National Cancer Institute to Come up at Jhajjar

The Centre today cleared a proposal for setting up of National Cancer Institute at the Jhajjar campus of All India
Institute of Medical Sciences (AIIMS), New Delhi, at a cost of Rs 2035 crore.
The cancer institute will be located in Badhsa village in Jhajjar of Haryana, near Delhi and will be completed in
a period of 45 months.
Approving the Health Ministry's proposal, the Union Cabinet cleared a long-pending demand of Haryana
government.
The step is being considered as a landmark in the area of cancer research in the country and shall lessen the
deficit of tertiary cancer care in the Northern region.
Cancer is emerging as a major public health concern in India, where 11 lakh new cases are diagnosed every
year and the mortality rate is 5.5 lakh per year.
Cancer treatment facilities in India are lagging behind when compared to WHO standards that requires a
radiotherapy machine per million population. India at present has 0.41 machines per million population and
the setting up of this institute will herald a new chapter in the initiative against cancer.
The Institute will have 710 beds for different facilities like surgical oncology, radiation oncology, medical
oncology, anaesthesia and palliative care and nuclear medicine. It will also have the first of its kind Tissue
Repository in India.
HSCC (India) Ltd, a public sector enterprise under the administrative control of the Health & Family Welfare
Ministry has been appointed as Project Consultant for it by AIIMS Delhi.
The National Cancer Institute will operate on the lines of NCI in USA and DKFZ in Germany as a nodal center
for indigenous research, promotive, preventive and curative aspects of care and human resource development.

The institute aims to plan, conduct and coordinate research on cancers which are more specific to India; like
tobacco related cancers, cancer of the uterine cervix, gall bladder cancer and liver cancers.
The Health Ministry note said the focus will be on understanding, analyzing causes and genesis of various
cancers. The Institute will further translate the knowledge gained to develop feasible strategies to improve
cancer care services by improvement in detection, diagnosis, treatment and quality of life of patients.
The proposed institute will broadly have clinical division, research divisions, and disease management groups
(DMGs).
These DMGs will go in to the details of all issues pertaining to management of various cancers, site wise,
besides other facilities.
The project consultant will be responsible for concept, detailed design & engineering, contracting, project
management and medical equipment procurement, installations and the commissioning of the Institute.

Source: http://www.newindianexpress.com/nation/National-Cancer-Institute-to-Come-up-at-Jhajjar/2013/12/26/article1966411.ece?service=print

Why Indian women should take cervical cancer vaccination seriously

Cervical cancer is the second most common cancer in women and is responsible for nearly 10 percent of cancer deaths in women - particularly in developing countries. In India, it kills over 74,000 women every year. Now, researchers have completed a systematic and comprehensive genomic analysis of cervical cancer in two different populations - identifying recurrent genetic mutations that were not previously found in cervical cancer. The findings also capture the role that human papillomavirus (HPV), a common viral infection of the reproductive tract, plays in the development of cervical cancer. A woman gets a cervical cancer vaccine in Netherlands. AFP. "While we don't have the complete answer yet in this case, what we are seeing is that, in two different populations, the causes of cervical cancer are similar and, fundamentally in both cases, it comes down to HPV-genome interaction,” said Matthew Meyerson, co-senior author of the paper and professor of pathology and medical oncology at Dana-Farber Cancer Institute in Boston. The team examined the genetic code in the protein-coding regions of the genome - on samples from 115 cervical cancer patients from Norway and Mexico. The study identified 13 mutations that occurred frequently enough across the samples to be considered significant in cervical cancer. Eight of these mutations had not been linked to the disease previously, and two had not previously been seen in any cancer type. In each case, the researchers compared genomic data derived from cervical cancer tumours with genomic data from healthy tissue from the same individual to determine what may have gone wrong - or mutated - in the genome to allow the cancer to develop. The mutations identified in tumours but not in healthy tissues from the same individuals are referred to as somatic mutations. “By analysing genomic data from diverse populations, we can discover patterns to disease progression in context of the full range of human genetic variation," said co-senior author Helga Salvesen. Among the most notable findings were somatic point mutations in the gene ERBB2, which was found in a small but significant subset of the tumours. Mutations in this gene, which is also known as Her-2, had not been previously been linked to cervical cancer, but it is a known oncogene common in breast cancer. Treatments exist that target the gene. The most striking finding was to learn more about how HPV - a primary risk factor for cervical cancer - is driving the disease. "Our findings further elucidate the key role HPV is playing in the development of cervical cancer, which in turn emphasises the importance of combating the disease by vaccinating against HPV," Meyerson said. The paper claimed the study bears important clinical implications for targeted therapeutics. "It is hoped that, as we combine vaccination strategies and novel targeted therapies, we will be better able to combat cervical cancer," the paper added. IANS

Read more at: http://www.firstpost.com/living/why-indian-women-should-take-cervical-cancer-vaccination-seriously-1307823.html?utm_source=ref_article

Union Cabinet to take up AIIMS cancer centre proposal tomorrow

The long-pending proposal for the setting up of the NationalCancer Institute at the second campus of the All-IndiaInstitute of Medical Sciences (AIIMS) in Haryana is likely to be taken up by the Union Cabinet at a meeting here tomorrow. 

