Deals of the Week Wants Cash on the Barrelhead

 

For pharmas making all but the largest acquisitions, cash is king. From speculative buyouts of preclinical start-ups all the way through bolt-on deals worth a few billion dollars, pharmas typically spend cash rather than swap stock to make their acquisitions. Except in the cases of mega-mergers, a pharma’s purchasing power lies on its balance sheet, not in its share price.

So when Moody’s Investor Service issued a March 18 study of the U.S. companies whose cash coffers were the richest, Deals of the Week couldn’t help but turn an eye to the seven health care companies named in the report. None of them has disclosed a pharma acquisition yet in 2013, but rumors are swirling that one will strike soon.

Pfizer was the wealthiest in the bunch, with $46.9 billion in the till at the end of 2012. That’s enough to place it fourth across all industries, behind only Apple, Microsoft and Google. And although Pfizer had the world’s best-selling drug for several years running until Lipitor (atorvastatin) lost patent protection in 2011, not all of its bounty came from product sales. It did, after all, pare off its nutrition business in an $11.85 billion sale to Nestle SA last year, not to mention its Capsugel unit to private equity firm Kohlberg Kravis Roberts in 2011. Pfizer hasn’t done a pharma acquisition since its (all-cash) takeout of NextWave Pharmaceuticals Inc. in November.

Ninth-place Amgen made four large cash buys in 2012, including deals for Micromet Inc., deCODE genetics EHF, KAI Pharmaceuticals Inc., and Mustafa Nevzat Pharmaceuticals that totaled more than $2.5 billion. But those made a small dent on Amgen’s balance sheet; Moody’s said the big biotech had $24.1 billion at year’s end. The report also noted that 78% of Amgen’s liquidity is located overseas; two of its four large 2012 deals were for non-U.S. companies.

Beyond Amgen, Johnson & Johnson wasn’t far behind at 13th place with $21.1 billion, while Merck was 15th with $16.1 billion. (J&J-owned Cordis made one device acquisition this month, buying Flexible Stenting Solutions Inc. for an undisclosed sum.)

Moody’s reported that Abbott had $15.2 billion in cash on Dec. 31, enough for 17th on the overall list, but a day later, the company split in two. Its pharma descendant, AbbVie, had $7.98 billion upon launch, according to a March 15 regulatory filing. Rounding out the top pharmas were Lilly at 23rd with $12 billion and Bristol-Myers Squibb at 40th with $6.4 billion.

More broadly, the pharma industry holds about 14% of the $1.45 trillion corporate cash pile, a share which has remained roughly the same for several years. It’s the second largest sector behind technology, which gained share to 38%, while energy is among the industries losing share.

If Big Pharma isn't yet striking, some companies are still buying, licensing, and partnering. You won't get thirty days in the jailhouse, but you won't be abreast of this week's dealmaking news without...

Valeant/Obagi: Canada’s Valeant Pharmaceuticals is again strengthening its dermatology business through acquisition, this time by buying Obagi Medical Products, the maker of several proprietary aesthetic and prescription skin-care lines sold through physician offices. The companies announced Valeant’s plans to acquire the Long Beach, Calif., company March 20 for $19.75 per share in cash, or about $360 million. Valeant’s offer represents a 42% premium to Obagi’s closing share price March 14, the last trading day prior to the disclosure of its fourth quarter and full-year 2012 earnings. The company generated sales of $120.7 million in 2012. Obagi’s portfolio includes a range of skin-care lines, including Obagi Nu-Derm, Obagi-C Rx, Obagi Condition & Enhance and ObagiCLENZIderm M.D. acne therapeutic system. Valeant has built itself into one of the world’s leading dermatology players through acquisitions. Last year, Valeant announced plans to buy Medicis Pharmaceutical for $2.6 billion, positioning it as the largest dermatology player in the U.S. and second in the world behind only Galderma. - Jessica Merrill

AstraZeneca/Moderna: Along with its new R&D strategy and organizational restructuring, AstraZeneca unveiled a massive bet on an early-stage biotech platform March 21 that suggests the big pharma has taken to heart its new CEO’s directive to be more willing to embrace risk. The deal, an option agreement for up to 40 programs across several therapeutic areas with privately held Moderna Therapeutics, carries an eye-catching price tag: $240 million up front, plus potential earn-outs. All told, Moderna, which aims to use messenger RNA (mRNA) as therapeutics, could earn more than $1 billion under the deal with AstraZeneca, announced March 21. That same day, AstraZeneca also unveiled a research partnership in cardiovascular, metabolic and regenerative disease with Sweden’s Karolinska Institute, one of several collaborations between those two groups in recent years. Beyond the $240 million upfront payment – the largest this year in a biotech/pharma collaboration and one of the biggest ever for a deal built around preclinical assets – Moderna also can earn up to $180 million in “technical milestones,” an arrangement Moderna CEO Stephane Bancel described as almost a secondary, contingent upfront payment. Moderna also could bring home development, regulatory and commercial milestones for each drug candidate licensed by AstraZeneca, as well as sales royalties ranging from the high single digits to low double digits. - Joseph Haas

Merck/Cerecor: Well-funded Baltimore start-up Cerecor has licensed a portfolio of neurology drugs from Merck that have shown potential in treating Parkinson’s disease. The program includes more than 2,000 molecules that inhibit catechol-O-methyltransferase, or COMT, a compound that breaks down dopamine in the brain and is linked to improving brain functions such as cognition, motivation and emotion. In a March 20 statement announcing the deal, Cerecor said Merck’s research has improved toxicity issues related to other COMT inhibitors. Marketed drugs in the class include Novartis’s Comtan (entacapone) and Valeant’s Tasmar (tolcapone), which typically are prescribed with levodopa, a synthetic form of the natural dopamine-producing chemical L-dopa. Terms of the Merck-Cerecor arrangement weren’t released, although Cerecor said it will pay milestones and royalties “consistent with other preclinical licenses in neuroscience.” The start-up has a Phase I anti-tussive drug, as well as a group of preclinical D-amino acid oxidase inhibitors obtained from Johns Hopkins University’s Brain Science Institute, in its pipeline. Last April, Cerecor raised $22 million in a Series A round using placement agent Maxim Group; the specific investors weren’t named. Former Celgene CEO Sol Barer is Cerecor’s chairman. - Paul Bonanos

