Bulk drug exports to grow 12-14% till 2018-19

India's bulk drug exports are likely to grow at an average rate of 12-14% till 2018-19 on the back of increasing shipments to countries including the US and Europe, an Assocham study said Monday.

Of late, the exports have shifted in favour of regulated markets evidently as there has been an increase in the share of these markets to about 49% in 2013-14 from about 43% in 2008-09, the Assocham-Yes Bank joint study said.

"India's bulk drug exports are likely to grow at a CAGR of 12-14% till 2018-19, driven largely by exports to regulated markets," The Associated Chambers of Commerce and Industry of India added.

The study also said that the domestic formulations market is likely to cross $20 billion mark by 2018-19 from a level of about $11 billion in 2013-14.

"The growth story of domestic formulations market is expected to remain strong, led by better healthcare diagnostic infrastructure," it added.

Johnson & Johnson Innovation Launches JLINX

Johnson & Johnson Innovation is expanding its company incubation strategy to include a new multifaceted initiative in Europe designed to identify and nurture early-stage companies actively pursuing research with the potential to transform human health. The initiative, a collaboration with Janssen Pharmaceutica NV, Inc. (Janssen), will be called Johnson & Johnson Innovation, JLINX (JLINX) and is designed to catalyze scientific innovations by offering start-ups flexible ways to grow and collaborate across the European life science ecosystem. 

JLINX will be located in a fully dedicated facility on the Janssen campus in Beerse, Belgium, and will be managed through a close collaboration between Johnson & Johnson Innovation and bioqube ventures, which will provide independent oversight for venture funding and company selection. JLINX will provide entrepreneurs with opportunities to share ideas and collaborate with each other while accessing a unique combination of resources including investment, infrastructure, and access to relevant internal and external scientific, technical and business expertise. The new initiative is accepting applications immediately and will be fully operational by this summer.

Biocon to co-develop, produce recombinant human insulin

 

Biopharma company Biocon has tied up with Mexico's Laboratorios PiSA S.A. de C.V (PiSA) to jointly develop and sell a generic recombinant human insulin in the United States, a $2-billion market, one of the largest for insulin worldwide.

Biocon expects the insulin product by 2020 in the US, which accounts for nearly 40% share of the global $ 5 billion insulin market.

PiSA, a market leader in Mexico, is an existing partner for over a decade with Biocon. Biocon's Insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing affordable access to insulins to patients, the company said in a statement.

“The insulin market is dominated by a handful of players - Novo Nordisk, Eli Lilly and Sanofi. We believe we have the capacity and the size to play a significant role in the insulin market in the world," Kiran Mazumdar-Shaw, Biocon Chairperson and managing director told a conference call on Thursday.

"It is an expensive process. All the biosimilars development for the US market is upwards of $ 30 million. We have tied up with PiSA where we get added advantage of cost of commercialisation" she said.

Biocon has a cost and profit sharing model with PiSA, which will make the final product for the US market. The India and the upcoming Malaysian facility will produce the drug substance.

The Bengaluru-based Biocon already has over 50% market share in RH insulin in Mexico and nearly 30-40% share in southeast Asia and other Latin American markets.

“The US is the best market for RH human insulin because of the pricing. It is a over-the-counter (OTC) and institutional market. It plays well for Biocon's strength, said Shaw.

Biocon, which had completed phase three trials in Europe for the RH insulin, would now use data from the trials to develop the insulin for the US after new European guidelines made the market unattractive for the company.

"Today, the price point for RH insulin in the US is over $ 100, in India, it is a fraction of it. Obviously, development costs for the US will make it more expensive than the Indian price," said Shaw. "We see an opportunity to market it in the US with a judicious discounting of the product."

Chugai receives Orphan Drug Designation for Tocilizumab

Chugai Pharmaceutical Co announced that it received from the Minister of Health, Labour and Welfare, a notification of orphan drug designation for human anti-human IL-6 receptor monoclonal antibody "tocilizumab," a drug under development for treatment of systemic scleroderma.

Systemic scleroderma is designated as an intractable disease, by the Ministry of Health, Labour and Welfare. It manifests skin hardening, and internal organs are affected associated with its progression. Its etiology is yet to be fully elucidated. Current therapeutic options are only symptomatic in nature, such as corticosteroids and immunosuppressants and no established treatment is in place that can alleviate signs and symptoms as a whole. A new therapeutic agent with improved efficacy has been long awaited.

