Pharmacy benefits management companies have emerged as the national standard for the management of prescription drugs in the United States. The objective of this study was to estimate the annual costs per treated patient of 8 biologics indicated for select immune-mediated inflammatory diseases: moderate to severe rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis.
Using the Medco pharmacy benefits-management database, data from patients aged 18 to 63 years with ≥1 claim for abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, or ustekinumab, dated between January 1, 2008 and August 31, 2011, were collected. Eligible patients were continuously enrolled for ≥180 days before and 360 days after the date of the first biologic claim (index date), and had ≥1 claim associated with a diagnosis of rheumatoid arthritis, moderate to severe plaque psoriasis, active psoriatic arthritis, and/or active ankylosing spondylitis in the 180 days before or 30 days after the index date. The annual total costs per treated patient were calculated as the total dose of the index biologic and all other biologics for which there was a claim in the postindex period, multiplied by the wholesale acquisition cost as of October 1, 2013, plus the costs associated with administrations (calculated as number of infusions multiplied by the 2013 Medicare Physician Fee Schedule costs).
Within the study population (N = 8306; 5356 (64.5%) women, 2950 men (35.5%), average age: 42.3 years (SD: 10.0)), the most commonly used biologics were etanercept (43.1%), adalimumab (31.0%), and infliximab (17.0%), which accounted for 91.1% of all biologic prescriptions. Total costs per treated patient across indications were as follows: adalimumab, $23,427 to $26,304; infliximab, $22,824 to $28,907; and etanercept, $21,468 to $27,748, whereas abatacept, certolizumab, golimumab, rituximab, and ustekinumab were associated with a larger range: $17,017 to $41,888.
The present study provides insight into the prescribing patterns and cost differences among 8 biologic agents used for the treatment of immune-mediated inflammatory diseases. This information may prove useful when designing a pharmacy benefits-management formulary.
Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

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Hyponatraemia (HN; serum sodium level < 135 mmol/l) is the most common electrolyte disturbance seen in clinical practice, and is associated with varying spectrum of symptoms. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the most common aetiology in hospitalised patients, and can be caused by several different underlying conditions.
The objectives of this study were to retrospectively examine the baseline characteristics, clinical outcomes and hospital resource utilisation of patients with HN and/or SIADH in Sweden over a 10-year period from 2001 to 2011. Additional analysis was performed on subpopulations of patients with hip fracture, pneumonia and small cell lung cancer (SCLC) to see if trends in outcomes were consistent across a broad range of aetiologies commonly associated with the condition.
Patient information was taken from the Swedish National Patient Registry, the Swedish Cancer Registry, the Swedish Cause of Death Register and the Swedish Prescribed Drug Register. A total of 34,537 patients (4.38%) were identified with HN and/or SIADH, with the incidence and prevalence rising over the 10-year study period.
Of the 34,537 patients identified, 841 had hip fracture, 2635 had pneumonia and 106 had SCLC. Compared with matched control patients, those with HN and/or SIADH had a longer length of hospital stay, a higher re-admission rate and a shorter time to re-admission.
This study showed that HN and/or SIADH negatively impact patient outcomes and healthcare resources related to hospital stay irrespective of the underlying cause. The impact of HN is not confined to the initial hospitalisation, as re-admission rates are also affected.
© 2016 John Wiley & Sons Ltd.

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On March 22, 2016 IntelGenx Corp. (TSX-V: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported financial results for the three and twelve-month periods ended December 31, 2015. All amounts are in U.S. Dollars unless otherwise stated (Filing, Q4/Annual, IntelGenx, 2015, MAR 22, 2016, View Source [SID:1234509840]).

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2015 Fourth Quarter Financial Highlights:

• Revenues reached $1.5 million, an increase of 82% over the same period last year

• Net comprehensive income was $233 thousand, compared to a net comprehensive loss of ($339 thousand) over the same period last year

• Adjusted EBITDA was $429 thousand, compared to a negative ($225 thousand) over the same period last year

• Cash and cash equivalents totaled $2.87 million as at December 31, 2015

2015 Twelve-Month Financial Highlights:

• Revenue was $5.1 million, an increase of 207% over the same period last year

• Net comprehensive income was $800 thousand, compared to a net comprehensive loss of ($2.2 million) over the same period last year

• Adjusted EBITDA was $1.7 million, compared to a negative ($1.6 million) over the same period last year

Recent Operational Highlights:

• Net sales of Forfivo XL continued to improve significantly in the fourth quarter of 2015 by 24% to $3 million ($5.4 million gross) compared to the third quarter of 2015

• For the past twelve months, net sales of Forfivo XL totaled $9.3 million ($17.4 million gross), an increase of 102% compared to the twelve-month period in 2014

• Received the remaining $2 million milestone payment from Edgemont Pharmaceuticals

• Construction completed of IntelGenx’ new state-of-the-art manufacturing and laboratory facilities which are expected to be fully operational by 2017

"We are most pleased with the record results and progress we have made as an organization in 2015," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "Our continued sales growth of Forfivo has enabled us to achieve two consecutive quarters of profitability. We have invested these profits back into transforming IntelGenx by building a stronger management team with the clear goal of accelerating the execution of our business plan coupled with the completion of the construction of our state-of-the-art manufacturing facilities. Both these strategic initiatives will enable us to become a global leader in pharmaceutical oral film development and manufacturing."