The proposal by the Union Ministry of Health and Family Welfare entails the setting up of a 600-bed Cancer Institute on the 300-acre second campus of the premier medical institute at Badsah village in the Jhajjar area of Haryana. 

Sources said that the proposed institute would be the biggest of its kind in the country and is to be equipped with facilities for treating different forms of cancer. 

The Expenditure Finance Committee (EFC) has already given its nod to the proposal. 

The matter, which has been pending for long, has been pursued by Haryana Chief Minister Bhupinder Singh Hoodaand his MP son, Deepinder Hooda. 

The institute will have 200 beds dedicated to clinical research and another 200 for palliative care of patients in advanced stages of cancer. 

Once cleared, the existing cancer research facility at AIIMS, Delhi, too, will be shifted to the second campus, which will also house branches of medical, surgical and radiation oncology. 

New centres of nuclear medicine, preventive oncology and psycho-oncology - counselling for cancer patients - will also be set up on the Jhajjar campus. 

The institute will also have a 24x7 cancer emergency ward, sources said.

Source: http://www.business-standard.com/article/pti-stories/union-cabinet-to-take-up-aiims-cancer-centre-proposal-tomorrow-113122500668_1.html

Strand unveils image database for cancer cure

Strand Scientific Intelligence of Strand Life Sciences on Tuesday unveiled an image database for better diagnosis and treatment of cancer patients. The Bangalore-based Strand subsidiary developed the Curie Image Database (CID), an image analysis and management platform, with the Paris-based Curie-Cancer of Institut Curie, a private foundation formed by Marie Curie (1867-1935) – the first women Nobel laureate.

“We have developed the image database using our Avadis platform to enable 250 scientists at Institut Curie and 10 other collaborating institutions across Europe to manage heterogeneous imaging data and complex analysis workflows,” Strand chief executive Vijay Chandru said in a statement. Strand has built an advanced genome sequencing-based diagnostic platform for oncology.

“We will also explore with Institute Curie an advanced platform that integrates genomic signatures of cancers and imaging data for better diagnosis and treatment of cancer patients,” Chandru said. As an image management system and an interactive research tool, the CID will allow data and analysis sharing for multidisciplinary projects between teams from different labs and institutes.

“The database will be able to handle the exponential growth and complexity of scientific and biomedical images generated by advanced microscopy systems,” said Jean Salamero, scientific director of cell and tissue imaging facility at Curie-Cancer.

Funding by a French network of institutions enabled the partners (Strand & Curie) to link the database to a secure storage infrastructure for image processing on dedicated clusters. ”We have contributed to the technology developed by Strand, whose roots are in India, as such a partnership project may help treatment of cancer,” Curie-Cancer director Damien Saluze said in the statement. 

Source: http://www.theindianrepublic.com/tech/strand-unveils-image-database-cancer-cure-100017085.html

GSK bets on emerging markets with $1 billion plan to raise stake in India unit

GlaxoSmithKline Plc (GSK) has decided to spend roughly $1 billion to raise its stake in its Indian pharmaceutical unit, betting on rising demand in emerging markets as sales in developed economies slow due to a wave of patent expirations.

With the latest India deal, GSK is set to spend close to $2 billion in roughly a year to increase its holdings in two listed Indian companies, its biggest incremental investment in any country in that period.

Emerging markets such as India and Brazil are an important plank of GSK Chief Executive Officer Andrew Witty's growth strategy, as he grapples with slower uptake of the company's products in the developed world.

GSK said on Monday it plans to raise its stake in its Indian pharmaceutical unit, GlaxoSmithKline Pharmaceutical , up to as much as 75 percent from 50.7 percent through an open offer in a deal worth about 629 million pounds.

In February, GSK lifted its stake in its publicly-listed Indian consumer healthcare subsidiary, GlaxoSmithKline Consumer Healthcare Ltd , to 72.5 percent from 43.2 percent for $901 million.

"What they are trying to indicate that this market can reward them nicely in the future," said Sarabjit Kour Nangra, a sector analyst at Angel Broking. "India is a growing market and GSK cannot afford to lose its hold."

Western drugmakers like GSK, Pfizer Inc , and AstraZeneca PLC , covet a bigger share of India's fast-growing $13 billion drugs market, but have been frustrated by a series of decisions on intellectual property and pricing.

India in August revoked a patent granted to GSK for its breast cancer drug Tykerb, a decision that followed a landmark court ruling disallowing patents for incremental innovations that was a blow to global pharmaceutical firms.

Despite the challenges, western drugmakers have been looking to raise their exposure in Asia's third-largest economy betting on an increase in healthcare spending. India currently spends about 5 percent of its gross domestic product on healthcare.

