After months of waiting on edge -- dare we say with its heart all a-flutter? -- Vancouver-based Cardiome Pharma said Dec. 29 that its partner Merck & Co. has "confirmed its plans for development" of an oral formulation of Cardiome's atrial fibrillation compound vernakalant.
Merck's decision gives Cardiome a lifeline it wasn't sure it had. Merck was supposed to start Phase III clinical trials in summer 2010, but those plans were delayed because Merck "continue[d] to optimize the clinical plan," Cardiome CEO Doug Janzen told analysts in August. Investors took that vague explanation with the same skepticism that greets a sports team owner's assurance that a troubled coach's job is safe; Cardiome's stock price lost nearly half its value in the three months following Janzen's description. (A setback in its injectable vernakalant program in October didn't help, either.)
Vernakalant, which would be used as maintenance therapy to prevent recurrence of AF in people with a history of the condition, is important for Merck, but it's crucial to Cardiome. The Canadians have no other notable mid-to-late-stage assets in their pipeline except for the IV formulation, which this summer received EU marketing authorization under the brand name Brinavess. In the US, where it is in Phase III trials, Astellas Pharma has development and commercial rights.
Janzen said in August that Merck was being "very, very thorough," "thoughtful," and "big" -- a reasonable proposition, he said, given the $250 million estimated price tag of a late-stage global cardiovascular program and the number of internal committee reviews a behemoth requires for even a modest change of course. After all, the asset had survived the gauntlet of Merck's internal review after its acquisition of Schering-Plough.
Now Cardiome says in a release that Merck has completed another review and that "we [at Cardiome] look forward to working with them as they advance the vernakalant (oral) program to maximize its potential." The release didn't elaborate on what those next steps will be, but Janzen has previously observed that Merck is looking only for a first-in-class, best-in-class compound, so its trials will have to demonstrate superior heart rhythm maintenance to Sanofi's Multaq, against which it will compete. "That is the question to ask and will likely be the basis of the clinical program," he said at a Piper Jaffray conference in New York in December. Whether that program would include an outcomes study or head-to-head clinical trials, isn't clear - but that could be where the clinical program is headed.
If at first you don't succeed, buy buy again. That could be Roche's diabetes motto these days.
The Swiss drug and diagnostic giant told our Pink Sheet colleagues Wednesday, Dec. 29 it has agreed to buy Marcadia Biotech, a private Indiana outfit that has already struck a couple Big Pharma partnerships, most recently licensing a preclinical glucagon analog to neighbor Eli Lilly & Co. for use in an injector pen.
Marcadia's lead program MAR701, a GLP-1/GIP dual agonist, is in Phase I, so it has a long way to go to replace what was Roche's most advanced experimental diabetes asset, the Phase III taspoglutide. Roche pulled the plug on trials of the drug earlier this year. At a conference in October, Roche's top clinical executive for metabolism Anders Svensson said insurers have set a much higher bar for Type-2 diabetes drugs, and that developers must do more than just demonstrate glycemic control: "For now diabetes is not nearly as attractive as it was a couple of years ago."
No financial details were forthcoming about the Marcadia buyout. We'll have to wait until Roche's next quarterly earnings call, a spokesman said. But "The Pink Sheet" Daily has more on the story, including reaction from Kelly Close, an industry consultant who first reported the merger in her newsletter. -- Lisa LaMotta
Just wanted to jump in and let you guys know that Katie and I are gearing up for Jonah's EB Auction Fundraiser. Last year's was amazing, and we hope to make it an annual event. We are so excited to get started! Last year, Katie had a vision of hopefully having 20 items and raising $1,000. Well, God and you guys knocked our socks off with your generosity, and we had around 130 items donated and raised close to $9,000 for DebRA. How 'bout them apples? We would love for this year to be even more successful (and even more fun, if that's possible), but we need your help to do it. Do you have anything you could donate? You can hand-make an item or donate new, bought items. Not sure what to donate? You or your company can donate a gift card to a restaurant or spa or even a gift card for a gas station or grocery store. Put your thinking caps on.
The auction will run from Thursday, February 24th at 8:00 pm to Sunday, February 27th (Jonah's birthday) at 8:00 pm. (Whatever 24 X 3 is) blissful hours to shop without guilt and to raise money for a cure for EB!
