Sandoz Receives European Commission Marketing Authorization for Omnitrope®
HOLZKIRCHEN, Germany, April 18, 2006 - Sandoz announced today that the European Commission has granted marketing authorization for the company’s recombinant human growth hormone Omnitrope®.
“We are pleased that the European Commission has taken the final step in approving Omnitrope for marketing in Europe, and we will quickly bring this product to market for the patients and physicians who need it,” said Dr. Andreas Rummelt, CEO Sandoz. “As more biotechnology-based products come off patent, Biosimilars will play an increasingly important role by providing lower-cost, safe and effective versions of patent-expired biological medicines .”
The European Commission’s decision to grant marketing authorization followed a positive opinion issued by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) in January. Omnitrope will be the first Biosimilar to be marketed that has been approved under the biosimilar pathway of the European Commission.
“Omnitrope is the first of several Biosimilar products that Sandoz is pursuing,” Rummelt stated. “We are committed to further development of this class of products as we anticipate the future needs of patients and physicians.”
Sandoz expects to begin marketing the product soon, following negotiations with government health authorities regarding pricing and other regulatory requirements. Germany and Austria will be the first markets in Europe where Omnitrope is going to be available. The product currently is on the market in Australia, where it was launched in November 2005.
With marketing authorization granted in Europe, Sandoz now hopes that the US Food and Drug Administration (FDA) will act to approve Omnitrope in the US, acknowledging the sound science that supports this product.
On April 10, the US District Court for the District of Columbia granted summary judgment in the company’s favor in its lawsuit against the US Food and Drug Administration (FDA) regarding its Omnitrope application. The summary judgment upholds the statutory deadline for FDA action on a pending new drug application, thereby requiring FDA to issue a decision on Sandoz’ application for Omnitrope, which was filed in July 2003. Sandoz had filed a lawsuit against the Agency in September 2005, seeking a ruling on its Omnitrope application.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, cost-efficient products that are no longer protected by patents. Sandoz has a portfolio of more than 600 active substances in over 5 000 forms worldwide. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these drugs along with pharmaceutical and biotechnological active substances and Anti-Infectives. In addition to the strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and EonLabs (U.S.) and sells its products in more than 110 countries. In 2005, Sandoz employed around 20,000 people worldwide and posted sales of USD 4.7 billion.
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