Chugai has been engaged in clinical development of tocilizumab as a drug for systemic scleroderma, in cooperation with its strategic alliance partner, Roche. A Phase III placebo-controlled clinical trial "focuSSced" is now under way. In February 2015, the results of the previous study, a Phase II clinical trial "faSScinate" indicated the possibility of improved efficacy of tocilizumab compared to existing drugs. Based on this finding, tocilizumab has been designated as a "Breakthrough Therapy" by the U.S. Food and Drug Administration. 

Reasons for Daraprim still costs USD 750 a pill

Since the news that Turing Pharmaceuticals had jacked up the price of the drug Daraprim by 5,000% broke in September, former CEO Martin Shkreli has become perhaps the most-hated public figure in America, resigned from his job and been arrested on civil and criminal securities fraud charges.

While much has changed in Shkreli’s life, when he testifies before the House Committee on Oversight and Government Reform on Thursday those who use Daraprim will be paying the exact same price they’ve paid for the last four months: $750 per pill. Fresh from drubbings in the press and presidential candidates, Shkreli said in late September that he would cut the cost of the drug, which cost $13.50 a pop before Turing acquired it and which many patients must take daily for years.

He didn’t say how much the price would be lowered, but it didn’t matter—he would swiftly renege on is promise. In late November, Turing announced discounts of up to 50% for hospitals—where only patients requiring hospitalization would benefit from the reduction—along with smaller, less costly bottles of the drug. The embattled biopharmaceutical company sought to portray its price hike as costly only to insurance companies and not consumers, according to documents.

The company also established patient assistance programs to take the focus away from what a 5,000% increase in price seemed likely to do to patient access, said the memo, which summarized more than 250,000 pages of Turing documents. But patients were still slapped with co-pays ranging from $1,000 to even more than $16,000, according to the memo. Access to the drug has also been impeded on the state level, where health departments—normally eligible for discounted Medicaid rates on drugs—have had difficulty gaining access, said Sean Dickson, manager of health care access at the National Alliance of State and Territorial AIDS Directors. And while hospitals can get discounted access to Daraprim, those terms are negotiated individually, and would only benefit patients getting initial treatment with the drug. 

Daraprim is used to treat parasitic infections and prevent a nervous system infection in those with HIV.

Wockhardt hits 52-week low

Shares of Wockhardt have dipped to its 52-week low at Rs 1,063, down 7% on the National Stock Exchange (NSE) in early morning trade in otherwise firm market.

Since January 15, 2016 the stock of drug maker has fallen 30% from Rs 1,515 after the US Food and Drugs Administration (FDA) raises concerns about manufacturing practices at the company’s Shendra plant in Maharashtra. The Nifty 50 index was down 0.28% during the period.

Wockhardt said that US FDA has made 9 observations for which appropriate reply would be submitted to inspecting authority in due course.

"Inspection of our manufacturing unit at E-1/1, MIDC, Shendra, Aurangabad by US FDA has since been completed. Further to inform you that Shendra manufacturing unit is a new facility and presently there are no supply of products from the said Unit to USA markets,” the company said in a regulatory filing on January 15.

Meanwhile, Wockhardt is schedule to announce its December 31, 2015 (Q3) quarter results on February 11, 2016.

At 09:56 AM, the stock was down 4.3% at Rs 1,094 as compared to 0.75% rise in Nifty 50 index. A combined 1.60 million shares changed hands on the counter on the NSE and BSE.

GSK Biologicals gets patent nod for pneumonia vaccine

GlaxoSmithKline Biologicals SA has received a favorable order from Indian Patent Office (IPO) for an invention related to improved Streptococcus Pneumonia vaccine. Patent Office, that has found out the company has removed all objections raised against the application stated ten claims submitted on 2nd June, 2015 stand granted for patent.

The company filed the application for "Comprising Streptococcus Pneumoniae Capsular Polysaccharide Conjugates' in June, 2008 and it was published on January, 2009, following which a first examination report was issued on March, 2011.In the first examination report, the Patent Office raised objections including 'claims lack novelty, inventive step and conflict with another application among others'.

The company argued claims in the application is different from that in other application it filed earlier and the claimed composition is new and provides an improved technical effect. The present invention optimises immune response elicited by different components in a pneumococal multivalent conjugate vaccine, argued the company.

The company also argued it is an object of the present invention to develop an improved formulation of a multiple serotype Streptococcus pneumoniae polysaccharide conjugate vaccine and the prior documents would not lead the skilled person to consider the particular composition of the claim to improve it and thus, the composition is novel and inventive.

