Dawnrays Pharmaceutical

Changing trends and development in healthcare infrastructure make way for wide range of new antibiotic entrants in the Indian pharmaceutical market. According to a report by Datamonitor titled, ‘High-end antibiotics usage in India,’ the market for high-end antibiotics in Indian hospitals was worth $685.8 million in FY 2010 (April 9 – March 10), having shown a year-on-year growth of 49.8%. The market is estimated to grow to about $1,841 mn by FY 2015 (April 14 to March 15), posting a compound annual growth rate of 21.8 percent.

Datamonitor noted in its report that as healthcare infrastructure improves in India and well-established hospital chains expand their presence across the country, the market for hospital antibiotics is likely to widen. Although the antibacterial market in India is currently dominated by generics, newer antibiotics are constantly being sought after.

The report noted that the swiftly transforming economic scenario in India has caused a shift in disease patterns and focus from communicable to non-communicable diseases. Despite this, infections remain one of the top five causes of mortality in India. A lack of antibiotic policies in hospitals and increasing pressure on healthcare delivery systems has led to the indiscriminate use of antibiotics. Furthermore, the availability of relatively sophisticated antibiotics, even without a prescription, leads to self-medication.  

Antibacterials represent the largest segment of the Indian pharmaceutical market and despite modest growth it remains the mainstay of the country’s pharmaceutical industry. A significant proportion of antibiotic usage occurs in hospitals and therefore tracking the consumption rates of high-end antibiotics within hospitals would provide useful insight into their antibiotic usage patterns. In order to develop a better understanding of the infection patterns as well as the prescription patterns of high-end antibiotics within Indian hospitals, Datamonitor has undertaken the study and analysis of the use of high-end antibiotics in leading hospitals in India.

The Datamonitor noted that the strengthening of the IPR regime in India is likely to support the introduction of new, patent-protected drugs; this coupled with the need for newer, broad-spectrum antibiotics may provide global as well as leading Indian pharmaceutical companies an opportunity to introduce premium-priced, hospital antibiotics in India in the near future.

The findings of the report point towards the rapid uptake of newer, premium-priced, broad spectrum antibiotics like fourth generation cephalosporins and carbapenems, which are quickly replacing older antibiotic categories such as third generation cephalosporins and broad spectrum penicillins.

After experiencing a growth phase over the past few years, the global pharma market is passing through a stagnant phase mainly due to patent expiry of blockbuster drugs and saturation of the pharma market in western countries.

The global market size of pharma industry was estimated at $748 bn in 2009 and the total size of the pharma market in the Asia Pacific region was $69 bn in 2009 as against $56.95 bn in 2008. The top 10 products alone contributed $3.3 bn to the pharma market in the Asia Pacific region in 2009, as opposed to $2.74 bn in 2008. According to IMS Health report, Lipitor, one of the top performing products of Pfizer leads the competitive market of Asia Pacific region with sales revenue of $800 mn in 2009. Lipitor is proven to lower bad cholesterol level by 39-60 percent and reduces the risk of heart attack and stroke.

Plavix, anti-platelet medicine, developed by Sanofi-aventis maintained its second position in the APAC market with sales revenues of $487.25 mn in 2009. AstraZeneca’s Crestor, which is prescribed to reduce the risk of heart attack and stroke, is in third position with sales revenue of $337.10 mn in 2009.

AstraZeneca’s Crestor, which is prescribed to reduce the risk of heart attack and stroke, is in third position with sales revenue of $337.10 mn in 2009. Crester registered an outstanding growth of 37.6 percent as pared to the revenues generated in 2008. Next in the list of top products are Nexium by AstraZeneca, Norvasc by Pfizer and Seretide by GlaxoSmithKline.

Zyprexa approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder generated revenues to the tune of $227.37 mn in 2009 and is marketed by Eli Lilly and Company and Glivec by Novartis that is used to treat certain types of cancer generated $204.2 mn last year.

