Sanofi net moves up by 9% to € 2.7 bn in Q3

Sanofi, a French pharma giant, has posted satisfactory performance during the third quarter ended September 2014 and its net profit increased by 9.3 per cent to € 2,716 million from €2,484 million in the corresponding period of last year. Its net sales grew by 4.1 per cent to €8,781 million from €8,432 million. EPS improved to €1.47 from €1.36 in the last period. Its R&D expenditure declined by 3 per cent to €1,146 million reflecting lower spend on oncology.

Christopher A Viehbacher, CEO, said, “We are pleased with our performance in the third quarter. We achieved solid business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78 per cent of sales and grew 10 per cent. We have recently seen a more challenging US diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in phase III as well as the FDA approval of Cerdelga and the licensing of Afrezza.”

Mexichem swings to profit

Mexichem (Tlalnepantla, Mexico) swung to profit, reporting net income of $52.8 million during the third quarter compared with a net loss of $62.8 million in the same period last year, according to the company's latest unaudited results.

This increase was primarily due to the impact of discontinued operations in the fluorine chain on last year's results. The company's consolidated net income from continuing operations contracted 47% year-on-year (YOY) in the third quarter, to $47.3 million from $88.9 million one year prior.

Bio-based chemicals to attract $1 bn investment

The bio-based materials and chemicals industry is poised to attract nearly $1 billion in investment this year, led notably by later-stage funding rounds, according to Lux Research. The estimated $974 million investment represents a 28% increase from 2013, suggesting companies that endured the waves of economic disruption have gained maturity and regained investors’ confidence.

“Over the last two years, funding for bio-based materials and chemicals has shifted decisively toward later-stage rounds, reflecting the growing maturing of the industry and the shift from R&D to production,” said Meraldo Antonio, Lux Research Associate and the lead author of the report titled, ‘Dynamics of venture capital funding in the bio-based chemicals industry’

Octapharma adds track & trace solution to Werum's PAS-X at their Vienna site

Octapharma, one of the largest independent manufacturers of human protein products worldwide, has added the PAS-X Track & Trace Serialization Aggregation solution to Werum's PAS-X at their production site in Vienna.

Octapharma has been committed to patient care and medical innovation for over 30 years. Its core business is the development, production and sale of human proteins from human plasma and human cell-lines. Patients in over 100 countries are treated with products in the areas of haematology, immunotherapy and critical care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.

Octapharma employs strict in-process quality control systems to ensure traceability, providing the complete documentation of the origin of all plasma donations, their processing and distribution to countries worldwide. The company requires a flexible and stringently validated system for marking, identifying and tracking their products.

In a first step, PAS-X Track & Trace will be operated in the packaging area for the Chinese market. The serialization data provided by the Chinese authorities are loaded and the used data are reported back. PAS-X Track & Trace is interfaced to the existing PAS-X and exchanges order and stock data with the MES.

ndoco Remedies net jumps by 40% to Rs.22.41 cr in Q2

Indoco Remedies, a Rs.700 crore plus pharma major from Mumbai, has posted satisfactory performance during the second quarter ended September 2014 and its net profit moved up by 39.7 per cent to Rs.22.41 crore from Rs.16.04 crore in the corresponding period of last year. Its EBDITA also improved sharply by 73.9 per cent to Rs.49.19 crore from Rs.33.44 crore. The company's standalone net sales improved by 16.1 per cent to Rs.226.42 crore from Rs.195.05 crore. With higher profit, its EPS worked out to Rs.2.43 as compared to Rs.1.74 in the last period.

The company's domestic sales increased to Rs.144.69 crore from Rs.127.59 crore, a growth of 13.4 per cent and its international sales went up by 21.2 per cent to Rs.81.73 crore from Rs.67.46 crore. The company launched six new products in the domestic market. Indoco's European sales contributed 61.9 per cent and US sales 21.9 per cent to its international sales.

BIRAC invites fresh proposals from biotech companies

The Biotechnology Industry Research Assistance Council (BIRAC), under its advanced technology scheme, Biotechnology Industry Partnership Programme (BIPP), has invited fresh proposals from biotech companies for support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of Start-ups and SMEs in key areas of national importance and public good.

BIRAC, a not-for-profit public sector undertaking set up by Department of Biotechnology (DBT), is running this scheme to promote and nurture innovation research in biotech enterprises specially start-ups and SMEs. Major thrust of the programme is towards funding technologies which address a major national problem and/or involves high level of innovation. The proposals spanning across the spectrum of pre-proof-of-concept to validation of established technologies are considered for support in the form of grant and/or loan.

The scheme supports large, medium, small scale companies as well as start-up on cost sharing basis. It would push for high risk, discovery linked innovation and accelerated technology development. Varying models of grants, loans or grant plus loans will be made available under the scheme.  It will be one of the most enabling mechanisms to promote R&D in biotech industry and public private partnership programmes.

US FDA approves Konica Minolta's AeroDR XE wireless digital

Konica Minolta Medical Imaging, a world class provider and market leader in medical diagnostic primary imaging, has received the US Food and Drug Administration (FDA) clearance for its new AeroDR XE wireless digital radiography solution.

