Replies to post #48853 on Biotech Values

[gym gravity]

is there a comprehensive list of biological patent expirations?

[Jonathan Robinson]

Probably part of the reason for the large late trade in MNTA.

Jon

[DewDiligence]

Addendum on Senate biogeneric bill:

1. I expect a shorter exclusivity period than 12 years in the final House/Senate compromise if the exclusivity applies to marketing per se.

2. The exclusivity period may be made to apply to clinical data rather than to marketing, which would allow a FoB company to circumvent the exclusivity period by running its own (abbreviated) clinical program.

[DewDiligence]

Teva Comments on the 'Biologics Price Competition and Innovation Act of 2007'

[The “Biologics Price Competition and Innovation Act of 2007” is the Senate bill described in #msg-20694180. A comparable bill has not yet been moved through the House. Thus, it’s too soon to say which features will survive a compromise between the two chambers—or even to say that a biogenerics bill will pass Congress this year. If a bill does get passed this year, I think it will likely specify a lower exclusivity period than 12 years.]

http://biz.yahoo.com/bw/070627/20070627005867.html?.v=1

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Wednesday June 27, 12:23 pm ET

JERUSALEM--(BUSINESS WIRE)--Today, the Senate Health, Education, Labor and Pensions committee will take a significant step forward to ensure that the Food and Drug Administration (FDA) has the regulatory pathway necessary to establish an approval process for generic biologics. Teva applauds the Committee, especially Senators Kennedy, Enzi, Clinton and Hatch for their leadership, as well as Senator Schumer, in taking these important steps. The fundamental approach of the Biologics Price Competition and Innovation Act of 2007 is to address the scientific, regulatory and legal issues involved in bringing affordable biologics to the marketplace. The bill will create a scientifically-rigorous, efficient, FDA-driven pathway for both biosimilar and biogeneric products and include a mechanism intended for timely resolution of patent disputes.
Unfortunately, there are two critical issues that undermine the promise of the bill for consumers, payers and employers who continue to face increasing health care costs. The first issue is the unprecedented twelve years of market exclusivity the bill provides to the innovator company for developing a compound. Teva, as a significant patent holder, supports strong incentives for innovation, however, twelve years of market exclusivity is four years beyond any other nation and seven years beyond the exclusivity period guaranteed for chemical drugs. Our hope is that the Congress will adopt a more constructive and balanced market exclusivity period that is closer to the Hatch Waxman Act. [The H-W exclusivity period for small-molecule drugs is five years for a new molecular entity and three years otherwise; these periods apply even if there is no patent on the compound.]

The second issue and the potentially fatal flaw that needs to be addressed before the bill moves forward is the loophole in the legislation that enables companies to secure multiple twelve year exclusivity periods for very minimal true innovation or improvement to an existing compound. Minor changes to a product would result in an additional 12 years of monopoly protection -- a practice commonly referred to as "evergreening." This issue could indefinitely delay consumer access to potentially life saving medicines. We do not believe it is the intent of the sponsors of this legislation to allow such evergreening. Teva looks forward to continuing to work with the bill's sponsors and other policymakers to rectify these concerns and fulfill the promise of true competition and access to affordable healthcare that this bill should offer.
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[DewDiligence]

New Survey on Biogenerics Legislation

Please refer to #msg-20694180 for a description of the Kennedy-Clinton-Enzi-Hatch bill (“K-C-E-H”), which is currently moving through the U.S. Senate.


Q1: What is your expectation for biogenerics legislation during 2007?

a) No biogenerics bill will be enacted into law during 2007.
b) A bill will be enacted into law in 2007
in substantially the same form as K-C-E-H.
c) A bill will be enacted into law in 2007 that
will be substantially different from K-C-E-H.


Q2 (To be answered only by those who selected answer “c” to Q1 above):
The main distinction between K-C-E-H and the bill to be enacted is:

a) The enacted bill will confer less than 12 years of
marketing exclusivity for branded biologic drugs.
b) The enacted bill will not allow substitutability
of a generic for a branded biologic drug.
c) Some other difference.

--
To vote, please go to
http://www.investorshub.com/boards/board_surveymenu.asp?board_id=1418
and select survey #92.

[DewDiligence]

FoB update: Rep. Dingell of Michigan is trying to stall
legislation on biogenerics. Whom is he beholden to?

http://online.wsj.com/article/SB118420428940564226.html

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House Acts to Boost FDA Powers; Biotech Fight Looms

By ANNA WILDE MATHEWS
July 12, 2007

WASHINGTON -- The House passed legislation that would bolster the powers of the Food and Drug Administration, but the vote sets up a confrontation with the Senate over whether to create a pathway for generic versions of biotechnology drugs.

The House FDA bill, approved 403-16, mostly parallels a bill that passed the Senate in May. Both versions would devote more money to monitoring the safety of marketed drugs and increase the agency's authority over medications that raise safety concerns. The agency would have the clear ability to order follow-up studies, restrict distribution and enforce changes to the medications' labels. The bills don't grant the FDA the power to force a moratorium on direct-to-consumer advertising, a tough restriction that was discussed earlier, though the agency would be able to levy fines for false and misleading promotions.

A compromise version of the two measures is expected to be completed in the next few months -- perhaps before the August recess -- because the legislation renews industry fees that fund much of the FDA's work. Both the House and Senate versions would also force drug companies to make public information from many clinical trials.

But there is a key divide between the Senate and House bills: the Senate will include language that creates a pathway for the FDA to approve copycat versions of biotech drugs [#msg-20694180], and the House bill doesn't address the issue. The Senate provisions reflect an agreement among a group of key senators including Democrat Edward Kennedy of Massachusetts and Republican Michael Enzi of Wyoming, the health-committee leaders.

Mr. Kennedy has said he will introduce that compromise, which was reached after the Senate passed its FDA bill, as part of the proceedings of the bicameral conference committee that will resolve differences between the House and Senate proposals.

A key question is whether House leaders, including Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat, will be willing to accept the move. Different House members have introduced divergent bills, but the Energy and Commerce Committee hasn't moved forward with any of them.

In an interview yesterday, Mr. Dingell signaled that he will oppose inclusion of the copycat biotech-drug language in a final bill. He said he supports a pathway for such drugs, but has safety concerns as well as questions about whether science is advanced enough to verify a copy's similarity to the original medication. [For reasons previously posted on this board, I think this is a bogus argument.] "There's really no record to justify that kind of action" in the House, which hasn't yet fully debated a bill, he said.

The issue is extremely important for the generics and biotech industries, and it has been the focus of extensive lobbying [no kidding]. Currently, the FDA doesn't have the power to approve generic versions of most biotech drugs, which have become some of the most important, and expensive, treatments. Generics makers will prod for inclusion of the Senate generic-biotech language. Biotech makers, though, are expected to push for the House to consider its own bill, which could stall the change.

A spokesman for the Biotechnology Industry Organization said "it's a complex issue, and it deserves full and deliberate consideration."

A spokeswoman for the Generic Pharmaceutical Association said in an email that the group is "cautiously optimistic" that the copycat-biotech provisions will be in the final FDA legislation.
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