Tuesday, 28 April 2015
Breast cancer on rise in India
For more than 4 decades, cervical cancer was the major killer disease in India. But Breast Cancer which has been on a steady rise has over taken cervical cancer as the most common and deadly killer disease of the new era. The 1 in 28 women in India was likely to develop breast cancer during her lifetime. A few decades back, breast cancer was seen only after fifty years of age and the number of young women suffering from this disease was lesser. Almost 65-70 per cent patients were above 50 years and only 30 to 35 per cent women were below 50 years.
This was stated by Dr R Ranga Rao, Head of Department & Director- Oncology , Max Super Speciality Hospital.
He said further, however, presently, breast cancer was more common in the younger age group and 50 per cent of all cases are in the 25 to 50 years age group. More than 70 per cent of the cases present in advanced stage was accounting for poor survival and high mortality.
Talking about facts on breast cancer, Dr Vivek Gupta, Sr. Consultant- Surgical Oncology, informed that it was estimated that there would be 1,55,000 new cases of breast cancer in the year 2015. About 76000 women in India were expected to die due to the disease. If we did not work on creating awareness about early detection of cancer, the figure could be much worse. Breast self examination and mammography were the noble technique to deduct breast cancer cases at early stages.
Dr Rudra Acharya, Sr Consultant- Surgical Oncology, pointed out that ironically most of the cases in our country are diagnosed very late and according to the statistics of WHO, more than 60% of the women were diagnosed with breast cancer at stage III or IV in India. This drastically affected the survival rate and treatment options for the patients.
Source:http://timesofindia.indiatimes.com/City/Chandigarh/Breast-cancer-on-rise-in-India/articleshow/47080768.cms
This was stated by Dr R Ranga Rao, Head of Department & Director- Oncology , Max Super Speciality Hospital.
He said further, however, presently, breast cancer was more common in the younger age group and 50 per cent of all cases are in the 25 to 50 years age group. More than 70 per cent of the cases present in advanced stage was accounting for poor survival and high mortality.
Talking about facts on breast cancer, Dr Vivek Gupta, Sr. Consultant- Surgical Oncology, informed that it was estimated that there would be 1,55,000 new cases of breast cancer in the year 2015. About 76000 women in India were expected to die due to the disease. If we did not work on creating awareness about early detection of cancer, the figure could be much worse. Breast self examination and mammography were the noble technique to deduct breast cancer cases at early stages.
Dr Rudra Acharya, Sr Consultant- Surgical Oncology, pointed out that ironically most of the cases in our country are diagnosed very late and according to the statistics of WHO, more than 60% of the women were diagnosed with breast cancer at stage III or IV in India. This drastically affected the survival rate and treatment options for the patients.
Source:http://timesofindia.indiatimes.com/City/Chandigarh/Breast-cancer-on-rise-in-India/articleshow/47080768.cms
Best of Astro’ to be held in India
Medical fraternity unites in a bid to discuss new technology/ treatment modalities to fight cancer
Kokilaben Hospital, in association with the’ Association of Radiation Oncologists of India (AROI)’, will host the BEST OF ASTRO Cancer Conference on 2-3 May 2015, Mumbai, a pioneer in clinical practice, guidelines and research being held for the first time outside US in India at KDAH.ASTRO, or The American Society for Radiation Oncology, is the largest radiation oncology body in the world.
Dr Ram Narain, Executive Director, KDAH, said, “Kokilaben Hospital has played a pivotal role in cancer care in the city and country, and is proud to host such a feast of cancer education. Events like Best of ASTRO are of utmost importance in the field of oncology as they help in the evolution of the discipline through discussions, leading to research and innovation. One can expect this event to be a benchmark in medical oncology in India that will eventually help the Indian Diaspora by bringing the best of treatments home.”
The first ‘Best of Astro’ in India will be represented by five eminent international faculties namely-Director of Radiation Oncology, US, Oncology Group; a member from Dana Farber Cancer Institute, Harvard University, Massachusetts; and three distinguished professionals from MD Anderson Cancer Centre, Houston, Texas. Beside this, 100 national and SAARC faculties and 400 delegates from India, Pakistan, Bangladesh, Nepal and Sri Lanka are expected to join this premier international scientific event. Participants will gain exposure to the latest science in radiation oncology in the context of day-to-day practice and treatment protocols.
