Company
(Location)

Product

Description

Indication

Status

Date


Abbott (Abbott Park, Ill.)

ABT-450/r, ABT-267, and ABT-333

Interferon-free regimen in combination with ribavirin

Hepatitis C virus

Phase IIb data showed sustained virological response at 12 weeks post-treatment in 99% of treatment-naive and 93% of null responder patients

10/16/12

Abbott (Abbott Park, Ill.)

Humira

Adalimumab; anti-TNF therapy

Crohn's disease; ulcerative colitis

CHMP adopted a positive opinion; in ulcerative colitis, Humira showed clinically meaningful rates of mucosal healing at week 52

10/22/12

Almirall SA (Barcelona, Spain)

Sativex

An endocannabinoid modulator

Multiple sclerosis

Data showed that, after three months, 41% of patients treated with Sativex, who were resistant to other therapies, had clinically relevant effects

10/16/12

A.P. Pharma Inc. (Redwood City, Calif.)

APF530

A long-acting formulation of granisetron

Chemotherapy-induced nausea and vomiting

FDA accepted the resubmitted NDA

10/17/12

Astellas Pharma Inc. (Tokyo)

Betmiga

Mirabegron; a once daily oral beta3-adrenoceptor agonist

Overactive bladder

CHMP adopted a positive opinion recommending approval

10/22/12

AstraZeneca plc (London)

Fulvestrant

Breast cancer therapy

Hormone therapy-naive postmenopausal breast cancer patients

Started a Phase III study to compare fulvestrant to Arimidex

10/30/12

Bayer Healthcare (unit of Bayer AG; Leverkusen, Germany)

Riociguat

First of a new class of soluble guanylate cyclase stimulators

Pulmonary arterial hypertension

Demonstrated a statistically significant improvement in the six-minute walk test in both treatment-naive patients and patients who previously had received endothelin receptor antagonists

10/23/12

Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis)

DPP-4 Trajenta

Linagliptin

Type II diabetes

Phase III data supported its use in Type II diabetes, including patients who are elderly and those with diabetic nephropathy

10/3/12

Bristol-Myers Squibb Co. (New York) and Pfizer Inc. (New York)

Eliquis

Apixaban

Nonvalvular atrial fibrillation

Reductions in stroke or systemic embolism, major bleeding and mortality demonstrated with Eliquis compared to warfarin were consistent across a wide range of scores

10/3/12

Bristol-Myers Squibb Co. (New York)

Orencia

Abatacept

Moderate to severe active rheumatoid arthritis

European Commission granted marketing authorization

10/8/12

Chiesi Group (Parma, Italy)

CHF 6001

PDE4 inhibitor

Asthma and chronic obstructive pulmonary disease

Completed a Phase I trial

10/17/12

CSL Behring LLC (King of Prussia, Pa.)

Hizentra

Immune globulin subcutaneous [human]

Primary immunodeficiency

Supported previously demonstrated safety and efficacy in a Phase III trial in Japan

10/8/12

Daiichi Sankyo Co. Ltd. (Tokyo)

Edoxaban

Once-daily oral Factor Xa inhibitor

To prevent recurrence of venous thromboembolism

Completed patient enrollment in a Phase III study

10/26/12

Eisai Europe Ltd. (Hatfield, UK)

Fycompa

Perampanel

Partial-onset seizures

Demonstrated efficacy and safety at clinically relevant doses in the pivotal Phase III program

10/5/12

Eisai Inc. (Woodcliff Lake, N.J.)

Fycompa

Perampanel

Partial-onset seizures

FDA approved Fycompa as an adjunctive treatment

10/24/12

Eli Lilly and Co. (Indianapolis)

Alimta

Pemetrexed

Locally advanced or metastatic nonsquamous non-small-cell lung cancer

FDA approved the label inclusion for Alimta with Phase III data demonstrating progression-free survival and overall survival advantages in the continuation maintenance setting

10/19/12

Eli Lilly and Co. (Indianapolis)

Cialis

Tadalafil 5 mg for once-daily use

Benign prostatic hyperplasia

European Commission approved Cialis

10/31/12

Eli Lilly and Co. (Indianapolis)

Ramucirumab

An antibody designed to bind the extracellular domain of vascular endothelial growth factor receptor 2

Metastatic gastric cancer

Phase III data showed it met its primary endpoint of overall survival

10/16/12

Eli Lilly and Co. (Indianapolis)

Solanezumab

A monoclonal antibody that binds specifically to soluble amyloid beta

Alzheimer's disease

Phase III data showed a statistically significant slowing of cognitive decline, representing a 34% reduction in decline

10/9/12

Grifols SA (Barcelona, Spain)

Alpha-1 HC

Aerosol

Cystic fibrosis

First patient was enrolled and dosed in a Phase II study

10/9/12

Grupo Ferrer Internacional SA (Barcelona, Spain)

Ozenoxacin

Formulated as a topical treatment

Infectious dermatological conditions

Successfully completed an absorption, tolerability and safety trial in patients from 2 months of age with impetigo

10/8/12

Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson)

Canagliflozin

A sodium glucose co-transporter 2 inhibitor

Type II diabetes

Substantially lowered blood glucose levels when used as add-on therapy

10/3/12

Janssen Research & Development Infectious Diseases - Diagnostics BVBA (Beerse, Belgium)

Incivo

Telaprevir

Genotype 1 hepatitis C virus

Phase III data showed noninferior sustained virological response rates

10/17/12

Janssen Research & Development LLC (Raritan, N.J.; unit of Johnson & Johnson)