In terms of growth, over the previous fiscal, besides Crestor, Sodium Chloride, which is used largely in China for medicinal purpose in hospitals clocked an outstanding growth of 35.6 percent. Chinese herbal product Shu Xue Ning churned sales revenue of $197.7 mn and registered 33.6 percent growth over the previous fiscal.

Top 10 Therapies

According to IMS Health, the top 10 therapies generated over $20 bn in the APAC market. Cephalosporins & combs generated $5.04 bn in 2009 and maintained its top position. It was followed by Kanpo & Chinese medicines that drove the market with $2.65 bn. Antiulcerants maintained its third position in the market with an estimated revenues of $2.43 billion.

Country Performances

China has the strongest market for pharma products and it contributes a major portion of the business in the APAC region. The market value of pharma products in China is $25.3 bn in 2009 followed by Korea at $9.3 bn and Australia at $9.2 bn. India, Malaysia and Singapore are valued at $8.2 bn, $572 mn and $446 mn respectively.

China

The pharma market in China is dominated by traditional herbal medicines. However, modern medicine also has its presence in the market. The IMS Health report states that the total value of the China pharma market was $25 bn in 2009 with seven out of top 10 products comprising traditional Chinese medicines. Sodium chloride stood at the top with a sales revenue of $211.14 mn in 2009 followed by Shu Xue Ning at $197.7 mn and Ke Lin Ao at $154.7 mn.

The World Health Organization has been insisting on the integration of modern and traditional medicines in order to form a new branch of medical science. Plavix developed by Sanofi-aventis generated sales of $130.9 mn in 2009 and Losec manufactured by AstraZeneca made business of $111.2 mn in China. Losec is a proton-pump inhibitor used for the treatment of stomach ulcers, severe gastro-oesophageal reflux disease (GORD) and Zollinger-Ellison syndrome.

Korea
 
In Korea, Plavix from Sanofi-aventis leads the market with revenue of $81.4 mn in 2009 followed by Lipitor from Pfizer at $62.2 mn. Glivec from Novartis is at the third position with sales revenue of $57.7 mn. Baraclude by Bristol-Myers Squibb made sales of $54.9 mn in 2009.

Baraclude or entecavir is a prescription medicine used for chronic infection of hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver. Hepatitis B is the world’s most common serious liver infection, affecting nearly one-third of the world’s population. Over time, chronic hepatitis B can lead to severe liver damage in some people.

Other top performing drugs in Korea are Stillen by Dong-A, Norvasc by Pfizer, Bacchus-D by Dong-A, Hepsera by GlaxoSmithKline, Diovan by Novartis and Dilatrend by Chong Kun Dang. Though the Korean pharma market is still dominated
by multinational companies, Korean companies like Dong-A and Chong Kun Dang are competing with the drug giants as they were able to secure three positions in the top performing products of Korea. With the prediction that healthcare spending in South Korea is expected to increase from $58.9 bn in 2009 to $80 billion in 2010, Korean companies are investing profits into generics and are developing their brand in a strong way in APAC market.

Australia

The pharma market in Australia is led by Lipitor with a record sales of $481.8 mn in 2009 followed by Crestor and Nexium both developed by AstraZeneca at $201 mn and $166.2 mn respectively.

Australia has relatively lower population and it has a growing elderly population. The country has an advanced health system, a high level of spending and a growing willingness to use cheaper medicines. The generic market is poised to grow, however, in terms of value, the branded market still has its dominance in Australia.

India

The total pharma market of India is valued at $8.2 bn and the top performing product of the country is Phensedyl Cough made by Mumbai-based Piramal Healthcare. The product did business of $39 mn in 2009. The next top performing products are Human Mixtard 30/70 by Abbott and Corex by Pfizer that did business of $38 mn and $35 mn respectively in 2009. Human Mixtard 70/30 is available as injectable and is a dualacting insulin. It is a biphasic formulation containing fast-acting and long-acting insulin. Corex is a cough syrup available in India, Pakistan, Bangladesh and a few other South Asian countries. Corex was the first brand in the Indian pharmaceutical industry to cross the $22 mn mark in 2005.

