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Eli Lilly, Amylin and Alkermes will be holding their collective breath this Friday when the FDA will reveal whether it will approve Byetta LAR, the long-acting form of the bestselling diabetes drug Byetta. Thanks to technology from Alkermes that helps the drug stay in the patient's bloodstream, Byetta LAR can be administered just once a week rather than requiring twice-daily injections. What's at stake for these companies? Amylin has the most invested. An approval could provide the drugmaker with billions in revenues for years to come. According to the Wall Street Journal, one analyst projected $2.1 billion in sales for the drug by 2015, while another industry watcher predicts $3 billion in U.S. sales. For Lilly, Byetta LAR would boost a product lineup that's facing one of the steepest patent cliffs in the coming years. And Alkermes is set to reap 7.5 percent royalty on worldwide sales. Xconomy's Luke Timmerman maps out the four possible outcomes from the FDA's decision Friday:
Needless to say, the stakes are high for all involved. - here's the Wall Street Journal report Related Articles: Cytokinetics announced today that its drug CK-2017357 has been granted orphan-drug designation by FDA. The drug is in trials for amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease), a condition that affects about 20,000 to 30,000 people in the U.S. Cytokinetics plans to initiate a Phase II trial for CK-2017357 in ALS patients in the first half of 2010. Cytokinetics release Shares of U.K.'s Neuropharm shot up 33 percent this morning when the developer announced that its board will explore the possibility of a return of cash to shareholders. The company is still hoping to pull off a deal for its lead autism candidate NPL-2008, which it put up for sale in November of last year. "The company is continuing talks with a potentially interested party, which is in the advanced stages of due diligence, but no indicative offer has yet been received from that party," Neuropharm says in a statement. Neuropharm's shares took a beating early last year after the biotech reported that its late-stage trial for an experimental autism therapy flunked its primary endpoint. But its stock was revived upon rumors that it was getting close to a deal for NPL-2008. In its release, the company notes it has significantly reduced its cash burn and had £6.18 million ($9.2 million) on hand as of Dec. 31, 2009. - here's Neuropharm's release Related Articles: > EKR Therapeutics has announced that its executive chairman John Bailye has been appointed interim president and CEO replacing Howard Weisman, who is no longer with the company. Weisman will also no longer serve on EKR's board of directors. Release > Human Genome Sciences has named David Southwell as CFO and EVP. Release > Robert Shepard has been appointed CMO of Cornerstone Pharmaceuticals. Release > Shengtai Pharmaceutical has appointed Hu Ye as its new CFO. Release > Talaris Advisors has named Derek Lee as CFO and corporate development officer. Release > Sandoz announced the appointment of Don DeGolyer as president of the company's U.S. operations and head of commercial operations for North America. > Phillip Frost will serve as the new chairman of the board of Teva Pharmaceutical Industries after Eli Hurvitz indicated he wishes to be released from his duties. Moshe Many has stepped down from his role as interim chairman and has been appointed vice chairman. Release > Protalix BioTherapeutics has reported that Eli Hurvitz is relinquishing his position as chairman and member of the board of directors. The board has unanimously appointed longstanding member Zeev Bronfeld to serve as interim chairman. Release > Charles Lannon has been named vice-chairman of the board at Kinex Pharmaceuticals. Release > China Yongxin Pharmaceutical has announced that Hal Lieberman, Laura Philips, Bing Li and Jingang Wang were appointed to its board of directors as independent directors. Release > 3SBio has announced changes to its board of directors. Liping Xu, company founder, executive director and VP, will retire from the board and her position as a company officer. Peiguo Cong will join the board and serve as an independent, non-executive director. Novartis has put up $10 million and promised up to €700 million more in milestones in exchange for an option on Transgene's promising, late-stage cancer immunotherapy. France's Transgene will hold on to control of the upcoming Phase IIb/III pivotal trial of TG4010 that is slated to get under way by the end of this year after enrolling about a thousand patients with non-small cell lung cancer. Once Novartis gets its hands on the IIb portion of the data, the pharma giant will have 90 days to decide whether it will exercise its option on the program. The data is scheduled to arrive in early 