If you are interested in donating items or some money for shipping costs (any money we don't have to spend on shipping goes to DebRA!), please email Katie at jonahsebauction(at)gmail(dot)com, and she will get back with you. We need to know what you'd like to donate and the value of the item. Katie will let you know the details from there. WOOHOO! Check out the auction site HERE to see how last year went.
Secondly, my EB friend, Janel (the one who did Jonah's AWESOME birthday cake) is hosting a fundraiser for DebRA right now. She sells Thirty One products and is offering a large personalized thermal tote for $20 or a personalized lunch tote for $18, and at least $7 from each bag goes directly to DebRA! Click HERE to see the bags, patterns, and font choices. If you are interested, you can print out and complete the order form HERE and mail her a $20 or $18 check to: Janel Waters, 912 S. Forest Creek Dr., St. Augustine, FL 32092. You can email Janel at janelwaters(at)comcast(dot)net with any questions. Oooohhh, I just had a thought. What if you bought a bag, $7 went to DebRA and then you turned around and donated it to the auction??!! Sorry, I'm getting carried away. I'll stop now.
Happy Shopping and don't forget to email Katie with your donation ideas! I can't wait! Oh yeah, Jonah's EB Auction has a page on Facebook. Click HERE to "like" it! Alright, I'm getting link happy. I'm really going to go now. I think I need a cold shower and possibly some Cheetos.
I started to do a Christmas post, but then I realized I took so many photos (and I have an "I can't delete photos even if they're blurry or I have five of almost the same exact thing and also I have to edit all my photos even if the edits look almost as crappy as the original" syndrome), I'll have to split this up in a couple posts. Basically, we had a wonderful time with Matt's family. There was the normal Jonah stuff we always have to do, but there was plenty of relaxing, book reading, Scrabble playing, way too much eating, laughing, talking, sleeping etc. I can't tell you how nice it was to be away from the house for a few days and to have so many family members who wanted to help out with and entertain Jonah. I love Matt's family so much, and I feel so blessed that God put me with them. And Jonah was a pure joy and so much fun. I LOVE THIS AGE! Every day I treasure it all up in my heart, trying to hold on to all his cuteness and hilarity. He seriously is such a charmer and I am completely in love and enamored with this child. (I'm going to pretend he's always going to be like this and he won't pitch fits, talk back, bite his friends, or find me embarrassing... let me bask in my denial.)
So anyway, I thought I'd start with the most important part of Christmas - the loot Jonah scored. (Just kidding, of course.) But seriously, this kid is spoiled rotten, and I'm pretty sure he has the most toys of any child on the face of the planet. Okay, maybe not as many as Tripp, but he's coming in a close second. I have many more meaningful and better photos to share, but that will come later, due to the aforementioned photo syndrome.
Oh yeah, before we get too materialistic, I wanted to show you how great Jonah's face looked on the 24th.
And this was the 26th. Both are pretty amazing compared to the last ones I posted, huh? God is good!
Now to the stuff (and this was only a portion of it...)
Rumblin' Chuck Truck (that he was slightly scared of at first).
Jungle thingy. Don't remember the name, but little animals with wheels slide down the path. Cute.
Jonah took a small break from "getting" to walk for the first time.
Stocking stuff: some books...
... and a wooden train... it would appear Santa did his stocking shopping at the dollar bin at Target.
The big one - a Fisher Price Laugh and Learn Something Something Pony.
Santa may have gotten this one more for Daddy than for Jonah, but I think it will bring them both lots of joy for the next several years. It's going to start out in Jonah's bedroom if we can do some rearranging and find a spot to put it.
A geometric shape stacker. I really like this. Jonah agrees.
A surprise gift from Granny and Grandaddy - a Power Wheels! (Which he was TERRIFIED of at first and only moderately scared of now.)
A Little People Barn. (Hat not included.)
And this, Friends, is what my living room looked like after we unpacked today. Did I mention we have two more Christmases on Saturday? And did I also mention that the two ottomans shown (and another one off the kitchen, not shown in the photo), are already full of toys? Yep, we have some serious sorting, organizing, and redistributing to other rooms to do. Can you even spot Jonah?
Seriously though, this child is so loved and toys or no toys, he'll never feel lonely or unloved. That's our promise to him - no matter what you go through or how much you endure, no matter our financial situation or where we live, no matter how much you have or how little, no matter what, you will NEVER think you are unloved or wish you had different parents. (Well, you may wish that but it won't be because we don't love you enough... it'll be because we won't let you get a cell phone at the age of eight or because we'll make you do your homework before you turn on the TV... but not because you don't feel loved.)
