Biotech Deals Keep Flowing, From Big Pharma to Industrials

by: The Burrill Report

By Marie Daghlian

There is never enough of a good thing and certainly this week, several life science companies ranging from Big Pharma to industrial biotech seemed to feel that one deal was not enough. Big pharma players Sanofi-Aventis (NYSE:SNY) and J&J’s (NYSE:JNJ) Ortho-McNeil-Janssen Pharmaceuticals, biotech company Metabolex, and renewable fuels and chemicals developer Amyris (NASDAQ:AMRS) each struck two or more agreements to strengthen their positions.
Sanofi-Aventis entered into a global strategic alliance to discover, develop, and commercialize microRNA therapeutics. The alliance is the largest microRNA partnership to date, worth potentially $750 million to Regulus, including $25 million upfront, $10 million in a future equity investment, and annual research support for three years with the option to extend the partnership for two additional years. The companies will collaborate on up to four microRNA targets, including Regulus’ lead fibrosis program targeting microRNA-21. Sanofi will also have a three-year option for a broader technology alliance which will be worth an additional $50 million to Regulus if exercised. Regulus is equally owned by Alnylam Pharmaceuticals (NASDAQ:ALNY) and Isis Pharmaceuticals (ISIS), which formed the company in 2007. [See story.]
“MicroRNAs are believed to be extremely important in human development and physiology,” says Marc Cluzel, Executive Vice-President of R&D at Sanofi. “Together with Regulus we will develop therapeutics which could potentially open a new paradigm in the treatment of major diseases and could offer an attractive new therapeutic approach for patients.”
Sanofi also inked a global licensing and development deal with privately-held Metabolex potentially worth $375 million to research, develop, and commercialize small molecules that modulate the G-protein coupled receptor 119, a receptor in the gut and pancreas that interacts with bioactive lipids to stimulate glucose-dependent incretin and insulin secretion.
Agonists of GPR119 represent a first-in-class oral treatment for type 2 diabetes that function through a unique dual mechanism of action that may offer improved glucose homeostasis over existing diabetes therapies, with the potential for weight loss and improved islet health. They have been the basis of several recent deals including a deal struck a week earlier between Boehringer Ingelheim and Neurocrine Biosciences (NASDAQ:NBIX) to discover new GPR119 agonists.
The Sanofi-Metabolex agreement includes MBX-2982, a potent selective orally active GPR119 agonist discovered by Metabolex that, along with a candidate from GSK, is at the head of a class of candidates in earlier stage development. MBX-2982 is currently in a multi-national 28-day phase 2 clinical study in patients with type 2 diabetes.
As part of their agreement, Metabolex will receive an upfront payment and will be eligible to receive development, regulatory, and specified commercial milestones that total as much as $375 million. Metabolex is also eligible to receive royalties on worldwide sales of marketed products.
A few days before striking the deal with Sanofi, Metabolix partnered its pre-clinical type 2 diabetes programs with Ortho-McNeil-Janssen Pharmaceuticals for an upfront payment and up to $330 million in development, regulatory, and commercial milestones.
The global development and exclusive license agreement with Ortho-McNeil-Janssen will further develop and discover the compounds for the treatment of type 2 diabetes and other disorders. Metabolex is also eligible to receive royalties on worldwide sales of marketed products.
Ortho-McNeil-Janssen Pharmaceuticals also struck a deal with Swedish biotech Diamyd Medical to develop and commercialize its type 1 diabetes therapy for an upfront fee of $45 million and potential milestones of $580 million, as well as tiered royalties on future sales. The companies will equally share costs for the development of Diamyd’s GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions, until results from the ongoing EU phase 3 study, expected in the first half of 2011. At that time, Ortho-McNeil-Janssen will have the right to fully assume responsibility for the development program upon reviewing the results.
Diamyd has kept exclusive rights for commercialization in the Nordic countries and retains the rights to the therapeutic use of the GAD65 gene and derivatives, fragments and variants of the GAD65 protein.
Emeryville, California-based Amyris aimed to beef up its position ahead of its IPO with the addition of six agreements. Amyris uses the tools of synthetic biology to engineer microbes, primarily years, to serve as living factories to convert plant-based sugars into renewable fuels and chemicals. The company largest deal is with French oil company Total that included a $133.2 million investment in its series D financing. Their strategic partnership will develop new products and build biological pathways to produce and commercialize renewable fuels and chemicals.
Other agreements include a joint venture with Brazilian ethanol producer Cosan (NYSE:CZZ) to produce and commercialize cane-based renewable chemicals; a multi-year collaboration with Proctor and Gamble (NYSE:PG) and Amyris to use its renewable chemical Biofene in certain specialty chemical applications within P&G’s products; a deal with Italian chemical company M&G to use Biofene in its plastics production and to explore the combined use of their technologies; a partnering deal with French renewable cosmetic ingredients producer Soliance for its renewable chemicals in cosmetic ingredients; and an undisclosed deal with Shell Western Trading & Supply, a subsidiary of Royal Dutch Shell (NYSE:RDS.A) that is active in crude oil and products trading in South America.
Two large M&A deals also made the headlines. In a deal valued at $3.2 billion, Canadian specialty pharma Biovail (BVF) will reverse merge with Valeant Pharmaceuticals International (NYSE:VRX), with the new company retaining the Valeant name. Valeant stockholders will receive a one-time special cash dividend of $16.77 per share immediately prior to closing of the merger and 1.7809 shares of Biovail common stock upon closing of the merger in exchange for each share of Valeant common stock they own. The transaction is expected to be completed by the end of the year at which time the combined company is expected to pay shareholders a one-time additional $1-a-share dividend. At that time, Biovail stockholders will own approximately 50.5 percent and Valeant stockholders will own approximately 49.5 percent of the shares of the combined company on a fully diluted basis.
The combined company will have a significantly expanded presence in North America and operations in eight other countries, working across four growth platforms: specialty central nervous system therapeutics, dermatology, Canada and emerging markets/branded generics.
J. Michael Pearson, currently chairman and CEO of Valeant, will serve as the new Valeant’s CEO, and Bill Wells, currently CEO of Biovail, will be the non-executive Chairman.
The new Valeant will retain Biovail’s corporate structure and related financial efficiencies, and expects to generate at least $175 million in annual cost synergies in the second year. It will be headquartered in Mississauga, Ontario and will remain a Canadian domiciled corporation, listed on both the Toronto and New York Stock Exchanges. The location of the combined company’s U.S. headquarters will be determined after the close of the transaction.
The deal caps a long campaign by Biovail to beef up its CNS treatments, one of Valeant’s strengths with its drugs for epilepsy, Parkinson’s disease, and migrains. In 2009 Biovail bought the rights to GSK’s antidepressant Wellbutrin, and in February it acquired the rights to commercialize Alexza’s treatment for schizophrenic or bipolar agitation.
Finally, German industrial and ag chemicals producer BASF will acquire specialty chemicals company Cognis Holding Luxembourg in a deal valued at $3.8 billion. Cognis is a worldwide supplier of innovative solutions and products based on renewable raw materials for the health and nutrition market, as well as the cosmetics, detergents and cleaners industries. The company is controlled by Permira Funds, GS Capital Partners and SV Life Sciences. The transaction is expected to close in November.

