Recent highlights on anti-cancer drugs market and development

Ø          Oncologists backing of combo products supporting cytotoxic market

Ø          Top 10 late-stage cancer drugs in 2012

Ø          Eli Lilly To Focus On Cancer, Diabetes In China, CEO Says

Ø          GC-Rise sponsors anti-cancer campaign in China

Ø          China Faces Economic Growth Threat As Tobacco Spurs Cancer Risk

Ø          Chinese colorectal cancer drug market forecast to grow to over $400 million in 2016

Ø          Week in Review: Ascletis In-Licenses China Rights to RNAi Cancer Drug

Ø          Panacea Biotech inaugurates new cancer drug facility in India

Ø          Russia's colorectal cancer drug market to reach over $480 million in 2016

Ø          Actavis to boost oncology presence in Turkey, with generic drug launches

Oncologists backing of combo products supporting cytotoxic market 13 May 2012 Print This ShareThis The popularity of combination therapies in the treatment of cancer is set to increase, which will help offset revenue losses in the cytotoxic therapies market due to blockbuster patent expiries, according to a new report by pharmaceutical experts GBI Research. The new report suggests that oncological drug treatments are evolving to involve biologic medication, which, in combination with cytotoxic drugs, is fast-becoming the top pharmaceutical therapy.The cytotoxic therapies market has eight major indications, namely breast cancer, cervical cancer, colorectal cancer, head and neck cancer, non-Hodgkin lymphoma, non-small cell lung cancer, ovarian cancer and prostate cancer. The average annual cost of therapy for cytotoxic therapies is estimated to decrease moderately over the coming years, to reach an approximate value of $7,660 by 2017. This is predicted to lead to a decrease in overall market value.

Taxotere and Gemzar leading products Major cytotoxic brands such as Taxotere (docetaxel) from Sanofi and Gemzar (gemcitabine) from Eli Lilly are currently the most commercially successful brands, with Taxotere achieving sales of $1.2 billion in 2011 and Gemzar recording global sales of $452.1m. Other brands such as Alimta (pemetrexed) and Xeloda (capecitabine) have also crossed the billion dollar mark in sales. However, these drugs are set to lose their patent protection in coming years, opening the market up to entry from generics. However, an increasing acceptance of combinations of cytotoxic medicines with monoclonal antibodies is anticipated to counter the decline on market value caused by the use of generic drugs in the future. The impressive therapeutic capabilities of biologics in controlling and treating oncological complications have led to their widespread use and popularity amongst patients and prescribers alike. This has also convinced pharmaceutical manufacturers to commence label extensions of their present biologics portfolio for multiple oncology complications, even in combination with cytotoxic medicines. This will support the continued development of cytotoxic drugs, despite the major safety hurdles that have previously led to a weak development pipeline. The cytotoxic therapies market accounted for $6.5 billion in revenue in 2002, before increasing at a compound annual growth rate (CAGR) of 5.8% to reach $10.1 billion in 2010. All factors considered, the value of the market is estimated to decline marginally by 2017.   

Top 10 late-stage cancer drugs in 2012 April 18, 2012 | By Ryan McBride Thousands of experimental meds are winding their way through various stages of clinical trials today, and the largest category among the contenders is cancer drugs. Of the hundreds of cancer programs under surveillance at FierceBiotech, we've culled the most promising programs we could find. We welcome contrary views about our picks, but we saw four of the 10 drugs we selected last year--Seattle Genetics' ($SGEN) Adcetris (brentuximab vedotin), Pfizer's ($PFE) Xalkori (crizotinib), Plexxikon's Zelboraf (vemurafenib, formerly code-named PLX4032) and Roche's ($RHHBY) Erivedge (vismodegib)--gain FDA approvals since last year. The others remain in the hunt for regulatory nods, and we've included many of them in this year's roundup. Like in last year's edition of this report, we've emphasized drugs that are at the very least headed into late-stage development. Most of the programs featured have provided compelling safety and efficacy data, yet we also highlighted a lesser-known drug called BBI608 because it's an excellent example of how the field of new drugs targeting cancer stem cells has matured. Dainippon Sumitomo saw enough promise in the program to scoop up its developer, Boston Biomedical,in a deal that could be worth more than $2.6 billion.  

