The Big Red Biotech Blog

Novartis Hops the Hep C Train

Novartis is the latest big pharma to take the hep C train looking for a chance at a multi-billion dollar payout.  It signed a pact for $440 M with Enanta Pharmaceuticals for its preclinical NS5A drug.  The deal calls for $34 M upfront and a possible milestone-based payout up to $406 M more.

The Enanta drug, EDP-239, is directed to the NS5A target that should provide effects across all three hep C genotypes and does not require the use of interferon.  Avoiding the use of interferon is seen as the goal by most of the leading contenders for the estimated $20 B plus hep C treatment market -- where an ever increasing crowd is now jockeying for position. See Fierce Biotech.

Posted by Bruce Lehr Feb 21st 2012.

Hepatitis C Deals Take Center Stage

Market analysts have projected that sales of products that are newly on the market or in late phase clinicals to treat hepatitis C could have worldwide sales in excess of $20 B by 2020. That's a big number! See Pharmalot.

So it is easy to see why more deals are happening in this area with a few more possibilities looming.  In just the past few weeks and months, Gilead bought Pharmasset for its PSI-7977 therapy for $11 B.  BMS followed suit to buy Inhibitex for its phase I hepatitis C drug for an impressive $2.5 B - a startling sum for a phase I compound that is still years from the market. Both acquiring companies are trying to introduce an oral hepatitis C treatment that does NOT rely on interferon (and its well described side-effects). See Fierce Biotech and PharmaGossip.

Now Merck is rumored to be a leading suitor to buy perhaps, Achillion for its hepatitis C treatments.  This would add to Merck's newly approved Victrellis and its mid-stage drug MK-5172 still in development. Merck also had previously announced a collaboration with Roche.

Said Merck's Roger Pomeranz at a recent JP Morgan Healthcare Conference, "Our goal is to be a leader in hepatitis C, and we will do what it takes to get there."  Merck is ready to do small or larger deals to rapidly build its position.  See Fierce Biotech.

The Game is On.

Posted by Bruce Lehr Jan 10th 2012.

ImmunoGen and Lilly Cut ADC Deal

From Fierce Biotech, ImmunoGen and Eli Lilly announced a deal for the latter to gain an exclusive license to a defined number of treatments utilizing the formers antibody drug conjugate technology.  ImmunoGen will receive $20 M in upfront payments, can earn up to $200 M in milestones and also can earn royalties when the drugs reach commercialization.

Lilly plans to exploit the ADC technology with its pipeline of oncology drugs to "develop agents with clear clinical benefit in specific patients populations."

Posted by Bruce Lehr Dec 20th 2011.

Top 10 Biotech Deal Terminations in 2011

Fierce Biotech recounts the Top 10 biotech deals with big pharma partners that were axed in 2011.  They state that the right deal can make a company and when it sours it can break it too. Pharma partners look to pull the plug ASAP on souring deals to save as much money as possible. It's a "Terminate often, terminate early" philosophy at work many times.

Analysts (passing out advice & when don't they) say under that scenario, it is critical that the biotech gets back all licensing rights without paying reverse royalties -- so they can repartner the deal!  Many deals are repartnered in just this manner. With regard to blockbusters coming from these type of deals, analysis reveals that 8% had been partnered, re[partner4d and launched to successful outcomes.

Top 10 Terminate Deals for 2011:

• GSK and Targacept (neuronal nicotine receptors)
• Shire and Renovo (Justiva for scarring)
•  Merck and Addex Pharmaceuticals (ADX63365 for schizophrenia)
• Janssen Pharmaceuticals (J&J) and Diamyd Medical (GAD65 for type I diabetes)
• Cephalon and ImmuPharma (lupus)
• Novartis and Peptimmune (PI-2301 for MS)
• Novartis and Paratek Pharmaceuticals (PTK 0796 wide spectrum antibiotic)
• Merck and Portola Pharmaceuticals (Betrixaban anticoagulant)
• Eli Lilly and Amylin (Byetta for type 2 diabetes)
• Solvay and Depomed (DM-1796 for pain)

Time to repartner up.

Posted by Bruce Lehr Dec 19th 2011.

 

 

Venture Funding Decrease is Big Pharma's Gain

From Fierce Biotech, it seems that big pharma has happily stepped into the funding void created by the collapse of venture funding for biotechs to do more deals earlier and cheaper than before.  Says Dan Zabrowski, head of Roche's drug partnership unit,  "We are doing around 50 to 60 partnership deals a year now, compared to around 30 deals per year before the crisis [of 2008]. Today, we start deals earlier with less upfront payments and share the risk with our partners."