I hope you all had a very Merry Christmas. I'll be back with more (and more walking videos) soon!
There was more bad news on Dec. 27 for those developing anti-nerve growth factor (NGF) drugs: U.S regulators put Regeneron's candidate REGN475, in development with Sanofi-Aventis, on hold late last week, Regeneron said in a regulatory filing Monday.
The latest setback for an NGF inhibitor was triggered by a patient in another company's trial developing a serious bone disorder, known as avascular necrosis. It's caused when a lack of blood supply causes bone tissue to die.
Following similar concerns around other NGF-targeting drugs in 2010, it's no surprise that by now FDA believes the whole class of drugs could be unsafe. Regeneron says as much in its filing: "The FDA believes this additional case provides evidence to suggest a class-effect." No word yet if or when REGN475, also known as SAR164877, will get a green light, but Regeneron noted that there are no current trials of the drug either enrolling or recruiting patients.
Trials in osteoarthritis pain of Pfizer's anti-NGF candidate tanezumab, believed to have been the most advanced in development, were put in hold in June 2010 following FDA concerns that a number of patients' osteoarthritis symptoms were worsening, rather than improving. In some cases this led to joint replacements. Because of the hold, Pfizer terminated most of its tanezumab trials earlier this year, but it is pressing on with two trials to study the drug, one in combination with opioid medication, the other as a standalone treatment in patients with chronic pancreatitis, according to clinicaltrials.gov.
None of this will provide much Yuletide cheer to the likes of Abbott, which paid a whopping $170 million up-front for PanGenetics' Phase I anti-NGF antibody last year, or AstraZeneca, whose MedImmune subsidiary has a Phase I stage anti-NGF antibody for osteoarthritic pain in the knee. J&J picked up a similar candidate from Amgen in 2008. [UPDATE: AZ and J&J have in fact suspended their programs, reports Bloomberg.]
Also in the pain domain but more positive was the news that King Pharmaceuticals and Pain Therapeutics' re-submission of abuse-resistant oxycodone (Remoxy) was accepted by FDA. This time, Pfizer will be pleased: it has agreed to buy King for a cool $3.6 billion. Image by flikrer johnnyalive used under a creative commons license.
I don't have long, but I just wanted to let you know, if you don't follow me on Twitter, that Jonah took his first steps on Christmas Eve. It was the best gift we could have asked for, and we continue to be amazed and thank God for all Jonah is able to do. (In the nature of Jonah, he waited to start walking until he had a huge crowd around who applauded him thunderously every time... he hasn't really done it since.)
Thanks to Aunt Katherine's sweet daddy for these videos. I'll have more once I get mine off my video camera. I know you'll be waiting on the edge of your seat to see him do the same thing over and over again from a slightly different angle.
On the face front, things are SO MUCH better. The night of the 23rd, he was still looking so rough, but we went to the Christmas Village thing anyway, thankyouverymuch. The morning of the 24th, his nose and cheek were completely healed with the scabs coming off. It seriously was an overnight miracle. His top lip is still rough and he has one big one left on his forehead, but it's scabbed and not causing him any pain. Thank you so much for your prayers. I know that they are what healed him.
Love you all. MERRY CHRISTMAS! (I'll have photos when we get home but we got snowed in for one more day. I can't say that I'm upset about it.)
Santa baby, slip an NDA under the tree for me, It’s been such a transformative year Santa baby, so hurry down the chimney tonight.
Santa baby, we’ll take some convertible debt – I bet We’ll roll it into a Series B before long Santa baby, so hurry down the chimney tonight
Think of all the M&As! Are IPOs a choice for biotech pure-plays? Next year, the milestones will come An exit by earnout, baby, that’s the new way.
Santa baby, our ex-US rights we’ll shop, you’ll drop Cash upfront plus biobucks Santa baby, so hurry down the chimney tonight!
IN VIVO Blog's Deals of the Week crew wishes you a happy and healthy 2011. In the meantime, sign your X on the line just like Eartha says, and point your sleigh toward...
