Company
(location)

Product

Description

Indication

Status

Date

Abbvie Inc. (North Chicago, Ill.)

ABT-888

Veliparib

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

Started a global phase III trial

4/16/14

Astrazeneca plc (London)

Byetta

Glucagon-like peptide 1 receptor agonist exenatide

Parkinson's disease

New results showed that those who previously had been exposed to exenatide had an advantage of 5.6 points over their controlled-tested counterparts when using the blinding MDS-UPDRS motor subscale

4/16/14

Astrazeneca plc (London) and Pfizer Inc. (New York)

12 drugs

12 drugs targeted to specific mutations

Advanced lung cancer

Opened a phase II trial testing 12 drugs in a single study

4/22/14

Bayer AG (Leverkusen, Germany)

Ciprofloxacin

Dry powder for inhalation

Non-cystic fibrosis bronchiectasis

FDA granted orphan drug designation

4/24/14

Bayer Healthcare (Whippany, N.J.)

Xofigo

Radium Ra 223 dichloride

Bone predominant metastatic castration-resistant prostate cancer

Began enrollment in a phase III trial studying Xofigo injection in combination with abiraterone acetate and prednisone/prednisolone

4/3/14

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Volasertib

A Polo-like kinase 1 inhibitor

Acute myeloid leukemia

FDA and European Commission granted orphan designation

4/18/14

Boehringer Ingelheim GmbH (Ingelheim, Germany)

Pradaxa Â

Dabigatran etexilate

Deep vein thrombosis and pulmonary embolism

The CHMP of the EMA issued a positive opinion recommending approval of Pradaxa Â; FDA approved it in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated

4/29/14

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

Epagliflozi-nand linagliptin

Combination tablet; sodium glucose co-transporter-2 inhibitor and a dipeptidyl peptidase-4 inhibitor

Type 2 diabetes

FDA accepted for filing an NDA

4/15/14

Bristol-Myers Squibb Co. (New York)

Daclatasvir and asunaprevir

An NS5A replication complex inhibitor and a NS3 protease inhibitor

Genotype 1b hepatitis C virus

Submitted an NDA; phase III data showed that DCV plus ASV given in a 24-week regimen gained SVR12 among treatment-naïve patients (90%), peg-interferon/ribavirin non-responders (82%) and peg-interferon/ribavirin ineligible or intolerant (82%)

4/8/14; 4/11/14

Bristol-Myers Squibb Co. (New York) and Gilead Sciences Inc. (Foster City, Calif.)

Atazanavir sulfate and cobicistat

A protease inhibitor and pharmacokinetic enhancer

HIV

Submitted an NDA

4/15/14

Daiichi Sankyo Co. Ltd. (Tokyo)

Edoxaban

Oral, once-daily direct factor Xa inhibitor

To prevent stroke and blood clot complications

Began enrolling patients into the phase III ENSURE-AF study

4/1/14

Dompe Group (Milan)

rhNGF

Recombinant human nerve growth factor eye drops

Retinitis pigmentosa

Started a phase Ib/II study to assess the safety and potential efficacy of the eye drops in two doses vs. placebo

4/4/14

Eisai Co. Ltd. (Tokyo)

Zonegran

Zonisamide

Partial epilepsy

Phase III data showed it was well tolerated and efficacious

4/23/14

Eli Lilly and Co. (Indianapolis)

Cyramza

Ramucirumab; a vascular endothelial growth factor receptor 2 antagonist

Advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma

FDA approved Cyramza as a single-agent treatment

4/23/14

Forest Laboratories Inc. (New York) and Gedeon Richter plc (Budapest, Hungary)

Cariprazine

An atypical antipsychotic

Depressive episodes of bipolar I disorder

Phase IIb data showed statistically significant improvements were observed in the 1.5 mg/day group relative to placebo at six weeks for the primary endpoint, the Montgomery-Asberg Depression Rating Scale total score, and the key secondary endpoint, the Clinical Global Impressions – Severity score

4/1/14

Glaxosmithkline plc (London)

Tanzeum

Albiglutide subcutaneous injection

Type 2 diabetes

FDA approved it

4/16/14

Glaxosmithkline plc (London)

Ellipta

Umeclidinium

Chronic obstructive pulmonary disease, including chronic bronchitis and emphysema

Received marketing authorization in Canada

4/18/14

Ipsen SA (Paris)

Dysport

An injectable form of botulinum toxin type A

Upper limb spasticity

Phase III data demonstrated a statistically significantly higher proportion of responders in muscle tone improvement vs. placebo

4/15/14

Janssen Biotech Inc. (Horsham, Pa.)

