Biotech Values

[Cactus Quave]

An old example of a Minor Deficiency letter

I found an example of Minor Deficiency letter received by SangStat in 1998. [Note; SangStat was bought by Genzyme in 2003] With this example being so old, it may not be particularly relevant. A few observations and comments:

1. Much of the text in the SangStat PR is identical to that of Teva's PR yesterday.
2. SangStat, however, went much further and included language to provide some details, timeline (2 - 3 weeks vs. "near future") and convey their optimism that CYCLOSPORINE would be ultimately approved.
3. I suspect that Teva used this PR as boilerplate for their own release. Whatever the case, why did Teva not also include some language provide details and to convey optimism of approval, particularly in light of their numerous comments saying that they expected approval?
4. CYCLOSPORINE was approved 9 months after receipt of the Minor Deficiency letter but their path may have been much more clear cut.

SangStat Receives Positive FDA Action Letter for CYCLOSPORINE; Bioequivalence Review Completed

Business Wire, Feb 12, 1998

MENLO PARK, Calif.—(BW HealthWire)—Feb. 12, 1998—SangStat, The Transplant Company(R) (NASDAQ:SANG), announced today that it has received correspondence from the U.S. Food and Drug Administration (FDA) indicating that the Agency has completed its review of the Company’s CYCLOSPORINE marketing application. An application for marketing Sang-35, SangStat’s proprietary CYCLOSPORINE product candidate, was submitted to the FDA in November, 1996 as a bioequivalent formulation to Neoral(R) for the prevention of rejection in organ transplant recipients.

The receipt of this action letter, called a Minor Deficiency letter, indicates that the FDA has completed its review of the CYCLOSPORINE abbreviated antibiotic drug application (AADA) including the Company’s responses to key questions during the review process. Prior to potential final product approval, the Office of Generic Drugs (OGD) requires responses to a short list of questions which SangStat intends to respond to within the next 2-3 weeks. Importantly, the remaining issues raised in this letter are not related to the bioequivalence trials.

The bulk cyclosporine drug substance used in SangStat’s application, supplied by Gensia Sicor, received FDA approval in July, 1997. A pre-approval inspection of the finished product manufacturing facility was deemed not necessary by the FDA.

Philippe Pouletty, M.D., SangStat’s Chairman and CEO said, “We are very pleased that the FDA has completed its review of the application and issued this key action letter for CYCLOSPORINE. Achieving this milestone is another significant accomplishment for SangStat.” He continued, “Subject to providing satisfactory responses to all questions the FDA may have, we look forward to receiving US market clearance for CYCLOSPORINE as a bioequivalent product to Neoral and launch.”

Cyclosporine is the leading immunosuppressive drug used in transplantation to prevent graft rejection. Cyclosporine is marketed by Novartis Ltd. in different formulations as Sandimmune(R) and Neoral with estimated worldwide sales of $1.3 billion in 1997. In the U.S. and Europe there are more than 200,000 transplant recipients requiring daily immunosuppressive therapy for the rest of their lives, the majority of whom take cyclosporine.

In December 1997, Amgen signed an agreement with SangStat for the exclusive commercial rights to SangStat’s CYCLOSPORINE for market approval and distribution in select countries in the Asia Pacific rim (Australia, New Zealand, China and Taiwan). SangStat intends to market directly its products, subject to regulatory approvals, in North America and Europe and seek well-established companies, like Amgen, as partners for marketing CYCLOSPORINE in other territories around the world.SangStat Receives Positive FDA Action Letter for CYCLOSPORINE; Bioequivalence Review Completed

News of the approval:

SangStat Gets US Approval For Generic Cyclosporine

3 November 1998

SangStat has been granted marketing approval in the USA for SangCya(cyclosporine 100mg/mL oral solution) for the prevention of rejection in solid organ transplant recipients. This is the first approval for the product, which is also the first alternative version of Novartis’ leading immunosuppressant Neoral. Novartis’ composition-of-matter patent expired in the USA in September 1995.