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Showing posts with label Crucell. Show all posts
Showing posts with label Crucell. Show all posts

Friday, September 17, 2010

DotW Contemplates the Beginning of the End for Genzyme


The biggest deal of the week wasn't a chart-topper just because of its size. It was also likely the tip of a much larger iceberg.

We're talking about Genzyme's sale of its genetic testing unit to Lab Corp. for $925 million. Combined with 1,000 layoffs at the big bio, the spinout of the unit -- at a price 30% to 40% higher than at least one analyst expected -- could be a big step toward getting Genzyme ready for a sale. It comes a year and a half after serious manufacturing problems at a Boston-area plant were first disclosed in early 2009, an event that opened top executives to criticism from tub-thumping shareholders.

Now, our chilly choice of metaphor a few sentences ago might lead you to think that anyone steaming toward a rendez-vous with Genzymic destiny could be making a mistake of Titanic proportions. You, dear reader, must let your powers of speculation be your guide. We're certainly not ones to scream at Chris Viehbacher to pull hard alee, or astern, or throttle the jibbers, or whatever you're supposed to say to a ship's captain who needs a course correction, fast. Sanofi has offered $69-a-share, but it could take an offer of $75-a-share to bring Genzyme to the negotiating table, analysts told our Pink Sheet colleagues this week.

Viebacher doesn't seem ready to rush headlong into anything, let alone a $18.5 billion disaster. After all, Genzyme is less an iceberg -- although you have to wonder if other manufacturing nightmares still lurk beneath the surface -- than a collection of islands, which like the Galapagos, have inhabitants that have evolved quite separately, and in some cases, more successfully than others. (We leave it to you to sort out the finches from the tortoises and figure out what the hell to do with the feral goats.)

The sale of the genetics business, combined with the planned sale of the diagnostics and pharmaceutical intermediaries units, don't automatically point Genzyme toward M&A. Nor do the layoffs. The Cambridge, Mass. biotech has plenty of reasons to shift resources around, whether it's hiring more in manufacturing to shore up quality control or amassing cash for a share buyback. The firm raised debt this summer to fund the first tranche of the buyback, and the Genetics unit sale will pay for the second tranche, Genzyme said. But CEO Henri Termeer has publicly said there's a "high probability" of a deal with Sanofi, so every move Genzyme makes from now on must be viewed in that context.

For Sanofi, the sell-off of Genetics and the other two businesses would make for a cleaner eventual acquisition of Genzyme, but otherwise shouldn't make much difference, as they're tangential to the French pharma's interests. Sanofi is willing to wait. Viehbacher said as much at a conference this week: "I don't think they are in a hurry and neither are we in hurry. I don't see anybody else coming into the deal, so that's not pushing anybody in terms of speed."

The wild cards, of course, are the shareholders. Viehbacher spent last week meeting with Genzyme's. Termeer has said his board, which includes dissident investors who agitated their way into the boardroom, is adamantly opposed to the current offer at $69 a share. And don't forget Sanofi's shareholders, which include French corporate titans L'Oreal, the cosmetics company, and the oil firm Total. They haven't revolted, but it seems they're casting a wary eye on the proceedings.

Viehbacher has already served notice early in his term that he'll only appease shareholders so much -- dividends yes, buybacks no -- so how he handles the Genzyme situation, given his previous pledges of no purchases over $20 billion, could be the defining moment of his tenure.

Same goes for Termeer, who was on the buying end of many acquisitions as he built Genzyme over twenty five years into the powerful but hodgy-podgy (or, if you prefer, "diversified") business it is today. He may well come to the end of his term as the big biotech's mastermind, even if Sanofi bows out. Should a deal not transpire (we'll keep the "NO DEAL!" JPEG warm), Genzyme's share price will likely sink back to the pre bear-hug level of the low $50s. With the activist shareholder presence on Genzyme's board, does anyone really believe Termeer can keep his post if the deal doesn't get done?

AstraZeneca/University College London and Cancer Research Technology: AstraZeneca this week revealed a pair of new arrangements to advance its stem-cell research targeting blindness related to diabetes and, separately, its oncology program. The Big Pharma said it will collaborate with researchers at University College London, led by Dr. Marcus Fruttiger, in a three-year partnership to explore uses of regenerative medicine to address diabetic retinopathy, a leading cause of blindness which afflicts about a quarter of Type I and more than half of Type II diabetes patients. The collaboration echoes Pfizer’s ophthalmological research deal with UCL, in which the two are searching for new therapies for age-related macular degeneration. AstraZeneca also said UK-based charity Cancer Research UK and its partner Cancer Research Technology would perform a Phase I/IIb clinical trial on oncology candidate AZD-3965, an inhibitor of the monocarboxylate transporter 1 (MCT1) that is crucial for cell metabolism. Once the trial is completed, AstraZeneca will retain a right to further develop the drug, or offer it to CRT to seek a different partner; the charity will receive a royalty on the drug’s revenues if it’s ever approved, regardless of which company develops it further. -- Paul Bonanos

