Pfizer, Merck ink pact to explore potential of combo of Xalkori and pembrolizumab

Pfizer and Merck & Co., known as MSD outside the United States and Canada, through a subsidiary, have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (Xalkori) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).  The financial terms of the agreement were not disclosed.

“This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology.  “Understanding the effects of combining one drug, Xalkori, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body’s immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients.”

This multi-centre, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study.

“We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck’s investigational immunotherapy pembrolizumab,” said Dr. Eric Rubin, vice president, Oncology, Merck Research Laboratories.  “Evidence from early studies of pembrolizumab monotherapy together with Xalkori’s proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer.

Argentina govt allows imports formulations from India

Argentinian government issued a notification permitting import of generic formulations from Indian pharmaceutical exporters. With this India becomes the 27th country to supply generic formulations to Argentina, a highly regulated market, further establishing India's expertise in this field and proving the capabilities of Indian manufacturers as a supplier of high quality raw materials at the global platform.

For the last 15 years, Argentina imported generic formulations from only 26 countries, listed with them and this move comes as an outcome of the huge effort put by the commerce ministry who had been successful in projecting the qualities of the Indian formulators.

Dr P V Appaji, director general of Pharmexcil, the commerce ministry have been ardently pushing for this matter on behalf of the industry with the Argentinian government, by sending delegates from the ministry and industry to pursue this matter at the earnest with their Argentinian counterparts.

AstraZeneca partners with Illumina to develop next generation

AstraZeneca has entered into a collaboration with gene sequencing company, Illumina, Inc., to develop its next generation sequencing (NGS) platform for companion diagnostic tests applicable across AstraZeneca’s oncology portfolio.

In the first instance, AstraZeneca intends to apply Illumina’s cutting-edge technology to a novel companion diagnostic test in pivotal studies for one of its investigational oncology compounds. This is expected to be one of the first NGS-based companion diagnostic tests for a novel drug in the world, and its application could speed the clinical trial process.

Illumina’s NGS technology allows rapid sequencing of multiple genes in a much faster and cheaper way than traditional DNA sequencing methods. Under the collaboration, it will be used to screen a panel of several gene sequences, scanning for all possible genetic variants — known and unknown — rather than specified mutations from a single tumour sample.

Clinigen buys global rights to oncology support therapy, Ethyol from AstraZeneca

Clinigen Group plc, a specialty global pharmaceutical company, has announced the acquisition of the global rights to the oncology support therapy, Ethyol (amifostine) from AstraZeneca.

Ethyol is a cytoprotective drug indicated as an adjuvant therapy to reduce the incidence of xerostomia (dry mouth) as a side-effect in patients undergoing post-operative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with the repeated administration of cisplatin in patients with advanced ovarian cancer.

In 1995, the US Food and Drug Administration (FDA) granted Ethyol a New Drug Application (NDA) and in 2013, Ethyol revenue was approximately $4.9million.

This is the second product Clinigen has acquired from AstraZeneca (the first being the anti-viral Foscavir in 2010), and the Group's third oncology support product adding to Cardioxane and Savene bringing the specialty pharmaceuticals portfolio to five products in total.

Under the terms of the agreement, Clinigen will assume full responsibility for the distribution of the product with immediate effect. AstraZeneca, working closely with Clinigen, will continue to manufacture the product whilst the NDA and Investigational New Drug ('IND') authorizations are transferred and the technical transfer to a third party manufacturer is completed.   The acquisition will be paid for in milestone related stage payments linked to the transfer of manufacturing.  The financial terms of the agreement are not disclosed.

AstraZeneca reports positive results from phase III programme of CAZ-AVI

AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, announced positive top-line results from RECLAIM-1 and RECLAIM-2, the pivotal phase III studies investigating the potential of the antibiotic ceftazidime-avibactam (CAZ-AVI) as a treatment for hospitalised adult patients with complicated intra-abdominal infections.










CAZ-AVI consists of a cephalosporin (ceftazidime), an established treatment for serious bacterial infections, and a next generation non-beta lactam beta-lactamase inhibitor (avibactam). CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing threat to public health. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.

The global RECLAIM-1 and RECLAIM-2 phase III studies both evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg / 500 mg) plus metronidazole, compared to meropenem, administered intravenously as a 30 minute infusion (1 g), in hospitalised adult patients with complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In the RECLAIM-1 and RECLAIM-2 phase III studies, CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). CAZ-AVI also treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem.

First-of-its-kind paediatric HIV treatment

Janssen, the pharmaceutical companies of Johnson & Johnson, has launched a first-of-its-kind paediatric HIV treatment donation programme to improve access to the company's approved HIV medicines for children and adolescents failing HIV treatment in sub-Saharan Africa.