Celgene/bluebird bio: Speaking of Celgene, the Summit, N.J., gene- and protein-regulation specialist has teamed up with 2012 Deals of the Year nominee bluebird bio in a gene-therapy deal (pdf) that will target oncology. Specifically, the two companies will collaborate to develop therapies that modify a patient’s own chimeric antigen receptor T-cells, then re-introduce them to target cancer cells. Although bluebird bio will foot the bill for Phase I trials on clinical products, Celgene will have the option to obtain a global license for each for an unspecified fee; bluebird bio retains the right to share U.S. rights in exchange for reduced milestone payments. Celgene’s upfront payment wasn’t revealed, but total fees including milestones for each product could total $225 million plus royalties. Celgene also agreed to collaborate on CAR T-cell research with scientists at the Center for Cell and Gene Therapy at Baylor College of Medicine, Texas Children’s Hospital and The Methodist Hospital, Houston. The team at bluebird bio also will have access to the scientists, led by Baylor professor Malcolm Brenner. - P.B.

NPS/Takeda: Two assets came full-circle March 19 as NPS Pharmaceuticals re-acquired ex-U.S. rights to a pair of rare disease drugs in a deal that will increase the equity position of Japanese pharma Takeda Pharmaceutical. NPS previously out-licensed the rights to teduglutide and PTH 1-84 in separate deals with Nycomed Pharma, which then was acquired by Takeda. In an unusual deal structure, NPS, which is marketing teduglutide in the U.S. as Gattex and hopes to file PTH 1-84 under the brand name Natpara later this year as a biologic therapy for hypoparathyroidism, brought the ex-U.S. rights to those two compounds in-house in exchange for $50 million in common stock. Down the road, Takeda can earn an additional $30 million, which will be either cash or additional equity at NPS’ discretion, when the two drugs achieve combined worldwide, single-year net sales of $750 million. Takeda holds an equity position of about 7% following this deal, NPS President and CEO Francois Nader said. Both the licensing fee and the sales-based milestone were structured as equity (although the milestone can be paid out as cash if NPS opts) partly to preserve cash, Nader said. An ex-U.S. license to both drugs is just the start of what NPS gains under the deal. The transaction also transfers an inventory of active pharmaceutical ingredients for both drugs to NPS, a less-expensive method for making teduglutide, a glucagon-like peptide 2 (GLP-2) analog, and a pen delivery system that could be used with PTH 1-84. - J.A.H.

CRT/Janssen: Cancer Research Technology, the technology transfer arm of world’s largest charity Cancer Research UK, and Janssen Biotech have joined in the search to find potential new multiple myeloma drugs. The duo hope they can identify molecules and develop potential medicines that block a key protein on a cell-signaling route called the unfolded protein response (UPR) pathway. Teams at The Institute of Cancer Research (ICR), led by Ian Collins in the Cancer Research UK Cancer Therapeutics Unit and Faith Davies in the Division of Molecular Pathology, will work alongside a team at Janssen. Together, Cancer Research UK and Janssen will fund up to 25 scientists, with Janssen providing some of the funding to support the research at the ICR in London. Janssen also will pay future milestones and royalties and take the lead on the clinical development of any potential drugs. The two sides announced their deal on March 21 but gave no financial details. CRT long ago moved beyond simply commercializing and managing the intellectual property generated by the £500 million in research funding provided by Cancer Research UK to five core research institutes across the U.K., as well as to researchers at dozens of other universities and organizations. The breadth of CRT’s academic network – it has sourced and managed IP from more than a dozen global charities and institutes, as well as that of Cancer Research UK-funded research and drug discovery – positions it as an important gateway to cancer-focused research in the U.K. It has a strong in-house drug-discovery capability and access to clinical development capabilities in conjunction with Cancer Research UK’s drug development office. Janssen Biotech is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. J&J earlier this month opened an innovation center in London but a spokesperson for the U.S. drug company said Janssen’s alliance with CRT was not the result of that center’s establishment. - Sten Stovall

Merck Serono/Nordic Bioscience and Merck KGaA/BMS: Merck Serono, a unit of Merck KGaA, said on March 18 it formed a strategic alliance with Denmark-based Nordic Bioscience AS around the German drug maker’s investigational therapy sprifermin, or recombinant human FGF-18, in osteoarthritis of the knee. Under the terms of the agreement, Nordic Bioscience will provide Merck with clinical development services on a shared-risk basis in exchange for a payment structure that includes service fees and potential milestone and royalty payments on the program. Financial terms of the collaboration were not disclosed; however. Merck retains full responsibility for the development and commercialization of the investigational drug. According to the World Health Organization, more than 5% of adults over 40 in developed countries, or more than 30 million people, suffer from osteoarthritis of the knee. A multi-national Phase IIb trial, dubbed the FORWARD study, is expected to begin enrolment in the second half of 2013 to evaluate further sprifermin for inhibition of the progression of structural damage, reduction in pain and improvement of physical function in patients with osteoarthritis of the knee. Sprifermin is a protein thought to induce chondrocyte stimulation leading to matrix synthesis and chondrocyte renewal. It is delivered by intra-articular injection. Two phase I trials in moderate/severe osteoarthritis of the knee previously were completed; a Phase II trial to evaluate the efficacy and safety in patients with cartilage injury of the knee is ongoing. The program was originally was in-licensed in 2004 from ZymoGenetics, a Bristol-Myers subsidiary. The next day, on March 19, Merck KGaA said it inked a deal with Bristol to promote type 2 diabetes drug Glucophage (metformin hydrochloride) under different formulations in China. Under terms of the agreement, Merck Serono and Bristol will co-promote Glucophage in China through a profit-sharing arrangement. Glucophage has been marketed by Bristol-Myers Squibb-SASS in China since 1999. The two companies will tap existing resources and complementary strengths, with Bristol-Myers Squibb-SASS continuing to manufacture Glucophage’s IR (immediate release) formulation. The collaboration will seek to expand the geographic distribution of Glucophage and provide diabetes-related health and medical information including education for health professionals. In addition, the co-promotion will significantly increase outreach to hospitals. Other terms of the agreement were not disclosed. -- S.S.

