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Pharma/Fine Chemicals Roundup – April 24
April 24, 2012 | By DEEPTI RAMESH
FDA STRENGTHENS INTERNATIONAL COLLABORATION TO ENSURE SAFETY OF IMPORTED PHARMA PRODUCTS
The U.S. Food and Drug Administration (FDA) says it is taking several steps to ensure that imported drugs meet the same rigorous standards for safety and quality as those manufactured domestically. The agency detailed its activities and strategies in a new report called ‘Global Engagement’, which was released yesterday. Each year from 2005-2011, imports of pharmaceutical products have increased at nearly 13%, FDA says. More than 80% of the active pharmaceutical ingredients (APIs) used to make medicines in the U.S. and 40% of finished dosage drugs consumed in the U.S. are imported, FDA says. FDA says it is using various strategies to increase its engagement in the global public health community. These strategies include establishing international offices and posts; strengthening regulatory capacity; harmonizing science-based standards; leveraging knowledge and resources; risk-based monitoring and inspection; global surveillance, preparedness, and emergency response; and advancing regulatory science.
NESTLÉ TO ACQUIRE PFIZER’S NUTRITION BUSINESS FOR $11.85 BILLION
Pfizer says it has entered into an agreement to divest its nutrition business to Nestlé (Vevey, Switzerland) for $11.85 billion in cash. Pfizer’s nutrition business recorded sales of about $2.1 billion in 2011, an increase of 15% versus 2010. Pfizer Nutrition is a global pediatric nutrition business with brands encompassing everyday and specialty infant and toddler formulas, follow-on formulas, as well as maternal and adult nutrition products. About 85% of Pfizer Nutrition’s sales are in emerging markets. The transaction is subject to regulatory approval and Pfizer expects the divestiture of the nutrition business to be completed by the first half of 2013. Nestlé says the acquisition is a strategic fit with Nestlé’s infant nutrition business, with a complementary product portfolio and a strong presence in high-growth markets. Nestlé expects the acquired business to record sales of $2.4 billion in 2012.
CATALYSTS, FINE CHEMICALS LIFT ALBEMARLE ABOVE ESTIMATES
Albemarle posted earnings of $108 million ($1.20/share) for the fiscal first quarter ended March 31, 2012, up 1% from the same year-ago period, as gains in catalysts and fine chemicals were enough to offset a drop in polymer solutions volumes. Analysts' estimates were for $1.16/share, as reported by Thomson Reuters (New York). Sales increased 2%, to $712 million. Fine chemistry sales increased 7%, to $190 million, on favorable pricing and volumes. Segment income surged 30%, to $39 million. Catalyst sales increased 12%, to $294 million, on pricing gains. Segment income of $82 million was 13% higher than the 2011 quarter.
GRACE AND FORMAC ANNOUNCE POSITIVE DATA FROM CLINICAL TRIAL DEMONSTRATING USE OF SILICA FOR DRUG DELIVERY
W. R. Grace, in partnership with Formac Pharmaceuticals (Heverlee, Belgium), announced positive data from initial human studies of the companies' mesoporous silica-based drug delivery technology. This was the first-ever clinical study to demonstrate the bioavailability enhancing properties of silica in humans, Grace says. Improved bioavailability enables active pharmaceutical ingredients (API's) to more effectively absorb into the body. This technology opens up a viable new avenue for the development of poorly soluble compounds, Grace says. The bioavailability profile of fenofibrate formulated with silica was compared to the marketed micronized formulation (Lipanthyl), in the study. The study results show a 54% higher bioavailability for the silica formulation than the marketed formulation.
POLICE CONFISCATE 77 MILLION CONTAMINATED CAPSULES IN CHINA
The Chinese government says that the Ministry of Public Security (Beijing) has confiscated 77 million capsules made from toxic chromium-contained industrial gelatin. Earlier this month, the State Food and Drug Administration (SFDA; Beijing) had issued a notice to suspend the selling and consumption of a list of capsules with excessive chromium contamination. Several drugs were packed into capsules made from industrial gelatin, which contains a much higher degree of chromium than edible gelatin, the government says. The Ministry of Public Security has arrested nine suspects, detained 54 people, and sealed 80 industrial gelatin and gel capsule manufacturing lines.
LONZA AND CSIRO PARTNER TO BRING INSECT SILK PRODUCTS TO THE MARKET FOR MEDICAL AND INDUSTRIAL APPLICATIONS
Lonza says it has formed a partnership with the Commonwealth Scientific and Industrial Research Organisation (CSIRO; Clayton South, Australia), to bring new insect silk products to the global market. Lonza and CSIRO have entered a joint development agreement to advance and market new insect silks for a range of medical and industrial applications. Insect silk is a potential key component in a wide range of new products and applications under development by the fast growing biotechnology manufacturing industry due to superior properties such as exceptional strength and toughness, Lonza says. Potential applications include composite fibers for the aviation and marine industries and medical applications including wound repair, drug delivery, and repairing and replacing human tissues such as membranes, ligaments, blood vessels and cartilage, Lonza says.MYLAN TO INVEST $500 MILLION IN IRELAND OVER NEXT FIVE YEARS
Mylan (Canonsburg, PA) says it will invest €76 million/year ($100 million/year) over the next five years in the company’s operations at Dublin and Galway in Ireland. Mylan will add more than 500 new positions to its Ireland-based workforce by 2016. Mylan currently employs about 700 people at its facilities in Ireland. The planned expansion of Mylan's operations in Ireland involves R&D and manufacturing capabilities within the company's respiratory, injectables and oral solids franchises.
Several pharmaceutical majors have recently announced plans to expand operations in Ireland. Abbott Laboratories (Chicago, IL) announced in February 2012 that it will invest €85 million to expand its pharmaceutical manufacturing operations at Sligo, Ireland.
And Eli Lilly also announced in February 2012 that it will invest €330 million in a new facility at the company’s Kinsale campus at Cork, Ireland.