Dr Rajesh Mistry, Director, Centre for Cancer, KDAH said, “In early stage lung cancer treatment, surgery has been the main and traditional option, but stereotactic body radiotherapy (a form of radiation) has emerged as a major treatment modality. Such conferences will help elaborate discussion on such useful techniques.”
Dr MC Pant, President, and Dr Rajesh Vashistha, Secretary General (Association of Radiation Oncologists of India) also commented, “It is a great opportunity for those who could not attend ASTRO annual conference in San Francisco, as attending a conference in the US is not only expensive but difficult logistically. It cannot get better than presenting and discussing the same abstracts and scientific presentations by eminent international and national faculties in India.”
Dr Kaustav Talapatra, Head – Department of Radiation Oncology, KDAH, and Organising Secretary and Coordinator, first BEST OF ASTRO Conference, India, said, “It is a matter of great pride for us at Kokilaben Hospital to host an international meet of such repute and magnitude. For the first time, ASTRO has officially licensed the “BEST of ASTRO” conference to three nations: Mexico, Turkey and India. Radiation as a treatment has become very prominent in treatment of various cancers like head and neck, cervix, breast, lung and brain. BEST OF ASTRO will help cancer specialists in a unique manner by informing us about the latest updates in the field and recent changes in practice of treatment. This will ultimately help our doctors improve cancer services by adding more scope to the opportunities available, which are at the core of discussion in this conference.”
Dr Sandeep Goyle, Consultant Medical Oncologist, and Kokilaben Dhirubhai Ambani Hospital, “The trend of organ preservation in cancer is on the rise and with modalities like radiation and chemotherapy, mutilating surgeries are on the decline. A multimodal approach has rendered better cosmetic and functional outcomes.”
Radiotherapy has been one of the mainstays in the treatment of cancer, with about half of all cancer patients receiving some type of radiation therapy during the course of their illness. In solid adult tumours, owing to its limited biological efficacy .High precision techniques have not only decreased the toxicities and side effects but has also helped improved survival in certain cancers, concluded Dr Talapatra.
Source:http://www.financialexpress.com/article/healthcare/happening-now/best-of-astro-to-be-held-in-india/67314/
Summer school for budding oncologists at Tata Memorial Hospital
Tata Memorial Hospital (TMH) Mumbai soon to open up a summer school for under graduates and post graduate medical students from civic and government-run medical colleges to study oncology. This novel initiative has been taken in collaboration with Kings College of London.
The Tata Memorial Hospital
Tata Memorial Hospital (TMH) Mumbai soon to open up a summer school for under graduates and post graduate medical students from civic and government-run medical colleges to study oncology. This novel initiative has been taken in collaboration with Kings College of London.
Since TMH is known to be a pioneer institute of oncology, it is an apt ground for budding oncologists. Oncology is essentially, a branch of medicine that deals with tumors. The suggested course at TMH will involve a ten-day basic oncology lecture padded with rounds of different areas of the hospitals related to the subject. Take for instance radiotherapy department, day care chemotherapy ward, out patient department, pain and palliative care department and oncology rehabilitation unit.
"The philosophy behind this course is to develop aptitude in oncology and to understand its basic principles. This year, we will be allowing fifty students for this ten-day program and students have been selected by screening," said Dr. Kailash Sharma, director of academics at TMH in his statement-of-purpose written by the students.
Owing to the fact that the hospital has a standalone super speciality institute offering degrees such as Master of Chirurgical (Mch) and Doctor in Medicine (DM) in radio therapy for students across the country, oncology is a sought-after department at TMH.
Sharma further added that, "We have kept a few reserved seats for sponsored candidates from government medical colleges and government-recognized cancer centers to provide trained and qualified human resource in the field of oncology."
