Sartorius Closes Accomplishment of the Biohit Liquid Handling Business - Sartorius Labs News

The liquid handling business will bring in an important part to the increment strategy of our laboratory unit,” comments Dr. Joachim Kreuzburg, CEO of Sartorius AG

• The Sartorius expansion significance
• Integration process has begun

Sartorius, a leading international process and laboratory technology provider, successfully accomplished its acquisition of the liquid handling business of the Finnish laboratory supplier Biohit Oyj. The dealing had been declared on October 26, 2011.

“I'm pleased that we have closed this acquisition as fast as planned. Our first priority in the consolidation process is to chop-chop offer our customers the entire range of products and services with as is high quality we’re known for, all from a exclusive source.”
With this purchase, Sartorius is pursuing its strategy to expand its product offering for laboratory applications. Mechanical and electronic pipettes are among the types of small instrumentation all but often used in laboratories. Up to now, the company has been offering its customers in this section primarily laboratory balances, laboratory water refining systems, moisture analyzers and consumables for sample preparation. As a result of this accomplishment, the Sartorius laboratory business will represent around one third of the Group’s future sales. The larger Sartorius Biotechnology division supplies products and services for the manufacture of biopharmaceuticals.


“The liquid handling business will make an significant part to the development strategy of our laboratory unit,” comments Dr. Joachim Kreuzburg, CEO of Sartorius AG. “I am proud of that we have closed this acquisition as fast as planned. Our first priority in the integration process is to quickly offer our customers the entire range of products and services with the same high quality we’re known for, all from a single source.”


This news transferred from German Version.
Source: Sartorius
Dr. Joachim Kreuzburg, CEO and Executive Board Chairman of Sartorius AG
A Profile of Biohit Liquid Handling Link

Glenmark in legal row with Napo Pharma

It was a collaboration that would have resulted in a proud first for the Indian pharmaceutical industry, but has landed in a legal tangle instead.

Glenmark Pharma has sought that an arbitration panel of the American Arbitration Association issue an interim order to direct its collaborator Napo Pharmaceuticals of the U.S. to comply with the terms of their collaboration agreement.

Glenmark, along with Napo and Salix Pharmaceuticals USA, had developed Crofelemer, a molecule initially discovered by Napo and used in treatment of diarrhoea in HIV positive patients. Glenmark entered into an agreement with Napo in July 2005, to synthesize Crofelemer and has successfully extracted and stabilised the compound. However, Napo terminated the agreement on November 10.

In a statement, Glenmark said it had filed an arbitration notice against Napo to obtain a declaration regarding the exclusive marketing and distribution rights that were granted to it as part of the collaboration agreement. “The subsequent press release of Napo claiming termination is completely unfounded and seems to be a reaction to the arbitration proceedings initiated by Glenmark. Napo doesn't have any basis to terminate the contract and Glenmark has sought a declaration from the arbitration panel that Napo's claims of breach are unfounded. The same panel will also rule regarding clarification of marketing rights as requested by Glenmark in the previous appeal.''

As per the agreement, Glenmark holds the exclusive rights to distribute Crofelemer in 140 countries while Salix would sell it in the regulated markets of North America, Japan and Europe. In August, Glenmark had filed an arbitration claim against Napo to disallow Crofelemer sales in the 140 countries through relief agencies. Glenmark received $15 million from Salix Pharma towards upgrading its API (active pharma ingredient) manufacturing facility for Crofelemer in July. Once commercialised, Glenmark would pay Napo a royalty of 10-15 per cent of sales while Salix will pay Glenmark the cost plus mark-up for the API, which would be synthesized at its U.S. plant.

Glenmark has the intellectual property (IP) and Salix has invested in conducting the clinical trials but Napo has raised the issue after completion of Phase 3 clinical trials. The next step involves filing an NDA (new drug application) with the US FDA (U.S. Food & Drug Administration), which takes around nine months.

Besides, Glenmark is conducting clinical trials for Crofelemer in cases of Acute Diarrhoea and paediatric Diarrhoea and Phase 2 trials would be completed before March 2012. Glenmark said that it “continues to develop Crofelemer for all indications that we have rights to. Filing timelines will be dependent on the availability of the complete regulatory dossier data. We anticipate such filings to begin in the rest of the world markets in 2012 and hope to obtain approvals by the first half of 2014 as planned.

The regulatory submission is dependent on a complete data package, which includes important elements in addition to the Phase 3 data.