Next in the row is Voltaren by Novartis that generated $34 mn in 2009. It is a non-steroidal anti-inflammatory drug (NSAID) taken to reduce inflammation and as an analgesic reducing pain in conditions such as arthritis or acute injury. It is used for musculoskeletal complaints, especially arthritis, rheumatoid arthritis, polymyositis, dermatomyositis, osteoarthritis, dental pain, TMJ, spondylarthritis, ankylosing spondylitis, gout attacks, and pain management in cases of kidney stones and gallstones. Other top performing products in India are Augmentin by GlaxoSmithKline, Zifi by FDC, Taxim by Alkem and Monocef by Aristopharma.

Malaysia

Lipitor maintained its top position in Malaysia and registered sales figure of $8 mn in 2009. It is followed by Plavic, Norvasc and Crestor as the top four products in the chart. The healthcare spending of Malaysia is growing at about 13 percent a year. This is indicative of a trend towards an increasingly healthy lifestyle and promises to open up opportunities for Malaysia’s pharmaceutical companies to meet the increased demand for healthcare products.

Domestic companies dominate the generics and over the counter (OTC) products, while multinational companies reign strong in branded drugs. The pharmaceutical industry in Malaysia relies heavily on imported products, which fulfill 70 percent of the demand. The major imported drugs in Malaysia are lifestyle drugs such as cholesterol lowering and anti-diabetics, cardiovascular, and oncology drugs.

Singapore

With the outbreak of Influenza A (H1N1) flu virus worldwide in 2009 and Singapore being on the radar of the virus outbreak, there was an urgent need for the medication to prevent the spread of the virus. Wide accessibility of Tamiflu by Roche in Singapore drove the product to touch the sales of approximately $8 mn. Roche has a stronghold in Singapore and besides Tamiflu its products Herception and Avastin are the top three products in the region. Herception registered sales revenue of $7 mn in 2009 and Avastin registered $6 mn.

Herceptin is used for the treatment of breast cancer and can be used for the treatment regimens including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel or as a single agent following multi-modality anthracycline-based therapy. Bevacizumab approved by the US Food and Drug Administration (FDA) are used for cancer treatments that are metastatic (have spread to other parts of the body).

Avastin is a humanized monoclonal antibody that recognizes and blocks vascular endothelial growth factor A (VEGF-A). VEGF-A is a chemical signal that stimulates the growth of new blood vessels (angiogenesis). Avastin is approved by the FDA for metastatic cancers. In Singapore, among the top 10 products, five are manufactured and branded by Roche, followed by AstraZeneca, of which three products Crestor, Nexium and Iressa are in the top 10 list.

Global Market

The total market value of the pharma products is estimated at $748 bn. The top 15 products in the global market contributed $95 billion in 2009. Lipitor maintained its top position in the consecutive year by registering a sales figure of $13.3 bn. Second in the list is Plavix that showed a growth of 4.9 percent over 2008 and made business of $9 bn in 2009.

Growth wise, Crestor by AstraZeneca performed well with a growth rate of 36.5 percent in 2009 over the previous year, followed by Abilify, which registered 30.7 percent growth. Abilify is indicated for the treatment of anti-depressant in adults. It can also be used for the treatment of manic and mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients between 10 and 17 years of age. It is taken for treatment of schizophrenia in adults and in adolescents between 13 and 17 years of age and treatment of irritability associated with autistic disorder in pediatric patients between six and 17 years of age.