"This really reflects the opportunity we see here in India, particularly the volume opportunity," said David Redfern, chief strategy officer of GSK, referring to the company decision to raise stake in the Indian unit.

"We have a broad range of medicines and vaccines and we really think over the next few years as India develops we can drive a substantial increase in volume to make more medicines and vaccines available to the Indian population."

ATTRACTIVE PREMIUM

The deal adds to the growing list of multinational companies raising their holdings in the local units as they look to reduce their reliance on traditional markets even as the Indian economy grew at its slowest pace in a decade in the last fiscal year.

Anglo-Dutch consumer goods company Unilever in July completed a deal to raise its stake in the Indian unit Hindustan Unilever to 67.28 percent from 52.48 percent in a deal worth about $3 billion.

GSK will buy up to 20.6 million shares of GlaxoSmithKline Pharmaceutical at 3,100 rupees a share, a premium of 26 percent over its closing market price on Friday. The stock rose as much as 20 percent on Monday to 2,952.15 rupees.

Nangra of Angel Broking said that the premium was attractive for investors who were planning to exit the stock in the near term, but long-term investors were likely to remain invested on future growth potential of the company.

GSK said that it planned to keep the Indian unit listed even after raising its stake.

As per Indian regulations, promoters of listed companies can hold up to a maximum 75 percent stake. If the promoter's shareholding rises beyond 75 percent, the company has to be de-listed from the bourse.

The deal will be funded by GSK's existing cash and will be earnings neutral for the first year and accretive thereafter, the company said. The tender offer will not impact expectations for the parent's long-term share buyback programme, it said.

GSK's Indian pharmaceuticals unit makes drugs for various areas including respiratory, cardiovascular, oncology, anti-infectives and dermatology. The offer is likely to begin in February and the deal is being managed by HSBC .

Source: http://www.business-standard.com/article/reuters/gsk-bets-on-emerging-markets-with-1-billion-plan-to-raise-stake-in-india-unit-113121600273_1.html

Tata Memorial Centre not utilising unds: Parliament panel

A parliamentary panel Wednesday pulled up the Tata Memorial Centre (TMC), a government institute for treatment of cancer, for not utilising funds and allowing the outlay to go waste.

"The committee takes a serious view on the matter that the approved outlay has been allowed to go waste and ultimately lapse in such a manner," the 31-member parliamentary committee said in its report tabled in parliament.

"The TMC has not been able to expand its activities despite the fact that there was no budgetary constraint.

"It has instead reiterated its routine and hackneyed reply that the Department of Atomic Energy is taking expeditious action for administrative and financial sanctions of plan projects," said the Committee on Science and Technology, Environment and Forest.

"The committee, therefore, recommends that administrative and procedural matters should in future be handled in a more proactive manner," it said.

The Mumbai-based Tata Memorial Centre is a premier institution that works for the treatment of cancer for the poor and the needy in the country.

In 1957, the union health ministry took over the Tata Memorial Hospital, a private enterprise. The administrative control of the centre was given to the Department of Atomic Energy in 1962.

"The committee feels that TMC must see its responsibilities through the prism of those who are suffering from the dreaded and deadly disease of cancer but has nobody to come to their rescue or their succour," it added.

The committee also recommended that the department of atomic energy focus its attention on research in the field of preventive oncology so that the incidence of cancer could be contained in the country.

In India, it is estimated that there are up to 2.5 million cancer patients at any given point of time with about 0.7 million new cases coming every year. Two-thirds of the new cancers are reported to be in advanced and incurable stages at the time of diagnosis.

More than 60 percent of the affected patients are in the prime of their life between the ages of 35 and 65 years.

Source: http://www.newstrackindia.com/newsdetails/2013/12/18/326--Tata-Memorial-Centre-not-utilising-unds-Parliament-panel-.html

Doctors and NGOs to draft guidelines on cancer soon

Oncologists and NGOs from across the country will draft a white paper comprising guidelines on cancer treatment and submit it to the Planning Commission at a conclave to be held in Tata Memorial Hospital, Parel after six weeks.

To create an organised structure for cancer treatment, more than 300 NGOs from across the country will be called for 'Can-India Conclave' — a conference aimed at uniting all sources for better health care facilities for cancer patients and their relatives.

"NGOs are working separately to aid cancer patients in the country. Through this conference, we will unite them under one umbrella and train them through various workshops on facility co-ordination for them. Accommodation, financial aid for treatment, food and travel will be handled separately by different NGOs under one banner," said Dr Purvish Parikh, an oncologist at TMH.

The idea was first generated on a micro-level in TMH after Shalini Jatia, a social worker, brought together independent NGOs to work in the hospital.

According to Dr Brijesh Arora, from the hospital's pediatric oncology department, the hospital receives more than 1,000 cancer patients every day, of which 80 per cent come from outside the city. "Since all NGOs have collaboration with the hospital's social work department, the relatives get a cheap place to live for the time the patient undergoes treatment. Some also receive monetary aid," he said.

