Deals Of The Week: Hunting For Dengue Fever Drugs Amid Climate Change

                                      Aedes aegypti busily transmitting virus

Dengue fever is on the move. This mosquito-borne viral disease is invading new parts of the world, helped by climate change, urbanization and increased travel. Europe last autumn had its first big outbreak since 1920 on the Portuguese island of Madeira, while in Florida, where Dengue fever was largely eradicated in the 1930s, around 10 cases were reported in August.

With no approved vaccines on the market to fight the virus, this DOTW reporter was heartened to learn that Johnson & Johnson’s Janssen Inc. is joining the hunt for drugs to treat the world's fastest-spreading tropical disease by linking with academic researchers in Belgium and Britain’s Wellcome Trust medical charity.

The tie-up between Janssen and researchers at the University of Leuven, who have received backing from Wellcome, will build on the discovery of a series of chemical compounds that are highly potent in preventing the replication of dengue virus. The compounds, which have yet to be tested in clinical trials, are active against all four types of the virus and have been shown to work in animal tests. Janssen will have the option of an exclusive, worldwide license to progress and commercialize compounds developed through the research program. Financial terms were not disclosed but Janssen will make upfront, milestone and royalty payments to the University of Leuven.

The collaboration, although long-term, reflects confidence in the feasibility of making an effective medicine against Dengue fever, which is sometimes known as tropical flu. Dengue fever is spread by the Aedes aegypti mosquito, which is now found in 150 countries. To put concerns in context: malaria causes more deaths, but it is on the decline and affects fewer than 100 countries, according to the World Health Organization (WHO). Dengue fever, on the other hand, affected only a handful of areas in the 1950s, but is now officially present in more than 125 countries, exposing half the world's population to the disease. The danger is greatest in the developing world, but the disease is also prevalent in the southern U.S. and parts of southern Europe. Aedes mosquitoes are now present in 18 European countries, often arriving via the importation of bamboo and second-hand tires.

No treatment exists for Dengue fever and vaccines are still in the research stage. Hopes for an effective dengue vaccine were set asunder in 2012, when an experimental tetravalent dengue vaccine from Sanofi Pasteur proved less effective than hoped in a mid-stage clinical trial in Thailand, producing only 30% efficacy. More successful, we hope, will be the latest crop of deals of the week, including: - Sten Stovall

Sanofi/Pozen: Sanofi Pasteur’s parent Sanofi has signed a license agreement with Pozen Inc. on the commercialization of Pozen's new-and-improved aspirin therapies, being developed to reduce gastric ulcers in cardiovascular patients. The deal, which could generate more than $35 million for the U.S.-based company, gives Sanofi exclusive U.S. rights to commercialize all of Pozen's combination drugs containing the proton pump inhibitor immediate-release omeprazole and 325 mg or less of enteric-coated aspirin. This refers currently to Pozen's PA8140 and PA32540 tablets.

PA32540/PA8140 layers 40 mg immediate-release omeprazole (Prilosec) around aspirin to provide the cardiac benefits of once-daily aspirin therapy while reducing the risk of aspirin-induced gastric ulcers. PA32540 contains 325 mg aspirin while PA8140 contains 81 mg aspirin.

The Chapel, Hill N.C.-based company has built a business around developing fixed-dose combination drugs, which are sold through its partners GlaxoSmithKline PLC and AstraZeneca PLC. Prozen previously said it planned to go it alone on PA32540 after frustrating relationships with its big pharma partners and disappointing sales of its migraine treatment Treximet (sumatriptan/naproxen) and pain reliever Vimovo (naproxen/esomeprazole). Its latest deal will see Sanofi pay Pozen $15 million up front, with Pozen eligible to receive pre-commercial milestone payments of $20 million and additional payments upon achievement of certain sales milestones. Pozen will also get double-digit tiered royalties on sales of licensed products by Sanofi and its affiliates in the U.S. Sanofi will have responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. Pozen will keep responsibility for obtaining approval of the NDA, after which Pozen will transfer the application to Sanofi. The application was submitted on March 27 and accepted for filing in May by FDA. - S.S.