2012. If Novartis decides to pull the trigger on the option--a deal structure that is growing increasingly common in drug development--Transgene will get a fee plus milestones along with co-promotion rights in a list of countries that includes France and China. Novartis will gain control of the program and take responsibility for further costs. "We believe this agreement represents the best way to accelerate development and create long term value for our shareholders," says Transgene CEO Philippe Archinard. "It is also consistent with the company's goal of becoming a fully integrated biopharmaceutical company as under this agreement Transgene will maintain certain commercialization and manufacturing rights." However, not everyone was impressed with the optional, uncertain terms of the agreement, andshares in the French biotechnology company went down 12 percent. "We view today's option announcement as slightly underwhelming, given that the ongoing burden of funding remains with Transgene for another two years," says Nomura Code analyst Gary Waanders. Because Novartis wants to see the outcome of a mid-stage Phase IIb clinical trial before exercising its option, Waanders said he was reviewing his "neutral" rating and fair value estimate of 21.80 euros a share. - check out the Transgene press release Related Articles:
König's fund has a history of getting in early at a developer. And as she emphatically hammered home during the rather informal hour-long exchange about corporate VC goals and objectives, Novartis' venture arm is on the lookout for game-changing technologies. An incremental, short-yardage health gain isn't the objective. Over the last year, König's longstanding interest in the cutting-edge has become an increasingly common feature in the drug development scene. As Big Pharma companies apply shock therapy to their R&D empires, it's clear that the top CEOs are focused on getting their organizations to think more like biotech organizations. If they can't become more efficient at development and shed some of the bureaucracy that has grown around their empires even as they grow bolder in their scientific objectives, then they won't be nimble enough to get out from under the avalanche of patent expirations that is tumbling their way. That process won't ever be pretty, but it is understandable. That's a lesson, though, that more biotech execs need to take to heart as well. Safety is great. Low risk is great--if you can find it, and I'm not sure you can. But if you aren't trying to change the game of health, it's going to be very difficult to find a licensing partner when you need one. Getting backing from a venture group that thinks that way is the best kind of validation you can hope for as you're going into the clinic. Thanks to everyone on the panel for a lively discussion. And we appreciated a big, receptive audience. Moving from the world of virtual, online news production to the world of face-to-face communication helps make simple truths come alive. - John Carroll twitter | email More from BIO-Europe: An FDA expert panel voted 9-3 Tuesday in favor of InterMune's Esbriet (pirfenidone), a treatment for idiopathic pulmonary fibrosis. IPF is a rare and fatal lung disease that affects approximately 200,000 people in the U.S. and Europe. If approved, Esbriet would be the first treatment for U.S. IPF sufferers. The treatment has already received approval in Japan on the condition that there will be a post-marketing period during which the drug won't be widely available until further data are available. Not all the panelists were convinced of the drug's efficacy; however, most voted that the potential benefits of the drug outweighed these concerns. "I voted yes because I've been straight down the middle the entire time. I didn't see substantive evidence of efficacy per the FDA regulations but there was clinical meaningful effect on the disease. You need to offer patients hope. If this offers a smidgen of hope, then it is worth approving," one panelist said, according to TheStreet's Adam Feuerstein. Added another, "I voted yes, opposite of my vote on the question of substantial efficacy because I don't believe there is substantial evidence of efficacy; but if I got this disease, I'd be on the next Delta flight to Japan." The FDA doesn't have to follow the panel's recommendations, but it usually does. In a conference call, CEO Dan Welch said that if the drug is approved, it may take the company some time to ramp up production. "We chose not to make certain investments in commercial or other areas of the company until we had visibility from this meeting. So one should not expect that Esbriet would be available immediately after the approval." During the call, analysts also attempted to suss out how InterMune would price the biologic if approved. InterMune also manufactures Actimmune, a