Issuu on Google+

BUSINESS AVENUES

144

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 145


BUSINESS AVENUES

146

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 147


BUSINESS AVENUES

148

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES JAS-ANZ

WHO GMP

CERTIFIED

EXPRESS PHARMA

QUALTIY ASSURED COMPANY

ISO 9001 : 2000

Accreditation by the Joint Accreditation System of Australia and New Zealand No S1470198AS

, Deo-Sprays.

30 -CIS, Baltic & Central Asian countries - South East Asian Countries - African Nations-Arab Nations

Regd. Office : 913, D-Mall, Netaji Subhash Place, Delhi - 34, INDIA Unit I : Uchani, G.T. Road, Karnal-132001 INDIA Unit II : Behind 47, Industrial Area, Paonta Sahib-173025. emails : paras@zeelab.co.in, zeeasia@gmail.com, info@zeelaboratories.com Phone : +91-184-2267310, 2267312 Fax : +91-184-2267344 Hand Phone : +919896134500, +919896117777, +919896113232

EXPRESS PHARMA

November 16-30, 2013 149


BUSINESS AVENUES

150

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 151


BUSINESS AVENUES

152

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 153


BUSINESS AVENUES

154

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 155


BUSINESS AVENUES

156

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 157


BUSINESS AVENUES

158

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 159


BUSINESS AVENUES

EXPRESS PHARMA

Lab Top FP Ad

160

November 16-30, 2013

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 161


BUSINESS AVENUES

162

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

EXPRESS PHARMA

November 16-30, 2013 163


BUSINESS AVENUES

164

November 16-30, 2013

EXPRESS PHARMA

EXPRESS PHARMA


BUSINESS AVENUES

EXPRESS PHARMA

PharmaPro_1_FP Ad

EXPRESS PHARMA

November 16-30, 2013 165


BUSINESS AVENUES

EXPRESS PHARMA

PharmaPro_2_FP Ad

166

November 16-30, 2013

EXPRESS PHARMA


RESEARCH REPORTS

The search for safer,better diabetes medication Marking World Diabetes Day on November 14, Viveka Roychowdhury gives an update on current research trends and some of the molecules in the pipeline

CITIES UNDER SIEGE 1

ACCORDING TO the International Diabetes Federation (IDF), an estimated 371 million people worldwide have been diagnosed with type 1 and type 2 diabetes (T2D), and with this expected to increase by 50 per cent over the next 20 years, the anti-diabetic therapy area is a hot area of research. T2D is the most common type, accounting for an estimated 90 per cent of all diabetes cases. November 14 is World Diabetes Day and education and prevention being the theme for the past five years, it is only to be expected that pharmaceutical companies go into overdrive, announcing patient awareness campaigns, collaborations and the like. China may have more diabetic patients but India is inching closer each day to becoming the diabetes capital of the world. Given the high rate of cases which go undiagnosed, the scenario is indeed worrying. An Abnormality Report put together by Indus Health Plus, which is involved in preventive healthcare check-ups, has shown rapid increase in numbers of diabetic across major cities in India as compared to any other disease. The report, based on findings from July 2012 to May 2013, also highlights the increasing trend of diabetes among females and youth. (BOX: Cities under siege)

Challenging collection of risk factors The treatment of diabetes is particularly challenging due to the collection of risk factors asso-

An Abnormality Report put together by Indus Health Plus, which is involved in preventive healthcare check-ups, has shown rapid increase in numbers of diabetics across major cities in India as compared to any other 2 disease.The report, based on 3 findings from July 2012 to May 2013, also highlights the increasing trend of diabetes among females and youth.

cent of those were working. There were men from the age bracket of 40-60s who were seen at a higher risk 4

3. PUNE ● In Pune too, those in the age bracket

5

1. DELHI ● 18 per cent increase amongst men

observed in diabetic cases, there was whooping increase of 39 per cent in females ● Delhites are evidently seen to have a sweet tooth. They also consume high amount of oil/ghee/butter in various cooked eatables.This has evidently increased the numbers of obesity, hypertension therefore giving a rise in the numbers of diabetes

of 30-40 were observed to be living at higher risk levels of diabetes. Even those from the age bracket of 20-30s were observed to have increased by 21 per cent cases of diabetes ● Younger women in the age bracket of 30-35 have been observed to have having extra junk and sweet stuff that has also elevated the chances of diabetes in them 4. HYDERABAD ● Increase in diabetes among women by 15 per cent ● Polished rice, carbohydrates, coconut and urban

trends is a major cause of diabetes

2. MUMBAI

5. BANGALORE

● In Mumbai, sugar levels were found to be high

● Clear increase noticed in the age group of 25-30

surprisingly amongst youth, especially between the age group of 25-35 years of age. 32 per cent of these were detected with diabetes ● A lot of stress is borne by population in the age bracket of 28-40 years age.This lot is mainly those from the MNC and IT industry with less physical activity as per their work portfolio.With 65 per cent of women detected as diabetic, almost more than 50 per

years both in male and female.While 40 per cent of the cases are because of genetic, 60 per cent of the detections are because of change in their lifestyle ● It was also observed during doctor consultation that not just middle age group population but also 40 per cent of the young Bangloreans ( 25-45 years) did not know the after effects of diabetes and the need to get test done.

ciated with it, and this is the main driver for research on better treatment options. Clinicians require different treatments and different combinations of treatments to focus on the different factors impacting diabetes at different stages of the condition as the disease progresses. The 49th Annual Meeting of the Euro-

pean Association for the Study of Diabetes (EASD) in Barcelona in September saw a number of pharmaceutical companies present research on promising investigational molecules. At a pre conference media briefing, Boehringer Ingelheim and Eli Lilly presented data on empagliflozin, an investigational

compound as well as safety data on as Trajenta (linagliptin), a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Boehringer Ingelheim's Trajenta has reportedly had a successful run in the the year since its launch globally and in India, and bagged two award: 'Marketing Excellence'

by OPPI & 'Pharmaceutical Brand of the Year' (New launch) by Frost & Sullivan.

Protecting the heart ... Experts stress that diabetes increases the risk of other diseases. For instance, cardiovascular events rank as the major cause of death in patients with diabetes, accounting for more than 50 per cent of all diabetes fatalities. Professor Mark Kearney, Professor of Cardiovascular and Diabetes Research, British Heart Foundation, University of Leeds, UK stressed that diabetes accelerates multiple aspects of heart failure. A practising cardiologist with an interest in heart failure and diabetes, he gave chilling examples from his practice to demonstrate the impact of diabetes. The risk of heart attack is less than five per cent in a nondiabetic but increases to 15 per cent in a diabetic. Even if diabetic patients survive a heart attack, they are left with left ventricular damage. Focussing on the diagnosis and treatment of modern day diabetic patients, he stressed the need for life style changes but also the need for new therapies and delivery modes.