Otsuka/Astex: While the California biotech wouldn’t reveal how long it’s been on the block, Astex Pharmaceuticals Inc. said it found its highest bidder in Japan’s Otsuka Pharmaceutical Co. Ltd.  The deal, revealed Sept. 4 by a Japanese news organization, has Otsuka paying $8.50 per share for all outstanding shares of Astex, a 48% premium to the company’s 30-day moving average, and above its close of $6.68 on Sept. 3, the day prior to the deal announcement. Otsuka is expected to issue a tender offer within 10 days that will remain open 20 days. The transaction has been approved by the boards of both companies. The deal is expected to close in the fourth quarter.

Otsuka, which is trying to shore up its top-line from the bloodshed it expects when its blockbuster schizophrenia drug Abilify (aripiprazole) goes off patent in 2015, will benefit from the royalties that Astex brings in on its already-marketed leukemia drug Dacogen (decitabine), which another Japanese drugmaker - Eisai Inc. - has worldwide exclusive rights to commercialize. With Eisai required to pay 20% royalties on sales, escalating to a maximum of 30%, Dacogen accounts for about $60 million to $70 million in royalty revenues for Astex annually. Astex also has a fragment-based discovery platform dubbed Pyramid that turns out small-molecule drug candidates with a variety of mechanisms of action, amplifying the effects of existing drugs or resensitizing cancers to their effects - Lisa LaMotta

Ultragenyx/Kyowa Hakko Kirin: Rare disease company Ultragenyx Pharmaceutical Inc. has partnered with Kyowa Hakko Kirin Co. Ltd. to develop and commercialize a treatment for X-linked hypophosphatemia (XLH). This is the first pharma partnership for the high-profile biotech, which raised a $75 million Series B round in late 2012 that included several crossover investors.

At that time, it planned an IPO for the first half of 2014.. The pair will collaborate to develop the candidate, KRN23, for the U.S., Canada and EU with Ultragenyx leading development in the XLH indication and the pair sharing marketing and profits in the U.S. and Canada. KHK will be responsible for the commercialization of KRN23 in the EU. Ultragenyx plans to develop and commercialize KRN23 in Mexico, Central and South America. Financial details of the deal were not disclosed. KRN23 is in a Phase I/II trial in adults with XLH; the partners plan to initiate a pediatric XLH trial in 2014. XLH is a metabolic bone disorder caused by excessive loss of phosphate in the urine leading to severe hypophosphatemia. The resulting inadequate bone mineralization leads to various abnormalities. These patients have low serum phosphate levels due to high levels of FGF23, a hormone that represses the reabsorption of phosphate from the urine. KRN23 is intended to bind to and render FGF23 inactive, leading to an increase in kidney tubular absorption of phosphate and increased serum phosphate levels. This would be the first disease-modifying treatment for XLH, according to the company. The current treatment for XLH is oral phosphate and vitamin D (calcitriol) therapy; patients must be closely monitored and are at risk for various complications. - Stacy Lawrence

Baxter/Coherus: Pfizer Inc. and Amgen Inc.’s blockbuster Enbrel (etanercept) may have won extended patent coverage in the U.S., but at least two biosimilars that could challenge the drug in certain territories are under development. The latest will come from a Sept. 3 partnership between Baxter International Inc. and Redwood City, Calif.-based biosimilar specialist Coherus BioSciences Inc., which will collaborate on development of an etanercept alternative in Europe, Canada, Brazil, and other unspecified locales.  Baxter will pay Coherus $30 million up front, plus up to $216 million in additional payments contingent on clinical development and regulatory milestones, according to the deal terms. It’s not yet clear whether they’ll pursue approval in Enbrel’s largest indication, rheumatoid arthritis, or whether the companies will aim for psoriasis, psoriatic arthritis, ankylosing spondylitis or another autoimmune-related indication.