After considering submissions during the hearing, Assistant Controller of Patents and Designs Abhijit Das issued an order granting the patent for ten claims submitted.
According to the documents, Streptococcus pneumoniae is the most common cause of invasive bacterial disease and Otitis media in infants and young children. Children less than two years of age do not mount an immune response to most polysaccharide vaccines, so it has been necessary to render the polysaccharides immunogenic by chemical conjugation to a protein carrier, it added.

Lupin Launches Generic Ortho Tri-Cyclen Lo Tablets

Pharma Major Lupin Limited (Lupin) announced that its US subsidiary Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of Janssen Pharmaceuticals Inc. (Janssen) Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg).

Lupin's Tri-Lo-Marzia™ Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) are the AB rated generic equivalent of Janssen Ortho Tri-Cyclen® Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg). It is indicated for use by women to prevent pregnancy.

Ortho Tri-Cyclen® Lo Tablets had US sales of USD 488.4 million (IMS MAT September 2015). The product represents Lupin’s 16th oral contraceptive launch in the US. The company has filed 37 oral contraceptive products with the FDA till date.

Sanofi Pasteur's Dengue Vaccine Approved in the Philippines

Sanofi Pasteur, the vaccines division of Sanofi, announced that the Philippines have granted marketing approval to Dengvaxia^®, making it the first vaccine to be licensed for the prevention of dengue in Asia. The Philippines' Food and Drug Administration approved Dengvaxia^®, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas.

Dengue fever burden in Asia continues to be the highest globally with an estimated 67 million people being sickened by the dengue annually.As an urban disease, dengue attacks populations of Asia in the form of unpredictable outbreaks capable of paralyzing health care systems, negatively impacting social and economic activity. Asian endemic countries spend an estimated 6.5 billion USD annually in both direct medical and indirect costs due to dengue.

Dengue is a major public health priority in tropical and subtropical countries in Asia and Latin America. Sanofi Pasteur is introducing Dengvaxia^® first in these countries where the vaccine has the greatest potential to reduce dengue burden globally and help to achieve the World Health Organization's goal to reduce dengue mortality by 50% and morbidity by 25% by 2020 in endemic countries. Sanofi Pasteur enrolled over 40,000 participants in extensive safety and clinical efficacy studies conducted mainly in endemic countries and built a dedicated vaccine production facility in France to secure adequate quality and quantity supply of the vaccine to meet endemic country demand upon introduction. 

Legal action against STADA’s Serbian subsidiary has been resolved

The insolvency administrator of Velefarm Holding as well as Velefarm VFB and the Serbian Hemofarm A.D., a subsidiary of STADA Arzneimittel AG,  on December 18, 2015 agreed on the resolution of a legal dispute. 

The settlement relates to the legal action taken by the insolvency administrator against Hemofarm, among others, in Belgrade’s commercial court in February 2014. At that time, the insolvency administrator had demanded that certain agreements and statements from the years 2010 and 2011 that had been reached between Hemofarm and companies of the Serbian wholesale group Velefarm with regard to the insolvent assets of Velefarm Holding and Velefarm VFB be declared invalid and, as a result, repayments to the insolvent assets be made.

 

Within the scope of the settlement, the insolvency administrator waives his original claim in the amount of Euro 54.2 million (in local currency) which he had filed in court. In return, Hemofarm waives most of a claim in the single-digit million euro range which was already fully impaired by STADA in 2010.

Leuplin PRO now Available in Japan

Takeda Pharmaceutical Company Limited announced that “Leuplin^® PRO for Injection Kit 22.5 mg” (hereafter 24-week depot formulation), the 24-week depot formulation of “Leuplin^®” (generic name: leuprorelin acetate), is now available in Japan for the treatment of prostate cancer and premenopausal breast cancer.

Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia. The 24-week depot formulation becomes available for the first time in the world for the treatment of premenopausal breast cancer.

The 24-week depot formulation can maintain stable blood concentration by sustained release using Takeda's unique microcapsule formulation technology through 24 weeks with a single injection. The new formulation providing sustained efficacy over a 24-week period will be a valuable addition to the available dosing options and provides the added benefit of less frequent dosing thus helping reduce the burden of treatment for patients with prostate cancer and premenopausal breast cancer.

