Other

PRODUCTS GENERATING BUZZ

METABOLIC

Bydureon (exenatide long-acting release) Amylin

Indication: Type 2 diabetes (Prereg.)

What the clinical trials found: In the DURATION-6 trial, Bydureon patients saw a reduction in A1C of 1.3 percentage points vs. 1.5 points for Novo Nordisk's Victoza. A tQT study showed Bydureon, even at high levels, did not prolong heart rhythms.

inThought Approvability Index and Comment: 88%. Following EU approval in June, US approval looks likely now that Amylin has answered FDA concerns. The question is, can Amylin, which is taking over the exenatide franchise from Eli Lilly, make the most of the opportunity? Novo's Victoza may be hard to beat. Estimated approval: January 2013 (Source: Wolters Kluwer inThought).

inThought Revenue forecast: $1.8 billion in peak sales by 2018

What the analysts are saying: This once-a-week version of twice-daily Byetta has had a long regulatory review but may significantly expand the GLP-1 market. PCPs and endocrinologists seem to view this class as a way to impact weight and, presumably, other co-morbidities like blood pressure and cholesterol. Still, these products can get hemmed in commercially unless they can broaden beyond a mostly niche patient base, affluent people unable to control their weight. Issues will be the same as they are with any new drug in the metabolic space—cost and ensuring endos and PCPs are familiar with how to best use the product. —Dave Jacobson, PhD, SVP, Roper global diabetes group, GfK HealthCare

ORPHAN DISEASE

GALNS (BMN-110) BioMarin

Indication: MPS IVa, or Morquio A syndrome (Phase III)

What the clinical trials found: Phase I/II 36-week data were encouraging, and additional 24-week extension data showed a durable response. A Phase III trial began in February 2011, with data scheduled to report in late 2012.

inThought Approvability Index and Comment: 75%. This product, which has orphan drug exclusivity in the US and EU, looks like it serves an unmet need. BioMarin has done this three times before, and this could be their fourth orphan drug. Expected approval: September 2013 (Source: Wolters Kluwer inThought).

inThought Revenue forecast: $272 million in peak sales by 2018

What the analysts are saying: The data for this drug look promising. Patients with MPS IVa who have been on GALNS for about two years are stable. But additional data, due out next year, are needed to help clarify the drug's prospects. Until then, it appears that GALNS is a niche product, but one with a lot of promise. It definitely meets a need; other than bone marrow transplant, there's nothing out there yet for MPS IVa. Patients—some 350,000 with the inherited genetic disorder—are looking for a silver bullet. —Marite Talbergs, SVP, research & consulting, GfK HealthCare

KEY PRODUCTS FROM OTHER CATEGORIES IN THE PIPELINE

To see this extended list of other products in these and other product categories in a separate window. click here.

METABOLIC

Bardoxolone Abbott
CKD (Ph. III)

BI 10773 Boehringer Ingelheim/Eli Lilly
Type 2 diabetes (Ph. III)

Dapagliflozin Bristol-Myers Squibb/AZ
Type 2 diabetes (Prereg.)

Kombiglyze XR BMS
Type 2 diabetes (Ph. III)

Lorcaserin Eisai/Arena
Obesity (Prereg.)

Arxxant Eli Lilly
Diabetic retinopathy (Prereg.).

Dulaglutide Eli Lilly
Type 2 diabetes (Ph. III)

Empagliflozin Eli Lilly
Type 2 diabetes (Ph. III)

LY 2963016 Eli Lilly
Type 2 diabetes (Ph. III)

Tradjenta+Actos Eli Lilly
Type 2 diabetes (Ph. III)

Otelixizumab GSK
Type 1 diabetes (Ph. III)

Syncria (albiglutide) GSK
Type 2 diabetes (Ph.
III)

Canagliflozin J&J
Type 2 diabetes (Ph. III)

Afrezza MannKind
Insulin inhalation (Prereg.)

MK-3102 Merck
Type 2 diabetes (Ph.
II/III)

Odanacatanib (MK-0822) Merck
Osteoporosis (Ph. III)

Januvia+Actos (MK-0431C) Merck
Type 2 diabetes (Ph. III)

Insulin degludec Novo Nordisk
Type 1 diabetes (Prereg.)

Aleglitazar Roche
Type 2 diabetes (Ph. III)

Lixisenatide Sanofi
Type 2 diabetes (Ph. III)

Alogliptin Takeda
Type 2 diabetes (Prereg.)

Alogliptin/pioglitazone Takeda
Type 2 diabetes (Prereg.)

TAK 875 Takeda
Type 2 diabetes (Ph. III)

Contrave Takeda/Orexigen
Obesity (Prereg.)

DiaPep 277 Teva
Type I diabetes (Ph. III)

Qnexa Vivus
Obesity (Prereg.)

ORPHAN PRODUCTS

Metreleptin Amylin
Lipodystrophy (Prereg.)

Migalastat GSK
Fabry's disease (Ph. III)

Taliglucerase alfa Pfizer
Gaucher's disease (Prereg.)

Ataluren PTC Therapeutics
Cystic fibrosis (Ph. III)

Kalydeco (ivacaftor) Vertex
Cystic fibrosis (Prereg.)

RESPIRATORY

Reslizumab Cephalon
Asthma (Ph. III)

Azelastine/fluticasone Cipla
Seasonal allergic rhinitis (Prereg.)

Olodaterol (BI-1744) Boehinger Ingelheim
COPD (Ph. III)

Aclidinium bromide Forest
COPD (Prereg.)

Aclidinium/formoterol Forest
COPD (Ph. III)

Aztreonam for inhalation solution Gilead
Bronchiectasis (Ph. III)

Umeclidinium (573719) GSK
COPD (Ph. III)

Relovair (642444) GSK
Asthma (Ph. III)

Sinapultide J&J
Neonatal resp. distress synd. (Prereg.)

Grass pollen allergy vaccine tablet Merck
Seasonal allergic rhinitis (Ph. III)

MK-7243 (SCH 697243) Merck
Allergy (Ph. III)

MK-3641 (SCH 039641) Merck
Allergy (Ph. III)

Glycopyrrolate inhalation (NVA 237) Novartis
COPD (Ph.
III)

Glycopyrrolate/indacaterol Novartis
COPD (Ph. III)

Beclometasone hydrofluoroalkane intranasal Teva
Perennial allergic rhinitis (Prereg.)

Albuterol+Spiromax Teva
Asthma/COPD (Ph. III)

FP Spiromax Teva
Asthma (Ph. III)

FSC Spriomax Teva
Asthma (Ph. III)

WOMEN'S HEALTH

Elagolix Abbott
Endometriosis (Ph. II/III)

Ethinylestradiol/gestodene patch Bayer
Contraception (Ph. III)

Prasterone vaginal Bayer
Vaginal atrophy (Ph. III)

LibiGel BioSante
Female sexual dysfunction (Ph. III)

Savvy Biosyn
Contraception (Ph. III)

Elonva Merck
Female infertility (Ph. III)

Estradiol/nomegestrol monophasic Merck
Contraception (Prereg.)

MK-8962 (SCH 900962) Merck
Fertility (Ph.
III)

Aprela Pfizer
Menopausal symptoms (Ph. III)

Oporia Pfizer
Postmenopausal osteoporosis (Prereg.)

Viviant Pfizer
Postmenopausal osteoporosis (Prereg.)

Ethinylestradiol/desogestrel Teva
Contraception (Ph. III)

Estradiol vaginal Warner Chilcott
Vaginal atrophy (Ph. III)