At a symposium entitled When Children Need HIV Treatment Beyond First-Line: How Can We All Respond? at the 17th International Conference on AIDS and STIs in Africa (ICASA), Ministries of Health (MOHs) in sub-Saharan Africa were invited to submit a formal Expression of Interest to participate in the charitable paediatric HIV treatment donation programme.

Through this programme, Janssen will donate its HIV medicines PREZISTA (darunavir) and INTELENCE (etravirine), including child-friendly formulations, free of charge to eligible countries with the clinical capacity and willingness to address second- and third-line paediatric HIV treatment. Each child enrolled will receive Janssen's donated HIV medicines as needed until they turn 19 at which point they will be transitioned into the adult national HIV programme or other designated by the national HIV programme for continued treatment.

The donation programme is intended to be a first step in a broader collaborative effort to build awareness, incite action, and advance learning around second- and third-line paediatric HIV treatment in sub-Saharan Africa. Janssen is working with the Elizabeth Glaser Paediatric AIDS Foundation, the Partnership for Supply Chain Management (PFSCM), and MAP International to fully maximize the impact and reach of this initiative.

"The donation programme is part of our longstanding commitment to help people living with HIV and enhance access to our medicines for those in need. Only a third of the three million children living with HIV are receiving medicines today, and of those children receiving treatment, a small but growing number are experiencing HIV treatment failures and are in need of new treatment options," said Paul Stoffels, MD, chief scientific officer, Johnson & Johnson and worldwide chairman, Janssen. "We hope this innovative donation programme is the first step in sparking further collaborative action across sub-Saharan Africa for children who are experiencing HIV treatment failure. Our vision is that these children receive the HIV treatment and care they need to stay healthy and grow to become healthy, productive young adults."

chikungunya vaccine induces robust antibody response

An experimental vaccine to prevent the mosquito-borne viral illness chikungunya elicited neutralising antibodies in all 25 adult volunteers who participated in a recent early-stage clinical trial conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The results are reported in the current issue of The Lancet.

The most distinctive symptom of chikungunya infection is severe joint pain accompanied by headache and fever. There are currently no vaccines or specific drug treatments for chikungunya. First identified in East Africa in the early 1950s, chikungunya virus caused sporadic illness in Africa and large urban outbreaks in Thailand and India in the 1960s and 1970s. It first appeared in the Western Hemisphere in late 2013.

As of August 8, more than 570,000 confirmed or suspected cases had been reported throughout the Americas. In the continental United States, 484 cases have been reported as of August 5, and the first two locally acquired infections were detected in Florida in mid-July.

“The two species of mosquito that spread chikungunya virus are found in parts of the continental United States, so it may just be a matter of time before this illness gains a foothold here,” said NIAID Director Anthony S. Fauci, M.D. “Therefore, it is prudent to begin addressing this emerging public health threat with the development of vaccines, such as this one, which was designed and tested by scientists from the NIAID Vaccine Research Center.”

FDA approves first non-invasive DNA screening test for colorectal cancer

The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

Colorectal cancer primarily affects people age 50 and older, and among cancers that affect both men and women, it is the third most common cancer and the second leading cause of cancer-related death in the United States, according to the Centers for Disease Control and Prevention (CDC). Colorectal cancer screening is effective at reducing illness and death related to colon cancer. The CDC estimates that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided
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Colorectal cancer occurs in the colon (large intestine) or rectum (the passageway that connects the colon to the anus). Most colorectal cancers start as abnormal raised or flat tissue growths on the wall of the large intestine or rectum (polyps). Some very large polyps are called advanced adenomas and are more likely than smaller polyps to progress to cancer.

UM SOM at forefront to develop vaccine for Ebola virus

As the number of lives taken by the Ebola virus in West Africa quickly approaches 1,000, and the US prepares as rapidly as it can, it is clear that little is known in the medical community about the virus. In fact, some experts point out that the number of medical professionals who can properly diagnose and recommend the next steps for treatment is alarmingly small.

Some scientists, however, like Alan Schmaljohn, Ph.D., Professor of Microbiology and Immunology at the University of Maryland School of Medicine (UM SOM), have spent decades studying the Ebola virus and similar viruses identifying key characteristics that have aided in the development of vaccines, antivirals and treatment methods.

As a leader of research and Chief in the Viral pathogenesis and Immunology Branch with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Dr. Schmaljohn was able to help identify three of the key antibodies that are used currently in combination with each other to treat patients infected with Ebola.

Dr. Schmaljohn is now one of the scientific leaders in the UM SOM partnership with Department of Defense contract recipient Paragon Bioservices in the manufacture of an Ebola virus vaccine for initial safety testing in humans.