Merck/Beijing Genomics Institute: With the president of Merck Research Laboratories Peter Kim in attendance, the Beijing Genomics Institute this week announced the signing of a statement of intent to form a working relationship with Merck. The organizations aim to utilize BGI’s high-throughput DNA sequencing and analysis capabilities in a research collaboration, primarily to analyze genomic and epigenetic data generated using Merck samples. “The key is epigenetics,” said one person familiar with the discussions. The deal comes at a time when several US-based next-generation sequencing companies are trying to establish a foothold in drug discovery, including current IPO hopefuls Complete Genomics and Pacific Biosciences, while also aiming at the more lucrative clinical diagnostics market down the road. At the same time, academic genome sequencing centers are operating more frequently as businesses, competing with commercial entities in terms of cost, throughput, and accuracy. For its part, BGI currently boasts a combined sequencing and bioinformatics staff of just under 4000, including 1500 bioinformaticians, and it expects to boost the overall number to 5000 by year-end. Given the scale and complexity of genetic information and the speed at which it is being obtained, a relationship with BGI could offer significant advantages, including on the regulatory front. “From the patient standpoint, we risk getting scooped by others outside this country, whether we are then sending the results to BGI in China to be interpreted or some other offshore thing,” cautions one CSO. -- Mark Ratner

GenMab/Seattle Genetics: The Danish firm GenMab has licensed Seattle Genetic's antibody-drug conjugate (ADC) platform to use with its own HuMax-TF antibody technology to develop drugs that target the Tissue Factor antigen. GenMab is responsible for all research, manufacturing, preclinical development and Phase I trials of ADCs that combine the two technologies. At the end of Phase I, Seattle Genetics has the right to opt into co-development and share all costs and profits fifty-fifty. If Seattle Genetics does not opt into a compound, GenMab would pay fees, milestones, and single-digit royalties on worldwide net sales. GenMab is paying Seattle Genetics an undisclosed upfront fee. The Seattle, WA-based biotech's ADC technology links cell-killing agents to antibodies to deliver precise payloads to tumor cells while leaving, in theory, healthy cells undisturbed. Its molecules have yet to reach FDA approval, but its lead, brentuximab vedotin, is in Phase III for Hodgkin lymphoma. The collaboration comes as GenMab shifts development focus on its flagship anti-CD20 product Arzerra (ofatumumab) to subcutaneous autoimmune indications. More accurately, GenMab's partner GlaxoSmithKline will make the shift, as it holds development rights to the compound. The partners amended in July their long-running collaboration to give GSK the autoimmune rights, a move that paid GenMab £90 M at the forfeit of development milestones. GenMab still helps pay for oncology development, but its contribution is capped at £145 M total. -- Alex Lash

Santarus/Pharming Group: Faced with a cash squeeze, Dutch protein therapeutics developer Pharming Group inked a deal with San Diego-based Santarus to license Pharming’s late-stage orphan drug Rhucin (conestat alfa) in North America. Santarus will obtain rights to Rhucin, a recombinant human C1 inhibitor which alleviates swelling related to hereditary angioedema, for $15 million up front, plus $5 million if and when the FDA grants approval of the drug’s biologic license application. Further milestones, including ones based on sales goals, are also built into the agreement. Pharming will still be in charge of obtaining approval of the BLA in the U.S., while Santarus will address regulatory hurdles in Canada and Mexico. In April, Pharming dealt away Rhucin’s distribution rights in 24 European countries to Swedish Orphan Biovitrum for an undisclosed amount. The upfront payment will help Pharming deal with a cash flow crunch due to a bond debt payment owed in the fall. Separately, Santarus said it had obtained Covella Pharmaceuticals and its anti-VLA-1 antibody program for $1.8 million plus royalties, future considerations and other expenses; that deal also includes an amended agreement with Biogen Idec, from which Covella licensed the program in January 2009. -- Paul Bonanos

Johnson & Johnson/Crucell: The far-flung Johnson & Johnson health care empire may be adding a vaccines unit as J&J bid €1.75 billion (about $2.3 billion) to buy Crucell NV on Sept. 17. The pharma giant said that if the deal goes through, Crucell would continue to operate as a subsidiary, retaining its facilities, ongoing programs, senior management and its “entrepreneurial culture that has fostered innovation and growth.” J&J’s bid works out to roughly €24.75 per outstanding share of the Netherlands-based vaccine maker, nearly a 58% premium over the closing price of €15.70-a-share on Sept. 17. Recall that in September 2009, J&J acquired a 17.9% stake in Crucell for €301.8 million, a 28% premium, in a transaction that also partners the two companies on an effort to develop a universal monoclonal antibody against all types of influenza A. That deal included a standstill agreement specifying that J&J would not attempt to increase its holding in Crucell for at least three years, but the acquisition bid is going forward as a mutual effort between the two companies. In a joint release, the companies indicated J&J’s board of directors and Crucell’s supervisory board have authorized the negotiations to proceed. This is not the first time a big pharma company has tried to acquire Crucell--Wyeth made a bid estimated at €1.35 billion in early 2009 but dropped the effort when it was bought out by Pfizer.--Joseph Haas

Photo courtesy of Flickr user Rob Lee.