Thanks to YouTube user cweiandnd for uploading the Louvin Brothers clip. Keep clicking, there's more where that came from.

Financings of the Fortnight, You're Now Cleared For Landing

 

As we write this, at least five biotechs are in registration for initial public offerings. Circling the runway, if you will. Could even be more, what with the allowances for hush-hush registration afforded by this year’s JOBS Act. One has just touched down – the first biotech issue in more than two months -- but only after making major concessions to the public markets. (See Regulus Therapeutics in our roundup below.)

There’s been buzz that 2012 could be the best year for biotech IPOs since 2007, the year before all things financial went to heck in a mortgage-backed handbasket. “Best since 2007” is a rather backhanded compliment, but we understand the feeling that there’s a little more sun shining. As our Pink Sheet brethren reported this week, for example, antibiotic developer Paratek Pharmaceuticals has picked itself off the mat to file for an IPO. In its filing the firm cites more confidence in the revamped FDA guidelines for antibiotic approvals – specifically in skin and skin-tissue infection, which Paratek’s lead candidate, once partnered with Novartis, aims to treat.

But there should be no illusion that landing an IPO will mean a short taxi to the gate and a swift, sprightly exit past the smiling cabin crew. In other words, there’s an oversized suitcase just waiting to tumble out of the overhead bin: IPOs aren’t boosting company valuations. This has been true for years, hence the motto “The IPO is just another round of financing.” But one would think that the rise in other indicators, such as slightly better post-IPO performance, less drastic “haircuts” (the difference between the proposed IPO terms and the eventual ones), and a broader pool of IPO buyers, would put some wind under the step-up wings. (OK, that metaphor is officially grounded.)

As our new colleague Stacy Lawrence reported last week, the step-ups from final venture round to IPO have remained tepid. In fact, according to research from law firm Fenwick & West, the real action recently has taken place earlier in the funding cycle: step-ups at Series B in the second quarter of 2012 averaged 63%, and at Series C, 26%. The jump in valuation at Series D was 9%, and at Series E or higher, it was -9%. Those early boosts in valuation, however, at least are helping the entire group trend in the right direction. In a four-quarter moving average, life sciences venture rounds had a 21% step-up. That’s up from 0% in the first quarter of 2010. Flatter than a flounder on a Nebraska two-lane blacktop, as Dan Rather might have said.

In other IPO news, the upcoming issue of Start-Up breaks down six years of biotech exits, both M&A and IPO, and looks at the companies with corporate venture backers. As we found more than a year ago, private biotechs with corporate VCs on board are acquired at higher returns than those without CVC backing.

Does the CVC magic rub off on IPOs, too? Tune into the new issue to find out. Also in the new Start-Up, we profile a biotech that could be first to market with a disease-modifying drug for an autism disorder; we delve into the unusual business model of a company fully owned by non-profit foundations but looking to attract venture backers; and we examine the strategies of companies working on psoriasis that patients hope will soon make the leap to orally administered treatments.

In Start-Up's annual VC survey, by the way, we asked participants if the aforementioned JOBS Act has had any of its intended effect on the IPO process:

It might be too soon to tell where the IPO market is going, but we, dear readers, are approaching our final destination. Please return your seat back to the upright position, lock your tray tables, and put your  electronic devices away -- except, of course, the one you're using to read the latest edition of....

Regulus Therapeutics: If haircuts have been less drastic this year, you wouldn’t know it from the Regulus IPO. The microRNA developer birthed by Alnylam Pharmaceuticals and Isis Pharmaceuticals made its public debut October 4, the first biotech IPO since July, selling 11.25 million shares at $4 a pop. It was a drastic shift from selling 4.55 million shares in the $10 to $12 range it hoped to hit. The cash raised by Regulus is roughly the same as it had first targeted, $45 million instead of $50 million, but the rest of the metrics were ugly. Seeing how the firm was owned by other drug companies, however, the immediate financial impact might not be as urgent as it would be for traditional venture backers. Before the IPO, Alnylam and Isis held 45% and 44% of Regulus, respectively, and Sanofi (9%) owned most of the rest. There were all sorts of side deals with the IPO, too. Regulus partner AstraZeneca agreed to buy $25 million in common stock at the IPO price, which gives AZ 6.25 million shares – practically an equal post-IPO share to Alnylam and Isis, according to the most recent regulatory filing. Other corporate owners are likely to buy in at the IPO, too: the filing indicates Sanofi, Isis and GlaxoSmithKline, which like AZ and Sanofi also is a development partner, have said they’re interested. Filings in coming days should reveal the extent of their purchases. Underwriters have 30 days to buy up to 1,687,500 extra shares. On its first day of trading Regulus closed at $4.20 a share, up 5%. – Alex Lash

Aragon Pharmaceuticals: When prostate cancer drug developer Aragon announced a $42 million Series C round in March, CEO Rich Heyman told "The Pink Sheet" DAILY that another private round was unlikely, but still on the table. Its new $50 million Series D round, then, represents somewhat of a course change for a company that was mulling a partnership before year’s end, and even acknowledged exploring a public offering late last year. Three days before revealing the D round, Aragon presented strong Phase II data for top candidate ARN-509. Unorthodox investor venBio led the round, and prior investors Topspin Fund, Aisling Capital, OrbiMed Advisors and The Column Group also joined. Validation for ARN-509 came with the August approval of another compound in the androgen receptor antagonist class, Medivation and Astellas’ Xtandi (enzalutamide), but that also could crowd the market as both drugs seek to compete with J&J’s Zytiga (abiraterone). Moreover, Aragon faces a breach-of-contract lawsuit from Medivation, which alleges that Aragon’s scientific co-founders, once researchers at the University of California, Los Angeles, hid ARN-509’s existence when Medivation licensed a series of similar compounds, including Xtandi, from the university. Aragon has filed a counterclaim; the original suit could reach trial early next year. – Paul Bonanos