“Several vaccine candidates for Ebolavirus are proceeding through initial manufacture toward safety testing in human volunteers,” Dr. Schmaljohn said. “Different vaccine candidates are based upon different ‘platforms’ in which selected viral proteins may be made ‘in the test tube’ and purified for injection, or may be added genetically as passengers of a different variety of virus that is weakened. Only human trials will provide the final answers as to which vaccines are best on the basis of many criteria, foremost being safety and efficacy,” he said.

Indian pharma industry

Indian pharma industry needs to arm itself to be in perpetual audit mode. This is because of the new stringent global regulatory norms that are being enforced and the frequent inspections by the international regulatory enforcement teams, said Dr Vinay G Nayak, president, technical operations, Alembic Pharmaceuticals.

Since 2008, the US FDA issued 483s warning letters and imposed ban on production plants of Indian pharma companies following non adherence to quality standards and have put the sector under surveillance. The only way to gain confidence of the regulator, clear doubts and relax scrutiny would be to put in place systems to document practices, prevent microbial contamination of drugs, bring in reliability and integrity in procedures across laboratory and manufacturing systems, he added.

The way forward for a confident regulatory compliance would be to automate process of manufacturing, computerise lab operations, install surveillance systems across the facility to bring in transparency and accountability at all levels. There should be review of standard operating procedures versus practice, said Dr Nayak in his presentation on ‘Quality audit case studies- major quality issues and trends’, presented at the recently concluded IPA Platinum jubilee event.

Endo's subsidiary Paladin launches Travelan in Canada

Endo International plc's subsidiary Paladin Labs Inc. has launched Travelan, a unique over-the-counter product to help reduce the risk of travellers’ diarrhoea.

Travelan is clinically proven to provide protection against the main cause of travellers’ diarrhoea in 90 per cent of consumers who use it. Travelan is a convenient option for all those travelling to at-risk regions such as Central and South America, Mexico, Africa, the Middle East and Asia. It does not require a prescription, and is not associated with any significant side effects.

It is estimated that there are over 5 million trips made by Canadians to at-risk regions every year. One-in-three Canadian vacationers have experienced, or have travelled with someone who has experienced, travellers' diarrhoea. Sources of Enterotoxigenic Escherichia Coli (ETEC) bacteria, which cause the majority of cases of travellers' diarrhoea, can include poorly cooked meat, contaminated raw vegetables or unpasteurized dairy products. Given that no food group can be regarded as "safe"4, research demonstrates that three-quarters of Canadians have indicated that they would take a preventive for travellers’ diarrhoea.

Wrongly labelling drugs under Sch H1 causing confusion to chemists

Concerned over the rising incidence of mislabelling of certain drugs as Schedule H1, pharmacists across the country have urged the regulatory body to urgently look into this matter to clear the confusion among the stakeholders. It was observed by pharmacists that many pharma companies have been wrongly labeling drugs under Schedule H1 category even though they do not fall under the same, creating a lot of skepticism and extra work for the pharmacists.

Schedule H1 which was included in the Drugs & Cosmetics Act after amending the Act in 2013, came into effect from March 1, 2014 consists of a list of only 46 drugs. However, experts point out that there are more products in the market that are being sold under this category than necessary. This they feel needs to be investigated to find out the possibility of any swindling in this matter.

What makes the matter worse for the pharmacists is that under the law, the retailers who are doing manual billing are required to keep separate bill books or separate series of  bill numbers, so that they can produce the records immediately when asked by the drug control officials. With such a long list of medicines it becomes tedious and cumbersome issue for many to keep a record of the drugs, especially when they are well aware that they do not fall under the category.

ReproCELL acquires 3D cell culture

Reinnervate Ltd, one of the leading companies in the field of 3D cell culture, has been acquired by ReproCELL of Shin-Yokohama in Japan. ReproCELL, a pioneer in the field of induced pluripotent stem cell biology supplies iPSC-dervided Hepatocytes, Neurons and Cardiomyocytes as well as a range of media and reagents for stem cell culture.

ReproCELL intends to combine it’s iPSC-derived cells with the Alvetex range of 3D cell culture products to produce and sell next-generation tools for drug toxicity testing, neuroscience and cancer research.




ReproCELL also announced the acquisition of BioServe Inc of Maryland, USA, a leading supplier of human tissues and other biological samples with one of the largest commercial biorepositories in the world.

ReproCELL plans to use the unparalleled access to human tissues to generate a wide range of disease-related iPSC lines for production of human disease cell models.

Aeterna Zentaris, ASCEND ink co-promotion pact for US market

Aeterna Zentaris Inc.,  a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology and endocrinology, announced a strategic co-promotion services agreement with ASCEND Therapeutics US, LLC, (ASCEND), a specialty pharmaceutical company solely focused on women's healthcare.

