Deals Of the Week, Once Again, Ponders Biosimilars

Teva Pharmaceutical Industries Ltd.’s and Lonza Group’s announcement on July 25 that they were formally ending their four-year-old biosimilars joint venture was hardly a surprise, given that late last year both companies said they were reviewing their relationship. Their decision certainly reflects the complexities of developing biosimilars, but it also is the consequence of each company’s new leadership, which has different priorities than those who forged the original deal.

Signed at a time when biosimilars seemed like an incredibly promising, albeit vague, long-term opportunity for an assortment of generics and pharma companies, the original deal was ambitious in scope. Each company committed to spend $300 million over six years on the alliance, estimating the cost of developing one biosimilar would be roughly $100 million – considered a lot at the time. Teva saw biosimilars “as a major growth driver” and positioned itself as “a leader in this market,” then President and CEO Shlomo Yanai said at the time. Lonza would bring large-scale biologics manufacturing and development expertise to the table, while Teva offered experience in clinical development and marketing of generic and branded drugs.

Four years later, even as the EU and U.S. regulatory pathways for biosimilars gain some clarity, the overall landscape for the field is as complex as ever. Like their competitors, Teva and Lonza held much of their work close to their vests, but they had counted on developing a franchise around a biosimilar version of Roche’s $7 billion Rituxan (rituximab) franchise, only to halt clinical development last October due to “changes in the regulatory and competitive environment.” They weren’t the only ones to face setbacks on rituximab programs: Celltrion Inc. and its partner Hospira Inc., and the Samsung Biologics/Quintiles Transnational Holdings Inc. alliances also are also in the midst of re-evaluating their biosimilar rituximab programs.

More telling, perhaps, new CEOs at each company are set on revamping priorities across the board. Lonza’s new CEO, Richard Ridinger, who joined the company in April 2012, is in the midst of re-organizing the company into two core areas, pharma and biotech and specialty ingredients. On an earnings call also on July 25, he said the company, which accounts for about a third of all mammalian cell culture manufacturing worldwide, would reduce its manufacturing footprint, including closing two plants. Lonza indicated that it holds CHF100 million ($107.6 million) in assets on its balance sheet in relationship to the joint venture and has expensed CHF38 million since its formation. The company estimates it will save CHF150 million by ending the deal.

Teva releases its second-quarter numbers on August 1, so the company isn’t providing accounting details or elaborating on the announcement. But CEO Jeremy Levin, who assumed his position in May 2012, is emphasizing greater selectivity and focus across the board, rationalizing overlapping projects, and improving the efficiency of an organization that had become unwieldy and unfocused, even as it has grown rapidly in the past decade. A lot of that rationalization is taking place in Europe, where markets are relentlessly unforgiving and where Teva’s –and its competitors’ – first attempts at biosimilars launches are occurring.

Biosimilars work continues at Teva internally. In comments earlier this year, both Levin and Chief Scientific Officer Michael Hayden said they would pursue biosimilars as part of a broader biologics program. Teva currently has several generic versions of marketed biologics on the market, although it went through traditional regulatory routes to get approvals: TevaGrastim, a generic version of Amgen Inc.’s Neulasta (pegfilgrastim) has been available in Europe for several years, for example. “I would say that in the biosimilars space, we still remain enthusiastic, but we’re going to be smart about it,” said Hayden in an investor call late last year, noting. “We're going to be in biosimilars in a very focused way.”

And since Teva is mum on the subject, it’s worth noting an observation by Frederick Wilkinson, president of Teva competitor Actavis Inc.’s specialty brands unit, on the latter’s own earnings call the same day as the Lonza-Teva announcement. Actavis has a joint venture in biosimilars with Amgen and Wilkinson said it expects a news update from that endeavor in August.  “I wouldn't actually read too much into it,” Wilkinson said of the ‘no deal.’ “If you looked at the Teva biosimilar program, they at some point had bought enough different companies that they had multiple projects going on the same product. And so, I think what they've done is probably very efficiently pruned their product line down to the leading entities within their biosimilar portfolio. Lonza for the last year has been out selling or trying to solicit use of space, so it has been obvious that the Lonza Teva relationship was not going to be as deep as it originally was [planned to be].” 

If you're looking for deals that may be smaller scale, but have a fresh start, here are some of the newest developments in what was generally a quiet deal-making week:--Wendy Diller

Adimab/Biogen &Adimab/GSK: Adimab’s tech transfer deals with GlaxoSmithKline  and Biogen Idec represent the small biotech’s greatest business development and financial successes to date.

The deals, each announced July 26, see Adimab setting up its technology platform inside its partners’ R&D shops. By licensing non-exclusive rights and transferring this antibody discovery and protein engineering platform to GSK and Biogen, Adimab enables its partners to expand their use of a technology that the biotech has until now tightly controlled. Both Biogen and GSK had previously allied with Adimab (GSK through the acquisition of Adimab partner Human Genome Sciences Inc.), but like the biotech’s 19 other partners, they were limited to one- or two-target “trials.”

GSK’s agreement is for an indefinite number of years, with unlimited product licenses across all therapeutic areas. Biogen’s deal is more limited – a seven year (renewable) term, limited to certain disease areas where Biogen has a presence, and a limited number of commercial licenses. Both companies can use the technology to pursue any antibody format – including antibody-drug conjugates or bispecific antibodies – and have retained options to access any future improvements or additions to the Adimab platform.
The financial specifics of the two new Adimab deals were not disclosed. In each, Adimab will receive a “significant” upfront cash payment, annual license fees for the lengths of the deal, R&D milestone payments, and royalties and commercial milestones on a defined number of therapeutic products.

The upfront funding from the two deals make Adimab a decidedly profitable discovery engine for the foreseeable future, and the company will make its first dividend payment to its venture investors later this year. It expects to sign one more platform transfer deal this year, and three per year through 2015.--Chris Morrison.