BBI608 – 10 Promising Late-Stage Cancer Drugs – 2012

Cabozantinib – 10 Promising Late-Stage Cancer Drugs – 2012

Carfilzomib – 10 Promising Late-Stage Cancer Drugs – 2012

Enzalutamide (formerly MDV3100) – 10 Promising Late-Stage Cancer Drugs – 2012

Ponatinib – 10 Promising Late-Stage Cancer Drugs – 2012

Regorafenib – 10 Promising Late-Stage Cancer Drugs – 2012

Talimogene laherparepvec (OncoVex) – 10 Promising Late-Stage Cancer Drugs – 2012

T-DM1 (trastuzumab emtansine) – 10 Promising Late-Stage Cancer Drugs – 2012

Tivozanib – 10 Promising Late-Stage Cancer Drugs – 2012

Zaltrap (aflibercept concentrate) 10 Promising Late-Stage Cancer Drugs – 2012  

Eli Lilly To Focus On Cancer, Diabetes In China, CEO Says By Bloomberg News - Mar 20, 2012 8:10 PM GMT+0800 Eli Lilly & Co. (LLY) will introduce more than a dozen products in China, including drugs for diabetes and cancer, in the next five years to help maintain sales growth, Chief Executive Officer John Lechleiter said. “Our goal is to be the fastest growing pharmaceutical company in China,” Lechleiter told reporters at a briefing in Beijing today. “We are increasing our investments in every aspect of our business,” he said. Lilly’s Chinese sales grew by 25 percent last year, faster than the industry average, after the Indianapolis-based drugmaker doubled its sales force in the Asian country over a three-year period, according to Lechleiter. The 58-year-old executive plans to raise Lilly’s share of revenue from China to more than 2 percent by focusing on “unmet needs.” As diabetes rates soar in China, Lilly is competing with drugmakers including Merck & Co. and Sanofi to try and unseat Bayer AG (BAYN) and Novo Nordisk A/S (NOVOB) as the biggest providers of diabetes medicines. At stake is a market that may triple to $2.1 billion in annual sales by 2019 from $700 million in 2009, according to Yifi Liu, an analyst for Datamonitor in Shanghai. Diabetes treatments were probably the main driver of Lilly’s 31 percent growth in third-quarter sales in China, Lechleiter said in November. Drug Quality, Reliability Still, the world’s fastest-growing major economy poses its share of challenges to pharmaceutical companies. Drugmakers, seeking new sources of growth as patents on their best-sellers expire, are facing pressure on margins in China as the government has vowed to extend drug-price cuts to trim the cost of caring for an aging population. Lechleiter said he hopes China won’t focus only on cutting drug prices. “While we understand the need of the government to save money and moderate the cost of providing health care, we also believe that other factors need to be taken into account,” he said. Drug quality and the reliability of supply should be considered, Lechleiter said. Lilly’s Cialis drug for treating erectile dysfunction, which was introduced in China in 2009, will soon surpass Pfizer Inc. (PFE)’s Viagra as the top seller for the condition in the nation’s markets where it is sold, Eric Baclet, president of Lilly China, said. “In our quest for leadership in some of these China cities, we feel very confident,” he said. Cialis was Lilly’s fifth best-selling pharmaceutical product in 2011, contributing $1.88 billion or 7.7 percent of sales, according to data compiled by Bloomberg.  