Healthcare providers in the demanding ER/Trauma rooms and ICU/CCU units need simple, reliable, and robust primary imaging solutions that deliver the information they need to make important patient care decisions quickly and confidently.

To address the needs of these fast-paced, extreme environments, Konica Minolta offers the simple yet powerful AeroDR XE, the lightest DR panel available today. Designed to provide unparalleled reliability and high-capacity imaging in extreme "on the go" environments the robust and highly durable AeroDR XE is also ideal for teaching hospitals, portable use and at the bedside.

Built to endure the rigors of extreme imaging environments outside the radiology department, the AeroDR XE combines the industry's most robust wireless DR panel with a simple yet powerful software interface.  As a result, users benefit from the best weight-to-load ratio – up to 661 lbs – and the highest bend and liquid resistance on the market. Weighing only 5.7 lbs, the AeroDR XE is the lightest panel on the market and easiest to handle.

Baxter International net dips by 14% to $468 mn in Q3

Baxter International net profit declined by 14 per cent during the third quarter ended September 2014 to $468 million from $544 million in the corresponding period of last year despite its net sales improved by 13 per cent to $4,197 million from $3,710 million.

These results reflect the income contribution from the vaccines franchise of $21 million and after-tax special items totaling $273 million primarily for intangible amortization and costs associated with upfront and product development milestone payments, integration of the company's acquisition of Gambro AB, and Baxter's planned separation.

Sales within the United States of $1.8 billion rose 7 per cent, while international sales of $2.4 billion increased 18 per cent. Including discontinued vaccines revenues, Baxter's global sales advanced 13 per cent to $4.3 billion and when also adjusting both periods for the contribution of Gambro, Baxter's sales rose 5 per cent, which was at the higher-end of the company's previously-issued guidance. Foreign currency did not have a material impact on sales growth in the quarter.

BioScience revenues of $1.7 billion grew 8 per cent from the prior-year period driven primarily by double-digit growth and continued strong demand for the company's hemophilia therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] and FEIBA (an inhibitor therapy), as well as the benefit from government collaborations and the timing of international tenders. BioScience sales, including vaccines, rose 7 per cent.

MorphoSys buys Lanthio Pharma's lanthipeptide technology

MorphoSys AG, a leading biotechnology companies focusing on fully human antibodies, and Lanthio Pharma, a privately held drug discovery company, announced the acquisition of Lanthio Pharma's lanthipeptide technology, which will be used for drug discovery by MorphoSys.

The acquisition was triggered by MorphoSys exercising an option within an ongoing collaboration and option agreement between the two companies. By exercising the option, MorphoSys takes over the lanthipeptide technology and all related intellectual property. Lanthio Pharma will continue to focus on building its portfolio of selected lanthipeptide drugs and will participate financially in MorphoSys's exploitation of the technology. Financial details were not disclosed.

"Lanthipeptides can become a complementary addition to our therapeutic antibody pipeline and will add more diversity to our drug discovery and development approaches," commented Dr. Marlies Sproll, chief scientific officer of MorphoSys AG. "The decision to acquire this technology was made following a feasibility study to establish high quality and diverse lanthipeptide-based libraries. This brings us closer to adding members of this class of stabilized peptides to our drug portfolio."

As part of its innovation capital initiative, MorphoSys entered a collaboration and option agreement with Lanthio Pharma in November 2012, which included an equity investment as part of the company's Series A financing round.

Chain of events that leads to Alzheimer’s disease

Scientists have for the first time replicated the full course of events underlying the development of Alzheimer's disease inside a lab. A novel 3D culture system replicates the course of Alzheimer's, which doctors feel could significantly reduce time and cost of drug development.

Researchers from the Massachusetts General Hospital in Boston showed that the deposition of beta-amyloid plaques in the brain is the first step in a cascade leading to the devastating neurodegenerative disease. They also identified the essential role in that process of an enzyme, inhibition of which could be a therapeutic target.

The MGH team used a gel-based, 3D culture system to grow human neural stem cells that carried variants in two genes — the amyloid precursor protein and presenilin 1 — known to underlie early-onset Familial Alzheimer's Disease (FAD). Both the genes were co-discovered in lead researcher Rudolph E Tanzi's laboratory.

Novartis receives NPPA notice imposing Rs 300-cr penalty for overcharging

The National Pharmaceutical Pricing Authority (NPPA) has slapped a Rs 300-crore fine on Swiss multinational Novartis for overcharging consumers on sale of Voveran, its best-selling painkiller medicine, according to a Business Standard report.

Voveran is based on diclofenac, a component that is under the government's direct price control, adds the report. According to IMS Health annual data, Voveran, with annual sales of about Rs 225 crore, was among the top 10 brands in the domestic drug retail market as of April this year

B Braun to distribute BSmart injection pressure monitor for PNBs

B. Braun Medical, the market leader in Regional Anaesthesia (RA),announced that it will become the exclusive US distributor of the BSmart injection pressure monitor for peripheral nerve blocks (PNBs) from Concert Medical, LLC. BSmart is the first disposable monitor for measuring of injection pressure during administration of PNBs.

