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Tag Archives: Sanofi-Aventis

Monday Biotech Deal Review: December 13, 2010

Welcome to your Monday Biotech Deal Review.  It was a bit of a slow week this week, with a few small private placement announcements, and some activity in the licensing sector.  Read on to learn more.   Read more of this post

Biotech Trends Update — Biosimilars Blur IP Constituencies: Novartis and Pfizer-Biocon are Featured in the Economist

Two 9-figure announcements this week mark a turning point for the biosimilars market, and one highlights the increasingly important role India plays in innovation.

  1. Pfizer linked up with India’s Biocon in a deal that will see Biocon take the lead in development of four biosimilar insulin products that gives Biocon $200 million up front. Coverage of the deal in the Business Standard highlights the country’s overall strength in biosimilars, which fall midway between new molecule development and small molecule generics in terms of the R&D and manufacturing sophistication required. Biocon cites the deal as proof that India can move up the value chain, doing for biosimilars what it did for generics. This is especially true if they continue to attract backing and partnerships from the Pfizers of the world.
  2. Novartis’ generics unit, Sandoz, reported Q3 revenues of $292 million from a single biosimilar product — enoxaparin, a copy of Sanofi-Aventis’ anticoagulant Lovenox — which is not expected to hit blockbuster status in its own right. As we have noted before, the high level of expertise required to make biosimilars creates a high barrier to entry and contributes to the field’s attractiveness to traditional pharmas (e.g., Pfizer, above) as well as to the major generics players. FierceBiotech notes further growth is expected as the first biosimilar antibodies hit the market in 2014-2015.

The Economist picked up the relevant trends in an article today entitled “Attack of the Biosimilars“:

1) “Innovator” pharmas are moving into the biosimilars business, reversing their recent role as the predominant plaintiffs in IP litigation:

“…it is ironic that the next great opportunity for traditional drugs firms is to do to the biotechnology interlopers exactly what the generics firms have done to them: shred their profit margins with cheaper copies…”

2) India in moving up the innovation value chain, increasing that country’s incentive to protect IP more forcefully:

“And as if to remind the world that new ideas don’t all come from America, it is the Indian firm that will design and manufacture the original drugs; Pfizer will only market them.”

Bottom line: biosimilars are at least as big a business as predicted. This success is another challenge to the concept that pharma’s patent cliff challenge will be met by more in-licensing from small biotechs or by increased R&D spending. Revenue is revenue, and biosimilars are poised to generate lots more of it.

Monday Biotech Deal Review: January 18, 2010

Another strong week for Canadian deals. Light on securities, but heavy on M&A, licensing and partnerships.  MedGenesis and Cyplasin brought assets in, Canada and Australia are doing a do-sa-do (Topigen-Pharmaxis, YM-Cytopia), and Trillium Therapeutics signed an out-license to Biogen, while Medicure is shopping its lead program around.  Less good news for Haemacure and Forbes Medi-Tech, but plenty of other deal info, including 7 HTX investments, to be found Read more of this post

Monday Biotech Deal Review: December 21, 2009

This week’s deal review shows no signs of a holiday showdown.  In Canada, BioMS’ deal with Spectral Diagnostics was interesting as a possible indicator of more to come and internationally, 5 new pharma deals were announced this morning including a $430 million deal that OncoGenex landed from Teva joining new links between Athersys and Pfizer, Lilly and Incyte, sanofi-aventis and Chattem and Seattle Genetics and GSK.  Check out the past week’s Canadian deal-making (and breaking) after the jump…

Three Need-To-Know Canadian Patent Decisions That Impact Pharma, Biotech and Generics Companies

In Canada, linkage regulations similar to the Hatch-Waxman Act in the U.S. ensure that generics manufacturers have to address relevant patents listed on the Patent Register (the analog to the Orange Book) if they want to market their product prior to the expiry of listed patents.   Generics manufacturers can do so either by accepting the terms of the patents, or by filing a Notice of Allegation (NOA) alleging, amongst other things, that they will not infringe the patent or that the patent is invalid.

Three recent decisions litigated in this context contain important notes for pharma companies, biotech companies, generics companies and their patent attorneys and agents. 