Kolltan/Children’s Hospital Of Philadelphia: Cancer-focused biotech Kolltan Pharmaceuticals announced a license of intellectual property and research agreement with Children’s Hospital of Philadelphia July 18 around discovery efforts for neuroblastoma therapeutics targeting anaplastic lymphoma kinase (ALK). Terms of the deal were not disclosed. Based in New Haven, Conn., Kolltan’s focus is on large-molecule approaches to receptor tyrosine kinase (RTK) inhibition – it has six programs ongoing at the discovery and preclinical stage and plans to file an IND for its first clinical candidate before year’s end. The firm will collaborate with researcher Yael Mosse, who studies the causes and potential therapeutic approaches for treatment of children diagnosed with neuroblastoma. In a statement, Mosse said ALK-targeted immunotherapy or antibody-drug conjugates may offer the best approach for patients whose tumors have an ALK mutation or amplification. “We believe immunotherapy and ADCs may provide a therapeutic option for the majority of patients with high-risk disease given the widespread expression of ALK on the cell surface of most neuroblastoma tumors,” she said.--Joseph Haas

Lilly/Transition: Transition Therapeutics  has obtained a worldwide exclusive license for Eli Lilly’s small molecule transcriptional regulator TT-601 for the treatment of osteoarthritis pain, the biotech announced on July 23. The compound has completed preclinical development, and Transition plans to take it into the clinic during the first half of 2014. TT-601 modulates the activity of a novel nuclear receptor target. Tony Cruz, CEO of Transition, says that molecules in this class “have shown target engagement in the joint space and efficacy in multiple animal models of joint pain.” Twenty-seven million Americans have OA. Under the agreement, Transition gets the rights to develop and possibly commercialize TT-601. Lilly keeps an option to reacquire the agent on review of proof-of-concept data, in which case Transition would be eligible for milestone payments of approximately $130 million and a high single-digit royalty on the sale of potential products containing TT-601.

Should Lilly not take the option, and the product comes to market, Lilly would be eligible for a low single-digit royalty from Transition. There’s a good chance Lilly will pull the trigger on the option. This deal comes on the heels of Lilly’s June 17 decision to exercise its option to reacquire another compound licensed to Transition, TT-401 for diabetes. Transition took a $7 million option fee, and could get up to $240 million in milestones from that deal. That goes back to a March 2010 deal between the partners in which TT-401 was included among a few other preclinical candidates from Lilly. Their partnering history began in 2008 with a non-option deal in which Lilly licensed TT-223 and other gastrin-based therapeutics for both Type I and II diabetes from Transition.--Michael Goodman

PolyTherics And Antitope Merge: Britain’s privately owned PolyTherics  and Antitope have merged their biopharma services businesses to tap growing demand from Big Pharma for services and technologies used in the search for biologics such as antibody-drug conjugates.

The enlarged group has a strong client base in the biotechnology and pharmaceutical industry, including the top ten biggest drug makers. It will offer conjugation technologies to generate more stable and homogeneous antibody drug conjugates, technologies to optimize the pharmacokinetics of biologics, technologies for immunogenicity screening, technologies to re-engineer antibodies, and proteins to reduce their immunogenicity, and cell line development technologies.

Antitope, founded in 2004, tests immune responses caused by antibody therapies and engineers modifications for the drugs. That expertise should complement the conjugation and polymer technologies from PolyTherics, which was created in 2002 as a University College London spin-off.

PolyTherics financed the merger with £13.5 million ($20.1 million) raised from a group of backers that includes Imperial Innovations, Invesco Perpetual, Mercia Fund Management, Advantage Enterprise & Innovation Fund, ProVen Health, Oxford Technology VCTs and high net worth individual's funds managed by Longbow Capital.--Sten Stovall

Deals Of The Week Wonders What Merck's Latest Biosimilars Move Really Means

Ever since Merck jumped into the biosimilar field in 2008 with a ferocious go get ’em attitude more fitting of an NFL tackle than a big pharma, we’ve been following their progress – and then lack of progress – closely. Back when most pharmaceutical manufacturers were still griping about defending their biologic brands, Merck’s early aggressive ambitions made an interesting case study in how a big pharma might strike offensively by positioning itself as a contender in the biosimilar space.

So the company’s announcement Feb. 20 that it has partnered with Korea’s Samsung Bioepsis to develop multiple undisclosed biosimilar candidates, while delivered quietly in a concise statement, struck us as a noteworthy change in strategy.

You didn’t have to read tea leaves to see that Merck’s original strategy wasn’t working out. In 2008, Merck established a business unit devoted to the field and pledged to invest $1.5 billion and launch six or more biosimilars between 2012 and 2017. But last year, as we reported here, the company closed Merck BioVentures, the unit it created devoted to biosimilars, and folded the research into biologics and vaccines at Merck Research Labs. And Mike Kamarck, the charismatic proponent of biosimilars who led Merck’s charge into the field, left the company.

Now, we can’t help but wonder what the latest announcement means for Merck’s biosimilar strategy.
Is it a reaffirmation of the company’s commitment to biosimilars, albeit through a more modest path, or is Merck effectively washing its hands of biosimilars while still holding out for some hope of an eventual commercial reward? Samsung will be responsible for preclinical and clinical development, manufacturing, clinical trials and registration of any candidates, while Merck will commercialize the products. It’s not clear how much Merck is putting behind the effort either, as the financials of the deal were not disclosed; Merck is paying Samsung an upfront and has agreed to milestones.

Merck declined to offer further insight on the move, but said the deal with Samsung will complement its internal effort. The only biosimilar Merck has in its internal pipeline that has been publicly disclosed, however, is a copy of Roche/Biogen Idec’s Rituxan, the one drug Samsung Bioepsis won’t be developing because the company – formed in 2011 out of joint venture between Samsung Biologics and Biogen – won’t make any biosimilar versions of Biogen products.

Given Merck’s inability to get new drugs to market of late, the decision to take a contract research approach to biosimilars may be the best way for Merck to hold onto the potential commercial upside of biosimilars without the investment internal development requires. Merck ran into the field at high speed, and we admired their optimism, but given the evolving regulatory and commercial dynamics, a cautious path may be the wiser one.

And let’s not forget why the decision to jump into biosimilars was easier for Merck to make than for some other big pharmas: Merck never had a history in biologics and hasn’t traditionally had treasured blockbuster biologic brands to protect. It gained some knowledge of the field and rights to Remicade in certain territories outside the U.S. through its mega-merger with Schering-Plough. But it’s hard to envision Merck’s inexperience as a competitive advantage in a notoriously difficult field like biologics. Development and manufacturing is just as hard for biosimilars, even when manufacturers have a reference molecule to use as a road map.

Three years after the U.S. government laid a regulatory framework for biosimilars, no applications have yet been filed through the new pathway with FDA. Today, while Merck has adopted a more subtle tone when it comes to biosimilars, Amgen – a biologics expert – is crowing about its grand ambitions for the field.