Sylvant

Siltuximab; an interleukin-6 antagonist

Castleman's disease

FDA approved it

4/25/14

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

Prezista combination

Once-daily, fixed-dose antiretroviral combination tablet containing protease inhibitor Prezista (darunavir) and cobicistat

HIV

Submitted an NDA

4/2/14

Janssen-Cilag International (Beerse, Belgium)

Vokanamet

A fixed-dose therapy combining canagliflozin and immediate-release metformin hydrochloride in a single tablet

Type 2 diabetes mellitus

European Commission approved Vokanamet

4/28/14

Lipella Pharmaceuticals Inc. (Pittsburgh, Pa.)

LP-09

Topical botulinum toxin type A formulation

Overactive bladder

Clinical data showed significant reductions in both urinary urgency and urinary frequency

4/9/14

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

MK-5172 and MK-8742

The NS3/4A protease inhibitor and an HCV NS5A replication complex inhibitor

Hepatitis C virus

Phase II data showed sustained viral responses with 12-week dosing in genotype 1 treatment-naïve patients reached 94% to 98%, even without ribavirin

4/11/14

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

Grastek

Immunotherapy tablet

Grass pollen allergy

FDA approved it

4/16/14

Novartis AG (Basel, Switzerland)

LCZ696

Angiotensin receptor neprilysin inhibitor

Chronic heart failure with reduced ejection fraction

The data monitoring committee unanimously recommended early closure of the PARADIGM-HF phase III study, indicating patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without hospitalization than those who received standard care

4/1/14

Novartis AG (Basel, Switzerland)

Zykadia

Ceritinib

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

FDA approved it

4/30/14

Pfizer Inc. (New York)

Tofacitinib

JAK inhibitor

Moderate to severe plaque psoriasis

Top-line phase III data showed that tofacitinb, as a 5-mg or 10-mg dose taken as a pill twice daily, met the primary endpoints of statistically significant superiority over placebo

4/23/14

Roche AG (Basel, Switzerland)

Roactemra

Tocilizumab; subcutaneous formulation

Moderate to severe active rheumatoid arthritis

Received a positive opinion from the CHMP

4/29/14

Sanofi Pasteur (vaccines division of Sanofi SA; Paris)

Vaccine

Dengue vaccine candidate

Dengue disease

Phase III data showed a reduction of 56% of dengue disease cases

4/29/14

Sanofi Pasteur MSD (Lyon, France)

Gardasil

Quadrivalent human papillomavirus vaccine

Papillomavirus

European Commission granted marketing authorization for a 2-dose schedule at 0 and six months in children ages 9 to 13

4/8/14

Sanofi SA (Paris)

Adacel

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed

To prevent tetanus, diphtheria and pertussis

FDA expanded the approved age indication of Adacel for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in subjects, ages 10 through 64

4/2/14

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Generic Lovaza

Omega-3-acid ethyl esters capsules

Hypertri-glyceridemia

Approved in the U.S.

4/9/14

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Pridopidine

An oral, small molecule

Huntington's disease

Enrolled the first patient in the Pride-HD study, a phase II trial

4/25/14

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Duoresp Spiromax

A new dry-powder inhaler containing a budesonide and formoterol fumarate dehydrate

Asthma and chronic obstructive pulmonary disease

The European Commission has granted marketing authorization

4/30/14

Twi Pharmaceuticals Inc. (Taipei)

Generic Procardia XL

Nifedipine extended-release tablets

Chronic cardiovascular disease

FDA approved it

4/8/14

Upsher-Smith Laboratories Inc. (Maple Grove, Minn.)

USL261

Intranasal midazolam

Epilepsy

Phase I data demonstrated it was rapidly absorbed and exhibited a short half-life

4/30/14

Notes

BLA = Biologics license application; CMA = Continuous marketing application; FDA = Food and Drug Administration; IND = Investigational new drug application; NDA = New drug application; PDUFA = Prescription Drug User Fee Act; SPA = Special protocol assessment.

Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue.

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