The Big Red Biotech Blog

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.

Sanofi Signs Two New Development Deals

Sanofi said earlier this year that it would focus development in diabetes, cancer and ophthamology.  Yesterday they announced two new deals in the diabetes and ophthamology areas. Sanofi will team with Columbia University Medical Center on new diabetes treatments.  These will be based on the osteoblast-secreted peptide, osteocalcin.  Osteocalcin helps regulate osteoblasts which produce a hormone that regulates blood sugar levels and fat deposition. The deal is for three years.

The second deal is between Sanofi and Europe's Vision Institute to gain access to its technology platforms to study vascular biology, inflammation, gene therapy and optic nerve regeneration.  Sanofi will have rights to any treatments discovered in the collaboration.  See Fierce Biotech.

 

 

Posted by Bruce Lehr March 26th 2011.

Seattle Genetics Stays Hot with Abbott ADC Deal This Time

Seattle Genetics that announced an extension of its deal with Takeda Millenium for its antibody drug conjugate technology earlier this month, now has another ADC deal with Abbott that focuses on a single cancer target.  The Abbott deal calls for $8 M upfront and could pay another $200 M in milestones.

This continues Seattle Genetics roll in signing licensing deals for its ADC technology in cancer therapeutics.  SeaGen now has 11 deals in place and have received licensing payments amounting to $158 M dollars.  ADC technology is widely expected to play a more and more important role in cancer treatment even though the first treatment has not made it all the way to commercialization yet.  SeaGen's SGN-35 for hodgkin's lymphoma is expected to be the first later this year. See Fierce Biotech.

 

Posted by Bruce Lehr March 25th 2011.

Five Prime Lands Big Deal with Human Genome Sciences

As told by Xconomy, Five Prime has concluded a deal with Human Genome Sciences (HGS) that will pay it $50 million upfront with the possibility of receiving upt to $445 million in additional milestones.  HGS will gain access to Five Prime's drug candidate FP-1039 and will have marketing rights in the US, Canada and Europe.

FP-1039 targets member of the fibroblast growth factor family and inhibits their action in stimulating blood vessel formation to feed tumors.  The drug can be targetted at multiple cancers. Five Prime hopes the deal signals the beginning of its evolution from a drug discovery company to one with therapeutic products in the pipeline.

 

Posted by Bruce Lehr March 17th 2011.

Takeda Extends ADC Deal with Seattle Genetics

Takeda's Millenium group has decided to go for another target in partnership with Seattle Genetics utilizing the latters ADC technology.  Millenium currently partners with SeaGen on SGN-35 or brentuximab vedotin for the treatment of Hodgkin's lymphoma. 

SGN-35 is an antibody drug conjugate or so-called "empowered antibody".  The antibody specifically targets the intended cancer cell with a coupled toxic compound to be delivered to kill that cell. SeaGen's SGN-35 and Genetech's T-DM1 both seek to be the first licensed ADC's and there is a lot of excitement for these technologies.

SeaGen says that it now has 10 collaborations on ADC projects and has generated more than $150 M in licensing fees to date -- with more milestones lingering out there as they products make it to market.  There are 11 ADCs in clinical development using Seattle Genetics technology. The latest Takeda extension validates the growing interest in the technology.  See Xconomy Seattle and Fierce Biotech.

 

Posted by Bruce Lehr March 15th 2011.

Epizyme Cuts Another Cancer Deal

Epizyme closed another pharma deal with Eisai to develop drugs against lymphomas and other cancers.  Epizyme will get $6 million upfront and can earn up to another $200 million in milestones.  The deal gives Eisai access to Epizymes EZH2 epigenetic enzyme targets.

Eisai continues its investment in cancer targets and technologies.  In addition to the EZH2 targe for therapies, Eisai and epizyme plan to produce a companion diagnostic to select patients who will be most responsive to the drugs that are deeveloped. This will be similar to the approach taken with Roche's Herceptin and Plexxikon/Roche's PLX4032. See Xconomy Boston.

 

 

Posted by Bruce Lehr March 13th 2011.

Merck Inks Own Anti-inflammatory Deal with Lycera

Merck announced a deal with Lycera for its anti-inflammatory drugs that target T-helper 17 (Th17) cells and block or reduce production of the inflammation-inducing IL-17 cytokine. The deal calls for Merck to give Lycera $12 M upfront and could allow them to earn as much as $295 M additionally for reaching milestones.  The drugs developed could be used to treat diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel syndrome and multiple sclerosis.

"We are delighted to be working with Merck, which brings industry leading expertise in drug discovery, development and commercialization to this collaboration," said Gary Glick, Lycera founder and CEO, "This is arguably one of the hottest targets out there."  See Fierce Biotech.