Roche/Chiasma: Roche and privately held Chiasma Inc inked a deal Feb. 18 to develop and commercialize the Israel-based biotech’s proprietary pill Octreolin, initially for acromegaly and, afterwards, for neuroendocrine tumors (NET). Their pact brings a new Phase III drug to Roche’s pipeline, targeting both an oncology (NET) and non-oncology indication (acromegaly). It gives Roche worldwide exclusive license to Octreolin, and Chiasma receives upfront payments of $65 million and future milestone payouts of up to $530 million, along with tiered, double-digit royalties on Octreolin net sales. Roche said it decided to partner with Chiasma and commercialize Octreolin in part because of the convenience and improved quality of life an oral therapy might offer patients. The pill may consequently command a higher price to injectables and there appears to be little oral competition on the horizon near-term. Delivering octreotide orally twice daily would be a major advantage for patients with acromegaly as they would avoid the painful monthly injections involved in current treatment options such as Novartis' Sandostatin LAR. - Sten Stovall

Chiesi/Cornerstone: Cornerstone Therapeutics’ majority shareholder is looking to buy out the company. North Carolina-based Cornerstone announced Feb. 20 that it received a letter from its majority shareholder – Italy’s Chiesi Farmaceutici – offering to buy the remaining outstanding shares of the company. Chiesi offered $6.40 to $6.70 per share for the 40% of the company it doesn’t already own – valuing the specialty pharma at $177 million. In a letter from Chiesi to the board of directors of Cornerstone, Chiesi’s CEO Ugo Di Francesco said the company “has adequate liquidity available and excellent relationships with our banks to effect an all cash bid.” Di Francesco added that Chiesi has “conducted an extensive review of Cornerstone based on publicly available information, our own deep experience in the pharmaceutical industry and consultations with our outside advisors.” The Italian drug maker plans “to move promptly” in regard to the bid “and is committed to working vigorously and expeditiously with [Cornerstone] to complete a transaction.” Cornerstone said in a statement that “no decisions have been made by the board of directors with respect to Chiesi’s proposal.” The two companies paired up in May 2009 when Chiesi granted Cornerstone an exclusive U.S. license to sell its porcine-derived lung surfactant Curosurf (poractant alfa) for a 10-year period. In return, Chiesi took an equity stake in the company that now accounts for a 60% share. - Lisa LaMotta

Janssen/Pharmacyclics/Abbott: Partners Janssen Biotech and Pharmacyclics will work with Abbott to develop a molecular diagnostic test to identify patients with a genetic sub-type of chronic lymphocytic leukemia (CLL). Abbott will develop the test using its proprietary FISH (fluorescence in situ hybridization) technology; the test will identify hard-to-treat CLL patients who have a deletion within chromosome 17p (del17p). These patients are likely to respond to ibrutinib, a small molecule inhibitor of Bruton tyrosine kinase (BTK). At the American Society of Hematology conference in December, the partners presented positive Phase Ib/II data in a subset of relapsed/refractory CLL patients with the 17p deletion. The partners have an ongoing Phase II trial for ibrutinib in CLL patients with the 17p deletion. The company expects enrollment in this trial will take about 12 months to complete. On Feb. 12, FDA granted breakthrough designation to ibrutinib to treat two B-cell malignancies: relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom’s macroglobulinemia (WM). This could mean an approval for ibrutinib as soon as early next year. Pharmacyclics’ share price has been on a white-hot streak since last May, climbing more than 200%. News of the breakthrough designation bumped shares up about 20%. Details of the Abbott partnership remain undisclosed. - Stacy Lawrence

Eisai/Valeant: Valeant Pharmaceuticals announced Feb. 21 that it has acquired U.S. rights from Eisai Inc., the U.S. subsidiary of Japan's Eisai Co. Ltd., for cutaneous T-cell lymphoma treatment Targretin (bexarotene). Eisai received $65 million up front and is eligible for additional payments tied to undisclosed milestones. In March 2011, Eisai granted exclusive rights to Minophagen Pharmaceutical to develop and commercialize Targretin in Japan, expanding that agreement in April 2012 to cover Asia, Oceania, the Middle East, Eastern Europe and other regions. And in a deal similar to the Valeant agreement, in December 2012, Eisai sold U.S. commercial rights to Gliadel Wafer (carmustine) for glioblastoma to Arbor Pharmaceuticals. Gliadel and Targretin are aging products. However, the company’s cancer pipeline – oncology is 70% of Eisai’s revenues – has shown recent signs of stumbling. Farletuzumab, which entered Eisai’s pipeline with its 2007 acquisition of Morphotek, demonstrated disappointing results last January in platinum-sensitive ovarian cancer, not meeting the primary PFS endpoint in its first Phase III attempt. And Halaven (eribulin), approved in the U.S. in 2010 for metastatic breast cancer, missed its primary endpoints last year in a head-to-head Phase III superiority study against Xeloda (capecitabine). Much of the excitement around eribulin at the time of its approval was the likelihood of extending its label, which is now drawn into question. Eisai said the deal with Valeant would maximize the product’s value in the U.S. It went on to add that the agreement would enable Eisai to “strategically reallocate resources to other mid-to-long-term business growth areas” but it didn’t elaborate. As for Valeant, this deal continues its strategy of acquiring what it considers to be undermanaged commercial assets. - Mike Goodman

UCB/ConfometRx: Belgium’s mid-sized pharma company, UCB, is to link up with the Santa Clara, Calif.-based G-protein coupled receptor (GPCR) structural biology firm, ConfometRx, to discover new drugs in UCB’s sweet spot, the neurosciences. As often stated, GPCRs are the target for 25%-30% of marketed products, but GPCR research is hampered by the difficulty in extracting active receptors from cell membranes for use in research and drug screens. ConfometRx is developing crystallization techniques for GPCRs to make the screening process easier for GPCR-targeted drugs and antibodies. The two-year, multi-target research collaboration between UCB and ConfometRx is intended to gain insights into modulating GPCR targets in order to design differentiated drugs, the companies said Feb. 21. ConfometRx will receive an upfront payment, research funding and milestones, but further details of the agreement were not disclosed. UCB is building “super-networks” of innovation, which include tie-ups with Harvard University and the University of Oxford’s medical sciences division over the past three years. ConfometRx already is collaborating on various GPCR-related research projects with Bristol-Myers Squibb, Novo Nordisk and Lundbeck, while other companies active in providing research insights in the GPCR space include Heptares Therapeutics of the U.K., France’s Domain Therapeutics and San Diego-based Receptos. - John Davis

Photo credit: Wikimedia Commons

Deals Of The Week: 'Tis The Season To Be Jolly

'Tis the Season to be Jolly, so deals of the week has finalized its last offering of the year, confident that dire warnings of apocalypse coinciding with the ending of a Mayan calendar are hokum.