Source: http://www.dnaindia.com/mumbai/report-summer-school-for-budding-oncologists-at-tata-memorial-hospital-2080774
Cancer Genetics expands next-generation sequencing capabilities in India
Launch solid tumor hotspot panel for biopharma and clinical customers throughout Asia
Cancer Genetics announced that Cancer Genetics India (CG India) has launched a next-generation sequencing (NGS) based panel targeting the five most common solid tumours: breast, colorectal, lung, skin and ovarian cancer for the Indian and broader Asian markets. The NGS-based panel provides a comprehensive genomic assessment of cancer mutations with dramatically increased sensitivity compared to other testing methodologies, and can be applied to over 370,000 patients annually in India alone. The NGS panel covers over 2,800 clinically validated, common cancer mutations and can be used from as little as 10 nanograms of DNA from a variety of sample types, including fresh frozen or formalin-fixed paraffin-embedded (FFPE) tissue.
The tests is expected to help CG India in its strategic initiative to generate a library of critical, actionable genomic data that can be used by clinicians for improved patient management and by researchers in India and worldwide to develop more targeted therapeutics.
“Cancer Genetics India’s NGS tumour hotspot panel will allow clinicians in India the capability to access the genomic information necessary to improve the diagnosis and management of patients with common cancers,” said Dr Vidudala Prasad, Head of Research and Development at Indo American Cancer Hospital in Hyderabad, India. “It also offers valuable genomic insights for investigators working on oncology-focused clinical trials,” he added.
CG India is now one of few companies in India that is making this NGS technology and mutation hotspot panel available for use by oncologists, biopharma companies, and research organisations. Panna Sharma, CEO of Cancer Genetics commented, “There is a critical need in India and Asia for high-quality assessment of cancer that is comprehensive, genomically-guided and supported with state of the art bioinformatics. The clinical and research community will find tremendous value in both the NGS panel and in our genomic database which we expect will be an invaluable tool in the improvement of cancer outcomes for patients and in the acceleration of novel discoveries into the marketplace.”
CG India is also in discussions with a number of biopharma and research companies in the formation of strategic collaborations and partnerships to use the NGS hotspot technology for discovery and accelerated research, informed a company release. The NGS panel addresses a significant, underserved and growing market, and is expected to contribute to CG India’s overall growth.
Reportedly, the use of the NGS hotspot panel will enable the collection of a large library of genomic data that can be used to improve the quality and accuracy of clinical research and discovery efforts. Sharma added, “CG India is among the first companies to launch NGS testing in India. This new panel further establishes us as a leader in DNA-based diagnostics in India. With the launch of this new panel, we are in a unique position to deepen our collaborations and partnerships with major cancer centres, academic government institutions, and biopharma companies focused on oncology research.”
Source: http://www.financialexpress.com/article/healthcare/happening-now/cancer-genetics-expands-next-generation-sequencing-capabilities-in-india/65937/
Monday, 27 April 2015
Top 25 Biopharma R&D Spenders of 2014
- Big pharma may be retreating from internal R&D, but big biotech has more than made up for it with its own ramped-up research spending. This year’s Top 25 Biopharma R&D Spenders plunked down $100.441 billion on research, including $94.108 billion from the top 20; up 6% from the $88.643 billion spent in 2011 by the Top 20 on GEN’s first such list.How much less is big pharma spending? Not too much less than four years ago, actually. The 10 largest heritage drug developers on the List shelled out a combined $69.077 billion in 2014, less than 1% below the $69.459 billion spent in 2011. The six biotechs appearing in both years’ Lists spent nearly 50% more on R&D in 2014 than three years earlier, their combined total jumping since 2011 to $14.85 billion. Their increases in R&D are larger than those of big pharmas—though it should be noted that only four companies on this List spent less on R&D in 2014 than 2013, though two companies have alerted INVESTORS
they plan to cut back in 2015.Reasons for the big biotech R&D surge are almost as varied as the companies involved. Biotech giants have spent recent years finalizing numerous late-stage trials for products that only lately have been launched to market. The most successful of those big-biotech drugs is Gilead Sciences’ Sovaldi, which zoomed to #2 on last week’s GEN List of Top 25 Best-Selling Drugs of 2014, cracking the eight-figure sales benchmark.Also, drug developers big and small have been gobbling each other up through mergers and acquisitions, many of which involved buyers that continued the R&D programs of the companies they bought. Another less obvious reason: The collaborations that are taking the place of internal R&D often involve upfront payments and promises to pay for a partner’s research, both funded through R&D budgets. One company on this List agreed to spend more than $1 billion upfront.Following is this year’s list of 25 biopharmas, ranked by their GAAP spending on R&D in 2014, as reported in annual filings or press releases. Each company is listed by name, 2014 R&D spending, 2013 R&D spending, and the percentage change from 2013.This year’s List omits one company that has appeared in past years’ lists of Top R&D Spenders. Merck KGaA was not scheduled to release full-year 2014 results until after the deadline of this List (March 3).