AstraZeneca continues strategic investment in China

AstraZeneca, along with MedImmune, its global biologics research and development arm, announced a range of strategic initiatives to accelerate the delivery of innovative biologics and targeted medicines to patients in China, the company’s second largest market globally and a key growth platform. The initiatives and investments include:

• A strategic alliance with WuXi AppTec, a leading Chinese biologics manufacturer and contract research organisation, to produce innovative biologics locally in China. Under the agreement, AstraZeneca has the option to acquire WuXi AppTec’s biologics manufacturing capacity in Wuxi City in the next few years through an overall investment approximating $100 million. Prior to that, Wuxi AppTec remains the company’s exclusive partner for R&D manufacturing for innovative biologics in China.
  This strategic alliance will bring cutting-edge research and technical capability for biologics to China with the aim of addressing unmet patient needs in AstraZeneca’s main therapy areas of respiratory, inflammation and autoimmunity; cardiovascular and metabolic diseases, and oncology. The alliance builds on the existing joint venture between MedImmune and WuXi AppTec to develop and commercialise MEDI5117, a novel biologic for autoimmune and inflammatory diseases, in China.

• An investment of $50 million to build an additional development and launch facility alongside our existing manufacturing site in Wuxi City to support the development and manufacture of innovative small molecules discovered in China and our global R&D sites.
  
• Additional investments include the creation of a new global hub for Pharmaceutical Development – alongside those in the UK and Sweden - with up to 50 scientists based in Shanghai and Wuxi City, to support both China and global needs. AstraZeneca is also establishing an integrated China medicines development organisation, bringing together early and late-stage medicines development across small molecules and biologics.

Novo Nordisk files for regulatory approval of faster-acting insulin

Novo Nordisk announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.

 

Novo Nordisk expects to file the new drug application for faster-acting insulin aspart to the US Food and Drug Administration before year-end 2015.  

The filing of faster-acting insulin aspart is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoRapid^® and an HbA_1c reduction on par with NovoRapid^®. For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA_1c reduction when dosed at mealtime or similar HbA_1c reduction when dosed 20 minutes after a meal compared to NovoRapid^®. Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoRapid^®. 

AstraZeneca Plans Mobile App for Ovarian Cancer Studies

AstraZeneca announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. Voluntis has developed the service in close clinical collaboration with AstraZeneca and the US National Cancer Institute (NCI). It is delivered through a smartphone app paired with a web portal to help clinicians and patients manage side effects of hypertension and diarrhoea sometimes associated with combination therapy with cediranib and olaparib. Such side effects are traditionally described to care teams through manual, time-consuming and non-digitised channels.

The app will be tested as a companion device in three separate clinical trials sponsored by the NCI beginning in the first quarter of 2016, under a Cooperative Research and Development Agreement between the NCI and AstraZeneca. This approach illustrates a clear focus on understanding the patient journey when developing therapeutic solutions. The service will also serve as a pilot within AstraZeneca’s broader strategy of using digital technology to complement treatment and to improve patient outcomes.

Cediranib is a highly potent, selective, orally-administered inhibitor of VEGF-1, -2 and -3 receptors. It has been shown to inhibit angiogenesis and lymphangiogenesis in the vascularization of platinum sensitive tumor types. In July 2015, cediranib filing was accepted by the European Medicines agency and awarded Orphan Drug status for the treatment of platinum sensitive relapse ovarian cancer. Cediranib also in development, in combination with Lynparza (olaparib), for platinum sensitive relapse ovarian cancer and platinum resistant relapse ovarian cancer.

Olaparib is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies. Olaparib is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer, and has been launched in the U.S. and Europe, with ongoing regulatory submissions across multiple markets. In addition to ovarian cancer, AstraZeneca is investigating the full potential of olaparib in multiple tumour types, with Phase III studies in second line gastric cancer, BRCA-mutated pancreatic cancer and adjuvant and metastatic BRCA-mutated breast cancers underway.

DATING APPS spreading STDs like Syphilis, gonorrhea, AIDS

Sexually transmitted diseases like syphilis and gonorrhea seem cutely archaic in the post AIDS world -the way images of people chain-smoking in offices look strange today.So it may come as a surprise to know that the US is looking at its highest rate of syphilis infection in recent memory. In fact, the number of syphilis cases has been mounting steadily for almost a decade. In November, the US Centers for Disease Control and Prevention (CDC) released a report that said syphilis rates rose for both genders in every region of the US in 2014. “Syphilis had become relatively rare in developed countries since the discovery of penicillin and... it looked as though the United States had all but eliminated the disease,“ writes Naomi Sharp in The Atlantic. But in 2002, the downward trend began to reverse. In fact, rates of the other two members of the archaic STD trio -chlamydia and gonorrhea -have also risen simultaneously for the first time. And it might be all related to dating apps and the casual hook-up culture they promote.