Business development executives are also ignoring such suspect perils, and are continuing to close on deals, collaborations and tie-ups, producing their own version of Christmas Cheer.

Europe is one region where holly bedecked halls will hopefully take the mind off austerity and its continuing toll on individuals' livelihoods and the funding of health care. At least no European country has succumbed to defaulting on their debts, yet.

So when office parties clog up your favourite eateries, and shopping in the malls and down the boulevards becomes too much of an assault course, return to your armchair to read who wound up under the mistletoe this week, in ...

Celgene/Sutro: Sutro Biopharma Inc. announced a collaboration Dec. 18 with Celgene Corp. to design and develop optimized antibody drug conjugates (ADCs) and bispecific antibodies (BSAs) for two undisclosed Celgene targets. The San-Francisco antibody specialist will also manufacture a naked antibody owned by Celgene using its high-yield, low-cost cell-free protein synthesis technology. The Celgene deal harnesses the Sutro platform’s strengths in combinatorial candidate design, post-lead optimization, and R&D scale up. Sutro CEO Bill Newell said the platform, using one basic cell-free extract, allowed them to make ADCs, BSAs, naked antibodies, and peptides. Sutro is responsible for the design and production of preclinical materials. Celgene will pay a "substantial" upfront consisting of cash and equity, as well as research, development, and regulatory milestones totaling over $500 million if all programs are successful. Sutro is also eligible for royalties on product sales. Although the deal conforms in some respects with Celgene’s earlier R&D collaborations – the equity investment has become a signature – the New Jersey biopharma will not take a seat on Sutro’s board. Coming on the heels of Celgene’s April collaboration with AnaptysBio Inc. and June tie-up with Inhibrx LLC, the deal represents a deepening of the biopharma’s involvement with next-generation antibody technologies. Beyond the cash and biobucks, Sutro and its investors get the validation of a high profile partner and the gratification of seeing a relentless and disciplined focus on its lab-to-commercial scale protein platform finally pay off – Michael Goodman

Biogen Idec/Duke University and Others: Adding to a commitment undertaken since George Scangos took over as CEO in 2010, Biogen Idec will provide more than $10 million in research funding to a consortium of academic research centers that will seek to identify new approaches to treating amyotrophic lateral sclerosis (ALS). The three-year initiative will encapsulate an earlier initiative with Duke University and the Hudson Alpha Institute to sequence the genomes of 1,000 living ALS patients. The efforts will involve researchers based at Harvard, Yale, Columbia and Rockefeller University, with Biogen Chief Scientific Officer Spyros Artavanis-Tsakonas spearheading the effort through his own lab at Harvard. Biogen’s hope is that by coordinating research and sharing results across a number of different disciplines, understanding of the mechanism of ALS can be accelerated and new targets and approaches to treatments discovered. The Cambridge, Mass., biotech also is involved in trying to develop a therapy for the disease, having licensed worldwide rights in 2010 to Knopp Neurosciences’ dexpramipexole, now in Phase III. – Joseph Haas

MorphoSys/Bio-Rad Laboratories: Germany’s MorphoSys has decided to trade its revenue-generating antibody reagent business for a “laser-like” focus on its therapeutic pipeline. The company announced Dec. 16 that Hercules, CA-based Bio-Rad Laboratories Inc. has agreed to pay €53 million ($69.7 million) to acquire its antibody reagent business, AbD Serotec. The price will include MorphoSys subsidiaries in Raleigh, North Carolina; Oxford, England; and Dusseldorf, Germany. The deal is expected to close in January 2013. The price also includes a non-exclusive license to MorphoSys's HuCAL (Human Combinatorial Antibody Library), a collection of several billion distinct fully human antibodies, for diagnostic applications. The German biotech's revenues have been largely dependent on AbD Serotec and incoming payments from antibody discovery partnerships based on HuCAL; during 2012, AbD Serotec generated 28%, or €13.7 million, of MorphoSys revenues. The deal will add AbD Serotec’s more than 15,000 antibodies, kits, and accessories to Bio-Rad’s portfolio of research and clinical diagnostic products. Bio-Rad will also receive milestone payments or royalties related to the AbD Serotec business, which was working with more than 20 diagnostic companies to develop antibodies for diagnostic use. MorphoSys will continue to rely on revenues from its HuCAL therapeutic partnerships. It has more than 60 of these with partners such as Pfizer Inc., Novartis AG, and Daiichi Sankyo Co. Ltd., which generated revenues of €32.1 million in the first nine months of 2012. – Lisa LaMotta

Amgen/ImmunoGen: With ImmunoGen’s T-DM1 (trastuzumab emtansine) on the verge of approval with collaborator Genentech/Roche, the company is continuing to attract partners for its targeted antibody payload (TAP) technology, which delivers a targeted cancer-killing agent to tumor cells. On Dec. 19, Amgen licensed the rights to use Immunogen's maytansinoid TAP technology to develop an anticancer therapeutic to a third target, having licensed rights to use the technology for two other targets in 2009. The original licensing option agreement was struck between the two companies in 2000. With each license Amgen chooses to option, ImmunoGen receives an upfront payment of $1 million and is entitled to $34 million in milestones, plus sales royalties. While ImmunoGen has brought in over $300 million in cash from partnerships over the last decade, the company has been trying to shift its focus to its own internal pipeline. It has three compounds in the clinic, with its lead compound, IMGN901, in Phase II in small cell lung cancer. - Lisa LaMotta

Intercell/Vivalis: A new European vaccine and antibody specialist, Valneva, will be formed by the proposed merger of two publicly quoted biotechs, Austria's Intercell AG and France's Vivalis, announced Dec. 17. Valneva will combine the product development and commercialization skills of Intercell with the vaccine cell line technology of Vivalis, and will become one of the few remaining independent European vaccine companies, after a string of takeovers and mergers in the sector over the past five years or so. Intercell develops and markets the Japanese encephalitis vaccine Ixiaro/Jespect, whose sales growth has not been as smooth as the company expected. In 2012, vaccine sales are likely to be 10% to 20% lower than expected, around €26.5 million to €28.5 million. Vivalis, whose EB66 embryonic duck cell line is used by numerous pharmaceutical companies to produce antibodies and vaccines, has also seen revenues decline in the first nine months of 2012 because of the ending of some manufacturing licenses. Through a stock merger, Vivalis shareholders will end up with 55% of Valneva. Intercell shareholders will also receive an earnout relating to the successful development of a Pseudomonas aeruginosa vaccine that the Austrian company's collaborator Novartis is currently evaluating in a Phase II/III clinical study. And a €40 million ($53 million) rights issue supported by France's strategic industry investor, Fonds Strategique d'Investissement (FSI), will follow the closing of the merger in May 2013. – John Davis