Around 11 lakh people are detected with cancer every year in India. However, cancer has not been listed as a notifiable disease. "The white paper will ask for listing cancer as a notifiable disease so that the government gets a count of cancer patients in the country and can handle it better," Parekh said.

The white paper will also propose a suggestion for allowing NGOs to become implementing agencies of government funds. "Last year, out of the total funds earmarked for cancer by the central government, only half was utilised. This year Rs 3,000 crore have been allotted and not all funds have been exhausted," Parekh said.

Jatia said that since NGOs have better means of connecting with patients, they should work with the government in close association. "Cancer patients who come from weaker economic backgrounds cannot afford the expensive treatment. The collaboration of NGOs with the government will benefit these people," she said.

Source:http://www.indianexpress.com/news/doctors-and-ngos-to-draft-guidelines-on-cancer-soon/1208569/2

Merck Serono Israel incubator nurtures early stage projects

Germany’s Merck KgaA (XETRA: MRK) unit Merck Serono is one of the most active healthcare corporations in Israel. The company, which has allotted €10 million to an incubator for new Israeli companies at its R&D center in Yavne, Inter-Lab, has now added two new companies to the project: Chanbio and Metabomed.

Chanbio is engaged in the discovery of antibodies that act on ion channels in the cell, a mechanism that could help treat multiple sclerosis. It should be remembered that Merck Serono’s lead product for the treatment of multiple sclerosis, Rebif, was developed in collaboration with the Weizmann Institute of Science. The current product is in the very early development stage, but the incubator exists precisely for products like this, says Inter-Lab managing director Regine Shevach. She predicts that 7-8 more companies will join the incubator by the end of 2014.

Merck Serono Israel Bioincubator manager Simone Botti says, “Ion channels belong to an important group of disease mechanisms. This field has the potential for the development of therapies for the treatment of a wide range of diseases.

Source:http://www.globes.co.il/serveen/globes/docview.asp?did=1000901878

Drug developer Compugen sees boost from Bayer oncology deal

Israel's Compugen, which is trying to develop commercial drugs using computer models, says it could turn a profit if it can secure two or three more deals like its recent partnership with Bayer in immuno-oncology.

The company, which does not yet have a drug on the market, agreed in August to hand over the rights to two proteins known as immune checkpoint inhibitors to the German drug firm for antibody-based cancer immunotherapies.

The deal calls for Compugen to receive $10 million up front, $30 million in milestone payments for joint pre-clinical work and more than $500 million for milestones beyond the pre-clinical stage.

If the products reach the market, Compugen will receive royalties from sales.

Chief Executive Anat Cohen-Dayag said the deal was proof that the company's concept of computer modelling can work, noting its share price has doubled to $10 on Nasdaq since the deal was announced.

"With our current expenditure rate, if we sign two to three deals like the one with Bayer we will be profitable," she told Reuters.

Compugen's revenue jumped to $1.6 million in the third quarter from $108,000 a year earlier but its net loss widened to $4.7 million, from $3.5 million a year earlier.

Compugen, set up in 1993 and listed on Nasdaq in 2000, had been run more like a research institute but now needs to bring in revenue and make a profit, Cohen-Dayag said.

It has identified seven other potential immune checkpoints that present opportunities for licensing deals in oncology as well as autoimmune diseases, she said.

She declined to comment on whether Compugen was in talks with other firms on any new deals.

U.S. investment bank Leerink Swann predicts the market for immuno-oncology drugs, which is now in its infancy, will reach $29 billion by 2025 from an estimated $14 billion in 2020.

"Our business model is to discover as many candidates as possible and selectively license them to pharma companies under revenue-sharing arrangements," Cohen-Dayag said.

IMMUNE CHECKPOINTS

Compugen focuses on immuno-oncology, or harnessing the immune system to fight cancer, specifically immune checkpoints. They work by unleashing the body's immune system to enable it to recognise and attack tumour cells.

To date, Bristol-Myers Squibb's melanoma treatment Yervoy is the only drug on the market based on immune checkpoints. Additional programmes are in clinical development at Bristol-Myers, Merck, Roche and others.

Compugen also has a joint venture with Merck KGaA division Merck Serono in the discovery of biomarkers to predict drug-induced toxicity. The project is funded by Merck Serono and Compugen is entitled to royalties from the end product.

Source: http://in.reuters.com/article/2013/11/25/compugen-oncology-idINL5N0J61OI20131125

Merck Serono Announces New Publication of Results of the Phase III START Trial Investigating Tecemotide in Non-Small Cell Lung Cancer in The Lancet Oncology

Merck Serono, the biopharmaceutical division of Merck, today announced that The Lancet Oncologyhas published results from the Phase III trial of its investigational MUC1 antigen specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC), known as the START* trial.