Some health officials point to apps like Tinder and Grindr that facilitate casual sex between partners who don't know each other's sexual histories.Epidemiologists believe dating apps can pose a diagnostic problem, since controlling the spread of syphilis -which is notoriously difficult to pin down as a cause of illness because it mimics the symptoms of many other diseases -relies on being able to notify an infected person's sexual partners.

“It's easier to meet partners [through dating apps] and not necessarily have identifying information and not be able to track them down later,“ says a CDC doctor. She also suggests that people might be less careful now that the threat of HIV AIDS is less immediate than it was in the 1990s, or that partners might use strategies to prevent HIV transmission that aren't as effective for other STDs. Condoms, for instance, are a good precaution but not a reliable prevention method for syphilis.

INJECTABLE POLIO VACCINE SHANIPV AVAILABLE FOR INDIAN INFANTS

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first shipment of ShanIPV(TM), a brand new injectable, inactivated polio vaccine (IPV) manufactured by its affiliate Shantha Biotechnics, in Hyderabad, India, will occur in a couple of days. These first vaccine doses will be available to implement one dose of IPV in India's immunization schedule for all infants.

Today, India is officially introducing IPV in their national immunization schedule, to supplement the iconic "drops on sugar" of oral polio vaccine (OPV). Over 20 million newborns will eventually benefit from this new vaccine every year. This is a critical step towards a polio-free future, a prospect that is now very close. India's 2014 certification as polio-free reassured experts that the decades-long global fight against polio was finally drawing to an end. Sanofi Pasteur and its affiliate Shantha Biotechnics will together produce most of India's IPV supply.

Only two countries in the world are still classified as polio endemic, meaning that wild polio virus passes routinely between members of the community. However, great progress has been made in both countries and the last case of polio in the world may possibly be only months away.

Sanofi Reward Four Researchers

Sanofi and the Institut Pasteur have attributed the Sanofi - Institut Pasteur Awards for the fourth year in a row. Four major researchers with international recognition have been rewarded for their works in two major fields for global health: tropical and neglected diseases and immunology.

Doctor Marco Vignuzzi - laureate in the Junior category - Viral Populations and Pathogenesis Research Unit, Institut Pasteur, Paris, France, and CNRS researcher, for his works on viral mutations presenting a short-term epidemic potential.

Doctor Mohamed-Ali Hakimi - laureate in the Junior category - Host-Pathogen Interactions & Immunity to Infections, Institut Albert Bonniot, Université Grenoble Alpes, France, Inserm - CNRS, for his researches on the functioning of the parasite Toxoplama gondii responsible for toxoplasmosis.

Professor Keith Matthews - laureate in the Mid-career category - Center for Immunity, Infection and Evolution, School of Biological Sciences, University of Edinburgh, United Kingdom, for his researches on the parasite Trypanosama brucei responsible for sleeping sickness.

Professor Emil Unanue - laureate in the Senior category - Department of Pathology and Immunology, Washington University School of Medicine, Saint Louis, USA, for his work on the recognition of proteins by the immune system, paving the way to the research of therapies against autoimmune diseases such as type 1 diabetes, multiple sclerosis or rheumatoid polyarthritis.

Global Analysis Of Metastatic Breast Cancer

Pfizer Inc., working collaboratively with the European School of Oncology (ESO), within the scope of the Advanced Breast Cancer Third International Consensus Conference (ABC3), released the Global Status of Metastatic Breast Cancer (MBC): A 2005 – 2015 Decade Report, which revealed both areas of improvement and substantial gaps in care, access to resources and support, and treatment outcomes for women with MBC.

MBC is the most advanced stage of breast cancer for which there is no cure. Further, public health experts estimate there will be a 43 percent increase in breast cancer related deaths globally from 2015 to 2030, the majority of which are a result of metastatic disease. Previous research has shown that women with MBC have distinct needs that are not often addressed and there are fewer patient and community resources available for these women compared with those for women with early-stage disease.

Over the past decade - due to the collective efforts of the broader breast cancer community - some progress has been made to address the unique needs of women with MBC. However, there is still a great deal of improvement that needs to be made in this area. The findings from theGlobal Status of MBC: A Decade Report reinforce the urgent need for change in MBC care, patient support, research and the important role increased disease awareness can play.