Who says a funding crunch is so bad?  This is not exactly a hardship for big pharma.

Posted by Bruce Lehr Dec 12th 2011.

GSK Hooks Up with Alnylam on siRNA Enabled Vaccines

GSK and the RNAi-company Alnylam announced a new licensing deal where by GSK will use siRNAs from the latter to apply to its vaccine program.  The Alnylam technology involved is termed VaxiRNA.  The deal is initially focused on influenza vaccine production. Under terms of the agreement, GSK will provide research funding and certain milestone payments to Alnylam. 

Alnylam’s VaxiRNA platform applies siRNAs for the silencing of specific genes that limit or prevent efficient growth of viruses in vaccine manufacturing systems, including those in cell culture.  Alnylam says this new platform addresses the significant unmet commercial need for innovative technologies that can improve the manufacture of vaccine products, especially where vaccine production is a limiting factor for the scale and speed of global immunization needs.

The deal comes at a good time for Alnylam, which lost partnerships with Novartis and Roche earlier in the year, and is expected to report a loss of 35 cents per share for Qtr 3 in a late day earnings call. They could use the shot in the arm so to speak. See GEN and Xconomy.

 

 

Posted by Bruce Lehr Nov 1st 2011.

Zymeworks and Merck Partner on Bi-specific Antibodies

Zymeworks and Merck announced a deal whereby the former's platform technology for the development of bi-specific antibodies will be applied to cancers and autoimmune diseases.  Zymeworks will receive an upfront payment (undisclosed) and have a shot at milestones and royalties that could reach $187 million.

Bi-specific antibodies have binding sites that can recognize two different targets.  The Zymeworks platform provides the means to engineer unique antibodies against multiple targets on a single cell. The proteins can also be engineered to circulate longer in the bloodstream or to induce a stronger immune response.

Merck made a good partner for Zymeworks as it provided some proof of principal data, upfront cash and credibility to draw more investors. It also can complement Zymeworks protein engineerign knowledge with its own drug development expertise and understanding of biology.  Now they both have to make it work as a producers of therapeutics. See Xconomy and Fierce Biotech.

Posted by Bruce Lehr Aug 30th 2011.

 

BI Licenses ProBioGen’s GlymaxX Platform for Fucose-Free Antibody Production

Boehringer Ingelheim (BI) obtained a nonexclusive license to ProBioGen's GlymaxX technology for the production of afucosylated antibodies. Fucose-deficient antibodies show enhanced antibody dependent cell-mediated cytoxicity (ADCC) -- typically making them more potent against tumor cells. 

GEN | News Highlights:BI Licenses ProBioGen’s GlymaxX Platform for Fucose-Free Antibody Production.

The GlymaxX platform enables the production of new and pre-existing producer cell clones and can be engineered in less than 10 weeks.  The technology competes against BioWa's (Kyowa Hakko's) Potelligent system for the production of afucosylated antibodies.  Presumably both technologies will be competing in oncology applications.

Posted by Bruce Lehr Aug 12th 2011.

Vical and Astellas Agree on CMV Vaccine Deal

Astellas will pay Vical $130 M for rights to its cytomegalovirus (CMV) vaccine to prevent the virus' reactivation in immunosuppressed transplant patients.  A phase III trial of TransVax in hematopoietic stem cell transplant patients and a phase II study in solid organ transplant recipients will begin in 2012.

Astellas will develop and commercialize the vaccine in the US and for the rest of the world.  It will also take on all development and commercialization costs.  Vical will retain rights to co-promote in the US and provide manufacturing support. The deal extends Astellas offering in the transplant market -- a key focus area. See Fierce Biotech.

 

 

 

Posted by Bruce Lehr July 15th 2011.

 

Sanofi MS Drug (from Genzyme) Advances

Sanofi reported yesterday that it had good news from the latest phase III trial with its MS drug, Lemtrada.  Lemtrada, you will remember, was the star player in the Genzyme-Sanofi valuation discussion and the main object of the contingent value rights (CVR) ultimately  crafted to close the deal.

In the latest news from the clinic, Lemtrada was compared to Merck's Rebif in the treatment of multiple sclerosis and patients showed a 55% reduction in relapse rates over  a two-year period. Surprisingly though, the drug fell short in showing a statistically signficant reduction in disability rates.  Sanofi still plans to press ahead with filings for regulatory approval in the USA and EU in early 2012.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 12th 2011.