Global Venture Financings
Company Location Amount Raised ($M)
Principal Focus
Amyris Biotechnologies Emeryville, CA $133.20 Renewable fuels and chemicals
Incline Therapeutics Redwood City, CA $43.00 Pain management
CytoPherx Ann Arbor, MI $5.00 Renal medical devices
Baxano San Jose, CA $30.00 Spinal medical devices
Brain Tunnelgenix Technologies Hamden, CT $4.00 Brain temperature monitoring
Molecular Detection Wayne, PA $1.40 Infectious disease diagnostics
Voyage Medical Redwood City, CA $20.60 Cardiac medical devices
QuantaLife Pleasanton, CA $7.50 Disease detection platform
Acceleron Pharma Cambridge, MA $8.40 Anemia therapeutics
Proventys Durham, NC $3.30 Personalized medicine
Presage Biosciences Seattle, WA $1.00 Clinical data provider
Nereus Pharmaceuticals San Diego, CA $20.00 Cancer therapeutics
Implandata Ophthalmic Products Hanover, Germany $0.86 Glaucoma monitoring
Grants and Contracts
Funding/Contracting Agency
Amount ($M)
Principal Focus
MedGenesis/ Biovail (Canada) Michael J Fox Foundation $2.10 Parkinson's disease
Ceregene Michael J Fox Foundation $2.50 Parkinson's disease
Escape Therapeutics CIRM $1.45 Gene/cell therapy
Apollo Endosurgery Cancer Prevention and Research Institute of Texas $5.00 Cancer medical devices
Mirna Therapeutics Cancer Prevention and Research Institute of Texas $10.30 miRNAI therapeutics
Strategic Polymer Sciences NIH NHLBI $2.20 Cardiovascular medical devices
GeneGo NCI Phase II SBIR n/a Data analysis platform
TriLink BioTechnologies Phase II SBIR $0.75 DNA ligation technology
Neuro Kinetics Phase II SBIR n/a Diabetic retinopathy diagnostics
Neoprobe Ohio Third Frontier $1.00 Medical imaging technology
Multimeric Biotherapeutics National Institute on Drug Abuse $0.35 Nicotine vaccine
Odyssey Thera Environmental Protection Agency $34.00 Toxin screening
Foresight Science & Technology National Institutes of Health $3.00 Commercialization support
Total Grants $25.65
Total Contracts $37.00
Raised $M