Janssen/Evotec: Janssen Pharmaceuticals Inc. has acquired an exclusive worldwide license to Evotec AG's NR2B subtype NMDA-antagonist portfolio of drug candidates, which have potential in the treatment of depression. Evotec will receive an upfront of $2 million from Janssen, with a further $6 million paid upon confirmation of certain preclinical properties of the candidates. The Hamburg, Germany-based company could also receive additional milestones totaling up to $67 million upon successful completion of certain clinical, regulatory and launch events for a first product. Additional, reduced milestones would be paid for the development of additional indications and/or compounds. Furthermore, Evotec could also receive an additional $100 million in commercial milestones depending on certain sales thresholds, and royalties that could be as high as double-digit on sales. However, a portion of the payments will be shared with Roche, which originally discovered the compounds. Evotec developed the compounds from discovery through to clinical studies, and Roche entered into an agreement in 2009 with Evotec on Phase II studies of portfolio compounds in treatment-resistant depression, although that collaboration ended in 2011 because of difficulties the study protocol caused in recruiting patients. - John Davis

MedImmune/Progenics: AstraZeneca's biologics arm is in-licensing Progenics Pharmaceuticals’ Clostridium difficile late-stage preclinical program as part of MedImmune’s search for monoclonal antibody candidates to prevent and treat bacterial infections. Under the deal, MedImmune will assess the potential efficacy and safety of antibodies targeting C. difficile toxins. Preliminary research suggests the antibodies are highly potent against most of C. difficile strains found in the U.S. and Asia, and are potent against hypervirulent strains. For Progenics, the move reflects its decision in 2011 to focus on its oncology programs. The biotech’s pipeline candidates include PSMA ADC, a human monoclonal antibody-drug conjugate in Phase II for prostate cancer, and preclinical stage novel phosphoinositide 3-kinase (PI3K) inhibitors for cancer. Clostridium difficile infections are the leading cause of hospital-acquired bacterial infections in the U.S. and are associated with more than 20,000 deaths and more than $1 billion in healthcare costs annually. The infection most often occurs in people who have been hospitalized, although up to 28% of cases are community-acquired through contaminated soil, water, pets, cattle, and food. – Sten Stovall

Merck/GE Healthcare: Merck & Co. Inc. is pitted in a tight race with Eli Lilly and Co. to bring the first BACE inhibitor to market for Alzheimer’s disease. The company announced Dec. 18 it has partnered GE Healthcare to use that company's imaging agent flutemetamol as a potential companion diagnostic to its BACE inhibitor, MK-8931. The announcement comes on the heels of Merck’s Dec. 3 announcement that it had started a Phase II/III study of the drug. Under the GE deal, Merck will use flutemetamol – a positron emission tomography (PET) imaging agent – to select patients for clinical trials of MK-8931, particularly a future trial in prodromal Alzheimer’s disease patients. That’s the phase in which patients have only mild cognitive impairments and have not yet been diagnosed with Alzheimer’s disease. Flutemetamol is being developed by GE to detect beta amyloid deposits in the brain, the buildup of which is believed to be a hallmark of Alzheimer’s disease. In Phase III testing, flutemetamol images showed a strong concordance with Alzheimer’s disease-associated beta amyloid brain pathology demonstrated in brain autopsy and in vivo-cortical biopsies, according to GE. Lilly already markets the PET tracer Amyvid (florbetapir), which shows the amount of beta-amyloid plaque in the brain, for use in diagnosing Alzheimer’s disease, following U.S. FDA approval in April this year. Merck said it opted to partner with GE on flutemetamol because the company had a long history in imaging, and access to infrastructure including PET scanners and cyclotrons that produce the radioactive isotopes used in the procedure. GE continues to own rights to the agent, is studying it independently, and plans to file the product with regulators in the near term - Jessica Merrill

Pfizer/Halozyme: The world’s biggest pharma is paying San Diego biotech Halozyme $8 million upfront for a worldwide license to Halozyme’s Enhanze technology to produce a pair of proprietary biologic drugs that can be administered subcutaneously. It is an earn-out-heavy deal, with Halozyme able to receive future licensing fees for up to four more targets, as well development, regulatory and sales-based milestones that could reach $507 million and royalties on net sales of any products reaching market. The targets and indications for the first two drugs to employ Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20) technology were not disclosed, although a release said one product would be for primary care and the other for a specialty care indication. Future target selections by Pfizer can be made on an exclusive or non-exclusive basis. By addressing volume limitations, the Enhanze platform enables biologics which otherwise might need to be administered intravenously to instead be subcutaneous injections. Halozyme says the delivery technology also could reduce the need for multiple injections, improve patient convenience and reduce health care system costs. The deal is positive news in a year that saw the company's fortunes dragged down by a delay and subsequent FDA complete response letter around Baxter's HyQ immunoglobulin product, which uses the Halozyme technology. – Joseph Haas

Merck/Hanwha Chemical: Is Merck stepping back from biosimilars? That’s a question some industry stakeholders are asking after Korea’s Hanwha Chemical disclosed Dec. 18 that Merck had terminated a deal for Hanwha’s biosimilar of Amgen/Pfizer’s blockbuster Enbrel (etanercept). Merck had acquired developmental and commercial rights to Hanwha’s late-stage biosimilar in 2011 (in all markets except Korea and Turkey), surprising many in the West who had not thought of the Korean conglomerate as a biopharma player. Hanwha received an undisclosed upfront payment and was eligible for technology transfer and regulatory milestones, and tiered royalties on sales. Total upside for the deal was $720 million, Hanwha said at the time. Since then Hanwha has moved forward in its home market, submitting its Enbrel biosimilar for KFDA approval several months ago after completion of local Phase I and Phase III trials. So what happened? A “routine pipeline review,” Merck told our sister publication PharmAsia News, emphasizing that its decision did not reflect a change in biosimilars strategy or commitment. Yet some may wonder. As reported first in the IN VIVO Blog, Merck cut bait on Merck Bioventures earlier this year, deciding to merge the biosimilars unit back into its biologics and vaccines division. And perhaps more to the point, Amgen threw a wrench in development plans for Enbrel biosimilars late last year when it announced a stealth patent that could keep competitors off the U.S. market until 2028. So what’s next? Merck says it will continue to pursue a portfolio of biosimilars and novel biologics that meet unmet needs, including a previously disclosed biosimilar of Roche’s rituximab. But the emphasis, at least to our ears, seems to be leaning more to the novel these days then the similar. As for Hanwha, it says it will look for other multinational partners, not only for etanercept, but also for the next biosimilar in its pipeline, Roche’s Herceptin (trastuzumab). In other words, you better stay tuned. -- Josh Berlin

mistletoe by lovelorn poets, via flickr/creative commons

Deals Of The Week: Pfizer Goes For An IPO

The big news this week was the deal that didn’t happen: the sale of Pfizer’s animal health division. Pfizer announced June 7 that it will split off the business into a new standalone company to be called Zoetis instead and that it is preparing to file an initial public offering of a minority ownership stake in the new company.