Note:
1 Figures are GAAP R&D expenses. Company also released non-gap “adjusted” R&D spending figures of $987.1 million for 2014, reflecting adjustments to R&D that included contingent consideration fair value adjustments, write-off of contingent consideration, accretion expense, operating results for assets held for sale, brand-related milestone payments and upfront option payments, accelerated depreciation and product transfer costs, acquisition-integration-and-restructuring expenses, acquisition accounting fair market value adjustment to stock-based compensation, and acquisition-related settlements.
2 Company has disclosed a “full year 2015 standalone financial forecast” that it expects to spend “approximately $1.1 billion” in non-GAAP R&D INVESTMENT.
3 Figures represent R&D expenses for the pharmaceuticals unit of the company’s Bayer HealthCare unit, including special items. Bayer also furnished figures for HealthCare R&D expenses before special items: $2.099 billion (€1.876 billion) in 2014, up 13.5% from $1.849 billion (€1.653 billion) in 2013.
4 Figures are GAAP R&D expenses. The increase in GAAP R&D expenses was attributed primarily due to increased clinical trial activity and an in-process R&D (IPR&D) impairment charge, partially offset by lower upfront payments for collaboration arrangements. Company also reported adjusted R&D figures of $1.651 billion in 2014, up 9.6% from $1.506 billion in 2013. Adjusted R&D expenses included expenses related to advancing clinical trials and expenses for collaboration-related payments to partners.
5 Figures are GAAP R&D expenses. Company also furnished non-GAAP expense figures of $2.585 billion in 2014, up 32.7% from $1.948 billion in 2013. The non-GAAP figures do not include stock-based compensation expenses, restructuring expenses, acquisition-related expenses, and acquisition-related contingent consideration re-measurement
6 Company cited the addition of R&D programs from Onyx Pharmaceuticals, the drug developer acquired for $9.7 billion in a deal completed in 2013; as well as support for later-stage clinical programs, offset partially by reduced expenses associated with marketed product support and Discovery Research & Translational Sciences.
7 Company has issued 2015 financial guidance that stated in part: “Research and development expenses decreasing in the low-single-digit range.”
8 2014 figure includes $278 million in “Upfront, milestone and other payments” expenses and $343 million in in-process R&D impairments expenses
9 Company has issued 2015 guidance to INVESTORS that revised downward its forecast of anticipated R&D spending this year, from $4.8 billion to $5.0 billion, to between $4.7 billion and $4.9 billion
10 Company also furnished “core” R&D figures that do not include onetime expenses. Core R&D spending fell to $4.795 billion (£3.113 billion) in 2014, down 8.3% from $5.228 billion (£3.394 billion) in 2013.
11 Company said its 2014 increase in R&D expense reflected higher spend in monoclonal antibodies development programs and Phase IV studies in rare diseases and multiple sclerosis, which were partially offset by internal costs savings.
12 Figure includes $497 million in restructuring expense and $141 million in “tangible amortization and impairments.” AstraZeneca also furnished “core” or non-GAAP R&D figures of $4.941 billion for 2014, up 15.7% from $4.269 billion in core R&D spending in 2013, “reflecting the expansion of the late-stage pipeline.”
13 Company said the full-year decline reflected targeted cost reductions and lower clinical development spending resulting from portfolio prioritization. In October 2013, company launched a restructuring of its R&D and commercial operations that included elimination of 8,500 jobs worldwide and identification of four key therapeutic areas: Oncology, DIABETES, acute hospital care, and vaccines. For 2015, company projected that its R&D expenses are expected “to be modestly above 2014 levels.”