Amgen and Micromet Make Cancer Deal

Amgen increased its activity in cancer drug development by reaching a deal with MicroMet, valued at up to $1B, to develop drugs for up to two solid cancer targets. The upfront for the deal is $14.1 million with the rest based on performance milestones and commercial royalties.

Amgen will gain access to Micromet's BITE antibodies which are designed to recruit the patient's own soldier T cells to attack tumors. Micromet has cut previous deals with other Big Pharma, including Bayer, Boehringer Ingelheim and Sanofi.  See Fierce Biotech.

 

Posted by Bruce Lehr July 12th 2011.

BMS adds Innate Pharma as its Latest Pearl

In keeping with its "string of pearls" acquisition model, BMS added Innate Pharma to its stable with a deal valued at $465 million. As is usual these days, there was a $35 M upfront payment with milestones that could land the remaining $430 million plus a potential double-digit royalty. The deal was the largest ever for a French biotech company.

BMS acquires rights to Innate's phase I anti-cancer mAb called IPH2102. Innate will continue to develop the drug against myeloid leukemia up through phase II with BMS doing the funding. See Fierce Biotech.

 

Posted by Bruce Lehr July 7th 2011.

 

Is Pharma Dealmaking Becoming More Difficult?

Yes it is.  No it isn't.  Depends upon whom you ask and when.

In a survey of 18- business development executives considering deals from 2006 through 2010, the responses were remarkably split I thought. The majority of biotech respondents (36%) said they could drive terms with pharma (though you can see 64% thought they were on equal footing or were more takers than givers of terms).

So we turn over to pharma.  well, 44% of pharma respondents (again the majority) said their negotiating power had increased with biotechs.

Is Pharma Dealmaking Becoming More Difficult? // Pharmalot.

What about upfront payments?  Biotechs (55%) said they had dropped - though 31% reported an increase. Flip sides of the coin to pharma, and 51% saw an increase with only 32% seeing a drop.  We in the same deals?  A more objective third party analysis of the reported deals shows about a 5% decrease in the upfront value for the 2006-2010 time period.

Average deal volumes and payments seemed to be pretty steady over the period.  Any loss of leverage pharma experienced due to dwindling pipelines and perhaps some desparation to license short-term revenues seems to have been counterbalanced by a bad funding-environment for the biotechs.  Status Quo.

Posted by Bruce Lehr June 16th 2011.

 

 

Vertex Deals with Alios on Hepatitis C Extension

Vertex Pharmaceuticals, fresh off its recent FDA approval of Incivek (telaprevir) for the treatment of hepatitis C infection, announced a new deal with Alios Pharmaceuticals for up to $775 million in development milestones for two programs - ALS 2200 and ALS 2158.  By acquiring these, Vertex hopes to develop hepatitis C cocktails that will cement its leadership position in the market by removing the need to continue the use of interferon.   

ALS 2000 and ALS 2158 are both nucleotide analogs that offer a high barrier to drug resistance, can be taken orally, and may only require a once a day dosage.  Further, both have fewer side effects than interferon that often causes flu-like symptoms to the patient. Thus the combined package of Incivek and the new drugs offer the opportunity to improve the safety, efficacy and ease of administration for the patient. See Fierce Biotech.

 

Posted by Bruce Lehr June 14th 2011.

SAFC and Pfenex Partner on Protein Production

SAFC and Pfenex have agreed to a partnership to produce therapeutic proteins and vaccine components for their joint clients.  Pfenex will be responsible for engineering bacterial strains and developing production processes that can be transferred to SAFC's GMP fermentation facilities in Jerusalem ( Download Jerusalem-insert) for scale up and manufacturing.

The strategic partnership will focus on identifying customers seeking the total solution, from the design and engineering of a robust production strain, process development, scale up and GMP production. SAFC will subsidize a portion of upfront costs in return for the a commitment to use its GMP manufacturing services.  See Outsourcing Pharma.

 

Posted by Bruce Lehr June 8th 2011.

PATH and GSK Team Up on Malaria

PATH, the non-profit group working to develop vaccines for developing countries, scored again with an announced collaboration with GSK for a vaccine against Malaria. The second generatin vaccine with combine a single dose vaccine from J&J's Crucell followed by two doses of GSK's RTS,S vaccine.  This is known as a 'prime-boost' strategy. See Xconomy.

Previously I've written about PATH's success in developing a meningitis vaccine and its subsequent deployment in African populations with the funding assistance of GAVI.  Now PATH is -- dare I say it -- moving down the path to attack malaria.

 
Posted by Bruce Lehr June 7th 2011.

