Replies to post #29373 on Biotech Values

[DewDiligence]

Re: Omnitrope approval and FDA's BS

To put it bluntly, the FDA’s contention that this is not a precedent-setting decision is BS, while NVS’ statement that the decision is precedent-setting is entirely justified.

The FDA’s argument for saying this is not precedent-setting is that the Agency has approved other protein drugs via Section 505; however, these prior approvals did not fall under via Section 505b2, specifically. This distinction makes all the difference in the world because a drug approved under Section 505b2—but not a drug merely approved under Section 505—may rely on the clinical data of the referenced branded drug (PFE’s Genotropin in this case) to demonstrate safety and efficacy.

Bottom line: the Omnitrope approval is good news for the companies who stand to benefit from generic biologics (NVS, TEVA, and possibly some smaller companies such as MNTA), and it is probably bad news for the likes of AMGN and DNA.

[DewDiligence]

Here’s NVS own PR on the Omnitrope decision:

http://biz.yahoo.com/iw/060531/0132169.html

>>
Sandoz gets precedent-setting US approval for Omnitrope(R) as first follow-on version of a previously approved recombinant biotechnology drug

Wednesday May 31, 4:30 am ET

HOLZKIRCHEN, GERMANY--(MARKET WIRE)--May 31, 2006 --

-- US approval a breakthrough in goal of making high-quality and cost-effective follow-on biotechnology medicines available for patients

-- Omnitrope now approved for treatment of growth disorders in children and adults in the US, the European Union and Australia

-- Sandoz committed to bringing other follow-on biotechnology medicines to patients worldwide following patent expiry

Sandoz announced today that the US Food and Drug Administration has granted approval for the company's recombinant human growth hormone Omnitrope as the first follow-on version of a previously approved recombinant biotechnology drug in the US.

Omnitrope was approved in the US using the so-called 505(b)(2) pathway of the Hatch-Waxman Act, becoming the first recombinant copy of a biotech drug to be approved by this manner.

Omnitrope is indicated for treatment of growth disorders in children and adults.

"The FDA's approval is a breakthrough in our goal of making high-quality and cost-effective follow-on biotechnology medicines like Omnitrope available for health care providers and patients worldwide," said Dr. Andreas Rummelt, CEO of Sandoz. "The approval of Omnitrope is a major step forward in bringing needed clarity to the approval process for follow-on biotechnology medicines in the US."

The FDA's decision follows the approval of Omnitrope on April 19 by the European Commission. Omnitrope is now on the market in Germany, with launches planned for additional countries in Europe later this year. Omnitrope is also available in Australia, where it was launched in November 2005.

Sandoz believes that rigorous scientific criteria should be consistently applied to the approval process for all follow-on biotechnology medicines. However, the unnecessary or unethical duplication of animal studies and human clinical trials should be avoided so that resources are not wasted that could otherwise be invested in innovation and continuous improvement.

Sandoz also believes that these types of medicines should be approved and produced once patents have expired without specific reference to the trade secrets and confidential commercial information of innovators.

Biotechnology medicines are produced in living organisms altered by recombinant technology, and being proteins, are larger than smaller pharmaceutical molecules produced by organic synthesis. However, using advanced product development, analytical methodologies and manufacturing processes, companies like Sandoz can manufacture high quality medicines and bring them to market with savings for patients and payors.

As more recombinant biotechnology medicines lose protection in the coming years, these products are expected to play a key role in the growth strategy of Sandoz.
<<