14 Company also furnished non-GAAP R&D figures of $6.532 billion for 2014, down 8.3% from $7.123 billion in 2013.
15 Company attributed the increase in its adjusted R&D expense “primarily due to incremental expenses associated with the ongoing Phase 3 programs for bococizumab, palbociclib, ertugliflozin and certain other new drug candidates, as well as potential new indications for previously approved products, especially for Xeljanz.” Company has also issued 2015 financial guidance projecting that its adjusted R&D expenses will be between $6.9 and $7.4 billion
16 Pfizer also furnished non-GAAP R&D figures of $7.153 billion for 2014, up 9.1% from $6.554 billion in 2013. Non-GAAP figures do not include onetime “certain significant items.” In 2014, significant items consisted mostly of a $1.163 billion charge associated with a collaboration with Merck KGaA, announced in November 2014, to jointly develop and commercialize an investigational anti-PD-L1 antibody now in development as a potential treatment for multiple types of cancer. The charge included an $850 million upfront cash payment as well as an additional amount of approximately $300 million reflecting the fair value for certain co-promotion rights for Xalkori granted to Merck KGaA. Significant items also included an $83 million charge for “Implementation costs and additional depreciation––asset restructuring” related to Pfizer cost-reduction and productivity initiatives
1 Figures are GAAP R&D expenses. Company also released non-gap “adjusted” R&D spending figures of $987.1 million for 2014, reflecting adjustments to R&D that included contingent consideration fair value adjustments, write-off of contingent consideration, accretion expense, operating results for assets held for sale, brand-related milestone payments and upfront option payments, accelerated depreciation and product transfer costs, acquisition-integration-and-restructuring expenses, acquisition accounting fair market value adjustment to stock-based compensation, and acquisition-related settlements.
2 Company has disclosed a “full year 2015 standalone financial forecast” that it expects to spend “approximately $1.1 billion” in non-GAAP R&D INVESTMENT
.3 Figures represent R&D expenses for the pharmaceuticals unit of the company’s Bayer HealthCare unit, including special items. Bayer also furnished figures for HealthCare R&D expenses before special items: $2.099 billion (€1.876 billion) in 2014, up 13.5% from $1.849 billion (€1.653 billion) in 2013.
4 Figures are GAAP R&D expenses. The increase in GAAP R&D expenses was attributed primarily due to increased clinical trial activity and an in-process R&D (IPR&D) impairment charge, partially offset by lower upfront payments for collaboration arrangements. Company also reported adjusted R&D figures of $1.651 billion in 2014, up 9.6% from $1.506 billion in 2013. Adjusted R&D expenses included expenses related to advancing clinical trials and expenses for collaboration-related payments to partners.
5 Figures are GAAP R&D expenses. Company also furnished non-GAAP expense figures of $2.585 billion in 2014, up 32.7% from $1.948 billion in 2013. The non-GAAP figures do not include stock-based compensation expenses, restructuring expenses, acquisition-related expenses, and acquisition-related contingent consideration re-measurement
6 Company cited the addition of R&D programs from Onyx Pharmaceuticals, the drug developer acquired for $9.7 billion in a deal completed in 2013; as well as support for later-stage clinical programs, offset partially by reduced expenses associated with marketed product support and Discovery Research & Translational Sciences.
7 Company has issued 2015 financial guidance that stated in part: “Research and development expenses decreasing in the low-single-digit range.”
8 2014 figure includes $278 million in “Upfront, milestone and other payments” expenses and $343 million in in-process R&D impairments expenses
9 Company has issued 2015 guidance to INVESTORS
that revised downward its forecast of anticipated R&D spending this year, from $4.8 billion to $5.0 billion, to between $4.7 billion and $4.9 billion10 Company also furnished “core” R&D figures that do not include onetime expenses. Core R&D spending fell to $4.795 billion (£3.113 billion) in 2014, down 8.3% from $5.228 billion (£3.394 billion) in 2013.
11 Company said its 2014 increase in R&D expense reflected higher spend in monoclonal antibodies development programs and Phase IV studies in rare diseases and multiple sclerosis, which were partially offset by internal costs savings.
12 Figure includes $497 million in restructuring expense and $141 million in “tangible amortization and impairments.” AstraZeneca also furnished “core” or non-GAAP R&D figures of $4.941 billion for 2014, up 15.7% from $4.269 billion in core R&D spending in 2013, “reflecting the expansion of the late-stage pipeline.”