Enbrel generated $4.2 billion in 2012 sales; Amgen shares co-promote rights to the drug in the U.S. and Canada with Pfizer under a deal that ends Oct. 31, with Amgen taking back all rights. Sandoz is already developing an etanercept biosimilar, although that company is hoping to gain its first approval in psoriasis. That company believes it can challenge Enbrel’s extended exclusivity, including two U.S. patents that expire in 2028 and 2029. Baxter has teamed with Momenta Pharmaceuticals Inc. in a December 2011 deal that is expected to yield between two and six new biosimilars. - Paul Bonanos

Novartis/Regenerex: Novartis AG and Regenerex LLC have inked an exclusive global licensing and research collaboration based on the Kentucky-based biotech’s hematopoietic stem cell-based FCRx platform. Regenerex’s Facilitating Cell Therapy (FCRx ) has shown encouraging results in Phase II trials involving 15 kidney transplant recipients, inducing stable immunological tolerance and graft survival without the need for lifelong immunosuppression.  Currently, solid organ transplant recipients need immunosuppressive drugs for life to prevent rejection. FCRx is an allogeneic hematopoietic stem cell based therapy platform that also contains facilitating cells derived from a donor. The platform supports the development of tolerance, or "bone marrow chimerism," in transplant recipients and the two hope chimerism will eventually render recipients tolerant to cell, tissue or organ transplants from the same donor, enabling transplant patients to discontinue immunosuppressive medications after building stable immunological tolerance. Beyond transplant, the partners will study FCRx’s potential for correcting serious genetic deficiencies such as inherited metabolic storage disorders and hemoglobinopathies, examples being metachromatic leukodystrophy and sickle cell disease. The companies did not provide financial details or timeframe for their collaboration in the Sept. 6 announcement. Novartis did say that the FCRx platform will broaden its current cell therapy portfolio, which includes two novel cell therapy platforms initially being investigated in hematological malignancies. HSC835, currently in a Phase II trial in patients with high-risk hematological malignancies, is a novel cell therapy approach that enables an expanded single umbilical cord blood derived hematopoietic stem cell transplant in patients with limited treatment options. A second cell therapy product, CTL019 is a chimeric antigen receptor T cell therapy currently in Phase II development in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). - S.S.

Thrombogenics/Bicycle: ThromboGenics NV has signed its second licensing deal in three months involving novel targets for diabetic eye disease, this time with U.K.-based Bicycle Therapeutics Ltd.  Bicycle's bicyclic peptide technology will be used to identify and optimize bicyclic peptides that inhibit what is believed to be a new target involved in vascular permeability, and ThromboGenics will have exclusive rights to clinically develop and commercialize the products. In return, Bicycle will receive an undisclosed upfront fee, development and regulatory milestones and royalties on sales, and will also collaborate with ThromboGenics on preclinical development. Their licensing pact was announced on Sept. 5. Now that ThromboGenics's lead product, the vitreomacular adhesion product Jetrea (ocriplasmin), has reached the market in the U.S and Europe, the Belgian biotech is casting around for new avenues to explore in ophthalmic diseases. It has nearly €200 million in cash, including milestone payments totaling €90 million from Jetrea's European licensee, Alcon (Novartis), so has the financial muscle to do so. In May, it licensed technology from Cambridge, Mass.-based Eleven Biotherapeutics to develop protein therapeutics aimed at another novel biologic target involved in diabetic macular edema (DME) and diabetic eye diseases. DME is of increasing interest to pharma companies because of its increasing prevalence and the possibility of improving on the current standard of care, lasers or VEGF inhibitor therapy. - John Davis

Santhera/Takeda: Santhera Pharmaceuticals AG of Switzerland reached agreement with Takeda Pharmaceutical Co. Ltd. on Sept. 3 to license back the European rights to its Phase III Duchenne muscular dystrophy (DMD) drug Catena (idebenone), increasing the Swiss company’s commercial flexibility. In return, Takeda gets an undisclosed percentage of future licensing and/or sales income generated by Santhera in DMD. Takeda acquired exclusive marketing rights for the medicine in Europe in 2005. Idebenone is a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase (NQO1) capable of transferring electrons directly onto complex III of the mitochondrial electron transport chain, thereby capable of restoring cellular energy levels.

