Biocon Unit Signs Deal For Clinical Research With US Company

Biotech company Biocon stated that its division 'Clinigene International' has signed a deal with US-based Spaulding Clinical Research to mutually offer clinical research solutions to both pharmaceutical plus biotechnology companies.

This affiliation establishes a cost-effective international footprint for clinical pharmacology services, offering up a chance for both organizations to take on pharmaceutical customers with regard to strategy.

Clinigene Chief Operating Officer Abhijit Barve stated: "Pharmaceutical clients globally are increasingly seeking strategies to expedite their early clinical development, streamlining processes while maintaining high quality.

Biocon to rope in global partner for oral insulin

Biotechnology major Biocon on Tuesday that said the tests conducted for its experimental oral insulin , IN-105 , have not met their primary end point. However, the company is upbeat on continuing its development with a global partner.

A press release from the company said that initial data analysis of the test showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7%, compared to a placebo. HbA1c is a test that measures the amount of glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the effectiveness of a drug to control blood sugar levels.

Kiran Mazumdar Shaw, MD and chairman of Biocon, said in the release: “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.” The company added that post-hoc analyses of self-monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm, which strongly suggested behavioural modification among patients , and which might have affected the primary outcome.

EMERSON PROCESS MANAGEMENT; Emerson Wins Major Automation Contract for Biopharmaceutical Plant in Singapore

Emerson Process Management, a global process control and automation leader and a business of Emerson (NYSE:EMR), has been selected by Switzerland-based Lonza Group Ltd. to provide engineering and design services and digital automation architecture and control technologies for a new Lonza biopharmaceutical plant in Singapore (see also Emerson Process Management).

The win is part of Emerson s growing portfolio of life sciences companies that rely on digital automation with predictive intelligence to reduce overall costs, improve reliability, ensure product quality, meet regulatory requirements, and optimize operations.

Emerson has an excellent track record in managing and controlling the highly complex processes involved in the biopharmaceutical industry, said Steve Sonnenberg, president, Emerson Process Management. This win is yet another example of how companies like Lonza can leverage our global resources and expertise to meet their objectives for safe, reliable, and on-time start-up of new manufacturing facilities.

In the Asia-Pacific region, Emerson also has been awarded automation contracts by Shanghai CP Guojian Pharmaceutical Co. Ltd. in China; Reliance Life Sciences, DSM Anti-Infectives India Ltd., and Biocon in India; and Lonza for a prior facility in Singapore.

Having installed the automation architecture in Lonza s first biopharmaceutical plant in Singapore, Emerson was chosen to implement its innovative PlantWeb ® technologies in the new plant that is expected to be completed in 2010 at a cost of $350US million. By following the original project models, employing best practices, and applying the experience gained during design and construction of the original facility, Emerson is expected to reduce Lonza s overall costs for the new plant.

Lonza will employ an array of Emerson products and services, including: PlantWeb digital automation architecture; DeltaV digital automation system; and intelligent digital devices, including Fisher ® and Baumann control valves with FIELDVUE ® digital valve controllers, Rosemount ® flowmeters and analyzers, Micro Motion ® Coriolis flowmeters, and Fisher pressure regulators. About Lonza Lonza is the world s leading contract manufacturer of monoclonal antibodies and recombinant proteins. Lonza undertakes highly specialized development and manufacturing services for the pharmaceutical and biotechnology industries based on more than 25 years of experience in mammalian cell culture and proprietary technology for large-scale manufacture of innovative biopharmaceutical products. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza Group Ltd. is headquartered in Basel, Switzerland, and is listed on the SWX Swiss Stock Exchange. About Emerson Process Management Emerson Process Management (www.emersonprocess.com), an Emerson business, is a leader in helping businesses automate their production, processing and distribution in the chemical, oil and gas, refining, pulp and paper, power, water and wastewater treatment, mining and metals, food and beverage, pharmaceutical and other industries. The company combines superior products and technology with industry-specific engineering, consulting, project management and maintenance services. Its brands include PlantWeb ®, Fisher ®, Rosemount ®, Micro Motion ®, Daniel ®, DeltaV , Ovation ®, and AMS ® Suite. About Emerson Emerson (NYSE:EMR), based in St. Louis, Missouri (USA), is a global leader in bringing technology and engineering together to provide innovative solutions to customers through its network power, process management, industrial automation, climate technologies, and appliance and tools businesses. Sales in fiscal 2008 were $24.8 billion and Emerson is ranked 94th on the Fortune 500 list of America s largest companies.