13 Company said the full-year decline reflected targeted cost reductions and lower clinical development spending resulting from portfolio prioritization. In October 2013, company launched a restructuring of its R&D and commercial operations that included elimination of 8,500 jobs worldwide and identification of four key therapeutic areas: Oncology, DIABETES
, acute hospital care, and vaccines. For 2015, company projected that its R&D expenses are expected “to be modestly above 2014 levels.”14 Company also furnished non-GAAP R&D figures of $6.532 billion for 2014, down 8.3% from $7.123 billion in 2013.
15 Company attributed the increase in its adjusted R&D expense “primarily due to incremental expenses associated with the ongoing Phase 3 programs for bococizumab, palbociclib, ertugliflozin and certain other new drug candidates, as well as potential new indications for previously approved products, especially for Xeljanz.” Company has also issued 2015 financial guidance projecting that its adjusted R&D expenses will be between $6.9 and $7.4 billion
16 Pfizer also furnished non-GAAP R&D figures of $7.153 billion for 2014, up 9.1% from $6.554 billion in 2013. Non-GAAP figures do not include onetime “certain significant items.” In 2014, significant items consisted mostly of a $1.163 billion charge associated with a collaboration with Merck KGaA, announced in November 2014, to jointly develop and commercialize an investigational anti-PD-L1 antibody now in development as a potential treatment for multiple types of cancer. The charge included an $850 million upfront cash payment as well as an additional amount of approximately $300 million reflecting the fair value for certain co-promotion rights for Xalkori granted to Merck KGaA. Significant items also included an $83 million charge for “Implementation costs and additional depreciation––asset restructuring” related to Pfizer cost-reduction and productivity initiatives
Top 10 M&A Deals of 2014
- Source: http://www.genengnews.com/insight-and-intelligenceand153/top-10-m-a-deals-of-2014/77900350/
- Just a few numbers show how far the value of 2014’s top deals involving biopharma mergers and acquisitions (M&A) has surpassed those of 2013: The biggest acquisition of 2014, at $66 billion, is more than four times that of 2013’s number-one (Thermo Fisher Scientific’s purchase of Life Technologies for $13.6 billion plus $1.5 billion in debt).The number of 2014 M&A deals exceeding $10 billion (five) is 2.5 times the two such deals that occurred in 2013, and the second deal barely surpassed eleven digits at $10.4 billion, the price Amgen paid for Onyx Therapeutics.Most importantly, the value of 2014’s top 10 M&A transactions reached a combined $179.05 billion—nearly three times the combined $66.4 billion of a year earlier.How did M&A deals get so huge? The revival of the financial markets, plus buyers’ willingness to pay big for new treatments, pushed M&A activity to new heights. So, too, did the trend of U.S. biotechs scrambling to slice their tax bills through “inversion” mergers with European partners—though the U.S. Treasury Department dampened that stampede somewhat through new regulationsThe new anti-inversion rules claimed two other megadeals. One of them would have made this list had it not fallen through: AbbVie’s aborted nearly $52 billion purchase of Shire. The other deal was Salix Pharmaceuticals’ planned merger with Cosmo Pharmaceuticals, which at $2.7 billion would have missed the list by a wide margin, coming in as only the 18th largest M&A deal of 2014. (A third megadeal, Pfizer’s ill-fated $116 billion attempt to buy AstraZeneca, ran afoul of opposition from the takeover target as well as the U.K. government of Prime Minister David Cameron, which sought guarantees that the buyer would not eliminate jobs and operations in the kingdom).So large are this past year’s mergers and acquisitions that the 11th largest deal narrowly missed this list despite its value of about $5.3 billion—Mylan’s purchase of Abbott Laboratories’ non-U.S. developed markets specialty and branded generic drug business. A deal that size would have ranked at No. 6 in 2013.Finally, what about next year? Veteran industry observer G. Steven Burrill, CEO of Burrill LLC and Burrill Media, said December 16 that he doesn’t foresee 2015 being an even hotter year for mergers and acquisitions, or initial public offerings for that matter: “The unprecedented IPO and M&A activity this year will make 2014 one for the record books and unlikely to ever be surpassed." Whether Burrill’s caution proves to be prudent remains to be seen.Below is a list of 2014’s top 10 largest M&A deals disclosed in 2013 by drug developers, tools/tech companies, and CROs, ranked by deal value in U.S. dollars. Each acquired company is listed along with its acquirer or prospective acquirer, the price, and the status of the deal.