Pfizer / Lpath: If you're on an L-path, and you cross two bridges, you arrive at Pfizer. That's this week's DOTW Zen koan. First, grasshopper, the deal: Pfizer paid the San Diego biotech $14 million for an option for worldwide rights to its Phase I wet AMD antibody Isonep, and it will split costs of upcoming Phase Ib and IIa trials. Pfizer will then have an undisclosed period of time to decide if it wants to fully take over Isonep. If it does, it will pay an undisclosed option fee, plus milestones up to $497.5 million and tiered double-digit sales royalties. Pfizer also gets a time-limited right of first refusal to another antibody Asonep, which Lpath plans to move into a pair of Phase IIa trials next year. During a call Dec. 21, Lpath CEO Scott Pancoast said Pfizer would have roughly two to three years to decide whether it wants to acquire the cancer candidate. Oh, the bridges? The first was a National Cancer Institute "Bridge" grant Lpath received in 2009, a new form of small-business grant to help life science companies make headway on translational projects and reach the clinic. The second was a $5 million private placement (7 million shares at 70 cents each) Lpath announced in November. Each investor also got two-year warrants to buy half again as many shares as they bought in the placement. Lpath's closing share price Dec. 22 was $1.02. -- Alex Lash
Biogen/Neurimmune: Neurimmune received its Christmas present early this year, but will investors? On Dec. 21 came news the Swiss biotech was selling three preclinical neurodegenerative programs to Biogen Idec for $32.5 million upfront and another $395 million in milestone payments. As part of the deal Biogen takes on responsibility for all further development—and importantly cost—for the compounds, which target the neurotoxic proteins alpha-synuclein, tau, and TDP-43.If Biogen seems enamored with Neurimmune’s proprietary Reverse Translational Medicine platform (this is the second time its inked a deal with Neurimmune), it’s a sure bet the biotech’s founders, Karsten Henco and Edward Stuart of HS Life Sciences aren’t complaining. The two gentlemen staked the company with $6 million nearly four years ago, and haven’t had to put in another dime, letting the partnerships fund the company’s growth. (Now that’s capital efficiency.) IN VIVO couldn’t determine if Neurimmune will pull a Knopp and return cash to Messieurs Henco and Stuart, but, by itself, the Dec. 21 upfront would seem to yield a tidy exit. Meantime, the deal is in keeping with Biogen Idec’s strategy of “focused diversification,” pretty words suggesting the company’s desire to amass capacity in areas closely related to its historical strength in multiple sclerosis. Alas, the very early nature of Neuroimmune assets means they can’t do anything to help Biogen, which is overly dependent on franchise products Avonex and Tysabri, from a revenue stand point. The need for additional marketed or very late stage clinical products suggests Biogen, which is in the process of hiring a new head of corporate development, could be on the prowl for bigger deals. It would be good to start 2011 off with a strong DOTY candidate, wouldn’t it?—Ellen Licking
GlaxoSmithKline/Proximagen: Santa baby, just slip an alpha-7 nicotinic acetylcholine receptor modulator under the tree for me. (Okay, so the rhyme scheme doesn’t really work.) We interrupt Santa’s mad dash around the globe to report a big pharma out-licensing event. Despite all the highfalutin talk about the need to balance the internal R&D spend with financing from external partners, big pharmas haven’t really demonstrated a willingness to out-license. GlaxoSmithKline, which spun out two investigational pain products into a new CNS company called Convergence Pharmaceuticals earlier this year, is one notable exception. This week comes news it’s out-licensing two development programs targeting cognition disorders and Parkinson’s disease to the British biotech Proximagen. Even though GSK notified the biopharma community in February that it was exiting certain CNS areas like depression, anxiety, and pain, it sounds like the asset transfer wasn’t for the faint of heart. According to “The Pink Sheet” DAILY, it still took nearly a year for Proximagen to get the compounds, which are positive allosteric modulators of the alpha-7 nicotinic acetylcholine and dopamine D1 receptors, out of the big pharma.Financial terms of the deal weren’t disclosed.--EL
Sanofi/Ascendis: Sanofi continues its bid to become an end-to-end player in the diabetes space, inking a drug delivery deal this week with specialty player Ascendis Pharma. The global licensing and patent transfer agreement gives Sanofi access to Ascendis’TransConLinker and Hydrogel carrier technology, which are designed to release molecules in the body in a precise, time-controlled fashion without the initial burst and high drug load that can come with other formulations. That would, of course, be a real boon in creating a better version of insulin. Sanofi currently has a lock on the long-acting insulin market with its juggernaut Lantus, but Novo Nordisk is giving the company a run for its money with competitor Degludec. Formulation changes to improve Lantus’ delivery would be one means of extending the life cycle of one of Sanofi’s most important products—and the only one not facing near-term patent expiration. The strategy also borrows a page out of Novo’s playbook. The Danish firm has used a strategy of incremental large molecule innovation to build its dominant position in insulin.--EL