  1. The Patent Act (post-1996) Imposes a Duty of Candour and Good Faith. In Lundbeck Canada Inc. et al  v. Ratiopharm Inc., Lundbeck’s patent was invalidated because the patent agents failed to “fully and fairly describe[]” the prior art in responding to an obviousness rejection raised by the patent examiner.  This decision may take on a broader impact, particularly if it is interpreted to require Canadian applicants to affirmatively inform examiners of aspects of the prior art that are both favourable and unfavourable.
  2. Formulation Patents Must Claim All Medicinal Ingredients.  In Bayer Inc. v. Canada (Minister of Health) et. al., Bayer’s patent was held to be ineligible for listing on the Patent Register, despite reading on the product.  Where the approved product contains a formulation with more than one medicinal ingredient, only patents that claim formulations containing all of the approved medicinal ingredients may be listed on the Patent Register, regardless of whether the product is covered by the patent claims.
  3. Disclaimers Can Be Validly Filed After Receipt of a NOA.  In sanofi-aventis Canada Inc. v. Hospira Healthcare Corporation, sanofi responded to Hospira’s NOA by filing a disclaimer in respect of a portion of one of sanofi’s listed patents.  Hospira argued that the Court should consider the sanofi patent as it read on the date the NOA was served and not as it read after the disclaimer was filed.  Although the court held (in favour of sanofi) that the patent should be read as of the date of the hearing, it also held that sanofi’s particular disclaimer was invalid because the patentee had not unequivocally testified that the disclaimer was a result of claiming too broadly in the patent as issued. Such an admission was necessary to the validity of the disclaimer.  The court also held that having attempted a disclaimer, sanofi could not subsequently assert against Hospira the portions of the patent it had attempted to disclaim.

Thanks to Kavita Ramamoorthy and the whole Life Sciences team.

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UPDATED Merial in Canada: Sanofi-Aventis to Buy Merck Out for $4 Billion, May (Re)Combine with Intervet Post-Merger

The New York Times’ DealBook blog reports that regulatory concerns about Merck’s purchase of Schering-Plough, presumably Schering’s Intervet animal health subsidiary, required Merck to divest its stake in Merial — its animal health JV with sanofi-aventis.  Sanofi is kindly obliging, for $4 billion.

Interestingly (given DealBook’s reporting that the JV divestiture is antitrust-driven), Merck, sanofi and Schering also entered into  a call option agreement (pdf), giving sanofi-aventis the option to combine Intervet with Merial following the Merck-Schering merger to form a new animal health joint venture with post-merger Merck.

The blurb on Merial Canada, which has what appears to be a small presence in Baie D’urfé Québec, is available for your viewing pleasure after the jump…

Trends Update — IP Constituencies: Rumors about GSK-Shantha Biotech

B&W_BlankMap-World-nobordersSince we’ve been following innovative activity in India and China as part of our Trends in 2009 series, we had noted a report at the end of March that GlaxoSmithKline and Sanofi-Aventis were each in talks to buy a majority stake in the Indian company Shantha Biotech from France’s Merieux Alliance, which owns 80 percent of the company.

A report in India’s Economic Times today, picked up by FierceBiotech, says that Sanofi had dropped out and that the deal with GSK has “[o]nly a few matters relating to the valuation” remaining.  This is a bit like saying Israel and the Palestinians are close to a peace accord with only a few matters related to borders remaining.  Hopefully GSK and Shantha/Merieux are closer (and friendlier) than that, but valuation is obviously a big issue, so I wouldn’t be counting any biosimilars before they hatch.

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Trends Update — IP Constituencies: Sanofi Buys Medley in Brazil

Continuing a trend we have been following of increased “innovator” pharma investment in global generics and biosimilars, Sanofi-Aventis is spending €500 million to acquire Medley, a  privately-held Brazilian manufacturer. The acquisition will make Sanofi Latin America’s biggest generics manufacturer.  A post at the WSJ Health Blog on the acquisition includes a nice overview of the other recent pharma-generics deals.

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Trends Update: ChinaBio and Shantha Biotech

One of our Trends in 2009 posts last week talked about the increasing innovative activity in India and China and increasing generics activity among innovator pharma.  This week starts with a relevant update on each front:

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