Friday, January 04, 2013

Deals of the Week Visits The Winner's Circle

Celgene Corp. continues its march to win the hearts and minds – or at least the votes – of the biopharma industry, as measured by The IN VIVO Blog’s Deals of the Year poll.

When the polls closed Jan. 4 for the 2012 contest, Epizyme Inc.’s April tie-up with Celgene walked away with nearly 60% of the vote in the Alliance category – the largest vote percentage in all three categories.
It's the second win in five years for a Celgene deal, following its $2.9 billion cash-and-stock-and-contingent value rights deal with Abraxis Bioscience targeting solid tumors in 2010.

This achievement could reflect widespread industry recognition for Celgene’s deal strategy over the years. Or perhaps it reflects a vigorous get-out-the-vote campaign in some quarters that would spark jealousy in Washington (and given our editors’ frequent entreaties to vote early and often, it's heart-warming to think our readers are listening).

Also taking the winners' circle this year was the Amylin Pharmaceuticals Inc./Bristol-Myers Squibb Co./AstraZeneca PLC three-way deal in the M&A category, barely edging out Biogen Idec Inc.’s acquisition of Stromedix Inc. The unique collaboration raises the stakes in the diabetes drug market, particularly the increasingly competitive market for glucagon-like peptide-1 agonist therapies, and its unusual structure allowed two pharmas to share the spoils of the recently-approved potential blockbuster Bydureon (long-acting exenatide).

And in the financing category, Foundation Medicine Inc.’s Series B took the honors, topping gene therapy company bluebird bio's funding. (One impassioned commenter devoted kind words to Intarcia's $210 million funding as well.) Foundation's funding was one of the smaller-sized deals vying for voters' favor, but the company has attracted interest from a large number of pharma companies for its genomics testing technology. The company raised a $43.5 million Series B round to fund marketing of its first product, FoundationOne, a test to identify all classes of genomic alterations (including copy number alterations, insertions, deletions and rearrangements) in about 200 cancer-related genes. 

As in past years, the IN VIVO Blog invites the winners to make acceptance speeches in this space. As for the new year, we've already got some new tales to tell. To the winners go the spoils, and to you, we present 2013's first...

AstraZeneca/Cellular Dynamics: Madison, Wisc.-based stem cell research company Cellular Dynamics International Inc. said AstraZeneca PLC will use its technology to conduct drug safety tests as part of the drug discovery process. In a deal announced Jan. 3, CDI said AstraZeneca would both use its broad-ranging, commercially available iCell products and genetically engineer new products using CDI’s MyCell lines for specific patient groups, as part of the discovery and testing process for novel compounds, including in vitro disease research. CDI markets induced pluripotent stem cell products, which are modified cells from biopsies taken from adult patients rather than harvested from embryonic lines, and can be differentiated into various tissue cell groups from an individual’s own stem cell line. The company, which has raised at least $100 million since 2004, believes that its cells can be used during the drug discovery and pre-clinical testing phases to reveal information about safety and efficacy while avoiding ethical concerns and reducing clinical costs.CDI also counts Roche as a customer and partner, under agreements dating to 2008 and since expanded multiple times. Financial terms of the new deal with AstraZeneca weren’t disclosed. -- P.B.

Pfizer/Philogen: The Italian-Swiss targeted antibody company Philogen SPA has attracted another big pharma collaborator, Pfizer Inc., for its angiogenesis-related products. The two companies announced Jan. 3 a worldwide licensing agreement to develop Philogen's Phase I antibody product, Dekavil, in autoimmune diseases. Pfizer intends to evaluate Dekavil in inflammatory bowel disease, as well as continuing Philogen's current clinical program in rheumatoid arthritis. The product consists of an antibody targeting inflammatory disease sites coupled to the immunoregulatory cytokine interleukin-10 (IL-10). Because IL-10 modulates immune responses rather than suppressing them, the companies hope Dekavil will not be associated with unwanted side effects. Philogen will receive an upfront payment and will be eligible to receive milestone and royalty payments, while Pfizer will have exclusive rights to market any products developed in the collaboration. Further terms were not disclosed. Pfizer already has a smaller collaboration with a Philogen unit, Philochem, involving the discovery of cancer targets. Philogen is also collaborating with New Jersey-based Actinium Pharmaceuticals Inc. on attaching alpha-particle emitting radionuclides to its antibodies, with Merck Serono on molecular biomarkers, and with MedImmune on encoded chemical libraries. Philogen researchers helped pioneer the targeting of cytokines, radionuclides, and drugs to the site of disease using antibodies against stromal (connective tissue) antigens. It has five products in Phase I/II studies: darleukin (L19 antibody linked to interleukin-2); teleukin (F16 antibody linked to IL-2); fibromun (L19 antibody linked to tumor necrosis factor); radretumab (F8 antibody labeled with I-131); and Dekavil (F8 antibody linked to Il-10). Back in 2011, Bayer withdrew from a near 12-year strategic collaboration with Philogen on radretumab and darleukin, citing a change of strategy and scuppering Philogen's planned IPO on an Italian stock exchange. -- John Davis

Sanofi Pasteur/Sutro: Protein therapeutics platform developer Sutro Biopharma Inc.’s latest partner intends to create new products using its cell-free protein synthesis technology. The privately held, South San Francisco-based start-up’s newest ally is vaccine specialist Sanofi Pasteur, which plans to develop two new vaccines based on Sutro’s platform. Specific terms of the deal, announced Jan. 3, were not revealed.
Sutro typically uses its platform to develop antibody-drug conjugates and bifunctional antibodies for oncology, but the new deal may range into new territories; the companies did not disclose which targets they will pursue. In December, Sutro announced a tie-up with Celgene Corp. under which the companies will discover ADCs and bifunctional antibodies; that alliance could be worth up to $500 million. Venture investors including Skyline Ventures, Lilly Ventures, Amgen Ventures, SV Life Sciences and Alta Partners have supplied Sutro with nearly $60 million since its 2003 inception, with the latest $18 million tranche of its Series C round arriving in May 2012. The company also inked a multi-year partnership with Pfizer in early 2011 to discover novel peptide-based therapeutics. -- P.B.

Pfizer/Repligen: Pfizer continued its multi-deal first week of 2013 on Jan. 3 by acquiring exclusive worldwide license to Repligen Corp.’s program for spinal muscular atrophy (SMA), led by Phase I, small-molecule candidate RG3039. Pfizer, which will pay Repligen $5 million upfront with the potential for up to $65 million in milestones and royalties on sales of any product reaching market for SMA, also gets backup compounds and enabling technologies from the Waltham, Mass.-based biotech.Repligen previously in-licensed ‘3039 from the patient group Families of SMA, which had invested more than $13 million in preclinical development. Under the deal, Repligen will complete two active cohorts of an ongoing Phase I trial in healthy volunteers, expected to finish during the first quarter of this year. At that point, Repligen will transfer the program to Pfizer, which will be responsible for all subsequent clinical development of ‘3039. The compound has orphan drug status in both the U.S. and Europe. Repligen President and CEO Walter Herlihy said the transaction is consistent with his firm’s strategic decision announced in August 2012 to seek external partners for its drug-development programs while focusing internally on bioprocessing. -- Joseph Haas

Takeda/Amylin: This was one tie-up that didn’t survive a change of control. Four months after the Roger-winning Bristol/AZ takeout of Amylin, a co-development partnership for obesity compounds between Amylin and Takeda was formally severed. It didn’t come as a shock: the partners had in fact discontinued development of their top candidate, the Phase II pramlintide/metreplin combo, in August 2011. Takeda had originally paid $75 million upfront in late 2009 to initiate the partnership. Development and sales milestones across the multiple programs could have totaled more than $1 billion. The deal called for development milestones up to $200 million for two specific products and up to $50 million for any additional products. Commercial milestones were set at $140 million per product related to first sale of the products and up to $800 million per product for other sales-based milestones. Amylin was responsible for all development through Phase II in the United States, with Takeda taking over for Phase III and for all phases outside the U.S. It is unlikely Takeda ever paid any milestones.-- Alex Lash

Thanks to Denise Peterson for this week's lead section.

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