… and the kidneys Besides cardiovascular events, kidney disease is another common complication of diabetic patients. Dipeptidyl peptidase-4 (DPP-4) inhibitors like Trajenta (linagliptin), have become the mainstay of treatment, according to Prof Cliff Bailey, Professor of Clinical Sci-

167 EXPRESS PHARMA November 16-30, 2013


RESEARCH

ences, Aston University, UK. DPP-4 inhibitors work by enhancing the secretion of incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) thus increasing insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels . Impairment of renal functions becomes even more of an issue with elderly patients and ongoing studies have tried to collect safety data in this patient group. Boehringer Ingelheim and Eli Lilly presented results from a post-hoc analysis of pooled data from seven clinical trials including 1,293 people with T2D aged 65 years or older which showed linagliptin was well tolerated including in the elderly with normal renal function to severe renal impairment. The overall incidence of adverse events was similar for linagliptin compared to placebo.

The new kid on the block Terming diabetes as the epidemic of the 21st century, Prof. Bernard Zinman, Director, Leadership Sinai Centre for Diabetes, Canada worries that it will “bankrupt the health systems of countries if we do not do

something about it.” T2D is clinical described as a dysregulation of glucose homeostasis characterised by persistent hyperglycaemia (high blood glucose levels over a long time), impaired ß-cell function (reduced ability of the pancreas to produce insulin) and insulin resistance (secreted insulin is less effective at lowering blood glucose in the body). Even though there are many treatments available for patients with T2D to reduce their blood glucose, many do not achieve their glycaemic goals. This may partly be due to side effects of medication such as weight gain, hypoglycaemia and gastrointestinal effects. Zinman explains that an important part of the biological evolution of man was the reabsorption of sugar in the kidneys, as the human body was programmed to conserve calories. But this survival tactic that helped our ancestors store nutrition in preparation for times when food might not be in plenty, creates a problem for TD2 patients as the reabsorbed glucose is re-circulated into the blood stream and results in high blood glucose levels (hyperglycaemia) as well as weight gain. Virtually all of the filtered glucose is reabsorbed by sodium

glucose cotransporters (SGLTs) in the kidney. Since SGLT2 inhibition targets glucose directly and works independently of ßcell function, this class of drugs has become the subject of study as a probable important clinical addition to the treatment regimen for people with T2D and their physicians. The use of SGLT2 inhibitors to increase elimination of glucose in the urine thus represented a unique way of turning a symptom of the disease (ie: increased glucose in the urine) into the treatment. Other drugs in the SGLT2 inhibitors class include canagliflozin, dapagliflozin, empagliflozin and ipragliflozin. In November 2012, AstraZeneca and Bristol-Myers Squibb's Forxiga/dapagliflozin was approved by the European Commission for the treatment of T2D in the European Union (EU) while in March this year, Johnson & Johnson's Invokana/ canagliflozin got US FDA approval for the treatment of T2D diabetes. Empagliflozin, one of the members of the SGLT2 group of compounds, is one of three research compounds under the Boehringer Ingelheim and Eli Lilly alliance for diabetes. At

EASD, the two companies presented results from a new analysis of pooled efficacy data from four Phase 3 trials of empagliflozin showing improved glycaemic parameters, body weight and blood pressure, in adults with T2D. The Phase 3 trial has enrolled more than 14,500 patients and comprises more than 10 multinational clinical trials. Also under investigation is the effect on the risk of hypoglycaemia and urinary tract and genital infections as the Phase 2 and 3 studies threw up key safety points related to an increase in adverse events related to genital infections; a similar rate of adverse events related to urinary tract infections compared to placebo; and a similar hypoglycaemic event rate compared to placebo in studies without sulphonylurea and insulin background therapy, according to a press release from the companies. On the sidelines of the media briefing, Dr Thomas Seck, Associate Therapeutic Area Head, responsible for Medical Affairs at the metabolism department at Boehringer Ingelheim confirmed that India is included in the Phase 2 and 3 studies of empagliflozin. He indicated that

around 30-40 per cent of patients in these studies are from Asia and of this, a majority are from India. Efficacy profiles of empagliflozin are somewhat similar and there might be differences in safety but it is difficult to make any conclusions with the data collected so far, says Seck. Basal insulin, the third compound in the BI-Lilly alliance, is currently in phase 3 and Seck indicated that the company hopes to be able to submit data to regulatory agencies by next year.

Education the key But treating diabetes needs a multipronged approach beyond research labs. (See report: Complexity of managing Type 2 diabetes is currently underestimated, reveals survey) The online survey showed that though managing T2D is complex, 90 per cent of physicians polled agreed that both healthcare practitioners and patients could gain from additional medical information and patient support materials. Education and awareness would seem to be as vital as the medicines themselves. viveka.r@expressindia.com

Complexityof managing Type 2 diabetes is currentlyunderestimated,reveals survey Around 800 physicians from Japan, China, India and South Korea participated in the poll BOEHRINGER INGELHEIM and Eli Lilly and Company announced results from a poll conducted with almost 800 physicians treating people with Type 2 Diabetes (T2D), in Japan, China, India and South Korea. 360 respondents were from India. As per the the online survey, 79 per cent of the physicians surveyed believed that the complexity of managing T2D is currently underestimated. However, the physicians also

168 EXPRESS PHARMA November 16-30, 2013

opined that despite these complexities, high quality, structured patient education can help to improve health outcomes and significantly improve quality of life in people with T2D. 90 per cent of physicians polled agreed that both healthcare practitioners and patients could gain from additional medical information and patient support materials. The survey highlighted the importance of managing cardiovascular risk in T2D. 94 per cent

of total respondents and 92 per cent of the Indian physicians who polled claimed that the management of cardiovascular risk influenced their decision when prescribing an oral antihyperglycaemic treatment. Half of the total physicians and 59 per cent of Indian respondents surveyed ranked ‘number of doses per day’ as the factor that influenced them the most when prescribing an oral antihyperglycaemic agent, in addi-

tion to the management of blood glucose. 39 per cent of Indian physicians surveyed ranked risk factors like obesity, smoking and hypertension as the most important challenge and 46 per cent ranked drug interactions as the least important challenge while managing T2D. “More than 60 per cent of the world’s diabetes population lives in Asia and physicians treating T2D in this region acknowledge that this is a complex condition,”

said Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Despite the challenges T2D can present in the face of rising prevalence, results from this survey show that healthcare professionals in Asia are evaluating the full spectrum of available treatments, dosing regimens, risk factors and co-morbidities to achieve the best possible health outcomes for their patients.” EP News Bureau-Mumbai


RESEARCH

New data presented at AASD demonstrate benefits of Trajenta (linagliptin) Linagliptin showed a statistically significant reduction in blood glucose in adults with Type 2 diabetes and liver disease BOEHRINGER INGELHEIM and Eli Lilly and Company announce new data that reinforce the efficacy and tolerability of linagliptin in people with Type 2 Diabetes (T2D) and liver disease, as well as Asian people with T2D aged 65 years or older. The data add to a growing body of clinical evidence supporting the use of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor from Boehringer Ingelheim (BI) and Eli Lilly and Company, in a broad range of adults with T2D. The data was announced during the 2013 International Conference on Diabetes and Metabolism & 5th Asian Association for the Study of Diabetes (AASD) Annual Scientific meeting. Adults with T2D aged 65 years or older and those with pre-existing liver and biliary disease are characterised by limited treatment options. With the rate of T2D rapidly growing in Asia, and the prevalence of T2D and hepatobiliary diseases being high, especially in Asian countries, effective and safe treatment options are increasingly becoming a priority. Moreover, given the major elimination of linagliptin via the entero-hepatic system, it is particularly important to further characterise the efficacy and safety of linagliptin in T2D patients with liver and biliary complications. Efficacy and tolerability in people with T2D and previous/current liver and biliary disease In a pooled analysis of 17 double-blind placebo controlled randomised clinical trials investigating the efficacy and tolerability of linagliptin in people with T2D and self-reported previous/current liver and biliary disease, results showed:

Linagliptin demonstrated a statistically significant placeboadjusted reduction in HbA1c of 0.52 and 0.62 per cent in patients with- and without hepatobiliary disorders, respectively, from baseline to 24 weeks. Overall incidence of adverse events (AEs) was similar for hepatobiliary (65.1 per cent – linagliptin; 68.0 per cent – placebo) and non-hepatobiliary patients (56.7 per cent – linagliptin; and 62.0 per cent placebo). Rates of serious AEs were 7.9 per cent vs. 9.9 per cent (linagliptin and placebo, respectively) in the hepatobiliary group, and 4.7 per cent vs. 6.6

per cent, (linagliptin and placebo, respectively) in the nonhepatobiliary group. Fewer patients in the linagliptin group experienced drug related AEs than placebo (12 per cent vs. 15.3 per cent hepatobiliary; 11.6 per cent vs. 13.6 per cent non-hepatobiliary); and hypoglycaemia was less frequent with linagliptin versus placebo (12.2 per cent vs. 19.2 per cent hepatobiliary; 11.9 vs. 14.8 non-hepatobiliary).

Efficacy and safety in Asian elderly people with T2D In a second pooled analysis investigating the efficacy and safety of linagliptin (as

monotherapy or in combination with common anti-hyperglycaemic drugs) in Asian people aged 65 years or older with uncontrolled T2D, results showed: Linagliptin demonstrated a statistically significant reduction in HbA1c of 0.90 per cent, compared to a 0.08 per cent reduction with placebo, resulting in a treatment difference of 0.82 per cent after 24 weeks.i Overall incidence of adverse events (AEs) or serious adverse events (SAEs) with linagliptin was similar to placebo (AE 53.6 per cent vs 61.9 per cent, and SAE 4.5 per cent vs. 6.9 per cent respectively). Drug-related AEs were

lower in the linagliptin arm than with placebo (12.6 per cent vs. 17.5 per cent, respectively); as was the occurrence of investigator defined hypoglycaemia (9.5 per cent vs. 18.1 per cent, respectively). The incidence of symptomatic hypoglycemia events was similar to placebo (1.1 per cent in linagliptin vs 1.5 per cent in placebo) when patients were not on insulin or sulphonylurea background therapy. Commenting on the studies, Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, said, “The effects of treatment on health and safety in specific groups of people with Type 2 Diabetes, such as the elderly and those with liver disease, must be considered when selecting the most appropriate therapy. However, those patients present complications that limit their choice of treatment. The findings that will be presented at AASD support linagliptin’s safety and efficacy in these populations with Type 2 Diabetes, and confirm that linagliptin is an important treatment option.” The US Food and Drug Administration (FDA), European Medicines Agency (EMA), Japan Pharmaceuticals and Medical Devices Agency (PMDA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin. With linagliptin, no dose adjustment is required regardless of renal function or hepatic impairment. EP News Bureau-Mumbai

169 EXPRESS PHARMA November 16-30, 2013


RESEARCH CLINICAL UPDATE

Bone Therapeutics’phase III osteonecrosis trial with PREOB hits a new milestone It has been touted by industry analysts as a potential blockbuster that could bring annual sales of over $3 billion Gosselies, Belgium BONE THERAPEUTICS, the regenerative therapy company addressing unmet needs in the field of orthopaedics via a minimally invasive approach, announces that its phase III pivotal trial to treat osteonecrosis with its lead bone forming cell product PREOB is actively running in 30 European centres. Bone Therapeutics obtained clearance from the competent authorities to launch the pivotal phase III trial with PREOB in osteonecrosis in 2012. 30 centres across Belgium, Germany, France and the Netherlands are active and ready to recruit patients to assess the safety and efficacy of PREOB in early stage osteonecro-

sis of the femoral head. Osteonecrosis is a rare disease affecting ~200,000 new patients each year in Europe and the USA. There is currently no treatment for osteonecrosis available. PREOB is a first-in-class autologous osteoblastic/bone forming cell product. PREOB is positioned as a first-line treatment as it is administered via a minimally invasive approach directly into the necrotic lesion, thereby avoiding the need for open surgery. PREOB has already acquired orphan drug status for the treatment of osteonecrosis in both Europe and the USA. The phase III study will enrol 130 adult patients who will be randomised 1:1 and either receive a

single administration of PREOB or placebo into the necrotic lesion using a core decompression procedure. Efficacy and safety endpoints will be determined in all patients at each scheduled visit over the 24month follow-up period using clinical (i.e., pain and function) and radiological evaluation. Enrico Bastianelli, CEO, Bone Therapeutics commented, “We are very pleased with the progress of this pivotal phase III trial for our most advanced autologous product PREOB. The significant interest we have seen from the centres so far reflects the excitement from the orthopaedic community in this unique approach.” Bone Therapeutics

RESEARCH UPDATES

US FDAapproves Sunovion Pharma’s seizure drug US HEALTH regulators approved a new drug made by Sunovion Pharmaceuticals, a US based unit of Japanese drugmaker Dainippon Sumitomo Pharma Co, as an add-on medicine to reduce seizures associated with epilepsy. The drug, to be sold under the brand name Aptiom and known chemically as eslicarbazepine,

170 EXPRESS PHARMA November 16-30, 2013

significantly reduced the frequency of epileptic seizures compared with a placebo in clinical trials. "Some patients with epilepsy do not achieve satisfactory seizure control from existing treatments," Eric Bastings, acting director of the FDA's Division of Neurology Products, said. "It is important we con-

tinue to make new treatment options available to patients. Like other antiepileptic drugs, Aptiom may cause suicidal thoughts or actions in a very small number of people, the Food and Drug Administration cautioned in its approval announcement. Reuters


RESEARCH

Agenus genital herpes vaccine succeeds in mid-stage trial AGENUS SAID a trial of its experimental genital herpes vaccine reduced the rate at which patients released the virus, reducing the likelihood of infecting others. The 15 per cent reduction in the release of the virus by patients receiving the vaccine in a mid-stage trial compared to those on a placebo, who showed no reduction. The vaccine, HerpV, also reduced the severity of the infection by 34 per cent. The mid-stage trial had 80 patients with a history of 1-9 herpes recurrences within the prior 12 months. Of them, 70 received the vaccine and 10 received placebo, Agenus said. HerpV, being developed as an "offthe-shelf" vaccine, contains Agenus's QS-21 Stimulon adjuvant that boosts specific immune responses. The trial tested the efficacy of the vaccine by measuring the release of the virus by patients 45 days before and after three injections of HerpV. A

majority of the patients also received a booster injection, given six months after the first vaccination. Genital herpes, a highly contagious sexually transmitted infection, is usually caused by the herpes simplex virus (HSV). There are two types of HSV and Agenus's vaccine targets HSV type 2, which most often causes genital herpes. According to the US Centers for Disease Control and Prevention, 776,000 people in the US get new herpes infections annually and one out of six people aged 14 to 49 years has genital HSV-2 infection. Agenus said it expected more data in the first half of 2014, showing how the patients fared after the booster shots. The company's partners are also testing the QS-21 Stimulon adjuvant in combination with other vaccines. Reuters