In global market, Seretide registered revenues of $8 bn in 2009. Seretide is used in asthma and chronic obstructive pulmonary disease and it contains fluticasone/salmeterol. Of the products that performed better in pharma segment at a global level, Lipitor, Plavix, Crestor, Nexium and Seretide are the products that made it to the top 10 products listing in the Asia Pacific region.

Large multinational pharmaceutical companies continue to be active in seeking acquisitions in emerging Asian markets such as India and China. With over $70 billion drugs coming off patent by 2012, pharmaceutical majors are looking to these regions for new revenue streams. India is an attractive destination for players looking to grow generics franchises.

There is a growing interest in the vaccines segment, where both India and China continue to attract large deals. Recent tie-ups include Sanofi Pasteur’s 80 percent stake in India’s Shantha Biotechnics for $781 million and Novartis’ 85 percent stake in China-based Zheijang Tianyuan Bio Pharma for $125 million, according to Ms Riddhima Saxena, reporter at mergermarket.

Meanwhile, the Chinese government, which controls many pharmaceutical companies, is pushing domestic consolidation. In India too, consolidation is expected to continue as large family controlled companies are China, India look for domestic consolidation seeking the benefits of selling out to strategic investors. Of note is the recent muli-billion dollar acquisition of Piramal Life Sciences’ diagnostics business by US-based Abbot Laboratories.

“There has also been an increase in clinical research outsourcing services to China and India followed by countries such as Malaysia, Vietnam and Singapore. China, which is home to several large contract research organizations (CROs), has attracted interest from the US companies. Charles River Laboratories recently bid $1.2 billion for China-based Wuxi Pharmatech. Meanwhile, Indian CROs could take more time to attract overseas interest on account of smaller scales. The Japanese market is also slowly opening up for consolidation. Domestic companies are engaging in deals with European and the US-based companies for opportunities in medical devices and pharmaceuticals and generics,” concludes Ms Saxena.

BIO is hosting a signing ceremony to welcome new members to the Biotechnology Industry Organization: Zhangjiang Hi-Tech Park and China Medical City.

BIO’s CEO, President James Greenwood will deliver the welcome speech.  BIO’s Executive Vice President for International Affairs Sean Darragh will also be present at the event.

Mr. Lanzhong Wang, General Manager of Zhangjiang Biotech Base, Zhangjiang Hi-Tech Park and Mr. Rong He, Head of China Medical City will speak briefly at the ceremony.

China has been striving to become an innovation country in biotechnology.  Promoted by central and local provincial government, many biotech-based parks are established by governmental supported fund and land.  Their main goal is attracting foreign companies/technologies into the park as well as establishing local Chinese companies within the park.  Each park is competing to bringing in top-notch biotech and pharmaceutical companies.

The attendees of the ceremony will be other park members and members from China’s biotech and pharmaceutical companies. BIO hopes this ceremony will be the first of many new entities from China to join BIO’s ranks.

Zhangjiang Hi-Tech Park

Zhangjiang Hi-Tech Park (Z-Park) is the oldest and most successful biotech park in China.  It is located in Shanghai and it houses many western multinational firms in the biotechnology, pharmaceutical and chemical businesses.

The Zhangjiang Bio-pharmaceutical industry has formed a model of cluster development, which has also become one of the most prominent and concentrated regions with domestic and international R&D organizations, innovation and new drug development.  Zhangjiang Life Science Cluster has formed a strong cluster with seven of the top 10 global multinational pharmaceutical companies setting up their R & D centers or headquarters in Zhangjiang. It plays an important role in creating an innovative drug R & D environment, and stimulates directly or indirectly the rapid growth of CRO business.

China Medical City

China Medical City (CMC) is located in the heart of Taizhou City in the Medical Hi-Tech Development Zone. CMC is positioning itself to become the country’s largest pharmaceutical, biotech, and medical equipment development zone, with cutting-edge support service and streamlined regulatory and registration processes. Considered a prime area for growth and stability, China Medical City is located on the Yangtze River only two hours from Nanjing and three hours from Shanghai.