Also, a U.S. dossier serves as an important starting point for customization for the rest of the world markets and in most emerging markets, a developed market approval is also considered obligatory prior to approval.''


Source: The Hindu

Merck commits $1.5 Billion to R&D in China - Merck & Co., Inc., about expansion in China.

Summary: Merck Co., (MSD) has a proud legacy of translating scientific breakthroughs into novel medicines and vaccines with proven ability to affect global human health


Detailed Article:
Merck & Co., Inc.,  Called MSD outside the United States and Canada, today announced the establishment of an Asia Research & Development (R&D) headquarters for advanced drug discovery and development situated in Beijing, China. The new facility is part of a $1.5 billion commitment the company has made to invest in R&D in China over the next 5 years.


The establishment of the MSD Asia R&D headquarters represents an important milestone as we implement our strategy of building capabilities, and relationships to succeed in fast growing geographic regions," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "By strategically locating in China, we are able to complement our existing R&D capabilities, and facilitate new collaborations with scientists in the region and across emerging markets.


Located in Wangjing Park, one of Beijing's rapidly expanding science and technology parks, the facility will consist of 47,000 square meters of office and laboratory space. The first phase of construction, scheduled to be completed by 2014, will provide capacity for approximately 600 employees working in the areas of drug discovery, translational research, clinical development, regulatory affairs and external scientific research programs.


"Merck/MSD has a proud legacy of translating scientific breakthroughs into novel medicines and vaccines with proven ability to impact global human health," said Michel Vounatsos, chairman and president, MSD in China. "We are immensely proud of the impact that MSD's medicines and vaccines have had on improving health for the people of China as we have grown our business here, and are we eager to build on this legacy by directly investing in R&D here in China to bring forward more innovations that can help people in China and around the world."


Merck conducts research in a broad range of therapeutic categories including cardiovascular disease and diabetes, which are becoming increasingly prevalent in China. The company's global scientific strategy is focused on retaining deep internal therapeutic area and functional expertise in core therapeutic areas while strategically collaborating to access external innovation.


Merck also maintains its commercial headquarters for MSD in China in Shanghai and has manufacturing capabilities at other locations throughout China.

Merck & Co., Inc., 

About Merck


Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.


Forward-Looking Statement


This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.


The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and healthcare legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the United States and internationally and the exposure to litigation and/or regulatory actions.


Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).


Source: Merck & Co.

TRACE brings out Report on Bribe Demands in the United States

TRACE brought out the 2011 BRIBEline U.S. Report today, the organization's 7th analysis of demands for bribes accounted in specific countries.  Previous reports have studied patterns of bribe demands in Brazil, Mexico, Ukraine, Russia, India and China.


"The America Report is another significant share to the prevention of graft," said TRACE Founder and President Alexandra Wrage.  "BRIBEline provides greater insight into what bribe transactions look like.  Companies, in turn, can shift employee training from an academic or legal analysis to a more practical, real-world discussion about what to look for and how to respond."


The United States Report summarizes and analyzes 73 bribery demands in the U.S. reported anonymously to TRACE's online Business Registry for International Bribery and Extortion (BRIBEline) between July 11, 2007 and November 15, 2011.


A key finding from the U.S. report is the preponderance of bribe solicitations made in exchange for an excessive reward.  All over one-third of bribe demands in the United States – the highest rate among countries studied to date by BRIBEline – are premised on an improper quid pro quo, such as winning new business (25% of all reported demands), agreeing to attempt to influence a government official in exchange for a bribe (5%) or receiving inappropriate favorable treatment, such as a favorable court ruling (4%).


The United States report also reveals that the private sector (representatives of companies) account for a significant source of bribe demands in the United States, representing 21% of all reported demands.  Nevertheless, the majority of bribe demands, nearly 60%, are made by a person associated with a government, whether at the federal, state or local level, including government officials (16%), the police (14%), officials of the party in office (8%), employees of state-owned entities (7%), members of the military (5%), city officials (4%), state officials (1%) and judges and judicial representatives (1%).


Seven of the bribes demanded by government officials were reported as originating from the Office of the U.S. President or the Office of the U.S. Vice President.  According to the anonymous bribe reporters, demands from these offices occurred between 2002 and 2007.