The drug is in a DMD Phase III study conducted in Europe and the U.S. Santhera also obtained the right to cross-reference Takeda's idebenone data for regulatory use in any indication in any territory. If Santhera makes use of the cross-references, Takeda is eligible to obtain a percentage from future licensing and/or sales income generated by Santhera in such indications. The two companies also ended a 2005 agreement for idebenone’s use treating Friedreich's ataxia. Santhera's €1 million ($1.3 million) contingent liability payable to Takeda under that has been waived, but Takeda is eligible to receive €1 million  as a percentage from future income generated by Santhera to offset this.- S.S.



Photo credit: Wikimedia Commons.

Deals Of The Week: Has BioCryst Struck Out?

As baseball executives gathered at the Opryland Hotel in Nashville during the week of Dec. 3 for the trade and free agency frenzy known as the winter meetings, the deal-making also continued in the biopharma corner. But just as executives from many major league teams were waiting for the strategies of big spenders like the Texas Rangers and Los Angeles Dodgers to materialize so they could make their corresponding moves, it was a week of frustration at BioCryst and Presidio as a planned merger that might have created a new significant player in the hepatitis C space crumbled under the weight of three rapid clinical setbacks.

In the aftermath of a third setback, FDA placing a clinical hold on oral hereditary angioedema compound BCX4161 the week of Nov. 26, the two companies announced Nov. 30 that they mutually had decided against a planned all-stock merger announced on Oct. 18 that would have created a new company with a wholly owned portfolio of three oral antiviral candidates for hepatitis C.

During an investor call Dec. 7, BioCryst announced that it will cut its staff by 50% while reducing planned cash-burn for 2013 by as much as 45% while it narrows its focus on the HAE and HCV programs, as well as preclinical broad-spectrum antiviral BCX4430. CEO Jon Stonehouse explained that the three clinical setbacks - the delay of a clinical trial for NS5B inhibitor BCX5191 in HCV because of toxicity concerns and the likely clinical failure of flu candidate peramivir - had eroded the North Carolina biotech's stock price.

"Despite these setbacks, we have a path forward for BioCryst to rebuild shareholder value because of our promising compounds," the exec said. "Following the review of BioCryst's assets, resources and cost structure, we concluded that restructuring and a highly focused approach to our development programs was required. This will preserve cash and enable BioCryst to reach near-term milestones that will give us greater insight regarding the opportunity and risk associated with our three core programs."

The planned merger with privately held Presidio not only would have combined HCV assets, but also would have brought BioCryst a needed injection of cash. The deal valued Presidio at $101 million and would have involved 24.5 million new shares in BioCryst being issued to Presidio's investors. At the same time, Presidio shareholders would commit to providing $25 million of a planned $60 capital raise for the new company.

Now, the retrenched BioCryst will cut down from 75 positions to a headcount of 37, which Stonehouse said reflected reductions evenly spread throughout the organization. Instead of spending $40 million in R&D and associated costs in 2013, the company now anticipates a cash-burn of $22 million to $25 million, excluding deal-related and restructuring costs. BioCryst will record a restructuring charge of between $2 million and $4 million during fourth quarter 2012.

The revised R&D plan is to study low doses of '5191 in HCV-infected chimpanzees in an attempt to demonstrate meaningful antiviral activity at lower doses than previously used in clinical trials. In November, BioCryst withdrew an IND for '5191 due to safety concerns regarding renal toxicity at the dosage thought needed to benefit human patients. BioCryst expects go-or-no-go data from the chimpanzee studies in early 2013, Stonehouse told the investor call.

The company also hopes to begin a Phase I study of '4161 in January 2013 to demonstrate the safety, level of drug exposure with oral administration and pharmacodynamic effects of the kallikrein inhibitor. BioCryst, which hopes to position '4161 as an oral prophylactic against HAE attacks, thinks such a product would be a game-changer in the rare disorder space. For now, however, the drug is stalled as FDA implemented a clinical hold on '4161 due to concerns about compounding of the drug at trial sites.

BioCryst also plans to seek medical journal publication of a manuscript describing the activity of '4430 in certain filoviruses. That candidate's prospects loom crucially because peramivir is considered virtually dead after a Phase III trial was ended due to poor efficacy findings.

While BioCryst and Presidio were mired in a "No-Deal," however, other biopharma companies were proactive just like the executives in the baseball world during the past week. Now, it is time to "play ball" with ...