Data included in the publication[1], and first presented at the American Society of Clinical Oncology (ASCO) 2013[2], showed that the primary endpoint of overall survival (OS) was not met. Median OS was 25.6 months for patients in the tecemotide group compared with 22.3 months for those in the placebo group (adjusted HR: 0.88, 95% CI 0.75-1.03, p=0.123). The publication includes an exploratory analysis of a predefined subgroup of patients in the START trial who received tecemotide after concurrent chemoradiotherapy (CRT).[1] Concurrent CRT is a combination of chemotherapy and radiotherapy given at the same time. Patients in this subgroup achieved a median OS of 30.8 months vs. 20.6 months in patients treated with placebo (n=806; HR: 0.78; 95% CI 0.64-0.95; p=0.016).[1]In patients receiving sequential CRT followed by tecemotide or placebo a median OS of 19.4 months was observed for the tecemotide group compared with 24.6 months for the placebo group (n=433; HR 1.12; 95% CI 0.87-1.44; p=0.38).

"These results have generated considerable interest within the scientific community and we hope that the publication will provide additional context to help inform future immuno-oncology research," said Dr. Charles Butts, Cross Cancer Institute, University of Alberta, Edmonton, Canada, clinical investigator of the START trial and member of the corresponding steering committee. "In the article we have hypothesized potential reasons why the combination with concurrent CRT demonstrated increased overall survival in START compared to combination with sequential CRT and we look forward to investigating tecemotide further to determine if it is a suitable therapeutic option that could help deliver positive outcomes for patients."

As previously announced, Merck Serono will continue the development of tecemotide under a new Phase III trial called START2, based on the results of the START trial. The START2 trial is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent CRT. Concurrent CRT is the standard of care for these patients. The trial's primary endpoint is OS. Merck has received Scientific Advice from the European Medicines Agency (EMA) on the program, and has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Phase III international randomized trial.

Dr. Annalisa Jenkins, Head of Global Head of Global Research and Development for Merck Serono, said: "The publication of the START trial confirms the interest of the scientific medical community in the potential that immunotherapy may offer for patients living with lung cancer. We continue to pursue development of tecemotide in the hope that it can potentially bring meaningful benefit for patients fighting this devastating disease."

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy designed to stimulate the body's immune system to identify and target cancer cells expressing the cell-surface glycoprotein MUC1.[3],[4] MUC1 is expressed in many cancers, including NSCLC, and has multiple roles in tumor growth and survival.[3],[5]

Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined.[6] NSCLC is the most common type of lung cancer, accounting for 80-85% of all lung cancers, and locally advanced or Stage III disease accounts for approximately 30% of patients with NSCLC.[7],[8] Unfortunately, at diagnosis, most patients have advanced or metastatic disease with a very poor prognosis.[9] There is an especially urgent and ongoing need for new approaches for patients with advanced, unresectable NSCLC.

[*] START: Stimulating Targeted Antigenic Responses To NSCLC

References

1. Butts C, et al. The Lancet Oncology 2013. Available at: http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70510-2/fulltext. Last accessed on December 9, 2013.
2. Shepherd F, et al. Poster discussion session at the European Cancer Congress 2013, September 29. Abstract No:3419.
3. Agrawal B, et al. Int Immunol 1998;10(12):1907-16.
4. Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.
5. Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.
6. Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM. GLOBOCAN 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available at:  http://globocan.iarc.fr. Last accessed on March 11, 2013.
7. D'Addario G, et al. Ann Oncol 2008;19 (suppl 2):ii39-40.
8. Crino L, et al. Ann Oncol 2010;21(suppl 5):v103-v115.
9. Bunn PA, et al. Oncologist 2008;13(suppl 1):1-4.

About tecemotide

Tecemotide is an investigational MUC1 antigen-specific cancer immunotherapy that is designed to stimulate the body's immune system to identify and target cells expressing the cell-surface glycoprotein MUC1. MUC1 is expressed in many cancers, including non-small cell lung cancer (NSCLC), and has multiple roles in tumor growth and survival. Tecemotide is currently being investigated in the Phase III START and INSPIRE trials for the treatment of unresectable, locally advanced Stage III NSCLC.

Merck obtained the exclusive worldwide rights for development and commercialization of tecemotide from Oncothyreon Inc., Seattle, Washington, U.S., in 2007, in an agreement replacing prior collaboration and supply agreements originally entered in 2001. In Japan, Merck entered into a co-development and co-marketing agreement for tecemotide with Ono Pharmaceutical Co., Ltd., Osaka, Japan.

The START2 trial is a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT). The primary endpoint of START2 trial is overall survival.

The initial Phase III trial START is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced (Stage IIIA or IIIB) NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemoradiotherapy (concurrent or sequential). The trial involves 1,239 patients in 33 countries. The primary endpoint of overall survival was not met in the START trial.

INSPIRE (tecemotide liposome vaccine trial In Asian NSCLC Patients: StimulatingImmune REsponse) is a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety and tolerability of tecemotide in patients suffering from unresectable, locally advanced Stage IIIA or IIIB NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy. The design of INSPIRE is almost identical to the START trial, however, due to the results of START, only subjects who have received concurrent CRT are being entered into INSPIRE. INSPIRE is enrolling approximately 420 unresectable, locally advanced Stage III NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

Tecemotide is currently under clinical investigation and has not been approved for use in the U.S., Europe, Canada, or elsewhere. Tecemotide has not been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.