GC-Rise sponsors anti-cancer campaign in China  Updated on 13 June 2012 GC-Rise Pharma-sponsored symposiums in more than 10 cities in China as part of anti-cancer campaign Anti-cancer campaigns in China, sponsored by GC-Rise Pharma Related Articles NATCO wins compulsory license for anti-cancer drug LegoChem offers new platform in anti-cancer therapy Singapore: GC-Rise Pharmaceutical exclusively sponsored a nation-wide anti-tumor academic exchange event initiated by the Committee of Gynecological Oncology, Chinese Anti-Cancer Association. The program will consist of several symposiums in more than 10 cities throughout the country, focusing on the diagnosis, treatment as well as the improvement of post-treatment life quality concerning gynecological tumors. The committee held its first symposium in Beijing on May 27, in which GC-Rise jointly explored how to improve life quality for women patients who have received tumor-removal operations with the medical experts. Professor Sheng Xiugui, a senior committee member of the association, said that, "Post-operation treatment is just as important as the operation itself; the life quality of patients after the operations should be given high attention." Sheng cited Remifemin, introduced by GC-Rise, a herbal drug that treats some of the effects of menopause, as a preferred product to alleviate or eliminate the symptoms of menopause after operations or chemotherapy such as profuse sweating, insomnia or emotional instability. GC-Rise introduced Remifemin from Germany at the end of 2008. After three years' expansion in China, its market share is now 11 percent, a top-three product in its segment. The company also teams up with CMC to make its voice heard through the CMC-GC-Rise Journal.  

China Faces Economic Growth Threat As Tobacco Spurs Cancer Risk  By Bloomberg News - Apr 3, 2012 12:00 AM GMT+0800 China, the world’s biggest cigarette market, may suffer slower economic growth because of cancer and other chronic diseases that are hurting the labor force, Health Minister Chen Zhu said. Non-communicable diseases which cause prolonged sickness are responsible for four out of five deaths in China, compared with about 63 percent globally, and absorb about 70 percent of the nation’s health spending, Chen said in an interview yesterday. Fighting the threat requires tighter scrutiny of the tobacco industry, linked to 1 million deaths in China, he said. Cigarettes are arranged for a photograph in New York, U.S. Photographer: Chris Goodney/Bloomberg China’s gross domestic product has grown an average 10 percent a year for the past three decades, transforming the nation into the world’s biggest exporter and replacing Japan as the second-biggest economy after the U.S. At the same time, the country now counts more than 90 million diabetes and 120 million chronic kidney disease sufferers -- the most in the world. “If we don’t curb the fast rise of chronic diseases in China, it will have an impact not just on people’s health, but also on society and the economy,” Chen, 59, said on the southwestern island of Hainan, where he is attending the Boao Forum for Asia. “It could affect the continuity of our economic growth because a lot of deaths caused by chronic diseases are in people younger than 60.” The government wants to improve the efficiency of health services as it grapples with a rising incidence of life-long diseases. While the elderly were looked after in the past by their children, urbanization and the nation’s one-child policy have eroded the tradition of family care, shifting the burden to the state.

$558 Billion Cost Unless preventative steps are taken, early deaths from so- called non-communicable diseases such as heart disease, stroke, diabetes and cancer will crimp China’s national income by $558 billion in the decade ending 2015, according to the World Health Organization. Half of sufferers who die of chronic diseases are under 65 years of age, according to the World Bank. China will consider expanding its health-care workforce and increasing resources near major cities to improve access, Chen said. The government will also look at introducing standards to ensure quality isn’t compromised amid a new tendering system tested in Anhui province that encourages drugmakers to compete for state contracts to supply essential medicines. “In evaluating the essential medicines, we need to put quality as the priority and not just the price,” Chen said. “The prices of drugs and equipment are a little bit high in China. Balancing the growth of the industry and controlling health expenditure is both a challenge and a dilemma for the government.”