CMC occupies 25 square kilometers, comprising several functional zones. The zones includes R&D, manufacturing, exhibition and trade, healthcare service, education, administration and related facilities.

BEIJING, April 20 (Xinhua) — To mourn the victims of a strong earthquake in northwest China’s Qinghai Province, national flags will fly at half-mast in the country and its embassies and consulates overseas on Wednesday, according to the State Council Tuesday.

To express the deep condolences for the quake victims, public entertainment will also be suspended on Wednesday, the State Council, China’s cabinet, said in an announcement.

As of 8 p.m. Monday, the 7.1-magnitude quake, which struck the Tibetan Autonomous Prefecture of Yushu last Wednesday, had killed more than 2,000 while 195 people were still missing, the rescue headquarters said.

China has emerged as an important economy that enhances registration and enforcement of intellectual property rights (IPRs). China is renowned as the world’s factory, with the emergence of an affluent and growing middle-class.

The Chinese government has worked assiduously to develop and implement modern and streamlined IP legislation. The filing, examination and registration system for patents, trade marks, and registered designs in China, work well in comparison to IP offices in other countries.

Of the significant world economies, China is also unique in offering two avenues—administrative and judicial—for the enforcement of IPRs. A major issue facing the judicial enforcement system is the quantum of damages awarded to successful IP owners. At present, judicially awarded damages do not provide a sufficient deterrent to third party infringement. The comparatively low levels of damages awarded have been argued to be sufficiently small to tempt would-be infringers to take on an infringement lawsuit risk. Nevertheless, this is slowly changing, as more advanced mechanisms for calculating damages have become available, and actual damages awarded have increased.

Another important IP issue, especially for brand and copyright owners, is the seemingly entrenched custom of low cost copying driven by the pull of the local Chinese market. It cannot be denied that brand and copyright owners continue to face significant problems in China. To effect cultural change to improve this situation we need further concerted efforts at all levels of Chinese society—it will take generations.

The situation for patentees has, at least, improved in the last decade, and continues to improve. Some Chinese provinces have also introduced further IP protection measures like policing IPRs at trade shows and exhibitions.

Notwithstanding the persisting difficulties, it is imperative that, in any given infringement situation, IP owners work closely with experienced local counsel to develop an enforcement strategy that is most likely to prove effective. In particular, owners should determine whether damages or an injunction is the desired outcome. If an injunction only is required, the administrative (as opposed to the judiciary) enforcement procedure may be more suitable and cost-effective.  Owners should also determine whether other means of enforcement might prove effective.

Chinese Enforcement System

In 2007, thousands of IPR infringement cases were decided in the Chinese courts and by administrative procedures. Foreign IPR holders alone proceeded within the vicinity of 2,000 lawsuits. These are staggering numbers, even when compared to the US. Economic analysis suggests that foreign companies actually fare better in the Chinese IP courts, as opposed to China based companies. Law enforcement courts in major cities such as Beijing and Shanghai are gaining experience in IP-related activities. In addition, a special IP court has now been proposed to accept and hear civil, administrative and criminal cases related to IPRs.

However, in 2007, average damages awarded by the Chinese courts amounted only to $13,100 (only 15 percent of the actual damages sought). There is anecdotal evidence to suggest that IP owners under-claim damages, so as to avoid prejudicing the court’s inclination to injunct an infringer. Thus, until the quantum of damages that make would-be infringers to seriously reconsider copying or counterfeiting, certain IPR infringement will continue to be rife in China.

Chinese law does not have the provisions for common law-style discovery, leading to IPR owners experiencing difficulties in establishing losses. Also, because of the low margins infringers make account for profits that does not provide an adequate remedy or deterrent. In cases where the amount of damages cannot be ascertained, the People’s Court may make an order for damages not exceeding a modest $73,000 based on the factual matrix of individual cases, subject to the latest amendment of patent laws where the maximum amount of damages is doubled.