Merck is a leading pharmaceutical, chemical and life science company with total revenues of € 11.2 billion in 2012, a history that began in 1668, and a future shaped by approx. 38,000 employees in 66 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

Source: http://pipelinereview.com/index.php/2013121052901/Vaccines/Merck-Serono-Announces-New-Publication-of-Results-of-the-Phase-III-START-Trial-Investigating-Tecemotide-in-Non-Small-Cell-Lung-Cancer-in-The-Lancet-Oncology.html

Pfizer’s Xalkori Granted Full FDA Approval for Lung Cancer Treatment, Potential Treatment for Mesothelioma Patients

The U.S. Food and Drug Administration announced last month that they have granted regular approval to the anti-cancer drug Xalkori, known generically as crizotinib, to treat patients with late-stage, metastatic non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. The FDA had previously granted accelerated approval for the drug that may also benefit mesothelioma patients. 

In order to determine if the drug will be an effective therapy, a genetic test will be performed to identify the ALK fusion gene. This test must be used to identify the ALK marker in a patient prior to a physician prescribing the twice-a-day pill. 

“XALKORI has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit, in a press release announcing the approval. “Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients.” 

Pleural mesothelioma is a rare form of lung cancer that invades the outer lining of the lungs called the mesothelium. The only known cause of mesothelioma is through inhalation or ingestion of airborne asbestos fibers.  The cancer is a diffuse malignancy that blurs the boundaries between malignant tissue and healthy tissue.  Lung cancer, however, is characterized by individual tumor masses with clear boundaries.  Even with this difference between the two pulmonary cancers, the treatments are often very similar. 

Pfizer, the maker of Xalkori, reports that about 3%-5% of people with NSCLC may test positive for the ALK fusion gene. There is a potential that the marker is also present in certain pleural mesothelioma cases making it a new treatment option for the disease. 

According to the Nov. 20 press release from the FDA, “the approval was based on demonstration of superior progression-free survival (PFS) and overall response rate (ORR) for crizotinib-treated patients compared to chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based doublet chemotherapy.”

Crizotinib, and the associated genetic test, is another step towards personalized cancer treatment that could benefit the 2,000 to 3,000 Americans diagnosed with mesothelioma each year.  Personalized care targeted to a patient’s unique characteristics and genetic makeup optimizes the potential for success of the treatment. 

Read more: http://www.mesotheliomahelp.net/blog/2013/12/pfizers-xalkori-granted-full-fda-approval-lung-cancer-treatment-potential-treatment-mesothelioma-patients#ixzz2nYkCzfxy 

Dr. Reddy’s Targets Roche’s Rituxan in Europe: Corporate India

Dr. Reddy’s Laboratories Ltd. (DRRD), India’s second-largest drugmaker, aims to be among the first three to four companies offering copies of biotechnology drugs, including a version of Roche Holding AG (ROG)’s Rituxan, in Europe.

A partnership the Hyderabad-based company struck with Merck KGaA (MRK)’s Merck Serono unit last year to develop cheaper copies of biologic cancer drugs could yield products in Europe in four years, Dr. Reddy’s Managing Director Satish Reddy said in an interview in Mumbai.

“The game-changer is biosimilars in developed markets, and since we don’t know how to do all that ourselves, we tied up with Merck Serono,” Reddy said. Making a version of rituximab, the ingredient in cancer-treatment Rituxan, is where “the big opportunity is in the developed markets, clearly; that’s where the big sales are,” he said.

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Dr. Reddy’s joins larger rivals including Novartis AG and Pfizer Inc. in the race to tap the market for biosimilar drugs, or copies of biotechnology therapies, forecast by IMS Health to grow to as much as $25 billion by 2020. The Indian drugmaker stands to benefit from its choice of partner for the biosimilar business, according to Sanford C. Bernstein & Co.’s Ronny Gal.

“German Merck actually has an oncology project on the market today -- Erbitux -- so they’ve partnered with somebody who knows what they’re doing,” said Gal, a pharmaceuticals analyst based in New York. “If Merck basically says we trust these guys, that they have a good enough product, we’re going to do the clinical trials, it’s reasonable that they’ll succeed.”

Europe First

The Indian drugmaker aims to tap the biologics market in the European Union where regulators this year approved a biosimilar monoclonal antibody, a copy of Johnson & Johnson’s rheumatoid arthritis treatment Remicade. In the U.S., the world’s biggest pharmaceuticals market, guidelines for approval of biosimilars are still not clear, according to Reddy.

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The aim of the partnership with Merck Serono is for Dr. Reddy’s to tap the German company for its knowledge of European drug regulations and clinical trials.

The companies aim to together develop, manufacture and commercialize a portfolio of four biosimilar drugs that Dr. Reddy’s already sells in India: copies of Roche’s blockbuster rituximab and Amgen Inc.’s blood-related therapies filgrastim, pegfilgrastim and darbepoetin alfa.

