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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Theratechnologies

Monday Deal Review: January 6, 2014

  Welcome to your Monday Biotech Deal Review for Janary 6, 2014! Happy New Year! Things in 2013 slowed considerably as we approached the holiday season, however January has gotten off to a good start.

Hit the break to see this week’s major biotech news, and thank you to Jennifer Ng of Norton Rose Fulbright Canada LLP for conbtributing to this week’s post.

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Monday Deal Review: December 16, 2013

  Welcome to your Monday Biotech Deal Review for December 16, 2013! This week saw Cangene announce thier acqusition by Emergent BioSolutions for CDN$236 million. Further, on the commercial side, Theratechnologies, Stellar Biotechnologies and NEOMED all made announcements in the collaboration space.

Hit the break to see this week’s major biotech news.

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Monday Deal Review: February 11, 2013

Welcome to your Monday Biotech Deal Review for February 11, 2013! This week saw YM Biosciences obtain the required court approval necessary before their plan of arrangement acquisition by Gilead could proceed. The transaction is essentially free to proceed by the effective date of the agreement. Cangene has acquired a hemophilia compound from the remaining assets of Inspiration Biopharmaceuticals, which is undergoing bankruptcy proceedings. Cangene paid $5.9 million for the compound. Also in the news, Stem Cell Therepuetics will undergo a plan of arrangement with Trillium Therepeutics, where the two companies will effectively be merged and continue to operate under Stem Cell’s name.

Of course, there was considerably more activity this week, so click through to get the full story!

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Monday Deal Review: January 21, 2013

Welcome to your Monday Biotech Deal Review for January 21, 2013!  Medicago made news last week with a $15 million loan agreement with an unnamed pharmaceutical company. The funds are being used for Medicago’s plant-based VLP vaccine pipeline. As the agreement provides for potential licensing options with that partner, we will be watching closely to see any further announcements.

YM Biosciences, as it continues with its plan of arrangement transaction with Gilead, has received the endorsement of two proxy firms who have recommended to shareholders that they vote in favour of the transaction. This will likely allow YM Biosciences to obtain the shareholder approval required by statute to be able to continue with the arrangement.

Paladin labs, meanwhile, has closed their acquisition of a controlling stake in Ativa Pharma of Mexicom, and has also in-licensed a new biologic from Apeiron Biologics. Also, last week we saw Theratechnologies conclude their recent issues with the NASDAQ exchange by voluntarily delisting. They remain on the TSX, however.

As always, click through to see more on these deals as well as the rest of last week’s major biotech activity.

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Monday Biotech Deal Review: August 13, 2012

Welcome to your Monday Biotech Deal Review for August 13, 2012.  Highlights from the previous two weeks include the announcement of an interim order for a plan of arrangement between QHR Technologies Inc. and Open EC Technologies and the announcement of a support agreement for the takeover of Life Bank by Insception Biosciences.  Read on to learn more. Read more of this post

Monday Biotech Deal Review: March 12, 2012

Welcome to your Monday Biotech Deal Review for Monday March 12, 2012.  Following a break, the Monday Biotech Deal Review is back with summaries of biotech transactions over the previous weeks.  Activity has been impressive over the past month, with pharma-giant Valeant Pharmaceuticals syndicating $600M in senior secured indebtedness under its existing senior credit facility to fund (among other things) future acquisitions, Alexion Pharmaceuticals completing its acquisition of Enobia Pharma for $610M and Futuremed Healthcare Products Corporation was acquired by Cardinal Health Inc.  Also of note was the recent $80.5M equity financing by YM BioSciences as well as the reverse takeover of The Atman Co. by Biotonix.  Read on to learn more.   Read more of this post

Valuation and other biotech mysteries – Part 6: The cost of developing a new drug

[Ed. This is the sixth part in Wayne's series. You can access the whole thing by clicking here. Please leave comments or questions on the blog and Wayne will address them in future posts in this series.]

