IHS Chemical Week


Pharma/fine chemicals roundup—20 June 2013

8:30 AM MDT | June 21, 2013 | By DEEPTI RAMESH

Ash Stevens to manufacture ponatinib API

Ash Stevens (Riverview, MI), a provider of global contract pharmaceutical drug substance development and active pharmaceutical ingredient (API) manufacturing services, says that the US FDA has approved Ash Stevens’ manufacturing facility at Riverview, for the manufacture of the API in Ariad Pharmaceuticals' recently approved oncology drug Iclusig -ponatinib. The drug was granted accelerated approval in December 2012 by the FDA for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia that is resistant or intolerant to prior tyrosine kinase inhibitor  therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia that is resistant or intolerant to prior TKI therapy.

European Commission fines Lundbeck and other pharma companies for delaying market entry of generics

The European Commission has found and sanctioned infringements of antitrust rules by several pharmaceutical companies, and it has imposed fines totaling €145 million ($191 million), including €93 million to be paid by Lundbeck (Valby, Denmark). Citalopram is a medicine developed by Lundbeck to treat the symptoms of major depression, and in 2002, this product, which was Lundbeck's best-selling medicine, was nearing the end of its life-cycle. The patent protection for the molecule had lapsed and the remaining patent protection was limited to certain manufacturing processes. It therefore became possible at that point for competitors – namely, Alpharma, Merck, Arrow and Ranbaxy - to enter the market with generic versions of citalopram. One of them started to sell generic citalopram while others were all preparing to launch their own versions of the product. When these generic competitors were close to entering the market, Lundbeck agreed with each of them that they would stay out against payment.  Patients, as a result, were deprived of access to cheaper medicines, and it also harmed the public health systems, which for a longer period had to artificially bear the costs of an expensive medicine – and one of the most widely prescribed antidepressants, the Commission says. These "pay-for-delay" deals constitute severe infringements of EU competition law and may cause severe harm to patients and taxpayers, the Commission says.
Lundbeck says it strongly disagrees with the Commission's decision and it intends to appeal. Over 600 analyses of the generic citalopram demonstrated that they were all produced with infringing processes and in many concurrent documents the generic companies acknowledged that their products violated Lundbeck's patents, Lundbeck says. Upon entering the agreements they were all reviewed by external anti-trust experts and the agreements were furthermore in 2004 reviewed by both the European Commission and the Danish Competition Authorities who stated that it could not be rendered probable that the agreements were restricting competition, Lundbeck says.

Avantor plant in India producing pharma chemicals

Avantor Performance Materials’ manufacturing plant at Panoli, India, is now producing pharmaceutical chemicals using contract cGMP standards, the company says. The plant makes salts and solvents for pharma production and research, Avantor says. Avantor bought the plant as part of the acquisition of RFCL in 2011. The plant was under construction at the time, and production commenced in December 2012, the company says.

Beyond IHS Chemical Week:

EU risks drug shortages if API import regs not waived for US says Socma
from in-PharmaTechnologist.com

Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.

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