Replies to post #112421 on Biotech Values

[biomaven0]

>WPI Anticipates Lipitor Bonanza

I would have thought Pfizer's agreement with Watson would have delayed launch of the authorized generic until another generic actually launched. So this doesn't make a lot of sense to me.

Peter

[bladerunner1717]

Dew,

Is the "authorized generic" always the exact same drug as the branded original, or can the generic maker make some modifications to the branded original?

I assume the "authorized generic" needs no FDA approval.


Bladerunner

[DewDiligence]

PFE, MYL settle Lipitor and Caduet patent cases:

http://finance.yahoo.com/news/Mylan-Announces-Lipitor-prnews-209565740.html?x=0&.v=1
http://finance.yahoo.com/news/Mylan-Announces-Caduet-prnews-2557401421.html?x=0&.v=1

No terms have been disclosed. The settlements are related insofar as Caduet is a combination pill of Lipitor + Norvasc.

I think PFE may now have settled with all of the Paragraph-IV challengers to Lipitor and Caduet. If this is not true, someone please chime in.

[DewDiligence]

MYL Sues FDA to Force Hatch-Waxman Decision on Generic Lipitor

[Ranbaxy, the Indian subsidiary of Daiichi Sankyo, has 180-day first-filer exclusivity under Hatch-Waxman but does not have FDA approval to launch, which holds up the launch of other generics that do have FDA approval. Meanwhile, WPI has the right to sell a Lipitor AG (which is not blocked by Ranbaxy’s first-filer status) and could see windfall profits (#msg-58721867).]

http://www.bloomberg.com/news/print/2011-03-21/mylan-sues-fda-seeking-to-block-ranbaxy-s-lipitor-copy-approval.html

›By Susan Decker, Catherine Larkin and Adi Narayan - Mar 21, 2011

Mylan Inc. sued the U.S. Food and Drug Administration, seeking to block India’s Ranbaxy Laboratories Ltd. (RBXY)’s exclusive rights to sell a generic version of Pfizer Inc. (PFE)’s cholesterol pill Lipitor, the world’s best- selling medicine.

In a complaint filed March 18 in federal court in Washington, Mylan said it and other generic-drug makers should be allowed to enter the market as soon as a patent expires. Ranbaxy declined to comment on the lawsuit in an e-mail statement.

Ranbaxy, 64 percent owned by Tokyo-based Daiichi Sankyo Co., fell the most in a month in Mumbai on speculation that Mylan’s move may hamper its plan to start selling the medicine in the world’s largest drug market in November. The company has said it is entitled to 180 days of marketing exclusivity as a reward for being the first to challenge the Lipitor patents.

“It is the first time someone is openly challenging Ranbaxy’s exclusivity for Lipitor,” Bino Pathiparampil, a Mumbai-based analyst at India Infoline Ltd., said. “It is incrementally negative for sure” for Ranbaxy.

Ranbaxy fell 4.2 percent to 449 rupees at 11:15 a.m. in Mumbai trading, the worst performer on the Bombay Stock Exchange 200 Index. It earlier dropped as much as 5.3 percent, the most since Feb. 24.
Agreement With Pfizer

Ranbaxy, based in Gurgaon near New Delhi, reached an agreement with Pfizer in 2008 to sell copies of the medicine beginning in November. It has not yet received the final regulatory approval on its application to sell the drug.

In its complaint, Mylan contends that Ranbaxy isn’t eligible for that marketing exclusivity because of “false and unreliable data” from its manufacturing site in Paonta Sahib, India, where the Lipitor copies would be produced.

Mylan said it wrote to the FDA in January and February, and met with agency officials on Feb. 14 to ask whether Ranbaxy’s claim to the marketing exclusivity or the entire application would be denied because of the improper information. The FDA hasn’t answered those questions, the company said.

“FDA’s indecision is depriving millions of Lipitor patients access to lower-cost generic Lipitor,” Mylan, based in Canonsburg, Pennsylvania, said in its complaint. It’s “costing the public billions of dollars in savings, and costing generic manufacturers billions of dollars in lost sales.”

