| This week's sponsor is Rules-Based Medicine. |  |
Today's Top Stories
1. Amgen widens cancer reach in $1B-plus Micromet deal
2. Sanofi MS drug shines, biotech strategy advances
3. Merrimack Pharma takes shot at $172.5M IPO with cancer contenders
4. Reports: Scrutiny of European rules to spur trials of pediatric drugs
5. Titan Pharma aims to carry Ph3 success to FDA meeting Also Noted: Novella Clinical
Spotlight On... Timmerman: Biotech success demands guts
Pharmas restock pipelines amid rise in FDA approvals; Watson inks pact to market experimental overactive bladder treatment; and much more... More Fierce Life Sciences News:
1. IBM cloud aids fight against superbugs
2. Novartis' desire for deals to return soon, CEO says
3. SurgiQuest closes $19M round
Today's Top News 1. Amgen widens cancer reach in $1B-plus Micromet deal
Amgen, the world's largest biotech, has firing up another deal to advance its expanded emphasis on cancer drug development. The biotech Micromet says that Amgen has become its latest major partner in the development of specialized antibody drugs that kick the body's immune system into action against tumors. For now, Micromet and Amgen aren't revealing which specific cancer targets are involved in the deal, but Amgen has the option to develop and commercialize Micromet's drugs against up to two solid tumor targets of its choosing. For this, Amgen is paying Micromet $14.1 million upfront. Micromet says that it could earn total potential payments from the two programs with Amgen of $977.1 million, which, when added to the down payment and potential sales royalties, puts this deal into the potential $1 billion-plus strata. For Amgen ($AMGN), the deal appears to be another in a number of calculated steps to build up its pipeline of novel cancer drugs, building on its potential $1 billion buyout of BioVex announced in January. With the Micromet ($MITI) deal, Amgen gets its hands on the developer's so-called BiTE antibodies, which pack a unique punch against cancer because they are designed to recruit the body's own soldier T cells to attack tumor cells. Micromet's technology has already helped the developer grab partnerships with major drug companies such as Bayer, Boehringer Ingelheim and Sanofi, among others. "The BiTE antibody provides an innovative approach to cancer therapy," Roger Perlmutter, head of R&D at Amgen, said. "Amgen is pleased to collaborate with the Micromet scientific team to deploy this technology against targets for the treatment of solid tumors." - here's Micromet's release
- see Reuters' coverage Related Articles:
Micromet drug shows promise against severe blood cancer
Micromet inks $475M antibody deal with Sanofi
Micromet - 2004 Fierce 15 revisited
Amgen bets $1B on BioVex's dual-mechanism cancer therapy Read more about: antibodies, Amgen, Micromet, Biotech deals
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 | An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist - Tuesday, July 26th, 1 pm ET / 10 am PT
Join us as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process.
Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more Register today. |
2. Sanofi MS drug shines, biotech strategy advances
Sanofi is seeing its increased focus on biotech drugs go according to plan, with positive results today from a late-stage trial of a multiple sclerosis treatment, Lemtrada, which the French drugmaker picked up through its $20 billion-plus buyout of biotech powerhouse Genzyme earlier this year. The study was an overall success, according to Sanofi ($SNY). In the Phase III trial comparing Lemtrada (or alemtuzumab) to Merck KGaA's approved MS drug Rebif, patients on Lemtrada showed a 55% reduction in relapse rates over a two-year period, meeting the primary goal of the study. Yet the drug fell short on showing a statistically significant reduction in disability rates compared to Rebif, which was the second primary endpoint of the study. Sanofi, whose Genzyme unit is developing Lemtrada for MS in partnership with Bayer Healthcare, can tout the results from this trial as it sells its non-core Dermik dermatology products business to Canadian drug company Valeant Pharmaceuticals $435 million in cash. The French pharma giant had previously revealed plans to sell off skin care products and ratchet up its focus on developing new treatments like Lemtrada. "Our strategy is based upon our growth platforms and innovation," Sanofi CEO Christopher Viehbacher said in a statement in connection with the Dermik sale. "This divestiture allows us to rationalize our portfolio and improve focus on our