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EU Regulators Analyze Origins of EMA-Approved Drugs

Altho MOST new medicines receiving send marketing authorization in the EU come from wide and medium-sized pharmaceutical companies, smaller firms and other institutions are major source of innovation year, a new report written by five European Medicines Agency Officials says.

The paper, published in Nature Reviews Drug Discovery Friday, identified all medicines Containing a new active substance recommended for marketing authorization by the Committee for Medicinal Products for Human Use and 2010 2012 Between Their origins and notes.

Significant findings Were:

• 49 percent of the drugs cam wide or medium-sized pharmaceutical companies from;
• 27 percent cam from small drugmakers, though odd Such organisms account for only 13 percent of marketing authorization holders;
• 17 percent cam from universities, public bodies and public-private partnerships;
• Private-private collaborations Accounted for seven percent, and
• 19 percent of applications for marketing authorization for orphan drugs and Were 61 percent of orphan drugs cam from SMEs.

Forty-five percent of North American Were drugmakers, the paper says, while 37 percent are European and 8 percent are from Japan, China, Israel and Australia.

The EU already HAS program to supporting SMEs, the paper says, Recommending new incentives for engagement with academics.

Novartis favorable opinion of the EU for Xolair

Pharmaceutical company Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EU for its Xolair treatment against chronic spontaneous urticaria (CSU), according to a statement released Friday.

The CHMP, which depends on the European Medicines Agency (EMA) has issued a "positive opinion" for the use of Xolair as adjunctive therapy in the treatment of chronic spontaneous urticaria in adults and adolescents 12 over years.

The European Commission generally follows the CHMP opinion and decides two months after notice thereof.

If Xolair is approved for this indication, the drug "will be the first and only treatment in the EU for 50% of patients with CSU and who do not respond to treatment with antihistamines," said Tim Wright, Head of Development Novartis Pharmaceuticals.

Novartis also announced that he would submit a new application to the CHMP for his Serelaxin drug in the treatment of acute heart failure after an unfavorable opinion.

The approval of this indication Serelaxin process also continues its way through the U.S. Agency Drug Administration (FDA) and 16 other countries.

Hybrigenics: orphan drug status for inecalcitol in the EU

The biopharmaceutical company Hybrigenics announced Tuesday that its flagship product, inecalcitol, received orphan drug designation by the European Commission, which confirmed the favorable opinion issued in December by the European Medicines Agency (EMA).

Inecalcitol was designated orphan drug for the indication of chronic lymphocytic leukemia (CLL), a statement said.

The orphan drug status gives access to assistance procedure by the EMA Committee for Orphan Medicinal "for collaborative protocol design of future clinical Phase III."

This status also guarantees Hybrigenics 10 years of exclusivity in the event of marketing in the pharmaceutical markets of the European Union, said the group.

Hybrigenics indicates that preclinical and preliminary clinical results "make plausible the possibility of significant benefit provided by Inecalcitol during the early phase of the disease compared to the simple surveillance".

"The clinical benefit should now be significantly demonstrated during the next phase of development of inecalcitol in CLL," adds Hybrigenics.

AB Science fall after another setback on its lead compound

The title of the pharmaceutical company AB Science collapsed Friday morning at the Paris Stock Exchange after suffering a setback for the use of its lead compound for pancreatic cancer.

A 10H42 (09H42 GMT), the value lost 16,56 11,94% in euros, while the CAC index let go 40 0,48%.

The group announced Thursday that a special committee of the European Medicines Agency (EMA) had rejected his application for conditional approval of its lead compound masitinib for treatment first indication of pancreatic cancer metastasized.

The Committee for Medicinal Products for Human Use (CHMP) was determined for methodological reasons, but also because of the toxicity of the treatment used in combination with another molecule and concerns about the purity of the product, the company said.

AB Science announced that it would appeal the decision, noting that existing treatments were ineffective in the fight against this
particularly virulent form of cancer.

"Our fears already expressed (...), are confirmed.

The CHMP opinion is a major setback, "said the broker Invest Securities.

The broker said that this setback is added to the one on the second line treatment of gastrointestinal tumors (GIST) "with the
same molecule, masitinib, the only AB Science ".

2013 late November, AB Science announced that it had received an initial negative opinion of the European Medicines Agency (EMA) on its lead compound masitinib in GIST indication.

This new announced Thursday is especially bad as "pancreatic cancer represented to us most of the valuation of AB Science" according Invest Securities or 7 euros per share.

The broker and reiterates its recommendation to "sell" the value and lowers its price target of EUR 11,9 4,9 euros.

Sanofi and Transgene begin construction of their production unit in Lyon

French pharmaceutical group Sanofi and biotechnology company Transgene announced on Wednesday the launch of the construction of a Lyon biomanufacturing unit will require an investment of approximately € 10 million.

"This industry leading platform, combining the excellence of Genzyme, Sanofi Pasteur and Transgene in the Lyon region, will be dedicated to the production of viral vectors with a wide range of technologies including mammalian cell culture (up 1 m3 ) through the use of single-use bioreactors, "said Philippe Luscan, executive vice president of Industrial Affairs, Sanofi said in a statement.

The two partners signed an agreement in March 2013 for the construction of the new unit on the site of Genzyme Polyclonals.
It will be the exclusive property of Sanofi but his two-year funding will be achieved parity.

"Transgene will be a special guest of the platform until 2028", said the two companies.

Transgene has an exclusive manufacturing immunotherapy products, but the site may enter into agreements with other companies in other products, Has was stressed to AFP.

According to this source, the first batches should be produced 2016 horizon before commercialization globally to unspecified date.

This new production "embodies the key elements needed to progress in global health, innovation and partnership," noted Mr. Lustan.

For its part, the CEO of Transgene Philippe Archinard stressed that "significant commercial production unit" resulted in "consolidated (er) future Transgene and franch (ir) the steps necessary to meet future market needs."

According to a spokesman for Sanofi, the construction site should 18 last month.

Moreover, no recruitment should be required before 2017, Has it said, adding that the numbers should come from redeployment from other companies Sanofi, including Genzyme Polyclonals.

During the announcement of the deal a year ago, Transgene hoped to present its first application for authorization to market a treatment from his research 2016.

But the construction of the new site was then scheduled to begin in the third quarter 2013, with completion expected in the first quarter 2015 work.

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