171 EXPRESS PHARMA November 16-30, 2013


RESEARCH

FDAupdates warning on Sanofi’s blood thinner Lovenox THE US Food and Drug Administration issued a new warning on the use of the anticoagulant Lovenox in patients fitted with a spinal catheter because of the risk of spinal column bleeding and potential paralysis. The FDA said that healthcare professionals should carefully consider timing when inserting or removing a spinal catheter in patients taking Lovenox, which is made by Sanofi SA, or its generic versions, which are sold under the name enoxaparin. The catheters, fine plastic tubes, are used to deliver

painkillers or anesthetics directly into the spine. The drugs already contain a warning that patients who have received or are scheduled to receive low molecular weight heparins such as Lovenox are at risk of developing an epidural or spinal bleed that can result in paralysis. But cases continue to occur, the agency said. As a result, the recommendations on timing will be added to the prescribing information. The FDA said placement or removal of the catheters should be delayed for at least 12 hours after a patient is dosed

with enoxaparin. In patients receiving higher doses of the drug a delay of 24 hours would be appropriate, and the drug should be given no sooner than four hours after a catheter is removed. Sanofi reported 170 instances of spinal or epidural bleeds, known as hematomas, associated with Lovenox between July 20, 1992, and January 31, 2013, the FDA said. Of those, the agency found that 100 cases contained a confirmed diagnosis. Lovenox is an injectible drug used to prevent blood

clots in the leg veins in patients who are on bed rest or who are undergoing hip or knee replacement or abdominal surgery. It is often used with warfarin, another anticoagulant, to treat blood clots in the leg. The FDA said all anticoagulants carry the risk of spinal bleeding when used in conjunction with epidural anesthesia or spinal puncture. "We are continuing to evaluate the safety of other anticoagulants to determine if additional label changes are needed," the agency said.

Roche in July presented data from a late-stage trial that showed Gazyva delayed disease progression in patients with CLL longer than its top-seller Rituxan. Final data from the study is expected to be presented at the American Society of Hematology’s annual meeting in December. The Swiss drugmaker is hoping its newer drug will help offset expected lost sales of its $7 billion-a-year Rituxan, after it loses US patent protection in Europe late this year. Rituxan, also known as MabThera, is an antibody against white blood cells that have the so-called CD20 protein on their surface. It is used to treat lymphomas, leukemias, transplant rejection and rheumatoid arthritis.

ZOGENIX SAID the US Food and Drug Administration approved its drug for treating pain severe enough to require around-the-clock, long-term treatment. The drug is approved for use in patients for whom alternate treatment has proved inadequate or ineffective. The FDA requires post-marketing studies for the drug, Zohydro ER, to assess the known risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks. Zohydro ER is an extended release formulation of a common painkiller hydrocodone, which belongs to a widely-used class of pain drugs known as opioids. (link.reuters.com/tes24v) Given the huge number of cases of abuse seen with opioids, Zohydro ER is not approved for as-needed pain relief. Abuse of prescription drugs has become a major concern for the US health regulator, which is trying to restrict access to such drugs. The agency recommended tighter restrictions on products that contain hydrocodone, present in commonly prescribed, potentially addictive drugs such as Vicodin. The most common side effects of Zohydro ER include constipation, nausea, fatigue, headache, dry mouth and itching, the FDA said .

Reuters

Reuters

Reuters

FDAapproves Roche leukemia drug Gazyva US REGULATORS said they approved a new treatment from Roche Holding AG for patients with chronic lymphocytic leukemia (CLL) who have not previously been treated for one of the most common forms of blood cancer. The US Food and Drug Administration said the new drug, Gazyva (obinutuzumab), works by helping certain immune system cells to attack cancer cells, and is meant to be used with a standard treatment for the disease called chlorambucil. It is the first drug having a ‘breakthrough therapy’ designation to win FDA approval, the agency said. The new designation indicates the medicine may offer substantial improvement over standard treatments for patients with serious or life-threatening diseases.

172 EXPRESS PHARMA November 16-30, 2013

Zogenix’s long-acting painkiller gets FDA approval


BIOPH

NEW WAYS TO GROW Foraying into newer areas like bio-betters will depend on India’s ability to comply with global and domestic regulations. Experts speak about how biopharma companies can chart their own paths to success

173 EXPRESS PHARMA November 16-30, 2013


BIOPH I N T E R V I E W

‘Not having data exclusivity is a boon for biosimilar or biobetter prospecting in India’ Dr Gopakumar G Nair, Founder, Gopakumar Nair Associates speaks with Usha Sharma and predicts that data exclusivity and other hurdles related to technology transfer will sum up the whole debate and will nail the 'biosimilar/biobetter dreams, at least in the short span of two to five years

BioPh S P E C I A L Comparing the evolution of the global biotech/ biopharma industry and in India, what are the steps for India to reach to the next level of maturity? Identifying, evaluating and mapping Indian biotech proficiency, both within the country as well as overseas (NRIs), is the most urgent priority for moving towards the next level of maturity. India needs to attract biotech talents and nurture them. In the fields of biotech education and training research, regulatory bodies and industry, India needs practically qualified human resources. China succeeded in attracting overseas Chinese to participate in its renowned biotech revolution which involved and integrated Taiwanese and Hong Kong-based professionals. India needs to look at human resources in biotech/ biopharma field, as a priority. Additionally and equally importantly, India needs to put in order and strengthen its biotech/biopharma regulatory agencies, systems and mechanisms. India is threatening itself with failure, with its regulatory

174 EXPRESS PHARMA November 16-30, 2013

mechanism falling far short of the growth potential. Growing at an average of 20 per cent year-on-year may turn out to be a pipe dream (leave alone maintaining the momentum), if prompt attention is not taken to resolve and remove these bottlenecks. The global market has evolved from biosimilars to ‘biobetters’. Do you think India is likely to be a hub for biobetters or a preferred destination in the near future? Biosimilars are facing stiff challenges from regulatory hurdles. Biobetters are the better bets but with better regulatory bottlenecks. India can become a hub for biobetters for this very reason provided we address the roadblocks speedily and efficiently. India has few biotech/biopharma industry leaders with proven enigmatic excellence. India also has many emerging young entrepreneurs and vibrantly innovative corporates most of whom are languishing for want of clear pathways to progress. With some hand holding from DBT and other expert bodies, India could move on with their biobetters and build confidence to extend their