 

Aveo Inks Another Cancer Development Deal

Aveo announced an agreement today with J&J to provide the latter access to its RON (Recepteur d'Origine Nantais) antibodies that regulate tumor growth, cancer survival and metastasis.   J&J will pay $15 million upfront in cash and by purchasing stock, and also committed up to $540 million in additional milestones.  J&J will also fund translational research using Aveo's Human Response Platform to identify biomarkers for patients most likely to respond to RON antibodies.

This follows another cancer deal for Aveo with Astellas earlier this year to give the latter access to Aveo's tivozanib. Aveo says the J&J deal furthers its plans to maximize the potential of its proprietary cancer biology platform.

This deal also follows several trends that seem well established in pharma at this point.  Namely, a modest upfront payment with big back end milestone payments.  There is also the funding of translational research which is rapidly becoming a buzz phrase/activity in many deals (see GSK today).  And the development of biomarkers/companion diagnostic tests to identify good responder populations is also gaining steam. See Fierce Biotech.

 

Posted by Bruce Lehr May 31st 2011.

Amylin Holds Serve In Suit Against Lilly

Amylin won a small victory by obtaining a restraining order from a federal judge in its suit to prevent Eli Lilly from selling BI's competitive drug, linagliptin, to the LIlly/Amylin developed Byetta with the same sales force it had dedicated to the latter.

Amylin Wins The First Round In Suit Against Lilly // Pharmalot.

Judge Janis Sammartino noted "love triangles exist in the corporate world too" (Great Quote) and also enjoined Lilly from disclosing any confidential info about Byetta to any reps who would sell linagliptin.  Lilly expressed disapointment in the court order and the mandatory expression of confidence that it would prevail upon further legal action. 

The analysts have had a field day in dissecting the company dynamics and motives underlying this squabble.  Read the post from the Pharmalot blog above for some of the intrigue. Some analysts think it woudl be better for Lilly to buy out Amylin or for the two to go their separate ways.

Posted by Bruce Lehr May 26th 2011.

Sanofi Inks Antibody Deal with India's Glenmark

Sanofi opened its checkbook again. This time in India as it inked a development deal with Glenmark Pharmaceuticals for therapeutic antibodies, and in particular to gain rights to a new MS therapy in development.

Sanofi will pay up to $663 million structured as $50 million in upfront payments and up to $613 million for reaching specified milestones. Sanofi will also have marketing rights to GBR 500, an antibody that combats inflammatory diseases like Crohn's disease and other autoimmune disorders.

"This is definitely significant because it's the first time an Indian company has developed the expertise to make biologic drugs" said Bino Pathiparampil, a pharma industry analyst.

Sanofi conitnues to expand its number of development deals external to the company and in emerging markets that it wishes to penetrate in the future.

 

Posted by Bruce Lehr May 17th 2011.

Merck and Roche to Market Hepatitis C Drugs Together

Just days ago Merck received word that its new hepatitis C drug boceprevir (Victrelis) was approved.  It indicated it would get busy marketing the product before Vertex recieves similar approval later this month. Today, Merck announced a co-marketing/selling deal with Roche to sell boceprevir and Roche's Pegasys interferon.  The companies are looking to develop a new cocktail treatment using both products.

Merck, Genentech Team Up on Hepatitis C Drugs, Raising Ante in Vertex Rivalry.

Thus Merck and Roche have teamed up to get a jump on Vertex in the race toward market share for the new hepatitis C drugs and the expected $3 billion to $10 billion market. This is particularly important perhaps as many observers think the Vertex drug (telaprevir or Incivek) is superior to Victrelis.  It will be interesting to see how this plays out with two Big Pharma powers selling the latter with a slight head start and clear pipeline to hepatitis specialists. Vertex does have its own marketing partner in J&J for selling its product outside the US. See Fierce Biotech and the Pharmalot blog.

Posted by Bruce Lehr May 17th 2011.

 

Amylin Sues Eli Lilly Over Diabetes Deal Breach

After 4 months of trying to work out an arrangment with Lilly, Amylin took the step to file a lawsuit in Federal court accusing Lilly of antic-competitive behavior in striking a deal with rival Boehringer Ingellheim to sell that company's new diabetes medication, linagliptin (or Tradjenta).

Amylin Sues Eli Lilly, Arguing Breach of Contract in Marketing Rival Diabetes Drug.

Amylin says this is in direct conflict with its agreement with Lilly to sell Byetta and its soon to be licensed (it hopes) next gen version called Bydureon.  Both are based on exenatide and are targeted at the same type 2 diabetes patients as linagliptin.  Amylin says in its suit that it is seeking to block Lilly from using the same sales force to sell both company's products.