Baxter/Gambro: In an effort to extend its global footprint to areas like Latin America, Europe and the Asia Pacific, Baxter International has agreed to pay $4 billion including the assumption of debt to acquire Swedish dialysis company Gambro, which reported revenues of $1.6 billion annually. Baxter is using its cash held overseas to pay for the transaction and the deal is expected to close in the first half of 2013. “With Baxter generating more than two-thirds of its cash overseas, we view the Gambro acquisition as a smart way to put that money to work,” wrote Leerink Swann analyst Danielle Antalffy in a note to investors. The acquisition rounds out Baxter’s kidney dialysis business, adding Gambro’s suite of hemodialysis products to its own peritoneal dialysis offerings. Gambro’s products typically are used in the hospital setting, while Baxter’s products usually are used in the home. Baxter expects to see $300 million in cost synergies by 2017 and add approximately 7% to sales over the next five years. The company currently brings in revenues of $13.8 billion. “Over the last three years, Gambro’s growth has been roughly flat, and Baxter's renal business has grown about 4%,” wrote Morgan Stanley analyst David Lewis. “Pro forma for the deal, Baxter believes it can accelerate growth to [about] 6% by investing to relieve Gambro capacity constraints, leveraging Baxter’s global selling infrastructure, using Gambro to accelerate the home HD launch, and using the new breadth of the business to pursue public/private partnerships.” - Lisa LaMotta

Optimer Pharmaceuticals/AstraZeneca: Building on its regional partnering strategy for Dificid (fidaxomicin), Optimer Pharmaceuticals has signed AstraZeneca to market the antibiotic in South America, including in Brazil, Central America, Mexico and the Caribbean in a deal announced Dec. 3. AstraZeneca has a “major market position in three key Latin American markets, Brazil, Mexico and Columbia, according to Optimer CEO Pedro Litchtinger. AstraZeneca will pay Optimer $1 million upfront, up to $3 million in milestones upon first commercial sale in certain countries, and up to $19 million in other milestones contingent on the achievement of sales-related targets in the region. In a related supply agreement, Optimer also stands to receive payments from AstraZeneca that amount to a double-digit percentage of net sales in the territory. One of a few big pharmas still investing in antibiotic drug development, AstraZeneca is Optimer’s fourth commercial partner. The company already has signed a co-commercialization deal with Cubist Pharmaceuticals in the U.S., and deals with Astellas Pharma in Japan and Europe and Specialised Therapeutics in Australia. It’s all part of a strategy Optimer says is focused on finding commercial leaders in key regions of the world while focusing its own attention and resources on North America, where it is building a commercial organization. The company still expects to sign at least one more partner to bring its Clostridium difficile infection treatment to China. - Jessica Merrill

Ironwood/Protagonist: Constipation drug seller Ironwood Pharmaceuticals and peptide discovery platform company Protagonist Therapeutics said Dec. 6 that they have expanded an existing partnership. The parties did not disclose terms or specifically differentiate the expanded partnership from its two-year-old predecessor, but expressed that both sides are pleased with the progress of the existing deal to discover new therapeutics addressing unmet needs, based on Protagonist’s Disulfide Rich Peptide (DRP) platform. Like the January 2011 deal, the new arrangement includes an upfront payment by Ironwood, along with milestones and royalties if a product advances through the clinic and is approved and marketed; Ironwood will continue to fund full-time staff within Ironwood’s walls in order to evaluate and develop potential products. The companies did not identify which therapeutic areas are covered under the existing or new partnership, and they have not announced any product candidates from the original collaboration yet. Ironwood says it has discovered most of its pipeline on its own thus far; it currently markets Linzess (linaclotide) for irritable bowel syndrome with constipation and chronic idiopathic constipation. Protagonist established a separate discovery collaboration with Zealand Pharma in June 2012. - Paul Bonanos