core businesses." Lemtrada still faces some tests en route to regulatory approval, for which Sanofi plans to file in the U.S. and European Union in early 2012. The late-stage trial in today's news, Care-MS I, tested the drug in patients with relapsing remitting forms of MS who had received no prior therapy. The company plans to reveal results from a trial dubbed Care-MS II in the fourth quarter of this year that recruited MS patients who had relapsed while on therapy, and success in that trial would help further distinguish Lemtrada as a potent new option for certain patients with the autoimmune disease. "(Lemtrada) is relatively effective but we need to have more details on the side effects, which are key in MS drugs," Jean-Jacques Le Fur, an analyst at Oddo & Cie. in Paris, told Bloomberg this morning. "It's a bit surprising" that the study's second target wasn't reached, he said. - here's Sanofi's release on Lemtrada
- read Bloomberg's report
- see what Reuters reported Related Articles:
Sanofi teams with Rib-X on new crop of antibiotics
Sanofi puts "open innovation" game plan to work on hearing loss Read more about: multiple sclerosis, Genzyme, Merck KgAA, Rebif
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3. Merrimack Pharma takes shot at $172.5M IPO with cancer contenders
Cancer drug developer Merrimack Pharmaceuticals has decided to tread in the cool IPO waters. The Cambridge, MA-based firm said on Friday that it wanted to raise as much as $172.5 million in a public debut, on the strength of its experimental targeted cancer drugs and partnership with French drug giant Sanofi. The company, founded in 1993, says that its strategy is to develop cancer drugs against specific growth drivers of tumors with companion diagnostics. Sanofi shelled out $60 million upfront to Merrimack to co-develop its lead antibody drug, called MM-121, which targets ErbB3 receptors on cells and is believed to play a role in cancer growth in a variety of tumors. Another top contender in the firm's pipeline is MM-398, which is a nano-encapsulated version of an approved chemotherapy drug that is expected to enter Phase III clinical trials for patients with pancreatic cancer by the end of this year. The company wants to trade on the Nasdaq under the ticker "MACK." Like most other IPO candidates in biotech before it, Merrimack is asking investors to make a bet on its future prospects--as the firm has no product revenue sales and loses millions of dollars per year. The biotech had an accumulated deficit of $285.1 million as of March 31, according to an SEC filing. And the firm appears to be years away from having any product revenue. While Merrimack hasn't yet disclosed how much it wants to sell its share for in its proposed IPO, previous biotechs that have completed such offerings like Ironwood and Aveo have had to settle for lower IPO prices than the firms initially sought. Still, Merrimack has some of the makings of a potential public biotech. It's got a high-profile partnership with a Big Pharma in Sanofi, four experimental drugs in clinical trials, and piece of the action in the always-hot field of oncology. The IPO market has been shrill toward biotechs with similar prospects in the past, but we'll see how public investors react to Merrimack's proposal in the months to come. Its backers such as Credit Suisse First Boston, Fidelity Investments, TPG-Axon Partners and others have millions riding on the proposed IPO's success. - here's the company's SEC filing for the IPO
- check out the Wall Street Journal's report
- read Reuters' article Related Articles:
Merrimack ropes back international rights to cancer drug in $220M pact
Sanofi executes a billion-dollar package of deals
Merrimack raises $77M for cancer work Read more about: Biotech IPO, Merrimack Pharmaceuticals
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4. Reports: Scrutiny of European rules to spur trials of pediatric drugs
It's well known that there's been a lack of drug development for the pediatric market. Yet reports in the Financial Times explore whether recent incentives in Europe for developers to address the dearth of pediatric drugs are too sweet. Taking effect in 2007, the European regulations give drug companies additional marketing exclusivity for drugs in return for their investment in developing medicines for children. The regulations have brought both huge jump in the number of applications to develop pediatric drugs and criticisms from those who believe the program could sidetrack developers from investing in important treatments for adults, the Financial Times reports. Pfizer ($PFE), which plans to introduce a chewable form of hit anti-cholesterol drug Lipitor in Europe in November, could reap an additional six months of marketing exclusivity in EU countries in return for developing the pediatric form of the drug. That additional time without competition to low-cost generic versions of the heart pill could be worth about $800 million to Pfizer, according to an FT report. - check out the FT articles on the policy issue and Pfizer's potential coup Related Articles:
Children often an afterthought in drug development
Pediatric program helps spur new drug research
Pfizer bids for $770M Lipitor extension in EU Read more about: Drug Development, Lipitor, Pfizer, pediatric drug development
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5. Titan Pharma aims to carry Ph3 success to FDA meeting
Titan Pharmaceuticals might have some momentum going into its planned talks with U.S. regulators this fall. The South San Francisco-based developer is reporting positive results of a confirmatory Phase III trial of its lead drug for opioid dependence. With opioid addiction raging, Titan's late-stage trial of its treatment Probuphine showed that the drug was superior to a placebo in staving off illicit use of opioids over a 24-week period and it met its goal of showing non-inferiority to the approved treatment Suboxone (which has the generic name buprenorphine). Further data from the trial will be revealed in the coming weeks and at a scientific meeting later this year. For now, Titan can claim a victory for Probuphine, which releases buprenorphine through an implant over the course of 6 months to boost compliance among patients with opioid dependence. The treatment is the most advanced in the small company's pipeline, making its success key to the company's business. "We are highly encouraged by these compelling findings, which confirm the positive results from our previously reported, placebo-controlled study, and believe that Probuphine represents an important medical advance in the effective treatment of patients suffering from opioid addiction," Katherine Beebe, Titan's chief development officer, said. "We look forward to continuing our ongoing dialogue with regulatory authorities to efficiently advance Probuphine toward approval and also to progressing discussions with potential commercialization business partners." - here's Titan's release Related Articles:
Titan takes $5M loan for studies on opioid addiction treatment
Titan execs exit posts in ongoing shakeup Read more about: Phase III, Titan Pharmaceuticals, R&D, opioids
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Also Noted | This week's sponsor is Novella Clinical. |  | Your goal is to give people more opportunities to enjoy life's little moments. We’re proud to be a part of your mission, and promise to give you the individual attention you deserve, with therapeutic and in-country expertise to help reach your goal.
www.novellaclinical.com/bd |
SPOTLIGHT ON... Timmerman: Biotech success demands guts With the odds stacked against them, intrepid biotech entrepreneurs have weathered the risky nature of drug development for decades in hopes of having an unlikely success. In these troubled financial times, however, Xconomy's Luke Timmerman writes today that developers need to keep their nerve to maintain their edge in this difficult industry. Indeed, behind some of the industry's successful drugs are those who wanted to quit on the drugs during development and those who championed further testing of the treatments. Column  @FierceBiotech: Pfizer's potential offload of biz units could aid R&D prospects. Article | Follow @FierceBiotech
> Watson Pharmaceuticals has shelled out an undisclosed sum to sell Antares Pharma's experimental treatment for overactive bladder in the U.S. and Canada. Report > TheStreet's Adam Feuerstein writes about the odds that developer Oncothyreon's ($ONTY) will succeed with its late-stage trial of a cancer immunotherapy Stimuvax in lung cancer patients. Item > Alnylam Pharmacueticals, a developer of gene-silencing drugs calls RNAi therapeutics, has asked regulators for permission to begin a Phase I clinical trial of its drug ALN-PCS for severe hypercholesterolemia. The firm hopes to begin the trial by the end of this year. Release > Acura Pharmaceuticals has appointed Robert B. Jones as its new president and CEO, replacing Andy Reddick, who passed away on April 28. Jones has been in the position on an interim basis since Reddick's death. Story > Biogen Idec ($BIIB) vet Andrew Hirsch has joined Waltham, MA-based