Investors had been anticipating either a sale of the business or a split-off since CEO Ian Read announced plans to shed the business last year along with its nutrition business, so the news isn’t exactly a surprise.

Still, Pfizer inked a deal for its nutritionals business with Nestle S.A. in April, offloading the business for $11.85 billion, a price that reflects a pretty premium over the $9 billion to $10 billion some analysts had predicted.

Pfizer’s decision to spin-out the business means rival big pharmas like Merck and Eli Lilly won’t be expanding with Pfizer’s assets. The chiefs at both companies have said they remain committed to animal health and the diversified business model. Of the three, Pfizer’s business is the largest with $4.2 billion in sales in 2011. Merck’s animal health business brought in $3.25 billion in sales and Lilly’s $1.67 billion.

A split-off offers tax advantages of a sale, which Read called out in a press release. “Our focus continues to be on taking the actions that will generate the greatest after-tax value for our shareholders,” he said. Analysts had valued a potential sale of the business at around $15 billion.

With the decision to spin-out the business, Pfizer is following a similar route to the one Bristol-Myers Squibb took when it spun-out its Mead Johnson nutritionals business in 2009. That move has been well-received on Wall Street. The initial offering was $24 per share and the stock closed June 7 at $81.12, representing around 70% growth.

Pfizer hasn’t priced the IPO, so it remains to be seen how much it will cost to buy into Zoetis, but Read has vowed to make the company independent by July 2013 so there is plenty of time to analyze the numbers and start wagering.

Elsewhere in the news, GlaxoSmithKline announced June 8 that it has extended its offer to buy Human Genome Sciences from the prior deadline of June 7 to June 29. Otherwise, it was a slowgoing week on the business development front ...

Merck KGaA/ Dr. Reddy's Laboratories – India's global generics firm Dr. Reddy's Laboratories, announced June 6 it was linking up with Merck Serono, the pharmaceutical division of Germany's Merck KGaA, to develop and commercialize biosimilar cancer products, principally monoclonal antibodies. The collaboration will exploit Merck Serono's expertise in biologics manufacturing, development and marketing, which includes the MS therapy Rebif (interferon beta-1a) and the anticancer Erbitux (cetuximab), and Dr. Reddy's pioneering role in biosimilars (it already markets four such products in India). No money is changing hands and the collaborators will share risks and rewards, with Dr. Reddy's conducting early development through Phase I, and Merck Serono taking over further clinical development and manufacturing. Merck Serono will commercialize the biosimilars globally, with Dr Reddy's receiving royalties, except for the U.S., where the companies will co-commercialize on a profit-sharing basis, and certain unspecified emerging markets, where marketing will be co-exclusive, or where Dr Reddy's will have exclusive rights. Biosimilars is a new sphere of activity for Merck KGaA, and one it can enter at a relatively low cost. That's important for the company, as it has just started an efficiency program which calls for R&D facility closures and job losses in order to make around €300 million in costs savings by 2014. For Dr Reddy's, it provides a source of research funding while keeping its options open outside of the oncology sector. – John Davis

Onyx/ Anderson Cancer Center – In just the latest of its research ties to biopharmaceutical companies, the MD Anderson Cancer Center at the University of Texas announced June 4 that it will collaborate with Onyx Pharmaceuticals in an effort to delineate the potential of that company’s anti-cancer candidates carfilzomib and oprozomib in multiple myeloma and lymphoma. Financial terms of the two-year research agreement were not disclosed. Carfilzomib, to be marketed under the brand name Kyprolis, is under review at FDA for relapsed and refractory multiple myeloma. Oprozomib, like carfilzomib, is an oral proteasome inhibitor, is Phase Ib/ II study in hematological malignancies. Onyx and MD Anderson personnel will oversee the collaboration together in a joint steering committee, with MD Anderson conducting all studies related to the agreement. The focus will be on the potential of proteasome inhibitors in tandem with other novel, early-stage cancer candidates, as well as to increase the biological understanding and enhance the clinical profile of the two Onyx compounds. MD Anderson’s most recent deal with private industry was the licensing of an experimental folate-binding protein (FBP) E39 vaccine for the prevention of recurrence of gynecological cancer to Galena Biopharma. – Joseph Haas

Picture credit: Wikimedia Commons

Merck Says Goodbye to Independent Biosimilars Unit

Merck BioVentures, the biosimilars endeavor set up by Merck & Co. in late 2008, is being subsumed into the biologics and vaccines division of Merck Research Laboratories. Mike Kamarck, who has led BioVentures since 2010, has left the company.

Merck tells In Vivo blog it has "established internal capabilities and external collaborations that create a strong foundation for future progress in the evolving biosimilars sector. As our pipeline of biosimilars and novel biologics continues to progress, we decided to combine development and align under one leader to facilitate decision making and prioritization of resources across the portfolio." That leader is Rich Murray, who is Merck's SVP biologics and vaccines research.

Kamarck's departure is either a blow for the company's biosimilar ambitions or a reflection of reduced expectations and investment for the business. Kamarck has been for the past few years probably the most visible Big Pharma executive on the biosimilars front, and Merck has been -- at least among large, brand-focused pharma companies -- the most bullish on biosimilars' regulatory and commercial prospects.

There have been several bumps in the road. The company's first big biosimilar hopeful was a version of Amgen's Aranesp. That project was discontinued in early 2010. The company also had big plans for its biosimilar version of Enbrel, which it licensed in Phase III from Korea's Hanwha in June 2011. Only a few months later Amgen laid waste to those plans, announcing a 'stealth patent' that could keep Enbrel biosimilars off the market for another 15 years.

Biosimilars may indeed be a new kind of innovation, one that brand-focused biologics companies would be foolish to discount and one they seem to be tripping over themselves to embrace (see Amgen/Watson, Baxter/Momenta, Biogen/Samsung).