The United States data also reveals a pattern of demands for high-value bribes. Approximately 60% of the U.S. bribe demands reported were characterized as recurring  -- that is, they were demanded more than a single time.  Some 44% of bribe demands were for amounts totaling less than $5,000; 25% were for amounts totaling more than $50,000; and over 10% were valued in excess of $500,000.  Cash was demanded in over 70% of the bribe solicitations; the remainder sought assistance with medical bills or tuition (10%); gifts, entertainment or hospitality (8%); sexual favors (7%); or special travel arrangements (3%).
According to TRACE's comparative analysis of bribe demand patterns in the seven nations for which it has completed reports, the U.S. has the lowest proportion of bribe demands made by government officials, and the highest proportion of bribes demands by private company officials.


"The U.S. BRIBEline data indicates that companies doing business in the United States should consider training their employees to appropriately respond to a bribe demand made by a powerful government official or business executive," says Wrage. "While the business incentive to provide the bribe may seem compelling, especially in a difficult economy, the risk-reward ratio shifts in light of increasing international enforcement of foreign bribery laws and vigorous enforcement in the United States of its domestic bribery laws.  In addition, the consequences of a bribery investigation or conviction are significant in terms of brand and reputational damage at a time when public sentiment against perceived corporate excesses and cozy relationships with government officials is at a high-water mark."


Source: TRACE INTERNATIONAL

FDA approved "Intermezzo" for insomnia characterized by sudden sleeplessness during midnight

The U.S. Food and Drug Administration (FDA) approved "Intermezzo" (zolpidem tartrate sublingual tablets) for use as required to care for insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.  


This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. Intermezzo shouldn't be taken if alcohol has been consumed or with any other sleep aid.


Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.


Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien.  Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men.


"For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking," said Robert Temple, M.D., deputy center director for clinical science in the FDA's Center for Drug Evaluation and Research. "With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving."


Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Care for Sleeplessness

Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.  
Intermezzo is a federally controlled substance because it can be abused or lead to dependence.
Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.
For information:


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


SOURCE: U.S. Food and Drug Administration

HeartWare to Present at the 23rd Annual Piper Jaffray Health Care Conference

HeartWare to Present at the 23rd Annual Piper Jaffray Health Care Conference

Pfizer to Acquire Excaliard Pharmaceuticals - Isis to Receive Up to $14 Million from Pfizer for Its Acquisition of Excaliard Pharmaceuticals

Excaliard’s lead product, EXC 001, an antisense oligonucleotide in phase 2, is designed to interrupt the process of fibrosis by inhibiting expression of connective tissue growth factor (CTGF). CTGF is a growth factor that can be over expressed in damaged skin or tissue following surgery or traumatic injury and lead to disfiguring skin scarring. The phase 2 program for EXC 001 has thus far produced positive clinical results in reducing scar severity. Upon completion of the acquisition, Pfizer plans to continue development of EXC 001 to address unmet medical needs in patient groups who suffer from excessive skin scarring. Currently, there are no FDA-approved products to reduce scar severity.

Excaliard Pharmaceuticals, INC.

“The acquisition of Excaliard is part of our corporate research and development strategy to actively complement our robust internal project pipeline with innovative and differentiated drugs from biotech partners,” said Mikael Dolsten, president, Worldwide Research and Development, Pfizer.

Jose-Carlos Gutierrez-Ramos, senior vice president, Biotherapeutics, Worldwide Research and Development, Pfizer, added: “The science behind Excaliard’s lead compound aligns well with our R&D focus on new treatments for fibrosis and tissue remodeling. We view EXC 001 as being well positioned to potentially become a novel, transformative therapy in a space with limited available treatment options.”

Pfizer

Gordon Foulkes, Excaliard’s CEO, said: “We are all excited about Pfizer becoming the company to move our drug forward. We began Excaliard just four years ago with closing the Series A financing. Since that time, using a virtual organization and maximum outsourcing, we were able to move from lead generation to the completion of three Phase 2 trials. The whole team has just done a fantastic job.”

While specific financial terms are confidential, Pfizer will provide to Excaliard an upfront payment and contingent payments if certain milestones are achieved. Isis Pharmaceuticals, Inc. is an equity owner of Excaliard and has granted Excaliard an exclusive worldwide license agreement for the development and commercialization of certain antisense drugs, including EXC 001. As such, Isis will receive a portion of the upfront and milestone payments paid by Pfizer to Excaliard.