Tobacco Addiction Tobacco also presents another dilemma in China, the world’s biggest producer and consumer of the aromatic leaves, accounting for 38 percent of cigarettes smoked worldwide in 2009. The State Tobacco Monopoly Administration, the industry regulator, runs the world’s biggest cigarette maker, China National Tobacco Corp. “The commercial activities of the tobacco companies should be totally separate from administrative supervision,” Chen said. “We are strengthening the leadership issue in China, and one of the key aims is to enhance the government’s supervision of the commercial activities related to tobacco,” he said. Rapid industrialization and migration to cities that brought sudden improvements in living conditions have contributed to the increase in chronic diseases, said Chen, who as a 16-year-old youth in 1970 was sent during the Cultural Revolution to work in rural Jiangxi province. He taught himself traditional Chinese medicine while working in the villages and began practicing as a so-called barefoot doctor, according to a 2007 interview he gave to the People’s Daily newspaper. Rush to Diabetes “The social transformation in China is remarkable, but it is also maybe too rapid,” Chen said yesterday. “Once people get past poverty and start to lead better lives then new challenges start to emerge like diabetes.” East Asians may be more susceptible to developing the metabolic condition because they tend to carry more of their body fat around their abdomens -- a more deleterious place to store energy, he said. “For East Asians to become diabetic, they don’t need to be very obese,” said Chen, who received formal medical training in Shanghai and a doctorate in 1989 from the Universite Paris Diderot, where he specialized in hematology. “We need to figure out the biomarkers related to these kinds of disease tendencies so we can identify the high-risk populations and offer them preventive measures,” he said. Chen is the first and sole minister-level Chinese official who doesn’t belong to any political party, and only the second minister not from the ruling Communist Party. He dedicates a small portion of his time -- about 2 percent -- to scientific research at the Shanghai Institute of Hematology, with the support of his wife, a doctor, and his mentor Wang Zhen-Yi, he said. Chen and Wang were both awarded the Szent-Gyorgyi Prize in January by the U.S. National Foundation for Cancer Research for their work on a new leukemia treatment. He didn’t rule out returning to the laboratory full time when his current term as health minister is slated to end in March next year. “It will depend on the needs of my people and my nation,” he said.   

Chinese colorectal cancer drug market forecast to grow to over $400 million in 2016  Article | 4 April 2012 The colorectal cancer drug market in China will grow from a value of $261 million in 2011 to $404 million in 2016, according to a new report from advisory firm Decision Resources, titled Colorectal Cancer in China, which notes that the increased use of targeted therapies will be a key factor driving growth in this market. Report findings reveal that, although two targeted therapies - Merck KGaA’s Erbitux (cetuximab) and Roche’s Avastin (bevacizumab) - have both been approved by the State Food and Drug Administration in China, the high cost of treatment with these agents has limited their use to colorectal cancer patients in the second- or third-line of therapy. However, Decision Resources expects between 2011 and 2016, Chinese oncologists will use Erbitux and Avastin earlier in the treatment algorithm and more frequently. Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here. “The use of Erbitux and Avastin in first-line treatment of metastatic colorectal cancer patients is common in the major markets, and we anticipate that practice will impact prescribing patterns in China,” said Decision Resources analyst Jing Wu, adding: “Because of the premium price of these agents, even a slight increase in patient share will drive increased sales and market growth.” Expanded reimbursement, spending power and diagnosis contributing to growth The analysis reveals that expanded reimbursement of drugs treating colorectal cancer, increased patient spending power and an increase in the number of diagnosed and drug-treated patient populations will also contribute to market growth. “The number of diagnosed incident cases of colorectal cancer in China will increase five percent annually over our ten-year forecast,” said Ms Wu, noting that “the increase is due mainly to an aging population and an increase in the age-adjusted risk of colorectal cancer due to increased exposure to various risk factors attributable to colorectal cancer.”  