The Tufts Center for the Study of Drug Development has been the source of the most comprehensive studies of new drug developments, including costs, success rates and strategies. Their estimates include the cost of the failures and the lost income from simply investing in government bonds. Neither of these factors is relevant to our current discussion although the former is critical to the success of the industry.

The clinical development pathways for both Theratechnologies Inc. (TSX:TH) (NASDAQ: THER) and Oncolytics Biotech (TSX:ONC)(NASDAQ:ONCY) have been outlined in previous parts of this blog series  and it is appropriate to look at the expenses for these companies. The expenses of Cardiome Pharma Corp. (NASDAQ: CRME) (TSX: COM) in their development of both intravenous and oral forms of vernakalant are also shown below. The information for all three companies was found from their annual financial statements at www.sedar.com in about 30 minutes.

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Monday Biotech Deal Review: June 20, 2011

Welcome to your Monday Biotech Deal Review for June 20, 2011.  Notable transactions from the previous week included the public offering of units by Resverlogix, as well as investments by HTX and the Business Development Bank of Canada in each of Milestone Pharmaceuticals  and Profound Medical Inc.  Read on to learn more. Read more of this post

Monday Biotech Deal Review: June 13, 2011

Welcome to your Monday Biotech Deal Review for June 13, 2011.  Notable stories include the completion of GeneNews’ early warrant exercise program and debenture conversion opportunity, resulting in gross proceeds of nearly $3M to the Company.  As well, Somaxon and Paladin Labs have teamed up for the commercialization of Selinor in Canada, South America and Africa.  Read on to learn more.  Read more of this post

Monday Biotech Deal Review: June 6, 2011

Welcome to your Monday Biotech Deal Review for June 6, 2011.  This week’s deal review is brought to you by Norton Rose OR LLP summer student Steven Zuccarelli who, before entering law school at Osgoode Hall Law School, obtained his B.Sc and M.Sc at McMaster University in Biochemistry and Health Sciences, respectively, where he was involved in researching peptide vaccine models.  Steven will be assisting over the summer months with the Monday Deal Review, and it’s great to have him aboard. 

Aside from some interesting commercial deals, as well as CardioComm’s related-party announcement of a $788k asset purchase, things were fairly slow last week.  Read on to learn more. 

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Valuation and other biotech mysteries – Part 4: Strategy and structure for Phase 3 clinical trials

[Ed. This is the fourth part in Wayne's series. You can access the whole thing by clicking here. Please leave comments or questions on the blog and Wayne will address them in future posts in this series.]

Very few independent Canadian biotech companies have successfully completed the development of a novel drug – so my first comment is congratulations to Theratechnologies. Now, let’s study what they did so we can learn how to assess other companies attempting the same feat. To repeat, my approach is to start at the end – regulatory approval – and study the pathway to that endpoint.

The FDA approval states that EGRIFTA™ (tesamorelin for injection) is indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. This approval is based primarily on proof of safety and efficacy from the Phase 3 trials. In order to determine their Phase 3 clinical strategy, Theratechnologies ran Phase 2 trials for a variety of indications, including COPD, sleep disorders, HIV-lipodystrophy, hip fractures, type 2 diabetes and flu vaccinations. They chose HIV-lipodystrophy as the best entry point for the commercialization of tesamorelin and may have considered the following factors in choosing this strategy.

  • Relative strength of the Phase 2 data for the various indications
  • Probability of success in Phase 3
  • Ability to recruit patients for the Phase 3 trials
  • Easily defined and measured clinical endpoints
  • Market potential for each indication
  • Interest of potential commercial partners for each indication

These are typical strategy and structure questions which help assess the risks and rewards about any pending or ongoing Phase 3 clinical trial program. We will look at quantifying potential rewards and more complete assessment of risks later in the series.

Here is a list of some clinical and regulatory events which occurred during the Phase 3 trials and subsequent regulatory review of tesamorelin (pulled from various AIFs in about 20 minutes).