India has many emerging young entrepreneurs and vibrantly innovative corporates most of whom are languishing for want of clear pathways to progress DR GOPAKUMAR G NAIR, Founder,Gopakumar Nair Associates

operations globally. However, the biobetters need to go through the entire marathon race as a new chemical entities (NCE) or new molecular entities (NME), which could be a herculean task, beyond the reach of Indian biotech companies and beyond the capacity of Indian regulatory bodies. Further the enormous investments in taking a molecule to market through the clinical and regulatory approvals will undoubtedly be beyond the reach of existing players, without active involvement from the government. What are the other opportunity areas in the biotech sector in India? India is a leader in generic pharma, both active pharmaceutical ingredients (APIs) and formulations. India is emerging as a leader in vaccines (at least few of them) thanks to the innovative enthusiasm of a couple of enterprising corporates. However, India has failed to integrate biology or biotechnology with chemistry in a big way. Indian API leaders need to adopt biotransformation approaches increasingly. Except one or two corporates who took early risks and entered the field of

stem-cell research, India has not given encouragement at national level to integrate stem cell research and commercialisation into chronic therapies and treatments. Labelled as the ‘Diabetics capital of the world’, India can transform itself to be the ‘Diabetic treatment and cure’ capital of the world with focus on stem cell therapy research and treatment centres. These are a few opportunity areas. I would not suggest any biotech research related Indian flora and fauna, especially herbs, plants and micro-organisms of Indian origin, for fear of the aggressive postures and threats of the biodiversity authority of India. Could you give examples of key biotech companies to watch for in India and mention what sets them apart? Biocon, Biocon and Biocon is what comes to one’s mind when asked to identify key biotech companies in India. Serum Institute, Panacea, Intas Biopharmaceuticals, Reddy Biologics are a few to look forward to. Others are NCBS-TIFR, National Centre for Biological Sciences (NCBS) though non-

Continued on Pg 175


BIOPH I N T E R V I E W

Continued from Pg 174

‘Biobetter drugs principal foundation of science to provide cost effective drugs’ Association of Biotechnology Led Enterprises (ABLE) has formulated a robust biosimilars policy for India and is considering the market complexity as there are a number of biotech companies involved in developing Biobetter drugs. Biobetter drugs will help in delivering superiority drugs at affordable cost informs Dr PM Murali, President, Association of Biotechnology Led Enterprises to Usha Sharma

BioPh S P E C I A L How many Indian companies are in the process of developing biobetters and by when are they likely to be introduced in India? Do you think this could be a viable path to success? Reliance Lifesciences, Dr Reddy’s Laboratories, Biocon and a number of other companies are having a good pipeline. I think most of their launches will happen when some of the patents expire. These are just some of the companies. There are a number of others who will also be coming out with other products. Tell us about the regulatory hurdles likely to be associated with biobetters approval? We formulated a robust biosimilars policy. The hurdles currently are on clinical trials. I am assuming this is being addressed. There are several other operational and administrative issues, which I think can be solved

with a sound dialogue. Biobetters will require a full set of clinical trials approved by the regulatory agencies. Do you think India's regulatory system is ready for it? Clinical trial issue is being addressed by the Supreme Court. I have a feeling that once the fundamental issues are addressed, we will have a good environment to work. This is not just for biosimilars or original biologics that can come from Indian companies but also for new chemical entities (NCE’s) and other devices that are going to emerge from India. Why should Indian biopharma companies move towards the biobetters market? The world looks for a number of products. India will play a key role in the coming years. The pipeline is robust. If the enabling environment is created, we stand to gain a lot in the future. Do you think biobetters will bring business

competitiveness in the market and provide cost effective drugs? Yes. That is the principal foundation for this branch of science.

Once the fundamental issues are addressed, we will have a good environment to work DR PM MURALI, President,Association of Biotechnology Led Enterprises

'Not having... commercial, Heterobio, Virchow biotech, Cipla, Zydus Cadila, GVK Biosciences and others. At least, based on private communication, one could expect Strides to invest their cash (through Agila deal) in biotech ventures. From the regulatory point of view, are India's laws for the biotech sector up to the mark? Are they being implemented as required? India needs to put its house in order with additional qualified manpower and convincingly adequate regulatory provisions and mechanisms, sooner the better for the biotech dreams. Implementation is the bane of India’s regulatory laws. Currently, Indian regulators are jittery and worried about the onslaught from the NGOs and the courts.

Going forward, what is the growth potential of biobetters in the global and Indian life science industry? If a superior drug at affordable costs can be developed and sold, there is nothing like it for the healthcare industry. Also, diseases like cancer will greatly benefit by giving adequate thrust to this area.

From an IP point of view, what are the hurdles for biopharma players in India? Even though the transnationals demand data exclusivity and cite this as a major hurdle for technology transfer and early entry of biologics into India, one must take note that not having data exclusivity is a boon for biosimilar or biobetter prospecting in India. Let us take the recent example of Trastuzumab (Herceptin). The innovator, Roche, had recently opted not to renew its patent for Trastuzumab in India. In spite of the Health and other Ministries publicly declaring their intention to grant approval for a biosimilar to Herceptin, no Indian biotech enterprise has at least, till now, known to have come forward to 'pick up the gauntlet'. This will sum up the whole debate and will nail the 'biosimilar /biobetter' dreams, at least in the short span of two to five years.

u.sharma@expressindia.com

u.sharma@expressindia.com

Presently, how big is the Indian biosimilars market and do you think this market will get adversely impacted by biobetters? Is it likely that biobetter players will kill the business of biosimilar players ? It is tough to give numbers here. But biosimlars is currently near $4 billion. And I expect that it should grow at compounded annual growth rate of 25-30 per cent.

175 EXPRESS PHARMA November 16-30, 2013


BIOPH I N T E R V I E W

‘Indian players are increasingly eyeing to capitalise on the opportunities in biobetters market’ Indian biosimilar sector has picked up momentum in the past few years. Shakthi M Nagappan, Executive Secretary – FABA, CEO, BioAsia talks about this sector's growth prospects, India-specific opportunities and challenges and more, in conversation with Usha Sharma

BioPh S P E C I A L What are the steps that India needs to take for reaching the next level of maturity in the biotech/biopharma space? India biotech market has evolved steadily and significantly over the past two decades – thanks to the progressive biotech policy and incentive schemes of Government of India. The sector has been growing at an average rate of 20 per cent in the past decade and is estimated to grow at 30 per cent in the next decade. The steep raise in the growth estimates can be attributed to the tremendous potential offered by the sector in addressing major global challenges in healthcare, agriculture and energy. For India to move towards the next level of maturity, innovation in research and processes holds the key. With the increasing disease burden, growing need for more efficient and affordable healthcare solutions, innovation holds the key and will drive the global life sciences economy in the coming years. Do you think India is likely to be a hub or a preferred destination for biobetters in

176 EXPRESS PHARMA November 16-30, 2013

the near future? Both, biosimilars and biobetters offer tremendous growth prospects to the companies. Indian biosimilar sector has picked up momentum in the past few years and in 2012, India had about 20 companies developing biosimilars with about 50 products in the market. Pledging more efficacious healthcare solutions with potentially less development costs and multiple product opportunities through platform approach, Indian players are increasingly eyeing to capitalise on the opportunities in biobetters market. Further, the segment which demonstrates improved profile and significant modifications from the innovator drugs also offers reduced litigation risks and better patenting opportunities. What are the other opportunities that lie in the biotech sector in India? Areas like medical technologies and diagnostics, regenerative medicine, personalised medicine and gene therapy, agriculture and food biotechnology promises tremendous growth opportunities for India. India is one of the most lucrative markets for medical devices

globally. With the market relying largely on imports currently, the country provides significant manufacturing opportunities for international and domestic players.