About Skin Scarring

In the U.S. alone, there are over 35 million surgical procedures annually. Despite the best surgical technique and post-operative wound care, many procedures result in undesirable skin scarring. In addition to fine-line scarring, scars can be raised (hypertrophic) or even grow beyond the original site of injury (keloids). The prevalence of hypertrophic scarring has been reported to be as high as 70% in certain populations.

The American Society for Aesthetic Plastic Surgery reports that over 5 million reconstructive procedures were performed in the US in 2009 and well over 1.5 million cosmetic surgical procedures. In addition, opportunities exist in other non-cosmetic surgical scars such as Caesarian sections (1.3 million/yr in the US), as well as trauma and burn patients.

Pfizer Inc.: Working together for a healthier world™

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.

About Excaliard Pharmaceuticals

Excaliard Pharmaceuticals, Inc. is a biotechnology company founded in 2007 focused on the development and commercialization of novel and innovative drugs for the amelioration of skin scarring and other fibrotic disorders. EXC 001 was co‐discovered by Excaliard Pharmaceuticals and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) and licensed to Excaliard. EXC 001 is a new chemical entity for potential treatment of skin scarring, an antisense oligonucleotide drug targeting expression of CTGF that is activated during skin scarring following the wound healing process.

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of November 22, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.

This release contains forward-looking information about an agreement by Pfizer to acquire Excaliard Pharmaceuticals, Inc. (Excaliard); about Excaliard’s product candidate EXC 001 and its potential benefits; and about Pfizer’s plan to further develop EXC 001. Such information involves substantial risks and uncertainties including, among other things, the satisfaction of conditions to closing the agreement; the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such product candidate as well as their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010 and in its reports on Form 10-Q and Form 8-K.


Source: 4 Traders

India's New Drug pricing policy will cost Rs 4,000 crore revenue loss to drug makers - Pharmaceutical News India

India's New Drug pricing policy will cost Rs 4,000 crore revenue loss to drug makers 





The proposed national drug pricing policy will cost drugmakers approximately 1,500 crore and stockists and traders collectively over 2,500 crore in revenue loss when it comes into effect.


While drugmaker GlaxoSmithKline Pharmaceuticals loss has been pegged at 137 crore, that of Ranbaxy Laboratories is estimated to be 115 crore, according to the study by pharmaceutical market research company AWACS. Other big drugmakers such as Abbott India, Zydus Cadila and Sanofi Aventis are projected to lose over 50 crore each.




Under the draft national pharmaceutical pricing policy released by the Department of Pharmaceuticals (DoP) last month, the ceiling price of 348 drugs under price control, both local and imported, will have to be the average price of the three top-selling brands in the segment at the time of policy implementation. The move seeks to plug a loophole in the country's drug laws that allow foreign drugmakers to arbitrarily fix prices.


"Companies stand to lose 1,485 crore while stockists and traders will collectively lose 2,671 crore," said Ameesh Masurekar, director of AWACS, the company formed by All Indian Origin Chemists & Distributors (AIOCD) and Trikaal Mediinfotech.


Ranbaxy and Zydus Cadila did not respond to a mail query. Sanofi Aventis, GSK and Abbott said it is premature to comment on revenue impact as the policy is at a draft stage.

Article On New Drug Pricing Policy

Shailesh Ayyangar, Aventis Pharma MD and VP South Asia for Sanofi, said the policy should ensure access of essential medicines to the masses and that it is working with the government to meet this objective. "But the policy should not create a situation that would stifle the industry's growth," he added.


A spokesperson for Abbott said it is also working with the industry and the government to finalise a policy.


These MNCs are expected to submit their comments through their lobby body. The study shows that in terms of revenue share, mid-sized firm Alkem Labs will lose 6.7% of its top line, or 104 crore.


The new pricing policy will bring about 60% of the 68,000-crore drug retail market under price control, compared with just 10% at present. While the industry has welcomed the moving away from the current cost-based pricing policy, they have raised objections to various sections of the new pricing formula.


Indian Pharmaceuticals Alliance, the lobby group of big Indian drugmakers, said the policy should have limited price regulation to 348 drugs and their specified strengths and dosages. Global drugmakers say the proposal to have the same pricing criteria for imported drugs is unfair as the cost of production outside India is higher. On the other hand, stockist and retailers are demanding higher margins saying the new policy will hit them badly.




All stakeholders are expected to give their views to the pharmaceuticals department before the month-end, the deadline for submitting feedback. Stockists and pharmacies say that in addition to reduced market size, their margins will be squeezed further as the share of medicines under price control, which offer less profits, has increased by five times.