Friday, April 09, 2010

Deals of the Week Pines for the Magic Number

Numbers are good. A couple of our favorites are 3 and 0, which happens to be the win-loss record of the San Francisco Giants after their opening series. We also like 59, the number of points Butler University scored against the Duke Blue Devils in Monday's NCAA championship game. Unfortunately Duke scored 61, prompting Butler fans the world over to ask head coach Brad Stevens -- who briefly had a marketing job at Eli Lilly before he joined Butler -- if he still had Prozac or Cymbalta samples to hand out. (If Stevens is fresh out, fans can just go to the Lilly Web site.)

We're thinking somberly of other numbers this morning: 34, the years John Paul Stevens will have served on the Supreme Court after his upcoming retirement, and 4, the number of miners still missing but possibly alive in West Virginia.

Our mind wanders to numbers in the wider world because here in the little sphere of biopharma deal-making, numbers were a wee bit hard to come by this week. Only one of our four chosen deals disclosed figures we could sink our teeth into, and even then it was all biobucks. Bah humbug!

Good thing, then, the deals this week were rich with more important things in life--unmet medical need for old scourges (malaria vaccine and tuberculosis) and cutting-edge science (stem-cell manipulation). We're all antsy to get our weekend started, so it's a-one, and a-two and...



Pfizer/MicuRx/Cumencor: With its April 6 deal with two biotechs to develop novel treatments for multi-drug resistant tuberculosis (MDR-TB), Pfizer not only addresses a critical unmet need in Asia but gains even more of a foothold in a key emerging market. Outside the developed world TB is an enormous problem, resulting in 5,000 deaths a day. China is a hotspot, with more than 25% of all cases of MDR-TB. The deal with US-China hybrid MicuRx and China-based Cumencor calls for Pfizer to provide an upfront payment, preclinical research funding, and downstream milestones linked to a drug’s development and commercialization. Specifics weren't disclosed, but even if the upfront money isn’t huge, it should push molecules well into the clinic since all the development work will be performed in Shanghai. For MicuRx, the agreement validates the biotech’s proprietary antibiotic discovery platform and is the firm's first deal since its $10 million Series A led by Morningside Group in 2007. For Pfizer, the deal highlights its interest in Asia-prevalent diseases, including head and neck cancer. In February, Pfizer signed a precompetitive deal with Lilly and Merck to form the not-for-profit the Asian Cancer Research Group. This week Pfizer highlighted its R&D efforts in Asia and its desire to increase the number of Asia-based clinical trials by 10%.--Ellen Foster Licking

Sanofi-Aventis/CureDM: Sanofi is in-licensing an early-stage compound with potential to restore a diabetic's ability to produce insulin and other pancreatic hormones, the company announced April 8. It is paying up to $335 million, plus sales royalties, to CureDM, a heretofore low-profile six-year-old startup, for global development and commercial rights to the novel human peptide, Pancreate. The firms did not break down the distribution of payments. The deal marks another move by Sanofi to bolster its diabetes business and eventually lessen its reliance on sales of its leading long-acting insulin Lantus and the short-acting insulin Apidra. It comes only a week after the Big Pharma bulked up the drug delivery portion of its leading diabetes franchise by entering into a deal with another small biotech, AgaMatrix, for blood glucose monitors.--Carlene Olsen

Fate Therapeutics/Verio Therapeutics: The San Diego stem-cell firm Fate bought a Canadian startup -- two scientists and their CEO, really -- for an undisclosed amount to bolster its efforts to develop drugs that push adult stem cells into therapeutic behavior. Fate has the small-molecule FT1050 in Phase 1 as a treatment to stimulate a cancer patient's hematopoietic stem cells to replenish after a cord blood transplant. Verio's scientists, based at a research hospital in Ottawa, are investigating protein-based drugs that encourage regeneration of cardiac, pancreatic and skeletal muscle tissues. The therapies could help repair damage due to heart attack, diabetes and muscular dystrophy. Verio CEO Frank Gleeson told "The Pink Sheet" DAILY that of Verio's preclinical compounds, the cardiac program has the clearest path to reaching the clinic. Verio has pulled in $1 million in seed funding; joining Fate lets it hire a few more scientists by year's end, Gleeson said. Fate in November closed a $30 million B round and execs say the cash should last for another year and a half, even with the Verio purchase. In addition to drug development, Fate aims to create a supply of induced pluripotent stem cells that it can license as discovery tools to drug firms.--A.L.