treatment for chronic granulomatous disease that's been used off-label for the treatment of IPF. On-label, Actimmune runs in the range of $8,000 to $20,000 per year. When used off-label for IPF patients, the annual cost price per year shoots up to $50,000. "I don't know what you draw from that," noted Welch, unwilling to reveal the possible price of Esbriet. A final decision is expected May 4. - check out InterMune's release Related Articles: Abbott has succeeded where Biogen Idec once failed. The company announced late Tuesday that it's purchasing Facet Biotech for $450 million, or $27 a share. That's 67 percent premium over the biotech's closing price of $16.21 earlier today. Abbott says the acquisition will boost its early- and mid-stage pharmaceutical pipeline. The developer has its eyes on two primary therapeutic areas--immunology and oncology. The highest-priority program is daclizumab, a Phase II biologic for multiple sclerosis that will move into Phase III trials in Q2 of 2010. Facet is already partnered with Biogen Idec on the compound. The biotech also has oncology compounds for multiple myeloma and chronic lymphocytic leukemia in early to mid-stage trials. Last year Biogen attempted to purchase Facet, eventually making a "best and final offer" of $430 million after its initial $356 million bid was deemed hopelessly unrealistic based on the developer's cash position and pipeline. But with the support of two major investors, Facet was able to fend Biogen off, while at the same time noting that it would be open to more substantial bids from other companies. Biogen will owe Facet a big milestone on the launch of a late-stage study for daclizumab. "This acquisition will further strengthen Abbott's biologics capabilities and pharmaceutical pipeline," says John Leonard, M.D., senior vice president, global pharmaceutical research and development, Abbott. "Daclizumab is a promising treatment for multiple sclerosis, a disease that has a significant unmet medical need, and has the potential to become an important treatment option for patients. We continue to explore multiple mechanisms to treat autoimmune diseases and cancer with both biologic and small molecule approaches." Abbott has been on a buying spree as of late. It spent $10 billion on new acquisitions last year, paying $3 billion for Advanced Medical Optics and $6.6 billion for the prescription drug business of Solvay. - here's Abbott's release Related Articles:
> San Diego-based Tocagen has raised almost $7.8 million from 75 investors in a Series D round of financing. Article > The FDA has granted ISTA Pharmaceuticals NDA for XiDay a PDUFA date of October 16, 2010. The company's request for a shorter, six-month priority review is still under consideration by the agency. ISTA release > INSYS Therapeutics announced positive results from the pivotal phase III efficacy trial for patients utilizing the Fentanyl Sublingual Spray (SL Spray) technology to treat breakthrough cancer pain. INSYS release > Amgen plans to sell $1 billion of senior notes in a two-part sale, reported IFR, a Thomson Reuters service. Report > Stirling Pharma, an Australian group, has taken over North Sydney-based Keata Pharma for about $3.6 million. Report And Finally... More than 100 researchers teamed up over two years pieced together a genetic blueprint of the bacteria that's found in the human digestive tract. Article After considering all of its options, Pasadena, CA-based AutoImmune has decided to liquidate its assets and to dissolve the company. The developer had been working on products to treat autoimmune and other cell-mediated inflammatory conditions. The company ran into trouble after the Phase III failure of multiple sclerosis drug dirucotide, a treatment it had been developing with BioMS. In October, AutoImmune retained Junewicz & Co. to explore its strategic options. Shuttering its operations proved to be the best course, and the company plans to distribute all available cash to stockholders. "After evaluating the Company's strategic options, the Board of Directors reached the conclusion that it is in the best interest of stockholders to liquidate and dissolve the Company," says CEO Robert Bishop in a statement. "In connection with the Company's plans to liquidate, we have begun the orderly wind down of the Company's operations, including seeking purchasers for the Company's intellectual property and other tangible and intangible assets and providing for the Company's outstanding and potential liabilities." - here's AutoImmune's release Related Article: Germany's Cellzome has inked a second drug discovery pact with GlaxoSmithKline in the field of inflammatory disease. Under the terms of the agreement, Cellzome will receive about $44.79 million in upfront payments. The companies will use Cellzome's Episphere technology to identify small