. Ciclesonide may provide useful advantages relative to other inhaled corticosteroids. Systemic exposure to ciclesonide is limited by targeted delivery, reducing the potential for side effects.
What the analysts had to say:
An inhaled corticosteroid with low systemic absorption is a relative unmet need in the asthma category. An approvable letter in 2004 and multiple handoffs have been hindrances, however.
—Sue Ramspacher, SVP, GfK Market Measures
Asthma could add $280 million to peak sales by 2011.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

Daxas (roflumilast) Nycomed
Indication: Asthma, COPD (Ph.III)
What the clinical trials found: The once-daily drug appears to be comparable in efficacy to inhaled corticosteroids in the treatment of asthma and COPD.
Adis R&D Insight Rating and Comment: 75, asthma; 73, COPD. Roflumilast appears well-tolerated; it does not appear to show the side effects of nausea and vomiting that have been a problem with other phosphodiesterase IV inhibitors.
What the analysts had to say:
Nycomed's Daxas looked promising early on, but things may have stalled after Pfizer decided not to pursue marketing rights and the product then missed some key clinical endpoints.
—Sue Ramspacher, SVP, GfK Market Measures

Claritin/Singulair (loratadine/montelukast)
Schering-Plough/Merck
Indication: Seasonal allergic rhinitis plus congestion (Ph.III)
What the clinical trials found: The drug appeared to be superior to either agent alone for the treatment of allergic seasonal rhinitis and demonstrated a consistent, clinically relevant effect on congestion that was not observed with the individual components.
What the analysts had to say:
The jury is still out on how likely physicians will be to adopt it.
—Sue Ramspacher, SVP, GfK Market Measures
The allergic rhinitis product could bring in $500 million in peak sales to each of Schering-Plough and Merck by 2012.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

Others
GENERATING BUZZ
Viviant (bazedoxifene)Wyeth
Indication: Postmenopausal osteoporosis prev., treatment (Filed)
What the clinical trials found: Phase III trials showed bazedoxifene prevented bone loss, reduced bone turnover, was generally well-tolerated in postmenopausal women with normal or low bone mineral density, and showed significant risk reduction for new vertebral fractures.
Adis R&D Insight Rating and Comment: 77, prevention; 75, treatment. Beneficial effects on postmenopausal symptoms and lack of major safety issues will add to the chances of approval, despite an approvable letter in April. (Source: Wolters Kluwer Health)
What the analysts had to say:
Estimated launch in January 2008, with predicted global peak sales of about $1 billion worldwide. Year of US peak sales: 2015.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

Suggamadex/ORG25969Organon/Schering-Plough
Indication: Reversing neuromuscular blockade in surgery (Ph.III)
What the clinical trials found: Sugammadex has shown the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade faster than the traditionally used drug.
Adis R&D Insight Rating and Comment: 78. Sugammadex administration represents a new approach to reversing nondepolarizing neuromuscular block. (Source: Wolters Kluwer Health)
What the analysts had to say:
Suggamadex could add $300 million to peak sales by 2014.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight

Rilpivirine/TMC278Tibotec Therapeutics
Indication: HIV-1 infections (Ph.II)
What the clinical trials found: A phase IIb study showed significant and sustained efficacy similar to that of efavirenz (Sustiva).
Adis R&D Insight Rating and Comment: 62. HIV viral strains are emerging which are resistant to currently available non-nucleoside reverse transcriptase inhibitors (NNRTIs), so there is still room in the market. (Source: Wolters Kluwer Health)
What the analysts had to say:
A QD co-formulated Rilpivirine + NRTI backbone could become the future first-line HIV treatment.
—Noah Pines, EVP,GfK V2
Rilpivirine could add $500 million to peak sales by 2016.
—Lehman Brothers PharmaPipelines estimates, cited by Adis R&D Insight
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