Antabio: The French antibiotic discovery startup said October 1 it completed the first-ever crowdfunding round for a biotech. It’s a difficult claim to verify, but if not exactly true, it’s certainly one of the few not just to have tapped anonymous, Internet-based donors – akin to the grassroots Internet fundraising that President Obama famously put to use in 2008 – but to have cashed them out in the black. Again, a hard claim to verify, but an Antabio spokeswoman told The In Vivo Blog in an e-mail that every one of the more than 200 crowd funders got a 2x return on investment. The total amount the company raised from them was €300,000. The crowd funders exited when a former Swiss biopharma executive, Christophe Richard, and other angels made personal investments in the company earlier this year. The firm is aiming to have its first candidate in the clinic by 2016. One area of focus is on treatments for bacteria that have developed resistance against carbapenems, the antibiotic class traditionally deployed against Gram-negative bacteria such as Escherichia coli, Pseudomonas aeruginosa and Salmonella. – A.L.

Asceneuron: The Swiss firm spun out this week from Merck KgAA’s Merck Serono unit with the group’s preclinical Alzheimer’s assets that target tau, one of the two major misfolding proteins associated with Alzheimer’s disease. Research into drugs that attack the tau-associated pathologies of Alzheimer’s disease have had a resurgence of late, in part because longstanding approaches to attacking beta amyloid, the other misfolding protein of AD, have failed in late-stage drug trials. Merck Serono, through its venture arm, will invest  €5 million in Asceneuron. Its staff will consist of eight current Merck Serono employees to move the preclinical assets into the clinic up to Phase I, at which point the firm says it will look to out-license or partner the three programs. It’s the third firm to emerge from the closure of the unit’s Geneva headquarters, announced in January, tempered by a €30 million fund to back spin-outs like Asceneuron. Merck KgAA bought the family-owned Serono for roughly $13 billion in 2006. -- A.L.

Photo courtesy of honorary FOTF co-pilot alantankenghoe via a Creative Commons license.

Deals Of The Week: Living With The Constancy Of Change In HCV Drug Development

One of the frequent thematic tropes found in the music of Canadian prog-rock trio Rush is the constancy of change, that change is constant, and constantly changing, etc. Anyone trying to follow hepatitis C drug development probably understands that message.

Just when it appeared that nucleoside polymerase inhibitors were the way to go in the effort to develop a paradigm-changing combination of all-oral, direct-acting antiviral drugs for the virus, a pair of recent setbacks in the “nuc” arena have made other classes of drugs and the companies developing them more relevant, and potentially more valuable.

Hence, the reported increased interest in Achillion Pharmaceuticals, which expects to produce early data for a proprietary combination of a protease inhibitor and an NS5A inhibitor during the first quarter of 2013. Once thought in danger of being left behind as the M&A mavens at big pharma circled Pharmasset, then Inhibitex, and continued to kick the tires on Idenix Pharmaceuticals, Achillion now is considered by many Wall Street analysts to be on the radar screen of HCV players such as Merck & Co., Bristol-Myers Squibb, Roche and possibly others.

Achillion raised $41.7 million in a registered direct offering just before Labor Day, placing 6.4 million new shares with QVT Financial LP at $6.57 per unit, its closing price on Aug. 31. That marked the New Haven, Conn.-based biotech’s third significant fund raise since August 2010, as it brought in $60.9 million through a follow-on public offering in June 2011, and $49.1 million under a PIPE (private investment in public equity) deal in August 2010.

But Wall Street widely expects that Achillion will have some big pharma R&D machinery behind its HCV efforts soon, maybe even before the Phase II combo data for protease inhibitor ACH-1625 (sovaprevir) and NS5A inhibitor ACH-3102 are unveiled.  (The firm also will disclose Phase I proof-of-concept data for ‘3102 this fall.)

Dismissed as barely relevant in the combo race as recently as earlier this year, Achillion may get a second chance thanks to the disastrous safety issues encountered by Bristol’s expensive nuc prospect, BMS-986094. The pharma paid $2.5 billion to buy that drug’s developer, Inhibitex, only months before shutting development of the drug down entirely in mid-August due to cardiotoxicity that killed one patient and hospitalized eight others.

The news then got worse or better, depending on your perspective, when FDA placed Idenix’s nuc, IDX184, and second-generation compound, IDX19368, on clinical hold because of concerns about their similarity in chemical structure to the Bristol nuc. It’s important to note that the “nuc” class is by no means dead – Gilead Sciences is still viewed as the leader in the HCV combo race thanks to the eye-opening data its nuc, GS-7977, is producing. And Vertex Pharmaceuticals is bringing a nuc licensed last year from Alios BioPharma into the clinic, as well.

Achillion has an analyst day presentation slated for Sept. 27, and with the expectation for POC data with ‘3102 and drug-drug interaction data for the ‘1625/‘3102 combination expected this quarter, Robert W. Baird & Co. analyst Thomas Russo thinks a partnership prior to the combo trial would make sense. “While lack of visibility makes this timing impossible to predict, generally speaking we’d view [a] non-exclusive collaboration positively because it would add shots on goal, external validation, and perhaps regimens that would augment investor excitement and conviction,” he wrote in an Aug. 8 note.

He added that Bristol and Abbott Laboratories have been demonstrating in the lab that high sustained virologic response (SVR) rates can be attained by antiviral combos not including a nuc. “Achillion’s pipeline features PIs and NS5A inhibitors that look best-in-class, complementary, and reasonably likely to succeed in interferon-free combos – all under its roof and/or via external collaboration,” Russo said. “We believe big players will fight on for some period longer, with some looking to fill gaps in their HCV pipelines and others perhaps looking for a complete solution.”

Sovaprevir, in triple-combination testing with existing standards ribavirin and pegylated interferon, has demonstrated effective inhibition of viral replication without generating “meaningful resistance,” an unending concern in the protease inhibitor class, wrote Brean Murray Carret & Co. analyst Brian Skorney on Aug. 9. “Although not a clear home run … [this is] a characteristic we believe is unique to only handful of antivirals in development for hep C,” he added.

Now, on to our weekly roundup of:

Merck KGaA/Symphogen – Danish biotech Symphogen AS has licensed its lead oncology product, Sym004, a mixture combining two antibodies targeting the epidermal growth factor receptor (EGFR) on tumor cells, to Merck KGaA for an upfront payment of €20 million ($25 million). Symphogen was evaluating Sym004 in two Phase I/II studies, which have shown initial signs of the drug’s clinical benefit and have been transferred into Merck’s control. The deal underlines the growing interest in combination therapies for cancer, as well as Merck’s desire to build on its marketed EGFR-targeted anticancer, Erbitux (cetuximab), which is its second largest-selling product, garnering sales of €855 million ($1.13 billion) in 2011. Merck receives exclusive development and commercialization rights for Sym004 worldwide, and now will fund all further development of the compound. In return, Symphogen receives the upfront and potentially could earn €225 million in clinical development and regulatory milestones, as well as €250 million in combined sales performance milestones and royalties on net worldwide sales, bringing the total potential value of the deal to €495 million. Merck is much in need of clinical-stage products that it can advance quickly following a string of late-stage product failures, which have prompted a management reorganization and the start of a cost-saving program including job losses at its R&D facilities in Switzerland, and across functions in Germany. – John Davis

Valeant/Medicis – In a move to become a leader in dermatology, Valeant Pharmaceuticals announced Sept. 3 that it has agreed to pay $44 per share, or $2.6 billion, for Scottsdale, Ariz.-based Medicis Pharmaceutical – representing a 39% premium to Medicis’ closing price of $31.56 on Aug. 31, the last trading day before the deal was announced. The Medicis acquisition, which will be funded entirely with debt, adding to the company’s $7.6 billion debt (as of the end of 2011), will make Valeant the largest dermatology player in the U.S. and second only to Galderma SA in the rest of the world. While Valeant has interests in several specialty pharma areas including dentistry and branded generics, the largest part of the business belongs to dermatologics with a focus on acne, eczema, and topical antivirals. Medicis brings a handful of products that will be complementary to Valeant’s current portfolio including the oral acne product Solodyne (minocycline oral), which will fit in with the company’s topical acne offerings. The company also makes aesthetic injectables like Restylane, Perlane and Dysport – which fit in with Valeant’s collagen stimulator Sculptra. Valeant expects $225 million in synergies – an estimate the company considers conservative and does not take into account any revenue upside or further upside from anything that may come out of the Medicis pipeline. According to Wells Fargo analyst Michael Tong, the deal will nearly double Valeant’s dermatology business, which was expected to produce revenues of $958.7 million in 2012 (analysts estimated Medicis would bring in approximately $820 million in revenues in 2012). – Lisa LaMotta

Medivir/Novadex – Achillion is not the only player in the HCV space looking to take advantage of recent stumbles by Bristol and Idenix. Medivir AB, which is developing Phase III protease inhibitor simprevir (TMC435) in tandem with Johnson & Johnson unit Janssen Pharmaceuticals for hepatitis C, announced a deal with Novadex Pharmaceuticals Sept. 6 in which it acquired a package of preclinical HCV assets, including novel nucleoside polymerase inhibitors. A release said the deal will include an upfront payment and potential milestones, but did not disclose specific terms. Medivir said the deal will include intellectual property and prodrug technologies that will further strengthen its HCV platform and know-how. The prodrug technologies could be applied to both protease inhibitors and nucleoside analogues to enhance their overall pharmacokinetic profiles, the company added. TMC435 also is being tested in combination with Bristol’s NS5A inhibitor daclatasvir (BMS790052) under a collaboration between Janssen and Bristol that was extended in April. – Joseph Haas

ImaginAb/MacroGenics – Two privately held companies in the antibody development space agreed Sept. 5 to collaborate on a pair of imaging products that could support ongoing development of new therapies. Los Angeles-based imaging specialist ImaginAb said it would develop a clinical imaging product for inhibition of the CD3 T-cell receptor based on an anti-CD3 therapy belonging to MacroGenics of Rockville, Md. The companies did not specifically name teplizumab as the therapy, but that is MacroGenics’ most advanced anti-CD3 program.ImaginAb also will develop a companion imaging agent for an immune-regulating B7-H3 target; MacroGenics’ Phase I clinical candidate, MGA271, addresses B7-H3. ImaginAb’s agents typically are used by partners to select patients and monitor responses to clinical treatments. The two companies share at least one investor, the oncology-focused Nextech Venture of Zurich. MacroGenics has raised more than $125 million from a long roster of venture investors since it was founded in 2000; five-year-old ImaginAb announced its $12.5 million Series A round in March 2012, and already has forged partnerships with drug companies such as Astellas Pharma and Oxford BioMedica, as well as a variety of cancer research organizations. Last month, ImaginAb named Eleven Biotherapeutics CEO Abbie Celniker as chair of its board of directors. – Paul Bonanos

Pfizer/SFJ Pharmaceuticals – Pfizer and SFJ Pharmaceuticals announced a collaborative development agreement Sept. 7 to conduct a Phase III trial for dacomitinib (PF-00299804), a pan-human epidermal growth factor receptor (pan-HER) inhibitor in advanced lung cancer. To be conducted at multiple sites in Asia and Europe, the Phase III trial will test the agent in patients with locally advanced or metastatic non-small cell lung cancer with activating mutations of epidermal growth factor receptor. SFJ will fund the trial and provide clinical development supervision as needed to prepare dacomitinib, an oral, once-daily, small molecule inhibitor of the HER-1, HER-2 and HER-4 tyrosine kinases, for regulatory filings as a first-line treatment in advanced NSCLC. If the compound obtains regulatory approval, SFJ will be in line to earn milestone and other earn-out payments. No other financial details were disclosed. This is the second collaboration between the world’s largest pharma and San Francisco-based SFJ, founded in 2009 a co-development partner for pharma and biotech. Earlier this year, the two partnered to run a Phase III trial in Asia of Inlyta (axitinib) for adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy. – JAH

Photo credit: Wikimedia 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

Deals of the Week Plays Moneyball

Sometimes picking a winner is easy. But if you ask a baseball general manager, a moviegoer, or a private equity investor, it's the hidden gems, the fixer-uppers, and the unexpected turnarounds that can be the most satisfying. Such salvage cases lie at the heart of Michael Lewis's 2003 book Moneyball, now a major motion picture, a baseball movie that isn't just that. The story of the Oakland Athletics' shoestring-budget team that enjoyed an amazing 20-game winning streak in 2002, it's described by Roger Ebert today as "a brainy baseball movie about cost-benefit analysis," an underdog story that incorporates business savvy, an understanding of human nature, and the relationship between analysis and instinct. (And if Hollywood can turn a book written by a business journalist about football into an Oscar-winning Sandra Bullock star turn, maybe Moneyball itself will be an unlikely success.)

For some drug makers, finding value in compounds where others don't see it is their own game of moneyball. As we'll discuss in an uncoming IN VIVO feature, central nervous system drug maker Jazz Pharmaceuticals went from trading under $1 in 2009 to a 52-week high of $47.88 this week, on the strength of several critical decisions that maximized value of underappreciated assets. It shuffled its priorities multiple times, eventually focusing on narcolepsy treatment Xyrem (sodium oxybate) -- at one point considered a backup plan, now a fast-growing, $200-million-plus-per-year drug -- while pulling additional value out of Luvox CR (fluvoxamine), a controlled-release version of an SSRI that had fallen out of favor in prior years and was withdrawn from the market by Solvay Pharmaceuticals. It's resulted in a windfall for Jazz as well as its PE stakeholders, including Kohlberg Kravis Roberts and Longitude Capital.

This week, Jazz hopes to have found another Scott Hatteberg, one of Moneyball's hidden talents, in Azur Pharma Ltd., an Irish specialty pharma with which it shares several traits in common. California-based Jazz used its strong equity position to merger with Azur in a stock transaction, giving its shareholders about 80 percent of the combined company. The deal will also allow Jazz to move its headquarters to Dublin, potentially resulting in a massive tax savings. Though many of Azur's strengths lie in CNS drugs, the deal also gives Jazz a beachhead in women's health. Analyst Gene Mack of Mizuho Securities USA wrote in a research note that the newly combined entity, Jazz Pharmaceuticals PLC, could even exceed its projection of $475 million in its first 12 months of existence.

If only the Oakland Athletics could relocate somewhere close to home that would allow them to generate more revenue. (Somewhere very close to the computer on which these words are being written, an Athletics season ticket holder sighs.) As they look up at the teams headed for the playoffs, we invite you to have a look at...

Bristol-Myers Squibb/Ono Pharmaceuticals: In a transaction that involves no cash moving in either direction, Bristol-Myers Squibb has expanded its territorial rights to an oncology antibody acquired in its 2009 purchase of Medarex, while Ono Pharmaceutical gets co-development and co-commercialization rights to rheumatoid arthritis drug Orencia (abatacept) in Japan. Ono can earn unspecified royalties if the antibody, BMS-936558/Ono-4538, an anti-programmed cell death (PD-1) antibody in clinical development in multiple types of cancer, reaches market. Bristol Senior VP-Strategy, Alliances and Transactions Jeremy Levin cautions not to consider this deal merely an asset swap. “It’s less a swap than it is an understanding that we have different strategic imperatives,” Levin said. “So we trade the value of an existing product that we like a lot, Orencia, for a product that we think helps build a tremendously important part of the immuno-oncology franchise.” Under the Sept. 20 agreement, Bristol’s rights to BMS-936558 expand to the entire world other than Japan, Korea and Taiwan; Ono will retain rights to the antibody in those markets (In the original Medarex/Ono deal, Medarex received North American rights to the antibody.) In the U.S., ’558 is in Phase I and Phase II trials in a variety of tumor types and treatment settings, Bristol says, including renal cell carcinoma and melanoma. Ono has advanced the compound to Phase II in melanoma in Japan.—Joseph Haas

Bristol-Myers Squibb/Ambrx: In the second deal under its “String of Pearls” strategy in two days, Bristol acquired worldwide rights Sept. 22 to two preclinical biologic candidates, one for type 2 diabetes and the other for heart failure. Ambrx will receive a $24 million upfront payment from Bristol in exchange for worldwide rights to research, develop and commercialize both ARX618, a fibroblast growth factor 21 (FGF 21) protein nearing the completion of preclinical development in type 2 diabetes, and an optimized version of relaxin hormone in earlier preclinical development for heart failure. The deal is Ambrx’s latest using its site-specific conjugation technology platforms to optimize molecules for big pharma partners, but also its first in two years. Ambrx optimized the two large molecule compounds for development using its ReCODE (Reconstituting Chemically Orthogonal Directed Engineering) technology platform. This technology allows the San Diego-based biotech to modify native proteins with amino acid building blocks beyond the common 20 amino acids known to nature to engineer enhanced candidates for therapeutic use. Beyond the $24 million upfront payment, Ambrx also is eligible for milestone and royalty payments on both programs. Of the two programs, ARX618 is said to be closer to entering clinical development. — JAH

Merck Serono/Peptimmune: Merck Serono, the pharmaceutical division of German conglomerate Merck KGaA, acquired the worldwide rights to PI-2301, a Phase II-ready candidate for multiple sclerosis, from cash-strapped Peptimmune on Sept. 19. While the official news release did not mention it, Merck Serono confirmed to DOTW that it paid $1.5 million up-front to Peptimmune for the rights to PI-2301, a second-generation peptide copolymer thought to offer the potential to enhance the immune system’s regulatory response. The compound has completed a Phase Ib study in MS, but Peptimmune, which is in the process liquidation after filing for bankruptcy earlier this year, no longer had the ability to advance the candidate further. PI-2301 which has a mechanism of action similar to Teva’s Copaxone (glatiramer), is believed to offer potential in a number of autoimmune indications, including Crohn’s disease, rheumatoid arthritis and uveitis. — JAH

Merck & Co./FKD Therapies Oy: Finland is considered by some to be a hotspot for gene therapy research, and is the location of a new company, FKD Therapies, set up to exploit a bunch of gene therapy assets found to be surplus to requirements at Merck. The Finnish company, led by gene therapy veteran Nigel Parker, formerly CEO of Ark Therapeutics, has licensed an alpha-interferon gene therapy from Merck, and has options on two other potential gene therapies. The alpha-interferon gene therapy is slated to go into Phase II trials for the treatment of bladder cancer next year. Along with other Big Pharmas, Merck has not been particularly prolific in licensing out technology and products that have fallen outside its tightened therapeutic focus, post-merger with Schering-Plough; the FKD Therapies deal is believed to be one of Merck's largest out-licensing deals in recent times in the pharmaceuticals arena. The U.S. company has taken an equity stake in FKD Therapies, which is also backed by the German investment bank, Wolbern Invest. FKD Therapies also has options on a recombinant adenoviral p21 gene to treat glaucoma surgery failure, and on a conditionally replicating adenoviral technology for the treatment of solid tumors. — John Davis

Merck Serono Re-Shuffle:Deckchairs on the Titanic?

Okay, so the Titanic analogy is a bit unfair. But it just kept springing to mind, reading about Merck Serono's latest two Big Pharma hires, Annalisa Jenkins (ex-BMS) and Belen Garijo (ex-Sanofi) who will, respectively, drive a new R&D organizational structure and re-shuffle the group's global commercial and marketing organization. The Merck Serono ship isn't exactly going full-steam ahead: oral MS drug cladribine, the post-Rebif hopeful with peak sales once slated at $1.5 billion, was officially scrapped June 22, after both European and U.S regulators had turned up their noses (mostly at a potential link to cancer). Cladribine's trip-up followed a string of other development setbacks and most probably prompted the departure of pharma CEO Elmar Schnee in December 2010.

Enter the Big Pharma blood to sort things out. (One thing Big Pharma execs should by now be highly-trained in is how to cut costs and try to boost R&D productivity). Stefan Oschmann, previously head of Merck & Co. Inc.'s emerging markets business, joined in January as President of Merck Serono (and also heads the company's consumer health division). After six months assessing the damage, he's now hiring in the troops to sort things out.

Belen Garijo, previously SVP Global Operations Region Europe and Sanofi Aventis, will take on a newly-created COO role and "define a highly competitive commercial and marketing strategy to strengthen Merck Serono's product brands and lead its global business to profitable growth across all therapeutic areas," says the release. Make what we've got work harder, in other words. And no doubt she'll also leverage some of the synergy-extracting experience gleaned from latterly leading the integration of Genzyme at Sanofi, as well as draw on Oschmann's emerging markets background.

Jenkins' appointment as Global Head of Drug Development & Medical marks the first step of a R&D overhaul that, certainly at first glance, appears familiar to anyone following Bigger Pharma's attempts to invigorate their innovation engines: the creation of a pre- and post-POC divide, with Jenkins heading post-POC development including life-cycle and regulatory functions, and Bernhard Kirschbaum, until now head of all R&D, looking after Global Research & Early Development to proof-of-concept. (This isn't the first time Merck has split R&D: earlier in his six-year career at Merck, Kirschbaum ran pre-clinical and global technologies, reflecting an older-fashioned R&D dividing line).

Yes, and the new R&D operation is going to be all about fostering agility, creativity and entrepreneurship, to allow more efficient use of resources, etc. etc....We've heard many similar stories before. What's more, if Eisai's R&D experience is anything to go by, Merck Serono's mid-cap credentials -- it has just 2500 R&D employees -- needn't rule it out of creating small, biotech-like autonomous units either, a la GSK's DPUs.

As yet, there are scant details on offer of Merck Serono's makeover: Oschmann isn't talking until at least the end of the year, we are told; perhaps understandable given that Jenkins and Garijo don't start until September.

But Oschmann likely knows the broad outlines of what he needs done, and has hired the appropriate troops to execute on the plan. Cost-cuts and efficiency drives will almost certainly feature strongly, as will in-licensing, especially to salvage the MS franchise. Line extensions for 13-year old, three-times-a-week injectable MS therapy Rebif (interferon beta-1a) continue (the company recently submitted an application to EMA for Rebif in early-stage MS) but are unlikely to be enough, particularly with MS competition from the likes of Biogen's Tysabri, Novartis' oral Gilenya and, perhaps soon, Sanofi/Genzyme's Lemtrada (though recent Phase III results for that drug were mixed).

Merck has done two neuro-degenerative diseases focused deals this year so far; expect that rate to increase. If it doesn't, maybe that deckchair analogy will creep back in after all, even though the company is somewhat protected from the full force of the elements by its 70% family ownership and its minority non-pharma operations.

image by flickrer Steve Parkinson used under creative commons

DOTW: Rising Temperatures

It's July and the temperature's rising -- and so are early stage deal values in oncology.

You want proof? The chart to the right, derived from our Strategic Transactions database, says it all. Average upfront deal values for Phase I oncology programs have soared from around $20 million in 2007 to more than $40 million this year, as big pharmas race to lock up first-in-class assets in what is now considered a core therapeutic area. Interestingly during this same period Phase III deal values for oncologics have declined from a 2008 high of $66 million to about $37 million.)

There are, of course, caveats to the analysis. In a given year, the individual number of oncology deals associated with a particular phase of development is small (on the order of 2 to 10); thus, any one deal can skew the average.

Despite the limitations of the data, there's no denying this week's deal between Bristol-Myers Squibb and Innate Pharma for worldwide rights to the biotech's Phase I immuno-oncology asset was a big one. Bristol, now the darling of analysts for its small is beautiful, double down on biopharma approach and the recent approval of Yervoy, paid $35 million upfront for Innate's novel humanized antibody, IPH2102.

In Phase I as a possible treatment for acute myelogenous leukemia, IPH2102 acts on innate immunity, a universal but so-far little explored biological process, in which natural killer (NK) cells are stimulated to attack cancer cells. When the antibody binds its target, it removes a block that inhibits the activity of NK cells; thus, this kind of therapy is expected to complement the more conventional adaptive immune response approach exploited by other immunotherapies. (And there's no doubt after this year's ASCO that combo therapies in oncology are becoming the path forward.)

In addition to the hefty upfront, BMS could pay up to $430 million more in milestones in addition to pre-specified double-digit sales royalties. Interestingly, Innate Pharma will continue to develop the molecule to the end of Phase II (at which point work transitions to the big pharma), with BMS picking up the development tab. A joint steering committee with representatives from both companies will oversee the development process, which will include exploring '2102's role in other cancer types, including solid tumors, and whether it should be used as a monotherapy or as part of a combo.

As noted in "The Pink Sheet" DAILY, one reason for the deal's size may stem from the fact that '2102 is a follow-on compound to a Phase II precusor molecule called '2101 that is being studied in multiple myeloma patients. Thus, while '2102 is a novel compound (its made by a different manufacturing process that is more amenable to regulatory approval than the earlier version), the existing data associated with '2101 likely provided BMS with additional comfort about the follow-on's mechanism of action and clinical utility.

What other therapy areas could also enjoy a torrid increase in deal value in the coming months? Deals for anti-infectives, especially medicines targeting pesky gram-negative microbes, seem poised for an uptick as certain big pharmas are cycling back into the space after ignoring it for years. Given the unmet medical need associated with Type II diabetes and obesity, it's tempting to think products in this arena should also command high values. (Zafgen and Catabasis are certainly hoping so.) But given the recent spate of regulatory failures associated with Contrave, lorcaserin, and Qnexa, expect pharma partners to be circumspect (er, wishy-washy) until there's significant data showing efficacy AND safety.

In the mean time, consider cooling off by diving into another edition of...

Roche/The Cancer Prevention and Research Institute of Texas: Dollar figures weren't announced in this week's alliance between Roche and CPRIT, but the deal is a reminder not just of the ongoing interest in oncology, but also the role academia can play as a source of that innovation. Under the terms of the agreement, CPRIT and Roche will jointly collaborate to identify new oncology-focused ventures and technologies originating from academic groups housed in Texas, with both organizations providing financial support to the nascent programs. The Swiss pharma will assess investment opportunities and offer support to selected ventures, including the ability to tap Roche personnel for help with drug development, and clinical and regulatory questions. As is typical of current pharma-academia collaborations these days, a joint committee will oversee research progress while the selected projects are in the accelerator program. It's the first large pharma partnership for CPRIT, which was formed in 2007 with support from the Long Horn state's citizenry to expedite the commercialization of cancer-related research originating from both public and private institutions within Texas.--EL

Johnson & Johnson/Pharmasset: Pharmasset Inc. and Johnson and Johnson's Janssen Therapeutics unit (the division formerly known as Tibotec) will study two investigational agents in combination for the treatment of hepatitis C without interferon, the current standard of care. The tie-up adds to the blizzard of ongoing studies to find a safe and effective interferon-free regimen and shows how companies must collaborate with potential competitors (is that collabetition or compellaboration?) in order to do so. As part of the clinical alliance announced July 6, Janssen will initiate a Phase II study evaluating the safety and efficacy of Pharmasset's key asset, the nucleotide polymerase inhibitor PSI-7977, in combination with its protease inhibitor TMC435. No money changed hands as a result of the collaboration. The study, which will enroll HCV genotype 1 patients who had a prior null response to peg-inteferon alfa and ribavirin, will evaluate the combination with and without ribavirin. With the announcement, PSI-7977 now is being studied in combination with three of the leading direct-acting antiviral classes: protease inhibitors, NS5A inhibitors, and nucleotide polymerase inhibitors. Earlier this year, Pharmasset and Bristol announced a clinical collaboration to study Bristol's NS5A replication complex inhibitor BMS-790052 with PSI-7977 and in May launched a Phase II trial in 84 previously untreated patients with HCV genotypes 1, 2, or 3.— Jessica Merrill

Rib-X/Sanofi: Ribosome-focused Rib-X Pharmaceuticals will receive $10 million upfront and could earn another $9 million in near-term research milestones under an agreement it signed with Sanofi July 6. The two companies will co-develop novel antibiotics to treat drug-resistant gram-negative and gram-positive hospital-acquired infections. Sanofi also gets the option to license molecules resulting from the research, with structured payouts going to Rib-X. The deal is structured as an exclusive worldwide research collaboration centered around Rib-X’s preclinical RX-04 program and initially pertains to four product profiles within an agreed-upon portion of the ribosome. But the deal essentially gives Sanofi “drilling rights” in that area, which is expected to yield potentially thousands of candidates, all of which Sanofi will have option rights to. Anything Sanofi does not option, however, will revert fully to Rib-X. Each molecule optioned and developed by Sanofi could yield up to $86 million in development and regulatory milestones as well as more than $100 million in commercial milestones, plus potential low double-digit royalties on sales. Privately held Rib-X also has the option to co-promote in the US one program of its choosing from the collaboration.—Joseph Haas

Merck KGaA/Idera: For every high profile oncology tie-up, there is also the inevitable no deal. This week came news that German pharma Merck KGAA would halt a key trial on a toll-like receptor 9 agonist that was a critical piece of its 2007 oncology partnership with Idera Pharmceuticals. Merck KGAA announced it would cease development of IMO-2055 as a potential treatment for first-line squamous cell carcinoma of the head and neck, based on results of a Phase I trial in combination with cisplatin/5-FU and Erbitux (cetuximab). The trial showed increased incidence of neutropenia and electrolyte imbalances. The stoppage doesn’t completely unravel the companies’ partnership, under which Merck KGaA paid Idera $41 million upfront and which included $381 million in potential milestone payments. The German company said it would continue a Phase II trial on IMO-2055 as a second-line treatment in combination with Erbitux in recurrent and/or metastatic SCCHN patients, and will continue to evaluate Idera’s other TLR9 agonists. It’s not the first failure for IMO-2055; the drug failed to meet its primary endpoint in a 2008 Phase II study of tumor response in advanced renal cell carcinoma patients, and Merck declined to initiate a dose-escalating component in a Phase Ib study of the drug in metastatic colorectal cancer. – Paul Bonanos

Image courtesy of flickrer cassandrajowett used with permission through a creative commons license.