Merck's move to reduce its BioVentures group at least in stature seems a step in the other direction and at odds with the bullish attitude of the newly converted and groups like Novartis' Sandoz unit, which just this week predicted incredible growth for its own biosimilars business. That said, it’s hard to say whether this retrenchment will be part of the long-term learning process or bigger strategic shift, as the whole field is in the midst of an evolution and successful business models have yet to fully materialize.

Twas DOTW Before Christmas ...

Twas DOTW before Christmas, when all through the house
Not a creature was stirring, not even a mouse.
The term sheets were hung by the chimney with care,
In hopes that St Gilead soon would be there.

The VCs were nestled all snug in their beds,
While visions of 20x danced in their heads.
Though mamma's kerchief biz had a low market cap,
As reverse-merger shell we'd name it after a cat.

When out on the lawn--

With apologies to Clement Clarke Moore, we'll stop there. It's a long damn poem and we've got a surprising amount of deals to get to this week -- nearly enough that we almost switched to a Twelve-Days-of-Christmas theme. It was not to be, but in any case, joyous readers who haven't yet shut down your laptops for some inexplicable reason, do feel free to finish or improve upon our parody for us in the comments. And to all a good ...

AstraZeneca/Hutchison MediPharma & AstraZeneca/Astellas: Avid followers of AstraZeneca's R&D pipeline have had a rollercoaster ride this week, with the U.K. pharmaceutical company announcing early-stage deals with Hutchison MediPharma and the Astellas subsidiary Prosidion, just a day after revealing it had suffered setbacks with two late-stage compounds, olaparib and TC-5214. The approach of the company’s patent cliff and the seemingly constant misfiring of AstraZeneca's R&D engine has sparked suggestions that larger-scale M&A might be a better option for AZ than the slow slog of building a research pipeline. AZ is paying Shanghai-based Hutchison MediPharma $20 million upfront for global licensing, co-development and commercialization rights to volitinib, an IND-stage c-Met receptor tyrosine kinase inhibitor. Hutchison MediPharma will continue to lead the compound's development in China; AZ is leading and funding development elsewhere. Hutchison could receive up to $120 million in clinical development and ‘first sale’ milestones. Additional commercial milestones and up to double-digit percentage royalties on net sales sweeten the pot. AstraZeneca has made significant investments of its own in China, including an R&D facility and its recently opened global clinical operations hub. It is the second largest-selling pharmaceutical company in the country, with a turnover of more than $1 billion in 2010. Hutchison MediPharma already has discovery deals in place with a raft of other multinationals, including Johnson & Johnson, Eli Lilly, and Merck KGaA, but this is the first time it has out-licensed one of its own research programs. Hutchison MediPharma is majority owned by UK-AIM listed Chi-Med, a healthcare group primarily based in China.

AstraZeneca's second in-licensing deal this week adds to the company's already significant efforts in the diabetes area. It picked up an option to acquire two of Prosidion's early-stage diabetes assets, PSN821 and PSN842. Both are potentially first-in-class GPR119 receptor agonists – the GPR119 receptor regulates incretin and insulin secretion, and in preclinical studies the compounds have lowered blood glucose, reduced food intake and reduced body weight. Financial terms were not revealed, other than to say AstraZeneca has paid a non-refundable fee, and will make upfront and milestone payments if it decides to exercise the option after Phase IIa. -- John Davis

Amgen/Watson: Amgen has finally tipped its hand regarding its biosimilar strategy after playing both sides of the issue for years. The Big Biotech and Watson Pharmaceuticals announced on December 19th an alliance to build an oncology biosimilars business focused on monoclonal antibodies. Amgen will make pre-commercial investments, taking the lead in R&D, manufacturing, and initial commercialization; while Watson will contribute $400 million to the venture along with its expertise in commercialization and life cycle management in highly competitive markets. The partners come late to the biosimilars party but still in time for the second wave of more complex biologics, most notably MAbs, projected to lose exclusivity post-2016. Watson, with its lower cost structure and competitive culture will take over commercialization if and when a certain level of maturity and competition sets in. How that level will be defined will be flexible, based on geographic and product characteristics. Neither company would disclose specifics as to how commercial responsibilities will evolve over time. Amgen’s proprietary oncology drugs are excluded from the deal, although both parties agreed that that provision could be revisited later. Should Amgen reverse that decision, Watson will have right of first refusal to negotiate a deal on those drugs. Importantly, Watson is free to develop biosimilar versions of Amgen’s drugs independent of the deal, either on its own or with partners. The deal allows both parties to pursue the biosimilar market together and independent of the alliance, an arrangement that could pit them against each other in the future. Amgen enters the biosimilars field in the context of a weak late-stage pipeline, competitive pressures, a mixed record on recent launches, and the recent departure of its CEO and head of R&D. -- Mike Goodman

Takeda/Intellikine: In one of two deals this week around inhibitors of phosphoinositide-3 kinase (PI3K), Takeda added to its US biotech holdings by purchasing Intellikine for $190 million upfront. In the deal announced Dec. 21, the Japanese pharma’s Millennium unit will take over global development responsibility for Intellikine’s two anti-cancer clinical programs. Intellikine, founded in 2007 and backed with $41 million in venture capital funding, also could earn up to $120 million in milestone payouts tied to potential clinical development events. With the acquisition, Millennium/Takeda also go into business with Infinity Pharmaceuticals, which paid $13.5 million upfront last year for a license to INK1197, a dual PI3K delta/gamma-selective inhibitor for inflammatory conditions. Now called IPI145, that compound moved into a pair of Phase I trials this past October. Driving the buyout were INK128, an mTOR C1/2 inhibitor slated to enter Phase II next year, and INK1117, a selective inhibitor of PI3K alpha, which entered clinical testing in September. -- Joseph A. Haas

Merck/Exelixis: In the other PI3K inhibitor deal this week, Merck on Dec. 21 paid $12 million upfront for an exclusive worldwide license to Exelixis’ PI3K-delta R&D program, including lead compound, XL499. Phase I-ready, the compound has shown potential application in preclinical study in rheumatoid arthritis, allergic asthma and hematologic malignancies, Exelixis says. Under the deal, Exelixis, whose internal focus is on the development of Phase III dual MET/VEGF inhibitor cabozantinib in multiple cancer indications, could earn regulatory and development milestones of up to $239 million from Merck, along with sales-performance milestones and royalties on net sales should any of its PI3K molecules reach the market. -- J.A.H. UPDATE: Exelixis announced via 8-k on Friday that it had parted ways with partner Sanofi -- the two companies had been working in the PI3k space since 2009.