The sector has been growing at an average rate of 20 per cent in the past decade and is estimated to grow at 30 per cent in the next decade SHAKTHI M NAGAPPAN, Executive Secretary – FABA, CEO,BioAsia

Do you think that India's laws for the biotech sector are at par with the global standards? Are they being implemented as required? Indian policy making agencies are investing significant efforts in enabling highly stringent but hassle free regulatory environment. Further, the Ministries have started to incentivise and fund early stage research, which will reduce the associated risks and encourage Indian players to focus on R&D. Decision on allowing 100 per cent FDI in pharma and biotech will also encourage more investment into the country and help create an ecosystem. There are indeed some areas that continue to remain a bottleneck, like delays in approvals, requirement for approvals from multiple agencies, etc. but they are being looked into by the Government. Establishment of proposed biotechnology regulatory authority of India could be a milestone in streamlining the regulations and regulatory

framework in India. From an IP point of view, what are the hurdles for biopharma players in India, for e.g. data exclusivity norms, etc. The challenge is to focus on the ways to balance out innovation with affordability and availability. In the context of India and other emerging markets, where there is a mushrooming disease burden, it is extremely important to keep in mind the fact that large chunk of these patients cannot afford healthcare and hence, drug monopoly can be highly devastating. Having said that, the innovative research demanding significant investment and involves considerable risk needs to be incentivised. Though the current IP regime attempts to prevent evergreening of patents, it creates a lot of room of ambiguity. There is an increasing need to relook at article 3D on Indian Patent Act for defining the lower limits of what constitutes a substantial modification, given the fact that even a slight modification in chemical structure of a drug is expected to have significant effect. u.sharma@expressindia.com


BIOPH

PRODUCT WATCH

Seward introduces searchable online database for sample preparation protocols BioPh S P E C I A L SEWARD, MANUFACTURER of the world leading range of Stomacher paddle blenders and Stomacher accessories used in sample preparation for microbiological analyses, has introduced a new application focused Resource Centre within its website – www.seward.co.uk.

The Seward online Resource Centre contains a growing and unique database of reference papers to help users identify how Stomacher laboratory paddle blenders may be used for different applications and protocols. All scientific papers referenced within the Resource Centre have

014 Tel: Board: 28543031/28543032/ 28543033/28543034 Fax: 28543035 E-mail: raghu.pillai@expressindia.com HEAD OFFICE MUMBAI Rajesh Bhatkal Business Publications Division, The Indian Express Limited., 1st Floor, Express Towers, Nariman Point, Mumbai-400021. India Tel: 67440503 / 02 Fax: 022-22885831 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com Branch Offices NEW DELHI Ambuj Kumar Business Publications Division, The Indian Express Limited, Basement, Express Building, 9 & 10 Bahadur Shah Zafar Marg, New Delhi, 110 002 Direct Line: 011-2346 5727 Board Line: 011-2370 2100-107 Ext-727 Mobile: 09999070900 E-mail: ambuj.kumar@expressindia.com CHENNAI Dr Raghu Pillai The Indian Express Limited, Business Publications Division, New No.37/C (Old No.16/C) 2nd Floor, Whites Road, Royapettah, Chennai - 600

BANGALORE Khaja Ali Business Publications Division, The Indian Express Ltd. 5th Floor, Devatha Plaza 131, Residency Road Bangalore - 560 025, INDIA Tel: 22231923/24/41/60 Fax: 22231925 Cell: 09741100008 E-mail: khaja.ali@expressindia.com HYDERABAD E. Mujahid The Indian Express Ltd. Business Publications Division, 6-3-885/7/B, Ground floor, V.V. Mansion, Somaji Guda, Hyderabad - 500082 Tel: 040 - 23418673/ 23418674/ 66631457 Telefax: 040 - 23418675 Mob: 09849039936 Email: e.mujahid@expressindia.com KOLKATA Ajanta Sengupta The Indian Express Limited Business Publications Division Express House NH-6 , Mouza - Prasastha &Ankurhati, PO

been read and assessed by Seward’s technical experts. Seward Stomacher products are used for a variety of applications within food, life science and environmental industries. Using the

- Salap P.S.- Domjur Dist - Howrah -711409 T No: 91- 33-66043842 Fax: +91 -33-66043825 Cell ; 09831182850 Email:ajanta.sengupta@expressindia.com KOCHI Dr Raghu Pillai Business Publications Division, The Indian Express Limited, Sankoorikal Building, 36/2248, Kaloor,Kadavanthara Road, Opp. Kaloor Private Bus Stand, Kaloor - 682 017 Tel: (0484) 2343152, 2343328 Fax: 2343153 E-mail: Kochi.bpd@expressindia.com raghu.pillai@expressindia.com COIMBATORE The Indian Express Limited, Business Publications Division, 1st Floor, 731, Avinashi Road, Opp. PRS Grounds, Coimbatore-641 018

Seward online resource centre, scientists can search for specific application protocols by industry, application and product, as well as recently added or most popular. Contact details Asia and Pacific Tel: +65 6519 2283 email:stevenlim @seward.co.uk

Tel: 2212157/2216718/2216732 E-mail: bpdcbe@vsnl.in JAIPUR The Indian Express Limited, C-7, Dwarika Puri, Jamna Lal Bajaj Marg, C-Scheme, Jaipur - 302001 Tel: 0141-370002/371272 Telefax: 91-141-376606 BHOPAL The Indian Express Limited, 6, Vidya Vihar, Professors Colony, Bhopal - 462002, Madhya Pradesh Tel: 0755-2661988 AHMEDABAD Rajesh Bhatkal The Indian Express Limited, 3rd Floor, Sambhav House, Nr. Judges Bunglow Bodakdev, Ahmedabad - 380 015. Tel: (91-79) 26872481 / 82 / 83 Fax: (91-79) 26873950 Mobile: 98213 13017 E-mail : rajesh.bhatkal@expressindia.com

IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express Limited. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

177 EXPRESS PHARMA November 16-30, 2013


PHARMA TECHNOLOGY REVIEW

Health hazards in pharma industry Vinay Pathak, Lab Head - 3M R&D Centre, Gurgaon, 3M Healthcare gives an insight on the health risks associated with the pharma industry and suggests means to mitigate these hazards

LITTLE IS known about the health risks of working in the pharmaceutical industry. On the surface, the industry looks clean. The production of medicinal demands a carefully maintained and sterile working environment and the white lab coats worn by workers add to the illusion of safety. The appearances are deceptive, though. Producing drugs and other medicinal may involve exposure to toxic industrial chemicals. And while the finished products may be lifesaving medications for sick people, they can be dangerous to healthy workers who are inhaling or absorbing them during the production process.

