Pharma/fine chemicals roundup—28 April 2015
12:10 AM MDT | April 28, 2015 | By DEEPTI RAMESH
FDA issues warning letter to API plant in China
The US FDA issued a warning letter on 6 April to the active pharmaceutical ingredient (API) manufacturing facility of Yunnan Hande Bio-Tech—located at Kunming, China—for violating cGMP. The warning letter was published on the FDA Web site on 21 April. An FDA inspection from 14–17 April 2014 at the Kunming facility identified significant deviations from cGMP for the manufacture of APIs, FDA says. FDA has conducted a detailed review of the company's responses since the inspection, which FDA says lack sufficiently corrective actions, FDA says.
The deviations at the API facility at Kunming include failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; failure of the company’s quality unit to ensure that materials are appropriately tested and the results are reported; and failure of the quality unit to exercise its responsibility to ensure the APIs manufactured at the facility are in compliance with cGMP, and meet established specifications for quality and purity, FDA says.
Novasep reports 20% Ebitda growth
Novasep (Pompey, France), a supplier of services and technologies to the life sciences and chemical industries, says that it generated sales close to €250 million ($272 million) for the full year 2014. Novasep had recorded sales of about €316 million in 2013. The company however reports a 20% growth in Ebitda in 2014 driven by the company’s focus on attractive projects and on controlling costs. Novasep, last year, sold it facility and the related business of its wholly-owned manufacturing subsidiary, Pharmachem Technologies (Freeport, Bahamas), to a local investor, and this divestment led to a €30 million cash flow and the removal a non-core business from the group, Novasep says.
“Looking back on 2014, it has been a pivotal year for Novasep. It was the first full year of the implementation of our strategic plan and we have clearly seen its relevance and benefits,” says Michel Spagnol, chairman and CEO of Novasep. “The positive market context and increased financial resources available to us since the sale of Pharmachem will contribute to our sales momentum in 2015. We are confident that we will be able to continue this very positive trend during the coming year.”
Teva offers to acquire Mylan
Teva Pharmaceutical Industries (Petaḥ Tiqwa, Israel) has proposed to acquire Mylan in a transaction valued at $82.00/Mylan share with the consideration to comprise about 50% cash and 50% stock. Teva’s proposal for Mylan implies a total equity value of about $43 billion, Teva says. The offer follows Mylan’s proposal earlier this month to acquire Perrigo (Dublin) for $28.9 billion. Perrigo announced that it has rejected the unsolicited offer from Mylan as the offer undervalued the company and its future growth prospects. Teva says that its proposal provides Mylan stockholders with a more attractive alternative to Mylan’s proposed acquisition of Perrigo as well as to Mylan on a standalone basis. Mylan announced on 27 April that its board of directors has unanimously rejected the unsolicited expression of interest from Teva to acquire Mylan. "After a comprehensive review conducted in consultation with its financial and legal advisors, the Mylan board concluded the approach did not meet any of the key criteria that would cause the Mylan board to depart from the company's successful and longstanding standalone strategy, and consider engaging in discussions to sell the company," Mylan says.
Teva is the world’s largest generic medicines producer, generating sales of $20.3 billion in 2014. Teva says that the proposed combination of Teva and Mylan would create a leading company in the pharmaceutical industry, well positioned to transform the global generics space. Teva’s board of directors has unanimously approved the proposal. In 2016, the combined company would have cash flow from operations greater than $6 billion, revenues greater than $30 billion, and Ebitda greater than $10 billion, Teva says.
Dottikon reports rise in sales, swings to profit
Fine chemicals company Dottikon Exclusive Synthesis (Dottikon ES; Dottikon, Switzerland) reports sales of 96.5 million Swiss francs ($101 million) for the fiscal year ended 31 March 2015, an increase of 7% over the previous fiscal year. Dottikon ES reports a net profit of SF1 million for the fiscal year, compared with a net loss of SF2.6 million in the previous fiscal year. Dottikon ES manufactures performance chemicals, intermediates, and exclusive active pharmaceutical ingredients for the chemical and pharmaceutical industries. The company specializes in hazardous reactions.
Recipharm appoints new boss for Italian unit
Recipharm (Jordbro, Sweden), a contract development and manufacturing organization that produces pharmaceuticals and active pharmaceutical ingredients, has announced the appointment of Giorgio Bruno as general manager of Recipharm Italia (Masate, Italy). Bruno will serve as CEO for all of Recipharm’s Italian operating companies, which have revenues of €57 million ($61 million) and that employ 257 people at six sites in the country. Bruno has senior management experience in the pharmaceutical industry, and has worked in both Italian and multinational pharmaceutical companies. In earlier roles he was responsible for quality and manufacturing at companies including Parke Davis, AstraZeneca, and Corden Pharma.
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