molecule candidates against targets from four different epigenetic classes. After they identify candidates, GSK will take over all preclinical and clinical development, as well as commercialization. If all programs under the alliance are successfully developed and commercialized, additional milestone payments could exceed $645 million, according to GSK. Cellzome and GSK signed their first inflammatory disease collaboration in September 2008. Through this partnership, the companies hope to identify and develop selective kinase inhibitors using Cellzome's Kinobeads technology. Cellzome also has partnered with Ortho-McNeil Pharmaceutical, Bayer HealthCare and Novartis on various projects. - read more in this report Related Article: Publisher's Note: This article was based on an embargoed press release posted on Genetic Engineering News' site, and has since been removed. The embargo will be lifted at 12:01am on Wednesday, March 10. - Arsalan Arif With Astellas Pharma and OSI Pharmaceuticals haggling over price, BNet Pharma wonders which biotechs could be next on the buyout menu. Mega-mergers might have been all the rage in 2009; however, with few targets left, the focus will shift to smaller acquisitions. Big Biotechs Biogen Idec and Gezyme could be on the menu, given Carl Icahn's involvement in the companies. So which smaller developers could be targets? Here's BNet's list:
- read the BNet article for more details The Pulmonary-Allergy Drugs Advisory Committee is meeting today to review InterMune's NDA for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis. As a result, trading of the company's stock has been halted. InterMune release
Just in case anyone might have missed that point, AstraZeneca's Geoff Collett, a business development executive, took a moment during a presentation this morning and highlighted a quote from his boss, David Brennan, that made it crystal clear: "Externalization will be a way of life going forward." Got it? The reason is simple, says Morgan Stanley's Andrew Baum. He tells the Financial Times that partnering on a drug program is less risky than relying on in-house projects and mid-stage programs Big Pharma companies collaborate on are likely to have a rate of return three times higher than the companies can earn on their own. But even as AstraZeneca joins a long list of big companies that are reengineering their whole approach to drug development, Brennan is also cautious about how much can be cut. "You still need to have sufficient in-house staff," he tells the FT, "to scrutinize external projects." These are lean times in the European biotech industry, but it was hard to see that in the packed presentation rooms at Bio-Europe Spring. On Tuesday morning a slate of big and small developers were on hand to provide a snapshot look at their partnering plans, and there was no shortage of would-be collaborators in the audience. In a form of biopharma speed dating, a host of companies including Novartis, AstraZeneca and Merck offered some highlights of their partnering interests. And there's a highly ecumenical approach to deal-making these days. "We're not married to one particular deal structure," says Collett. In this climate, it helps to keep an open mind. - John Carroll twitter | email More from BIO-Europe: London-based Ark Therapeutics' efforts to pioneer a gene-based brain cancer therapy in Europe hit a new hurdle today as European regulators demanded a new trial of Cerepro ahead of any approval. Ark pulled its marketing application, which had been rejected last December, and says it's considering selling the company. An expert advisory panel for the European Medicines Agency decided at the end of last year that Cerepro failed to measure up to its efficacy standards. The therapy is Ark's lead program, and this new setback drove its shares down 15 percent, leaving the developer studying its options. "Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value," the company says in a statement. A number of approaches have been made to the company, it added, but there's no guarantee of an offer. - here's the press release Related Article: South San Francisco-based Exelixis is axing 270 jobs--40 percent of its workforce--as it circles its wagons around its top three cancer programs. Citing SEC documents, the San Francisco Business Times reports that the axe will fall hardest on the company's drug discovery unit. And the developer says that slashing its budget for salaries, lab supplies and clinical trial costs will help the company save $90 million through 2011. The spotlight now will primarily focus on three cancer programs--for XL184, XL147 and XL765--while its preclinical development program has been scaled to produce one new IND per year. Exelixis will continue development of XL888, an orally available small molecule inhibitor of HSP90 currently in Phase