An Amylin statement said the company was disapponted that "we could not resolve this matter amicably" and thus took the legal route for relief. Amylin says it still wants to work with Lilly on additional exenatide based products. 

At least one analyst commented, that Amylin might be inclined to pick a new partner (or even be acquired) if the right match came along and it could teminate the Lilly agreement at reasonable cost and have its selling efforts covered. Meanwhile, Bydureon activities are still pending and the court case goes on.  See Fierce Biotech and Pharmalot blog.

 

Posted by Bruce Lehr May 16th 2011.

Merck and J&J Agree to Agree on Remicade

Merck and J&J have cut a deal to end their arbitration dispute over the fate of the Remicade (& Simponi) deal that J&J and Schering-Plough had in place prior to its acquisition by Merck. J&J had claimed the Merck takeover should cancel the deal under a change-of-control provision in the original contract.  Merck had tried to side step that with a "reverse merger" argument -- which didn't really pass the smell test.

Merck And Johnson & Johnson End Remicade Spat // Pharmalot.

Now the two Pharma giants have come to a cash agreement and presumably everybody's happy.  Merck will retain rights on the two drugs in Europe, Russia and Turkey where about 70% of its $2.8 billion sales lie anyway -- and will split profits 50:50 with J&J.  J&J will recpature exclusive rights in Canada, Central and South America, the Middle East, Africa and the Asia Pacific -- most of the pharmerging markets except Russia and Turkey.

J&J also gets a $500 M one-time consolation prize from Merck payable this month.  Righ after the tax man calleth no doubt.

 

 

 

 

Posted by Bruce Lehr April 15th 2011.

Vertex and CF Foundation Team Up

The Cystic Fibrosis Foundation today agreed to fund two CF drugs in Vertex Pharmaceuticals pipeline to the tune of $75 M.  The deal is for 5 years and will support R&D activities on two drugs, VX-661 and VX-809. In return, the CF Foundation will also receive royalties on future drug sales.

VX-661 will enter phase II trials later this year and VX-809 is at an earlier stage of development. Both drugs seek to increase CF transmembrane conductance regulator (CFTR) protein function by increasing the protein's movment to the cell surface.  Missing or defective CFTR proteins are the underlying cause of CF.  See Fierce Biotech.

In February, Vertex announced good results with its CF drug VX-770 in a phase III trial conducted with a subtype of CF patients -- who account for about 4% who have the disease.  Vertex expects to file an NDA on this drug later this year.

 

 

Posted by Bruce Lehr April 8th 2011.

Pfizer Goes Into Rare Disease Discovery Deal

Pfizer reported cutting a deal with San Diego's Zacharon Pharmaceuticals today that could pay the latter up to $210 M.  It is a very early stage deal allowing Pfizer access to Zacharon's molecules related to treating lysosomal storage disorders.  Pfizer agreed to an undisclosed upfront payment and will also contribute R&D funding.  Zacharon can earn additional milestone payments for commercialization and sales targets. The project's success will be the responsibility of Pfizer's new orphan and genetic diseases division.

Orphan disease targets have become increasing favorites of Big Pharma as about 25% of all new drug approvals since 2005 have been aimed at them according to the FDA. Orphan drugs can receive expedited review by the agency, often command higher prices, and receive market exclusivity which requires less marketing expense as well.

Current treatments for lysosomal disorders can relieve some of the symptoms but usually have little effect on neurological pathology as they don't typically cross the blood-brain barrier.  Zacharon has been able to identify molecules that can cross the barrier and thereby offer hope of a therapeutic effect in the brain.  See WSJ.

 

 

Posted by Bruce Lehr April 6th 2011.  

Novartis invests in Chinese vaccine maker

Novartis acquired a majority stake in vaccine maker Zhejian Tianyuan Bio-Pharmaceutical, as a continuing part of its growth strategy in China.  Novartis now holds an 85% share in the company.

Novartis invests in Chinese vaccine maker.

Andrin Oswald, Novartis head of of vaccines and diagnostics indicates that the agreement will combine Novartis strengths in its pipeline with Tianyuan's knowledge and access to the Chinese market, which is estimated to be $1 billion annually.

Novartis is counting on the vacine acquisition to help it accelerate its sales growth in China to above 30 percent rates and has also announced it will be adding more to the sales force in China to aid that effort.

 

 

 

Posted by Bruce Lehr March 28th 2011.