MD Anderson Cancer Center/GlaxoSmithKline – University of Texas’ MD Anderson Cancer Center has tapped GlaxoSmithKline to help it develop and commercialize an antibody discovered by scientists at the center. Anderson will handle preclinical activities, while GSK will be responsible for clinical development and commercialization. Under the deal announced Dec. 7, the cancer center will receive an undisclosed upfront payment as well as research funding and development milestones. Anderson indicated that the deal could result in $335 million in payments for the center, as well as royalties on any commercial products that are developed. The antibodies activate OX40, a protein that stimulates the immune response in T-cells against cancer. "This agreement is not only a testament to the vision shared by GSK and MD Anderson that successful clinical development of oncology drugs requires seamless integration of drug development expertise and deep biological knowledge," said Giulio Draetta, director of the Institute of Applied Cancer Science at Anderson, in a statement. - L.L.

Mediolanum/Genovax: Eporgen Venture, one of Italy’s first suppliers of seed capital to life science companies from a network of private, non-institutional Italian investors, reported on Dec. 4 the first major transaction by one of its portfolio companies, Genovax, which has sold its Phase II-ready potential therapeutic cancer vaccine, GX-301, to the Italian pharma company Mediolanum Farmaceutici. Eporgen President Konstantinos Efthymiopoulos expects several other transactions involving Eporgen-supported companies to complete in the next few months, and is aiming to raise up to €10 million ($13 million) in additional financing to develop other assets to proof-of-concept in its portfolio companies, which ideally but not necessarily would be clinical proof-of-concept. Italian research and science is as good as in other European countries, Efthymiopoulos said, although he acknowledged that life science entrepreneurship and the network of academic technology transfer offices is not as highly developed. It is only a question of time before the country catches up with its neighbors, he asserted. GX301 will boost its research interests in oncology, Mediolanum said; it will take over all future development and commercialization activities for GX301. A Phase II study in patients with prostate cancer is expected to start in the first half of 2013. - John Davis

StemBANCC: One of the largest European “open innovation” projects to date will see Switzerland’s Roche and the U.K.’s Oxford University coordinate the work of nine other pharmaceutical companies and 22 other academic institutions in Europe on creating more than 1,500 human-induced pluripotent stem cell lines to use as disease models to discover new therapies. This and other new EU projects announced Dec. 5 echo themes for TransCelerate BioPharma, an initiative announced Sept. 18 involving 10 international drug companies which also seeks to identify and solve common drug-development challenges, although focused more on regulatory than research issues. The EU’s StemBANCC project, a public-private partnership formed as part of the EU’s Innovative Medicines Initiative (IMI) will have a budget of €55.6 million ($73 million). The funding will include €26 million from IMI’s EU funds and “in-kind” funding of €21 million from the participating drug companies. The in-kind funding includes company employees and their costs, access to research equipment, facilities and database access. The cell lines, of which 500 will be derived from patients, will be used to set up models of disease, like diabetes or dementia, in order to accelerate the drug-development process. - J.D.

Photo credit: Wikimedia Commons

Deals of the Week Screams ¡GOOOOOOOOOLLLLLLL!

In honor of the 2010 FIFA World Cup, IN VIVO Blog is channelling its inner Andres Cantor. Come on, there’s a little bit of the Argentinian-born sportscaster in all of us. Perhaps you did your best Cantor this morning when South Africa's Siphiwe Tshabalala found the upper right near corner of the net for the tournament's first score. Alas, host South Africa later surrendered an equalizer to Mexico, and the opening match Friday ended in a 1-1 draw.

It wasn't the only tussle this week that ended without a clear winner. Henri Termeer, CEO of Genzyme, and activist shareholder Carl Icahn have been kicking the ball up and down the pitch for months, and the compromise between the two gentlemen announced Wednesday was definitely your humble blogger’s favorite deal of the week, even if it doesn’t count as a traditional tie-up.

In finding a middle path, both parties gave up something. Icahn has to make do with just two Genzyme board seats, and his right-hand man Alex Denner isn’t one of them. Termeer, meanwhile, must satisfy the demands of Icahn’s representatives if he wants to avoid the fate of Jim Mullen, who just stepped down as CEO of Cambridge, Mass. neighbor Biogen Idec.