Rituxan is generally used to treat blood cancers.

‘Completely Change’

Dr. Reddy’s is doing early development of the molecules, while Merck Serono will manufacture the compounds and lead later-stage trials. The companies are sharing the cost of research and development.

“The tie-up should work,” Reddy said. “We should launch a product that should take significant market share. That will completely change the complexion of our playing space.”

The drugmaker, which posted profit of 16.8 billion rupees ($274 million) on sales of 116 billion rupees in the 12 months ended March, is boosting spending on development that includes clinical trials for biotechnology drugs. Generics, or copycat drugs, contributed almost 70 percent of revenue last year and the company has said it plans to make more complex products.

Dr. Reddy’s copy of rituximab, Reditux, has been available in India since 2007. Its approval has been based on smaller clinical trials than are likely to be required in Europe or the U.S, according to IMS Health.

Rituximab, marketed by Roche and Biogen Idec Inc. as Rituxan and MabThera, had sales of $6 billion last year, making it the ninth-largest pharmaceutical product in the world, according to IMS Health.

Guidelines

Roche doesn’t expect a biosimilar of Rituxan to reach the market before 2016, the Basel, Switzerland-based company said in an e-mailed statement.

Shares of Dr. Reddy’s have gained 33 percent this year in Mumbai, while the benchmark S&P BSE Sensex has added 9 percent.

The European Medicines Agency was the world’s first regulatory body to issue guidelines on biosimilars, and the World Health Organization and countries including Canada, Australia and South Africa followed the EMA’s lead.

The U.S. Food and Drug Administration hasn’t yet decided on norms on establishing the interchangeability of a biosimilar product with the original.

The global biologics market reached almost $170 billion in sales in 2012, with the U.S. accounting for 49 percent and the European Union contributing 22 percent, according to IMS Health. “Biologics market growth is still largely driven by mature markets,” Sarah Rickwood and Stefano Di Biase, analysts at the Danbury, Connecticut-based company, wrote in a report.

$25 Billion

The market for copies of the costly biotechnology therapies could grow to as much as $25 billion in 2020 from $2.5 billion in 2012, according to IMS Health.

Stada Arzneimittel AG agreed in October to sell under license in Europe Apotex Inc.’s version of filgrastim after the biosimilar received approval from the European Commission.

Still, making a copy of the Roche cancer drug could prove more challenging, Dr. Reddy’s Reddy said. “It is that much more complex compared to the growth hormones or filgrastim.”

South Korea’s Celltrion Inc. postponed a late-stage trial of its biosimilar of rituximab in April, on the advice of some state regulators.

“The development and marketing of biosimilars is quite different from that of generics and pose significant challenges for aspiring players,” IMS Health’s Rickwood and Di Biase wrote. “They require significant investment, technical capability, and clinical trial expertise.”

Source: http://www.businessweek.com/news/2013-12-11/dr-dot-reddy-s-targets-roche-s-rituxan-in-europe-corporate-india

Torrent to acquire formulation biz of Elder for Rs 2,000 cr - Express Pharma Online

Torrent to acquire formulation biz of Elder for Rs 2,000 cr - Express Pharma Online

Celon, Aurobindo in cancer, hormonal drugs joint venture

Celon Laboratories Ltd has entered a 40:60 joint venture with Aurobindo Pharma to develop, manufacture and market niche oncology and hormonal generic formulations.

Under the deal, Aurobindo and Celon, a company funded by Sequoia Capital, will incorporate a special purpose vehicle for the joint venture, called Eugia Pharma Specialities Ltd. According to a press release, the venture will market the niche products in the US and Europe markets.

Both the companies will make significant investments towards the venture. Celon will transfer to it one of its new hormonal manufacturing facilities at Biotech Park at Shamirpet here, which enables the company to file or submit products for the US and other markets from 2014 onwards.

Celon, focused on oncology, critical care and gynaecology, has research and manufacturing facilities here.

 Source: http://www.thehindubusinessline.com/companies/celon-aurobindo-in-cancer-hormonal-drugs-joint-venture/article5440905.ece

Eli Lilly enters branded generics; launches four cancer drugs | Business Standard

Eli Lilly enters branded generics; launches four cancer drugs | Business Standard

Cadila to launch new affordable lung cancer drug soon

The drug named Mycidac-C is competitively priced at Rs 40,000 for a 10-course injection. It is much cheaper than other similar drugs in the market, which could help take the drug global.

Cadila Pharma is hoping to make lung cancer treatment more affordable with the launch of its new drug this month. The drug named Mycidac-C is competitively priced at Rs 40,000 for a 10-course injection. It is much cheaper than other similar drugs in the market, which could help take the drug global.