GlaxoSmithKline/Crucell: The two firms said Apr. 6 they would join forces on a next-generation malaria vaccine by combining two existing vaccines, but they'll need outside help to pay for it. Terms weren't disclosed, but the firms will each contribute a vaccine candidate and seek third-party funding for clinical trials. If a Phase I/IIa trial is successful, they will ask for financial help from public or non-profit partners to push into later-stage trials. The deal follows a 2003 agreement GSK and Crucell signed with the Walter Reed Army Institute of Research to test their then-preclinical vaccines both as standalone and combined candidates. Data suggested a combined approach would be more effective. Malaria is the fifth deadliest infectious disease in the world, and second deadliest in Africa. The agreement is the latest in a series of R&D tie-ups by the Dutch vaccine maker, which has benefited from going against industry trends and expanding its R&D footprint. --A.L.

Photo courtesy of flickr user fringley.

Wednesday, February 10, 2010

Crucell: Revving the R&D Engine

You have to feel sorry for biopharma R&D chiefs these days. As cash flow and profit-and-loss sparing efforts become de rigueur, it sure seems like the CFOs are in the drivers' seats with the R&D heads strapped into the passenger seat along for a very bumpy ride.

There's no question folks like Pfizer's wonder twin powers, Martin McKay and Mikael Dolsten, and GSK's Moncef Slaoui are being asked to do more with a shrinking R&D pool. AstraZeneca, too, is rethinking its R&D approach, putting greater emphasis on externalization thanks to a restructuring to create 8 innovative medicine units (or I-Meds, a very Apple-like parlance).

To be fair, when a company like Pfizer announces its winnowing its R&D budget from $11 billion to $8 billion, there's still some serious cash going to internal programs. But it's an interesting example of cognitive dissonance when R&D heads admit "yep, we're all about innovation AND we're shrinking R&D."

Thus, it was practically shocking to hear a public mid-sized company--European no less--vocally declaim its intention to plow signficant cash resources back into its R&D efforts on the same day that GSK offered more clarity on coming pink slips.

The company revving it's R&D engine? Dutch vaccine maker Crucell, who reported on its Feb. 9 year-end earnings call cash and short-term liquidities of about €428 million. Given the company's laden coffers (continued strong operating cash flow in CFO-speak), Crucell's CFO Leo Kruimer told investors: "We've made a conscious decision to increase R&D spending and development spending especially by as much as one-third vis-à-vis this year, while we maintain a very healthy operating profit."

Say WHAAAT? You mean there's no dividend? (Maybe that's the reason the stock was off even after the company reported better than expected numbers.)

Crucell, unlike many other biopharmas, has had a very good year. For starters, vaccines are a hot commodity as nearly every big pharma sees the importance of diversifying into this arena. Crucell has leveraged the interest into a number of lucrative partnerships, including a $70 million contract with NIAID/NIH to develop infectious disease vaccines, and the big kahuna, an alliance with Johnson & Johnson in September 2009 that included an 18% equity stake worth $443.5 million for Crucell.

Indeed, it's the partnership with J&J--now undeniably Crucell's big brother--that has removed the quarterly earnings pressure (at least for a little bit), allowing more resources to flow to R&D. Calling the balance sheet "magnificent" Crucell CEO Ronald Brus said, "With the right investments and the right people we should be able to do things quicker...and why we did invest a lot in new leadership in that R&D arena." (For those keeping count, Crucell increased R&D personnel by 120 in '09.)

But it likely won't be just internal R&D that benefits from the cash. Most analysts predict Crucell will bolster capabilities via acquisitions (sound familiar?) as it tries to out-gun competitors such as Panacea Biotech and Shantha Biotechnics.

Brus dodged a direct question on the matter from Needham analyst Alan Carr, averring,"We're not looking for acquisitions to fill our pipeline because I think our pipeline has never been as full as it is today." Instead the focus will be on deals that "could significantly improve revenues and profit of the longer run."

In a follow-up interview with Reuters, Brus clarified Crucell's current thinking. "If we would make an acquisition, it would be of a profitable product or products that are very close to being launched on the market rather than a pipeline product," he said.

Ah.

It will be interesting to keep tabs on Crucell in the coming months, especially if future deals vault the biotech into Big Pharma's realm of must-have acquisition targets. The great irony, of course, being that much of Crucell's new found vigor is a direct result from being left at the M&A altar in early 2009.

Till then, you science types looking for new digs? Try Crucell, who's apparently not afraid to burn some R&D rubber.


(Image courtesy of flickrer shyha used with permission through a creative commons license.)