Some general health hazards General health hazards in the manufacture of pharma products include: dust and noise exposures, repetitive motion disorders, exposure to formaldehyde, and exposure to ultraviolet radiation. Dust becomes airborne during manufacture and is a problem for operators; in addition, filling and packaging of the finished product may pose an allergic hazard from dust. Ensuring sterility of the product often involves exposure to formaldehyde and ultraviolet radiation. Formaldehyde may cause lung cancer, Hodgkins disease, and prostate cancer. Acute exposures can cause pulmonary edema (lungs fill with fluid, making breathing impossible) and pneumonia leading to death. Formaldehyde also causes allergic dermatitis. Ultraviolet lamps used to maintain sterility pose a prob-

178 EXPRESS PHARMA November 16-30, 2013

lem too. Although non-ionising (meaning the radiation does not have an electrical charge and therefore causes less damage to cells), ultra-violet radiation is dangerous and can cause skin cancer. The first sign of overexposure is dry, inelastic, and wrinkled skin. Various localised skin sores may develop and should be interpreted as a warning signal. Light-skinned people are most susceptible since their skin lacks pigments that would protect them from overexposure. The constant repetitive motion associated with packaging and filling could lead to carpal tunnel syndrome or tendinitis. Tendinitis is most commonly caused by repetitive and twisting hand motions. Tendinitis symptoms usually are pain and tenderness in the affected area hand, wrist, or forearm. Swelling can also be a symptom. The ability to use the hand is often greatly reduced, with exertion only causing greater pain. Tendinitis can be effectively treated with rest, perhaps in combination with heat and use of a splint. But the cause must be eliminated or tendinitis will develop again. Carpal tunnel syndrome is usually caused by repeated bending and twisting of the wrist, especially when force is applied. Carpal tunnel symptoms include pain in the hand, numbness, tingling, and burning sensations, a dry shiny palm, and clumsiness of the hands. The symptoms often are most acute at night and usually are confined to one side of the hand. Carpal tunnel syn-

Medical treatments include wearing a wrist splint at night and physical therapy. In some cases, anti-inflammatory drugs are prescribed, and surgery may be required in very severe cases. It is very important to remember that treatments for tendinitis and carpal tunnel syndrome will not work unless the cause of the problem, the job or tool design, is changed to eliminate the twisting and bending of the hand and wrist.

While the finished products may be lifesaving medications for sick people, they can be dangerous to healthy workers who are inhaling or absorbing them during the production process VINAY PATHAK, Lab Head - 3M R&D Centre, Gurgaon, 3M Healthcare

drome can best be treated by eliminating the twisting and bending that caused it in the first place, by switching jobs or changing the way a job is done.

Some specific health hazards Hazards specific to the pharma industry result from exposure to the active drug which usually takes place during the last phase of production.

Hormones Health impairment due to pharma products has been described and observed mainly in hormone and antibiotics production workers. The effects of occupational exposure to hormones may be severe. For male workers, exposure to estrogens may give rise to breast development; for female workers, there may be menstrual disorders, abnormal overgrowth of the endometrium and excessive bleeding during menopause. Exposure of male workers to progestogen may bring about a lack of sexual drive and testicular pain. On the other hand, exposure of female workers to androgens is known to cause menstrual and ovarian function disorders, diminished fertility, increased frequency of spontaneous abortions, and

symptoms of masculinity.

Antibiotics Antibiotics are chemical substances capable of destroying micro-organisms such as bacteria and viruses that cause infection in animals and humans. The principal ones are: erythromycin, the penicillins, the tetracyclines, streptomycin, and clindanycin. The effects of occupational exposure to antibiotics can include Allergic reactions: Itching and redness of the eyes, runny nose, skin rashes, asthma, and occasionally shock due to an allergic reaction (anaphylaxis). Vitamin deficiency: Workers with repeated exposure to antibiotics experience a change in the number and type of bacteria which are normally present in the intestines which break down and absorb vitamins in the intestines. Fungal infections: Daily exposure to antibiotic dust can lead to fungal infections of the skin and nails. Additionally, women workers may develop vaginal yeast infections following exposure to antibiotics. Toxic effects: Exposure to certain antibiotics may lead to development of some of the toxic side effects that occur when that drug is given as medicine. Other effects: Older female workers have been incorrectly told that flushing may be due to hormonal changes rather than the antibiotic drugs they are inadvertently taking in. Headaches and stuffy nose are other common complaints. Allergic heart disorders, bronchial asthma, poisoning,


PHARMA TECHNOLOGY REVIEW and allergic disorders of the liver have also been reported. Some experts are concerned that prolonged contact with antibiotics may cause cancer, although there have been no studies confirming this suspicion. Described below are common adverse reactions to some specific antibiotics.

INFORMATION ON WORKING WITH DRUGS MUST BE INTERPRETED WITH CAUTION BECAUSE ... ■

Penicillin Because of the highly allergenic nature of the penicillins and their extensive use, many people have become allergic to them. The most serious reaction is shock. This type of acute reaction usually occurs minutes after exposure. Symptoms are tightness in the chest, asthmatic breathing, dizziness, swelling of the lips, tongue, or face, edema of the lungs, heart failure and in some cases, death. Other reactions are hives, ‘black hairy tongue,’ fungus infection, and rectal itch.

gastrointestinal tract and other internal routes are the normal routes of entry for pharma drugs in patients. Practically no research has been conducted on the relationship between external dose, internal dose, and effects.

SUGGESTIONS FOR CONTROLLING EXPOSURES ■

■ ■ ■

Tetracycline

Workers can be exposed to more than one drug at a time and the effects of multiple exposures are not known. The effects of short exposures to a variety of drugs may be very different from the effects of longer exposures to only one or two drugs. The routes of absorption are different.The respiratory system and skin are the main routes of entry for pharma products in the workplace.The

Use a respirator with a high-efficiency (HEPA) filter. All respirators should be checked to make sure they fit well enough to really protect you. Wear gloves that will protect your skin from contact. Wear long sleeves to keep the drug from getting on your arms. Wash your hands whenever you leave your work area.

Modification of the bacteria of the intestines and other organs has been reported following occupational exposure to tetracycline (as well as to streptomycin and penicillin). In workers exposed to tetracycline and to streptomycin, modification of the bacteria led to a drop in the body's vitamin content, especially of the B vitamins. Another problem associated with occupational exposure to tetracycline is drug resistance. Workers may develop infections that are resistant to treatment with tetracycline.

flushed face. Nitrates dilate the blood vessels and make blood pressure fall. As a result, dizziness and even fainting may occur. Other more serious effects are heart pain, heart attacks, and sudden death following ‘withdrawal’ from exposure.

Drugs for heart disease

Tranquilisers

Nitroglycerin, commonly used in dynamite, is also the basis of several medicines for heart patients -- isosorbide dinitrate, pentaerythritol tetranitrate, and mannitol hexanitrate. Nitrates act on the blood vessels of the body and their effects are felt in several ways. Almost everyone exposed to nitro dust experiences a severe pounding headache which is caused by the relaxation of the blood vessels within the skull. Headaches may be accompanied by a rapid heart beat and a

Both chlordiazepoxide and meprobamate are prescribed as sedatives. Both are habituating and additive. In combination with alcohol, they may cause a person to lose consciousness and in high doses, can lead to coma and death. Workers producing tranquilisers are at risk of these adverse effects and have found that they pass out over a beer after work. There is a real danger of accidents, both in the plant and on the way home, when workers become drowsy as a result of exposure to tran-

Noise: Exposure to noise can be alleviated by acoustic enclosures of high-noise sections of packaging lines. Also, programmed job rotation for the personnel working on manufacturing and packaging lines may be useful in reducing monotony and limiting exposure to noise.

Mechanical hazards: Appropriate devices doing away with, or guarding against, possible "hand traps" should be installed.

quilisers and barbiturates.

Antidepressants Tricyclic antidepressants like amitriptyline, nortriptyline, and imipramine can cause irregular heartbeat (cardiac arrhythmias), posing a particular problem for production workers with heart conditions.