But both Icahn and Termeer/Genzyme also gained significantly. Termeer, for now, keeps his job and avoids the circus of a proxy fight. With some representation on the board, Icahn can still fight for more seats in the future if he chooses. As Charles Elson, a professor at University of Delaware's Weinberg Center for Corporate Governance, told our sister publication “The Pink Sheet” DAILY, “Whether it’s four [seats] or one, the fact that you have someone express your viewpoint…is [what’s] important.” The upshot: if that viewpoint is convincing enough, other board members will eventually come around.

In addition, both Icahn and Termeer avoided spending the weekend on the phone trying to sway major shareholders to their cause, when all parties involved would no doubt prefer to watch the beautiful game -- including Saturday’s not-to-be-missed England-U.S. tilt.

One set of winners to emerge from the boardroom draw were Genzyme shareholders, according to Bernstein Research analyst Geoffrey Porges. In a June 9 note, he called the solution “logical” because it introduces Icahn’s influence into the company without the conflict posed by overlap with Biogen’s board representation.

Who else scored a gooooooooooooooooal this week? Maybe Alzheimer’s patients and their loved ones. Five major drug makers -- Johnson & Johnson, GlaxoSmithKline, AstraZeneca PLC, Sanofi-Aventis, and Abbott Laboratories -- have joined forces to share data from 11 failed Alzheimer’s-drug clinical trials. (Data will also be available to outsiders who have valid scientific questions.) Under the auspices of the Critical Path Initiative, it’s the latest evolution in private-public partnerships, and it’s hoped that sifting through massive loads of patient data, researchers will glean new insights into this tricky disease. It's also notable for who’s not participating, at least not yet: Pfizer, which suffered an embarrassing setback earlier this year when its collaboration with Medivation for the Phase III Dimebon blew up.

Meanwhile, rumors are swirling that FDA suppressed negative data associated with the controversial diabetes medicine Avandia. That should add even more drama to the upcoming advisory committee review (or as we dubbed it last week, a "re-review") of the ramifications of allowing long-term safety studies of the medicine to commence.

In other news of pharma potentially behaving badly, it seems more likely that subpoenas will fly as Congress aims to get to the bottom of the recent recall of Johnson & Johnson’s children’s Tylenol. According to a Friday NYT story, Democratic Representative Edolphus Towns, chair of the House Committee on Oversight and Government Reform, says the health care giant has used delaying tactics and hasn’t been forthright with his committee. Even as J&J denies these accusations, a key goooooooooooooal for the drug maker has got to be burnishing its public image.

Whether you tune into the ballet of the masses or opt for the opera of the people, remember this essential piece of soccer wisdom: “Soccer is simple, but it is difficult to play simple.” The same could be said for biopharma deal making. Game on.



Grifols/Talecris: Hoping a merger with a smaller company might pass muster with the US Federal Trade Commission, Talecris Biotherapeutics is trying the business combination route again, about a year after its planned merger with Australia’s CSL was shot down by the FTC. (In FIFA terms, call it round 2, Spain vs. U.S.) In a deal announced June 7, Spanish firm Grifols SA, the number four company worldwide in the plasma protein therapeutics space, plans to buy Talecris, the number three player, for $3.4 billion in cash and stock, while also assuming the U.S. co’s hefty $600 million debt. In essence, the merger provides Grifols an increased North American commercial presence, while Talecris aims to accomplish two primary goals: an exit for remaining venture backer Cerberus Capital Management and improved capacity and efficiency in plasma collection. Formed in 2005 when Bayer spun out its plasma business to Cerberus and Ampersand Ventures, Talecris went public last fall. Cerberus, however, remained a 49% stakeholder in the public company. Even though the tie-up reduces the number of plasma protein players from five to four, Grifols and Talecris believe this deal has a better shot with the FTC than the CSL/Talecris marriage, because it won’t create a duopoly controlling 80% of the plasma protein market. Instead the top three players -- Bayer Baxter, CSL, and Grifols/Talecris -- will have a roughly equal share of the market. -- Joseph Haas