Week in Review: Ascletis In-Licenses China Rights to RNAi Cancer Drug publication date: Jul 14, 2012 Richard Daverman, PhD  Ascletis Pharma, a US-China JV that made headlines one year ago when it announced $100 million in initial startup capital, in-licensed China rights to its first drug candidate, an innovative RNAi molecule from Alnylam Pharma (NSDQ: ALNY) (see story). ALN-VSP is being developed for liver cancers including hepatocellular carcinoma (HCC). Ascletis will have exclusive rights for ALN-VSP in China, Hong Kong, Macau and Taiwan. Alnylam will retain rights to the drug for the rest of the world.  Yunnan Walvax Biotech (SHE: 300142) obtained a 51% stake in Shanghai Fengmao Biotech (see story). Walvax, previously known as a vaccine maker, will establish subsidiaries of Fengmao to produce five monoclonal antibodies and a sustained-release version of the anemia treatment EPO. Walvax will invest $16 million in cash, while other investors will contribute a monoclonal technology valued at $14.6 million.  HAO Capital, a Beijing-headquartered private equity firm, teamed up with TCL Group, a consumer electronics company that has a medical device subsidiary, to form a JV called TCL Healthcare (see story). The JV will target the high-end diagnostic imaging market in China. The capitalization of the JV was not disclosed.  Siegfried Holding (SIX: SFZN), a Swiss CMO, is building an API and intermediates production facility in Nantong (see story). The construction is being supported by the Nantong Economic and Technological Development Area (NETDA). Siegfried said additional land at the site may be used in the future for building a finished drug facility.  

Trials and Approvals Oculus Innovative Sciences (NSDQ: OCLS) of California received SFDA approval for MicrocynR Hydrogel, a topical treatment for moistening, repairing and healing of acute and chronic wounds (see story). With the approval in hand, Shanghai Sunvic, the China partner of Oculus, will launch the product in Q3 of 2012, marketing Microcyn Hydrogel in both the OTC and professional healthcare markets in China.  

Government and Regulatory The SFDA has issued new regulations governing the purity and safety of excipients, the pharmacologically inactive substances that drugmakers add to stabilize or deliver a drug’s active ingredients (see story). The new rules, which go into effect on October 1, place responsibility for the safety of the excipient on the drug company that uses it. The regulations also require excipient makers to test their products and prove they meet all specifications.   

Panacea Biotech inaugurates new cancer drug facility in India Article | 28 March 2012 Indian health care management company Panacea Biotec says that it has inaugurated a new state-of-the-art oncology facility at Baddi, Himachal Pradesh, to meet the growing demand of anti-cancer products in the country. This new manufacturing plant will entail an annual production capacity of around 1.2 million vials, and has been set up in compliance with various international regulatory standards such as current Good Manufacturing Practice (cGMP) of the US Food and Drug Administration and UK regulatory agency. The plant has been set up with a project cost of around 550 million rupees ($10.3 million).  Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here. At the inauguration, Rajesh Jain, joint managing director of Panacea Biotec, said the new capacity “will not only enable us to scale up production of our innovative range of anti-cancer products, but also offer substantial affordable innovative medicine to consumers at large." Panacea Biotec has been aggressively ramping up its production capacity, as well as introducing new business lines to cater to emerging business opportunities in various therapeutic segments. The company has released products for sales from commercial production from March 2012.

Points to drug shortages in the USA Dr Jain added: "With this new facility, Panacea Biotec has taken another leap towards becoming one of the prominent players in anti-cancer formulation business globally. This new facility will improve our ability to develop and deliver world class affordable medicine, and will also equip us to keep pace with the growing demand for anti-cancer products globally. For certain oncology products, due to insufficient manufacturing capacity, industry consolidation, lack of redundancy and complex manufacturing process, the US market regularly faces shortages. In the year 2011, US FDA had to resort to multiple temporary importations from unapproved sources to mitigate drug shortages.” India accounts for 7.5% of the total new cases of cancer globally. In India, cervical and breast cancer are the most common, contributing over 26 per cent to the total cases, followed by lung, mouth, pharynx and esophageal cancer. The oncology market in India is about $186 million, and is expected to reach $693 million by end of 2013 with a compound annual growth rate (CAGR) of nearly 21%. Panacea Biotec says it is in process of registering its range of anti-cancer products in emerging “rest of the world” markets and in Europe and the US market.  