Standards for exposure prevention There are no OSHA standards regulating exposure to pharma. The lack of knowledge about workplace effects of pharma products explains why there are no Threshold Limit Values (TLVs) for pharmacologically active substances (except for acetylsalicylic acid -- a value of 5 mg/m3, 1979). Now and then threshold limits are recommended for pharma products by research workers, mostly in the former USSR. The almost complete absence

of official data shows that it is necessary to reduce exposures to the lowest possible levels.

Studies Some researchers have concluded that it is difficult to evaluate causes of morbidity in pharma workers because manufacturing processes and additives differ between factories and exposures are to multiple chemicals. Mortality: A 1988 study of 826 pharma workers found increased death risk from cancer and suicide. Men had elevated rates of cancers of the colon, central nervous system, and kidney; women had elevated rates of breast cancer. Morbidity: Many workers develop allergic reactions to medicinals that involve bronchial sensitivity, asthma, and difficulty in breathing. It is difficult to evaluate morbidity in pharma workers because of

Some researchers have concluded that it is difficult to evaluate causes of morbidity in pharma workers because manufacturing processes and additives differ between factories and exposures are to multiple chemicals the wide diversity of chemicals used in the manufacturing process. Asbestosis: The respiratory disease found most often among OCAW members working at pharma plants is asbestosis, a disease which often leads to increased mortality. The threat of asbestos-induced disease is potentially present at all pharma plants built before the ’70s. Maintenance workers are especially at risk. Reproductive effects: One study of women found an increase in spontaneous abortion increasing with exposure to methylene chloride, benzene, estrogens, and toluene. Twelve of the 24 female production workers had intermenstrual bleeding. Exposure to solvents and methylene chloride in particular may have harmful effects on pregnancy.

179 EXPRESS PHARMA November 16-30, 2013


PHARMA LIFE APPOINTMENT

Thomas Temple elected Chairman of USP Board of Trustees To guide USP’s mission to improve global health through quality standards for medicines and foods THOMAS R TEMPLE has been elected as the new chairman of its Board of Trustees of US Pharmacopeial Convention (USP). Under Temple’s leadership, the Board will guide the global health organisation as it expands the creation and use of science-based standards that help ensure the quality, purity and strength of medicines, dietary supplements and food ingredients. He succeeds Duane Kirking, who has served as chairman of the Board since January 2009. “The quality of medicines and foods worldwide is the focus of USP and my focus as chairman will be working with

our management, convention membership, the council of experts and other USP volunteers, along with the Board of Trustees, to continue that vital mission,” said Temple. “I am honoured to be elected by my colleagues to this position and look forward to continuing this important work. I would also like to thank my predecessor, Kirking, for his outstanding leadership.” “The importance and relevance of our standards for medicines and foods are increasingly critical in today’s global marketplace,” said Roger L Williams, Chief Executive Officer, USP. “Our work developing

those standards and raising the quality of products wherever possible will be our continued charge under Temple as we move forward.” Temple has served as a Trustee of the Board since 2010, and recently created his own consulting firm after retiring as Executive Vice President and Chief Executive Officer of the Iowa Pharmacy Association (IPA), a position held since 1980. Today he serves as president of Tom Temple Consulting and as director of strategic communications for the University of Iowa College of Pharmacy. Temple is a member of several professional organisations

including the IPA, the American Pharmacists Association, the National Alliance of State Pharmacy Associations (NASPA), and the American Society of Association Executives. A past president of NASPA, he has also served as a board member for the APhA Foundation, the University of Iowa Alumni Association, the Alliance for Patient Medication Safety, the Pharmacy Marketing Group, and the Iowa Initiative to Reduce Unintended Pregnancies. Temple received a BS degree in biology from Northern Illinois University, a BS degree in pharmacy from the Univer-

sity of Illinois, and an MS degree in pharmacy administration from the University of Iowa. EP News Bureau - Mumbai

AWARD Bilcare’s nonClonableID Technology‘nciD’was conferred the prestigious EMS - IEH 2013 Award for its valuable contribution to Patient Safety & Well Being by AIIMS, New Delhi & Oklahoma State University, US recenty at the 2nd International Conference on Emergency Medical Service Systems & Innovation and Entrepreneurship in Healthcare 2013. Dr Praful Naik, Executive Director & Chief Scientific Officer, Bilcare accepted the award on the company’s behalf

183 EXPRESS PHARMA November 16-30, 2013


PHARMA LIFE NEW COURSE

Biocon unveils Biocon Academy To offer ‘Biocon KGI Certificate in Bio-Sciences’ in collaboration with Keck Graduate Institute, US

BIOCON WILL set up Biocon Academy, a centre of excellence for advanced learning in applied bio-sciences. Biocon Academy set up in Bangalore aims to train and develop industry-ready talent for India’s biopharma sector and enable global competitiveness. The academy will offer advanced learning in biosciences that will provide the required proficiency for enhanced career prospects in biotechnology for engineering and science graduates. It will connect the industry and academia to maximise the opportunities for aspiring biotechnologists and to address the skill deficit of the sector. The academy will focus on developing the spirit of experimentation, application of knowledge and the innovation skills of the bioscientists in India, to make them employable in the biotech sector. The academy’s flagship programme in collaboration with Keck Graduate Institute,

184 EXPRESS PHARMA November 16-30, 2013

California, the ‘Biocon KGI Certificate Programme in Biosciences,’ has started for enrollment, for the January 2014 session. The deadline for online application submission is December 6, 2013. Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, said, “Biocon is pleased to partner with KGI in its new training initiative, the Biocon Academy, aimed at developing a new cadre of life sciences professionals. KGI is uniquely qualified, through its outstanding faculty and its state-of-the-art infrastructure that includes the Amgen Bioprocessing Centre, to help us with this endeavour. Given the growing stature of India’s life sciences industry, both Biocon and the Indian life sciences sector as a whole will benefit greatly from this collaboration.” She added, “Biocon Academy aims to bring world class training programmes for biotech students in India

The academy will offer advanced learning in biosciences that will provide the required proficiency for enhanced career prospects in biotechnology for engineering and science graduates. It will connect the industry and academia to maximise the opportunities for aspiring biotechnologists through customised programmes like the Biocon KGI Certificate programme in Biosciences and make them employable. In keeping with our commitment to affordability and greater access, Biocon will offer a merit scholarship of 75 per cent of the course fee for all the meritorious students selected through an in-

tensive selection process.” Sheldon M Schuster, President, Keck Graduate Institute, said, “We are proud to be working in partnership with Biocon to develop a unique educational experience for students and scientists who want to develop skills for working in a complex, global, highly regulated industry, one that

that has tremendous capacity to improve lives. Through our collaboration with the scientists and subject matter experts at Biocon, KGI has developed an applied, graduate level curriculum that will be focused on teamwork and will reflect current industry dynamics. Graduates with the Biocon Academy-KGI certificate in bioscience will have added skills that will help them to be immediate contributors as employees.” He added, ”KGI faculty will deliver courses synchronously to students at the Biocon Academy facility using developed technology, supported by experts in the life sciences industry at Biocon. Set up in Bangalore, Biocon Academy will provide the biotech industry the best professionals with the right orientation and training -- thus leading the way in transforming the industry and the community.” EP News Bureau - Mumbai


REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.


Express Pharma 16-30 November 2013, Part III