Financial Results:

Total revenues for the three-month period ended December 31, 2015 amounted to $1.5 million, representing an increase of $677 thousand or 82% compared to $825 thousand for the three-month period ended December 31, 2014. Total revenues for the twelve-month period ended December 31, 2015 amounted to $5.1 million representing an increase of $3.4 million or 207% compared to $1.7 million for the twelve-month period ended December 31, 2014. The increases for the three-month and twelve-month periods ended December 31, 2015 compared to the last year’s corresponding periods are mainly attributable to the attainment of milestones, totaling $2.7 million from IntelGenx’ licensing partner Edgemont. The milestone was triggered by Edgemont reaching in July 2015, $7 million of cumulative net trade sales of Forfivo XL over the preceding 12 months. From the $2.7 million milestones, $1 million was received in the third quarter. From the remaining balance, $1 million was received in the fourth quarter and $1 million was received in the first quarter of 2016, with revenue to be recognized in the first quarter of 2016 of $333 thousand. Nevertheless, 3/6 of the $2 million was recognized as revenue in the fourth quarter and 5/6 of the $2 million was recognized as revenue in the twelve-month period ended December 31, 2015.

Operating costs and expenses were $3.71 million for the twelve-month period of 2015, versus $3.44 million for the corresponding period of 2014.

For the twelve-month period of 2015, the Company generated operating income of $1.4 million compared to an operating loss of ($1.8 million) for the comparable period of 2014.

Net comprehensive income was $800 thousand or $0.01 on a basic and diluted per share basis for the twelve-month period of 2015 compared to a net comprehensive loss of ($2.2 million) or ($0.03) on a basic and diluted per share basis for the comparable period of 2014.

"We are focused on a strong financial discipline in managing our expenses and ensuring high standards of financial controls be implemented throughout the organization," said Mr. Andre Godin, Executive Vice-President and CFO of IntelGenx. "We are committed to working at building the visibility of the corporation in the marketplace."

Cash on hand as at December 31, 2015 was $2.87 million, representing a decrease of ($1.53 million) compared with the balance of $4.4 million as at December 31, 2014. The decrease in cash relates primarily to the investments made into our state-of-the-art manufacturing and laboratory facilities.

It is challenging to evaluate how tumour pathophysiology influences nanomedicine therapeutic effect; however, this is a key question in drug delivery. An advanced analytical method was developed to quantify the spatial distribution of drug-induced effect in tumours with varied stromal morphologies. The analysis utilises standard immunohistochemistry images and quantifies the frequency of positive staining as a function of distance from the stroma. Two stromal morphologies – Estuary and Tumour Island – were classified in 28 tumours from a lung cancer explant model in mice treated with liposomal doxorubicin. Analysis demonstrated that Estuary-like tumours presented a highly convoluted tumour-stroma interface, with most tumour cells in close proximity to vessels; these tumours were 8.8-fold more responsive to liposomal doxorubicin than were Tumour Island-like tumours, which were nearly unresponsive to liposomal doxorubicin. SDARS analysis allows the relative treatment effect to be assessed in tumours individually, and enables investigation of nanomedicine delivery in complex tumour pathophysiologies.
Advances in nanotechnology have brought about many novel treatment modalities for cancer. Nonetheless, there is no standard evaluation technique for tumor cells’ drug response. The authors here utilized patient-derived tumour xenograft (PDTX) models to have a more translatable pre-clinical evaluation platform for nanomedicine drugs. They then used advanced imaging acquisition technique to analyze tumor stromal morphology, which they named Spatial Distribution of Apoptosis Relative to Stroma (SDARS). The findings would have significant clinical impact as it would help predict the eventual clinical drug response.
Copyright © 2015 Elsevier Inc. All rights reserved.

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Polymer-drug conjugates (PDCs) are drug delivery systems where one or more drug(s) are covalently attached to the functional groups of the polymer directly or through a spacer. Several anticancer drugs that have been used to synthesize PDCs are currently under clinical trials. PDCs have shown enhanced tumor accumulation, increased therapeutic index, and prolonged circulation, accompanied by a sustained release of the bound drug. Distinct cell uptake mechanisms make PDCs less sensitive to efflux pumps associated with the development of multi-drug resistance. However, the effectiveness of PDCs as a delivery system primarily depends on the drug, polymer, type of linkage, and presence of targeting groups. Due to the availability of different functional groups and spacers, it is possible to control drug release as well as multi-functionalize PDCs, thereby increasing their versatility as drug carriers. Furthermore, active tumor uptake may be achieved by using the concept of drug targeting. However, functionalization alters the in vivo behavior of the polymer, signifying the evaluation of safety and effectiveness of PDCs. Several PDCs are currently being tested in different phases of clinical trials. This review focuses on critical aspects in the design of PDCs when used in cancer drug delivery.

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