Russia's colorectal cancer drug market to reach over $480 million in 2016  31 May 2012 Print This ShareThis The colorectal cancer (CRC) drug market in Russia will grow 3% annually to $487 million in 2016, according to a new report from Decision Resources titled Colorectal Cancer in Russia. Changes in medical practice, a growing CRC patient population and the launches of four novel branded CRC therapies are key factors contributing to this growth. Anticipated changes in medical practice include increased access to KRAS testing in Russia, which in turn will increase the use of premium-priced EGFR inhibitors such as Merck KGaA’s Erbitux (cetuximab) and Amgen’s Vectibix (panitumumab), as the testing will identify potential responders to these two therapies. Additionally, the introduction of Erbitux onto Russia’s List of Essential Medicines and the anticipated inclusion of Vectibix on the same registry before 2016 will likely lead to an increase in the use of these agents. The report predicts. “Testing for KRAS mutations was not included in the 2006 Russian CRC treatment guidelines nor is the cost of testing currently covered by mandatory health insurance,” said Decision Resources analyst Natalia Reoutova. “Nevertheless, Russian oncologists we interviewed are optimistic that testing will become more readily available in the future. Many cite the Improvement of Molecular-Genetic Testing for Oncology Diseases in the Russian Federation that is funded by Merck and AstraZeneca as a key to their anticipated increase in the rates of genetic testing,” she added.

New drug launches anticipated The report also forecasts a launch of four novel branded therapies in Russia between 2013 and 2016, namely, Regeneron/Sanofi’s Zaltrap (aflibercept) - which is expected to become the highest-selling new therapy to enter the market during Decision Resources’ forecast period - Bayer’s regorafenib, Alchemia’s HA-irinotecan and ImClone Systems/Eli Lilly’s ramucirumab. The new report features extensive primary research with Russian oncologists as well as a market outlook by drug and class through 2016 and colorectal cancer epidemiology through 2021.  

Actavis to boost oncology presence in Turkey, with generic drug launches Article | 30 November 2011 Iceland-headquartered generic drugmaker Actavis is planning to increase its presence in Turkey next year and make a real difference within the country's oncology sector. Drawing on its “expertise in affordable, high quality and technologically advanced oncology products, Actavis Turkey will launch a range of oncology medicines in 2012, along with various other new products,” said the company, the global number four in the generic sector. Actavis chief executive and chairman Claudio Albrecht believes there is huge potential for growth within the Turkish oncology market, noting: "Actavis helps more than one million oncology patients every year around the world, with medicine that's made at our flexible, high capacity and high quality EU manufacturing sites. Actavis Turkey can offer added value in oncology, delivering great quality for patients at affordable prices." Enjoying this article? Have the leading Biopharma news & analysis delivered daily on email by signing up for our FREE email newsletter here. To include generic docetaxel, irinotecan, gemcitabine, vinorelbine, fludarabine, etoposide and topotecan Outlining the company's plans for 2012, Actavis Turkey country manager Serdar Sozeri confirmed that a major oncology offering would be launched in 2012. "The new molecules available to the Turkish market will include docetaxel, irinotecan, gemcitabine, vinorelbine, fludarabine, etoposide and topotecan. These new oncology products will help support Turkish people in the battle against cancer, and for health care professionals there is the added advantage of Actavis' innovative safety-enhancing developments,” he said. Mr Sozeri continued: “Building on detailed consultation in more than 40 markets, Actavis continues to develop new and often unique oncology presentations. Recent developments include ready-to-use mini-bags and reformulations of old powder-form cytotoxic pharmaceuticals.” Revenues for the Actavis Group are expected to top 2 billion euros ($2.65 billion) in 2012, with the Turkish market forecast to contribute around 38 million euros. Globally, Actavis' hospital business ranks amongst the top 10 hospital generics players, with 630 dedicated hospital employees present in more than 30 markets and two high-quality manufacturing sites in Italy and Romania. It has manufacturing capacity for 42 million vials and markets in excess of 150 hospital products, a number that is set to increase rapidly with hundreds of applications currently pending and an ambitious development pipeline, the company noted.