biotech startup Avila Therapeutics as the firm's first chief financial officer. Release Pharma News @FiercePharma: Nine of 10 Big Pharmas cut sales reps in 2010. Report | Follow @FiercePharma > Valeant snaps up Sanofi's Dermik for $425M. News > Bayer's Yasmin to face EU generics this year. Story > Pfizer bids for $770M Lipitor extension in EU. Item Biotech IT News > Two computational biology standouts honored. Report > IBM cloud aids fight against superbugs. Story > Health informatics giant Optum changes CEOs. Article > Sequencing giant BGI advances in bioinformatics game. Report > BioTox buys CRO Bio-Quant, eyes software integration. Story > Biomolecular computer shows promise in detecting disease. Article Medical Device News > FDA may change premarket notification requirements for radiology devices. Report > SurgiQuest closes $19M round. Piece > QIAGEN amends offer for Cellestis, provides update on Ipsogen. News > BD gets partial win in patent case. Story > Medtronic advises doctors of pump problem. Article > Medtronic buys two surgical products companies. Report And Finally... The Wall Street Journal reports that, amid a jump in FDA approvals of new drugs this year, pharmas are restocking their pipelines. Article > An Expert Briefing: Biotechnology 101- An Industry Overview for the Non-Scientist Join us Tuesday, July 26th, 1 pm ET / 10 am PT as we define biotechnology and briefly explore the various biotechnology sectors. We will also focus on the healthcare sector and explain how basic science and technology are used during the drug discovery process. Topics include: DNA, Proteins, Recombinant DNA, Small and Large Molecule Drugs, and more. Register Today
| > BioImmersion: Biotech for the Non-Scientist - July 13-15, 2011 - Chicago, IL Three-day class delivering an in-depth understanding of both fundamental and advanced science and technology concepts. Focusing on the healthcare industry, participants learn about biologics- what they are, how they are discovered, how they are developed and how they are used as therapies. Learn More. > Partnerships in Clinical Trials Latin America - Aug 2011 - Sao Paolo, BR The world's leading clinical drug development and outsourcing event returns to Latin America for its 2nd Annual Partnerships in Clinical Trials Latin America meeting- bringing its unique formats, high-level strategic discussions, and unparalleled networking to Sao Paulo, Brazil. Visit www.PCTLA.com. > Rutgers Mini MBA: BioPharma Innovation Program > Skill-building and Summer Fun in Boston! Boston offers exciting summer options for visitors of all ages. You could see a movie in the local park, listen to a concert on City Hall Plaza, or learn to paint on the waterfront. So why not explore Boston in August and build your professional skills at the same time? > Disruptive Innovations in Clinical Trials - September 15-16, 2011 - Philadelphia, PA Led by Pfizer and Novartis, this groundbreaking conference delivers only case studies that demonstrate either a disruptive or an innovative approach to advancing clinical trials. Mobile Clinical Trials, Virtual Trials, Open Source Clinical Development are just a few examples of case studies featured. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > Partnership Opportunities in Drug Delivery - October 5-6, 2011 - Boston, MA Keynoted by Dr Robert Langer of MIT, this is a strategic level event for pharma and biotech BD&L executives to meet a wide range of drug delivery companies with the latest technologies. Fierce readers receive 15% off with code FBEL. Register or learn more: click here > BIO China 2011 - October 12-13 - Shanghai, China Organized by the Biotechnology Industry Organization (BIO) and Shanghai Zhangjiang Hi-Tech Park (Z-Park), BIO China will bring together executives from biotechnology, pharmaceutical companies and investment firms from North America, Europe and Asia to meet and explore business opportunities with China's emerging biotech sector. Registration Now Open.
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| > Regional BD Director We are considering candidates for a Regional Business Development (BD) Director to join our BD team! The ideal candidate should have specific experience calling on and selling into the R&D and clinical development/operations and study start up side of the industry, including but not limited to Phase I-IIIB as well as Phase IV post marketing surveillance, outcomes research and patient registry programs. Learn more. > Need a job? Need to hire? Visit FierceBiotech Jobs | |
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