Year

Month

Event

2004

June

Announced Phase 3 clinical strategy

2005

March

FDA approval to start first Phase 3 trial
 

June

First patient enrolled in first Phase 3 trial

2006

March

Patient enrolment completed in first Phase 3 trial
 

August

SPA for second Phase 3 trial
 

October

Last patient in first trial completed 3 months of treatment
 

December

Positive 3-month data from first Phase 3 trial

2007

January

Started patient enrolment in second Phase 3 trial
 

May

52-week treatment completed in last patient in first Phase 1 trial
 

September

Completed enrolment in second Phase 3 trial
 

October

Positive 52-week data from first Phase 3 trial

2008

April

26-week treatment completed in last patient in second Phase 3 trial
 

June

Positive 26-week data from second Phase 3 trial
 

October

EMD Serono licensed U.S. rights to tesamorelin
 

December

Positive 52-week data from second Phase 3 trial

2009

May

Filed New Drug Application (NDA)
 

November

Announced that the FDA will schedule an advisory committee meeting

2010

January

Announced that FDA will reschedule advisory committee meeting due to administrative delay at FDA
 

May 25

Briefing documents for advisory committee released
 

May 27

Advisory committee meeting; 16 – 0 vote in favour of recommending FDA approve tesamorelin
 

November

EGRIFTA (tesamorelin for injection) approved by the FDA for the treatment of HIV-lipodystrophy

By looking at this list, we can create a general list of Phase 3 questions. It is unlikely that any company will answer all or even most of these questions, so other sources such as analyst reports are useful.

  • How many Phase 3 clinical trials will be needed?
  • How many patients will have to be enrolled in these trials?
  • Will the trials be run concurrently or consecutively?
  • How long do you expect patient enrolment to take?
  • What is the timing of the interim analyses at which an independent board will assess continuance of the trials?
  • How long do you have to treat and follow the final patient before you can compile the final data?
  • What delay do you expect from the time top-line final data is released until an NDA (or BLA) can be filed?
  • Will the NDA be subject to accelerated or standard review timelines?
  • What will the cost of these clinical trials be, exclusive of ongoing corporate expenses?

The most complete outline of the clinical trial structure is contained in the Investigators Brochure and Clinical Trial Protocol but these are confidential company documents. The best current disclosure on trial structure is usually found at http://clinicaltrials.gov. This searchable database can be used to find the structure of a specific clinical trial, all clinical trials for specific medical conditions, the drugs being tested in those trials (competition information) and much more.

For the biotech investor, run a historic price chart for TSX:TH, plot all of the events in the table above and see what effect, if any, there was on the share price. If you did this for several companies that took products through Phase 3, whether successful or not, you may be able to spot some trends on what events you think impact share prices. Remember that share prices will also be impacted by other factors including company financings, announcements from competitors, sector trends and global financial events.

Monday Biotech Deal Review: March 14, 2011

Welcome to your Monday Biotech Deal Review for March 14, 2011.  This week was a fairly slow week for Canadian biotech, but there were nevertheless a couple of interesting announcements.  Pharmagesic acquired over 90% of the restricted voting shares of WEX Pharmaceuticals marking the conclusion of its bid, and Theratechnologies has backed away from its previously announced U.S. IPO due to unacceptable pricing conditions.  Read on to learn more.  Read more of this post

Monday Biotech Deal Review: February 28, 2011

Welcome to your Monday biotech deal review for February 28, 2011.  In addition to the usual reviews of biotech corporate activity, this week featured the announcement of Theratechnologies’ U.S. IPO, the closing of a $40M bought deal by Paladin Labs, Angiotech’s recapitalization amendment and the appointment of a Receiver for LAB Research.  Read on to learn more.   Read more of this post