At present, stockists get 8% and retailers 16% on medicines under price control, compared with 10% and 20% for those that are not. The current policy allows up to 100% margin over the cost of production. This margin is shared between pharma companies (76%), chemists (16%) and stockists (8%).


AIOCD general secretary Suresh Gupta said the new proposal allows about 200%-300% top up on most drugs. "When there is a sharp rise in margins for drugmakers on many brands, chemists and retailers should also share the benefit to make up for losses in other segments." he said.


Source: Fierce Pharma

Drugmakers’ Returns on Research decline with Pipeline Projects Fail - Drug Maker's News - Pharmaceutical News

The top drugmakers saw falls on their investments in new products decline 29 % from last year (2010) as more experimental drugs failed at unaffordable belated levels of development, according to a report.
Pharmaceutical-company returns on research and development fell by 3.4 % points to 8.4 % this year, the report by consulting firm Deloitte LLP found. The study considered the 12 drugmakers that spend the most on R&D, including New York-based Pfizer Inc. (PFE), Paris-based Sanofi and Japan’s Takeda Pharmaceutical Co.
There were fewer drugs in the final phase of testing or undergoing review by regulators, down from an average of 23 per company in 2010 to 18 this year, the study found. At the same time, the cost of bringing a new medicine to market rose from $830 million to $1.05 billion. More drugs are failing in development and at later stages than a year ago, said Julian Remnant, a partner with Deloitte and the report’s author.
“We continue to see a level of late stage drug failures,” Remnant said in a telephone interview. “That’s something that should not be happening to the extent it still is.”
The report assessed the future potential returns of R&D projects. Returns from investment can fall because a product fails in a study or because of a lack of new drug candidates with future potential returns, Remnant said.
Other companies analyzed in the report are Roche Holding AG (ROG), AstraZeneca Plc (AZN), Merck & Co., Novartis AG (NOVN), GlaxoSmithKline Plc (GSK), Amgen Inc. (AMGN), Eli Lilly & Co. (LLY), Johnson & Johnson (JNJ), Bristol- Myers Squibb Co.
Drug Development Setbacks
Merck, based in Whitehouse Station, New Jersey, this year halted one study and narrowed another on anti-clotting pill vorapaxar after bleeding risks were found. Sanofi discontinued development of a potential successor to its Multaq heart-rhythm drug after it failed to prevent sudden deaths in patients. Glaxo’s experimental diabetes drug albiglutide failed to control blood-sugar levels better than Novo Nordisk A/S’s Victoza treatment. Sangamo BioSciences Inc., based in Richmond, California, decided to stop developing its diabetic neuropathy drug after it failed to show it was any better than a placebo.
“The ROI story over the last few years has been gloomy news,” said Erik Gordon, a business professor at the University of Michigan who follows the industry. Companies are tackling more complex diseases he said, and generating lower returns for their efforts.
“It’s more expensive to get to the failure, and there are more failures,” he said in a phone interview.
Late-Stage Drugs
Along with more failures, there are also fewer drugs in the late stages of development -- 220 this year compared with 270 last year -- Remnant said.
“That could be a signal that the industry is investing in quality,” he said, with companies paring down their research portfolios to focus on the most promising drugs.
Remnant said it will be a challenge for companies to keep their pipelines generating new products as they come under pressure to cut costs as drugs already on the market lose patent protection and with it, revenue.
From now through 2015, $171 billion in global pharmaceutical sales will lose patent protection and face generic competition, according to Gary Gatyas, a spokesman for IMS Health in Parsippany, New Jersey, which tracks the pharmaceutical industry. Pfizer’s cholesterol pill Lipitor, the world’s best-selling medicine that generated $10.7 billion last year, goes off patent at the end of this month.
“R&D is a very common target for short-term cost cutting,” Remnant said. Research “is in a battle for capital,” he said.
Pfizer, facing losses in Lipitor sales, plans to divest its animal health and nutritional units so it can focus on producing new medicines. Abbott Laboratories (ABT), in October, announced that it is splitting into two companies, one focused only on prescription drugs.
“I think it’s a new era,” Gordon said. “People who invest in pharma companies have to expect, not as a permanent condition, but as a long term trend, a lower rate of return than they had during the golden blockbuster years.”