I, XL139 and XL413, compounds co-developed with BMS, as well as its preclinical program focused on PI3K delta "Our priority is to see ourselves through to the anticipated filing of our first NDA for XL184 in the second half of 2011," said George A. Scangos, president and CEO of Exelixis. - check out the Exelixis release for more information Related Articles: French drugmakers ExonHit Therapeutics and bioMérieux have decided against pursuing their collaboration in colon cancer after a recent review of data by a scientific committee. Both companies say they will continue to collaborate in the field of prostate cancer. "ExonHit's technology was able to produce a robust and reproducible test however, the final results from the colon cancer program did not reach the level of performance we were aiming to achieve. Therefore, we have decided together with bioMérieux to focus our efforts on the prostate cancer program," Loïc Maurel, president of the management board of ExonHit, says in a statement. In European trading, ExonHit lost 4.9 percent to €3.32 ($4.53), but BioMerieux, which makes tests for HIV and hepatitis, jumped 4.1 percent to €83.61 ($114.15), according to the Financial Times. - check out the press release Related Article: The FDA has approved Cell Therapeutics' facility to manufacture Pixuvri (pixantrone), an experimental cancer drug that is currently under review. The NerPharMa facility, which belongs to Nerviano Medical Sciences, is based in Nerviano, Italy. "FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved," says Craig Philips, president of CTIC. Cell Therapeutics' closely-watched pixantrone is a potential treatment for relapsed/refractory aggressive non-Hodgkin's lymphoma. The FDA's decision will be a make-or-break moment for the struggling developer, with many analysts expecting the FDA to rule against the drug. FDA staffers have raised questions about the treatment, expressing concerns about both the drug's effectiveness, as well as its safety profile. An ODAC meeting is scheduled for March 22, and the FDA is expected to make a final decision on approval of the NDA for pixantrone by April 23. - see CTIC's release Related Articles: The Pulmonary-Allergy Drugs Advisory Committee will meet tomorrow to discuss InterMune's idiopathic pulmonary fibrosis candidate pirfenidone, a product FDA staffers expressed concern about in briefing documents. FDA reviewers said only one of the company's two key trials showed efficacy, and "the clinical significance of the treatment effect size is uncertain." Despite the agency's concerns, investors who were braced for a more negative analysis sent the company's shares soaring Friday. Report In a terse announcement released Friday, Santa Clara, CA-based XenoPort said it's cutting 50 percent of its 219-person staff and refocusing its development efforts on its late-stage product candidates. The decision follows the FDA's February 18 rejection of XenoPort and GlaxoSmithKline's application for Horizant, an experimental restless leg syndrome treatment. The FDA was spooked by animal data in which Horizant caused cancer in rats. And considering RLS isn't a life-threatening condition, the agency was unwilling to approve a drug with that kind of risk. "The unexpected setback in the approval of Horizant has forced us to conduct a thorough review of our operating plans. We have made the difficult decision to restructure the company to prioritize later-stage development activity and eliminate our discovery research efforts," says Ronald Barrett, Ph.D., XenoPort's CEO. The move will save the company about $15.6 million annually. XenoPort says it would continue to pursue approval of Horizant in the U.S. and Japan. It's also working to complete a Phase IIb trial of arbaclofen placarbil in gastroesophageal reflux disease and initiating a Phase II trial of XP21279 for Parkinson's disease. - here's Xenoport's release Related Articles:
Straight in-licensing is out, say the Big Pharma companies. Collaborating with biotech companies in the hope of exchanging cash for an injection of entrepreneurial enthusiasm and innovation--all while managing major internal reorganizations--is in. "We're very comfortable with having a very light touch" managing drugs through proof-of-concept, Shelagh Wilson, GlaxoSmithKline's vice president in charge of its Centre of Excellence for External Drug Discovery (CEEDD), told the gathering crowd in Barcelona this morning. Glaxo "pioneered option-based deals" she adds, and that is increasingly where the biopharma giant is headed. For Isabelle Thizon De Gaulle, Sanofi-Aventis' vice president of R&D scouting and partnering, the reality is that the need to diversify in a time of intense internal restructuring has put a spotlight on external relationships. She focused on Sanofi's decision last October to buy Fovea for €370 million as a