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CHMP turns down Pfizer’s Gaucher drug Elelyso

Drug deemed not to be superior to Shire’s Vpriv

The European Medicines Agency's (EMA) primary advisory committee has recommended against approval of Protalix and Pfizer's Gaucher disease treatment Elelyso (taliglucerase alfa), despite concluding that the benefits of treatment outweighed its risks.

The Committee for Medicinal Products for Human Use (CHMP) said it was forced to take the stance because Shire's Vpriv (velaglucerase alfa) is already approved with orphan drug designation for the same condition in August 2010, giving it 10 years of marketing exclusivity in the EU.

"In this case, the CHMP concluded that Elelyso is similar to Vpriv, as they are both enzyme replacement therapies that work in the same way," said the EMA in a statement.

While exemptions to this exclusivity can be granted if a new therapy is shown to be superior to the existing drug, or if the latter has supply constraints, but these did not apply in this case, said the agency.

Pfizer and Protalix had sought approval based on the supply problems that have plagued another Gaucher disease drug, namely Genzyme's Cerezyme (imiglucerase) which has been impacted by manufacturing problems over the last couple of years.

The two companies were also hoping that the lower price of Elelyso would stand in its favour, as well as the fact that Cerezyme should in fact have been the first orphan enzyme replacement therapy for Gaucher's, although this category did not exist when it was first approved in 1997.

Protalix' chief executive David Aviezer said the development was "obviously a setback", adding that it would be working with Pfizer to try to overturn the decision. The companies won approval for Elelyso in the US in May, prompting a $25m milestone payment from Pfizer to Protalix.

Other CHMP decisions

Among the other decisions made at the latest CHMP meeting on June 18-21 were opinions for following drugs intended for marketing in the EU:

- Nycomed Danmark's Revestive (teduglutide) for the treatment of adult patients with short bowel syndrome; Revestive is the first drug to be recommended for approval in this indication in the EU, and was shown in clinical trials to preserve mucosal integrity by promoting repair and normal growth of the intestine. It has been designated an orphan drug for this indication.

- Novartis Europharm's Seebri/Enurev/Tovanor Breezhaler (glycopyrronium bromide) for chronic obstructive pulmonary disease; the once-daily long-acting muscarinic antagonist (LAMA) is recommended for use as maintenance therapy administered either alone or in combination with other treatments.

- AstraZeneca's Zinforo (ceftaroline fosamil), a new antibiotic; the oxyimino cephalosporin is recommended as a treatment for adults with complicated skin and soft tissue infections (cSSTI) and community-acquired pneumonia (CAP).

25th June 2012

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