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Tag Archives: Lumira Capital

Biotech Trends in 2011: Biosimilars

In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.

The biosimilars market has also evolved in a couple of unexpected ways: 

  1. Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
  2. At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”

As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.

This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Ontario Emerging Technologies Fund (OETF) Shows Signs of Life (Sciences), Adds Biotech Investments and Investors

An announcement this morning from the OETF — Ontario’s (née) $250 million co-investment fund — shows positive signs for potential matching investments in the life sciences.

First, the OETF announced an investment in Natrix Separations. BDC wore the “Qualified Investor” hat on that one, but Natrix is in GrowthWorks’ Canadian Fund portfolio, so we know at least one life sciences VC has found a way to access the OETF funds.

Second, the OETF announced that Lumira Capital and CTI Life Sciences Fund are now Qualified Investors. Both have extensive life science portfolios (Lumira, CTI) and recent successful exits (Lumira: Resonant, Ception; CTI: TargeGen).

So, is this the tip of the biotech iceberg for the OETF? The level of disclosure required to qualify has been cited as a barrier to VC participation in OETF investments and some structural challenges remain for life science companies hoping to leverage the fund’s money; so it’s too soon to say. It sure is encouraging to discover that these challenges aren’t prohibitive. Stay tuned…

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Cephalon-Ception’s Canadian Connection: Great News for Lumira Capital and McMaster in $250 million Option Deal

At the beginning of 2009, when Ception Therapeutics was working on mid-stage trials of its lead compound, it struck an option deal with Cephalon (NASDAQ: CEPH): $100 million up-front, and an option to acquire the rest of Ception for $250 million more. 

This week, Cephalon exercised the option after taking a look at Phase II results for Cinquil (reslizumab), a novel biologic that could potentially be used to treat asthma and Pediatric Eosinophilic Esophagitis. 

Among many other beneficiaries, foremost among them hopefully being patients, this deal is great news for Canadian-based VC firm Lumira Capital*, which co-led the deal, and for McMaster University, which did some of the clinical work on the drug. 

According to FierceBiotech, the $350 million paid so far is not the end of the story either, as Ception shareholders will benefit from future clinical and regulatory milestones.

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* occasional contributors to this publication.

New Data Shows 70% of Canada’s Biotech Companies Have Under 12 Months’ Cash. BIOTECanada’s New Ask: Government Loans.

Canadian moneyA Canwest story today highlights new BIOTECanada data showing 70% of survey respondents have under 1 year of cash, up from 50% in January.  FierceBiotech picked it up as well, guaranteeing a full dose of international attention.  

Even though the remaining 30% of respondents likely include some with big recent successes — Bioniche, Allostera and Zymeworks — and some with creative approaches — ConjuChem, Neuromed, etc. — the top-line number is grim indeed.  Plus, as Kasia Majewski points out:

“Most firms have found away to extend their cash, but they’ve done that by massive layoffs, by shutting done operations to the bare bones. So essentially the lights are on but there’s one guy home.”

Given that there has been no systemic cash infusion, it’s not surprising that the number of firms in trouble has gone up since January. 

On the other hand:

There is a bolus of fund-of-funds and direct capital waiting to be deployed, including:

Plus, Lumira Capital’s Q2 newsletter (pdf) points to the new BDC money, Alberta Investment Management Corp’s PE plans and the new Alberta Enterprise Corporation as potential additional sources of funding in the medium term.

BIOTECanada bottom line:

In the winter, the organization was focused on tax initiatives.  Yesterday, though, the focus was entirely on

“negotiations with Industry Canada to obtain a loan program for Canada’s biotech sector that can hold the industry over until capital markets rebound. … [Specifically,] government loans to be repaid after a two- year period at six per cent interest.”

Maybe it’s the new money looming on the horizon, or the seeming lack of traction for the tax policy asks, but the focus has definitely shifted.

My bottom line:

Even the new loan program advocated by BIOTECanada will not help if the other government funding doesn’t make it to biotech companies and VCs. We’ve been keeping an OVCF scoreboard that still shows a goose-egg for biotech investments.  It may be early days for these new capital sources, but the hour is late for Canadian biotech companies.

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Introducing…

Beni Rovinski of Lumira Capital joined the blog today.  Beni is a Managing Director focused on US and Canadian mid- to late-stage private and public companies involved in drug discovery and development, biological and small molecule therapeutics, drug delivery and specialty pharmaceuticals.  Take a look at his full bio here.

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Funding Gap?

A perennial question: is there a gap in available funding for startups?

Some cool data from Lumira Capital’s latest newsletter (pdf) compares VC funding in the U.S. and Canada using the traditional 10:1 baseline expectation.  By this measure, Canada’s gap is in late-stage VC funding; but in light of the across-the-board drop seen in Q4 investment numbers, we may be heading for significant problems on both sides of the border.  A story in today’s New York Times suggests the same decrease is likely to be reflected in 2009’s angel investments.

A gap implies there’s something on the other side, but if there’s really a shortfall from research funding (or before) through pharma M&A, maybe we need to re-brand the “gap”.

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