way to illustrate the company's intent to diversify into new drug platforms and technology, used its $500 million buyout deal with BiPar to discuss its attempt to vaccinate itself with a dose of entrepreneurial spirit, and reviewed how a recent collaboration with a group of French academic groups is a sign of its interest in staying up with innovation without trying to have it all in-house. Biotech chiefs have heard a lot of this before. But the trend is heating up in Europe, and has some potential surprises for some--on both sides of the Atlantic. Wilson is out in Barcelona to talk deals, and she's offering any developer that teams up with Glaxo access to in-house expertise at cost along with CROs and other preferred providers at the company's negotiated rate. Glaxo, of course, is quite choosy about who it partners with, and has some clear ideas in mind as to what it's looking for. As an example, Wilson cited CEEDD's $680 million deal last fall with Prosensa, a Dutch biotech which had a small portfolio of RNA programs in the pipeline for Duchenne Muscular Dystrophy, or DMD. Glaxo wound up in-licensing the lead program, which was going into late-stage studies, while optioning the rest of the DMD work. Given that Glaxo had recently established a rare-disease unit, the alliance helped illustrate the company's new-found commitment to orphan drugs as well as its reliance on options for earlier-stage therapies. It all sounds great from a biotech perspective, but Ignacio Faus, CEO of Palau Pharma, added a note on the potential pitfalls when he mentioned his own out-licensing experience. Back in 2005, he told the crowd, he licensed an early-stage program to Organon, which later merged with Schering-Plough, which later merged with Merck. His program is still in Phase I. The reality, he says, is that once you license a program to another company, "it's out of your hands." These days, Palau adds, he keeps control of programs through proof-of-concept, and then hands over control. - John Carroll twitter | email AstraZeneca says that its experimental oncology drug Recentin flunked a late-stage, head-to-head showdown with Avastin as a treatment for colon cancer. But the European drug company says that it will wait until it sees late-stage results as a combo therapy with chemo--versus chemotherapy alone--before it makes a final decision on the future of the program. According to researchers, Recentin failed to demonstrate that it wasn't inferior to Avastin in keeping patients alive without disease progression. Now they want to see the data comparing Recentin and chemotherapy against chemo alone before it decides whether it will push ahead with a marketing application. But the program is clearly in deep trouble, given that researchers had to halt a trial two years ago after seeing an elevated risk of side effects compared to lung cancer patients receiving chemo alone. "It is disappointing, but not unexpected given the failure of an earlier trial," wrote Royal Bank of Scotland Group Plc analyst Michael Leacock. "We had in 50 percent success probability and a sales figure of $192 million in 2014, so it's not important in relation to the $28 billion of sales we forecast in 2014." "While we recognized that challenging Avastin would be a high hurdle, it is still disappointing," noted Alan Barge, head of oncology at AstraZeneca. - read the story from Bloomberg Related Articles: In a significant setback, Biogen Idec and Roche have suspended the troubled development program of ocrelizumab for rheumatoid arthritis, and analysts are already questioning if work related to multiple sclerosis may soon follow. The companies made their move after an independent safety board said that the risks outweighed the potential benefit from the experimental therapy, noting that serious and opportunistic infections had afflicted patients taking the therapy, some of whom died. Safety concerns had already forced researchers to halt two clinical trials for rheumatoid arthritis and lupus. "The news wasn't completely unexpected since some trials were on hold before," notes Birgit Kulhoff, an analyst at Rahn & Bodmer. "However, with the obvious fatalities the drug has a high likelihood of not being approvable. I would expect that the MS trials will be stopped as well." "Patient safety is of the utmost importance in all of our drug development programs," says Roche's Chief Medical Officer Hal Barron. Kulhoff had projected blockbuster sales if the drug had gone on to an approval for all three indications. - see the companies' release Related Article: Just 16 months after raising $20 million in its first round of funding, Massachusetts-based Alnara Pharmaceuticals says it's preparing an NDA for its cystic fibrosis treatment. It's a drug that was once held by the now-defunct Altus Pharmaceuticals, which was the victim of the economic