Optimer Pharmaceuticals Inc. Reports Operating Results

OPTIMER PHARMACEUTICALS INC. is a biopharmaceutical company focused on discovering developing & commercializing innovative anti-infective products for the treatment of serious infections. Optimer is currently focused on discovering developing & commercializing innovative anti-infective products in diseases of unmet needs and where current therapeutic options have limitations. Optimer has two late-stage anti-infective product candidates. OPT-80 currently in two pivotal Phase 3 clinical trials is being developed for the treatment of Clostridium difficile infection the most common hospital-acquired diarrhea. Prulifloxacin also in two pivotal Phase 3 clinical trials is an antibiotic being developed for the treatment of travelers? diarrhea a form of infectious diarrhea. The Company has also licensed technologies and therapeutic targets from The Scripps Research Institute and The Memorial Sloan-Kettering Cancer Center. These licenses form the core of Optimer's carbohydrat Optimer Pharmaceuticals Inc. has a market cap of $420 million; its shares were traded at around $12.71 with and P/S ratio of 410.4.
Highlight of Business Operations:Grant Revenues. Grant revenues for the three months ended March 31, 2009 and 2008 were $83,000 and $487,000, respectively. The decrease of $404,000, or 83%, was primarily due to the conclusion of one of two National Institutes of Health grants.

Research and Development Expense. Research and development expense for the three months ended March 31, 2009 and 2008 was $8.8 million and $6.9 million, respectively, an increase of $1.9 million, or 27%. The increase was primarily due to an increase in development and regulatory expenses related to fidaxomicin and prulifloxacin.

General and Administrative Expense. General and administrative expense for the three months ended March 31, 2009 and 2008 was $2.0 million and $1.7 million, respectively. The increase of $311,000, or 18%, was due to higher compensation expenses, including $318,000 of stock compensation expense, an increase of $77,000 over the same period in the prior year, as well as higher consulting expenses.

Interest Income and Other, net. Net interest income and other for the three months ended March 31, 2009 and 2008 was $187,000 and $581,000, respectively. The decrease was primarily due to lower average balances as well as lower interest rates on cash, cash equivalents and investments.

As of March 31, 2009, cash, cash equivalents and short-term investments totaled approximately $62.6 million as compared to $39.3 million as of December 31, 2008, an increase of approximately $23.3 million. The increase in our cash, cash equivalents and short-term investments was primarily due to the $32.9 million raised in a registered direct offering of our common stock in March 2009.

In February 2007, we regained worldwide rights to fidaxomicin from Par under a prospective buy-back agreement. We are obligated to pay Par a one-time $5.0 million milestone payment, a 5% royalty on net sales by us or our affiliates of fidaxomicin in North America and Israel, and a 1.5% royalty on net sales by us or our affiliates of fidaxomicin in the rest of the world. In addition, in the event we license our right to market fidaxomicin in the rest of the world, we will be required to pay Par a 6.25% royalty on net revenues we receive related to fidaxomicin. We are obligated to pay each of these royalties, if any, on a country-by-country basis for seven years commencing on the applicable commercial launch in each such country. In connection with the exercise of our rights under the prospective buy-back agreement, Par assigned to us a supply agreement with Biocon. Under this agreement, Biocon is obligated to supply to us our requirements of the fidaxomicin active pharmaceutical ingredients for certain markets. We may be obligated to pay a $3.0 million prepayment to Biocon, subject to future set-offs.