2013: The year's biggest Drug Development stories

Alkermes reported positive results from a Phase I study of schizophrenia drug ALKS 3831 while Takeda secured European approval for three new type 2 diabetes therapies Vipidia, Vipdomet and Incresync. Drugdevelopment-technology.com wraps-up the key headlines from 2013.


schizophrenia brain image

Alkermes reports positive results from Phase I study of schizophrenia drug

Biopharmaceutical company Alkermes reported positive results from a Phase I study of ALKS 3831, which evaluated the orally-administered drug candidate as a broad spectrum treatment for schizophrenia.

ALKS 3831 comprises a novel opioid modulator, ALKS 33, and antipsychotic drug olanzapine, which is commercially available as Zyprexa.

Alkermes chief medical officer Dr Elliot Ehrich said that combining the opioid-modulating properties of ALKS 33 with olanzapine provides the possibility for a wider spectrum of schizophrenia, as the drug has two marked benefits for patients and physicians.

Takeda secures European approval for three new type 2 diabetes therapies

Takeda diabetes treatment

Japan-based Takeda Pharmaceutical Company received marketing authorisation (MA) from the European Commission (EC) for its three new type 2 diabetes therapies Vipidia (alogliptin), Vipdomet (alogliptin with metformin) and Incresync (alogliptin with pioglitazone).

Vipidia has been designed to treat type 2 diabetes in adults aged 18 years and older to improve glycaemic control in combination with other glucose lowering medicinal products including insulin.

Vipdomet and Incresync will be used for the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus

Sucampo reports promising results from Phase IIa lumbar spinal stenosis study

Sucampo Pharmaceuticals reported positive results from its Phase IIa study evaluating safety and efficacy of an intravenously (IV) administered compound of the company's proprietary ion channel activator programme in patients with lumbar spinal stenosis.

In this proof of concept study, patients who received the ion channel activator have experienced a statistically significant improvement in pain, as determined by improvements in the visual analogue scale score, compared with placebo.

Although the extent of improvement was not statistically significant, improvements in the primary and other efficacy measures have been observed, including pain-associated quality of life measures for patients treated with the ion channel activator.

Advaxis announces initiation of Phase I/II study of HPV vaccine

Advaxis HPV vaccine

US-based clinical-stage biotechnology firm Advaxis announced the start a Phase I/II trial of its lead immunotherapy drug candidate ADXS-HPV in 25 patients with human papillomavirus (HPV) positive head and neck cancer.

The Icahn School of Medicine at Mount Sinai (ISMMS) will be responsible for carrying out the clinical trial, which is aimed at assessing the effects of ADXS-HPV in patients who are initially diagnosed with HPV-associated head and neck cancer, prior to receiving any chemotherapy or radiation.

According to the company, the non-randomised investigator-initiated trial will be a major first step toward understanding the drug's potential to treat this type of cancer before chemotherapy or radiation and its potential to reduce the need for these treatments.


AstraZeneca starts Phase III trial of lung cancer drug selumetinib

AstraZeneca began the randomised, double-blind, placebo-controlled Phase III clinical study of its oral, potent, selective MEK inhibitor selumetinib as second-line therapy to treat patients with advanced non-small-cell lung cancer (NSCLC) tumours.

The 'SELumetinib Evaluation as Combination Therapy-1' (SELECT-1) study is intended to assess the safety and efficacy of selumetinib plus docetaxel to treat patients who are KRAS mutation-positive, a sub-type of lung cancer related with poor prognosis and limited treatment options.

The SELECT-1 study is designed to evaluate progression free survival (PFS) and overall survival (OS).

Orexigen files European marketing authorisation application for weight loss drug Contrave

Orexigen weight loss drug contrave

Biopharmaceutical firm Orexigen Therapeutics (OREX) submitted the marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its Contrave drug.

The company hopes to win approval for Contrave to manage obesity, including weight loss and maintenance of weight loss, in combination with lifestyle modification.

The company expects to make Contrave available to physicians and their patients in Europe in early 2015, subject to completion of the review process and potential approval in the second half of 2014.

Celgene's Phase III study of oral Revlimid meets primary endpoint

Celgene International's Phase III study (MM-020/IFM 07-01) of oral Revlimid (Lenalidomide) in combination with low-dose dexamethasone (Rd) met its primary endpoint of progression-free survival (PFS) in patients newly diagnosed with multiple myeloma.

According to the data, the combination demonstrated a statistically significant improvement in PFS against a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).

A total of 1,623 patients ineligible for autologous stem cell transplantation have been randomised in the study with continuous oral lenalidomide plus low-dose dexamethasone until disease progression.

CytomX partners with Pfizer to develop Probody drug conjugates in oncology

Pfizer headquarters

Biotechnology company CytomX Therapeutics signed a strategic agreement with Pfizer for the development and commercialisation of multiple Probody drug conjugates (PDCs) in the field of oncology.

The collaboration will result in a highly differentiated approach to developing safe and effective antibody drug conjugates (ADCs) using CytomX's novel Probody platform.

As per the agreement, Pfizer will make approximately $25m in upfront, research reimbursement and preclinical milestone payments, $610m in regulatory and sales milestones, in addition to tiered royalties on sales.

Eli Lilly terminates Phase III rheumatoid arthritis tabalumab programme

Eli Lilly

Eli Lilly and Company announced the termination of its Phase III rheumatoid arthritis (RA) programme for tabalumab based on negative efficacy results.

Tabalumab is an anti-BAFF (B cell activating factor) monoclonal antibody, which failed to demonstrate efficacy for the treatment of RA.

The termination was not due to safety issues and ILLUMINATE, a tabalumab Phase III programme for systemic lupus erythematosus, is ongoing and will continue as scheduled.

Sanofi's diabetes drug Lyxumia meets primary endpoint in Phase IIIb study

French pharmaceutical firm Sanofi released results of a 24-week Phase IIIb clinical trial showing that Lyxumia (lixisenatide) met the primary endpoint of non-inferiority in blood sugar lowering (HbA1c) when given to patients either before breakfast or the main meal.

The results showed that lixisenatide can effectively lower blood sugar at either time of administration and also achieve a comparable reduction in body weight, regardless of the meal before, which the drug was administered.

In addition, gastrointestinal tolerability was comparable regardless of time of administration, with no cases of severe hypoglycemia in either arm.

Pfizer Celecoxib meets primary endpoint in Phase IV juvenile idiopathic arthritis trial

Pfizer Celecoxib met its primary endpoint in a Phase IV trial evaluating its effects on blood pressure in paediatric patients with juvenile idiopathic arthritis (JIA).

No virtual difference in the primary and secondary endpoints, systolic blood pressure and diastolic blood pressure, between the celecoxib and naproxen treatment groups were noted.

A similar safety profile was observed in both the groups. Headache, nausea and joint aches were the most common adverse events reported in both treatment groups.

UK university develops new drug development technology

UK's De Montfort University (DMU) developed new technology to speed up and reduce the cost of drug development.

The technology was developed to offer new products and services, based on a set of proteins found in the human liver named cytochrome P450s (CYPs).

The technology is designed to provide the proteins, required for the identification of new chemical compounds that are potentially useful without being toxic to humans, in a cost-effective and convenient format.