Company
(location)

Product

Description

Indication

Status

Date

AUTOIMMUNE

Pfizer Inc. (New York)

Xeljanz

Tofacitinib; a JAK inhibitor

Moderate to severe chronic plaque psoriasis

FDA accepted for review the supplemental NDA

2/6/15

CANCER

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

Lenvatinib

Multityrosine kinase inhibitor

Progressive, radioactive iodine-refractory differentiated thyroid cancer

Results from the pivotal phase III Select study demonstrated that the therapy was "associated with significant improvements in progression-free survival" (PFS) and response rates among patients in the randomized, double-blind, placebo-controlled trial; median PFS was 18.3 months in the lenvatinib group vs. 3.6 months in the placebo group (hazard ratio for progression or death, 0.21; 99 percent confidence interval, 0.14 to 0.31; p<0.001); the response rate was 64.8% in the lenvatinib group (four complete responses and 165 partial responses) and 1.5% in the placebo group (P<0.001); FDA approved it for patients whose disease progressed following radioactive iodine therapy

2/13/15

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

Halaven

Eribulin

Soft-tissue sarcomas

Halaven demonstrated a statistically significant extension in overall survival vs. dacarbazine in a randomized, open-label phase III study of the drugs

2/26/15

Janssen-Cilag International NV (Beerse, Belgium)

Velcade

Bortezomib

Mantle cell lymphoma

The European Commission approved a variation to the marketing authorization for Velcade in the additional indication of previously untreated mantle cell lymphoma in adults who are not suited for blood stem cell transplantation, in combination with Rituxan (rituximab, Biogen Idec Inc./Roche AG), cyclophosphamide, doxorubicin and prednisone

2/9/15

Novartis AG (Basel, Switzerland)

LBH589

Panobinostat; a histone deacetylase inhibitor

Multiple myeloma (MM)

Although the FDA's Oncologic Drugs Advisory Committee did not recommend approval for patients with previously treated MM when used in combination with bortezomib and dexamethasone, the agency approved the drug

2/24/15

Novartis AG (Basel, Switzerland)

Farydak

Panobinostat; a histone deacetylase inhibitor

Multiple myeloma

Gained conditional FDA approval

2/25/15

Pfizer Inc. (New York)

Palbociclib

Cyclin-dependent kinase inhibitor

Advanced or metastatic breast cancer

FDA approved it

2/4/15

Roche Holding AG (Basel, Switzerland)

Gazyva

Obinutuzumab; anti-CD20 therapy

Non-Hodgkin's lymphoma

Phase III data showed that people lived significantly longer without disease worsening or death when treated with Gazyva plus bendamustine (Treanda, Cephalon Inc.) followed by Gazyva alone, compared to bendamustine alone

2/5/15

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Ixazomib

The first oral proteasome inhibitor

Relapsed or refractory multiple myeloma

The randomized, double-blind, placebo-controlled TOURMALINE-MM1 pivotal phase III trial showed it achieved its primary endpoint of improving progression-free survival at the first pre-specified interim analysis

2/11/15

Valeant Pharmaceuticals International Inc. (Laval, Quebec)

Provenge

Sipuleucel-T

Prostate cancer

New long-term, preliminary results from the phase II STAND trial demonstrated a robust immune response with Provenge that continues two years after completing treatment in men with biochemically recurrent prostate cancer

2/26/15

CARDIOVASCULAR

Baxter International Inc. (Deerfield, Ill.)