The Top 25 Best-Selling Drugs of 2014
- Bad press didn’t hurt Sovaldi™ (sofosbuvir) after all. The Hepatitis C virus (HCV) treatment drew the wrath of three members of Congress, who demanded that developer Gilead Sciences justify its $84,000 price for a full 12-week treatment course of Sovaldi. The company offered its justification and didn’t have to worry about too much fallout from the criticism, since its three Congressional critics were top Democrats in the Republican-majority House of Representatives.Even better for Gilead, which barely began marketing Sovaldi at the end of 2013, sales of the HCV treatment zoomed into eight figures—high enough to place near the top of GEN’s latest version of its List of Top 25 Best-Selling Drugs, reflecting drug sales reported for 2014.Unlike last year’s Top 25 Best-Selling Drugs of 2013, this year’s list had only 24 drugs generating total sales of $3 billion or more. That allowed the 25th best-selling drug of 2014 to make this year’s list (it appeared in GEN’s Top 20 Best-Selling Drugs list in 2012 but missed 2013), despite sales in only the high-$2 billion range.Biopharma is in a transition period as the blockbusters of the past decade fade. They have either fallen off the proverbial patent cliff (Novartis’ Diovan, which lost US exclusivity in 2012) or succumbed to a stronger U.S. dollar against European and Asian currencies despite rising sales (Novo Nordisk’s NovoLog, which also missed this year’s list). At the same time, the next generation of multi-billion-dollar drugs takes time to build the billions in sales needed to make the best-seller list—but can be expected to do so starting next year.At the top, last year’s winner finished #1 again, and with higher sales than 2013. Indeed more than half (16) of the Top 25 best-selling drugs did better in 2014 than the previous year. Among the top three disease categories, six best-selling drugs have indications for forms of cancer, and five for arthritis. Five indications—asthma/COPD, DIABETES, heart disease, HIV, and multiple sclerosis—are each represented on the list by two best sellers.One likely top-seller of 2014 not on the list is Boehringer Ingelheim’s Spiriva, which racked up €3.552 billion ($4.019 billion) in 2013. However, BI will not release full-year 2014 data until April 22, just as it waited until April 2014 to release 2013 data, explaining its absence from GEN’s list.Top-selling drugs are ranked based on sales or revenue reported for 2014 by biopharma companies in press announcements, annual reports, INVESTOR materials, and/or conference calls. Each drug is listed by name, sponsor(s), diseases indicated, 2014 sales, 2013 sales, and the percentage change between both years.
#19. Januvia (sitagliptin)
Sponsor(s): Merck & Co.Indication(s): Type 2 DIABETES in adults2014 sales: $3.931 billion2013 sales: $4.004 billion% Change: (1.8%)
#12. Lyrica (pregabalin)
Sponsor(s): PfizerIndication(s): Neuropathic pain associated with DIABETIC peripheral neuropathy; postherpetic neuralgia; adjunctive therapy for adult patients with partial onset seizures; fibromyalgia; neuropathic pain associated with spinal cord injury2014 sales: $5.168 billion2013 sales: $4.595 billion% Change: 12.5%
Notes:
1 Does not include sales from Bristol-Myers Squibb, since BMS combines sales of bulk efavirenz used in Atripla with sales of BMS’ Sustiva in a reporting category called “Sustiva franchise.” BMS reported full-year 2014 “Sustiva franchise” sales of $1.444 billion, down 11% over 2013.
2 “Prevnar family” consists of Prevnar 13/Prevenar 13 and Prevnar/Prevenar (7-valent), Pfizer’s pneumococcal conjugate vaccines for the prevention of various syndromes of pneumococcal disease.
3 Otsuka records net sales and then pays a portion of that as a fee to BMS, as detailed under the companies’ development and commercialization agreement covering the U.S. That portion was 51.5% beginning in 2012 and 50% beginning in 2013 “through the expected loss of U.S. exclusivity in 2015,” according to an extension of the agreement announced in 2009. See: http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announces-extension-us-agreement-abilify-and-estab. During 2014, BMS recorded $2.020 billion in worldwide revenues for Abilify, down 11.8% from $2.289 billion in 2013.
4 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Abilify as generating $5.265 billion for Otsuka.