Source: Pharma Biz

Biotech's largest expenders 2011 - Biotechnology News - Biopharma News for 2011

Biotechnology Article based on Pharmabiz (Source)

If you add up the R&D budgets for the top 15 public biotechs in the world, you will discover a tab that runs right about $10 billion. That's not chickenfeed, by hook or by crook, but to put it in some position, it is interesting to note that Roche, which has the largest research budget for any biopharma on the planet, spent a bit more than that last year advancing new drugs and technology.
Having noted that, I believe that a combination of the peak projected sales for all the experimental drugs you'll find in the biotech pipeline beneath would rival all that Roche is processing.
For year 2011, we have decided to sharpen the focus for our report on the biggest biotech R&D spenders. We've excluded some of the tool and tech companies that were on last year's Top 15 report so we can devote our attention to drug discovery and development.
M&A activity is also transforming the top 15 biotech companies on the list. These are 2010 numbers, so Genzyme is still with us for the last time. Next year, look for it under the Sanofi banner. I dropped OSI Pharma, which was taken over by Astellas in a $4 billion deal last year 2010. Abraxis BioScience is also gone, bought up by fast-growing Celgene, which jumps to third place in this new lineup. Genmab dropped off the list as it cut R&D costs down to $103 million.

I made an executive decision to play with the list a little as well. While the EU included Switzerland's Actelion as a pharma company, I see it as more of a biotech, rushing to see if a Phase III study of a lead program can give it a replacement for the steadily fading blockbuster that has funded the company's R&D operations. Failure is not an option, but it is a distinct possibility, and a high-stakes development program like that can't be ignored. Also, Exelixis was inexplicably listed under pharma.
With all the M&A activity that has dominated the biopharma industry over the past year, it will be interesting to see who will be added when we come back in 2012.

Amgen - $2.8Billions (€2.15Billion)
Biogen Idec - $1.25Billion (€930Million)
Celgene - $1.13Billion (€833Million)
Gilead Sciences - $1.07Billion (€789Million)
Genzyme - $866.6Million (€628Million)
Vertex Pharmaceuticals - *$637.4Millions (€463.6Million)
Actelion - $539Million (CHF 484.3Million)
Regeneron Pharmaceuticals - $489Million
CSL - $334Million (€242Million)
Exelixis - $210.7Million (€153Million)
United Therapeutics - $171Million (€124Million)
Cubist Pharmaceuticals -  $161.4Million (€117Million)
Amylin Pharmaceuticals - $157.3Million (€114Million)
BioMarin Pharmaceutical - $147.3Million (€109.3Million)
Seattle Genetics -  $146.4Million (€109.1Million)

Stem Cell Scientist talks about New Drug evolution Process

Pharmaceutical companies should address stem cells for a more effective and cost-efficient way to try out with new medications, Harvard professor Lee L. Rubin said in a presentation yesterday.


Rubin, who is the Stem Cell and Regenerative Biological science professor and a director at the Harvard Stem Cell Institute, said that because stem cells mimic the biological environment of the human body, they are an effective precursor to the long and pricey clinical trial phase.


Rubin was decisive of the current model for drug development, which costs upwards of $1 billion per successful drug due to the extremely high failure rate of experimental medication. Big Pharma’s current business model is to produce several hundred potential compounds a year and simply “hope among them works,” he said.


“Most scientists agree that the drug discovery system, as presently practiced in the pharmaceutical industry, is bad,” Rubin said.

The stem cell expert advocated testing the effectiveness of medication on the cellular level using stem cells—which he argued serve as strong models for human physiology. Today, experimental drugs usually do not experience the environment of a human cell until the medicine has reached clinical trials, after millions of dollars have already been sunk into the potentially ineffective drug.


Stem cells have traditionally been used to model embryo development in vitro and as a source of cells for cell replacement therapy. Rubin believes they have yet more potential.


“Instead of using stem cells as the therapeutic, use stem cells to discover the therapeutic,” he said.


But Rubin said that large pharmaceutical companies tend to stick with institutional approaches to drug development.


“Most big companies have a certain level of inertia ... and pharmaceutical companies tend to follow that trend,” Rubin said.


But Rubin acknowledge that because pharmaceutical companies function as businesses, they must follow sensible profit-making strategies, opening the door for his innovative proposal.


One student in attendance said he appreciated the lecture’s applied approach to science.


“Rather than focusing on the broad science of stem cells and regenerative biology, this seminar was most helpful in elucidating the direction and impact of this kind of research,” Rhed Shi ’15 said. “I think that is a very important aspect of science and how it is relevant to society.”


Source: Digital News