BAX 335

Factor IX gene therapy

Hemophilia B

Phase I/II data showed that six patients in three dosing cohorts were treated in the trial, with evidence of dose-related response; so far none have developed FIX inhibitors; in the two highest dose cohorts, FIX activity levels of about 10% or higher were observed in two patients, who experienced no bleeding events

2/17/15

Eli Lilly and Co. (Indianapolis)

Evacetrapid

A selective inhibitor of cholesteryl ester transfer protein

High-risk atherosclerotic cardiovascular disease

Accepted the recommendation of the ACCELERATE study academic executive committee, based on emerging science in the cardiovascular field, and will extend the phase III trial of evacetrapib by approximately six months

2/20/15

CENTRAL NERVOUS SYSTEM

Pfizer Inc. (New York)

ALO-02

Oxycodone hydrochloride and naltrexone hydrochloride

To manage pain

FDA accepted for review the NDA for ALO-02 extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate

2/17/15

Pierre Fabre Pharmaceuticals (Castres, France)

F17464

A selective dopamine D3 receptor antagonist

Schizophrenia

Started a phase IIa program

2/4/15

Shire plc (Dublin)

Vyvanse

Lisdexamfetamine dimesylate

Moderate to severe binge eating disorder

FDA approved Vyvanse

2/3/15

Teva Pharmaceutical Industries Ltd. (Jerusalem)

CEP-33237

Hydrocodone bitartrate extended-release tablets formulated with its abuse deterrence technology

Severe pain

FDA has accepted for review its NDA

2/26/15

DIABETES

Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Conn.) and Eli Lilly and Co. (Indianapolis)

Glyxambi

Empagliflozin/linagliptin tablets

Type 2 diabetes

FDA approved Glyxambi tablets as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments

2/3/15

Daiichi Sankyo Co. Ltd. (Tokyo)

DS-5565

Mirogabalin; selective alpha-2 delta ligand

Diabetic peripheral neuropathic pain

Enrolled the first patients a phase III program held across Asia

2/5/15

Novo Nordisk A/S (Bagsvaerd, Denmark)

OG217SC

Oral formulation of long-acting GLP-1 analogue semaglutide

Type 2 diabetes

Completed the phase II trial in which patients treated with oral semaglutide in five doses ranging from 2.5 mg to 40 mg achieved dose-dependent HbA1c improvements of 0.7% to 1.9% after 26 weeks; people treated with 1 mg subcutaneous semaglutide or placebo achieved improvements of 1.9% and 0.3% respectively; all doses of oral semaglutide were statistically superior to placebo

2/23/15

Sanofi SA (Paris)

Toujeo

Insulin glargine (rDNA origin) injection, 300 U/mL

Type 1 and 2 diabetes

FDA approved it to improve glycemic control in adults with type 1 and type 2 diabetes

2/27/15

GASTROINTESTINAL

Actavis plc (Dublin)

Budesonide

Extended-release tablets; generic version of Uceris (Salix Pharmaceuticals Inc.)

Active, mild to moderate ulcerative colitis

Filed an abbreviated NDA with the FDA seeking approval to market Budesonide extended-release tablets, 9 mg

2/26/15

INFECTION

Actavis plc (Dublin)

Teflaro

Ceftaroline-fosamil

Concurrent bacteremia in acute bacterial skin and skin structure infections

FDA accepted for filing Actavis' supplemental NDA

2/5/15

Bristol-Myers Squibb Co. (New York)

Evotaz

Atanzanavir 300 mg/cobicistat 150 mg tablets

HIV

FDA approved it in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults

2/2/15

Bristol-Myers Squibb Co. (New York)

BMS-663068

HIV-1 attachment inhibitor

HIV

A phase IIb trial comparing BMS-663068 to Reyataz found the drugs achieved similar virologic response rates (HIV-1 RNA <50 c/mL) and immunologic reconstitution through 48 weeks; specifically, 61% to 82% of BMS-663068 patients had HIV-1 RNA levels of less than 50 c/mL, compared to 71% of Reyataz/ritonavir patients at week 48

2/26/15

Bristol-Myers Squibb Co. (New York)

BMS-955176

HIV-1 maturation inhibitor

HIV

Phase IIa data confirmed the antiretroviral activity of BMS-955176 and support its further clinical development

2/27/15

CSL Behring (King of Prussia, Pa.)

rIX-FP

Long-acting fusion protein linking recombinant coagulation factor IX

Hemophilia B

FDA has accepted its BLA for review

2/5/15

Janssen Therapeutics (Titusville, N.J.)