Primary Survey Highlights

Three new studies evaluating the current state of breast cancer from the perspective of breast cancer care centers, patient support organizations and the general population found:

• More than half of 582 surveyed oncologists and other healthcare practitioners in the U.S., Europe, Latin America and Australia, report that they have not been trained on how to effectively deliver difficult information to their patients and have a desire for more training.
• The majority of the 50 interviewed patient support organizations in North America, Europe, Asia Pacific, Latin America, Africa and the Middle East, recognize women with MBC require more support than those with early-stage disease, but report a range of barriers that can impact efforts to meet patient needs, including limited resources, cultural views and logistics.
• There is a global lack of familiarity with metastatic or advanced breast cancer among the general public leading to widespread misperceptions about the disease, according to a survey of more than 14,000 people in 14 countries throughout Europe, Latin America, the Middle East, Africa and the Asia Pacific.
  • The survey also found that among the general public, approximately 1 out of 5 people believe that those with metastatic breast cancer should keep their diagnosis a secret and not discuss their disease with anyone other than their physician, potentially contributing to the stigma that is associated with MBC and leading to feelings of isolation by the patient.

These findings reinforce results from a 2014 survey conducted by Pfizer and breast cancer leaders in the United States that found the majority of Americans (60%) know little to nothing about MBC.

Secondary Analysis Highlights

An analysis of more than 3,000 previously published articles and abstracts identified key limitations to progress for women with MBC over the past decade relating to patient care, the environmental landscape and scientific research, including:

• Despite the benefits of supportive and palliative care to the quality of life for patients, implementation of supportive care has been variable across certain countries and significant gaps remain.
• Better psychological support for women with MBC is needed to ease the end-of-life care experience, particularly when it comes to anxieties about what they may experience.
• There has not been a significant improvement in the quality of life for women with MBC in more than a decade, and there has even been a slight decrease since 2004.
• The pace of innovation in MBC appears to have slowed in recent years with treatment advances, clinical research, publications and guideline development, particularly when compared with other tumor types, such as melanoma and lung cancer.

Grifols agrees long term loan with the European Investment Bank

Grifols one of the world's largest plasma product manufacturers and a pioneer in the research and development of therapeutic alternatives designed to contribute to both scientific and social development, has agreed a loan for 100 million euros with the European Investment Bank (EIB) following conclusion of financial and legal negotiations, including due diligence.

 

Grifols will use the EIB loan to support its investment in R&D, focusing primarily on the search for new indications for plasma proteins, including the treatment of Alzheimer's disease, vascular diseases, cardiovascular surgery and arterial thrombosis, amongst others.

Grifols is one of the first European companies to receive a loan from the new European Fund for Strategic Investments (EFSI), also known as the Juncker Plan. This is an initiative supported by the EIB and the European Commission, with the aim of reactivating investment in strategic projects throughout Europe, and its objectives include strengthening R&D in European companies.

Grifols hopes that its successful engagement with the EIB will encourage other Spanish companies to consider this source of funding for their projects.

Bayer’s Eye Drug Recommended for EU Approval

The European Committee for Medicinal Products for Human Use (CHMP) has recommended aflibercept solution for injection into the eye for the treatment of visual impairment due to myopic choroidal neovascularization for approval in the EU. Myopic CNV is a disease of the retina associated with high degrees of myopia (near-sightedness) and frequently affects people of working age. It is a common cause of blindness in near-sighted subjects worldwide.

The CHMP's positive recommendation is based on the results of the Phase 3 MYRROR study in patients with myopic CNV. Patients receiving aflibercept solution for injection had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of 12.1 letters, while patients receiving sham injections lost two letters (p<0.0001), as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard instrument used in medical research to measure visual acuity. The efficacy gains seen at week 24 were maintained and even extended further in the aflibercept arm until week 48.

Myopic choroidal neovascularization (mCNV) is a disease of the retina in persons who are severely myopic (typically at least minus six diopters) and have pathological changes in the back of the eye. The disease is characterized by an abnormally elongated eye with a physical stretching of the sclera, choroid and retina, resulting in degenerative and progressive changes. These degenerative changes can induce the development of choroidal neovascularization. Anti-VEGF therapy has already been shown to be effective in the treatment of wet age-related macular degeneration (wet AMD), which is also characterized by an acute growth of new, abnormal blood vessels in the retina.