ImmunoGen/Lilly: Despite a licensing deal with Eli Lilly & Co. announced on Dec. 20, ImmunoGen CEO Dan Junius says that the company’s first priority is still its wholly-owned pipeline (which currently has one compound in the clinic and another in IND), a stance the company announced in early 2011. Yet, in an interview Junius acknowledges that partnerships – like the one with Lilly – help the company “leverage its resources and affords ImmunoGen a scale that would not be possible otherwise." ImmunoGen will receive a $20 million upfront in exchange for the rights to an undisclosed number of licenses to ImmunoGen’s TAP (Targeted Antibody Payload) technology. The TAP technology will be used with Lilly’s monoclonal antibodies to develop antibody-drug conjugates (ADC) for the treatment of cancer. ImmunoGen will potentially receive $200 million in milestones for each target that is developed under the collaboration, as well as royalty payments. Any compounds that result for the collaboration will be added to Lilly's cancer portfolio, which includes Alimta (pemetrexed) and Gemzar (gemcitabine), which has seen declining sales since going generic. ADC technology, which allows a monoclonal antibody to carry a therapeutic payload that can target a specific tumor type, has become a hot area in the oncology space. Look for a new feature on the next generation of ADC drugs and drug developers in the next START-UP. -- Lisa LaMotta

Agenus/NewVac: Massachusetts-based Agenus announced Dec. 19 that it has signed a development and commercialization agreement with Russia’s NewVac, a subsidiary of ChemRar High Tech Center, whereby NewVac will commercialize Agenus' Oncophage in Russia and other CIS countries. Oncophage (HSPPC-96; vitespen) is a non-cell based protein pharmaceutical that uses a patient’s own tumor cells to activate an immune response through recognition of their cancer’s unique antigens. The vaccine is currently approved in Russia for the treatment of renal cell carcinoma in the adjuvant setting; a population of about 5,000 to 6,000 people. Agenus currently manufactures the vaccine in Lexington, Mass. NewVac will build a manufacturing facility in Russia where it will begin to make the product itself, and Agensus will get an unspecified royalty on sales. NewVac also will begin studying Oncophage in other indications – specifically melanoma, ovarian cancer and lung cancer. It will be responsible for all costs of development, but Agenus will again receive royalties. Agenus (nee Antigenics) has been having a tough time over the last few years as its stock price dipped below $1 after the failure of Oncophage to meet certain endpoints in renal cancer in a pivotal trial and the rejection of the drug by European authorities. Despite the trial failure, the company had enough clinical evidence to pursue approval in Russia. -- L.L.

Metamark/Janssen: Privately held Metamark Genetics has inked a deal with Johnson & Johnson subsidiary Janssen Biotech for its cancer diagnostic platform. The Massachusetts-based company will get an undisclosed upfront, as well as $365 million in potential milestone payments and royalties on products associated with the companion dx -- no small feat for a diagnostics play. Metamark's Prognosis Determinants platform is meant to identify specific cancer targets that may play a casual in promoting tumor progression. -- L.L.

BMS/Gladstone: Bristol-Myers Squibb and the Gladstone Institutes in San Francisco are teaming up for three years to investigate novel targets in Alzheimer's disease, the groups said Thursday, December 22. The partnership will focus on tau-mediated dysfunction. Tau is one protein in the brain implicated in Alzheimer's; normally it provides internal structure to healthy neurons, but as neurons die, the tau aggregates into clumps, or "tangles," in the brains of Alzheimer's patients, although it's unclear if the tangles are a cause or an effect of the pathology of the disease. Other companies such as TauRx and Allon Therapeutics have investigated tau-related interventions, but most clinical development in Alzheimer's has focused on amyloid beta (a-beta), the protein that aggregates into tell-tale plaques in the brains of victims. BMS and Gladstone did not disclose terms of their three-year discovery-stage collaboration. They have a common bond: Gladstone president R. Sanders "Sandy" Williams is on the BMS board of directors. The next year should be a big one in Alzheimer's research, with data due from high-profile Phase III trials of bapineuzumab, an anti-a-beta treatment developed by Elan and now mainly in the hands of Johnson & Johnson and Pfizer. Bristol's most advanced Alzheimer's treatment is in Phase II trials. -- Alex Lash

Viropharma/Meritage: Viropharma has paid $7.5 million up-front, and could pay $12.5 million more in development milestones, for the right to acquire Meritage Pharma at pre-set terms. We love a good option-to-buy around here. As we've seen before, they don't always work out, but as in the case of the recently abandoned Actelion/Trophos option, they can provide a good way to both finance development of a rare- or orphan-disease drug candidate as well as set up investors with a tidy if not home-run return. To wit, Meritage is pursuing development of oral budesonide against eosinophilic esophagitis, a chronic inflammatory condition for which no drug is approved. Phase IIb data from a pediatric study were presented in May 2011 at the DDW conference. The company, which emerged from the rubble of the once-promising pediatric specialty play Verus Pharmaceuticals, is narrowly focused around oral budesonide and backed by $30.5 million from Domain Associates, Laterell Venture Partners and the Vertical Group. Like Verus (and a large handful of other biotechs) it's the brain-child of founder, chairman and prolific entrepreneur Cam Garner. Following the completion of additional Phase II work, and once FDA has agreed on a Phase III plan for oral budesonide, Viropharma can opt to pay $69.9 million plus earn-outs to acquire the program. --CM

Baxter/Momenta: Baxter and Momenta said on Dec. 22 that they would team up to develop and commercialize follow-on biologics (that's biosimilars to some of you). Momenta gets $33 million up-front and up to $470 million $391 million in potential future milestones, $28 million in potential option fees, plus royalties. The deal adds Baxter to current Momenta partner Sandoz, which sells Momenta's generic Lovenox and hopes to one day sell its generic Copaxone as well, and comes on the heels of a flurry of activity in the biosimilars space. Besides Amgen/Watson, above, two weeks ago Biogen got together with Samsung Biologics in a biosimilars JV. Now that everyone's into the pool, expect to see a lot of splashing around. As a November feature in IN VIVO describes, for several recent entrants, the biosimilars game isn't just about creating copies; it's about promoting and branding a new kind of hybrid proposition where the innovation isn't in the molecule, but in how you make it, position it, and support it. In this sense biosimilars reflect the broader payor-driven push away from scientific novelty toward a focus on value. --CM & MS