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Pharma/Fine Chemicals Roundup – February 14
6:14 AM MST | February 14, 2012 | By DEEPTI RAMESH
LONZA PLANS API JOINT VENTURE IN SOUTH AFRICA
Lonza says it is in discussions with the South African government for establishing a joint venture called Ketlaphela to build an active pharmaceutical ingredient (API) manufacturing facility for anti-retroviral medicines in South Africa. The discussions are at an early stage and no deal has been signed yet, Lonza says. The jv facility will involve a total investment of about rand1.6 billion ($208 million), which will include a rand500 million investment by Lonza, local press reports say. Construction of the plant is expected to begin next year, and the plant is expected to become operational in 2016, reports say.
CAMBREX REPORTS FALL IN FOURTH-QUARTER PROFITS
Cambrex (East Rutherford, NJ) reported an 84% fall in net profits for the fourth quarter ended December 31, 2011, compared with the year-ago quarter, to $741,000. Net sales for the quarter increased 5.3%, to $66.58 million. For the full year 2011, net profits increased nearly 14%, to $10.96 million. Full-year net sales increased 12.3%, to about $252.7 million.
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PHARMACEUTICALS: ASIAN CONTRACT MANUFACTURERS POSE CHALLENGE TO WESTERN FIRMS
The contract fine chemicals market is becoming more competitive, leading contract manufacturing organizations (CMO) and analysts say. The global pharmaceutical outsourcing market is growing, particularly in the fields of highly potent active pharmaceutical ingredients (HPAPI) and biopharmaceuticals, and so is competition from Chinese and Indian-or ‘Chindian’-CMOs.
SHANGHAI PHARMACEUTICALS ACQUIRES CHINESE API FIRM
Shanghai Pharmaceuticals (Shanghai, China) says it will acquire a 70% stake in Changzhou Kony Pharm (Changzhou, China), and will also purchase the remaining 30% stake in the next two years. Kony Pharm manufactures active pharmaceutical ingredients (APIs) and pharma intermediates. Financial details of the deal were not disclosed. Kony Pharm is estimated to have sales of about Rmb115 million ($19 million) in 2011, and is expected to maintain high growth in the future, Shanghai Pharmaceuticals says.
FDA SEEKS BUDGET OF $4.5 BILLION
The U.S. Food and Drug Administration (FDA) says it is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year 2013 budget – a 17% increase over the FDA enacted budget for fiscal year 2012. The fiscal year 2013 request covers the period from October 1, 2012 to September 30, 2013. Industry user fees would fund 98% of the proposed budget increase. In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA budget also contains increased funding for priorities such as import safety, medical countermeasures and research facilities to protect patients and consumers, FDA says.
“Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalization and allow FDA to fulfill its public health duties more efficiently,” says Margaret A. Hamburg, commissioner of Food and Drug.
The FDA fiscal year 2013 budget includes initiatives to protect patients, which recommends new user fees to support FDA generic drug activities and to support development and review of biosimilar biological products. The initiative also includes resources to equip laboratory facilities on FDA’s White Oak, MD campus for research. The budget includes food and drug inspections in China, with $10 million in new resources for FDA to enhance collaboration with Chinese counterparts and increase the agency’s presence in and expertise on China. This investment will strengthen the safety of the food and drugs produced in China for export to the U.S., FDA says.
PCAS REPORTS RISE IN SALES
Fine and specialty chemicals group and a leading manufacturer of active pharmaceutical ingredients, PCAS (Longjumeau, France), has recorded a 11% increase in fourth-quarter sales, compared with the year-ago period, to €45.2 million. Full-year 2011 sales increased 3.8%, compared with 2010, to €164.5 million. The pharmaceutical synthesis business of the company reported a 2.7% rise in full-year sales, to €102 million and the fine specialty chemicals business of the company recorded a 5.6% rise in full-year sales, to €62.5 million. Earnings were not disclosed.
During the first five months of the year, the pharmaceutical synthesis business was affected by the planned reduction in the contribution from the contract between PCAS and Sanofi, effective since May 2010, PCAS says. Excluding this contract, the exclusive and non-exclusive pharma businesses increased by 13%, PCAS says. The company’s fine specialty chemicals business has continued its growth during the fourth quarter, where sales increased 12.6% compared with the same period of 2010.
HIKAL REPORTS INCREASE IN NET PROFITS AND SALES
Hikal (Mumbai), an active ingredients and intermediates manufacturer, says net profits for its fiscal third quarter ended December 31, 2011, more than doubled year over year to Rs130 million ($2.63 million) . Sales were also up by 84%, to Rs1.855 billion in the fiscal third quarter. Ebitda increased by 74% and profit before tax (PBT) more than doubled in fiscal third quarter, to Rs463 million and Rs127 million, respectively. Sales of the pharmaceutical and crop protection businesses of Hikal also grew significantly by 92% and 68%, respectively, in the fiscal third quarter.