‘Tainted by Misconduct’

Mylan wants a court to force the FDA to say publicly whether Ranbaxy’s application “is tainted by Ranbaxy’s misconduct” and that therefore the application must be denied and the 180-day reward voided. A victory for Mylan would let it enter the market 11 months earlier than expected.

Ranbaxy is working with regulators to resolve outstanding questions and is confident that it will get the FDA approval for its copy this year, Chuck Caprariello, a company spokesman, said in an interview last month.

Lipitor sales fell 6 percent to $10.7 billion last year as generic competitors arrived in Spain and Canada. New York-based Pfizer’s product has been the world’s biggest-selling medicine for the past 10 years.

The case is Mylan Pharmaceuticals Inc. v. U.S. Food and Drug Administration, 11-566, U.S. District Court for the District of Columbia (Washington).‹

[DewDiligence]

Teva Launches ‘At-Risk’ Generic Lipitor in UK

http://www.ft.com/cms/s/0/cd21640a-a593-11e0-83b2-00144feabdc0.html

›July 3, 2011 10:44 pm
By Andrew Jack in London

Teva, the world’s biggest generic drugs company, has probably generated more than £14m ($23m) in UK sales from its version of Lipitor, Pfizer’s blockbuster anti-cholesterol drug, in a short-term sales blitz last month launched defiantly before the patent expiry.

Industry experts estimated that the company shipped more than two months’ stock of atorvastatin – the generic name for Lipitor – in June. This comprised up to 700,000 packets of the drug, sold at a discount of at least 15 per cent to the previous trade price.

Teva’s move came before a High Court injunction sought by Pfizer to block the sales. The dispute highlights intensifying efforts by rival drug companies to tap sales from atorvastatin, the world’s top-selling prescription medicine, which generated $11bn in revenues last year for Pfizer.

Teva took the highly unusual decision in the UK of launching its cut-price version on June 20, before the patent expiry due next year and without a court ruling to support its case that the patent was invalid.

Pfizer then took legal action and won an injunction last week to stop further sales of Teva’s version. The US-based group also took the rare step of seeking to prevent drug distributors and pharmacies from selling it.

The freeze will remain in place at least until July 11, when the court will reconvene.

While the injunction prevents further sales of Teva’s version of Lipitor, the company moved swiftly to sell large quantities of its product to two wholesalers – AAH and Phoenix – which in turn rapidly sold them on to pharmacies.

Pfizer has been selling Lipitor exclusively through Alliance.

The pharmacies, which have not been subjected to the injunction, stand to benefit financially, since under current government rules they will pay the discounted generic price to the drug distributors while being reimbursed for the coming months by the National Health Service at the patented Lipitor price. [That’s a neat trick for the pharmacies!]

Teva is betting that it will be able to overturn the patent, while fostering brand loyalty among patients by taking the initiative and establishing itself as the first alternative supplier.

“The first mover has a huge commercial advantage,” said Douglas Campbell, a barrister at Three New Square, which specialises in intellectual property cases.

Teva said in a statement: “We feel strongly that we are acting in the interests of sustainable and affordable healthcare.” [Does this apply to Copaxone too? :- )] “We maintain our view that the patent protection in place for Lipitor is invalid; and we intend to win the case and resume supply as soon as possible.”

However, Pfizer stressed that it would “continue to pursue vigorously all appropriate legal remedies to prevent infringement of its valid intellectual property rights and [it] reserves the right to claim damages from any infringing party”.

It said that that could include fresh efforts to seek injunctions against pharmacies, even though the court last month rejected its efforts to include Rowlands, a high street chain, in the original freeze on sales.‹

[DewDiligence]

Typically vacuous commentary by Zacks:

http://finance.yahoo.com/news/Marginal-Beat-for-zacks-1970609535.html?x=0&.v=1

Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor in November.

LOL—as though investors did not know this already.

[DewDiligence]

PFE settles Lipitor patent suit with RDY:

http://finance.yahoo.com/news/Dr-Reddys-Announces-bw-3170082914.html?x=0&.v=1

As far as I know, all generic challengers on Lipitor have now settled with PFE. The only remaining suspense in the Lipitor case concerns what the FDA will do about Ranbaxy, who has first-filer status but does not yet have an approved ANDA.