Monday Biotech Deal Review: February 7, 2011

Welcome to your Monday Biotech Deal Review for February 7, 2011.  It was a fairly busy week for Canadian biotech – Angiotech has followed suit in the U.S. on the heels of last week’s CCAA filing, a number of acquisitions were announced, and there was some activity in biotech licensing.  Read on to learn more.  Read more of this post

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

Monday Biotech Deal Review: December 6, 2010

Welcome to your Monday Biotech Deal Review.  There was some activity with Angiotech last week, with extension agreements being executed extending certain deadlines dealing with Angiotech’s proposed recapitalization as well as a preliminary loss in court against Rex Medical L.P.  Read on to learn more, as well as your usual assortment of biotech news.  Read more of this post

Q3 Canadian Healthcare Review – Weakness Continues BUT Some Bright Spots

Data in the Q3 2010 Canadian Healthcare Review from the Equicom Group (co-authored by James Smith, Vice President Healthcare at Equicom and myself) shows a continuation of the weakness in biotech financing which we have seen in 2009 and 2010.

Bounceback From the Financial Crisis May Have Masked 2009 Weakness

While the level of funding seen during 2009 was a concern, the problem may have been partially hidden by the many large share price increases from lows they hit as a result of the financial crisis in late 2008. The level of funding in 2010 is lower and the impact of lower funding is now being seen in share price performance. Lower cash resources have resulted in lower activity levels and survival concerns, which has probably been a factor in the 40% or greater share price drop in the first 9 months of 2010 for 31 of 105 healthcare companies in the share price performance assessment. The bright spot is that investors can still make money in the sector, as 13 companies had their share prices increase by greater than 40% in that same period.

Protox and Oncolytics Start Q4 With a Bang

The $35 million dollar financing by Protox announced in September did not count in the Q3 total because the financing was not closed by September 30. The first $10 million tranche of that financing and the recent $25 million dollar bought deal financing by Oncolytics Biotech are a good start for Q4.

Pending Regulatory News May Build Buzz

There are also some upcoming events which could help create a little momentum in the sector. While Cardiome has had a delay in a U.S. Phase 3 study of its iv vernakalant (already approved in the E.U.), the start of Phase 3 trials of the oral version by its partner Merck would be a good boost. Theratechnologies is still waiting for the FDA decision on tesamorelin after the unanimous recommendation from an advisory committee. Bioniche’s parter Endo is expected to both release results from the first Phase 3 study of Urocidin™ and also start the second Phase 3 trial.

Evolution at Valeant and Angiotech

Two large companies continue to evolve. Valeant is slowly exiting from the NCE business and going back to its specialty pharma roots as it gives back clinical programs which were acquired by the prior Biovail management. Angiotech has announced a major debt restructuring which will cut its ongoing financing costs but will also result in major dilution for current common shareholders.

More to Come on Profitable Canadian Healthcare Companies

My focus as a biotech analyst over the years has been the development stage companies. The Canadian healthcare sector also includes numerous companies which are not only profitable but also do monthly distributions to shareholders. I will take a look at these companies in a future post.

Monday Biotech Deal Review: October 18, 2010

Despite the short week, it was a busy one in the Canadian biotech sector. Read on to learn about the Labopharm / Paladin licensing deal, Ondine’s new facelift (and 15:1 equity liposuction), and various other biotech updates and news. 

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Monday Biotech Deal Review: February 15, 2010

A busy Monday Deal Review is headlined by Labopharm and ProMetric on the securities front, MDS’ final divestiture on the M&Eh front and Biovail and Bioniche on the licensing front, and there’s lots more activity behind those for over $100 million of deals.  Check out all the details (and the witty headlines) after the jump…

Monday Deal Review: June 8, 2009

B&W_BigNickelWell, it’s a day late, but no dollars short.  Here is an action-packed Deal Review.  Read on for some debt settlement, some creditor un-settlment (a BIA filing), and all kinds of M&A related rejigging…

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Monday Deal Review: March 30, 2009

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