crisis that started in 2008. During that time the company went into a free-fall that eventually landed it in Fierce's 2009 Biotech Graveyard. Before its demise, Altus transferred the rights to its CF drug Trizytek (liprotamase) to Cystic Fibrosis Foundation Therapeutics. Alnara Pharmaceuticals president and CEO Alexey Margolin was a veteran of Altus and had worked on the Trizytek program during his time at the company. After leaving Altus, he founded Alnara and bought the exclusive worldwide rights to liprotamase from CFFT. "We never thought we would work on this drug program again, but the CF Foundation felt that our...company was best positioned to move it forward quickly," Alnara CBO and former Altus employee Bob Gallotto tells Mass High Tech. Margolin's company ramped up quickly, hiring 35 laid-off Altus employees who'd worked on the liprotamase program. The drug will be submitted to the FDA shortly, and the company hopes to have an approval in hand in six to 10 months. - read the Mass High Tech article Related Articles: In its first investment community meeting since 2007, Bristol-Myers Squibb yesterday highlighted its pipeline and discussed the company's major priorities over the next several years. "I am fully confident in our ability to deliver on our three major strategic imperatives--driving our performance in the next few years, raising our earnings base in 2013 and sustaining growth in 2014 and beyond," said new CEO Lamberto Andreotti. BMS is bracing for a plunge in profits when Plavix goes off-patent in 2012. BMS also offered analysts an overview of its pipeline portfolio. In a release, the company said it's produced 10 new products in the past seven years and has 60 compounds in development, with seven in full development. Its late-stage drug candidates include ipilimumab (skin cancer); brivanib (liver diseases); XL-184 (cancer); dapagliflozin (diabetes); belatacept (organ transplant); and apixaban (blood thinner). It's also working on additional indications for approved drugs Sprycel, Orencia and Onglyza. The company expects five of its late-stage compunds to be launched by 2012. - here's the BMS release Related Articles: Hutchison China MediTech, or Chi-Med, the pharmaceutical company controlled by Hong Kong billionaire Li Ka-shing, is looking for a partner this year for its experimental treatment for a bowel disorder--and rumor has it that Abbott Laboratories may be in the mix. Chi-Med, is "very aggressively working with everyone in the gastrointestinal space" on a licensing deal, CEO Christian Hogg tells Chicago's Daily Herald. Although Hogg declined to name potential partners, Abbott and Johnson & Johnson are among companies that sell products for ailments of the digestive tract. Neither company would comment on the rumor. A partnership with Chi-Med would offer drugmakers a way to invest further in China, where the government plans to spend $125 billion to start a national health insurance system, according to the Herald. The company, which develops drugs based on traditional Chinese medicine and botanical ingredients, also distributes pharmaceuticals in China and sells consumer-health products. In 2009, HMPL-004 returned encouraging Phase IIb results for ulcerative colitis, according to a March 4 earnings statement. The company is now in a position to out-license HMPL-004 to a global partner for continued Phase III development and commercialization. It also had three novel, small molecule drugs emerge from pre-clinical last year. HMPL-011 is a first-in-class drug for inflammation, that was approved to enter Phase I trials in Australia. HMPL-012 and HMPL-013 are two angiogenesis inhibiting oncology drugs that are currently under IND review by the China State Food and Drug Administration. The cancer treatment market in China is believed likely to become the largest in the world over the next 20 years, according to the company. In addition, Chi-Med plans to spin off its drug-development business within two years. And it's attracting the attention from private equity and strategic investors. A MediPharma spinoff "is something we're deeply in discussions on now. It's more likely to be an IPO. We'd be quite unique in that we'd be the first biotech IPO out of China. I imagine we'd start that process in a year or two," Hogg tells the paper. - read the earnings statement (.pdf) Related Article: InterMune announced today that it will meet with an FDA expert panel next Tuesday to review its NDA for pirfenidone. The drug is a treatment for a rare and chronic lung disease called idiopathic pulmonary fibrosis. Report Apixaban, an oral anticoagulant being developed by Bristol-Myers Squibb and Pfizer, was statistically superior to Sanofi-Aventis' Lovenox (enoxaparin) in reducing the incidence of venous thromboembolism in patients undergoing elective total knee replacement surgery, according