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