Though the case is seen as an anomaly, the largest ever successful damages claim was $44.3 million awarded to Chint Group in 2007. The trend in Chinese court is to award greater damages in IPR infringement matters, and this will get strengthened as more transparent accounting procedures and systems are adopted by the Chinese legislature.

Administrative Procedures

Compared to the Chinese court procedure, various administrative enforcement procedures available in China are fast, simple and cost-effective. The procedures are mainly employed to secure an injunction at a low-cost and within a short time frame. Decisions can be issued 3-6 months after case receipt, but can be as fast as five days, when accompanied by a raid action. The procedure can also be used to secure delivery, and destruction of goods and collateral materials.

Occasionally, it is possible to track down the source of infringed products using such administrative measures. It is also possible to request severe punishment for infringers, but more often modest fines are applicable. Sometimes the administrative action can provide a referral for a subsequent criminal action.

The administrative procedure cannot be used to secure damages, and administrative fines are typically quite small and thus ineffective to stop serious or repeat infringers.

Judicial Procedure

When compared to Western common law court procedures, the Chinese court procedure is still relatively fast and cost-effective. However, final hearings and decisions are not issued within the year (especially for cases where foreign parties are involved), and hotly contested cases can become protracted. Chinese judges are working assiduously to ensure fair and open trials. In addition, in the absence of discovery procedures, plaintiffs must employ pre-litigation investigation to try and uncover, develop and trap evidence. This can prove to be a risky and uncertain process and can result in destruction of valuable evidence. Care also needs to be taken to ensure jurisdictional control.

IP system in China

After 30 years of its ‘open door policy’, China has started to move from a manufacturing based to a knowledge-based economy and, in the process, has adopted improved IP laws, judicial processes and enforcement procedures. There have also been significant cultural shifts within Chinese society in the perception and recognition of intellectual property rights (IPRs).

Whilst Western governments and respected commentators continue to highlight remaining deficiencies in the Chinese IP system. The general improvement in the IP system is noteworthy and is moving in the right direction. Quantum of damages and a culturally-driven practice of counterfeiting well-known brands and copyright works remain as significant issues.

Mr Johnson Lam was appointed as a solicitor of the High Court of Hong Kong SAR in September 2005. He primarily assists in intellectual property matters. He has a special interest in China matters. He completed Master of Laws in China Laws, co-hosted by the City University of Hong Kong and the Remin University of China. He also assists in general litigation matters.

With the Pharmaceutical sector experiencing a revamp, DUPHAT 2010 is also reinvented to cater to the needs of a large segment of population of its target audience from UAE, GCC, Arab and Europe.

DUPHAT 2010 will provide an avenue for mutual interaction to discuss and deliberate the radical changes and advances in the Pharmaceutical discipline during a dynamic 3-day program embracing conference presentations, scientific workshops, technology exhibitions and poster presentations.

It is committed this year to new challenges affecting the pharmaceutical world. The gathering will therefore focus on the exchanges concerning various aspects in the science of pharmacy.

The 15th edition of DUPHAT as customary shall be held in collaboration with the Dubai Health Authority, Dubai, UAE and in association with Ministry of Health UAE, American Society of Health System Pharmacists (ASHP), European Federation for Pharmaceutical Sciences (EUFEPS), European Society of Clinical Pharmacists (ESCP), Society of Hospital Pharmacists of Australia (SPHA), International Association of Therapeutic Drug Monitoring & Clinical Toxicology (IATDMCT), Canadian Pharmacists Association (CPhA), International Society for Pharmacoepidemiology (ISPE), Utrecht University, The Netherlands, European Society of Oncology Pharmacy (ESOP) and Monash University.

The scientific gathering will enable participants to come to grips with the experts in the field of pharmacy science with activities parallel to the conference resulting to long-term benefits and providing continuing medical education. The exhibition will reveal avant-garde technologies.