Simponi

Golimumab

Ulcerative colitis

Phase III findings showed significantly more patients with moderately to severely active UC who responded to induction therapy maintained clinical response through week 54, the primary endpoint, compared with placebo

10/23/12

Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson)

Stelara

Ustekinumab

Moderate to severe plaque psoriasis

Data from the 52-week study in Prague, Czech Republic, demonstrated it is effective, generally well tolerated and improves quality of life

10/4/12

Janssen Biotech Inc. (Horsham, Pa.; unit of Johnson & Johnson)

Stelara

Ustekinumab

Moderate to severe Crohn's disease

Phase IIb data showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, compared to placebo patients (40% vs. 24%)

10/4/12

Merck & Co. Inc. (Whitehouse Station, N.J.)

HPV4

Quadrivalent human papillomavirus vaccine

Human papillomavirus

A study of nearly 200,000 young females found that immunization was associated only with same-day syncope and skin infections in the two weeks after vaccination

10/3/12

Merck & Co. Inc. (Whitehouse Station, N.J.)

MK-3102

Once-weekly DPP-4 inhibitor

Type II diabetes

Phase IIb data showed it significantly lowered blood sugar in the 12-week study, compared to placebo, with an incidence of symptomatic hypoglycemia that was similar to placebo

10/4/12

Merck & Co. Inc. (Whitehouse Station, N.J.)

Odanacatib

A cathepsin K inhibitor

Osteoporosis

Phase II data showed it significantly increased bone mineral density over a two-year period

10/16/12

Novo Nordisk A/S (Bagsvaerd, Denmark)

Tresiba

Insulin degludec

Diabetes

Was approved in Japan

10/1/12

Novo Nordisk A/S (Bagsvaerd, Denmark)

Turoctocog alfa

A third-generation recombinant coagulation Factor VIII

Hemophilia A

Submitted a marketing application in Europe and the U.S.

10/17/12

Novo Nordisk A/S (Bagsvaerd, Denmark)

Tresiba and Ryzodeg

Insulin degludec, a once-daily basal insulin; and an insulin degludec/insulin aspart combination

Diabetes

CHMP adopted a positive opinion from both products

10/22/12

Pfizer Inc. (New York)

Chantix/Champix

Varenicline

Smoking cessation

Completed a study that met its primary and secondary endpoints, with subjects in the varenicline group having a higher likelihood of quitting at week 12 and at week 52

10/17/12

Pfizer Inc. (New York)

Inlyta

Axitinib

Advanced renal cell carcinoma

Phase III study did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival vs. Nexavar in treatment-naive patients

10/18/12

Pfizer Inc. (New York)

Prevenar 13

Pneumococcal polysaccharide conjugate vaccine

Pneumonia

Top-line data showed the immune response in 18 to 49-year-olds was noninferior to the immune response in the 60 to 64-year-old age group

10/8/12

Pfizer Inc. (New York)

ALO-02

Oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules

Moderate-to-severe chronic, noncancer pain

Phase III data showed that the adverse event profile was as expected, with the most common adverse events being nausea, constipation, vomiting and headache

10/12/12

Pfizer Inc. (New York)

Xalkori

Crizotinib

Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer

European Commission gave conditional marketing authorization

10/25/12

Pierre Fabre Dermatolgie Laboratories (Castres, France)

Propranolol

Oral solution

Infantile hemangioma

Phase III data showed it resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants treated

10/11/12

Sanofi Pasteur (Swiftwater, Pa.; vaccines division of Sanofi SA)

Fluzone

Influenza virus vaccine; quadrivalent formulation

Influenza

Filed an sBLA

10/19/12

Sigma-Tau Pharmaceuticals Inc. (Gaithersburg, Md.)

Cystaran

Cysteamine ophthalmic solution

Corneal cysteine crystal accumulation as a result of cystinosis

FDA approved it

10/5/12

Stiefel (Research Triangle Park, N.C.)

Sorilux Foam

Calcipotriene

Plaque psoriasis of the scalp

FDA approved a supplemental NDA

10/1/12

Sunovion Pharmaceuticals Inc. (Marlborough, Mass.)

Latuda

Lurasidone

Depressive episodes associated with bipolar depression

FDA accepted for review two sNDAs

10/31/12

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) and H. Lundbeck A/S (Copenhagen, Denmark)

Lu AA21004

Vortioxetine

Major depressive disorder

Submitted an NDA

10/3/12

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Glatiramer acetate

Therapeutic agent in the MS drug Copaxone

Multiple sclerosis

Phase III data showed it significantly reduced annualized relapse rates by 34.4%

10/11/12

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Laquinimod

A once-daily, oral immunomodulator

Crohn's disease

Phase IIa data showed treatment gave a remission rate of 48.3%, compared to 15.9% for patients receiving placebo

10/23/12

Watson Pharmaceuticals Inc. (Parsippany, N.J.)

Trospium Chloride Extended-release Capsules

Generic equivalent to Sanctura XR (Allergen Inc.)

Overactive bladder

Received approval of the aNDA

10/16/12

Wilex AG (Frankfurt, Germany)

Rencarex

Girentuximab

Clear cell renal carcinoma

Phase III trial showed it failed to meet th eprimary endpoint of disease-free survival

10/17/12


Notes:

The date indicated refers to the BioWorld Today issue in which the news item can be found.