to study results published in The Lancet. The ADVANCE-2 study evaluated the efficacy and safety of apixaban compared with subcutaneous Lovenox for reducing the risk of venous thromboembolism in patients undergoing elective total knee replacement surgery. When apixaban was compared with enoxaparin, the primary efficacy endpoint occurred in 15.1 percent of patients in the apixaban group and 24.4 percent of patients in the enoxaparin group, demonstrating a statistically significant relative risk reduction for apixaban of 38 percent. "One of the major concerns for orthopedic surgeons using oral anticoagulants for venous thromboembolism prevention in knee surgery is the significant risk of bleeding," says Michael Rud Lassen, of the Hoersholm Hospital in Copenhagen, Denmark and lead investigator for the study. "We are encouraged by the ADVANCE-2 data, which demonstrated better antithrombotic effect and comparable bleeding rates for apixaban compared with enoxaparin." Apixaban is one of a number of new oral anticoagulants, including Boehringer Ingelheim's Pradaxa and Xarelto from Bayer and Johnson & Johnson, hoping to compete against Lovenox, according to Reuters. - check out the press release Related Articles: Canada's Resverlogix is in mid-stage trials for its experimental drug RVX-208. The company, which has no marketed products, is hoping it can achieve the Holy Grail of heart disease drug development: Finding a product that can raise "good" HDL cholesterol. It's a tree that Pfizer has been barking up for years, but without success. In 2004, the pharma giant spent $1.3 billion purchasing Esperion Therapeutics, and with it the rights to ApoA-1 Milano. The drug, heralded as "Drano for the heart," looked promising. But Pfizer abandoned development after it determined producing the therapy would be too expensive. It eventually sold the ApoA-1 Milano rights to the Medicines Company. And then, of course, was the now-legendary failure of the CETP inhibitor torcetrapib, which was once projected to bring in $13 billion in annual sales. The day after Pfizer announced the late-stage failure of the drug, its stock dropped 11 percent, taking with it $21 billion in market value. The company would go on to cut almost all its early-stage heart disease work--as well as 10,000 jobs. Bloomberg notes that after pouring $2 billion into developing a "good" cholesterol drug, Pfizer is still facing the loss of Lipitor patent protection and doesn't have a new heart drug to take its place. Cleveland Clinic cardiologist Steve Nissen was the lead investigator for both Pfizer drugs, and he's also the lead for RVX-208. He points out that the drug works differently than other drugs by activating a protein that causes the production of HDL. The drug is currently in Phase II testing. Not surprisingly, there's been a lot of interest from Big Pharma; if the drug works, it could be as big as Lipitor. But there are hurdles left yet to overcome. Nissen isn't giving up, though. "Hope springs eternal," he tells Bloomberg. "We need to keep trying to find an HDL-raising strategy that works." - read the Bloomberg article Related Articles: Tolerx will find out later this year whether 10 years of work and $150 million will pay off with a new approach to treating autoimmune diseases. Researchers for the company are following the lives of 240 people with Type 1 diabetes who signed up for their pivotal trial of an experimental drug that is designed to alter the balance of immune system cells. And the Cambridge, MA-based company's CEO, Doug Ringler, tells Xconomy's Luke Timmerman that if they're right, the new drug will significantly reduce patients' dependence on insulin and their exposure to harsh side effects. "This is a new therapeutic paradigm. It represents opportunities and challenges," Ringler says. "This isn't a cure, but the data we have so far suggest it's the closest thing to a cure we have." GlaxoSmithKline will be paying close attention. The pharma company signed on as a collaborator with Tolerx back in 2007, promising to pay up to $760 million for a successful development program. Tolerx was a 2008 Fierce 15 company. - here's the article from Xconomy Related Articles: |
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BARCELONA - On Monday evening I moderated a panel on corporate venture financing at BIO-Europe Spring, joined by Roel Bulthuis, the head of Merck Serono Ventures, Anja (it's pronounced Anya) König, managing director of Novartis Venture Fund, Patrick Krol, a partner with Aescap and Malcolm Weir, the CEO at Heptares. I'd spoken with Weir before about his U.K. biotech company and knew that he and König went back. Novartis is an investor in Heptares, which we featured last year as 
@FierceBiotech: Between 4Q07 and 4Q09, 25 percent of US public biotechs disappeared (half via M&A), says BIO. | Follow