Replies to post #108174 on Biotech Values

[DewDiligence]

The hurdle for an Advair generic in the US is not the drug, but rather the inhalation device. That’s why both NVS and Teva gave up on such a project.

[DewDiligence]

Vectura Receives NVS Order for Generic-Advair Inhalers

[Advair, GSK’s biggest product at $7B+ per annum, is a case where it will be easier to bring generics to market in Europe than in the US. Advair’s being a drug-device combination makes it problematic for a US generic to show sameness for an ANDA, and the FDA has been reluctant to allow 505b2 NDA’s for inhaled drugs; this is presumably the reason NVS recently pulled out of a partnership to develop a US Advair generic. In Europe, on the other hand, the generic-Advair device need not be identical, and companies can market what is effectively a branded generic of Advair that relies on GSK’s clinical data. Germany nullified GSK’s main Advair patent in May 2010 (#msg-50392405).]

http://finance.yahoo.com/news/UPDATE-1-Inhaler-order-boost-rc-4261665836.html?x=0&.v=98

›Tuesday November 16, 2010, 9:58 am EST
By Paul Sandle

LONDON, Nov 16 (Reuters) - Inhaled drugs specialist Vectura (VEC.L) sought to bolster confidence in the potential for a generic rival to Glaxo's lung drug Advair in Europe on Tuesday as its partner Sandoz ordered a first batch of Vectura inhaler devices.

Sandoz, the generic division of Novartis (NVS), is the European partner for Vectura's V315, a potential generic version of Advair, GlaxoSmithKline's (GSK) top-selling lung drug.

Chief Executive Chris Blackwell said: "I don't think Sandoz would be placing orders for a device technology to deliver a product unless they were pretty confident it had a good chance of getting approval."

Teva Pharmaceutical Industries (TEVA) earlier this month backed away from developing a U.S. generic copy of Advair.

"There is the possibility that Sandoz can lead with this product and establish a strong market before competitors get there," Blackwell said.

Novartis is not taking the drug forward in the United States, however, likely because it cannot see clear route to approval [see comments in the prologue of this post].

Blackwell said he was assessing the FDA's requirements and was in active talks with a number of licensing partners.

Shares in Vectura were 6.6 percent higher at 68.5 pence by 1426 GMT, as KBC Peel Hunt analyst Paul Cuddon said the launch of the Sandoz product might now be anticipated towards the latter half of 2011.

"Generic Advair is getting closer to launch in Europe, and NVA237 (for chronic obstructive pulmonary disease) is nearing completion of a pivotal phase III trial (March 2011) and so we see positive near-term catalysts for the shares," he said.

Blackwell also said he was looking for a partner for Vectura's treatment for Parkinson' disease, a proprietary formulation of apomorphine delivered using its dry-power inhalation technology that has "orphan status" in Europe, after it reported positive Phase II trials.

Vectura posted core earnings of 6.3 million pounds ($10 million), up 174 percent, on 15 percent higher revenue of 26.3 million pounds for the six months to end-November, in line with analyst estimates.‹

[DewDiligence]

Lupin could be first US filer for generic Advair:

http://articles.economictimes.indiatimes.com/2012-07-26/news/32869722_1_vinita-gupta-lupin-pharma-generic-drug

This is a tricky approval to pull off because of the need to replicate the device as well as the drug; NVS and Teva both gave up on such a project despite the lure of Advair’s huge US sales.