Pfizer/Phylogica: Australian peptide drug discovery specialist Phylogica has struck its third licensing deal in the past year, agreeing to allow Pfizer to discover peptide-based vaccines using its proprietary platform. Pfizer will pay just $500,000 upfront for the license, but downstream payments, options and royalties of undisclosed size could potentially drive the deal’s value as high as $134 million. Founded in 2001, the Perth-based company has also signed separate licensing agreements with Roche and AstraZeneca’s Medimmune subsidiary. The Roche deal covers a mechanism allowing large molecules to attack disease targets inside of cells, while the MedImmune deal addresses antimicrobial peptides that attack the Gram-negative bacterium Pseudomonas aeruginosa. The latter deal, revealed in August 2010, includes a small upfront commitment of just $750,000 plus a 12-month commitment that will double that amount.—PB
Gilead/Arresto: Gilead Sciences took a step beyond its traditional focus in infectious disease by acquiring Palo Alto, CA-based Arresto Biosciences, which is developing disease-modifying drugs that target extracellular enzymes to treat fibrotic disease and cancer. The deal’s price tag is a robust $225 million and includes potential earn-outs; that’s striking in a period when pharmas have shown a greater interest in alliances than acquisitions and is also notable given the development stage of Arresto’s assets. Arresto’s lead candidate is a Phase I drug for idiopathic pulmonary fibrosis, a condition in which the lungs become scarred for unknown reasons. If approved, its compound AB0024 would be the first biologic drug for the condition, currently treated only through lung transplants. This is an area Gilead knows well, having spent considerable time trying to develop its own medicine in the space, Letairis (ambrisentan). Did Saint Nick arrive with the Arresto acquisition in the nick of time? On Dec. 22, after the market’s close, Gilead announced it was scuppering development of Phase III Letairis, which only slows disease progression but doesn’t address its root cause. Arresto, which is three years old has raised an undisclosed amount from a syndicate of backers including Kleiner Perkins Caufield & Byers, HealthCare Ventures, Northgate Capital, DAG Ventures, and Abbott Biotech Ventures.--PB
Pfizer / Adolor: The name is supposed to mean "without pain," but after this week you could read it with a melancholy sigh: Ah, dolor. In its latest setback, Adolor said in a regulatory filing Dec. 21 Pfizer would sever ties three years after it licensed rights to two of Adolor's pain programs, ADL5859 and ADL5747. The termination is effective March 2011. Pfizer said during its R&D day Sept. 27 that '5859 was among several drugs it was dropping from its pipeline, but there was no mention of '5747. Still, the writing has been on the wall since June, when the companies reported disappointing Phase IIa results for both delta opioid receptor programs in osteoarthritis. Neither drug performed better than placebo.Originally signed in December 2007, the deal called for $30 million upfront, nearly $2 million in immediate R&D reimbursement, and up to $232.5 million in milestones for the two programs. The first payment was due at the start of Phase IIb trials. Adolor was responsible for development through Phase IIa, and in for the US market could look forward to a reasonable split of costs and revenues -- 60% for Pfizer, 40% for Adolor -- plus a co-promote option. For the rest of the world, Pfizer had full rights, with sales royalties going to Adolor. – AL
AstraZeneca/Abbott Laboratories: Nothing like burying bad news in the slow days ahead of a holiday. Abbott and partner AZ, which hasn’t had much good news to report recently, announced Dec. 22 that they have decided to discontinue the development of Certriad (rosuvastatin calcium and fenofibric acid), and will unwind their licensing and co-development agreement in January 2011. Certriad is a combination pill that brings together AstraZeneca's statin Crestor and Abbott's fibrate TriLipix and is meant to lower bad cholesterol and improve good cholesterol in patients at risk of heart disease. The companies said the decision was made “after careful review and consideration” of the “complete response” that was handed down by FDA in March 2010. Little information about the complete response was given to shareholders at the time of its issue, but analysts at Leerink Swan speculated a “worst-case scenario in which the FDA might require more long-term data” was a possibility. Adding credence to this assertion, AstraZeneca said in its Dec. 22 statement that “development of Certriad is no longer commercially attractive.”—Lisa LaMotta