Rajiv Modi, chairman and managing director of Cadila Pharma has his hands full. While preparing for the launch of Cadila's latest research and development (R&D) success - its non-small cell lung cancer drug - the Mycidac-C, Modi is simultaneously working on taking it global. After spending over a Rs 100 crore on developing the novel drug, the company is now aiming to launch the drug in South East Asia, Africa and Latin America. Cadila is also on the look out for a suitable oncology partner to introduce the drug in developed markets. Rajiv Modi, cmd of Cadila Pharma says we have completely de-risked the product and have conducted a fairly large clinical trial in India. But for making regulatory submissions in large markets like US, EU, Japan we are looking for a global oncology player who has more experience and expertise to take forward the global clinical trials and filings for this drug. He adds, “The first target of course is the Indian market.” India has nearly 50,000 new cases of lung cancer every year and Cadila hopes the competitively priced Mycidac-C, which is available at almost one-tenth the cost of existing therapies will be able to make a dent in the Rs 300 crore market for lung cancer drugs. “We have priced Mycidac-C at Rs.40,000 for a full course of 10 injections required during chemotherapy,” says Modi. With Cadila ready for the launch of the drug in India this month, the company says it is now progressing on its existing R&D pipeline to hunt for more novel drugs in the area of vaccines, infectious diseases and gastro-enterology.

Source: http://www.moneycontrol.com/news/cnbc-tv18-comments/cadila-to-launch-new-affordable-lung-cancer-drug-soon_1000841.html 

Gujarat pharma firms vie for share in cancer drug space

Companies like Zydus Cadila, Intas Pharma and Cadila Pharmaceuticals have come up with cancer drugs in recent times

As the anti-cancer drug market in India, estimated to be around Rs 2,000 crore in 2013, is slated to grow to Rs 3,881 crore by FY17, pharma companies are rushing to cash in on the segment.

Reflecting the global trend wherein pharma majors are trying to have enough cancer-fighting drugs in their pipeline, several Gujarat-based companies too have upped their ante to come up with new products in the segment.

Companies like Zydus Cadila, Intas Pharma and Cadila Pharmaceuticals have come up with cancer drugs in the recent times. A Mumbai-based analyst said that "While for companies this means higher revenues, for patients too, it would mean more affordable drugs."

She added that firms are focussing more on the cancer segment as it is a high-margin segment and it is slated to emerge as one of the largest therapeutic segments in the domestic market in the next five years.

According to a recent study by Frost and Sullivan, at least 8,00,000 new cancer cases come up in India every year. The country had around 2.8 million cases of all types of cancer put together in 2012.

Ahmedabad-based Intas Pharmaceuticals had launched a biosimilar version of Rituximab called Mabtas in April this year that is used in treating diseases like leukemia and rheumatoid arthritis.

A senior company official said on grounds of anonymity that, "We are working on a few more products and expect to launch at least a couple of them during 2013-14 fiscal. These would be speciality products, mainly in the area of cancer."

Biosimilars are nothing but biologic medical products whose active drug substance is made by a living organism or is derived from a living organism by means of recombinant DNA and other methods.

Companies like Zydus Cadila had developed and launched Nudoxa, a product that is used mainly for treating breast and ovarian cancer way back in 2008. The company, in fact, has a joint venture called Zydus BSV Pharma private ltd, in alliance with Bharat Serums and Vaccines Ltd which operates in the space of both novel and patented oncology product, as well as generic oncology segment by way of contract manufacturing.

The clinical trial for breast cancer product has been completed, and the company has claimed that the outcome is a favourable one. Also, the joint venture has finalised design on pivotal clinical trials and applications were submitted to the Drug Controller General of India (DCGI) during 2012-13.

A source in the company said that Zydus is close to launching a vaccine for cervical cancer in women. The human papilloma virus (HPV) causes cervical cancer, and Zydus is actively working on developing a vaccine for HPV. Trials are likely to be complete by 2014. According to experts, cervical cancer is most common in Indian women, and every one out of four women who die of cervical cancer in the world in an Indian.

Competition is getting stiff in the anti-cancer drug market in India. Local drug makers are fighting for market share with multi-national companies who have a range of patented as well as generic drugs. As for example, in the cervical cancer vaccine space, MSD Pharmaceuticals, the Indian arm of Merck & Co, and the GlaxoSmithKline market two HPV vaccines under the brand name of Gardasil and Cervarix respectively. Swiss pharma major F. Hoffmann-La Roche Ltd, which has several cancer drugs in its kitty, has cut prices of three of its key cancer drugs last year following increased competition in the Indian market.

Privately held pharma major Cadila Pharmaceuticals too has recently launched a drug for treating non-small cell lung cancer (NSCLC) called Mycidac-C which will be available in India within a month.

Roche's Avastin, which is used for similar treatment costs around Rs 37,000 for a single vial. In comparison, Cadila's Mycidac-C costs Rs 40,000 for a dose of 10 injections, or Rs 4,000 per injection. Cadila is working on coming up with more cancer therapies, however, the company did not wish to disclose further details.

Source: http://www.business-standard.com/article/companies/gujarat-pharma-firms-vie-for-share-in-cancer-drug-space-113120200335_1.html