Sanofi-Pasteur/Vivalis: This week’s announcement from Vivalis that it was teaming up with Sanofi to discover and develop monoclonal antibodies against several infectious-disease targets marks the fourth time the two companies have teamed up. Apparently they like each other’s company. In this latest pact, Vivalis will receive €3 million upfront plus up to €35 million in milestones, plus royalties per program for access to its Humalex Mab platform and worldwide rights on resulting antibodies. Previously Vivalis has in three separate deals granted to S-P (twice) and Acambis (now part of S-P) access to its various embryonic stem cell lines for vaccine and antibody production. This week’s deal is based on newer technology that Vivalis itself acquired only this year. Humalex came into the biotech through its January 2010 €10.4 million acquisition of compatriot Humalys SAS, a move designed to broaden its product offering and potential biz-dev opportunities. Humalys shareholders are eligible for up to €15 million in milestone payments based on pharmaceutical partnerships for the Humalex technology. So far, so good. -- Chris Morrison

Forest/TransTech Pharma: Forest Laboratories isn't giving up on Type 2 diabetes. Just two months after scrapping an expensive deal with Phenomix for the late-stage dipeptidyl-peptidase-4 inhibitor dutogliptin, Forest is jumping back in. The specialty pharma has, however, learned its lesson: while it’s spending pretty big money -- $50 million up front and potentially more than $1 billion in milestones -- for a suite of Phase I and preclinical compounds, at least they belong to a novel class of medicines. The deal centers around TransTech’s highly selective glucokinase activators, which target an enzyme found in the liver and pancreas involved in glucose sensing. Transtech’s ability to specifically regulate the liver glucokinase enzyme was apparently key to the deal. When the pancreatic enzyme is targeted, it results in excessive insulin secretion, which can result in potentially life-threatening hypoglycemia. But the Forest/Transtech team certainly doesn’t have this target class to themselves. AstraZeneca, Amgen, and Eli Lilly also have GKAs in the clinic. This week’s announcement shows early stage deal-making for potentially first-in-class molecules still has legs--and the terms are on par with Amgen’s December alliance with Array for its Phase I GKA, ARRY-403. Even as analysts lauded the deal for its long term potential, the arrangement does little to help Forest replenish a portfolio that’s facing patent pressure. Forest’s two biggest products, Lexapro and Namenda, go generic in 2012 and 2015, respectively. -- Jessica Merrill

GlaxoSmithKline/Laboratorios Phoenix: Will the sun never set on the Glaxovian Empire? GSK's latest international foray has the US/UK behemoth spending $253 million cash for Laboratorios Phoenix, an Argentinian branded-generics firm with about £70 million (US $101 million) in annual sales last year, making it the eighth largest drug seller in the country according to IMS. GSK will add products in areas that include cardiovascular, gastroenterology and urology, plus a primary sales force and a manufacturing plant near Buenos Aires. GSK already has an Argentinian division with 2009 sales of £100 million, £56 million of which came from pharmaceuticals, but it said it would keep the entity legally separate from Phoenix. Dust off your atlases and grab your Rick Steves packing cubes, here's a list of GSK's regional deals since the start of 2009. Last month it bought a nearly 10% stake in South Korea's Dong-A Pharmaceutical and in December it snapped up 12.6% of Japan's JCR Pharmaceuticals, after also creating joint ventures with two different Chinese biotechs, Jinagsu Walvax Biotech and Shenzhen Neptunus Interlong Bio-Technique. Don’t forget its purchases of UCB's emerging markets business for €515 million (US $621 million) and Bristol-Myers Squibb's branded-generics operations in Lebanon, Syria, Yemen, Jordan and Libya for $23 million. Piled onto all this pharmerging goodness is Glaxo’s deal to sell Dr. Reddy's products in several regions and its 19% stake in South African generics firm Aspen Pharmacare. At risk of making light of pharmaceutical colonialism, we point out that GSK is one of several massive drug makers playing a "Great Game" of international acquisition. Our colleague Wendy Diller renewed her passport to sort out the emerging-market land grab in this IN VIVO feature. -- Alex Lash

Photo courtesy of flickr user CLF.

Editor's note: This post was updated on June 14th to indicate the top three players in the plasma protein market: Baxter, CSL, and Talecris/Grifols. Bayer was inappropriately mentioned as part of an editing error.