 

 

 

Posted by Bruce Lehr March 4th 2011.

 

Aveo Pharma Lands $1.4B Deal with Astellas

Astellas Pharma and Aveo Pharmaceuticals agreed to terms on a deal that will pay Aveo $125 M upfront ($75 M licensing & $50 M in R&D funding) plus potential milestone payments as high as $1.3 B.  Astellas will gain access to Aveo's late stage, lead drug candidate tivozanib for treatment of renal cell carcinoma (RCC). RCC affects about 58,000 per year in the US, with 13,000 deaths and represents about 90% of all kidney cancers.

Aveo Pharma Lands $1.4B Deal with Astellas, A Few Months Ahead of Cancer Trial Result.

Tivozanib is a blocks the VEGF receptor and prevents blood vessel formation in tumors.  In previous clinicals, tivozanib has been able to achieve progression free survival (PFS) for up to 15 months - a dramatic improvment over current therapies. Aveo will now take the drug into phase III trials head to head versus Bayer/Onyx Pharmaceutical's Nexavar (sorafenib).  Aveo's goal is to best Nexavar by at least 3 months in extending PFS in these patients.  Nexavar normally achieved 5-6 months PFS in previous studies.

The cash infusion from Astellas will help Aveo extend its indication with tivozanib to other cancers like breast and colon.

 

Posted by Bruce Lehr Feb 17th 2011.

Delbiopharm Partners on RNAi with Marina Biotech

Delbiopharm and Marina Biotech will partner on the development of treatments against bladder cancer using Marina's RNAi technology.  Delbio will pay $25 M in R&D milestones and Marina will also receive royalties on sales of any therapeutic reaching commericialization.

In additon to bladder cancer, Marina's pipeline has therapies aimed at treating familial adenomatous polyposis and hepatocellular carcinoma.  See Fierce Biotech.

Posted by Bruce Lehr Feb 5th 2011.

 

Are Merck And J&J Fighting Over A Shrinking Pie?

The Pharmalot blog is trying to take all the fun out of the Merck-J&J arbitration battle over the fate of Remicade and its follow-on Simponi.  The blog makes the observation that the rheumatoid arthritis and related inflammatory diseases space is crowded with competitors.   It questions how fast the pie is shrinking?

Are Merck And J&J Fighting Over A Shrinking Pie? // Pharmalot.

Remicade sold $4.6 B globally last year.  But its $3 B in US sales were flat.  However, its $1.48 B in non-US sales grew by 24% - and it is the non-US sales that are at the core of the dispute.  Schering-Plough had distribution rights on these non-US sales and that is what J&J is trying to claim as a result of Merck's takeover of Schering-Plough.

Even if Simponi has been slow taking off, and does not seem to be displacing Enbrel and Humira significantly, the sales associated with both Remicade and Simponi outside the US are still significant -- and I'm sure J&J still wants to win the arbitration battle....

 

 

 

 

Posted by Bruce Lehr Jan 27th 2011.

Merck Serono Teams with Domain Therapeutics on Parkinson's Drugs

Merck Serono agreed to a $178 M deal with Domain Therapeutics to target new therapies for Parkinson's disease and other neurodegenerative disorders. The deal provides Domain with Eur 2 M upfront for R&D and potential milestones of another Eu 132 M.  Merck will gain access to Domain's G-Protein Coupled Receptor (GPCR) compounds.  See Fierce Biotech.

 

 

Posted by Bruce Lehr Jan 21st 2011.

Theraclone Strikes $632M Deal With Pfizer to Discover Antibodies

As reported in Xconomy, Theraclone was saved by a deal with Pfizer to license its I-STAR antibody discovery platform that could eventually be valued at up to $632 M.  For this money, Pfizer has secured exclusive rights to 4 unnamed targets - two in infectious disease areas and two in cancer.

Theraclone Strikes $632M Deal With Pfizer to Discover Antibodies for Cancer, Infections.

Theraclone's acting president, Steve Gillis, says that Theraclone will realize $189 to $252 M in near to mid-term milestones.  Theraclone lost its president in June and has been increasingly challenged to raise venture funding in a tough economic and biotech investment environment.

A Pfizer vice president says the deal furthers its aims "to be on the leading edge of biotherapeutics and antibody discovery."  I-STAR can quickly test tens of thousands of antibodies to find those with the most biologic activity - thus speeding Pfizer's drug development using the technology.

 

 

Posted by Bruce Lehr Jan 20th 2011.

Ariad Pharma Stock Up 25 Percent on Phase III Data

Ariad reported very positive results with its drug, ridaforolimus, in a phase III trial with patients with soft-tissue and bone tumors. The study showed patients' median progression-free survival increased by 21% to 17.7 weeks as compared to a placebo.

Ariad Pharma Stock Up More than 25 Percent on Positive Phase III Data.

Merck, which paid Ariad $50 M upfront plus $19 M in R&D funding in May, plans to file for approval this year.  Merck could pay Ariad an additional $514 M in milestones if the drug is commercially successful. Merck also plans to develop the drug toward other cancers. Ariad's stock rose more than 25% on the basis of the positive phase III news.

 

 

Posted by Bruce Lehr January 20th 2011.

MedImmune Licenses AMG-108 from Amgen

As reported in PBR, MedImmune has signed a licensing deal with Amgen for its AMG-108 monoclonal to the IL-1 pathway.  MedImmune has secured worldwide rights outside of Japan. Amgen received an undisclosed upfront payment with additiona milestones and royalties on commercial sales.

MedImmune believes the IL-1 pathway is important in a variety of inflammatory conditions, and AMG 108 represents a compelling opportunity for it to explore this antibody's activity against various diseases for which patients need new treatment options.

 

 

Posted by Bruce Lehr Jan 14th 2011.

Epizyme Nails $650 M GSK Deal

GSK has agreed to pay $20 M upfront plus up to another $630 M in milestones payments to gain access to Epizyme's gene-regulating enzyme technology.  The enzymes, called histone methyltransferases (HMTs), have application to diseases like cancer, inflammation, metabolic diseases, and neurodegenerative diseases.  Epigenetic enzyme determine whether genes are turned on or turned off.

Epizyme's CEO and president, Robert Gould, said the company's goal is to develop personalized medicine therapeutics based on our understanding of the role played by HMTs in human disease. See Xconomy and Fierce Biotech.

 

 

Posted by Bruce Lehr Jan 13th 2011.

Lilly Teams with Boehringer Ingelheim on Diabetes

Seeking Alpha analyzes the diabetes portfolio that is formed by the recent Eli Lilly and Boehringer Ingelheim deal.  For €300m ($390m), Lilly gains access to two Boehringer products – a DPP-IV inhibitor and a SGLT-2 inhibitor – while putting more development and commercial muscle behind its own long-acting insulin products in development.  Unfortunately, none of the products are first in class.  There may be some potential for a few of the products to be best in class.

The deal's appeal, according to its participants, is the wide range of therapeutic classes being addressed by the combined portfolio. The deal includes Boehringer’s SGLT-2 inhibitor BI10773, now in phase III trials; two mid-stage Lilly insulin analogue products, LY2605541 and glargine competitor LY2963016; and a co-development option for Lilly’s anti-TGF-beta 1 monoclonal antibody planned for diabetes patients with chronic kidney disease.  Lilly's rationale is that payers are more attracted to companies offering products which cover the entire progression of the disease.

Lilly does have a need to fill its late-stage pipeline; picking up a filed product and a phase III product appear to be good bets for a company with as steep and deep a patent cliff as the one it faces.

For more on this deal, see WSJ Health blog and the WSJ online Health.

 

Posted by Bruce Lehr Jan 13th 2011.

 

 

 

 

Amgen And Xencor Enter Option Deal for Autoimmune Diseases

As reported int he Medical News Today, Amgen and Xencor have agreed to terms to co-develop Xencor's novel XmAb®5871, an Fc- engineered monoclonal antibody dually targeting CD19 and CD32b markers.  The drug is designed to immunomodulate B-cell function and has applicability in the treatment of autoimmune diseases.  The CD32b pathway is considered to be novel and has not been exploited therapeutically before now.

Amgen And Xencor Enter Option Deal To Co-Develop Xencor's Novel Antibody For Autoimmune Diseases.

Under the terms of the agreement, Amgen has the option to an exclusive worldwide license following the completion of a pre-defined Phase 2 study. Xencor will lead all clinical development until that time. Xencor will receive an up-front and early development milestone payments. 

In return for the license, Xencor will receive an option-exercise fee which, combined with the up-front and early development milestones, will total $75 million, and Xencor could receive up to an additional $425 million in clinical, regulatory and commercialization milestone payments. Xencor will receive tiered royalties on future sales of XmAb5871.

"XmAb5871 provides a novel approach to suppress B-cell function which will enhance Amgen's internal efforts in inflammatory diseases," said Joseph P. Miletich, M.D., Ph.D., senior vice president, Research & Development at Amgen. "We are delighted to have the opportunity to partner with Xencor in exploring their novel immunomodulatory approach."

 

Posted by Bruce Lehr Jan 8th 2011.