“We want to be the customer’s first choice for delivering RA safely and effectively,” said Joe Cleary, group product director of pain control marketing at B.Braun. “In the coming months, B.Braun will highlight ways to integrate complementary monitoring modalities (injection pressure, ultrasound and stimulation) and share the benefits. We call it ISM, or Injection Safety Monitoring,” added Cleary.

Practitioners already document resistance to injection, however, objective pressure monitoring is a relatively new concept.

Isis Pharma earns $18 mn milestone payment from GSK for advancing phase 2/3 study of ISIS-TTRRx

Isis Pharmaceuticals announced that the company has earned an $18 million milestone payment from GlaxoSmithKline (GSK) related to the advancement of the phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy (FAP).

"ISIS-TTRRx is the most advanced drug in our collaboration with GSK, and aside from Kynamro, it is also the furthest advanced in our late-stage clinical pipeline.  We have patients who have completed fifteen months of therapy and are now receiving ISIS-TTRRx in our open-label extension study," said B. Lynne Parshall, chief operating officer at Isis.  "The rapid development of ISIS-TTRRx from a research-stage programme to a drug in a late-stage clinical trial is a testament to the efficiency and productivity of our drug discovery technology platform.  As this programme advances, we will continue to benefit from GSK's resources and expertise as well as earn additional milestone payments."

Bristol-Myers Squibb withdraws asunaprevir NDA from US FDA

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the US, Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration (US FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an

Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. For example, in Japan we were pleased to receive regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.

NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

Nitto Denko starts patient dosing in phase 1b study of new anti-fibrosis drug in US

Nitto Denko Corporation announces the initiation of a phase-1b clinical study in the US started on September 2014, to administer a new anti-fibrosis drug in patients for the assessment of safety and efficacy.

Nitto has been developing an RNAi based drug for treating fibrosis in the liver and other organs since 2008 in collaboration with Sapporo Medical University and Hokkaido University. In March 2014, a phase-1 clinical study in healthy volunteers was completed and no remarkable adverse events were observed, even at the highest dose tested. After thorough analysis of the data, the study results were summarised in a Clinical Study Report which concluded that the drug was safe and well tolerated. These results served as the basis of the phase-1b clinical study plan.

The clinical study plan has been approved by a central Institutional Review Board (IRB). This allows Nitto to initiate the phase-1b clinical study in subjects with moderate to severe liver fibrosis for the assessment of safety and efficacy of the drug. Following the start of the US study, Nitto will also conduct a clinical study in Japan

Sagent Pharma recalls - ketorolac tromethamine inj due to incorrect labels

Sagent Pharmaceuticals, a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, announced the voluntary nationwide recall of three lots of ketorolac tromethamine injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent.

Sagent has initiated this voluntary recall of ketorolac tromethamine injection, USP, 30mg/mL to the user level due to labelling the product with the incorrect expiration date. The labelled expiration date is longer than the known stability of the product.

Sagent is not aware of any adverse patient events resulting from the use of this product.

Cell Cure seeks US FDA permission to begin phase I/IIa

HBL Hadasit Bio-Holdings Ltd., and Cell Cure Neurosciences Ltd. (Cell Cure) announced that Cell Cure has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) seeking to initiate a phase I/IIa clinical trial of OpRegen in patients with geographic atrophy (GA), the advanced stage of the dry form of age-related macular degeneration (dry-AMD).

OpRegen consists of retinal pigment epithelial (RPE) cells derived from human embryonic stem cells and is intended to be administered as a single dose into the subretinal space of patients’ eyes in order to treat this leading cause of visual impairment.

The design of the proposed clinical trial, “Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy,” is based on a pre-IND meeting with the FDA.. Patients will undergo a single transplantation and the study will explore three different doses of OpRegen. Following transplantation, the patients will be followed over 12 months at specified intervals and then at longer time periods, to evaluate the safety and tolerability of the product. A secondary objective of the clinical trial will be to explore the ability of transplanted OpRegen to moderate the disease progression.

GSK announces $5 mn Fund to advance bioelectronic medicines research

GSK announced a $5 million Innovation Challenge Fund (ICF) to further encourage and advance collaborative research as part of its effort to develop bioelectronic medicines. The fund will support academic groups and small companies who want to develop solutions for GSK’s Bioelectronics Innovation Challenge, which was developed by a group of leading scientists from around the world. This funding programme is in addition to GSK’s prior commitment of a $1 million award, announced in December 2013, for the team that first solves the Challenge.

Bioelectronic medicine is a relatively new scientific field which could one day result in a new class of treatments that would not be pills or injections but miniaturised, implantable devices. The hope is that these devices could be programmed to read and correct the electrical signals that pass along the nerves of the body, to treat disorders as diverse as inflammatory bowel disease, arthritis, asthma, hypertension and diabetes. Since 2013, GSK has committed significant resource to research in this field.