5 Effective January 1, 2014, Amgen acquired rights to pegfilgrastim and filgrastim from Roche. Roche had held those rights under license from Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. See Amgen announcement of October 22, 2013:http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1866783. Kyowa Hakko Kirin retains rights to pegfilgrastim under the name Peglasta® in Singapore and Thailand, and under the name Neulasta® in Taiwan. Kyowa Hakko Kirin retains rights to filgrastim under the name Gran in China, Japan, South Korea, Malaysia, and Taiwan. Kirin reports sales under the combined listing of “Gran.”
6 In 2013, pegfilgrastim and filgrastim were sold by Roche in 100 markets under the brands Neulastim and Neupogen, respectively. Roche did not disclose sales figures on either drug for 2013.
7 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Crestor as generating $0.372 billion for Shionogi, and $5.994 billion for both Shiopnogi and AstraZeneca combined.
8 A decline in the U.K. pound since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Advair as generating $8.783 billion.
9 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Herceptin as generating $6.839 billion.
10 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Avastin as generating $7.037 billion.
11 A decline in the Euro since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Lantus as generating $7.849 billion.
12 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Rituxan as generating $8.920 billion ($7.820 billion [CHF 6.951 billion] Roche + $1.1 billion Biogen Idec)
13 Biogen Idec figures include sales from a next-generation version of Rituxan, Gazyva (obinutuzumab), which launched in November 2013.
1 Does not include sales from Bristol-Myers Squibb, since BMS combines sales of bulk efavirenz used in Atripla with sales of BMS’ Sustiva in a reporting category called “Sustiva franchise.” BMS reported full-year 2014 “Sustiva franchise” sales of $1.444 billion, down 11% over 2013.
2 “Prevnar family” consists of Prevnar 13/Prevenar 13 and Prevnar/Prevenar (7-valent), Pfizer’s pneumococcal conjugate vaccines for the prevention of various syndromes of pneumococcal disease.
3 Otsuka records net sales and then pays a portion of that as a fee to BMS, as detailed under the companies’ development and commercialization agreement covering the U.S. That portion was 51.5% beginning in 2012 and 50% beginning in 2013 “through the expected loss of U.S. exclusivity in 2015,” according to an extension of the agreement announced in 2009. See: http://news.bms.com/press-release/financial-news/bristol-myers-squibb-announces-extension-us-agreement-abilify-and-estab. During 2014, BMS recorded $2.020 billion in worldwide revenues for Abilify, down 11.8% from $2.289 billion in 2013.
4 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Abilify as generating $5.265 billion for Otsuka.
5 Effective January 1, 2014, Amgen acquired rights to pegfilgrastim and filgrastim from Roche. Roche had held those rights under license from Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. See Amgen announcement of October 22, 2013:http://www.amgen.com/media/media_pr_detail.jsp?releaseID=1866783. Kyowa Hakko Kirin retains rights to pegfilgrastim under the name Peglasta® in Singapore and Thailand, and under the name Neulasta® in Taiwan. Kyowa Hakko Kirin retains rights to filgrastim under the name Gran in China, Japan, South Korea, Malaysia, and Taiwan. Kirin reports sales under the combined listing of “Gran.”
6 In 2013, pegfilgrastim and filgrastim were sold by Roche in 100 markets under the brands Neulastim and Neupogen, respectively. Roche did not disclose sales figures on either drug for 2013.
7 A decline in the Japanese Yen since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Crestor as generating $0.372 billion for Shionogi, and $5.994 billion for both Shiopnogi and AstraZeneca combined.
8 A decline in the U.K. pound since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Advair as generating $8.783 billion.
9 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Herceptin as generating $6.839 billion.
10 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Avastin as generating $7.037 billion.
11 A decline in the Euro since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Lantus as generating $7.849 billion.
12 A decline in the Swiss Franc since last year accounts for the lower result for 2013 than originally reported on last year’s GEN List of “Top 25 Best-Selling Drugs of 2013,” which listed Rituxan as generating $8.920 billion ($7.820 billion [CHF 6.951 billion] Roche + $1.1 billion Biogen Idec)
13 Biogen Idec figures include sales from a next-generation version of Rituxan, Gazyva (obinutuzumab), which launched in November 2013.
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