US FDA ordered by US judge to rule on human growth

[Junkyard Dog]

US FDA ordered by US judge to rule on human growth hormone Omnitrope - report

ZURICH (AFX) - The US Food and Drug administration was ordered by a US federal judge to rule on Omnitrope, a human growth hormone product made by Sandoz, a generics unit of Novartis AG, the Wall Street Journal Europe reported.

Omnitrope is a biogeneric copy of Pfizer Inc's Genotropin. The judge criticized the FDA's hesitative attitude concerning generic versions of biotechnological medicines, the paper said.

The FDA in 2004 said it had finalised its examination of the medication but said it would postpone a decision on admission until a new code of practice for these new class of generic medications has been developed, the NZZ am Sonntag reported at the weekend.

Sandoz filed its application for Omnitrope in July 2003.

In January, Sandoz received a favourable opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on growth hormone Omnitrope.

The EU commission has not ruled on Omnitrope yet.

[Junkyard Dog]

Novartis Could See Positive Pipeline News

Standard & Poor's Equity Research maintained a "buy" rating on Novartis as the Swiss pharmaceutical giant nears the closing of its $5.4 billion acquisition of flu vaccine maker Chiron.

Research analyst Herman Saftlas expects Novartis (nyse: NVS - news - people ) to complete the purchase of Emeryville, Calif.-based Chiron (nasdaq: CHIR - news - people ) later this week.

"We believe this should position Novartis as a top tier vaccine producer at a time when the global vaccine business stands to benefit from pandemic fears and from breakthroughs in vaccine technology," the analyst wrote in a client note.

Saftlas noted that Chiron should also bolster Novartis' position for generic versions of biotech drugs. "We note that a U.S. judge recently ordered the U.S. Food and Drug Administration to decide on Novartis' generic human growth hormone," he said.

Sandoz, the generic drugs unit of Novartis, filed a lawsuit against the FDA in September 2005 seeking a ruling on a pending application for Omnitrope, a human growth hormone similar to Genotropin. Omnitrope is currently approved for sale in Australia.

"We think there could be positive pipeline news over the near term," said Saftlas.

The S&P analyst has a 12-month price target of $61 on Novartis. Novartis will acquire Chiron for $48 per share.

Genotropin is marketed in the U.S. by Pfizer (nyse: PFE - news - people ), which licensed the drug from Novo Nordisk (nyse: NVO - news - people ).

[Junkyard Dog]

Novartis generics unit Sandoz gets EU approval for Omnitrope

ZURICH (AFX) - Novartis AG said its generics unit Sandoz has been granted European Commission approval for the company's recombinant human growth hormone Omnitrope, the first biosimilar -- a copy of an off-patent biotech drug -- to be marketed following approval under the Commission's biosimilars approval process.

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 is currently on the market in Australia, where it was launched in November 2005.

Sandoz now hopes that the US Food and Drug Administration (FDA) will approve Omnitrope in the US, it added.

[Junkyard Dog]

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.



About Sandoz

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.

This release contains certain "forward-looking statements" relating to the Group's business, which can be identified by the use of forward-looking terminology, or by express or implied discussions regarding strategies, plans and expectations. Such statements reflect the current plans or views of the Group with respect to future events and are subject to certain risks, uncertainties and assumptions. Management's expectations could be affected by, among other things, competition in general, and other risks referred to in Novartis AG's Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.