Financing Type
BioSante Pharmaceuticals BPAX $15.00 PIPE--RDO
Aradigm ARDM $5.00 PIPE
Patient Safety Technologies OTC:PSTX $6.00 PIPE
Neuralstem CUR $10.00 PIPE--RDO
Palatin Technologies PTN $2.00 PIPE--RDO
Pall Corporation PLL $375.00 Debt
Covidien (Ireland) COV $1,500.00 Debt
Aurora Diagnostics Private $335.00 Credit facility
Boston Scientific BSX $3,000.00 3-year term loan and revolving credit facility
NON-US $1,500.00
Deal Value
in $M

Biovail (Canada) Valeant Pharmaceuticals $3,200.00 Specialty pharmaceuticals
Chemaphor (Canada) 7552882 Canada (Canada) $0.50 Stem cells
Sosei Group (Japan) Activus (Japan) n/a Tools/Technology
Incline Therapeutics ALZA Corporation (J&J) n/a Pain management
Cadence Pharmaceuticals Incline Therapeutics $3.50 Pain management
BASF (Germany) Cognis Holding (Luxembourg) $3,815.00 Specialty chemicals
Piramal Healthcare (India) BioSyntech (Canada) $3.90 Medtech
Petroleo Brasileiro (Petrobras-Brazil) Sao Martinho (Brazil) $240.00 Biofuels
Olympus (Japan) Spiration n/a Medical devices
Gilead Sciences CGI Pharmaceuticals $120.00 Inflammation
Company/Licensee Company/Licenser Deal Value
in $M
Sigma-Tau Pharmaceuticals (Italy) Dyax $105.00 Cardiovascular partnership
Bristol-Myers Squibb Exelixis $17.00 Cancer drug rights
Cypress Bioscience BioLineRx (Israel) $190.00 Neurology license
Sanofi-Aventis (France) Regulus Therapeutics $750.00 microRNA therapeutics alliance
Santaris Pharma (Denmark) miRagen Therapeutics n/a microRNA therapeutics alliance
Ortho-McNeil-Janssen Pharmaceutical (J&J) Metabolex $330.00 Diabetes drug license
Ortho-McNeil-Janssen Pharmaceuticals (J&J) Diamyd Medical (Sweden) $625.00 Diabetes drug license
Sanofi-Aventis (France) Metabolex $375.00 Diabetes drugs license
GlaxoSmithKline (United Kingdom) Medivir (Sweden) n/a OTC-Infectious license
Bristol-Myers Squibb Saladax Biomedical n/a Companion Diagnostics
Hologic IsoRay Medical n/a Medical device license
Medco Health Solutions Celesio (Germany) n/a Healthcare joint venture
Geisinger Health System Cernostics n/a Diagnostic partnership
Pepsico Senomyx $7.50 Flavor ingredients collaboration
Merck Adcock Ingram (South Africa) n/a Pharmaceutical collaboration
Soliance Amyris n/a Renewable cosmetics partnership
Cosan (Brazil) Amyris n/a Renewable chemicals joint venture
Total (France) Amyris $50.00 Renewable fuels and chemicals partnership
Proctor & Gamble Amyris n/a Renewable chemicals collaboration and supply
M&G Finanziaria (Italy) Amyris n/a Renewable chemicals collaboration