QDIS Blog

Xenical has passed the first hurdle to going over the counter. The FDA sent an approvable letter to GlaxoSmithkline regarding Alli the name for over-the-counter prescription drug Xenical. This will be the first approved weight loss drug to be sold OTC and will likely be a blockbuster in the huge weight loss market. Xenical has been available by prescription since 1999 and has world wide sales of about $500 million. Although GSK received an “approvable” letter the FDA has asked for more information but it evidently wasn’t much since the company has stated they will not need to submit any more human data. GSK hopes to have Alli in drugs stores before the end of the year. While GSK has licensed the rights for over-ther counter drug, Roche is the manufacturer and still has the prescription rights. This will be interesting since Sanofi-Aventis also has a diet drug called Rimonabant (It may be called Acomplia) in the works. Sanofi-Aventis has been asked for more information by the FDA and that may involve more human testing resulting in significant delays. The company hasn’t commented on what the FDA requested, but some financial houses downgraded Sanofi-Aventis back in February. Merck has also been investigating a drug similar to Sanofi’s known as only as “L-000899055″. Merck has been pretty silent regarding this drug. The weight loss industry should be an interesting to keep an eye on in the next couple of years.

Technorati Tags: FDA, weight loss

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

A second drug, Relenza (zanamivir) has been approved by the FDA for prevention on the flu.

Relenza

While it has been approved since July 1999 for treating the flu, it is now approved for preventing it. The only other drug approved for prevention of the flu in the US is Tamiflu (oseltamivir phosphate). This is good news in that there are now alternative to Tamiflu if a world wide flu pandemic should occur. Also, Relenza is inhaled while Tamilfu is taken orally. Also, the manufacturing process appears to be much simpler than Tamiflu involving 6 steps and starts from a more readily available material (sialic acid).

Also, a Taiwan company is said to have cracked the manufacturing process although they have stated they have no interest in infringing on GlaxoSmithkline’s patent on Relenza. The same Taiwan company is said to also have identified the manufacturing process for Tamilfu as well.

Tamiflu

I recently posted about Roche having additional contract manufacturers lined up to potentially make Tamiflu if needed.

Relenza is manufactured and distributed by GlaxoSmithKline; Tamiflu is manufactured and distributed by Roche.

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Recently Michigan State University had a news release describing Kevin Walker’s work investigating 5 enzymes that are may pave the way to producing Taxol ® (paclitaxel) from E. Coli. His group is investigating five enzymes important for the functionalization of the paclitaxel core. Having started my career at Bristol-Myers Squibb (BMS) in the early 90’s I have been exposed to the chemistry and development related to paclitaxel for almost 15 years in the industry and now as a consultant, taxane related work is a key part of my business. While I find the work recently reported in Chemistry and Biology interesting I’m wondering if they aren’t somewhat behind in this area. BMS has been collaborating with Phyton to produce Taxol via plant cell culture since 1993 and this is how BMS currently produces Taxol®. I do think this could potentially be useful for next generation taxane products. While there have been numerous derivatives described in the literature and in patents, with the exception of Taxotere® (doectaxel), none have yet been brought to market.

While I’m hopeful that some of these derivatives may hold hope for the future. Paclitaxel and most derivatives all suffer from poor solubility and problems with formulation. I spent five years at a previous employer working on putting paclitaxel and other drugs on a poly-amino acid polymer which dramatically improved both solubility as well as drug distribution to the tumor tissue. I think the combination of these drugs with appropriate polymer backbones is a promising technology for the future.

Technorati Tags: Taxol

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |