Licensing deals

United Therapeutics' stock plunges on trial failure

John Carroll — Mon, 17 Nov 2008 09:45:12 -0500

News of a new licensing deal with Eli Lilly couldn't stop the market rout that took place this morning after United Therapeutics reported that the oral formulation of its pulmonary arterial hypertension drug failed to meet its primary endpoint in a late-stage clinical trial. Its stock plunged 32 percent ahead of the opening.

United Therapeutics said it would pay $150 million to Lilly for the rights to sell the erectile dysfunction drug Cialis as a hypertension therapy. The FDA is currently reviewing the application for the new use of Cialis. United Therapeutics makes the intravenous hypertension drug Remodulin and has been working on a new, oral formulation of that drug. Interim results were released today with full results expected in March.

"While we are disappointed we did not achieve a statistically significant result for the primary endpoint, we believe the results fully support the continued development of oral treprostinil (Remodulin) especially when the treatment effect is evaluated based on the dose achieved in the Freedom C study," said COO Roger Jeffs.

- view United Therapeutics' statement
- read the AP report on the licensing deal
- check out the AP story on the trial results

Daiichi, ArQule ink $75M development pact

Maureen Martino — Mon, 10 Nov 2008 10:38:44 -0500

ArQule and Daiichi Sankyo have formed an R&D partnership with two separate agreements. First, Daiichi will give ArQule $60 million up front and additional sales and milestone payments to co-develop ARQ 197, a cancer treatment. The companies will collaborate on the drug in the U.S., Europe, South America and the rest of the world, excluding certain parts of Asia where Kyowa has exclusive rights to the drug.

In addition, Daiichi will pay $15 million for use of ArQule's kinase inhibitor discovery platform to develop new cancer therapies. Daiichi will have the option to license two compounds directed to targets identified using this discovery platform.

"For ArQule, this strategic relationship will achieve several product development, scientific and financial objectives," said Paolo Pucci (photo), chief executive officer of ArQule. "First, it will allow us to optimize a clinical program with ARQ 197 that elicits the full therapeutic potential of this highly selective c-Met inhibitor. Second, it supports and further validates the application of our proprietary technology platform to the discovery of a new generation of selective inhibitors of kinases implicated in cancer. Finally, it provides meaningful, non-dilutive infusions of cash, as well as an opportunity for cost sharing."

- see this release for more

Onyx, BTG ink $320M licensing deal

Maureen Martino — Fri, 07 Nov 2008 10:33:32 -0500

In another pipeline-building move, California's Onyx Pharmaceuticals has shelled out $320 million for BTG's preclinical anticancer compound, BGC 945. BTG gets $13 million up front and could receive development milestone payments of up to $72 million plus additional payments of up to $235 million for commercialization milestones. BTG will also receive a royalty on any future sales worldwide.

"Onyx has a strong track record in developing and commercialising novel cancer therapeutics, as evidenced by their success with Nexavar, and we see the company as an ideal partner to take BGC 945 forward," commented Louise Makin, BTG's CEO. "This agreement is in line with our strategy to realise value from our current pipeline as we focus new investments on acquiring and developing later-stage products." BTG recently purchased Protherics to form the UK's biggest biotech company.

Earlier this year Onyx was dealt a blow when its cancer drug Nexavar failed a clinical trial for non-small cell lung cancer. The drug is already approved for liver cancer.

- see BTG's release

Allergan, Polyphor ink development deal

Calisha Myers — Fri, 31 Oct 2008 09:49:35 -0400

Allergan is busy these days. Yesterday, the California biotech announced a deal with Spectrum Pharmaceuticals, which, among other things, gave Allergan exclusive rights to apaziquone for the treatment of bladder cancer outside of the U.S. and Asia. Today, Switzerland's Polyphor announced it has inked a deal with Allergan that gives the company exclusive rights to develop Polyphor's protein epitope mimetics (PEM) cytokine inhibitors for the treatment of conditions and diseases of the eye. Under the agreement, Polyphor will receive $7 million upfront to collaborate with Allergan and identify compounds that will work with the biotech's drug delivery system, compounds which Allergan will progress through clinical development.

Switzerland-based Polyphor is entitled to receive up to $61 million in research, development and milestones, in addition to royalties on product sales.

"I am delighted about this agreement with Allergan, which is another important milestone for our company," said Polyphor CEO Dr. Jean-Pierre Obrecht. After the scientific proof-of-concept, we now have a first commercial validation of Polyphor's proprietary Protein Epitope Mimetics Technology."

- check out the Polyphor release

Merck Serono, Theratechnologies ink $215M deal

Maureen Martino — Wed, 29 Oct 2008 10:00:32 -0400

Merck Serono has signed a deal to license the U.S. commercialization right to tesamorelin, a drug to treat excess abdominal fat in HIV patients with lipodystrophy. Theratechnologies retains rights to the drug outside the U.S. Under the terms of the agreement, the company will receive an upfront payment of $30 million and up to $215 million in additional payments for the drug. Theratechnologies will be responsible for conducting research and development for additional indications.

Back in January, Theratechnologies said it was conducting a strategic review of its options, including selling the company. The deal gives the company an influx of cash that will allow it to explore other indications for the drug. "These milestone and royalty payments provide Theratechnologies with a fully-financed business plan through the commercialization of tesamorelin for its first indication in the US. Theratechnologies will also have the financial flexibility to pursue the development of a second indication and build the long term value of the compound," noted Mr. Luc Tanguay, Senior Executive Vice President and CFO of Theratechnologies.

- see the release for more

Celgene terminates MethylGene licensing deal

John Carroll — Mon, 27 Oct 2008 11:42:41 -0400

MethylGene announced that Celgene has terminated their licensing agreement for oncology histone deacetylase inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. Furthermore, the company announced that it will implement a strategic initiative to focus its resources on the clinical development of its proprietary pipeline. MethylGene release

Glaxo snags Alzheimer's vax rights

John Carroll — Thu, 23 Oct 2008 09:45:20 -0400

GlaxoSmithKline has put down €22.5 million and promised up to €430 million more to license the rights to two early-stage Alzheimer's disease vaccines from Austria's AFFiRiS. Glaxo picks up exclusive rights to two vaccines in Phase I testing and an option on preclinical candidates.

The deal is an endorsement of AFFiRiS' technology. The biotech boasts of being able to design proteins that have very specific binding abilities, a key feature for anyone creating a vaccine that can attack the beta-amyloid associated with Alzheimer's.

"We are impressed with the AFFiRiS technology--combined with our expertise in innovative adjuvant systems--this collaboration will improve our chance of success in the discovery of new treatments against this major disease," said Jean Stephenne (photo), president and general manager of GlaxoSmithKline Biologicals.

- read the joint release

Indevus inks licensing pact, lands FDA deal

John Carroll — Mon, 29 Sep 2008 11:50:35 -0400

Indevus Pharmaceuticals ended last week on the upbeat news that it had struck a licensing deal for one of its experimental therapies and worked out an advantageous arrangement with the FDA on another drug up for approval. The news sent the company's shares up 86 percent.

Teva signed on to develop the stuttering drug pagoclone in a deal which is worth up to $92.5 million for Indevus in milestone payments. Under certain circumstances the deal can be structured for a 50/50 royalty split.

On another front, Indevus announced that the FDA gave it a green light to submit additional data for the testosterone replacement therapy Nebido rather than mount a new trial for the therapy. The agency's concerns are centered on adverse reactions at the injection site. Indevus can now resubmit its applications in the first quarter of next year rather than face a lengthy delay for a new trial. An approval could come in the fourth quarter of 2009.

- check out the Indevus release regarding the licensing deal
- read the Indevus release regarding the FDA agreement

GSK signs $1.5 drug dev deal with Cellzome

Maureen Martino — Wed, 10 Sep 2008 12:32:06 -0400

GlaxoSmithKline is teaming up with Cellzome, which is developing kinase-targeted drugs, in a deal that could be worth up to $1.5 billion. The pact will target inflammatory diseases such as rheumatoid arthritis or multiple sclerosis. GSK is paying £14.4 million upfront to license drug candidates from Cellzome's kinase programs directed against four identified targets. Three additional targets will be selected by both companies. Cellzome will use its technology to identify small molecule inhibitors for the chosen targets, and then develop the most promising drugs. GSK has first dibs on licensing the products Cellzome develops, but Cellzome will retain rights to the drug candidates if GSK takes a pass.

Cellzome could gain up to £118 million per program in milestones and "double digit royalties" on net sales.

"GSK is committed to becoming a world leader in immuno-inflammation drug discovery by finding transformative medicines through internal efforts and external collaborations," said Jose Carlos Gutierrez-Ramos, head of GSK's Immuno-Inflammation Centre of Excellence for Drug Discovery. "Cellzome's Kinobeads technology will provide a distinct advantage because it uses native kinases directly isolated from human cells and tissues."

This is just one of a number of deals GSK has inked in the last several months. The company has signed deals with Valeant, Harvard, the Disease Institute of Boston and, most notably, a $3.25 billion deal with Actelion. The string of deals reflect the new CEO Andrew Witty's strategic move to look outside the company for innovations in drug technology.

- see GSK's release for details

Medivation shares soar on $725M Pfizer deal

John Carroll — Wed, 03 Sep 2008 10:13:35 -0400

Medivation investors were treated to a 31 percent spike in their stock value after news broke this morning of a big licensing deal with Pfizer. The pharma giant will shell out a whopping $225 million upfront fee and up to $500 million more in regulatory milestones in exchange for 60 percent of the U.S. profits from Dimebon. Medivation retains the rights to market the drug candidate--now in late-stage testing for Alzheimer's while also being studied for Huntington's disease--to specialty physicians in the U.S. and Pfizer will cover 60 percent of development costs. Pfizer gains regulatory and commercialization responsibility outside of the U.S. and will also pay Medivation sales milestones and royalties.

"After a rigorous process that garnered substantial interest, we believe that Pfizer is the ideal partner, sharing our vision for Dimebon and capable of maximizing its potential globally," said Dr. David Hung, president and chief executive officer of Medivation.

In a recent trial, Dimebon proved effective in preventing brain cell death in patients with both Huntington's and Alzheimer's disease. The therapy is designed to improve the performance of mitochondria inside cells, thus improving brain function.

- check out the Medivation release
- read the AP report

ACT says it has found key to limitless blood supply

John Carroll — Wed, 20 Aug 2008 10:21:29 -0400

Advanced Cell Technology may be running out of cash, but the biotech still knows how to garner headlines around the world. The company is reporting that it has been able to gin quantities of red blood cells from human embryonic stem cells. And that could create a virtually limitless supply of blood--as well as a possible pathway to the company's survival.

While others have made red blood cells from ESCs, ACT and researchers at the University of Illinois at Chicago and Mayo Clinic have created a way to make billions of red blood cells. A six-well plate of ESCs spawned 10 billion to 100 billion red blood cells. And that could eventually make routine blood shortages a thing of the past. Dr. George Daly from the Harvard Stem Cell Institute told the Boston Globe that this new work constituted a "very nice proof-of-principle." But he cautioned that there's a deeply entrenched system in place for gaining blood supplies.

About 16 people still work for the cash-strapped ACT, which raised $250,000 this month from a tech licensing deal with BioTime.

--read the article in the Boston Globe

BMS inks $710M development deal with PDL

John Carroll — Wed, 20 Aug 2008 10:20:13 -0400

Bristol-Myers Squibb is paying $30 million upfront in a licensing deal for PDL BioPharma's experimental blood cancer vaccine elotuzumab. And will it pay up to $680 million more if the Phase I cancer therapy hits all of its development and sales milestones. The anti-CS1 antibody binds to a protein that plays a key role in multiple myeloma, flagging it for destruction by the human immune system. BMS agreed to cover 80 percent of the development costs with PDL putting up 20 percent. The two plan to share profits in the U.S. And the deal includes an option to collaborate on PDL241 after it completes preliminary testing.

"Consistent with our company's strategy to integrate external innovation and to expand our capabilities, this collaboration will further strengthen our pipeline of agents targeting hematologic malignancies, which includes SPRYCEL and tanespimycin, an Hsp90 inhibitor from our recent acquisition of Kosan Biosciences," said Francis Cuss, M.D., senior vice president, discovery and exploratory clinical research, Bristol-Myers Squibb.

--read the AP report
--read the Bristol-Myers Squibb release

2008's Billion-dollar deals (H1)

Maureen Martino — Wed, 23 Jul 2008 08:38:00 -0400

The first half of 2008 has drawn to a close, with deal-making still on a roll. In the first six months of this year, companies inked six pacts--both buyouts and licensing deals--that exceed the billion-dollar mark. Novartis has the biggest buyout so far, diversifying with the purchase of eye care company Alcon. But Takeda takes the prize for the busiest drug developer; the Japanese company made inroads in the U.S market, which included massive buyout of Millennium and two big licensing deals with Amgen and Alnylam.

Of course, the second half of 2008 is off to a strong start, with Roche offering $44 billion for an increased stake in Genentech and GSK shelling out $3.25 billion to partner with Actelion on a new insomnia therapy. The Roche/Genentech deal could be the biggest of the year, but for now, check out this list of deals from the first half--and keep an eye out for more big moves from drug developers in 2008.

1. Novartis and Alcon - $39B

2. Takeda and Millennium - $8.8B

3. Daiichi and Ranbaxy - $4.6B

4. Genzyme and Isis - $1.9B

5. Amgen and Takeda - $1B

6. Takeda and Alnylam - $1B

PTC inks $437M pact with Genzyme

John Carroll — Thu, 17 Jul 2008 10:57:42 -0400

PTC Therapeutics has snared a rich licensing deal with Genzyme for its lead development program. Genzyme has agreed to pay $100 million up front for PTC124, which is in Phase IIb for Duchenne Muscular Dystrophy. PTC124 also completed a mid-stage trial for cystic fibrosis with "promising" results. PTC retains commercialization rights in the U.S. and Canada with Genzyme taking over the rest of the world. Genzyme will pay up to $337 million in milestones.

PTC--a 2007 Fierce 15 company--has linked 2,400 genetic disorders to nonsense mutations. By targeting a specific type of genetic alteration--nonsense mutations--PTC124 bypasses the defect and leads to the restoration of a functional protein. Nonsense mutations inactivate gene function and are known to cause anywhere from five to 70 percent of the individual cases of most of these inherited diseases.

"Over the past two decades, Genzyme has successfully developed four therapies for patients with severe genetic diseases. PTC124 is a powerful new approach that holds great potential to help CF and DMD patients, and many others with a variety of devastating diseases," stated Henri A. Termeer, Genzyme's chairman and CEO. "This collaboration is an excellent strategic fit for Genzyme and will be managed within the company's stated financial guidance."

"One of PTC's earliest scientific insights was that targeting nonsense mutations represented a novel approach to treating a large number of genetic disorders. The translation of that insight through the discovery and rapid development of PTC124 has been very gratifying," commented Stuart W. Peltz, Ph.D., PTC's president and chief executive officer.

- read this release for more

ALSO: Xconomy examines Genzyme's late-stage MS drug Campath, which could go head to head against Biogen Idec's Avonex and Tysabri for the multibillion-dollar MS market. Report

Top 5 deals of the first half of 2007

Maureen Martino — Tue, 11 Sep 2007 08:52:11 -0400

Deal-making continued at a blistering pace in the first half of 2007, as drug giants snapped up promising therapies from smaller developers in order to beef up their pipelines. See the companies below for a look at the biggest deals so far this year.

1. AstraZeneca and Bristol-Myers Squibb
2. Novartis and Antisoma
3. Shire and Renovo
4. Sanofi-Aventis and Oxford BioMedica
5. Amgen and Cytokinetics