Under the terms of the agreement, expected to start in the fourth quarter of 2014, Aeterna Zentaris will use its newly established commercial structure to market, in specific US territories, ASCEND's EstroGel a non-patch transdermal US Food & Drug Administration (FDA) approved and commercialized estrogen replacement therapy. For its part, ASCEND would market, in specific US territories, Macrilen, Aeterna Zentaris' product for use in the evaluation of adult growth-hormone deficiency (AGHD), for which a New Drug Application (NDA) is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of November 5, 2014. In consideration for these co-promotion services, each party will be entitled to receive, from the other party, commissions on net sales of each other's product.

Medical devices industry needs separate set of rules

AdvaMed, an association of medical device manufacturers, stressed that in the light of many regulatory hurdles the industry is facing in India, it is high time for the government to frame a specific set of acts and rules for the medical devices industry. The association welcomed the government’s effort to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non- communicable diseases.

AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”

ANI Pharma buys US rights for Vancocin capsules from Shire

ANI Pharmaceuticals, an integrated specialty pharmaceutical company, has acquired the US rights for Vancocin 125 mg and 250 mg capsules from Shire plc, a global biopharmaceutical company.

In addition, ANI acquired from Shire approved ANDAs for the currently non-marketed products vancomycin hydrochloride injectable 500 mg, 1 gm and 10 gm ($45 million in 2013 market value, per IMS Health) and vancomycin hydrochloride oral solution 250 mg and 500 mg. ANI paid $11 million in cash for the rights to Vancocin together with existing inventories on hand. Following a transition period, ANI intends to launch Vancocin capsules under its own label during the fourth quarter of 2014. The transaction is immediately accretive and sales of Vancocin capsules are expected to generate approximately $5.4 million in revenues and $4 million in non-GAAP EBITDA annually.

Arthur S. Przybyl, ANI’s president and chief executive officer, stated, “We are excited to add Vancocin capsules to our portfolio of mature brand products. In addition, we will immediately begin exploring opportunities to launch both vancomycin injectable and vancomycin oral solution. Year to date we have invested $23 million in two mature brand acquisitions that will contribute a combined $9.4 million in annual revenues and $8 million in annual non-GAAP EBITDA. At the same time, we are continuing to advance our internal generic product development pipeline while selectively pursuing acquisitions and partnerships that augment those efforts.

Maha FDA files FIR against stockists for refusing to supply medicines

To ensure compliance to the conditions of wholesale licence and Drug Price Control Order (DPCO-2013), Maharashtra Food and Drug Administration (FDA) has filed an FIR against a stockist at Bhiwandi Police Station for refusing to supply medicines in contravention to DPCO and Essential Supplies Maintenance Act (ESMA). This is the first such case detected by the state regulator since it intensified its drive last month against errant wholesalers.



The state as of today has 18000 wholesalers including those who export and import. Out of which, there are around 4000 stockists who supply to the retail trade. FDA has intensified the crackdown on the errant wholesalers from last month considering the fact that until last year unfair practice of constraining the supply of medicines by a handful of drug dealers was rampant.

Takeda Pharma net dips by 6.2%

Takeda Pharmaceutical Company of Japan has posted lower net profit of Yen 34 billion during the first quarter ended June 2014 as against Yen 36 billion in the corresponding period of last year due to stagnant sales, higher input costs and launch of new products in the US. Its revenue improved marginally by 0.2 per cent to Yen 411 billion from Yen 410 billion. Its earnings per share worked out to Yen 42.40 as compared to Yen 45.53 in the last period.

The company's sales of Ethical drugs improved only by 0.5 per cent to Yen 372 billion as its sales in Japan declined by 2.2 per cent to Yen 138 billion. Contribution from sales increase of products launched in and after 2010 such as Asilva and Nesina could not fully absorb the decrease in sales mainly due to the National Health Insurance price reduction and the penetration of generic products. However, its overseas sales improved by 2.7 per cent to Yen 234 billion due to higher sales of Velcade in the US and Pantoprazole in emerging markets including Asia.  

US FDA announces FY 2015 animal drug user fee rates for ADUFA & AGDUFA

The US Food and Drug Administration (FDA) announced in the Federal Register the fiscal year 2015 rates and payment procedures for animal drugs subject to user fees under the Animal Drug User Fee Amendments of 2013 (ADUFA III) and Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II).

ADUFA, originally signed into law in 2003 and reauthorized in 2008 and 2013, amends the Federal Food, Drug, and Cosmetic Act and authorizes FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These resources support FDA’s responsibilities to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals that produce food for consumption. ADUFA III reauthorizes FDA to collect user fees through FY 2018.

Dow Corning opens application development centre in Mumbai

Dow Corning, one of the leading global players in innovative silicon-based technologies, has set up a new application development centre in Mumbai to serve the growing demand for silicone materials and services in the India region. This centre enables state-of-the art local support for Dow Corning’s global innovation and sustainability initiatives, as well as closer collaboration with customers to provide solutions customised for the region.