Prezcobix

Darunavir 800 mg/cobicistat 150 mg tablets

HIV

FDA approved it for the treatment of HIV-1 in combination with other antiretroviral agents

2/2/15

Pfizer Inc. (New York)

Trumenba

Meningococcal group B vaccine

Meningococcal group B virus

Top-line results of a phase II study of Trumenba co-administered with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diptheria and pertussis (Tdap) vaccines in more than 2,600 healthy individuals, ages 10 through 12, showed it met its co-primary immunogenicity objectives

2/25/15

MISCELLANEOUS

Antares Pharma Inc. (Ewing, N.J.)

Testosterone enanthate

Administered once weekly by subcutaneous injection using its Quickshot auto injector

Testosterone deficiency

Positive top-line pharmacokinetic data showed it achieved the primary endpoint in an ongoing phase III study, called QST-13-003

2/26/15

Astellas Pharma Inc. (Tokyo)

Advagraf

Prolonged-release capsules; tacrolimus

Graft-vs.-host disease

Results published in the American Journal of Transplantation showed that liver transplant patients treated early with the compound experienced a significantly increased graft survival benefit of 8% at three years post-transplant compared with patients treated with the current standard of care, tacrolimus immediate release

2/23/15

Chiesi Farmaceutici SpA (Parma, Italy)

Holoclar

A medicine containing stem cells

Burns to the eye

European Commission approved it to treat a rare condition caused by burns to the eye, specifically limbal stem cell deficiency due to physical or chemical burns, which can cause blindness if untreated

2/23/15

Pfizer Inc. (New York)

Elelyso

Taliglucerase alfa

Type 1 Gaucher disease

Phase III data showed that treatment-naïve patients treated with Elelyso for 36 months showed clinical improvements, as measured by a decrease in spleen and liver volume and an increase in platelet count

2/13/15

Sanofi SA (Paris)

Olipudase alfa

Recombinant human acid sphingomyelinase

Non-neurological manifestations of acid sphingomyelinase deficiency, or Niemann-Pick disease type B

The Genzyme unit presented data from the phase Ib study that showed that the dose-escalation regimen was well tolerated, with all patients reaching the maximum dose of 3 mg/kg; no serious or severe adverse events or deaths were reported

2/17/15

RESPIRATORY

Meda AB (Goteborg, Sweden)

Dymista

Single formulation azelastine hydrochloride and fluticastone propionate nasal spray

Seasonal allergic rhinitis

FDA approved it for patients older than 6 years and younger than 12

2/24/15

Takeda Pharmaceutical International GmbH (Zurich, Switzerland)

Daxas

Roflumilast

Chronic obstructive pulmonary disease (COPD)

Results of the REACT study demonstrated Daxas significantly reduced exacerbations and hospitalizations in patients with COPD who are at risk of frequent and severe exacerbations despite already receiving inhalation therapy with ICS/LABA combinations or triple (LAMA/ICS/LABA) therapy; the study showed that Daxas significantly reduced the rate of severe exacerbations by 24.3% (p = 0.0175) and those requiring hospitalization by 23.9% (p = 0.0209)

2/17/15

Teva Pharmaceutical Industries Ltd. (Jerusalem)

Reslizumab

Anti-interleukin-5 monoclonal antibody

Clinical asthma exacerbations

Data from two replicate 52-week phase III global studies showed that treatment with reslizumab significantly reduced the annual rate of clinical asthma exacerbations, compared to placebo, significantly improved lung function and provided sustained improvement in multiple secondary measures of asthma control in patients with asthma and elevated blood eosinophils who were inadequately controlled on an inhaled corticosteroid-based regimen

2/25/15

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.

For more information about individual companies and/or products, see Thomson Reuters Cortellis.