Business and Science for BD & others
#56, February 2011
FDA ODAC: Accelerated approvals getting harder
Under FDA Accelerated Approval, cancer drugs (and drugs for other terminal diseases with few options) have been approved on a surrogate endpoint such as tumor shrinkage (rather than the clinical benefit such as survival), reaching patients a median of 3.6 years before the post-marketing confirmation of the clinical endpoint. Now, following the initiation of withdrawal of approval of Avastin for HER-2-negative metastatic breast cancer, after the post-marketing trials failed to confirm a survival benefit, the Oncology Drug Advisory Committee met to affirm that two confirmatory trials by sponsors are needed in the post-marketing period. The FDA wants to see that the confirmatory trials are begun before accelerated approval is sought. http://journals.lww.com/oncology-times/blog/onlinefirst/pages/post.aspx?PostID=132 . This increase in stringency was also signaled when the FDA refused to consider accelerated approval for the Roche Immunogen antibody drug conjugateT-DM1, saying that the treatment choices had not been exhausted, despite an average of 7 prior therapies for these breast cancer patients.
AstraZeneca deal for cost-effectiveness data from Wellpoint
AstraZeneca will pay Wellpoint to access data on the outcomes of chronic diseases for up to 36 million Americans. Payers are increasingly asking for data on a drug’s economic value, on outcomes such as hospital length of stay, readmissions, overall health status, and cost of care. The data also could point to the areas in greatest need of new therapies to treat and prevent disease. http://news.morningstar.com/newsnet/ViewNews.aspx?article=/DJ/201102020945DOWJONESDJONLINE000277_univ.xml
IPO market rebounding somewhat
Ernst and Young reported that in 2010, 121 companies filed to go public on US exchanges, up from only 6 in 2008. 16 of the new IPO filings were based in China and 22 were based in California. 24 were biotech or pharmaceutical companies. 2/3rd of the young companies were asking for less than $100 million. http://www.xconomy.com/national/2011/02/08/ernst-young-says-ipos-continue-to-gain-steam-in-2011/. On Jan. 3, BDO released a national survey of investment bankers that showed 65 percent of respondents expect more biotech IPOs this year, ranking behind only technology and energy company IPOs.
Big deals in 2010
Current Agreements reported 3,300 deal announcements in 2010, with 560 stating a headline value. 16 deals claimed over $1B in total value, down from 17 claiming that $1B total value in 2009. The biggest upfront was in the deal granting Abbott exclusive rights to develop and commercialize Reata’s bardoxolone outside the US (excluding certain Asian markets). Bardoxolone is urrently in late Phase 2 for chronic kidney disease and diabetic nephropathy. Reata will receive upfront and near-term cash payments of $450 million for the licensing rights to the Nrf2 transcription modulator and a minority equity investment in the company.
The leading dealmaker of 2010 in terms of deal dollars disclosed was Sanofi-Aventis, committing a total of $4,631 million in headline value announcements (with 32 announced deals), closely followed by Boehringer Ingelheim committing a total of $4,533 million (with 10 announced deals).
US Patent Reform Act of 2011 – first-to-file
The US Senate Judiciary Committee approved the Patent Reform Act of 2011 which would convert the US to the first-to-file system common to most of the world, from the current first-to-invent system. Patentability will be judged on whether any prior art was available prior to the filing date. A one-year grace period would remain in effect, but only for the inventor's own disclosures (and disclosures derived from the inventor). Obviousness will also be judged as of the effective filing date. Other changes in third party challenges and fees are also in the bill, which is backed by BIO. Changes may yet be made by the House. http://www.patentlyo.com/patent/2011/02/patent-reform-act-of-2011-an-overview.html
Public sector research institutions contributed to 153 approved drugs
An NEJM analysis of IP listings for FDA approved drugs found that 153 approved drugs or vaccines (9.3% of all approvals) had some IP licensed from a public sector institution (universities, federal labs, the NIH, research hospitals and non-profit research institutes). 19% of priority reviews had some IP from the public sector. The IP could have been screening, method of synthesis, composition of matter, method of treatment, formulation, or a device. Unfortunately, the paper does not break down the numbers of the relative proportions of these different contributions. Oncology and infection were the most common indications. http://www.nejm.org/doi/full/10.1056/NEJMsa1008268#t=articleMethods
Increasing FDA inspections of oversees manufacturing plants
About 40% of the drugs in the US are imported. But the FDA inspects oversees drug manufacturing plants only once every 9 years on average, compared with once every 30 months for US plants, according to the GAO. The FDA plans to outsource more of the inspections and share data with other countries to lower the overall number of inspections. http://www.businessweek.com/news/2011-02-10/more-outsourcing-planned-for-fda-overseas-factory-inspections.html
Generic drugs take 2.5 years to get FDA approval
Generic drugs now make up nearly 3/4ths of all drug prescriptions in the US. Generic drug manufacturers are lining up to support paying user fees to speed up FDA approvals of generic drugs, currently taking 2.5 years on average (compared to an average of 1.4 years for FDA approval for CDER approved drugs in 2010, according to Deloitte Recap). Plant inspections are one of the hold ups. Branded drug companies already pay user fees to the FDA to support staff to speed up approvals. The Wall St. Journal Feb 16, 2011.
Biologics down to 5 years exclusivity, elimination of pay-to-delay, as a trade for PDUFA fee changes?
Obama’s budget proposes that the period of exclusivity on biologics would be cut to 5 years from the 12 years recently enacted in the biosimilars act in healthcare reform. The White House budget also would eliminate the right to “pay-to-delay”, where the prescription drug originators pay generic manufacturers to not enter the market. Steven Burrill speculates that these might be bargaining positions to get bigger fees for the FDA in the renewal of the Prescription Drug User Fee Act in 2012. http://seekingalpha.com/article/253781-has-obama-set-two-more-chips-on-the-table-in-the-biotech-poker-game?source=email_partial_daily_dispatch In the meantime, the proposals introduce new uncertainty.
Recently announced deals for my clients – YEAH!
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